Irish PharmaChem Yearbook 2019

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Irish PharmaChem Buyers Guide 2019

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CONTENTS 56 Industrial Cleaning

3 Minister’s Foreword

Unrivalled expertise and a determination to innovate define AQS Environmental Solutions’ cleaning and waste management services.

The story of pharmaceutical manufacturing in Ireland is one defined principally by success, writes Heather Humphreys TD, Minister for Business, Enterprise and Innovation.

58 Documentation Solutions

4 Sector Overview

TWi is a leading technical writing and information design service provider, offering high-quality, flexible, and scalable documentation solutions.

As BioPharmaChem Ireland approaches its 25th anniversary, Director Matt Moran assesses the impact the organisation has had on the Irish pharmaceutical and chemical sector and the challenges ahead.

8 Biopharma Ambition 2018 The 2018 BioPharma Ambition Conference identified the opportunities and challenges facing the sector in the long term, writes Nessa Fennelly, BioPharmaChem Ireland.

15 Laboratory Apprenticeships BioPharmaChem Ireland has developed two apprenticeship programmes, which will help to open a vocational route into careers in the pharmaceutical sector in Ireland.

18 Plastics What does the EU circular economy package hold in store for plastics?

22 Brexit and Medicines Supply Philip Hannon, Communications and Public Affairs Manager, Irish Pharmaceutical Healthcare Association, assesses the potential implications of Brexit on medicine supply in Ireland.

59 API and Intermediates

8 BioPharma Ambition 2018 40 Development Consulting & Quality Management PharmaLex started 25 years ago with a vision to be the largest specialised global provider of regulated services, handling all health agency requirements.

42 Precision Manufactured Buildings Portakabin is making an impact on Ireland’s pharmaceutical industry, offering unrivalled quality that’s precisely engineered and built to last.

Killian O’Driscoll, Director of Projects, NIBRT, puts forward the case for the implementation of Industry 4.0 technologies in the Irish biopharma industry.

28 Legislation Dr Majella Cosgrave, Senior Inspector, Health and Safety Authority, examines the impact of REACH and CLP on the Irish biopharma and chemical sector.

32 Serialisation Serialisation brings with it an opportunity to leverage the value of regulatory compliance, writes Maria Svejdar, Head of Marketing and Communications, GS1 Ireland.

35 SSPC SSPC, based at University of Limerick, has proved itself the standard bearer for industrial/academic scientific collaboration worldwide.

38 Product Testing Eurofins BioPharma Product Testing Ireland is expanding its facility and introducing a new training programme to support bioanalytical and molecular cell biology testing.

Brenntag Pharma offers a comprehensive range of products for the formulation of pharmaceuticals and the chemical synthesis of APIs.

44 Packaging 46 Microbiology & Sterility Testing Tramore-based Source BioScience Ireland offer a wide range of microbiology and sterility testing services.

48 Instrument Maintenance and Calibration Endress+Hauser can help clients to reduce costs without increasing risks or losing compliance.

50 Raw Materials Univar’s extensive global network provides pharmaceutical manufacturers with one-stop access to a broad range of excipients, APIs and process ingredients.

52 CHEMICAL DISTRIBUTION David Anchell, Managing Director, Camida, discusses the evolution of his specialist chemical distribution company over its 30 years in business.

54 Chemical Waste Disposal Chemishield is a world first software platform that prevents incompatible mixing of chemical waste during the disposal process.

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Managing Director: Patrick Aylward Editorial and Marketing Director: Kathleen Belton Editor: John Walshe Irish PharmaChem | Industry Buyers Guide 2019

60 Water & Waste Water Treatment

The Chemifloc group of companies specialises in water, waste water treatment and industrial chemicals and laboratory technical services.

62 Logistics

Director of Pharmaceutical + Healthcare for Kuehne + Nagel Ireland, Adam O’Sullivan, on investing in logistics solutions for the pharmaceutical and healthcare industry.

63 Active Pharmaceuticals Expansion at Hovione Ireland.

43 Brenntag

Delivering ‘on time, everytime’ is the secret behind the continued success of Limerick Packaging.

24 Industry 4.0

SK biotek is a CDMO specialising in the manufacture of cGMP API and intermediates via advanced synthesis, continuous processing, controlled substances and high containment for global pharmaceutical companies.

64 Environmental Services Veolia helps Irish pharmaceutical and chemical companies to remain both sustainable and competitive.

66 Waste Management Indaver are helping to use less fossil feedstocks and limiting their environmental impact through safe and sustainable waste management.

68 Biotechnology Introducing MSD Biotech, Dublin

68 Barcoding Holfeld’s Axicon 15000: a fresh approach to barcoding.

70 Data Integrity

Charles River’s QC microbial solutions deliver accurate, relevant and reliable data to fuel confident decisions on product quality and contamination control.

73 Workwear

ScrubEx, the scrubs dispensing machine, can provide up to a 40% reduction in usage of scrub suits or workwear textiles.

74 Material Handling

Henley Forklift Group has been providing nationwide material handling solutions to Irish clients since 1973.

76 Containment Systems

ProSys Containment and Sampling Technology are experts in containment systems, aseptic isolators and sampling equipment for biopharmaceuticals.

LISTINGS SECTION

Chemical Suppliers General Suppliers Company Listings Useful References

79 80 86 96

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Minister’s Foreword

A World-Renowned Home for Global Firms Heather Humphreys TD, Minister for Business, Enterprise and Innovation, underlines the Government’s commitment to growing and developing the pharmaceutical industry in Ireland. As Minister for Business, Enterprise and Innovation, ● More than 28,500 jobs directly employed in the I am honoured to contribute the foreword to the pharmaceutical & biotech FDI sectors in Ireland 2019 Irish PharmaChem Yearbook and Directory. in 2017. The story of pharmaceutical manufacturing In my foreword to last year’s Yearbook, I in Ireland is one defined principally by success. highlighted the work of the National Institute for I am determined to see that story continue and Bioprocessing Research and Training (NIBRT) and I to ensure that our country remains a welcome am very pleased to do so again. That is because we home to the world’s leading pharmaceutical remain immensely proud to have this world-class firms. The reasons companies choose to locate facility in our country. It’s justifiably recognised here are well-known, with our star attraction as a global leader in the provision of cuttingbeing our first-class and highly qualified edge training and is cited, time and again, as a workforce. Ireland has many other advantages, key factor in attracting new biopharmaceutical including our EU membership and pro-business investment to Ireland. The Government continues policy environment, but the history of the to support NIBRT and the work that it does and pharmaceutical industry here is rooted in the we wish the Institute every success as it begins a skills and talent of our people. ground-breaking new collaboration with Jefferson Heather Humphreys TD, Minister for University in Philadelphia. One of the great benefits of that investment, Business, Enterprise and Innovation. of course, has been the growth of the sector right around the country. While Cork has long been recognised as a cluster Facing the Brexit Challenge of global stature, it is particularly encouraging to witness the continuing As we look towards 2019, our focus is on consolidating the country’s development of the industry elsewhere. Regional development is economic strengths and addressing areas where we need to improve. at the very centre of our Government’s economic policy and the Competition for global investment is intense but we are confident that pharmaceutical sector’s growth across the country increasingly we can remain, through hard-work and application, a world-renowned represents a shining example of what we can achieve in that space. home for global firms. We must also address the challenges posed by Brexit, which is why the Government is doing everything it can to Pharma Facts strengthen the resilience of Irish enterprise. My Department, and its agencies, are at the forefront of that national effort to ensure firms here While Ireland is now recognised as a thriving European economy, it was – big or small, overseas or indigenous – are equipped to deal with the not long ago that we were experiencing our own significant economic UK’s withdrawal from the European Union. difficulties. It’s important, as we work to build an ever more robust enterprise ecosystem here, that we do not forget how we overcame the Finally, I want to underline again the Government’s commitment problems of the past, and particularly how crucial exports were to our to further growing and developing the pharmaceutical industry here. recovery. In that context, it would be remiss of me not to pay tribute to We know how important it is to our economy and we look forward to the contribution of the pharmaceutical sector to our economic growth attracting and sustaining further job-rich investment from the sector in recent years. The industry’s statistics, as they say, really do speak for well into the future. I wish the industry, and all its firms and the people themselves: who work for them, continued success in 2019 and beyond. ● 90 manufacturing plants, over 40 of which are FDA approved, operating across the country; Heather Humphreys TD, ● A total amount of over €10 billion investment in biopharma in the Minister for Business, Enterprise and Innovation last decade;

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Sector Overview As BioPharmaChem Ireland approaches its 25th anniversary, Director Matt Moran assesses the impact the organisation has had on the Irish pharmaceutical and chemical sector, and assesses the challenges ahead for the sector here.

Facing the Challenges Ahead As BioPharmaChem Ireland prepares to celebrate its 25th anniversary in 2019 I find myself in reflective mode; reflecting on much achieved since we set up BPCI, originally The Irish Pharmaceutical and Chemical Manufacturers Federation or IPCMF, as it was known as back in those days in the 1990s. The association has more or less tripled in size since then from an association dominated by small molecule drug substance or Active Pharmaceutical Ingredient (API) manufacturing to a diverse organisation comprising five industry platforms: API, Finished Drug Product, Biotech, Chemicals and Contract Manufacturing and Supply. The growth and diversification of BPCI mirrors the growth and diversification of the sector in Ireland. I feel that BPCI has played no small part in driving this process. I reflect on The Technology Foresight Exercise in the mid90s, where BPCI strongly urged Government to prioritise Biotechology for the future: this predates the establishment of Science Foundation Ireland (SFI) and The National Institute for Bioprocessing Research and

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Training (NIBRT). This proved a wise strategy as recent growth in the biotech sector in Ireland has proven, taking up much of the slack generated by a continuing flattening of demand for small molecule production exacerbated by the patent cliff of the early noughties.

No Room for Complacency Ireland remains firmly at the centre of biopharmaceutical and chemical manufacturing and remains one of leading hubs in the globe. However, this is an industry that is changing continually; Ireland remains a small open economy, always susceptible to global uncertainty. We cannot be complacent, nor can we rest on our laurels. We need to keep our relative competitiveness and capacity to keep innovating central to all we do. BPCI has published a series of strategy documents commencing in 2010. As we feel we have reached another inflection point on our development curve, now is an ideal time to prepare and launch our fifth strategy statement. The membership of BPCI are working hard Irish PharmaChem | Industry Buyers Guide 2019


Sector Overview on this at the moment and the report will be launched in 2019. Undoubtedly, investment flows into the sector continue to be strong, with an average of one billion euro per year being invested in capital for the last decade. Notable investments include Bristol Myers Squibb’s new biotech facility in West Dublin, this is flanked by the biotech plants of Alexion and Mallinkrodt. Not a million miles away, Shire’s Biotech facility is well on the way towards completion; MSD have announced that their new oncology drug Keytruda will be manufactured at a brand-new state of the art bio manufacturing plant on the site of their now closed solid oral dose plant in Swords, Co. Dublin. Meanwhile WuXi are set to be the first biopharmaceutical investment by a Chinese company outside mainland China. Each of the investments range from €300m to one billion euro

Some of the major investments that have taken place over the last two years.

Local Success Stories Each of the above investments are being made by leading multinational companies; foreign direct investment has driven the majority of success and growth that the sector has enjoyed since establishing back in the 1960s. It is heartening, therefore, to hear of more success from locally established companies. Chanelle in the west of Ireland has long been one of Ireland’s best known locally grown success stories. Founded and ably led by Michael Burke, they recently announced another major expansion at their Loughrea facility. Irish start-up Eirgen, purchased by Opko, are completing construction of a brand new facility in the South East. Contract development and manufacturing company, APC, continues to go from strength to strength and recently announced the addition of large molecule capability to add to their well-known expertise in continuous small molecule development. Genomics Medicines Ireland have exploded onto the scene, positioned to be a global leader in pharmacogenomics. Start-ups such as Sigmoid, Inflection Biosciences, Opsona, Avectas and Inflazome all show promise.

BPCI has just launched an Apprenticeship Programme aimed at laboratory technicians and analysts, which will allow school leavers to enter the industry directly and to acquire qualifications while working at the same time.

Looking to the Future So what of the future? BPCI sees digitisation of manufacturing as offering enormous opportunities to this sector. BPCI strongly supports the initiative in the Factory 4.0 space being led by NIBRT with the support of The Boston Consulting Group. This initiative will bring together major Biopharma companies and local and international technology companies to develop a test bed in digital technologies as they can be applied in the Biopharmaceutical manufacturing setting. Advanced Therapeutic Medicinal Products or ATMPs such as cellular and gene therapies will present new opportunities to cure a range of diseases in the future. They present a whole new paradigm for the manufacture and supply Irish PharmaChem | Industry Buyers Guide 2019

of medicines. Currently, it is only possible to administer these products in a clinical setting on a one-to-one basis. At some stage, though, it will be necessary to be able to manufacture such products in an industrial setting. This presents significant challenges and it is important that, as a centre for the manufacture of Biopharmaceuticals, Ireland positions itself in this arena. Takeda plan to manufacture gene therapy-based products in this country. Ireland should dedicate efforts to build such capability and Government could invest in this via its Disruptive Technologies Fund. BPCI would recommend this. All this development will place further pressure on the talent pipeline and BPCI

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Sector Overview BioPharmaChem Ireland was instrumental in the growth and development of Ireland’s biotech sector.

continues to prioritise this issue. In the view of BPCI, the only way to address this is though expansion of the overall talent pool and BCPI has been working with Government and with educational institutions to address this.

New Apprenticeship Programme BPCI has just launched an Apprenticeship Programme aimed at laboratory technicians and analysts, which will allow school leavers to enter the industry directly and to acquire qualifications while working at the same time. This vocational route into the sector is traditional in Germany and in Switzerland and potentially gives employment access to a cohort who may not have considered working in the sector before. It also allows companies to employ those who live close to their facilities who may not have pursued a traditional third level qualification. BPCI also sponsor the BioPharmaChem Skillnet, which provides invaluable support in training and development to biopharmachem companies. In conclusion, the sector finds itself in robust health as BPCI enters its 25th year of existence. To quote that often-used phrase, “Much done - more to do”: I and the team and members of BPCI relish meeting the challenges that lie ahead.

Advanced Therapeutic Medicinal Products or ATMPs such as cellular and gene therapies will present new opportunities to cure a range of diseases in the future.

Investment flows into the Irish pharma sector continue to be strong, with an average of one billion euro per year being invested in capital for the last decade.

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Irish PharmaChem | Industry Buyers Guide 2019


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BioPharma Ambition Almost 500 delegates attended the BioPharma Ambition Conference.

BioPharma Conference Addresses the Future Challenges The 2018 BioPharma Ambition Conference assessed the opportunities and challenges facing the sector in the long term, writes Nessa Fennelly, Senior Executive, BioPharmaChem Ireland. 10 8

Irish PharmaChem | Industry Buyers Guide 2019


BioPharma Ambition

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Pictured at BioPharma Ambition 2018 are (l-r): Anton Savage, event MC; David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC; Dr Lorraine Nolan, Chief Executive, Health Products Regulatory Authority; and Matt Moran, Director, BioPharmaChem Ireland. Almost 500 delegates attended the BioPharma Ambition Conference, which took place in Dublin on February 21 and 22, 2018. The event sponsors were PwC and McKesson. Agency partners were Intertrade Ireland and IDA Ireland, whilst pharma patrons included Abbvie, Eli Lilly, Emerson, GE Healthcare, Janssen Sciences Ireland, Mallinckrodt Pharmaceuticals, MSD, Pfizer and Sanofi. Exhibitors at the event included LSC, Pharmalex, Technically Write it and The KeepWell Mark. The 2018 event was the second such event run by The Irish Pharmaceutical Healthcare Association (IPHA), BioPharmaChem Ireland (BPCI) and the National Institute for Bioprocessing Research and Training (NIBRT). The organisations combined represent the research-based and manufacturing side of the biopharmaceutical industry.

needs. As an all-island event, it also highlights important north-south collaboration. The conference provided a perfect platform to showcase Ireland’s booming biopharma industry. Biopharmaceuticals are the largest exporting sector of goods from Ireland, accounting for 55% of all export goods. The sector has invested €10 billion in Ireland over the past decade. Government was represented at BioPharma Ambition by Minister of State for Health, Jim Daly TD, who spoke of Ireland as one of the

leading research, development and innovation locations in the world and acknowledged the importance of the sector in building a “competitive, innovative and resilient Ireland”. He also highlighted the sector’s contribution to the economy in terms of investment, jobs and exports. In a break-out session on tax, Jean Delaney, Pharmaceutical & Life Sciences Leader and Tax Partner, Ireland, PwC, stated, “Ireland has had 60 years of a tax policy that is aimed at giving good return on investment to both

Jean Delaney, Pharmaceutical & Life Sciences Leader and Tax Partner, Ireland, PwC.

A Major International Event BioPharma Ambition is now a major international event for the global biopharmaceutical industry. The sector in Ireland employs over 28,000 people (set to rise to 36,000 by 2020). In 2017, the island of Ireland was the sixth largest medicinal and pharmaceutical manufacturing hub in the world. The inaugural BioPharma Ambition event took place in 2016 and through its success, demonstrated the benefit of bringing together thought leaders and stakeholders across the global biopharma network to discuss innovation and its application to unmet medical Irish PharmaChem | Industry Buyers Guide 2019

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BioPharma Ambition Irish indigenous manufacturers but also to foreign direct investment, and it has worked”. She acknowledged that we are entering a state of flux with Brexit. as well as US tax changes coming down the tracks. She concluded, however, that “as a gateway to the EU with access to over 500m consumers, Ireland remains a very attractive location in which to invest”. Dr Lorraine Nolan, CEO of the HPRA, said that she believed the biopharma industry was well positioned to successfully navigate Brexit. CEO of the IDA, Martin Shanahan, asserted that Brexit provided Ireland with many opportunities.

Collaboration is Key NIBRT and Jefferson University of Philadelphia used the conference as an opportunity to launch their ground-breaking collaboration in setting up the first education and training centre for biologics manufacturing in North America, thereby illustrating the importance of international partnerships. The Cancer Trails Ireland and Northern Ireland Cancer Trials Network cross-border research project was also presented at the conference and demonstrated the potential to transform how research is conducted on the island of Ireland. An additional collaboration presented at the conference was that of Janssen and UCC, while also announced was the forthcoming launch of (bio)pharma Europe, an industry/ academic partnership led out of the University of Limerick, looking at creating a more innovative environment for pharmaceutical manufacturing in Europe. Dr Richard Schilsky, Senior Vice President

Scott Lawson, Director, Pharma & Life Sciences Practice, PwC.

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BioPharma in Ireland. Vital for a healthy economy. The world’s top ten BioPharma companies have operations in Ireland. Ireland has a history of attracting highly successful global companies to its shores. The BioPharma industry is no exception. It’s a vital part of our economy, investing approximately $10 billion in biotech facilities here. Today, BioPharma is our largest exporter of goods and employs 26,000 people in Ireland directly, with over 55% employed outside the Dublin region. IDA Ireland’s ambition is about having ambition for Ireland. As the best in global enterprise make their home here, we can look forward to seeing significant employment and export opportunities grow. Which benefits all of us.

Right place Right time www.idaireland.com

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BioPharma Ambition Minister of State for Health, Jim Daly TD, addresses attendees.

Progress will depend ❝ on collaboration: to go fast, go alone; to go far, go together.

and Chief Medical Officer, ASCO, argued that collaboration is vital to the future development of the international biopharma industry: “Progress will depend on collaboration: to go fast, go alone; to go far, go together.”

Next Gen. Therapeutics The conference looked at what is required for the next generation of therapeutics. The industry is at an inflection point and is increasingly making more targeted drugs for smaller populations; therefore, industry is working ever more closely with researchers and scientists to determine if a drug will succeed or fail. Genetic medicine represents the “third wave” of pharma innovation, we were told at the conference, and will have a transformative impact on patients. Case studies over the

Dominic Carolan, CEO, NIBRT.

two-day conference pointed to the fact that the biopharma sector is at the cutting edge in this regard. Sean Ennis, Chief Scientific Officer, Genomics Medicine Ireland, said, “Ireland is a rich source for genomic research and is the ideal symbiotic environment for developing precision medicine.”

The Onset of Digitalisation The conference addressed the onset of digitalisation and the emergence of disruptive technologies. Scott Lawson, PwC UK Director for Pharma and Life Sciences, advised companies to transform their business models from end to end. To be a success in Industry 4.0, companies will need to embrace and understand new technologies such as AI, data analytics, 3D printing, and continuous manufacturing, to name but a few.

NIBRT’s CEO Dominic Carolan pointed out that “our huge growth in this sector required a bioprocessing skills requirement”. Technical skills remain critical to this sector. In tandem, regulations must be modernised to become more science and risk based. Global regulators need to support novel manufacturing processes. The sector also needs to deal effectively with the level of data it generates. Dr Muhammad Ali, Executive Director, Regional Healthcare Solutions Strategy, MSD International, said, “Data is increasingly fast and furious. I believe that AI can be a gift to modern medicine, transforming the way it is both taught and used.”

Recognising the Challenges Ahead The biopharma sector in Ireland represented export figures of €67 billion in 2017. This demonstrates the strength of the sector. However, we must be cognisant of the need, alongside opportunities, to identify weaknesses and potential threats. The Biopharma Ambition Conference Report in its conclusion stated “Industry 4.0 and the changing global healthcare landscape brings a raft of new challenges for the biopharmaceutical industry; integration of emerging technologies, digitisation, regulatory hurdles, access, pricing and reimbursement, and R&D productivity and costs. What this will mean in the short, medium and long-term for the sector is already the subject of intense discussion, and Biopharma Ambition helped to illustrate how the industry is taking care to diversify and collaborate.” Closing the conference, Matt Moran, Director of BiopharmaChem Ireland, asserted that both innovation and the patient are key: “This meeting helps to represent an end-to-end industry. One that flourishes due to its supply of innovation but one that allows patients to access that innovation.”

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Irish PharmaChem | Industry Buyers Guide 2019


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Laboratory Apprenticeships The first class of Level 6 apprentices began their apprenticeship on October 8, 2018, splitting their week between IT Tallaght and some of the world’s leading pharma companies.

New Laboratory Apprenticeship Programmes Launched Following the 2016 Expert Group on Future Skills Needs Report, which recommended the development of new apprenticeship programmes for the biopharma sector, with the aim of opening a vocational route into careers, BioPharmaChem Ireland, along with an industry led consortium and lead academic provider, Institute of Technology Tallaght, developed two academically accredited apprenticeship programmes in direct response to the report with the aim of meeting sector needs. In June 2018, two new apprenticeship programmes were successfully validated: ● Level 6 Higher Certificate in Science – Laboratory Technician (2-year Apprenticeship); ● Level 7 Ordinary Bachelor of Science Degree – Laboratory Analyst (3-year Apprenticeship). Thanks to strong industry engagement, the first class of Level 6 apprentices began their apprenticeship on October 8, 2018, working three days each week with some of the world’s Irish PharmaChem | Industry Buyers Guide 2019

leading companies operating out of Ireland, including Helsinn Birex Pharmaceuticals, APC, SK biotech, Mylan, Takeda, Alexion, Allergan, Pfizer and Merck, while attending IT Tallaght for the remaining two days of the week. “The laboratory apprenticeships offer candidates the unique opportunity to earn nationally recognised qualifications, while also gaining invaluable hands-on work experience with world leading companies,” explained Orla Reynolds, Laboratory Apprenticeship Manager. “Developed by industry for industry, these laboratory apprenticeships address and tackle industry skills gaps and shortages. Such apprenticeships are an unrivalled opportunity for companies to access a new talent pipeline and drive business growth. “We’re seeing an unprecedented demand for experienced laboratory personnel across not only the biopharma and chemical manufacturing sectors, but also medical devices and diagnostics, food and drink and

BioPharmaChem Ireland have developed two apprenticeship programmes, which will help to open a vocational route into careers in the pharmaceutical sector in Ireland, allowing the apprentices to ‘earn while they learn’.

analytical testing laboratories,” Reynolds continued. “This is a trend that is likely to grow, with 4,000 new jobs to be added in the medtech sector and 8,400 jobs in biopharma by 2020.”

Laboratory Apprenticeships Launched by Minister Richard Bruton The two new apprenticeship schemes were officially launched by Minister for Communications, Climate Action and the Environment, Richard Bruton TD, along with the industry led consortium and lead academic provider, Institute of Technology Tallaght, on Friday, November 2, 2018. Speaking at the launch, the Minister said, “I’m delighted to be here today to launch these two new Laboratory Apprenticeships and I congratulate all involved - the Institute of Technology Tallaght, BioPharmaChem Ireland, the industry consortium, and all employers who are participating. Both apprenticeships

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Laboratory Apprenticeships offer fantastic opportunities for participants in the sector, to ‘earn while they learn’ and receive an excellent education, while also gaining relevant work experience in some of Ireland’s leading companies.” Minister Bruton went on to stress that “This Government has set the ambition to make Ireland’s Education and Training Service the best in Europe within a decade. Growing the number of people choosing apprenticeships and expanding the number of programmes available to them is key to achieving this ambition. We launched a plan in early 2017 to increase registrations to 50,000 by 2020. Today’s launch of the new laboratory apprenticeship directly contributes to the realisation of this ambition.”

Growing Ambition The laboratory apprenticeships are “earn while you learn” higher certificate and degree programmes that combine paid on the job training with academic study, leading to a Level 6 Higher Certificate in Science as a Laboratory Technician and a Level 7 Ordinary Bachelor of Science Degree as a Laboratory Analyst. Both laboratory apprenticeship programmes have been developed to support a learning structure of three days in industry and two days in academia. This structure facilitates the continuous learning and hands-on work experience undertaken by the apprentice who, with the support of leading professionals and regional Institutes of Technology, will learn the behaviours and skills necessary for a successful career in a laboratory environment. Apprenticeship programmes have been

identified as one of the most to invest in upskilling present staff effective ways to meet current and while ensuring a talent pipeline to future skills demands across many back fill roles. sectors. With a predicated 8,400 What’s Next? jobs to be added to the sector by 2020 and a recognised shortage Classes are scheduled for 2019, to be of skilled laboratory personnel, the run out of lead academic provider, laboratory apprenticeships were IT Tallaght, as well as regional developed by industry to tackle Institutes of Technology across these growing demands and Orla Reynolds, Laboratory Ireland. Both programmes are futureproof the industry. Apprenticeship Manager, demand driven and rely on industry The introduction of the national BioPharmaChem Ireland. engagement and commitment to be successful. Level 6 and Level 7 Laboratory Apprenticeship programmes offers industry an excellent For further information and to get opportunity to increase their staff retention involved in this exciting initiative, please and productivity, while driving business contact orla.reynolds@ibec.ie or visit growth: furthermore, companies can continue www.laboratoryapprenticeships.

Steven O Manage

Pictured are (l-r): Andrew Hayes, HR Director, Helsinn Birex Pharmaceuticals and Chair of Laboratory Apprenticeship Consortium; Orla Reynolds, Apprenticeship Manager, BioPharmaChem Ireland; Thomas Stone, President of IT Tallaght; Matt Moran, Director of BioPharmaChem Ireland; Minister for Communications, Climate Action and the Environment, Richard Bruton TD; Martin Wells, Commercial Director, Ibec; and John Behan, Head of Science Department, IT Tallaght.

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Irish PharmaChem | Industry Buyers Guide 2019



Plastics and the Circular Economy

Plastics and the Circular Economy In December 2015, the European Commission launched the Circular Economy Package: Closing the loop - An EU action plan for the Circular Economy (1). The aim of the circular economy package is to move us, as European citizens, from a buy-use-dispose lifestyle to a society where items are designed with easy dismantle after use in mind and therefore the parts can be reused again and again. The value of products, materials and resources will be maintained for as long as possible in the value chain and this will be achieved though changes in product design, consumption and waste management. The EU’s circular economy package contains a suite of tools to help implement the changes required. These include an action plan, the development of strategies for specific issues, the revision of the EU waste directives (2) and the setting of targets up to 2025, 2030 and 2035.

How will it affect Plastics? The circular economy package highlights the plastics sector as a priority area. The sector will face specific challenges in Europe’s transition to a circular economy, because of the specificities of the products or value-chains, the environmental footprint or dependency on material from outside Europe. As part of the circular economy package, the EU has revised the current waste legislation (2008 EU Directive). New waste directives (3) were adopted in July 2018 and set the following targets: ● Re-use/ recycle 65% of municipal waste by 2035; ● Reduce landfill to max. of 10% of municipal waste by 2035; ● Re-use/ recycle 70% of all Packaging waste

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What does the EU circular economy package hold in store for plastics? asks Anne Murphy, Circular Economy Executive, Ibec. by 2030; ● Re-use/ recycle 55% of Plastic Packaging waste by 2030. In addition to the above targets, in January 2018, the European Commission published ‘A European Strategy for Plastics in a Circular Economy’ (4). The Plastics Strategy aims to help all players in the plastic production chain in the transition to ensuring that all plastic packaging is reusable or easily recyclable in a cost-effective manner by 2030. While recognising the contribution of the plastics industry to Europe’s future economic prosperity, the Plastics Strategy seeks to address the inter-related problem areas: ● The plastic sector’s continuing high dependence on virgin fossil feedstock for producing polymers; ● The low rate of reuse and recycling of plastic (compared to other waste streams) due to quality issues; ● New sources of plastic leakage such as microplastics which are unintendedly released into the air, land and waterways; ● Uncertainty over the fate of much waste plastic exported outside of Europe; ● The growing consumption of single-use and short life plastics; ● Unacceptably high volumes of plastic waste that end up littering the environment, particularly in sensitive marine ecosystems.

Plastic Microbeads One of the problem areas identified in the Plastics Strategy is the leakage of microplastics into the air, land and waterways. Microplastics

are tiny fragments of plastic below 5mm in size and originate from a variety of sources, primarily from the disintegration of larger plastics. Plastic microbeads are hard, solid plastic beads that may be used in a variety of products, such as scrubs, shower gels and toothpastes. Plastic microbeads which are intentionally added to products represent a relatively small proportion of all microplastics in the sea. However, since they are relatively easy to prevent, the Plastics Strategy proposes to begin the process to restrict the intentional addition of plastic microbeads to products via REACH. In line with REACH procedures for restricting substances that pose a risk to the environment or health, the European Commission requested ECHA to assess the scientific evidence for taking regulatory action on intentionally-added plastic microbeads to products of any kind. In January 2018, ECHA announced that it would examine the need for an EU-wide restriction on the placing on the market or use of intentionally-added plastic microbeads in products or uses that intentionally release microplastics to the environment. In July 2018, ECHA published a note on substance identification and the potential scope of a restriction on uses of microplastics (5).

What has industry done to date? In October 2015, the cosmetics industry across Europe took the collective responsible decision to remove plastic microbeads from products where they may reach the marine environment. The use of plastic microbeads in products continues to decrease and the industry is on Irish PharmaChem | Industry Buyers Guide 2019

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Irish PharmaChem | Industry Buyers Guide 2019


Plastics and the Circular Economy In May 2018, the European Commission proposed a Directive on the reduction of the impact of single use plastic products on the environment.

track to have voluntarily removed all plastic microbeads from rinse-off cosmetics by 2020. The implementation of the Plastics Strategy will require actions and commitment from all players in the plastic value chain, from plastic producers and designers, through brands and retailers, to recyclers. The Plastics Strategy aims to boost investment in the plastics sector and promote well-regulated markets for secondary raw materials (6). Quality standards and new guidance for sorted plastic waste and recycled plastics will also be developed. In addition to the Plastics Strategy, the European Commission is currently reviewing the relationship between chemicals, products and waste legislation (7). This review is regarded as one of the most important with regards to the success of the Circular Economy package, as the European Commission needs to identify how to increase recycling and reuse of plastics while protecting human health, ensuring product safety, complying with current regulations such as REACH, CLP and RoHS, and ensuring that EU producers are not at a competitive disadvantage. Barriers to increasing recycling rates and reuse of materials have been identified by the European Commission. These issues include the chemical composition of recycled plastics;

lack of information about the possible presence of chemicals of very high concern; incidental contamination during the recycling process; ensuring there is a level playing field between EU-produced and imported articles. Unless they are addressed, these uncertainties could discourage demand for recycled plastics in new products with specific safety requirements and thus create a significant obstacle to achieving higher recycling rates.

Directive on Single Use Plastics In May 2018, as part of the Circular Economy packaging, the European Commission proposed a Directive on the reduction of the impact of certain plastic products on the environment (8). This proposed Directive is commonly known as the Directive on single use plastics. The aim of the proposed Directive is to reduce marine litter. The European Commission has identified the 10 single-use/ short-life plastic products most often found on Europe’s beaches and seas, as well as lost and abandoned fishing gear. The items identified in the proposed Directive will be subject to a variety of measures, varying from labelling to extended producer responsibility schemes to market ban.

The Circular Economy Production From waste to resources

Waste management

Consumption

The aim of the circular economy package is to

The aim of the circular economy package is to move us, as European citizens, from a move us, as European citizens, from a buy-usebuy-use-dispose lifestyle to a society where items are designed with easy dismantle dispose to aparts society areagain. after use in lifestyle mind and the can bewhere reused items again and

designed with easy dismantle after use in mind and therefore the parts can be reused again and again.

Irish PharmaChem | Industry Buyers Guide 2019

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Plastics and the Circular Economy The root causes of litter are poor waste management practices and infrastructure, littering by citizens and lack of public awareness.

Items identified as being one of the top 10 single-use/ short-life plastic products most often found on Europe’s beaches and seas include cotton buds, wet wipes and feminine hygiene products such as sanitary towels, tampons and tampon applicators. The Directive proposes the following: ● Market ban on cotton buds with plastic sticks except those intended for medical use; ● Awareness raising and labelling information on sanitary towels, tampons and wet wipes to prevent littering and incorrect waste disposal options; ● Establishment of an extended producer responsibility scheme for wet wipes. The proposed Directive calls for producers of items that are subject to an extended producer responsibility scheme, such as wet wipes, to cover the costs of collection, transport and treatment of waste, as well as the cost of awareness raising and clean-up of litter costs. The root causes of litter are poor waste management practices and infrastructure, littering by citizens and lack of public awareness. Litter clean-up and prevention cannot be the sole responsibility of producers, as producers do not have the levers to solve the litter problem alone. Citizens have a behavioural role as well. In addition to producers, other involved stakeholders,

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including private or public waste operators and local authorities, need to take action to improve waste management systems and infrastructure, including sewage systems, to carry out educational programmes such as Think before you Flush (9) and to enforce antilittering laws and EU wastewater legislation.

What Can Your Business Do? Examine your supply chain. Communicate, engage and work with stakeholders all along your supply chain, including sub tiers of your supply chain. Explain your long-term vision and how you plan to become a more sustainable business with your supply chain partners. You have the power to educate and influence others to become more sustainable businesses also. Responsible use of packaging. Optimise your use of plastic in your primary, secondary and tertiary packaging. If considering alternatives to plastic, beware of knee-jerk plastic phase-out as this could result in unintended consequences. A full life cycle analysis of proposed alternatives needs to be undertaken that includes the environmental and social impacts to ensure that the overall result is a net environmental improvement. If you need any more information please contact Anne Murphy, Circular Economy Executive, Ibec. Email: anne.murphy@ibec.ie. Tel: (01) 6051693.

References 1. ht t ps ://eur-lex.europa .eu/resource. html?uri=cellar:8a8ef5e8-99a0-11e5-b3b701aa75ed71a1.0012.02/DOC_1&format=PDF 2. The plastic packaging waste recycling target under the 2008 Directive on waste (2008/98/EC) is 22.5%, that is exclusively material that is recycled back into plastics. Ireland’s current recycling rate is 34% (2015 data) which is a 6% drop in plastic packaging waste recycling from the 2013 published data (40%) due to contamination. 3. https://www.consilium.europa.eu/en/ press/press-releases/2018/05/22/wastemanagement-and-recycling-council-adoptsnew-rules/ 4. ht t ps ://eur-lex.europa .eu/resource. html?uri=cellar:2df5d1d2-fac7-11e7-b8f501aa75ed71a1.0001.02/DOC_1&format=PDF 5. h t t p s : / / e c h a . e u r o p a . e u / documents/10162/13641/note_on_ substance_identification_potential_ scope_en.pdf/6f26697e-70b5-9ebe-6b592e11085de791 6. http://ec.europa.eu/environment/greengrowth/raw-materials/index_en.htm 7. h t t p s : / / e u r - l e x . e u r o p a . eu/legal-content/EN/TXT/ PDF/?uri=CELEX:52018DC0032&from=EN 8. http://europa.eu/rapid/press-release_IP18-3927_en.htm 9. http://thinkbeforeyouflush.org/

Irish PharmaChem | Industry Buyers Guide 2019


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Brexit and Medicines Supply

The Brexit Conundrum Any commentary on the impact of Brexit is subject to a constantly shifting narrative. No one can predict with any certainty what the final outcome can be. But what is beyond doubt is the scale of the preparations Ireland’s pharmaceutical industry are undertaking to minimise any potential disruption to the continued supply of medicines to patients in Ireland. These preparations, which have primarily involved ensuring regulatory and supply chain readiness and compliance, have been under way for some time ahead of a final determination of how the UK leaves the European Union, with or without a deal. When the UK leaves, be it in the context of a hard or soft Brexit, Ireland will be uniquely exposed. So much of what we export and import either goes to the UK or flows through it. With the UK set to become a ‘third country’, complications in the flow of goods are bound to emerge. Medicines would appear to be particularly vulnerable, as up to 70% of our supply comes through the UK. This is why the industry is preparing assiduously to ensure continuity in the supply of medicines. The pharmaceutical industry has a major stake in the lives, livelihoods and lifestyles of people across the country. The medicines we make, jobs we provide and standards of living

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Philip Hannon, Communications and Public Affairs Manager, Irish Pharmaceutical Healthcare Association, assesses the potential implications of Brexit on medicine supply in Ireland. we enhance help improve Ireland’s society and economy. Our industry, just like many others, wants to help ensure that, after Brexit, Ireland functions as normal, with any risks to the supply of medicines mitigated by proper planning.

The Regulatory Challenge The industry has been working in the background with relevant public health stakeholders on appropriate Brexit preparedness. The main challenge for the industry is a regulatory one, rather than a trade one. Companies have been contingencyplanning for well over a year, with the main consideration around supply chains. Companies have been examining how supply chains might be reorganised when the UK is treated as a non-EU country. The ideal outcome for us would be a UK that stays handin-hand with the EU on medicines regulation. In the IPHA’s case, we have engaged with key State authorities - the HSE, HPRA, the Revenue Commissioners (in respect of Customs) and the Department of Health - on

planning for the management of medicines availability. Our shared goal is continuity of medicines supply for patients in Ireland, whatever the final Brexit outcome. Preparedness is critical. Every month, 45m patient packs of medicine are supplied from the UK to the EU27, and 37m patient packs are supplied from the EU27 to the UK. That’s one billion medicines packs per year. It’s one measure of the importance of medicines for human health, facilitated by regulatory alignment and free trade. Whatever the outcome of the final Brexit, it is critical that Irish patients, as well as patients across Europe, can continue to access their medicines without disruption. Preparing for Brexit has not been without challenges. It has been time-consuming, costly and complex for our industry. But our overriding priority has been to ensure continuity in the supply of innovative medicines to Irish patients. Our stock levels reflect that commitment. Our aim is that patients should not feel the need to worry about medicines shortages. Irish PharmaChem | Industry Buyers Guide 2019


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Industry 4.0

The Case for Biopharma 4.0 Killian O’Driscoll, Director of Projects, NIBRT, puts forward the case for the implementation of Industry 4.0 technologies in the Irish biopharma industry.

“The biggest innovations of the 21st century will be at the intersection of biology and technology. A new era is beginning”: these are the words of legendary Apple founder Steve Jobs. As biopharma manufacturing becomes increasingly globalised, increasingly complex and more highly regulated, the sector must become more effective and cost efficient at manufacturing its products. In other industries, the deployment of Industry 4.0 technologies has driven huge benefits to manufacturing , including the aerospace and defence, automotive, and food and beverage sectors. For example: ● BMW has created “connected factories”, with sensor-fitted equipment providing real-time data and identification of potential errors before they occur, as well as opportunities for process optimisation; ● Boeing has achieved a 40% improvement in first-time quality of parts and systems by using a digital twin asset development model; ● Unilever has increased OEE by 4% through the introduction of Internet-of-Things in their manufacturing plants.

However,

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biopharma

manufacturing

is

currently significantly behind other advanced manufacturing sectors in its adoption of disruptive Industry 4.0 technologies. There are several reasons for the slow adoption of 4.0 technologies, with some of the most common problem statements from biopharma enterprises including: ● How do we implement 4.0 in a highly regulated, GMP environment? ● Where do we start, and how do we prioritise given the number of technologies and vendors? ● How do we implement disruptive technologies in a way that is truly scalable? ● How to we integrate these technologies with our existing systems? ● Is there clear value and payback for our operations? ● What will a facility look like in 2025? What does best in class adoption look like? Furthermore, studies from the World Economic Forum indicate that 70% of businesses investing in technologies such as big data analytics, artificial intelligence or 3D printing are not able to take the projects beyond pilot phase. Historically, innovation within the biopharma Irish PharmaChem | Industry Buyers Guide 2019


Industry 4.0 manufacturing has been constrained by the highly regulated nature of the biopharma manufacturing environment. However, the FDA is now taking proactive steps to facilitate the implementation of emerging manufacturing technologies: “We’re also committed to fostering more advanced manufacturing technologies, implemented in a way that leads to more innovative, consistent and dependable manufacturing of drug and biological products,” noted FDA Commissioner Scott Gottlieb .

Biopharma 4.0 Alliance NIBRT, in partnership with the Boston Consulting Group (BCG), have established the Biopharma 4.0 Alliance, which provides the platform, capabilities and expertise needed to deliver step-change in performance through smarter adoption of disruptive Industry 4.0 technologies. These digital technologies, many developed by Irish SMEs and RPOs, can transform the entire biopharma value chain, increasing flexibility, quality and speed. The aim for the Biopharma 4.0 Alliance includes establishing NIBRT as a Digital Demonstrator to: ● Enable small & medium sized enterprises (SMEs) and research performing organisations (RPOs) to develop and deploy their Industry 4.0 technologies in NIBRT’s advanced biopharma manufacturing environment. ● Establish proof-of-concept of the transformation these disruptive technologies can deliver for biopharma and related advanced manufacturing enterprises. ● Deploy and commercialise the technologies in multi-national biopharma enterprises to deliver transformative benefits to their global operations.

Components of the Biopharma 4.0 Alliance. integrated, world-class facility which will take new technologies from their inception to deployment in some of the largest global biopharmacos, whilst driving cutting-edge research, fostering collaboration within the business and embedding deep expertise, both within the Alliance participants and in those visitors to the NIBRT Digital Demonstrator.

The Value of the Digital Demonstrator By way of a specific example of the value of the

costly and very risky, which is why they are not widely taking place today, especially in regulated environments. The output of Biopharma 4.0 Alliance would include an integrated augmented reality interface to a state-of-the-art, working biological plant, and which is deployed in NIBRT’s award-winning pilot plant. Having an integrated solution at the ready, and having it proven out in the pilot plant would accelerate the adoption of this key technology beyond the point which is currently organically

Deployment of Industry 4.0 technologies in an advanced biopharma fill-finish facility.

Digital Demonstrator Biopharma 4.0 will be realised through a solution consisting of three key components. Between them, these components will transform the deployment of Industry 4.0 technologies in Irish biopharma and beyond:

1. B4 Alliance Community: Coordinated by NIBRT and BCG, this invested group of global biopharma companies will drive thought leadership in the sphere of Industry 4.0 through an annual roundtable, supplemented by ongoing trainings and webinars, fostering collaboration and knowledge-sharing 2. Innovation Incubator: Dedicated space in NIBRT in which members of the Alliance will carry out cutting-edge industrial research, and in which biopharma companies can carry out one-off evaluation of use cases with Irish SMEs and other partners 3. Digital Showcase: An immersive training experience, supplementing NIBRT’s existing GMP-like training facilities, which will allow participants from across the biopharma industry and beyond to experience new technologies first hand. The Biopharma 4.0 Alliance will provide a truly Irish PharmaChem | Industry Buyers Guide 2019

Digital Demonstrator, the use of augmented reality as an interface to production processes (e.g. work instructions) and equipment (e.g. as ‘virtual’ HMIs) has been well established, as the potential returns on investment are huge, with significant benefits to companies’ bottom line (e.g. Boeing proved that aircraft wing assembly was 30% faster, and with 94% less error) . However, the obstacles which many companies face in progressing beyond very simple pilots are that there are no standard reference deployments of successful integrations, no roadmaps for manufacturers to follow, and that there are no integrated solutions available. These factors make any potential deployment of this technology

possible, proving a huge benefit to Irish based biopharma manufacturers and their employees. A representation of how Biopharma 4.0 technologies may be deployed in advanced manufacturing facilities is shown above.

Key Impacts The key impacts for biopharma manufacturing include: ● Risk mitigation: de-risking of implementing disruptive 4.0 technologies in a highly regulated manufacturing environment; ● Quality: improved product quality and assurance through big data and smart analytics; meeting and going beyond increased

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Industry 4.0 regulatory scrutiny in areas such as process robustness and data integrity; ● Flexibility: increased manufacturing flexibility through better visibility of live end-to-end supply chain status, as well as through automation executing production for a large number of more complex products; ● Productivity: increased productivity through a higher level of automation and controls on human intervention that reduces production time, enables better asset utilisation and inventory management, amongst others; ● Speed:

increased speed of scale-up and speed to market through data driven programme management; ● Training

& collaboration: increased collaboration in the production network through consistent data availability; ● Environment

protection: better environment protection through optimised use of resources; ● Innovative

capability: increased innovative capability through new technological possibilities in manufacturing and to win future corporate investment and high value job creation.

International Competition Ireland has had notable success in attracting foreign direct investment (FDI) of biopharma manufacturing facilities. However, it is a highly competitive international process and competing jurisdictions are also seeing significant investment with a particular focus on “facilities of the future” underpinned by industry 4.0 technologies. For example: ● In 2018, Amgen will start commercial operations at its “facility of the future” in Singapore. This facility was built in half the time, at a quarter of the capital costs and has a third of the operating expense. It has a strong focus on disposable technologies, modular lay-out and real-time monitoring and the site is capable of reducing the cost per gram of protein by as much as 60% from a conventional facility . ● In October 2018, Samsung Biologics opened its third facility in South Korea to give a total of 360,000 litres of biologics manufacturing capacity, making it thelargest Contract Development and Manufacturing Organisation (CDMO) in the world. Remarkably, Samsung Biologics was only founded in 2011, but by leveraging expertise from its electronics manufacturing division has reduced construction costs and timelines by 50% . A notable achievement in the Irish context is the recognition from the World Economic Forum for Johnson & Johnson DePuy Synthes, Cork, for their “process driven digital twin” – whereby the factory has used Internet of Things technology to create digital representations of physical assets, leading to advanced machine insights, resulting in lower operating costs and a reduction in machine downtime . If Ireland is to remain competitive as a location for FDI and to develop innovative SME technology, then it must have the capability

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Representatives from NIBRT, Pfizer, GE and the Medicine Maker discuss impact of 4.0 on biopharma. to support such “facilities of the future” and to outpace competing jurisdictions, such as: ● In March 2017, the US Department of Commerce launched National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) a US$70m investment over five years to accelerate innovation in biopharmaceutical manufacturing, support the development of standards to enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading workforce to support an industry sector that is supplying medicines for patients around the globe. ● In October 2018, the Pharma Innovation Programme Singapore (€22m) was signed with A*STAR, MSD, Pfizer, GSK, National University of Singapore, Nanyang Technology University and the Singapore Institute of Technology, with a focus on increasing productivity and operational efficiency through technology and data analytics. ● In order to prepare for the next generation of new therapies (such as cell and gene therapies), countries such as UK and Sweden have made significant investments in digital manufacturing technologies which will underpin personalised/ precision manufacturing, with a particular focus on assisting SMEs to commercialise their products.

Conclusion In January 2018, the World Economic Forum in a survey of 1,400 C Level Executives concluded the “Fourth Industrial Revolution will change the world – but only 14% of execs are ready for it”. The Biopharma 4.0 Alliance aims to ensure that the Irish biopharma industry is well positioned to lead the 4.0 revolution and continue our success in biopharma manufacturing.

References: Steve Jobs: The Exclusive Biography by Walter Isaacson https://www.bcg.com/en-gb/publications/2017/lean-meets-industry-4.0.aspx http://aviationweek.com/connected-aerospace/industry-40-s-impactaviation-design-and-mro https://www.automotiveworld.com/articles/industry-4-0-digital-transformation-automotive-industry/ https://www.foodengineeringmag.com/articles/97490-industry-40simpact-on-the-food-and-beverage-industry https://www.bmwgroup.com/en/innovation/innovation%20-%20 company/industrie-4-0.html https://www.aviationtoday.com/2018/09/14/boeing-ceo-talks-digital-twin-era-aviation/ https://www.parsable.com/press-releases/unilever-implements-parsables-industry-4-0-connected-worker-platform-to-drive-plant-productivity http://www.biopharminternational.com/industry-40-biopharmaceutical-manufacturing-0 https://www.fda.gov/Drugs/NewsEvents/ucm557448.htm https://www.weforum.org/press/2018/09/europe-asia-lead-the-wayto-the-factories-of-the-future/ https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm619435.htm T. Richardson et al. Fusing self-reported and sensor data from mixed-reality training. In Proceedings of the Interservice/Industry Training, Simulation, and Education Conference, I/ITSEC ’14 (Orlando, FL, 1-4 Dec), p1–12. 2014 https://www.biopharma-reporter.com/Article/2017/05/23/Amgen-beyond-Singapore-Bioprocess-intensification-and-integration https://www.biopharma-reporter.com/Article/2018/10/12/SamsungBioLogics-opens-third-plant-contemplates-a-fourth-in-Korea https://www.weforum.org/press/2018/09/europe-asia-lead-the-wayto-the-factories-of-the-future/ https://niimbl.force.com/s/ https://www.businesstimes.com.sg/government-economy/pharma-manufacturing-in-singapore-gets-s34m-boost https://ct.catapult.org.uk/ https://www.gelifesciences.com/en/us/solutions/bioprocessing/ services/testa-innovation-center https://www.weforum.org/agenda/2018/01/87-of-ceos-say-thefourth-industrial-revolution-will-improve-equality-but-are-theyready-for-it/

Irish PharmaChem | Industry Buyers Guide 2019


Does your company have a supply chain back up plan? With so much uncertainty around Brexit and the threat of potential trade barriers, it can be challenging when it comes to evaluating the potential impacts to supply chains. From our perspective here at NCC, we believe it is essential that organisations assume a worst case scenario, in others words a no deal Brexit. In that event, does your company have a back up plan for materials currently sourced from or transited through the UK?

The effects of disruption to the supply chain It may appear to be advantageous to purchase from UK manufacturers due to the drop in the value of Sterling, however this will be quickly eroded by tariffs in the event of a hard Brexit. Additionally current contracts may need to be revisited or renegotiated. We recommend that organisations conduct a supply chain audit to ensure that there is a fall back position for all materials, the risk of not doing so could otherwise be very costly.

Require assistance? If your company requires assistance in relation to Brexit then NCC can help. Our in-house experts work directly with our customers to create a customised strategy that seeks to find the most reliable, competitive and efficient solutions. With a dedicated Logistics and Compliance Team, we have the experience and the expertise when it comes to sourcing and regulatory challenges including REACH. For further information on how NCC can assist your company contact Christy Smith 01 613 1406 or email CSmith@ncc.ie NCC.IE


Legislation

REACH and CLP: The Story So Far Dr Majella Cosgrave, Senior Inspector, Health and Safety Authority, assesses the impact of REACH and CLP on the Irish biopharma and chemical sector, and the likely impact of Brexit on the regulatory environment.

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For all companies in the Irish biopharma and chemical sector, sound chemical management is essential to ensure both humans and the environment are safe from harm. There is a large amount of legislation relating to chemicals, such as the Chemicals Agents Regulations and COMAH, that companies must ensure compliance with. In addition to such regulations, for the Irish biopharma and chemical sector, the ones with the greatest impact are probably the REACH Regulation, along with the Classification, Labelling and Packaging Regulation (CLP). REACH has been in force for over 10 years now. The last registration deadline passed this

year and the European Commission’s second REACH review was published earlier in the year. It is, therefore, a good time to take a look at how REACH is working and what are the key issues and developments it has brought.

Second REACH Review The European Commission’s second REACH review was published in March 2018. It concluded that the Regulation is effective, but there is room for improvement. Many benefits are listed in the review, including improved risk management. It is recognised that we are now better able to address the risks posed by chemicals to human health and the

Irish PharmaChem | Industry Buyers Guide 2019


Legislation

environment, with there being a fundamental link between the information gathering done by companies and the ability of authorities to take risk management measures based on this information. Industry now also has a much better knowledge about the safe use of their substances and this increased knowledge also brings benefits to workers, the environment and consumers. The review also showed many challenges and areas for improvement, including compliance with registration obligations, keeping registrations updated, improving the evaluation processes, in addition to the area of dealing with substances in articles. One core issue that emerged is authorisation, which appears to be not yet working ideally. The review showed that the authorisation process should be more efficient and predictable for industry.

Registration A key task for companies since REACH entered into force has been registration, with this being a requirement for all substances manufactured in the EU, or imported into the EU, at greater than one tonne per annum. No registration effectively means no market access for that substance, so it is vital that companies ensure that their substances are registered. Registration has been on a phased basis, with there being three deadlines, in 2010, 2013 and 2018. As all deadlines have now passed, all substances (unless exempt) on the market at greater than one tonne per annum should be registered. Following the last deadline in May 2018, over 13,000 European companies have submitted information to ECHA in nearly 90,000 registrations. The largest share came from Germany (25%), UK (14%) and France (10%), with Ireland having the 8th highest number of registrations at 3,746. As a result of registration, we now know more about the chemicals used in Europe than ever before and most of the information is accessible through the European Chemicals Agency’s (ECHA) website. ECHA, the EU Member States and the European Commission will use this increased knowledge to take action where necessary, for example, by restricting or authorising certain uses of chemicals. While companies may now have their registrations in place, they are reminded that Irish PharmaChem | Industry Buyers Guide 2019

registration is not just a one-time exercise and a company’s legal obligations do not end after they receive their registration number. Up-to-date information is needed to ensure that chemicals are being used safely and companies must ensure that they update their registrations whenever new information becomes available.

Authorisation Authorisation continues to have a significant impact within the biopharma and chemicals sector. Under authorisation, any substance that is identified as a substance of very high concern (SVHC) and included on the authorisation list (Annex XIV) needs an authorisation to be in place for its continued use beyond a certain date. For the sector here in Ireland, there are a number of substances that are known to be critical within the industry, such as Triton X, which are included on the authorisation list and a number of Irish companies have applied for, and been granted, authorisations for different substances.

Keep Up to Date To ensure they are aware of potential changes as regards their substances, companies are advised to monitor both the Public Activities Coordination Tool (PACT) and the Registry of Intentions (RoI) on ECHA’s website, in addition to the public consultations on proposals to identify substances as SVHCs and on proposals to add substances to Annex XIV. The PACT lists the substances for which a risk management option analysis (RMOA) or an informal hazard assessment for PBT/ vPvB (persistent, bioaccumulative and toxic/ very persistent and very bioaccumulative) properties or endocrine disruptor properties is either under development or has been completed. The RoI indicates the substances for which a harmonised classification and labelling (CLH), substance of very high concern (SVHC) or restriction dossier is planned to be submitted to ECHA.

Brexit and REACH On March 29, 2017, the United Kingdom submitted its intention to withdraw from the European Union. This means that, unless a ratified withdrawal agreement establishes another date, from 30 March 2019, the

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Legislation

effect as of the date of the UK withdrawal. This means that the Irish company will need to rely on a supplier with a valid authorisation from amongst the EU-27/EEA. If this is not possible, and the Irish company wishes to continue using the substance after the date of the UK withdrawal, then they will need to apply for an authorisation themselves.

United Kingdom will become a ‘third country’. Although we do not yet know the eventual outcomes of the Brexit negotiations, potentially significant implications for Irish companies are anticipated due to our shared market with the UK and, therefore, Irish companies are now encouraged to consider the potential impact of Brexit on their business. Regarding REACH, the UK’s withdrawal from the EU will have implications for Irish companies who source their chemicals from UK suppliers. At present, such companies are downstream users and as such have no registration obligations. However, after the UK withdraws from the EU, any substances imported into Ireland from the UK will be deemed as being imported from outside the EU. Thus, any Irish company who continues to source their substances from a UK supplier after Brexit will lose their downstream status and will have a role as an EU importer and thus will have registration obligations. Any Irish company finding themselves in such a situation should speak to their UK supplier and determine their plans postwithdrawal - will they appoint an Only Representative in one of the EU-27 Member States (if they are a manufacturer) for example? Alternatively, if the Irish company wishes to avoid future registration obligations, they should now consider sourcing those chemicals from another supplier based in one of the EU27/EEA countries. Additionally, Irish registrants who are in a joint submission for which a UK based company is the lead registrant and owner of data for which the Irish company has obtained a letter of access, allowing them to refer to the data, need to be aware that the UK company’s registration will be non-existent following the UK withdrawal. Finally, regarding registration post-Brexit, if an Irish company is considered as a downstream user under REACH due to the appointment by their non-EU supplier of an Only Representative (OR), and that OR is based in the UK, then the Irish company needs to be aware that once the UK leaves the EU, the UK based company can no longer act as OR. Brexit will also impact authorisations under REACH. If an Irish company relies on a REACH authorisation granted to a UK supplier, then they should be aware that their use will no longer be covered after the UK leaves the EU. REACH authorisations will lose their legal

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CLP

Dr. Majella Cosgrave, Senior Inspector, Health and Safety Authority

The CLP Regulation was introduced in 2008 to address concerns relating to how chemical hazards were being communicated differently around the globe. It outlines criteria for determining the physical, health and environmental hazards of chemical substances and mixtures, along with rules for labelling and packaging. It includes a requirement to notify hazardous substances to a classification and labelling inventory at ECHA, along with a system for harmonising the classification of certain substances of high concern. More recently, CLP incorporated a new annex (annex VIII), the aim of which is to harmonise the information provided by companies to poison centres to enable then to formulate an emergency health response. This new annex requires companies to include a unique formula identifier (UFI) on the label of products. There is a transitional period for companies to comply with these new requirements, beginning from 2020. CLP has been adapted to technical progress 14 times over the past decade and this will continue on an on-going basis. The two main drivers for change are amendments to the GHS every biennium, along with the addition of, or amendments to, substances that are subject to harmonised classification. The Biopharma and chemical sector is encouraged to check chemical inventories and ensure that the classification and labelling information on file is up-to-date. This is critical to ensuring safe use, given that the CLP hazard label is one of the key tools used when undertaking a risk assessment.

Help is at hand Companies in need of assistance, or with questions on any aspects of REACH or CLP, are reminded to contact the Chemicals Helpdesk at the HSA, by emailing chemicals@hsa.ie or by calling 1890 289 389. Irish PharmaChem | Industry Buyers Guide 2019


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Serialisation

The Serialisation Opportunity

Serialisation brings with it an opportunity to leverage the value of regulatory compliance, writes Maria Svejdar, Head of Marketing and Communications, GS1 Ireland. The requirements for the serialised identification of pharmaceutical and other healthcare products increases globally year on year, in an effort to help industry and all stakeholders to secure the supply chain. Counterfeit medicines present a serious risk to public health. Counterfeits are often ineffective, delivering no medical benefit to patients, and at worst, can actively harm patients. While complex and resource intensive to implement, the introduction of new processes and systems to meet regulatory requirements offers business benefits in terms of supply chain efficiency, product visibility, as well as deeper system integration and data insights. But an organisation’s ability to draw out that value depends on a number of factors, including inhouse skills and training, human and financial resources, and a commitment to move from siloed data to integrated platforms with the adoption of global data standards. In a survey last year, conducted jointly by GS1 Ireland and serialisation experts ESP, it was found that 56% of respondents did not have a company-wide education programme relating to serialisation. Training and information sharing processes are one of the critical success factors of any serialisation programme to not only meet the immediate regulatory requirements but are vital to unlock those follow-on business benefits. Serialisation readiness creates the need for dynamic, cross-functional teams to include the diverse requirements and inputs from all affected departments; from IT and packaging

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Any organisation from across the pharmaceutical supply chain that needs further support regarding training, systems integration or the implementation of data standards, particularly in regard to the electronic sharing of data with the regulatory authorities, is welcome to contact GS1 Ireland for advice and support.

line modifications, to artwork, labelling, QA and RA, as well as customer-facing and commercial departments. In addition to internal organisation changes, serialisation readiness is a cross-industry, multipartner collaborative challenge. It requires engagement with multiple stakeholders to succeed, including national regulatory authorities, national EMVS managers, pharma manufacturers, wholesalers, distributors, IT specialists, and logistics providers, as well as end-of-chain partners such as retail and hospital pharmacies. Any organisation from across the supply chain that needs further support regarding training, systems integration or the implementation of data standards, particularly in regard to the electronic sharing of data with the regulatory authorities, is welcome to contact GS1 Ireland for advice and support.

See www.gs1ie.org/healthcare for contact details.

On the Immediate Horizon: FMD 2019 Two serialisation regulations GS1 members are currently preparing for are the EU Falsified Medicines Directive (FMD) and the next phase of the US Drug Supply Chain Security Act (DSCSA). The EU Falsified Medicines Directive takes effect on February 9, 2019. It is unique (visa-vis the US DSCSA for example) in terms of introduction of both the registration and decommissioning of all prescription medicines. To facilitate the registration and Irish PharmaChem | Industry Buyers Guide 2019


Serialisation

decommissioning process, the European Medicines Verification Organisation (EMVO) has been established, along with corresponding national authorities (the IMVO in Ireland) to manage the European Medicines Verification System (EMVS). The FMD requires the registration of all saleable lots of prescription medication in the EMVS and their decommissioning at defined points of dispense further down along the supply chain. For pharma companies and contract manufacturers, in addition to implementing internal system and production changes to create serialised product, additional changes are required to enable the external sharing of the production data with the EMVO. At the time of writing, only about 25% of the relevant organisations had completed their registration and/or testing with the EMVO, begging questions of the sector’s true readiness for the FMD by February 2019.

Risk 4. Full Track & Trace

High

TK

CH CH

SK

RU RU

IN

1. Lot Level Traceability

BZ CH CH

US US I

US US

3. Centralised Reporting 2. Unit Level Serialisation

Low

Moderate

EU EU

SA SA AG

IR IR

SK

US

US EG

US US SA

OM

OM OM JD LB QA QA UAE

JD

I

2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

Global Readiness Timeline Chart Oct 2018 provided courtesy of Enterprise System Partners (ESP). *Chart refers to the manufacture and distribution of prescription pharmaceutical medicines

Evolving National Coding Requirements: NTIN to GTIN Globally, there is an increasing need to move from national identification systems (referred to as NTIN or national identification number) to a global trade item number (or GTIN). Use of a common identification standard across markets globally is needed to drive and deliver the efficiency, tracking, reporting and safety objectives of these regulations and is to be strongly welcomed to simplify packaging and reporting processes in particular. EAN 13 coding is widespread in many European countries, with many such as Belgium and the Nordic countries beginning the transition from national to global coding. The GS1 EU-FMD Coding Tracker is available to help keep members up-to-date on the evolving landscape. The overarching driver for the regulatory identification and tracking of serialised pharmaceutical products is patient safety. The regulations in each jurisdiction aim to enhance patient safety by introducing measures that further secure the legitimate supply chain and prevent fraudulent or counterfeit product from entering it. In Europe, this includes not only serialised identification but also tamperevident packaging and product registration with the European Medicines Verification System or EMVS.

Changing requirements have had significant impact on both brand and contract manufacturers as they adapt their processes to create serialised product. The statutory obligations include the placement of serialised information not only on the product but then to store and share that information (as required) in line with specific national regulatory requirements. The current phase of this undertaking is for manufacturers and their supply chain partners to use the already captured information to support the placing of the serialised product in

a compliant way into the hands of the patient. According to serialisation experts Enterprise System Partners (ESP), when executing your serialisation strategy, it is vital to ensure it: ● Is not sensitive to subtle changes in regulations; ● Allows for phased execution; ● Avoids unnecessary complexity.

GS1, as a neutral third party, is ideally placed to offer you expert advice on your serialisation efforts. For more information, visit www.gs1ie.org.

Overview of Global Readiness Timelines Keeping track of the different national and regional requirements is time consuming and complex and in turn creates an ever-increasing need for more efficiency in manufacturing processes, streamlining data management and increasing the use of standards to reduce or remove variations. Irish PharmaChem | Industry Buyers Guide 2019

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SSPC

SSPC, the Science Foundation Ireland (SFI) Pharmaceutical Research Centre, based at University of Limerick, has proved itself the standard bearer for industrial/academic scientific collaboration worldwide.

Realising the Power of Collaboration order to achieve the objectives of the centre, with a mission to position Ireland as a global hub for process innovation and advanced manufacturing in the pharmaceutical industry. Currently, the research programme consists of three research strands: ● New Frontiers in Pharma Synthesis ● Crystal Growth & Design ● Drug Product Formulation & Manufacturing. With significant expertise in crystallisation, the focus of the SSPC has expanded upstream into wet chemistry, including synthetic organic chemistry and biocatalysis, and downstream, into advanced formulation of the active pharmaceutical ingredient (API) into a drug product. Fundamental research by the SSPC significantly increased the sector’s capability to produce pharmaceutical solids with predefined characteristics, including crystalline or amorphous composition, particle size, habit and morphology, tensile strength, powder flow and release properties.

Leading Tangential Initiatives Sean Kelly MEP is pictured with SSPC General Manager, Dr Denise Croker. SSPC is a hub of Irish pharmaceutically relevant research expertise, comprising of in excess of 40 academic researchers and over 20 industrial partners. The aim of the Centre is to address industry challenges through the execution of excellent science and research, expand our understanding of fundamental concepts associated with pharmaceutical manufacturing, to train the next generation of highly skilled pharmaceutical scientists and engineers, and engage with the public to increase awareness and challenge perceptions of science and engineering in the general and the school-going populations. The creation of this multifaceted collaboration first came to life as the Solid State Pharmaceutical Cluster in December 2007, funded for five years through Science Foundation Ireland’s Strategic Research Cluster (SRC) programme. The founding director, Professor Kieran Hodnett, initially contacted 10 pharmaceutical companies Irish PharmaChem | Industry Buyers Guide 2019

in Ireland to enquire about whether they were interested in joining forces to create a critical mass of research activity in the sector in Ireland. Nine responses were immediate and the Cluster was born. Today, SSPC comprises over 20 industry partners and 150 active researchers, with an initial investment of €40m in funding for six years from mid-2013 to 2019. SSPC has a substantial effect on the yield of Research and Development (R&D) and economic outputs in Ireland and forms the support mechanism that will help build Ireland as a global leader in innovation.

Interdisciplinary Approach The range of expertise, spanning synthesis, crystallisation and formulation, is truly unique. It enables a symbiotic and interdisciplinary approach to the complex research challenges proposed in

SSPC’s unique collaborations and strong relationships ensures industry partners have access to leading researchers and, in addition, is ensuring that Ireland is becoming a more attractive base for international research leaders. SSPC has a strong governance model in place that operates under the direction and supervision of several advisory bodies to ensure all research activities contribute to the vision and strategic goals set forth in its governing agreements and its underlying ethos. With innovation central to the industry lifespan and success, facilitating knowledge sharing is critical in measuring the modern collaboration and its successes, as knowledge generates innovation. Knowledge sharing is a crucial component and the central basis for expanding innovation within a project. As such, Centre stakeholders benefit from the links and connectivity established throughout many partnerships that enhance the creation of innovative ideas. A unique and noteworthy achievement of the Centre is the agreement of over 20 pharmaceutical companies to work together in

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SSPC the pre-competitive research environment. This is unprecedented within the pharmaceutical industry globally, an achievement that developed through the collaborative culture developed within the Centre. SSPC is making real impacts for advanced pharmaceutical manufacturing, in addition to emerging research areas in biopharmaceutical processing. The influential work of the individual Principal Investigators has given increasing weight to the collective outputs of the Centre, which includes 293 peer-reviewed journal articles in the years 2013-2017.

Centre Activities A key activity for the centre in the past two years has been its championing of (bio) Pharma Europe, with its collaborative partners, BioPharma Chemical Ireland (BPCI), Science Foundation Ireland, Enterprise Ireland, IDA, National Institute for Bioprocessing Research & Training (NIBRT), and Pharmaceutical Manufacturing and Technology Centre (PMTC). Through collaborative efforts, this group seeks to raise the profile of the Irish (bio) pharmaceutical sector in Europe, to increase opportunities for research collaborations within the EU funding space, and in doing so, to maximise EU research funding opportunities that represent the needs of the Irish (bio)pharmaceutical stakeholders. The relationships between industry and research centres are an important part of innovation. SSPC prides itself on how its partners come together collectively and share mutual interests and objectives. SSPC continues to meet industry needs; for example, in January 2018 a specialist diploma in Regulatory Affairs was launched, in association with the University of Limerick, and is now running for a second semester. In June 2018, the Centre launched a new initiative called Women In SSPC (WiSSPC); set up to combat gender inequalities in the research team. The mission is to foster a culture of equality across the Centre, identify existing barriers to female progression, and put measures in place to address these barriers, as there is less female participation at post-doctoral level and issues remain concerning women leaving academia. In addition, the exemplar Education and Public Engagement programme that the Centre presents promotes STEM subjects to schoolchildren and the wider public. The Centre is committed to efforts to increase awareness of research and scientific issues across economic and social groups in Ireland to increase those who pursue STEM careers.

Pictured at the PMTC knowledge day at the Kemmy Business School, University of Limerick, are Dr Chris Eldin, Director, PMTC, and Professor Gavin Walker, Bernal Chair of Pharmaceutical Powder Eng. Picture: Fusionshooters.

SSPC’s Education and Public Engagement team are pictured meeting President Michael D. Higgins at the EU Scientist 2018 event at the RDS. as a range of bespoke training and development initiatives to support the acceleration of research centre commercialisation.

The Future 2019-2025 SSPC-PharM5 After a rigorous six-year review and proposal submission in 2017, SSPC has secured renewal of funding which will forge new partnerships and research outputs. The research programme of SSPC-PharM5 will broaden the Centre’s activities so that it will cover the full scope of pharmaceutical R&D, with the exception of the discovery of new chemical entities. Aligning the research with industry needs will enable a more predictive design-led approach in developing drug substances, drug products and the processes to manufacture them. There will be a disruptive change in how we manufacture drug substance (DS) and drug product (DP) and End to End levels ultimately leading to an Industry 4.0 approach, requiring expertise in in Continuous Manufacturing, Flow Chemistry, End-to-End flow from API to DP. SSPC places an importance on building relationships to generate links between academia and industry, recognising priority research areas and outcomes. An understanding exists that such partnerships will improve creativity, skills and help

to forge new ideas. Now, as the Centre readies itself up to move into a new era, in the words of Centre Co-Director, Professor Michael Zaworotko, “SSPC is open for business and going global – SSPC’s scope and scale will bring to fruition its mission to become the leading centre of excellence for shaping the future of the global pharmaceutical industry.”

The agreement of over 20 pharmaceutical companies to work together in the precompetitive research environment is unprecedented within the pharmaceutical industry globally.

SSPC Co-Directors and Bernal Professors, Professor Gavin Walker and Professor Michael Zaworotko, pictured outside the Bernal Institute, University of Limerick.

Specialised Business Incubation Facilities SSPC benefits from specialised business incubation facilities housed at each partner campus to leverage knowledge, research and experience in the areas of entrepreneurship, technology and management, business incubation, intellectual property support, as well

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Irish PharmaChem | Industry Buyers Guide 2019


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Product Testing Eurofins’ laboratory in Dungarvan, Co. Waterford, saw a major building expansion, increasing capacity from 2,700m2 to 9,000m2.

Major Expansion at Eurofins’ Dungarvan Lab 2018 is an exciting year for Eurofins’ laboratory in Dungarvan, Co. Waterford, as it sees the completion of a major building expansion. This large expansion project will increase the capacity from 2,700m2 to 9,000m2, adding 4,400m2 to its footprint, with laboratories designated specifically to Bioanalytics & Molecular Cell Biology joining the existing 2,700 m2 laboratory. The development of an 1,800m2 second site on the campus has allowed for expansion of their stability storage capacity, additional laboratory space for raw materials, microbiology validation studies, training and the introduction of a new device testing laboratory. Currently, Eurofins are seeing increased demand to support the full set of release testing of client biologic products from this single site. The expansion will increase the current Bioanlaytical Testing Area and introduce new technologies in molecular and cell biology, such as Bioassay, ELISA and qPCR. This will provide clients with increased flexibility within the Eurofins network, and it will also make the business more agile, with key testing capabilities available all at one site.

Partnership with NIBRT To ensure they have sufficiently trained personnel on site and to support this Biologic growth phase in Dungarvan, there was a requirement to maximise the Eurofins training programme in Ireland. Eurofins engaged with the National Institute of Bioprocessing Research and Training (NIBRT) based on the campus of the University College of Dublin to develop a Eurofins bespoke training programme with a Bioanalytical and Molecular & Cell Biology focus. Eurofins BioPharma Product Testing is fully invested in this programme, and their technical

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BioPharma Product Testing Ireland is expanding its facility and introducing a new training programme to support bioanalytical and molecular cell biology testing. leads worked closely with NIBRT to develop the bespoke programme, and the first Bioanalytical and Molecular & Cell Biology training programme was delivered to four Eurofins trainees in September 2017. The Eurofins / NIBRT Bioanalytical and Molecular & Cell Biology Training Course has accomplished many key objectives for the business. It has introduced and developed the candidates’ scientific knowledge of the biopharmaceutical industry from the early stages of developing a biologic drug product from genetic engineering through to the production process and the analytical requirements to assess the critical attributes of a biologic product.

hands-on, practical exercises in the laboratory. This training has given the candidates an allencompassing experience and has allowed them to take on more challenging analysis early on in their career with Eurofins. Given the success of their September intake, Eurofins ran this programme again at the NIBRT facility in April 2018, and shared this training opportunity with the Eurofins network of biologic laboratories. This expansion and investment into bespoke biologic training reinforces Eurofins’ commitment to enhancing their services and quality and continues to strengthen their agility to customers.

Small-Scale Biopharmaceutical Production Process

From starting materials through finished product testing, Eurofins BioPharma Product Testing’s 28 facilities in 16 countries deliver the world’s most comprehensive scope of harmonised GMP testing services and seamless regulatory acceptance. As they have grown to become the world’s largest network of GMP product testing laboratories, they continue to uphold their founding promise of personal service and impeccable quality. When the world awaits your product, choose the laboratory that provides complete capabilities and rigorous quality systems you can trust.

The NIBRT Facility has a small-scale biopharmaceutical production process, that allows candidates to see the various stages in the upstream and downstream of a biopharmaceutical production plant. The importance of each stage in the biological production lifecycle is reviewed with the candidates in detail and how the Bio-analytics and Molecular Cell Biology Analysis plays a role in identifying the critical attributes of a biologic product. This will enable Eurofins’ personnel to have more of an in-depth understanding of clients’ products and production process. The candidates are introduced to the science behind the suite of testing required in the Bioanalytics and Molecular & Cell Biology, with

Harmonised GMP Testing Services

Global Is Local Eurofins BioPharma Product Testing’s local presence ensures personal service, backed by a unique global breadth of harmonised Irish PharmaChem | Industry Buyers Guide 2019


Product Testing

capabilities that support all functional areas of bio/pharmaceutical drug development and manufacturing, including method development, microbiology, process validation and quality control. With a global capacity of more than 92,000m2 and 28 facilities located in Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, India, Netherlands, New Zealand, Spain, Sweden, Switzerland, UK and the US, their network of GMP laboratories and vast experience allow them to support projects of any size from conception to market. Furthermore, they have teams of scientists placed at more than 70 client facilities worldwide through their award-winning Professional Scientific Services (PSS) insourcing programme.

Experience the Expertise Eurofins BioPharma Product Testing offers complete CMC Testing Services for the bio/ pharmaceutical industry, including all starting material, process intermediates, drug substance, drug product and manufacturing support, as well as broad technical expertise in biochemistry, molecular & cell biology, virology, chemistry and microbiology.

International Presence Means Global Regulatory Compliance Operating under strict, harmonised quality procedures, their laboratories offer a broad range of methodologies under GMP authorisation, ISO 17025 accreditation and ISO 9000 certification, and all analyses are performed according to European and British Pharmacopoeia (EP), integrity, United States Pharmacopoeia (USP) and Japanese Pharmacopoeia (JP), as well as specific customer methods.

Collaboration Drives Cost-Effectiveness At Eurofins BioPharma Product Testing, their fundamental philosophy is to help clients efficiently allocate their research and manufacturing expenditures by strategically engaging them to meet their unique outsourcing needs. As your project progresses to further enhance open dialogue and assist your decision making, they provide timely and secure access to comprehensive laboratory information through

their innovative, 24-hour online data access tool, ● Comprehensive stability and release LabAccess.com. programmes for clinical and marketed products; ● Complete biochemical and chemical Comprehensive Services characterisation and microbial identification; Eurofins BioPharma Product Testing offers the flexibility to manage your testing programmes ● Raw material and excipient testing (USP/ NF, more efficiently through your choice of three EP, JP); unique service models, including their award- ● Production and non-production cell banking, winning Professional Scientific Services (PSS), including full characterisation; Full Time Equivalent (FTE) or traditional fee-for- ● Lot release/unprocessed bulk testing; service. You can choose the best, most cost- ● Process/facilities validation, including viral effective service solution for your project goals. clearance, residual impurities testing, Their breadth of services includes: extractables & leachables, water testing, monitoring, disinfectant ● Method establishment, including environmental method development, feasibility, optimisation, efficacy and on-site sample collection; cGMP qualification and validation, as well as ● Consulting/protocol writing; verification of compendial methods; ● GMP Manufacturing.

For more information, contact: Eurofins BioPharma Product Testing Clogherane, Dungarvan, County Waterford X35 T628, Ireland Telephone: +353 (0) 58 48300 E-mail: pharma@eurofins.com Website: www.Eurofins.com/ Biopharma

Irish PharmaChem | Industry Buyers Guide 2019

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Development Consulting & Quality Management

PharmaLex is one of the largest specialised providers of development consulting, regulatory affairs, quality management & compliance and pharmacovigilance, epidemiology and risk management worldwide. Their teams of experts can take you through early strategic planning activities and non-clinical requirements to clinical development, through regulatory submission processes and finally guide you to market approval and product maintenance post-launch activities. PharmaLex started 25 years ago with a vision to be the largest specialised global provider of regulated services, handling all health agency requirements. Their ambition was to make a difference to how the industry interacts and works effectively with health authorities, through the provision of their expertise and resources.

PharmaLex: 25 Years and Growing PharmaLex started 25 years ago with a vision to be the largest specialised global provider of regulated services, handling all health agency requirements.

Ann McGee Ann has over 30 years’ work experience in the pharmaceutical industry, as both a regulator and a consultant. Her experience spans quality and regulatory compliance (GXP) across the product lifecycle. Ann has inspected nationally and internationally on behalf of the EMEA for GXP compliance and has advised on best practice guidance for the pharmaceutical industry. Ann will work with teams to implement recommendations and solutions with the goal of establishing sustainable compliance in your operations.

Expert Guidance PharmaLex Ireland, with a team comprising a number of former EU and US FDA Regulatory Inspectors, work at a strategic and tactical level with their clients, providing holistic advice, guidance and solutions across the entire product lifecycle. By being part of PharmaLex, they have the bandwidth to support the diverse demands their clients are facing. They offer immediately accessible support and training to build knowledge and inhouse capability, providing companies with the tools to make informed decisions and improve operation efficiency. By working with the PharmaLex Ireland Team, clients benefit from practical solutions and expert guidance relating to their regulatory challenges.

Ann McGee, Managing Director, PharmaLex Ireland

Follow PharmaLex on social media: Twitter: @PharmaLex_IRL LinkedIn: www.linkedin.com/showcase/pharmalexireland/

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Keeping you informed www.pharmalex.com/country/ireland Pharmaceutical Serialisation – Are You Ready? In May 2018, PharmaLex Ireland highlighted the imminent deadlines associated with the requirement to implement pharmaceutical serialisation within the EU and EEA. Under the Falsified Medicines Directive (FMD) 2011/62/EU, Marketing Authorisation Holders (MAHs) must ensure that an effective end-to-end verification system is in place for prescription medicines to prevent falsified medicinal products from

entering the supply chain by February 9, 2019. For more information, see https://www. pharmalex.com/pharmaceutic al-serialisation-are-you-ready/. Continued supply of medicines to patients in the UK post-Brexit Brexit or no Brexit, deal or no-deal, patients in the UK and the EU will continue to need treatment for all conditions after March 29, 2019. In the event of a no-deal Brexit, UK Marketing Authorisation Holders (MAHs) will need to ensure continued authorisation and, hence, supply of medicines in the UK. For more information, see https://www.pharmalex.com/supply-of-medicine-post-brexit/ Irish PharmaChem | Industry Buyers Guide 2019


● A PHARMALEX SOLUTION THAT EXCEEDS YOUR EVOLVING NEEDS

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Development Bring products to commercial launch faster by streamlining product development and introduction processes.

Technology Transfer Robust Technology Transfer with expert knowledge and personnel across all stages of the transfer process.

Regulatory Approval End-to-end regulatory support from consultants with extensive experience in all routes of EU and US licensing approval.

Manufacture Expert GMP technical, quality and compliance consultancy and solutions provided by a team that includes former EU and US FDA Regulatory Inspectors.

Distribution EU and US Good Distribution Practice compliance from a global network of expert consultants, including former EU GDP Regulatory Inspectors.

Post Market Support in understanding and complying with the legal obligations of the Marketing Authorisation (MA) Holder.

Product Discontinuation Meet the regulatory requirements during and after production discontinuation.

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Precision Manufactured Buildings For Genzyme, the Portakabin team designed and built a separate two-module building for use as the gowning room, which would connect the non-sterile office building with the sterile areas of the main building.

A Flexible Space Solution As specialists in providing precision manufactured buildings, the Portakabin team are delivering space across the country, designed to fulfil requirements from every area of the biopharmaceutical industry. From cleanrooms to canteens and from offices to welfare, Portakabin is capable of delivering high-quality space in a fraction of the time to traditional construction. With the industry expected to continue to increase manufacture of new products across the board, many biopharma companies are looking for ways to expand quickly into new territories and develop production on current locations. “With our experience and expertise in providing precision manufactured spaces, delivering to the exacting standards of the pharmaceutical industry comes as second nature to us,” Mike Sheedy from Portakabin explains. “Our commitment is to provide the highest quality working environments, in line with the demanding expectations of some of the largest global pharmaceutical companies.”

Delivering Space Quickly Dynamic and adaptive operations such as biopharma require a flexible response to demand. Portakabin is able to deliver space quickly to increase the ability to decant large volumes of a workforce into a location without risking an interruption to outputs. “We have unrivalled experience in working with some of the biggest companies in Ireland

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Offsite construction expert Portakabin is making an impact on Ireland’s pharmaceutical industry, offering unrivalled quality, that’s precisely engineered and built to last. at the moment, including MSD Brinny, Janssen, Eli Lilly and Bristol-Myers Squibb,” Sheedy reveals. “When these businesses require action quickly, Portakabin can create much needed space where and when it’s needed most. Our durability and flexibility ensures rapid delivery and timely installation, something we know is at the top of every Facilities Manager’s wishlist.” With technical expertise working with a range of requirements, Portakabin has recently engineered, built and installed ‘Category 2’ laboratories for biochemical research at the University of Oxford, as well as office space to cleanroom standards for biotechnology giant Genzyme.

The Genzyme Project When world-leading biotechnology company, Genzyme, based in Dungarvan, embarked on a €95m expansion project, it needed to find office accommodation for almost 100 engineers. The interim facilities not only needed to provide high-quality office space for the Genzyme staff and contractors, but also a hygienic ‘gowning room’ for staff entering the sterile clean-room area of the main building. “We offer premium-quality and using patented building systems, can create bright, attractive buildings of any size or

configuration,” Sheedy notes. “This offers exceptional levels of insulation and airtightness, providing a comfortable, warm and welcoming office environment that’s also energy efficient. Throughout the process, our project team will manage every aspect, from design through to installation and finishes. “For Genzyme, we designed and built a separate two-module building for use as the gowning room, which would connect the non-sterile office building with the sterile areas of the main building,” he continues. “We had to ensure the building met the strict cleanroom standards required to satisfy Genzyme’s rigorous quality-control procedures. The gowning room was designed to be positioned five metres above the ground on structural steel supports, so that it gave direct access to both sterile and non-sterile areas of the site.” Eoin Carroll, Project Engineer at Genzyme, says: “We wanted to give the project team the same quality of surroundings as they were accustomed to in their normal offices. We chose Portakabin to provide our interim offices and they provided buildings of the standard we needed, as well as offering the most competitive deal. The buildings fulfilled all our expectations and provided the ideal environment for the team working on this important project.” Irish PharmaChem | Industry Buyers Guide 2019


Brenntag Pharma

Brenntag Pharma: Your Partner for Success needs are fulfilled quickly and efficiently. Customers can confidently focus on their core business, using Brenntag Pharma’s extensive range of products and services, such as: • Excipients (binders, coatings, emulsifiers, flavours); • Intermediates; • Process chemicals; • Solvents; • Filling of liquid excipients.

Supply Chain Solutions

Brenntag Pharma is the preferred distribution partner in the pharmaceutical, veterinary and healthcare industries. Brenntag Pharma offers a comprehensive range of products for the formulation of pharmaceuticals and the chemical synthesis of Active Pharmaceutical Ingredients (APIs). Their dedicated team of chemists and pharmacists develops innovative, tailor-made solutions, be it oral dosage administration, e.g. tablets and capsules, or

Irish PharmaChem | Industry Buyers Guide 2019

parenteral administration, such as injections and infusions.

Highest Quality Ingredients Based on a global network of suppliers, Brenntag Pharma procures the highest quality ingredients on the market, while their global logistics ensure that their customers’ business

Their extensive network of Brenntag sites across the UK & Ireland (including Brenntag Dublin and Brenntag Belfast) is key to their success for providing total supply chain solutions to customers. Their sites are ISO and ESAD certified and their QMS system/ warehouse is regularly audited by pharmaceutical companies. Brenntag Pharma support their customers’ R&D and product development teams throughout projects and various stages of new product developments, supplying not only products but ideas and information on market trends to create a competitive edge for their formulations.

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Packaging

Limerick Packaging: Where the Client is King

Delivering ‘on time, everytime’ is the secret behind the continued success of Limerick Packaging, explains Connie Ryan, Managing Director.

When Limerick Packaging began operating back in 2002, entrepreneurs Connie Ryan and Mike Boland wished for a client list of 60 customers. Today, that list is 400-strong and growing all the time. So what’s the secret? “We steadfastly stand by our company motto and deliver ‘on time, everytime’,” explains MD Connie Ryan. Employment numbers too have grown exponentially. When Limerick Packaging first opened their doors, there were a grand total of three employees. Today, there are more than 30. Ryan is extremely proud of the fact that Limerick Packaging have held onto most of the companies who they began dealing with at the company’s formation. He’s equally delighted that once Limerick Packaging start to work with a customer, they usually end up not only keeping the customer on their client list, but increasing the amount of business they do with them. “This is simply down to the fact that we deliver ‘on time, everytime’,” he reiterates. “If you wanted to know why our business has grown, that is exactly why. Mike Boland, our Sales Director, says to customers, new and old, ‘We’ll work hard, so you don’t have to’. This means that our customers’ buying teams can concentrate on other aspects of their business because they don’t have to worry about chasing packaging,” Ryan insists. “We put the customer first,” he continues, “but to be fair, if our customers hadn’t put us first initially, we’d never be in this position. We have customers today that we had in 2002, so the loyalty of our customers is hugely important for us and a big factor in our success.”

Stocking to Purchase Order Many pharma/medical and food companies throughout Ireland are able to concentrate on their core business, safe in the knowledge that the packaging materials they need are but a phone-call away in Limerick Packaging. These companies no longer have stores full of boxes that they don’t need and a packing hall without the boxes they do need. They have zero capital tied up in packaging stocks, allowing that money to be invested in turnover that perpetuates the business, and they have production and valueadded activities where once they had stores. Once Limerick Packaging get to fully understand their customers’ business, they stock product to Purchase Order and deliver daily or weekly as required: if a customer phones by noon today with a call-off for product, Limerick Packaging will deliver tomorrow, anywhere in Ireland, via its own delivery fleet. The affable MD reveals that in its early years, Limerick Packaging was “heavily dependent” on the electronics industry, “but we realised in around 2005 that this market was going to shrink and we needed to get into markets that were expanding so we very deliberately targeted medical/ pharma and food.” “We didn’t have to change our business model

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Irish PharmaChem | Industry Buyers Guide 2019


Packaging

because that’s based on one thing only: delivering on time,” Ryan explains, “but what has changed is that we have grown beyond what we believed we could achieve. Truth be told, I would say we underestimated the value and the benefit to our customers of us delivering on time consistently.”

The Pharma/Medical Arena The pharma/medical arena has become hugely important to Limerick Packaging, who number a host of blue chip companies among their client base. Along with their standard range of Corrugated Boxes in regular slotted case form and die-cut format, Limerick Packaging’s extensive product range incluces Retail Ready Packs (SRP/ RRP) in either Litho print, Pre-Print Flexo or high quality Post-Print Flexo. They also supply industrial polythene bags, sheets and pallet hoods, pallet edgeguards, high quality post-printed boxes, pallet-wrap, strapping, strapping accessories, tapes and a full range of protective foams. One of the biggest changes over the years, Ryan insists, has been the advent of Retail Ready Packaging. “It has opened us up to a lot more potential customers, given that we have a lot of expertise in that area, particularly on the printing side,” he insists. “Retail Ready Packaging continues to power ahead like a steam-train. Anyone who was Irish PharmaChem | Industry Buyers Guide 2019

resisting has had to jump on board. You can see it in retail outlets, where there is consistency of colour across packs and your eye is immediately drawn to the product you require based on the Retail Ready Packaging.”

Key Packaging Attributes Product quality, print finish and pack strength are key in designing the right packaging, according to the MD. “It could start out as the most beautiful box you have ever seen, but by the time the transport channel is finished with it, it could be unattractive on-shelf, so you have to ensure the box is strong enough for it to arrive in the condition it left the packaging company,” Ryan explains, before going on to highlight some of the other challenges Limerick Packaging take on board when designing a new pack. “If we’re designing a pack for a customer, it has to make economic sense,” he reveals. “We can’t make a box for a euro, if a box for 50 cent will do the job perfectly. It has to be able to package the product and to hold its contents safely; to inform both the retailer and end-user of what’s inside; it has to arrive in good condition; it has to look presentable on shelf; and we have to consider the environment at all stages during production. With our eye on the environment, we have to make sure that the box is fit for purpose

but not over-fit for purpose.” Most of Limerick Packaging’s work is in corrugated cardboard containers, which dovetails nicely with the sustainability agenda, as their packaging is easily recyclable, an important concern for both industry and consumers. So what does the future hold for this one-of-akind packaging supplier? “We will continue to work hard for our customers so they don’t have to, and we’re going to strive to continue growing, innovating and bringing to market what our customers want, both now and in the future.”

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Microbiology & Sterility Testing

Top Source for Microbiology & Sterility Testing Tramore-based Source BioScience Ireland offer a wide range of microbiology and sterility testing services, which can be customised to suit the requirements of their clients. Source BioScience Ireland now offer a wide range of microbiology and sterility testing services. With significant investment in their laboratories, located in Tramore, Co. Waterford, they are compliant to EU GMP, USP, ISO standards and regulations, to meet clients’ expectations. While they offer an extensive range of testing options, Soirve BioScience can also customise and validate testing, depending on the requirements of their clients. Their sterility laboratory incorporates Grade A isolators that utilise gassing cycles of hydrogen peroxide vapour, providing assurance of sanitisation prior to testing, thus allowing quicker turnaround times compared to conventional isolators or laminar flow cabinets. They operate enclosed filtration systems and medical device testing through direct inoculation and membrane filtration. Microbiology and sterility testing are crucial aspects towards the development and life cycle of a product. At Source BioScience, they understand the importance of quality and need for quicker turnaround times. The benefits of using Source BioScience Ireland’s Micro/Sterility testing services include: ● Fast TAT’s ● Standard & Customised Testing ● Method Validation ● Bacterial endotoxin testing ● Microbial limits testing ● Bioburden determination ● Biological indicator testing ● Microbial identification ● Sterility testing ● Medical Device testing

Stability Storage Services Stability storage services from Source BioScience support a wide range of industries, including: ● Pharmaceutical and biopharmaceutical ● Food ● Biological ● Medical Device ● Bulk Milk Production ● Cosmetics, health and beauty ● Chemical and industrial Source BioScience Ireland have a wide range of storage conditions available, including all ICH conditions, as well as unique,

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bespoke conditions to suit your individual requirements. As the manufacturers of the equipment we use, they also have no limitations on the size or volume of product they can store. All of their equipment is validated annually and is subject to regular maintenance by their experienced engineers, who are available 24/7 to provide a fast response service. Their storage suites are also monitored by 21CFR Part 11 compliant 6180A Eurotherm data acquisition systems, and are all connected to a back-up generator. This ensures 100% operational redundancy and protects the integrity of your samples for assured sample safety.

Controlled Environment Storage Source BioScience Ireland offer controlled environment storage and stability storage at custom conditions. They have environmental rooms and cabinets available that can be customised and validated to your specific requirements; freeze/thaw, spark proof for aerosols, off-site storage of quarantine samples, any condition can be accommodated at their GMP compliant storage facilities. They also offer a full complement of controlled environment products, stability storage cabinets, reach-in chambers and walk-in rooms to meet any need, whether large or small. Their manufacturing and design capabilities allow Source BioScience Ireland to design, manufacture, install and validate any need in any space any temperature or humidity condition required. “Our staff are experienced engineers able to meet any demand on their expertise and we welcome the opportunity to speak with you in more detail about how we can be of assistance to you,” explains Russell Wheatcroft, Commercial Director, Source BioScience Ireland.

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Irish PharmaChem | Industry Buyers Guide 2019

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Instrument Maintenance and Calibration Endress+Hauser offer complete peace of mind with the right calibration partner.

The Experts in Calibration Maintaining compliance with demanding industry, legal and market quality standards is particularly challenging if your plant assets are not perfectly managed. You probably own a large heterogeneous installed base of instrumentation. Do you know which assets are critical to your processes and if they are providing accurate information? How do you know if they are obsolete or need to be updated? If you don’t have transparency, how do you manage the risk of non-compliance? Endress+Hauser consultants help you get a comprehensive view of your installed base and give insights to improve process availability and minimise the risk of downtime. Collecting instrument data using mobile apps is the first step. This data is then filed into a database with 24/7 online access. Based on safety, quality and identification, obsolescence risks and migration priorities are identified and recommendations for device replacement are specified quickly. Their consultants can help you improve your installed base maintenance, while keeping your processes in compliance. They will help reduce its complexity through standardisation, recommend the relevant calibration intervals and methods for each technology according to its criticality. They also help digitalise your plant by offering appropriate solutions to integrate devices into an IIoT environment, which enables you to quickly provide valuable information to the right people. Endress+Hauser offers unique expertise

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Do you want to reduce costs without increasing risks or losing compliance? Endress+Hauser can help you to do this, while gaining detailed insight into your installed base and helping you comply with requirements. Endress+Hauser consultants help you get a comprehensive view of your installed base and give insights to improve process availability and minimise the risk of downtime.

regarding maintenance and calibration of your assets. Their expertise arises from more than 60 years of experience in instrumentation across a variety of industries. Their dedicated experts are located all over the world to better provide you with relevant analysis of your installed base and recommendations to maintain compliance.

Complete Peace of Mind with the Right Calibration Partner Regular calibration is essential to keep the instrumentation controlling your critical processes in spec. Endress+Hauser provides timely, traceable, and cost-effective services that are accompanied by clear and concise calibration certificates. From accurate on-site testing to fully accredited laboratory calibration, they carry out and advise on every aspect of instrument calibration to meet all your business requirements.

How They Can Support You Endress+Hauser continually strive for the best quality industry standards to provide customers with cost-effective and sustainable solutions for each project. They offer a full range of calibration services for your instrumentation equipment. Therefore, their engineers and Irish PharmaChem | Industry Buyers Guide 2019


Instrument Maintenance and Calibration

technicians handle all aspects of on-site instrument calibration services. Your individual needs and technical core processes are always their focus. They offer: ● Traceable calibration of any measurement instrumentation; ●

Endress+Hauser offers unique expertise regarding maintenance and calibration of your assets.

Clear and comprehensive calibration certificate with conformity statement;

● Centralised access to all your calibration documentation and calibration history on demand.

Benefits Traceable and accredited instrument calibration: Full compliance and audit readiness with complete and traceable calibration performed according to ISO 17025. The high-level corporate standards of their service capabilities and operating personnel’s technical expertise ensure a consistent calibration approach with secure results for all of your process instrumentation. Highest accuracy with laboratory services: Putting their metrology expertise to work will provide secure, accurate and consistent results throughout the devices’ lifecycle. Their calibration laboratories are located worldwide, equipped with highly skilled personnel and state-of-the-art metrology. Their primary standards laboratory has the resources you need to meet the full traceability of your calibration. High quality service from a global instrumentation partner: Keep all your processes working reliably and your devices in spec. Be assured, the best quality and consistent performance of their instrument calibration services will be executed, no matter the location. Their extensive services are available locally with globally managed competences: ● Proficiency testing to monitor local laboratories’ continuing performance; ●

Harmonised calibration standards;

Technical training and a qualification management system to improve the skills of all service engineers.

Get Detailed Insights to Ensure Compliance Keeping compliance and reducing cost without compromising risk might be a challenge. Very often, transparency about obsolete and critical assets is missing in plants, specifically after many years in operation.

Endress+Hauser consultants can help you get full transparency of your installed base and deliver insights to improve process availability and minimise risks. For example, outcomes may include advice on adequate calibration intervals and methods for your quality critical assets.

Make Safe Measurement Your Priority Endress+Hauser’s compliant calibration ensures the safety of your processes and products to prevent harm to users, consumers and the environment. A smooth and safe-running plant is a top priority and compliant calibration is an integral part of its operation. Their broad range of instrument calibration services offers the best unique on-site experience. Irish PharmaChem | Industry Buyers Guide 2019

Regular calibration is essential to keep the instrumentation controlling your critical processes in spec.

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Raw Materials Univar’s extensive global network provides pharmaceutical manufacturers with one-stop access to a broad range of excipients, APIs and process ingredients.

Univar: Your Raw Materials Partner

Univar is a global distributor of established and novel excipients, colours, APIs and solvent and synthesis chemistry for all dosage forms. Their relationships with world-leading producers gives access to a comprehensive portfolio of formulation and synthesis materials, all delivered with comprehensive regulatory and technical support and great customer service. Univar understand the importance of having access to a safe and dependable supply of quality and performance-based ingredients for your pharmaceutical formulations. Their extensive global network provides pharmaceutical manufacturers with one-stop access to a broad range of excipients, APIs and process ingredients, when and where customers need them. Their customers receive technical and regulatory expertise that enables the safe delivery of a total solutions approach, from product selection, new product development and early phase trials, through to scale-up and commercialisation.

Key Areas

● Customer Service: their locally based industry dedicated teams understand your needs throughout the supply chain and product life cycle; ● Quality Assurance: ensuring the supply of the right products with the correct audit trail and full traceability, along with robust change control processes; ● Security of Supply: global supply chains with strong quality assured partners who are here today and tomorrow; ● Technical and Regulatory Support: providing product recommendations and ensuring all documentation is completed on time and in full in support of audit compliance and your license applications.

Developing Tailored Solutions Aware of the challenges and demands of the industry, Univar’s experts work closely with customers to address individual challenges by developing tailored solutions to help reduce total costs of operation, while providing a dependable and secure source of supply. For more information, call (01) 4019800 or email irelandsalesoffice@univar.com.

Univar Pharmaceutical Ingredients safely delivers value to customers in four key areas: Univar understand the importance of having access to a safe and dependable supply of quality and performance-based ingredients for your pharmaceutical formulations.

Univar’s experts work closely with customers to address individual challenges by developing tailored solutions to help reduce total costs of operation, while providing a dependable and secure source of supply.

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Irish PharmaChem | Industry Buyers Guide 2019


Ireland’s leading source of high quality pharmaceutical ingredients Univar is Ireland’s leading source of high quality ingredients to the pharmaceutical sector. Our purpose built site has been designed to meet the regulatory compliance demands of our pharmaceutical customers. We are serious about safety and we are committed to making a positive impact on environmental issues in handling fine chemicals. Univar is the partner of choice for many of the world’s leading pharmaceutical ingredient manufacturers. Whether you are looking for APIs, Excipients, Process chemicals, Solvents or Intermediates we can provide technical and regulatory support. To discuss your specific needs please contact our sales office To discuss your specific needs please contact our sales office on +353 1 4019800 or email us at Irelandsalesoffice@unvar.com


Chemical Distribution

Camida Celebrating ‘Pearl Anniversary’ David Anchell, Managing Director, Camida, discusses the evolution of his specialist chemical distribution company as it celebrates 30 years in business.

“Pearls of Wisdom: a succinct, often sarcastic, insightful saying, piece of advice or moral precept.” On September 3, 2018, Camida was 30 years in existence (our Pearl Anniversary if you like)! The author, John Steinbeck, once said, “Ideas are like rabbits. You get a couple, learn how to handle them and pretty soon you have a dozen.”

Foundation Principles So, I had an idea way back then; what if we started a Specialist (Chemical Distribution) Company, based on: ●

David Anchell, Managing Director, Camida.

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Genuine customer needs and efficiently fulfilling their requests; ● Focusing on and exceeding service expectations and integrity rather than financial gain; ● Honestly and transparency inherent in all the company does, always; ● A desire to reward and motivate any future employees so they too buy into the philosophy to ‘exceed expectations’; ● Understanding and conforming to the highest of standards required by our exacting and exciting industry; ● Sharing any success with which we may be blessed with our employees and with the community. The idea was that not only would such a

company create success and sufficient income to enable its growth, but that it would also be an enjoyable work experience - ‘fun’ if you like.

Trying New Ideas Since then, our ‘bunnies’ have bred and we have constantly tried new ideas to innovate our Camida activities. Some of these have worked and some have been less successful. But all of them have been developed with the foundation principles listed already at their heart. They may be around since our inception in 1988, but we don’t intend to change those principles no matter which innovations we may evoke to complement them. It’s been a privilege to work with you all over the last 30 years: colleagues, customers, suppliers, partners and the community at large. Thanks for sharing those years with us. To paraphrase Issac Asimov: “Thirty years may seem a long time but not when you’re looking back at them – you wonder then how they vanished so quickly!”

About Camida From organic intermediates to biochemicals, from performance chemicals to food ingredients, Camida can source, manage and deliver your needs. Whether your business is in pharmaceuticals, food, biotechnology or surface coatings, they meet the highest industry standards and conform to the most stringent international protocols. Tap into Camida’s global network and over 30 years’ experience in sourcing specialised chemicals. They understand your needs, provide solutions, and above all, they exceed your expectations. Visit www.camida.com, email info@camida.com or phone +353-52-6125455

Irish PharmaChem | Industry Buyers Guide 2019 1



Chemical Waste Disposal

Chemishield Has You Covered Chemishield is a world first software platform that prevents incompatible mixing of chemical waste during the disposal process by removing the need for users to think about chemical compatibility in laboratory environments, safeguarding people and plant. The Chemishield software platform delivers safer segregation and labelling of chemical waste, which greatly reduces in-lab accidents caused by mismanaged disposal of chemical waste. The pioneering solution enhances safety in the laboratory whilst also aligning

with regulations on packaging of hazardous chemicals and the communication of these hazards to users through labelling.

Current Market Problems Safety - Disposal of chemical waste poses many hazards resulting from compatibility and labelling issues: lost time accidents, fatalities, facility downtime, delays in product release and plant damage; Traceability - Lack of a ‘Cradle to Grave’ audit trail: existing paper-based systems make facilities vulnerable due to reliance on manual inputting and personnel;

Compliance - With stringent EU legislation and regulations, companies face two major issues within the life sciences when utilising chemicals: the Waste Framework Directive and CLP Regulations. Current practices mean a lack of ‘audit readiness’, downtime retrieving vulnerable records, financial and reputational Innovative software solution delivering safer segregation and labelling of chemical waste. damage.

The Solution: Safe Chemical Disposal Users of Chemishield have a three-step validation process to follow. Step 1:

Chemical Lifecycle Traceability - cradle to grave Safe Chemical Disposal - remove the need for users to think Regulatory Compliance - audit readiness

Optimize waste streams decrease disposal costs

Chemishield enhances safety in the laboratory whilst also aligning with regulations on packaging of hazardous chemicals and the communication of these hazards to users through labelling.

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They will enter details of chemicals they intend to dispose in the Chemishield system. Step 2: Chemishield will determine the specific waste containers to be used. Step 3: Prior to pouring the waste into the container, the technician will be asked to validate that the container they have selected matches the waste container specified by the Chemishield system.

Environmental Health & Safety (EHS) / Disposal Operatives managing waste also employ the three-step Chemishield safety check when decanting smaller containers into larger containers. Chemishield has a data dictionary of chemicals and their compatibility with each other: this dictionary is utilised to determine the safety of mixing chemicals during the waste process.

Chemical Lifecycle Traceability Intelligent software captures data on all chemicals being disposed by laboratory personnel in each laboratory where the system is deployed. Once a bottle of waste leaves a laboratory, the EHS/Disposal Operator can manage how containers of waste are prepared for shipping off-site. This identifies exactly what chemicals are contained in it, who disposed of the chemical and when it was disposed. Further to this, Chemishield offers two methods of extracting container data, a printable report or downloadable CSV file, detailing the exact chemical contents of the container. This benefits waste disposal companies in understanding what is in each container. Throughout the process, a unique QR Code identification methodology is used: therefore, Chemishield offers unprecedented chemical waste data from laboratory of source through to the waste disposal facility.

Regulatory Compliance Chemishield tracks chemical waste data from point of origin to waste disposal facility, thus providing compliance with the Waste Framework Directive. In addition to this, lab managers and waste disposal companies can work in tandem to make fact-based decisions regarding the waste that they are disposing. Decisions that can be made include how to best manage this waste to reduce costs of processing by separating chemicals at source or identifying chemicals suitable for recycling (both Chemishield features are configurable by the lab manager) in compliance with the framework directive. Chemishield also offers CLP compliance in its labelling for containers and bottles. Chemishield knows exactly what is contained within each waste container. Therefore, when it is printing the label for the container, the exact contents, plus all the ancillary information regarding hazard warnings, health precautions and hazard pictorial symbols are correctly reflected on the label. This allows any person along the disposal chain to clearly understand what chemical they are dealing with and the precautions they need to follow to safely handle wthis waste container. For more information, contact Chemishield: Tel@ (051) 576025 Web: www.chemishield.com Email: info@chemishield.com Twitter: @chemishield Irish PharmaChem | Industry Buyers Guide 2019


“SAFETY, COMPLIANCE & INNOVATION�

Ensuring Safety

Easily Traceable

Compliance

Reducing Costs

Lab Technicians will use

Capturing data on all

Chemishield tracks chemical

Waste streams that are not

Chemishield daily to dispose

chemicals being disposed of.

waste data from point of

optimized from a recyclability

of chemicals. Chemishield

Each container will identify

origin to waste disposal

perspective, drive up disposal

uses an automated chemical

what chemicals are contained

facility, providing full

costs. Chemishield can

compatibility engine to ensure

in it, who disposed of the

compliance with the Waste

optimize this process

safety during disposal.

chemical & when.

Framework Directive.

reducing costs.

12:05 PM

SCAN

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Lab Technician

Lab Manager

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DEMO & PRICING To see how Chemishield could help you improve your laboratory waste disposal process, please get in touch for a demo of our platform and for more pricing information. +353 51-576025

@Chemishield

info@chemishield.com

www.chemishield.com

EHS operator


Industrial Cleaning

AQS: The Industrial Cleaning Experts Unrivalled expertise and a determination to innovate define AQS Environmental Solutions’ cleaning and waste management services for chemicals and pharma clients. From pipe surveying, integrity testing and repair to chemical tank cleaning and waste removal, AQS Environmental Solutions delivers responsive and sustainable industrial cleaning and waste services to chemicals and pharma clients nationwide. The experience of its teams is backed by rigorous safety and quality standards. AQS has achieved OHAS 18001 accreditation and during 2018, also achieved ISO 9001:2015, the quality management system standard. It carries out all internal training in line with clients’ quality and safety procedures.

Delivering More AQS is part of Lanes Group plc, the UK’s largest drainage and asset maintenance specialist. It also has strategic partnerships that deliver additional cutting-edge technologies. For example, it works with Panton McLeod to provide tank and reservoir cleaning using Panton McLeod’s pioneering PM88 system. This allows assets to be cleaned less invasively and more quickly.

End-to-End Service AQS acts as an end-to-end service partner. It carries out CCTV camera surveys and hydrostatic testing of pipes, sumps and industrial tanks. It can then devise effective cleaning and repair services for any issues identified. Its teams manage preventative maintenance programmes to ensure IPCC compliance, and respond 24 hours a day to urgent issues, including untoward incidents.

Technical Excellence AQS operates the most modern fleet of ADR combined suction and jetting tankers, operated by Hazchem-qualified drivers. Its custom-built DISAB vacuum technology can remove all types of wet and dry sludge, slurry, filter cakes and sediments, as well as powders, granular materials, aggregates, ash and soil. This technology enhances sustainability in a number of key ways. Productivity is

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increased. Risks are minimised, by reducing manual handling and the need for confined space operation. Tasks can be carried out more easily within the envelope of a continuous production process.

Bespoke Solutions Working closely with production, site management and HSQE teams, AQS often helps its pharma and chemical industry clients design and implement bespoke cleaning and waste solutions. Its teams regularly work closely with other contractors, for example during process and production development.

Pipe and Bund Rehabilitation Pipe rehabilitation, rather than replacement, is a growing trend in the pharma and chemicals sectors. The technology reduces costs and minimises lost production time. AQS provides a comprehensive pipe rehabilitation service, and can also rehabilitate bunds, manholes and other drainage infrastructure using

cost-effective, industry-proven and certified methods.

Process Integration AQS is considered by many clients to be a key manufacturing partner. Its range of services and its problem-solving approach to their application are valued as an integral part of the pharma and chemical production process. Examples include scheduled changing of filter media, sludge collection and disposal and a wide range of planned preventative maintenance works, including gully cleaning, interceptor desludging and other general cleaning activities. These specialist services are added to the full range of industrial services that AQS delivers to its pharma and chemicals clients. With AQS, it really is a case of one supplier, one call, many solutions. For more information, visit www.aqsenvironmentalsolutions.ie, email info@aqssolutions.ie, or call 1800 500 020. Irish PharmaChem | Industry Buyers Guide 2019



Documentation Solutions

Reduce Human Error and Enhance Training •

TWi is a leading technical writing and information design service provider, offering high-quality, flexible, and scalable documentation solutions for bio/pharma and medical device companies.

Consultancy and support on documentation and information management;

Your Challenges:

Flexible, scalable, and customised service offerings that can integrate with your teams;

Producing effective CAPAs to improve your Human Error Reduction (HER) programme;

Reducing ambiguity and unnecessary complexity in SOPs, BMRs and IFUs that may lead to confusion and human error;

User-focused approach to documentation development;

• •

Tailored training in technical communication skills and strategies.

The Results

“TWi created a top-quality operator manual, for our new bench-top DNA library prep workflow, BD-CLiC. We needed TWi’s assistance in adhering to the detailed style and content guidelines stipulated by the larger Becton Dickenson (BD) group. TWi simplified things by sourcing and managing a translation partner, so we didn’t have to engage with a second vendor,” said John Malone, BD-Gencell, Ireland.

maintaining quality and ensuring regulatory compliance;

• Developing the skills of your team.

and IFUs; Enhanced documentation quality, consistency, and usability; Greater operational efficiency, saving time and resources.

TWi’s Solutions

Partner with TWi

“TWi is partnering with us on an extensive global project to simplify internal process documentation and make it easily accessible through an online playbook,” explains Len James, Director of Process Improvement, Janssen Biologics Europe. “The writing team quickly got up to speed on the complex subject matter of drug development and offered a fresh, objective perspective. TWi is greatly enhancing the usability of our content.”

Information design and technical communication expertise;

With TWi’s help, your documentation becomes a valuable business asset.

For more information, see www.technicallywriteit.com.

Creating user-friendly product information documents and user manuals;

• Achieving resource efficiencies, while

• High-quality CAPAs and reduced human errors; • Standardised and user-friendly SOPs, BMRs • •

Documentation Solutions  Improve documentation quality, consistency, and usability  More effectively comply with regulatory requirements  Standardise SOP’s and WI’s  Save time and resources  Enhance cross-organisational knowledge sharing  Flexible service offerings to meet your needs!

Stand Out TECHNICAL WRITING INFORMATION DESIGN TRAINING & CONSULTING

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From the Crowd

CONTACT US Ⓣ +353 (0) 21 2428800 Ⓔ info@technicallywriteit.com Ⓦ www.technicallywriteit.com

Irish PharmaChem | Industry Buyers Guide 2019


API and Intermediates SK biotek is a CDMO specialising in the manufacture of cGMP API and intermediates via advanced synthesis, continuous processing, controlled substances and high containment for global pharmaceutical companies.

SK biotek Ireland was formed in January 2018, but their state-of-the-art facility at Swords, Co. Dublin, has been manufacturing API and intermediates for over 50 years. Leaders in operational excellence and continuous improvement, it is the birthplace of some of the world’s leading therapeutics. Their Swords Campus has built exceptional technical capabilities within the R&D group, with extensive experience in custom development from clinical phases to commercial launch and scale-up for products. For the last 30 years, SK biotek’s Swords Campus has maintained its leadership in the development, scale-up and commercial manufacture of highly potent chemical intermediates and API. It has been the launch and manufacturing site for numerous Highly Potent APIs (HPAPIs) in the last three decades.

Offering Multi-Scale Plants SK biotek Ireland can today offer multi-scale plants (from grams to 100s of kg) capable of

SK biotek: Manufacturing Excellence handling material with Occupational Exposure Limit (OEL) ≥ 1 µg/m3. The Swords Campus also hosts a fully integrated facility capable of handling material with Occupational Exposure Limit (OEL) ≥ 10 ng/m3, 10,000 times lower than the generally accepted limit of ≤ 100 µg/m3 for highly potent compounds. This integrated facility combines manufacturing plants, R&D and QC laboratories within the same building. Through the implementation of a strong safety compliance policy and adherence to high-quality and safety standards, the Swords Campus has a proven track record as a reliable supplier of HPAPIs to multiple customers. AMPAC Fine Chemicals (AFC) became part of the SK family in mid-2018, expanding their manufacturing footprint to the US. AFC is a custom manufacturer of APIs and intermediates, and has been solving problems for customers through technology and innovation to reliably deliver quality products for over 75 years. With integrated facilities in California, Texas, and Virginia, specialising in process development, scale-up, and cGMP compliant production from kilograms to multiton quantities, AFC have developed capabilities that support a wide range of processes and technologies. SK biotek and AFC are wholly owned subsidiaries of the South Korean conglomerate, SK holdings, a global leader in energy, chemicals and information technology. This creates substantial market synergies by combining highly complementary assets and expertise of these companies, further enabling them to provide the highest quality services to customers.

suppliers of late phase and commercial pharmaceutical materials using continuous processing. Continuous flow processing has many potential advantages over traditional batch processing; it’s not just greener, highly efficient, cost effective and regulatory supported, it also has the capability to achieve low temperature reactions, hazardous reactions (Azide Reactions/Hydrogen Peroxide etc.), high pressure (300 ATM), high temperature reactions (600°) and catalytic reactions. “At SK, we have a solution to meet all your needs,” commented Steve Barr, Vice President Business Development. “We are renowned for providing customers with both process development and commercial manufacturing expertise and our robust adherence to cGMP standards ensures it’s right first time. “As an SK biotek customer, you will see our commitment to work with you and stand over your product as if it were our own. After all, we have been producing the world’s most recognised drugs for decades.”

A Broad Portfolio As part of the SK family, AMPAC and SK biotek combined are able to provide customers with a broader portfolio of offerings. With over 1000m³ of capacity globally, across three continents, they have capacity to manufacture API, intermediates and HPAPI from grams to multi-tons across the full product lifecycle. Their plants in Korea are the leading Irish PharmaChem | Industry Buyers Guide 2019

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Water & Waste Water Treatment

The Chemifloc group of companies specialises in water, waste water treatment and industrial chemicals and laboratory technical services.

The H²O Files The Chemifloc group is a wholly Irish owned group of companies specialising in water and waste water treatment chemicals (Chemifloc Ltd), Industrial Chemicals (GI Chemicals) and laboratory technical services (Chemilab Water Services). The Chemifloc group facilitates the delivery of drinking water to homes and businesses throughout the island of Ireland, provides the basis for environmental protection by treatment of municipal wastewater and meets both the in-process and waste treatment requirements of Irish industry. Their Chemilab Water Services technical team facilitates continuous optimisation of current practices within the industry, as well as engaging with their customers on forward looking research projects. Chemifloc Ltd specialises in the manufacture and supply of the full suite of products required during the water treatment process: ● Coagulation/Flocculation: Aluminium Sulphate, Polyaluminium Chloride, Ferric Aluminium Sulphate, Ferric Sulphate, Ferric Chloride, Sulphuric Acid (PH) control, Polyelectrolytes, Powder Activated Carbon; ● Disinfection: Sodium Chlorite & Hypochlorite; ● pH Correction: Sodium Hydroxide, Lime. Chemifloc Ltd also specialises in the manufacture and supply of the full suite of products required during the waste water treatment process: ● Coagulation/Flocculation: Ferric Sulphate, Ferric Chloride; ● Odour and Septicity control: Ferric Nitrate, Sodium Nitrate, Calcium Nitrate.

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In addition, Chemifloc Ltd offers a variety of general chemicals such as Urea solution for SCR-diesel vehicles (Chemblue), iron based added micro-nutrients for combating sludge bulking problem (bulk floc), Antifoam, Salts etc.

Tailoring Solutions to Your Requirements Chemifloc Ltd has a large manufacturing and storage facility in Shannon, Co. Clare, and has the capability to tailor and develop solutions to meet specific customer requirements. In order to facilitate prompt delivery, they have the largest fleet of bulk chemical tankers and ADR drivers in Ireland, complemented by a fleet of rigid trucks to facilitate intermediate bulk and small pack size deliveries. They have recently invested approximately €10m in bulk storage facilities in Shannon Foynes Port at a critical time in Ireland. Security of supply is an essential assurance for their customers in these uncertain times for trade, particularly given the uncertainty created by Brexit.

GI Chemicals DAC GI Chemicals DAC is a subsidiary of Chemifloc and focuses on the supply of industrial chemicals in bulk tanker format in Ireland,

with storage tanks in Cork, Foynes and New Ross. GI Chemicals DAC supplies Hydrochloric Acid, Sulphuric Acid and a range of concentrations of both Sodium Hydroxide and Potassium Hydroxide. The company has ISO 9001:2015 certification and has received FECC Accreditation to Responsible Care.

Investing in New Laboratory The Chemifloc group has recently invested in a new technical laboratory at their facility in Shannon, Co. Clare, called Chemilab Water Services. Primarily, this facility will provide coagulation study (jar testing) facilities to optimise the treatment process in the production of drinking water. This facility will help water treatment undertakers, including local authorities and private industry, to determine the best form of treatment using inorganic coagulants and flocculants to produce the highest quality water.

Irish PharmaChem | Industry Buyers Guide 2019


The Chemifloc Group Irelands largest indigenous manufacturer supplier and distributor of Water treatment and Industrial bulk Chemicals GI CHEMICALS DAC a newly formed subsidiary within the Chemifloc group formerly traded as Gouldings Industrial Chemical. ISO 9001.2015 and IBEC certified the Group has operations located in Shannon, Foynes, Cork and New Ross

Supplying to Industry the following: • Caustic soda Solutions • Sulphuric Acid solutions • Hydrochloric acid solutions • Caustic Potash solutions • All bulk formats catered for all industry sectors Contact us at:

info@gichemicals.ie

Supplying to Industry the following: • Flocculent and Coagulant aids for water and waste treatment processes • Odour and Septicity control chemicals • Disinfection chemicals • PH correction chemicals • CHEMLABS Laboratory Analytical services for water systems Contact us at:

info@chemifloc.ie

Chemifloc Group Smithstown Industrial Estate, Shannon, Co. Clare, V14 VY67 Phone: +353-61-708699 Website: www.chemifloc.ie www.gichemicals.ie


LOGISTICS Kuehne + Nagel continue to invest in solutions which focus on high compliance and regulatory standards for the pharma and healthcare industry.

Kuehne + Nagel Focus on the Future Director of Pharmaceutical + Healthcare for Kuehne + Nagel Ireland, Adam O’Sullivan, talks about investing in logistics solutions for the pharmaceutical and healthcare industry.

have this standard across all three transport modes - air, road and sea - in strategically located IATA CIEV certified stations. “Kuehne + Nagel was the first company in the logistics industry to be given IATA certification for its entire pharma air network,” continues O’Sullivan. “We also continue to invest locally for pharma companies with a newly built bespoke facility in Dublin which has been HPRA certified for temperature controlled requirements. We have also recently upgraded our facilities in Cork to the same standards.”

Logistics solutions for the pharma and healthcare industry are among the most important growth drivers for Kuehne + Nagel’s business as they continue to invest in solutions for this industry. In particular, their focus continues to be on offering solutions which focus on high compliance and regulatory standards for the pharma and healthcare industry. “We have over 2,000 people in our global care team who are trained, GxP compliant professionals across our network that monitor and deliver consignments according to the strict and precise requirements pertaining to the industry,” notes Adam O’Sullivan, Director of Pharmaceutical + Healthcare for Kuehne + Nagel Ireland. “This means that every single touchpoint is only managed by a person who is an expert in GxP compliance. Moreover, we

With the ongoing market growth for temperature-controlled shipments, Kuehne + Nagel is investing in its European pharma fleet to strengthen the KN PharmaChain overland service in the region. Kuehne + Nagel has successfully deployed 35 new pharma trailers and before the end of 2018, another 45 are being added to the existing fleet, with a further planned expansion of 200 trailers in the coming years. This pharma fleet is part of the KN PharmaChain network, providing multimodal GxP compliant door-to-door shipping on a global scale, enhanced visibility and traceability of the deliveries, as well as intensive and proactive risk management and integrated warehousing services. The new pharma trailers are fully GxP compliant and offer state-of-the-art technology for temperature controlled

Investing in its Pharma Fleet

transports, including dual temperature, double-deck equipment, TAPA (Transport Asset Protection Association) compliant integrated security locks to be opened remotely with a unique code, integrated control panel, printer for temperature report and GPS control for positioning, temperature, door sensors, coupling and technical status.

Analysing Risk “Moreover, we have a dedicated team in Kuehne + Nagel Ireland who analyse the risks when transporting goods in advance of the goods moving,” O’Sullivan advises. “The team can then offset those risks with the use of technology. In simple terms, they analyse routes and modes of transport and advise pharma companies before they send their shipment of a better alternative in order to minimise the risk of temperature deviation, for example.” In today’s strict regulatory environment, there is certainly no shortage of regulations that pertain directly to the pharmaceutical industry. “Quality is of the utmost importance at Kuehne + Nagel and we have integrated high standards of quality into the heart of the operation of our business,” O’Sullivan maintains. “Locally, here in Kuehne + Nagel Ireland, we go beyond just the industry standards of quality. We actively invite our customers to perform their own audits at our premises, allowing them to inspect our quality standards and procedures first hand.”

For more information, contact Adam O’Sullivan, Director Pharma + Healthcare, Kuehne + Nagel Ireland. Email: adam.osullivan@kuehne-nagel.com. Tel: (01) 8239777. Irish PharmaChem | Industry Buyers Guide 2019 62


Active Pharmaceuticals

Expansion at Hovione Ireland Hovione Loughbeg supplies medium and large-scale manufacturing active pharmaceutical and drug product intermediates that are approved by European, US and Asian health authorities. Over the last four years, the site has continued to successfully transfer new products, acquire new business, achieve multiple regulatory approvals and attract key talent to the site, which now boasts close to 200 team members.

Adding Capacity In May 2018, Hovione concluded the re-instatement of a second active pharmaceutical ingredient building on the site, adding further significant

capacity, technical capability and expansion opportunities. This promising expansion creates career development opportunities for existing and new team members. The site now has all three production buildings in operation for the first time in its history. This major investment in the Loughbeg facility will enable further diversity in the product portfolio and brings major additional capacity to the Hovione group, providing enhanced flexibility and agility to both existing and future customers. “We at Hovione Ireland are looking forward to celebrating our 10th year of operation in 2019,” explains Paul Downing, Hovione Ireland General

Manager, “which is also the 60th anniversary of the founding of the company in Portugal.”

In It For Life “Hovione is a pharmaceutical company dedicated to helping pharmaceutical customers bring new and off-patent drugs to market,” Downing explains. “We do well what is difficult, to give our customers what they cannot find elsewhere.”

hovione.ie

Irish PharmaChem | Industry Buyers Guide 2019

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Environmental Services

Giving Industry the Competitive Edge Veolia helps Irish pharmaceutical and chemical companies to remain both sustainable and competitive. To stay competitive, today’s industries need to work exceptionally hard – to keep production costs low, reduce CO² emissions and meet the strictest environmental, quality and regulatory targets. But without the right solutions in place, achieving those goals can seem like an impossible task.

Knowledge and Expertise No one understands that better than Veolia. Across Ireland, they work with all the major industry sectors to help their customers remain competitive and sustainable. “With our knowledge and expertise, we deliver the guaranteed services that optimise energy and water use, maintain your facilities, recycle materials and manage your hazardous waste,” explains Fergus Elebert, Regional Director. “By doing this, we enable you to focus on your core business and innovation, while we ensure your operations get complete support. Our approach means we work in partnership with your teams to help you reduce costs, improve

your green credentials and achieve energy security.”

24/7 Year-Round Support The fast paced development of the pharmaceutical and chemical industries require an adaptive and flexible service to maintain product quality and output. Veolia’s complete sustainable facilities management services are designed to give you the competitive edge with industry-leading solutions and 24/7 support. It’s built on solid experience gained working at more than 4,000 industrial sites globally and backed by a deep understanding of the challenges and issues that industry faces in terms of performance, production and compliance.

Guaranteed Services Veolia designs and implements solutions aimed at improving access to resources, while at the same time protecting and renewing those same resources under its ‘Resourcing

the World’ strategy. “Our global presence and our diverse range of skills means that we can deliver a truly integrated range of energy, utilities, maintenance, calibration, water treatment, hazardous waste disposal and total waste management services,” Elebert notes. “We back these with risk guarantee schemes that protect your plant from outages and ensure you receive a guaranteed supply. This includes replacing or refurbishing plant that underperforms or fails, without you incurring additional costs. We can apply the same guarantee to operation and maintenance contracts for core activities and additional back-up services. So with Veolia you can enjoy total peace of mind, guaranteed.”

Optimising Utilities and Cutting Carbon As part of their utilities management services, Veolia can investigate how and where energy and water is used on-site. By focusing on the efficiency of all your systems and processes, they can recommend a programme of upgrades to equipment and operations that could reduce your energy use even further. “To ensure our solutions exactly match your needs, we have highly qualified engineers, designers and software systems specialists,” reveals Sean Molloy, Director of Business Development. “They work to exacting standards to ensure you benefit from cost-efficient and sustainable long-term solutions that are seamlessly implemented.”

“Our success supports on your success” Veolia’s partnership approach ensures that your current and future needs are identified and met, delivering real benefits, including: guaranteed energy and carbon reduction, risk based maintenance strategies, security of supply, flexible operation to suit market conditions and carbon strategy, sharing the risk and reward, greater accountability and environmental capability support. “The success is reflected in your bottom line,” Molloy concludes, “as our performance gives you class leading results that boost both your CR reports, and your annual reports.” To learn more about how Veolia can help you contact Sean Molloy on (01) 8701200; email sean.molloy@veolia.com or visit www.veolia.ie.

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Irish PharmaChem | Industry Buyers Guide 2019 1


Resourcing the world

Giving industry the competitive edge To stay competitive, industry today needs to work exceptionally hard – to keep production costs low, reduce CO2 emissions and meet the strictest environmental, quality and regulatory targets. To find out how Veolia’s range of sustainable resource management solutions can help you unlock efficiencies and achieve your goals call Sean Molloy on (01) 870 1200, email: sean.molloy@veolia.com or visit: www.veolia.ie

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Waste Management

Safe and Sustainable Waste Management

Indaver help convert waste to energy at their Meath plant.

Indaver are helping to use less fossil feedstocks and limiting their environmental impact through safe and sustainable waste management, writes Dr Ruth Appelbe, Industrial Waste Services Manager. For a clean and safe planet, we have to use less primary and fossil feedstocks and recover, reuse and recycle materials efficiently. Indaver are making this possible with sustainable waste management, as well as protecting the materials chain from contamination and limiting our impact on the environment.

Energy Recovery We recover energy from waste through thermal treatment. This energy goes to heating networks, such as the new industrial steam network ECLUSE in the port of Antwerp, and to electricity grids, such as in Meath. It is supplied to users as steam, heating and electricity. This approach has a lot of advantages. Indaver are avoiding and reducing CO2 emissions. We are reducing dependency on limited fossil fuels, replacing them with renewable energy sources, such as green gas from composting VGF waste.

Materials Recovery We have to be sure that the products that are made from recovered raw materials have the same quality as products from primary raw materials and that they are equally safe. In Indaver’s high-tech installations, we recover as many valuable high-quality materials as possible from the waste we treat. We supplement mechanical recycling methods with new techniques for chemical and thermal recycling, such as molecule management.

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This breaks down hazardous industrial and pharmaceutical waste to its basic building blocks. New high-quality products are then made from these building blocks.

Protecting the Food and Materials Chain At the same time, we are protecting the environment and the food and materials chains from contamination. In Indaver’s thermal treatments, we are not just recovering energy; we are also destroying the hazardous residues that must not end up in the materials chain. Any contaminants we can’t destroy are treated and/or stored away securely. That is our ‘Safe Sink’ guarantee. This prevents hazardous particles from causing any damage, now or in the future.

Dr Ruth Appelbe, Industrial Waste Services Manager, Indaver Ireland.

Impact on the Environment Finally, Indaver are trying to keep the environmental impact of our own activities to a minimum. We monitor this closely and aim to have a minimal impact on the air, water and soil. Indaver use water and energy sparingly in our own processes. We are always looking for ways to reduce our own use of raw materials and we substitute new materials with recovered materials where possible. We try to limit our ecological footprint when transporting waste. In fact, Indaver’s activities meet the strictest environmental standards. Irish PharmaChem | Industry Buyers Guide 2019


Pharma Waste Experts n Reliable and financially stable partner n Over 30 years experience of Irish waste industry n Maximum material & energy recycling using own Irish Waste-to-Energy facilities n Full compliant & traceable waste management n User-friendly, secure online portal with in-depth reporting n EU organisation offering a broad range of solutions

info@indaver.ie | Tel. +353 1 280 4534 | www.indaver.ie


blin eather erprise ng

Biotechnology

Introducing MSD Biotech, Dublin In early 2018, MSD, also known as Merck & Co., Inc. of Kenilworth, NJ, USA, announced plans to develop a new biotechnology facility in Dublin, with the expected creation of up to 350 new jobs. Known as MSD Biotech, Dublin, the facility will be constructed on an existing MSD-owned property, the site of its former facility in Swords, Co. Dublin. It will play a pivotal role in the manufacture of MSD’s biologics-based medicines, including in the area of immuno-oncology, and will expand MSD’s current internal network of biologics drug substance manufacturing plants. Site preparation, facility design and construction are well underway and full manufacturing operations are expected to begin in 2021. The new site will be led by Michael Flanagan, an experienced biopharma operations director with over 25 years’ experience, most recently as Director of Manufacturing with BMS.

Exciting Career Opportunities “The medicines made in this facility will treat some of the world’s most challenging conditions and illnesses and will positively

impact patient lives not only in Ireland but worldwide,” explains Ger Brennan, Managing Director of MSD Ireland (Human Health) Ltd. “The careers that will be available in this facility and in MSD’s sites across Ireland offer graduates and those already in the sector some of the most exciting career opportunities in the world. The expansion of our presence in Ireland is a testament to the talent of our Irish employees and the standard of our existing operations. It reinforces MSD’s commitment to Ireland and our standing in the global network.” MSD Ireland is one of the country’s leading healthcare companies, having first

established here over 50 years ago. The company currently employs over 1,900 employees, across four sites in Ballydine, Co. Tipperary; Brinny, Co. Cork; Carlow and Dublin, and in addition, operates substantial human health and animal health businesses. Details about open roles in MSD, Ireland are available on www.msdirelandjobs.com.

Pictured at the launch of MSD Biotech, Dublin are: Martin Shanahan, CEO, IDA Ireland; Heather Humphreys TD, Minister for Business, Enterprise and Innovation; and Ger Brennan, Managing Director of MSD Ireland (Human Health).

Barcoding

Holfeld’s Axicon 15000: A Fresh approach to Barcoding The Falsification of Medicines Directive and Unique Device Identification for healthcare products require global standards for labelling. The traceability data needs to be encoded into one dimensional and two dimensional barcodes, which must be easy to scan in the appropriate environment, for example at the hospital bedside, in a pharmacy or in distribution. GS1’s general specifications define suitable barcodes and barcode sizes for a particular environment in their application specification tables. The data in the barcodes is encoded in a defined format to allow correct processing. The GS1 system defines a set of fixed length and variable length fields, each labelled by an Application Identifier (AI). The Axicon 15000 series verifiers take a fresh approach. The user can select the application specifications that they wish to comply with. The verifier can be set up to check against particular application specification tables in

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number (in the old CEN standard) and as letter (in the old ANSI standard).

Sample screens for 1D and 2D barcodes the GS1 general specifications. The print quality of the code is verified to ISO/IEC 15415 for 2D

barcodes or to ISO/IEC 15416 for linear barcodes. The print quality is given a grade, which is expressed as a

User-Friendly System The verifier uses the measuring aperture specified in the application specification. If there is a conflict (e.g. the barcode may be at an applicable size for healthcare retail or healthcare distribution), then the software will ask you to make a choice. This is a user-friendly way of ensuring that not only is the barcode readable but that it is the correct symbology, the correct size and that the data is properly formatted. The data checks include ensuring that the mandatory Application Identifiers are used and that they are presented in the right order. The use of the verifier and the recording of data can be controlled in a way that is consistent with 21CFR part 11. Access to the program is restricted by harnessing the security features of the Windows operating system.

Irish PharmaChem | Industry Buyers Guide 2019


INVENTING FOR LIFE At MSD we have and always will be... Inventing for Life. These three powerful words reflect our commitment to inventing new medicines and vaccines that save lives by preventing and fighting disease. MSD Ireland is one of the country’s leading healthcare companies, having first established here over 50 years ago. We currently employ over 1,900 employees across four sites in Ballydine, Co Tipperary, Brinny, Co Cork, Carlow and Dublin, with an additional site, MSD Biotech, Dublin planned for 2021. We have substantial Human Health and Animal Health businesses, have invested $2.5 billion in our Irish operations and are consistently ranked as one of Ireland’s top 20 companies. A member of Guaranteed Irish, we are proud to be one of Ireland’s leading exporters and our Irish sites manufacture approximately half of MSD’s top twenty products, saving and enhancing lives in over sixty countries around the world.

Learn more about the opportunities available in MSD Ireland at www.msdirelandjobs.com

Copyright © 2018 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All Rights Reserved.

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Data Integrity of LAL, requiring minimal preparation and no technical training, removing as much potential for human error as possible. The flexible Endosafe testing platforms all generate the objective electronic data that has become the expectation in today’s high volume testing environment. Calculations and analysis performed by the readers likewise remove user subjectivity, providing a clear picture of product quality that is essential to both mitigate risk and maintain cGMP compliance. Discover how to remove subjectivity from your endotoxin testing at www.criver.com/cartridges.

Accugenix Microbial Identification

How Are You Addressing Risk Management and Data Integrity? Charles River Microbial Solutions addresses data integrity in the QC Lab and the importance of delivering accurate, relevant and reliable data to fuel confident decisions on product quality and contamination control. Data drives every decision in the lab, so ensuring it is accurate, relevant, and reliable is critical to support confident decisions on product quality and safety. Patients expect their medications to be safe and effective. Consequently, a drug’s safety requirements extend beyond clinical trials and must be upheld through a rigorous QC testing program. As the foundation for cGMP compliance, data is an essential component of an organisation’s quality system. It can be challenging to securely collect, manage, and maintain data that is accurate and valid. With an increase in FDA warning letters and cGMP inspection violations, regulatory agencies are setting the expectation that organisations be proactive in their efforts at adhering to data integrity standards.

Newly issued global guidance documents communicate the increasing requirements on data integrity, making many organisations aware of existing gaps and deficiencies in their data and reporting.

Endosafe Endotoxin Testing Through reducing much of the time, accessories, and subjectivity associated with the traditional qualitative gel-clot test, Endosafe LAL cartridge technology has long supported micro QC managers’ efforts to produce rapid, accurate endotoxin results, while adhering to rigorous data integrity standards. The need for the preparation of standard curves and long incubations has been eliminated, as their cartridges provide quantitative results in 15 minutes. The robust assay optimises the use

A drug’s safety requirements extend beyond clinical trials and must be upheld through a rigorous testing programme.

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Accurate identification of microorganisms is an important part of a comprehensive environmental monitoring (EM) program. Many phenotypic identification (ID) methods rely on visual reads of the assay, depending mainly on human interpretation of the final result. Errors or misinterpretation in phenotypic assay readouts can lead to inaccurate data, which jeopardises data integrity. Accugenix identification services and Axcess system offer well-designed and controlled genotypic and proteotypic methods that provide objective results. Relevant reference libraries and consistent procedures optimised for pharmaceutical applications further promote accurate results and minimise the breach of integrity with critical microbial ID data. See how to minimise contamination risk and maximise control over EM at www.criver.com/accugenix.

Celsis Rapid Microbial Detection The recent trend toward the ‘four eyes principle’ as a safeguard against subjectivity in result reporting suggests that the occurrence of analyst-dependent errors is becoming more apparent in traditional testing. Relying on selfgoverned methods such as visual inspection can yield inconsistent results through differences in opinion, experience, or even an analyst’s visual acuity. When combined with a manual or analyst-dependent result reporting process, establishing a reliable audit trail can generate unnecessary risk. Efficient quality control labs realise that rapid microbial methods, such as the Celsis system, not only provide functional operation benefits for day-to-day efficiency, but also mitigate subjectivity from testing through the use of objective and reagent-based automated testing, coupled with comprehensive data analysis and result reporting software. Learn the operational and risk mitigating advantages of Celsis at www.criver.com/celsis. Addressing data integrity in the QC lab is a drug’s safety requirements extended beyond clinical trials and must be upheld through a rigorous testing programme. As the foundation for current Good Manufacturing Practice (cGMP) compliance, data is an essential component of an organisation’s quality system. View more resources on www.criver.com/data. Irish PharmaChem | Industry Buyers Guide 2019


How confident are you in your data? In its accuracy? Security? Integrity? Data drives every

manufacturing process can lead to product release

decision in the lab, so ensuring it’s right, reliable, and

delays and added costs. Standardize your microbial QC

complete is critical to powering confident decisions

testing and quality assurance program with our portfolio

on product quality and contamination control. Not

of Endosafe® endotoxin testing, Celsis® rapid microbial

having accurate answers at critical junctures in your

detection, and Accugenix® microbial identification.

Take control of the integrity of your data at www.criver.com/MicrobialSolutions


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SPECIALIST
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capacity chillers to medical storage cabinets and temperature control systems. Cross Technical Solutions Ltd. PRODUCTS
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Utilising
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and
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our
clients
to
be
fully
compliant
with
the
current
 legislative
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environmental
guidelines.
We
provide
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Equipment,
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Rated
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and
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a
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and
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Pharmaceutical
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in
particular,
we
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first
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our
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base
when
it
comes
to
servicing,
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and
replacing
all
types
refrigeration
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from
large
capacity
chillers
to
medical
storage
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temperature
control
systems.

www.crosstechnicalsolutions.ie

Cross
Technical
Solutions
Ltd.
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26,
Cookstown
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Technical
Solutions
Ltd.
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Tallaght,
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24
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26,
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Ireland
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Tallaght,
Dublin
24
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405
6777
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Ireland
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(+353)
01
4136932
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405
6777
 sales@crosstechnicalsolutions.ie
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4136932
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 sales@crosstechnicalsolutions.ie

www.crosstechnicalsolutions.ie


Workwear Professional workwear is one of the key components for most successful companies. What one wears often defines the person. In other words, clothes can make the man or woman. The benefits of appropriate workwear are many and can bring great rewards both to companies and to their staff in terms of saving costs, looking professional, boosting morale and increasing productivity. Providing a workforce with professional and suitable work attire can also improve the overall security and safety of a workforce, particularly if the company is one which might have a sensitive work environment. The pharmaceutical industry is one such sector. Employees working in this area often need to be protected from what can be a hazardous and critical work environment, involving sensitive pharmaceutical products and processes and where there can be many contaminants, such as chemical substances and non-hazardous and hazardous particles. Thankfully, those working in the pharmaceutical industry all over Ireland can now access the clothing that they need through a garment dispensing machine that has been introduced to Europe by a progressive business in rural County Cork. Effectively, ScrubEx is a garment dispenser and returns system that will soon prove indispensable to those working in the pharmaceutical industry. The ScrubEx system gives rapid access to garments necessary to those employed in the pharmaceutical and other similar industries. This innovative product from O’Flynn Medical means that it takes just six seconds for an authorised staff member, using the correct ID Card or similar, to access their garments. Ultimately, it results in minimal disruption to the already pressurised working day.

Reducing Workwear Replacement Costs ScrubEx has been a great success since O’Flynn Medical brought it to the market in 2008. Over 100 ScrubEx systems have been installed since then, as more and more companies recognise it as a worthwhile investment, which can provide up to a 40% reduction in usage of scrub suit or workwear textiles. This is because the machine eliminates all unauthorised scrub use by using a credit system that dictates how many garments a staff member can have at any one time, resulting in reduced garment use and simultaneously providing an audit trail of how often staff members change and launder their garments. This ultimately has large cost savings, as well as ensuring the safety and protection of employees and company processes and products. The machines themselves are quick and easy to fill. Overall, they can reduce scrub suit or workwear replacement costs by up to 90%, making the machine ideally suited to the Irish PharmaChem | Industry Buyers Guide 2019

Deirdre O’Flynn and Robbie Halley are pictured at the installation of ScrubEx at Dairygold’s nutritional complex in Mallow, Co. Cork.

ScrubEx: Your Workwear Partner

ScrubEx, the scrubs dispensing machine, can provide up to a 40% reduction in the usage of scrub suits or workwear textiles, writes Aileen Hickie Cooper.

pharmaceutical industry. “We ensure the ScrubEx assessment and implementation is as easy as possible for companies, by getting to know the current process the facility is using and addressing any local concerns prior to a decision being made,” explains Conor O’Flynn, Chief Operations Officer of O’Flynn Medical.

Family-Run Company ScrubEx is only one string in the bow of O’Flynn Medical. The family-run company, based in Millstreet, Co. Cork, was started in 2000 by Tadhg and Anne O’Flynn and has since become one of Ireland’s leading medical equipment suppliers. ScrubEx has been an integral part of that expansion and attracted the interest and

investment of many companies both within and outside the healthcare sector. This expansion has meant increased employment at the Millstreet-based headquarters, where over 27 staff are now working. The company also has offices in the UK and Germany, as well as regional depots in Dublin, Clonmel, Tralee and Galway. Being a family-run company means O’Flynn Medical has a personal appreciation of its clients and values their custom, as many are long term customers of the company. “The success of the company can be attributed both to the quality products we supply and the wonderful team we have, who work tirelessly to ensure customer satisfaction,” concludes Tadhg O’Flynn.

73


Material Handling Henley offers nationwide service, and its team of engineers undergoes continuous training, which ensures the highest standard of knowledge on each machine.

Henley: Raising the Bar on Forklifts

Henley Forklift Group has been providing nationwide material handling solutions to Irish clients since 1973. Founded in 1973, Henley Forklift has secured its position as a leading supplier of material handling equipment and service in Ireland over the last 45 years. During this time, Henley has worked closely with the pharmaceutical and life sciences industry, keeping pace with innovations within the sectors and providing specific handling solutions to meet the significant changes that have occurred in material handling and logistics.

Henry Forklift Group’s portfolio includes Rocla’s very narrow aisle Automated Guided Vehicles.

74

For almost 40 years, Henley has been the sole Irish distributor of the complete range of Mitsubishi Forklift Trucks. Mitsubishi has seen considerable expansion in recent years, with its acquisition of UniCarriers and Rocla Automated Guided Vehicles (AGV). From conventional forklift trucks, to warehouse handling equipment and narrow aisle AGVs, the range of equipment offered by Henley meets the requirements of today’s demanding market. To support the pharma industry, Henley offers both purpose-built and converted equipment to operate in hazardous environments and in cleanroom applications. Henley’s German partner, Sichelschmidt GmbH is a manufacturer of purpose-built, ATEX Certified explosionproof forklifts and cleanroom handling equipment. Where modifications to forklift trucks are needed to meet the requirements of Zone 1/21 and Zone 2/22, Henley works closely with Mitrex BV and Pyroban to deliver machines that meet their clients’ specifications. Henley also offers an extensive range of hygienically designed stainless steel equipment, both manual and powered, to meet the demands of this growing sector.

Nationwide Service Network Henley’s regional service network is well known throughout the country and widely respected for the level of efficiency and expertise provided. Its team of engineers undergoes continuous training, which ensures the highest standard of knowledge on each machine. With this expertise, Henley engineers aim to achieve a very high first-time fix rate. The company has developed a solid network of highly trained people across the country, north and south, ensuring that customer support is local in all regions. “Each local team cares for the customers in their area; they are our top priority,” explains Brian O’Connell, Sales Director. “Our customers gain the advantage of having a fully-serviced local office within easy reach to deal with all sales, hire or service requirements as they arise.”

Rental Fleet In addition to its sales and service offerings, Henley maintains a sizeable rental fleet from each of its regional offices. The machines are both modern and well-equipped to meet the demand for short and long-term hire. Many customers also benefit from Henley’s fleet management service, which provides a designated fleet manager to advise on the best way to manage and improve forklift usage, thereby controlling the total cost of ownership. Today, Henley continues to broaden its product and service offering, with a view to delivering cost effective and efficient solutions to its clients. It has leveraged its 45 years of experience and the expertise garnered over that time to the benefit of all its customers throughout Ireland . Irish PharmaChem | Industry Buyers Guide 2019



Containment Systems

The Containment Experts ProSys Containment and Sampling Technology is a market leader in the design, manufacture and servicing of containment systems, aseptic (ISO 5) isolators and sampling equipment for the bio-pharmaceutical sector. ProSys have specialist in-house knowledge, experience and capabilities for the management of peptides, ADC’s, vaccines, cell therapies and cultures within high containment and Grade A ISO5 micro environments. The bio-pharmaceutical market today is characterised by competing forces, such as strong market growth, emerging product pipelines (particularly centred on oncology and cell therapy treatments), combined with increasing globalisation and governmental influence. These developments within the industry are being reflected in the geographic reach of ProSys installed systems, with the company now having a well-established presence in all major markets from Europe to the USA and Asia.

More Complex Containment Isolation Systems As the nature of pharmaceuticals migrates towards small volume, more personalised treatment models, the nature of their business is also changing. Containment isolator systems are becoming more complex, larger and with higher containment performance targets. Entire process steps such as reaction, crystallisation, separation, lyophilisation, drying etc are now being integrated into isolator operations. ProSys’ involvement in projects now begins much earlier than in the past; typically at feasibility or concept stage, where they work with clients to define process steps, containment boundaries and equipment configuration. This early engagement approach speeds up decision

42 76

When it comes to containment systems, aseptic isolators and sampling equipment for biopharmaceuticals, ProSys Containment and Sampling Technology are the experts.

making; equipment lead times and ultimately has traditionally been focused on ‘operator ‘speed to market’ for drug product. protection’, the latter has concentrated on ‘product protection’ using Grade A (ISO5) micro environment isolator systems, typically Increasing Potency of with integrated bio-decontamination systems Active Ingredients based on H202. ProSys has a well established In addition to the equipment itself becoming presence within the aseptic market, providing more complex, a key emerging trend within complex ‘engineered to order’ systems for the industry is the increasing potency of active vaccines production, filling applications and ingredients used in drug manufacturing, sterility testing. particularly for ADCs (anti-body drug A recent example of their work in this area conjugates). ProSys is actively working with its was the supply of two no. ISO5 Grade A isolators client base on <10ng/m3(OEB6) containment projects, concentrating specifically on for vaccine production. The equipment had developing containment protocols, testing integrated incubator systems, which were methodologies etc to ensure consistent, designed and built by ProSys in addition to a verifiable equipment performance during vial filling system. operation. As an organisation, ProSys operates within Potent Compound Handling both the traditional API manufacturing and ProSys are now also working with clients on the biologics market sectors. While the former potent compound handling within aseptic ISO5 isolator environments. Innovative solutions to maintaining aseptic isolator conditions, whilst mitigating against potential operator exposure to potent compounds, are being developed by ProSys, in collaboration with their clients. The design and manufacture of liquid and powder sampling systems continues to be Containment a core competence of ProSys, as their range isolator systems of equipment is highly regarded by the are becoming pharmaceutical industry for its ability to provide more complex, consistent, representative and verifiable results. larger and As the bio-pharmaceutical market continues with higher to change and develop, so also does ProSys. containment However, their business continues to be performance based on a ‘customer intimacy’ model with a targets. deep understanding of client needs, excellent equipment to match those requirements, and superior service and attention to detail throughout the product life cycle.

Irish PharmaChem | Industry Buyers Guide 2019


ProSys Isolator Technology for the Biopharmaceutical Industry ●

ASEPTIC FILL ● STERILITY TEST ● CELL/GENE THERAPY ● PRODUCT CONTAINMENT ● PROCESS INTEGRATION

ProSys Group IDA Industrial Park, Carrigtohill, Co. Cork. Tel: +353 21 4853900 www.prosysgroup.com



CHEMICAL SUPPLIERS

2 0 1 2

Acids & alkalis AQS Environmental Solutions Associated Chemicals Ltd Brenntag Ireland Camida Ltd Charles Tennant & Co Ltd Chemco Ireland Ltd Chemifloc Ltd Fisher Scientific Ireland Ltd Goulding Chemicals Ltd Heterochem Dist Ltd National Chemical Company Ocon Chemicals Ltd Q1 Scientific Solv-Echem Ireland Ltd Univar

Activated carbons Associated Chemicals Ltd Brenntag Ireland Chemco Ireland Ltd Chemifloc Ltd Fisher Scientific Ireland Ltd National Chemical Company Univar

Charles Tennant & Co Ltd Chemco Ireland Ltd Corcoran Chemicals Limited Heterochem Dist Ltd National Chemical Company P.K. Chemicals Ltd Univar

fine chemicals A&C Your Global GMP Partner Arran Chemical Company Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Betco Marketing Ltd Brenntag Ireland Camida Ltd Chemco Ireland Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd National Chemical Company Ocon Chemicals Ltd SK Biotek Solv-Echem Ireland Ltd

gases National Chemical Company

ACTIVE PHARMACEUTICAL INGREDIENTS SK Biotek

biochemicals Arran Chemical Company Associated Chemicals Ltd Betco Marketing Ltd Camida Ltd Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Pharmalex Univar

biocides Associated Chemicals Ltd Brenntag Ireland Camida Ltd Chemifloc Ltd Fisher Scientific Ireland Ltd Heterochem Dist Ltd Univar

catalysts Arran Chemical Company Associated Chemicals Ltd Camida Ltd Fisher Scientific Ireland Ltd National Chemical Company

chiral compounds Arran Chemical Company Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Camida Ltd Fisher Scientific Ireland Ltd Hovione Ltd National Chemical Company SK Biotek

excipients A&C Your Global GMP Partner Associated Chemicals Ltd Betco Marketing Ltd Brenntag Ireland Camida Ltd

Irish PharmaChem | Industry Buyers Guide 2019

heterocyclics Arran Chemical Company Associated Chemicals Ltd Camida Ltd National Chemical Company

INDUSTRIAL chemicals Chemifloc Ltd

inorganic chemicals Associated Chemicals Ltd Brenntag Ireland Camida Ltd Chemco Ireland Ltd Chemifloc Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd Langanbach Services Ltd National Chemical Company Solv-Echem Ireland Ltd Univar

laboratory reagents Associated Chemicals Ltd Chemifloc Ltd Fisher Scientific Ireland Ltd Heterochem Dist Ltd Ocon Chemicals Ltd P.J. Bonner & Company Solv-Echem Ireland Ltd Water Chromatography Ireland

Misc. chemicals

Arran Chemical Company Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Brenntag Ireland Camida Ltd Chemco Ireland Ltd Chemifloc Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Ocon Chemicals Ltd P.K. Chemicals Ltd Solv-Echem Ireland Ltd Univar

oilS, fats and waxes

Associated Chemicals Ltd Brenntag Ireland Charles Tennant & Co Ltd Corcoran Chemicals Limited Heterochem Dist Ltd

organic intermediates Arran Chemical Company Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Betco Marketing Ltd Camida Ltd Fisher Scientific Ireland Ltd Hovione Ltd National Chemical Company Roche Ireland Ltd SK Biotek Univar

organometallics Arran Chemical Company Associated Chemicals Ltd Camida Ltd

reagents Associated Chemicals Ltd Camida Ltd Chemifloc Ltd Fisher Scientific Ireland Ltd Heterochem Dist Ltd National Chemical Company Ocon Chemicals Ltd Water Chromatography Ireland

silanes Arran Chemical Company Associated Chemicals Ltd Brenntag Ireland Camida Ltd Fisher Scientific Ireland Ltd Heterochem Dist Ltd Ocon Chemicals Ltd Univar

solvents A&C Your Global GMP Partner Betco Marketing Ltd Brenntag Ireland Camida Ltd Charles Tennant & Co Ltd Chemco Ireland Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd National Chemical Company Ocon Chemicals Ltd Teva Pharmaceuticals Ireland Univar Water Chromatography Ireland

surfactants A&C Your Global GMP Partner Associated Chemicals Ltd Brenntag Ireland Camida Ltd Charles Tennant & Co Ltd Chemifloc Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Langanbach Services Ltd Univar

WATER /WASTE WATER TREATMENT CHEMICALS

Chemifloc Ltd

79


GENERAL SUPPLIERS

2 0 1 2

ACTUATORS WrenTech Ltd

AERATORS WrenTech Ltd

AGITATORS CPI Technology Ltd Quitmann O’Neill WrenTech Ltd

AIR / ROAD / OCEAN FREIGHT Hazchem Training Ltd

ALUMINIUM PRODUCTS Chemifloc Ltd Quitmann O’Neill

ANALYSIS SERVICES Almac Sciences Ltd Anecto Chemifloc Ltd Corcoran Products Ltd Eurofins Biopharma Product Testing Particular Sciences Ltd

ANALYTICAL EQUIPMENT ABB Ltd Chemifloc Ltd Eurolec Instrumentation Ltd Fisher Scientific Ireland Ltd LABPLAN Particular Sciences Ltd P.J. Bonner & Company

ASSOCIATIONS GS1 Ireland

AUTOCLAVES Fisher Scientific Ireland Ltd Ocon Chemicals Ltd WrenTech Ltd

AUTOMATION ABB Ltd Callaghan Engineering Goliath Packaging Systems Ltd LABPLAN O’Flynn Medical Ltd P.J. Bonner & Company ProSys Containment and Sampling Technology Weber Packaging Solutions Ltd

BAGGING SYSTEMS Goliath Packaging Systems Ltd

80

BAG IN BOX Goliath Packaging Systems Ltd

BALANCES Fisher Scientific Ireland Ltd Ocon Chemicals Ltd P.J. Bonner & Company

BARCODE VERIFICATION Goliath Packaging Systems Ltd Holfeld Graphics

BARCODING / LABELLING / TRACEABILITY Corcoran Products Ltd Goliath Packaging Systems Ltd GS1 Ireland Indaver Ireland Millmount Healthcare Weber Packaging Solutions Ltd

BIOPHARMACEUTICALS Alkermes Pharma Ireland Limited Almac Sciences Ltd Hovione MSD Ireland National Chemical Company Pharmalex

BIOTECHNOLOGY ABB Ltd Almac Sciences Ltd Callaghan Engineering Labplan MSD Ireland Ocon Chemicals Ltd Particular Sciences Ltd Pharmalex Thornshaw Scientific

BLENDERS Fisher Scientific Ireland Ltd WrenTech Ltd

BLISTERING / DE-BLISTERING Holfeld Graphics

BLOWERS CPI Technology Ltd Flexachem Manufacturing Ltd

BPRV BS&B Safety Systems Ltd

BREATHER VENTS BS&B Safety Systems Ltd Quitmann O’Neill

BURSTING / RUPTURE DISCS BS&B Safety Systems Ltd CPI Technology Ltd Flexachem Manufacturing Ltd

CABINETS Cross Technical Solutions Fisher Scientific Ireland Ltd Weber Packaging Solutions Ltd

CAD Callaghan Engineering

CALIBRATION Endress & Hauser (Ireland) Ltd Eurolec Instrumentation Ltd Holfeld Graphics Labplan Ocon Chemicals Ltd P.J. Bonner & Company Veolia Water Chromatography Ireland

CASE ERECTING / PACKING Goliath Packaging Systems Ltd

CASE SEALING Goliath Packaging Systems Ltd

CENTRIFUGES AQS Environmental Solutions CPI Technology Ltd Fisher Scientific Ireland Ltd Labplan Ocon Chemicals Ltd

CHEMICAL CONSULTANTS A&C Your Global GMP Partner Callaghan Engineering Chemifloc Ltd Corcoran Chemicals Limited Hazchem Training Ltd

CHILLED WATER Daikin Europe

CHROMATOGRAPHY Chemifloc Ltd Fisher Scientific Ireland Ltd Labplan Ocon Chemicals Ltd Water Chromatography Ireland

CLEANROOMS Callaghan Engineering Charles River Microbial Solutions Cross Technical Solutions Dawson Rentals Ireland Ltd Fisher Scientific Ireland Ltd Millmount Healthcare Ocon Chemicals Ltd Irish PharmaChem | Industry Buyers Guide 2019


GENERAL SUPPLIERS CLEANING SERVICES / EQUIPMENT AQS Environmental Solutions WrenTech Ltd

CLINICAL RESEARCH ORGANISATION Charles River Microbial Solutions

COLD CHAIN PACKAGING Cold Move CRS Pharma Solutions Cross Technical Solutions Millmount Healthcare Quitmann O’Neill

COMPRESSED AIR / COMPRESSORS Festo Ltd

COMPUTER SYSTEMS Charles River Microbial Solutions Chemishield Premier Validation Weber Packaging Solutions Ltd

CONDENSORS CPI Technology Ltd Cross Technical Solutions Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

CONDITION MONITORING Charles River Microbial Solutions Flexachem Manufacturing Ltd P.J. Bonner & Company Q1 Scientific

CONSTRUCTION MANAGEMENT Callaghan Engineering Portakabin Allspace

CONSULTANCY Hazchem Training Ltd

CONTRACT DEVELOPMENT & MARKETING Charles River Microbial Solutions Hovione

CONTRACT MANUFACTURING Hovione

CONTRACT PHARMA SERVICES Alkermes Pharma Ireland Limited Avara Shannon Pharmaceutical Services Charles River Microbial Solutions Eurofins Biopharma Product Testing Hovione Indaver Ireland McGee Pharma International Pharmalex

CONVEYORS Goliath Packaging Systems Ltd Weber Packaging Solutions Ltd WrenTech Ltd

Irish PharmaChem | Industry Buyers Guide 2019

COOLING SYSTEMS CPI Technology Ltd Cross Technical Solutions CRS Pharma Solutions Daikin Europe Dawson Rentals Ireland Ltd

DATA ACQUISITION ABB Ltd Charles River Microbial Solutions Eurolec Instrumentation Ltd Labplan P.J. Bonner & Company Weber Packaging Solutions Ltd

DEHUMIDIFIERS CRS Pharma Solutions

DESIGN Callaghan Engineering Graham Hart (Process Technology) Ltd Nelipak Healthcare Packaging Ocon Chemicals Ltd Pharmalex Pilz Ireland Protech Plastics Quitmann O’Neill WrenTech Ltd

DISPERSERS Fisher Scientific Ireland Ltd

DISTILLATION A&C Your Global GMP Partner CPI Technology Ltd Fisher Scientific Ireland Ltd Graham Hart (Process Technology) Ltd Labplan Ocon Chemicals Ltd Soltec (Ireland) LtdDRAINS

DOCUMENTation SOLUTIONS Charles River Microbial Solutions TWi

DRAINS AQS Environmental Solutions

DRIERS CPI Technology Ltd

DRUMS / CONTAINERS Carbon Group Complas Packaging Ltd Corcoran Products Ltd Industrial Packaging Ltd Interpac Ocon Chemicals Ltd Protech Plastics Quitmann O’Neill WrenTech Ltd

EDUCATION & TRAINING Charles River Microbial Solutions CPI Technology Ltd Euraxess GS1 Ireland

Holfeld Graphics HRB Clinic Research Facility Pharmalex Pilz Ireland Science Foundation Ireland (SFI) Water Chromatography Ireland

EFFLUENT MONITORING / TREATMENT Carbon Group Flexachem Manufacturing Ltd Veolia

ELECTRICAL Callaghan Engineering

ELECTRICAL SUPPLY Bord Gais

ELECTRONIC COMPONENTS Pilz Ireland

ENERGY EFFICIENCY / MANAGEMENT Berkley Group Callaghan Engineering Daikin Europe Sustainable Energy Authority of Ireland Veolia

ENGINEERING SERVICES Berkley Group Callaghan Engineering Charles River Microbial Solutions Chemishield Eurolec Instrumentation Ltd Pilz Ireland

ENVIRONMENTAL CONSULTING ABB Ltd Callaghan Engineering Charles River Microbial Solutions Pilz Ireland Quitmann O’Neill Veolia

ENVIRONMENTAL MONITORING Charles River Microbial Solutions

ENVIRONMENTAL SERVICES / EQUIPMENT ABB Ltd AQS Environmental Solutions Charles River Microbial Solutions O’Flynn Medical Ltd Pilz Ireland P.J. Bonner & Company Quitmann O’Neill Veolia

EVAPORATORS Cross Technical Solutions Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd Labplan

EXHIBITION DESIGN & DISPLAY Clip Ltd Ireland

81


GENERAL SUPPLIERS EXPLOSION PROOFING Henley Forklift Group Limited Pilz Ireland

EXPLOSION PROTECTION / PANELS BS&B Safety Systems Ltd CPI Technology Ltd Henley Forklift Group Limited Pilz Ireland

EXTRUDERS BS&B Safety Systems Ltd

FACILITY DESIGN Callaghan Engineering McGee Pharma International Pharmalex

FACILITIES MANAGEMENT AQS Environmental Solutions Hochtief Facility Management Kuehne + Nagel O’Flynn Medical Ltd Portakabin Ireland Ltd Quitmann O’Neill Veolia

FILLING EQUIPMENT Goliath Packaging Systems Ltd Idex Pump Technologies (Ireland) Ltd Quitmann O’Neill WrenTech Ltd

FILTERS CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Idex Pump Technologies (Ireland) Ltd Ocon Chemicals Ltd

FILTRATION Associated Chemicals Ltd CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Ocon Chemicals Ltd

FIRE DETECTION / PREVENTION / PROTECTION BS&B Safety Systems Ltd

FLAME ARRESTERS BS&B Safety Systems Ltd

FLEXCO PLATES Holfeld Graphics

FLOW CONTROL CPI Technology Ltd Flexachem Manufacturing Ltd

FLUID HANDLING CPI Technology Ltd Interpac Labplan ProSys Containment and Sampling Technology Quitmann O’Neill WrenTech Ltd

FUME CUPBOARDS Fisher Scientific Ireland Ltd

82

Ocon Chemicals Ltd

FURNACES Fisher Scientific Ireland Ltd

GAS DETECTION Bord Gais Fisher Scientific Ireland Ltd

GAS SUPPLY Bord Gais Corcoran Products Ltd

GAUGES BS&B Safety Systems Ltd Fisher Scientific Ireland Ltd Ocon Chemicals Ltd

GLASSWARE Associated Chemicals Ltd CPI Technology Ltd Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Quitmann O’Neill

GRINDING CPI Technology Ltd Fisher Scientific Ireland Ltd

HAZARDOUS WASTE DISPOSAL / TREATMENT Chemishield Indaver Ireland Industrial Packaging Ltd Interpac Ocon Chemicals Ltd Quitmann O’Neill Soltec (Ireland) Ltd Veolia

HEALTH & SAFETY / FIRST AID Charles River Microbial Solutions Hazchem Training Ltd Ocon Chemicals Ltd Pilz Ireland

HEAT EXCHANGERS BS&B Safety Systems Ltd CPI Technology Ltd Graham Hart (Process Technology) Ltd Labplan

HOMOGENISERS CPI Technology Ltd Fisher Scientific Ireland Ltd WrenTech Ltd

HOSES CPI Technology Ltd

HUMIDITY / HUMIDIFIERS Dawson Rentals Ireland Ltd Interpac P. J. Bonner & Company

HYDRAULICS WrenTech Ltd

INCINERATION Indaver Ireland Veolia

INCUBATORS Charles River Microbial Solutions Cross Technical Solutions Fisher Scientific Ireland Ltd Ocon Chemicals Ltd ProSys Containment and Sampling Technology

INJECTION MOULDING Allstop Europe Ltd Quitmann O’Neill

INSPECTION EQUIPMENT Holfeld Graphics Lister Machine Tools Ltd O’Flynn Medical Ltd P.J. Bonner & Company Weber Packaging Solutions Ltd

INSTRUMENTATION ABB Ltd BS&B Safety Systems Ltd Callaghan Engineering Charles River Microbial Solutions Endress & Hauser (Ireland) Ltd Eurolec Instrumentation Ltd Labplan Ocon Chemicals Ltd P.J. Bonner & Company

IT Callaghan Engineering Charles River Microbial Solutions Weber Packaging Solutions Ltd Westbourne Global IT Solutions Ltd

INVESTMENT Goodbody Stockbrokers

INVESTMENT PROMOTION AGENCY IDA Ireland

ISOLATORS ProSys Containment and Sampling Technology

LABELLING Goliath Packaging Systems Ltd

LABORATORY EQUIPMENT / SUPPLIES Carbon Group Charles River Microbial Solutions Chemishield Eurolec Instrumentation Ltd Fisher Scientific Ireland Ltd Labplan Ocon Chemicals Ltd O’Flynn Medical Ltd Particular Sciences Ltd P. J. Bonner & Company ProSys Containment and Sampling Technology Solv-Echem Ireland Ltd Westbourne Global IT Solutions Ltd WrenTech Ltd

LABORATORY SERVICES Chemifloc Ltd Irish PharmaChem | Industry Buyers Guide 2019


GENERAL SUPPLIERS LEGAL / FINANCIAL / INSURANCE Goodbody Stockbrokers

LOGISTICS AQS Environmental Solutions C&G Logistics Group Chemco Ireland Ltd Cold Move Kuehne + Nagel Quitmann O’Neill Solv-Echem Ireland Ltd Weber Packaging Solutions Ltd

LIFTS & HOISTS Goliath Packaging Systems Ltd WrenTech Ltd

LIFT TABLES Goliath Packaging Systems Ltd

LIQUID FILLING & CAPPING Goliath Packaging Systems Ltd

MACHINE TOOLS Lister Machine Tools Ltd Soltec (Ireland) Ltd

MAINTENANCE AQS Environmental Solutions CPI Technology Ltd Cross Technical Solutions Eurolec Instrumentation Ltd Hochtief Facility Management Particular Sciences Ltd P. J. Bonner & Company Water Chromatography Ireland Weber Packaging Solutions Ltd

MANUFACTURERS A&C Your Global GMP Partner Abbvie Bemis Healthcare Packaging BS&B Safety Systems Ltd Daikin Europe Endress & Hauser (Ireland) Ltd Eurolec Instrumentation Ltd Portakabin Ireland Ltd Quitmann O’Neill Thornshaw Scientific

MATERIALS HANDLING / FORKLIFTS / PALLET TRUCKS Goliath Packaging Systems Ltd Henley Forklift Group Limited Interpac Toyota Material Handling Ireland Ltd Weber Packaging Solutions Ltd WrenTech Ltd

MECHANICAL ENGINEERING SERVICES Berkley Group Callaghan Engineering CPI Technology Ltd Pilz Ireland Veolia Weber Packaging Solutions Ltd

MECHANICAL & PROCESS ENGINEERING Callaghan Engineering CPI Technology Ltd P. J. Bonner & Company Weber Packaging Solutions Ltd Irish PharmaChem | Industry Buyers Guide 2019

MEDICAL DEVICE MANUFACTURE B. Braun Medical Charles River Microbial Solutions

MEMBRANE FILTRATION SYSTEMS Microfiltration: Fisher Scientific Ireland Ltd Nanofiltration: Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Ultrafiltration: Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Reverse osmosis: Fisher Scientific Ireland Ltd Ocon Chemicals Ltd

METERS Bord Gais CPI Technology Ltd Fisher Scientific Ireland Ltd Ocon Chemicals Ltd P. J. Bonner & Company

MICRO QC Charles River Microbial Solutions

MICROSCOPES Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Particular Sciences Ltd P. J. Bonner & Company

MILLING Avara Shannon Pharmaceutical Services CPI Technology Ltd Fisher Scientific Ireland Ltd WrenTech Ltd

MIXERS CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd WrenTech Ltd

NOISE / ODOUR CONTROL Associated Chemicals Ltd Flexachem Manufacturing Ltd

OEM MANUFACTURING Anecto B. Braun Medical

PACKAGING / DESIGN Anecto Bemis Healthcare Packaging Charles Tennant & Co Ltd Complas Packaging Ltd Industrial Packaging Ltd Interpac Limerick Packaging Nelipak Healthcare Packaging Protech Plastics Quitmann O’Neill Weber Packaging Solutions Ltd

PACKAGING / MACHINERY Goliath Packaging Systems Ltd Interpac Millmount Healthcare NPP Group Ltd

Limerick Packaging Nelipak Healthcare Packaging Quitmann O’Neill Smurfit Kappa Ireland Weber Packaging Solutions Ltd WrenTech Ltd

PALLETS Interpac Quitmann O’Neill

PALLET INVERTING Goliath Packaging Systems Ltd

PARTICLE SIZing SURFACE AREA Particular Sciences Ltd

PHARMACEUTICAL FABRICATION Charles River Microbial Solutions ProSys Containment and Sampling Technology Roche Ireland Ltd

PHARMACEUTICAL MANUFACTURE Abbvie

PIPES / CORES Ocon Chemicals Ltd Protech Plastics Quitmann O’Neill Smurfit Kappa Ireland

PLASTIC CONTAINERS Carbon Group Measom Freer Interpac Ocon Chemicals Ltd PrimePac Ltd Protech Plastics Quitmann O’Neill

PLASTIC CORES / TUBES Ocon Chemicals Ltd Protech Plastics Quitmann O’Neill Smurfit Kappa Ireland

PNEUMATICS Flexachem Manufacturing Ltd

POLLUTION CONTROL Callaghan Engineering Veolia

POWDER HANDLING AQS Environmental Solutions Carbon Group CPI Technology Ltd Goliath Packaging Systems Ltd Industrial Packaging Ltd Interpac ProSys Containment and Sampling Technology Quitmann O’Neill WrenTech Ltd

PRESSURE MEASUREMENT/ SWITCHES / VESSELS CPI Technology Ltd Eurolec Instrumentation Ltd Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

83


GENERAL SUPPLIERS PRESSURE RELIEF BS&B Safety Systems Ltd CPI Technology Ltd Flexachem Manufacturing Ltd Pilz Ireland

PRINT PACKAGING Contego Packaging Group Holfeld Graphics Limerick Packaging Protech Plastics Quitmann O’Neill Weber Packaging Solutions Ltd

PROCESS CONTROL ABB Ltd BS&B Safety Systems Ltd Callaghan Engineering Charles River Microbial Solutions O’Flynn Medical Ltd Pilz Ireland P. J. Bonner & Company

PROCESS DESIGN ABB Ltd BS&B Safety Systems Ltd Callaghan Engineering Pharmalex Pilz Ireland

PROCESS & MECHANICAL ENGINEERING CONTRACTORS Pilz Ireland

PROJECT MANAGEMENT ABB Ltd Callaghan Engineering Chemishield Pharmalex Pilz Ireland

PROTECTIVE CLOTHING / APPaRATUS Ocon Chemicals Ltd O’Flynn Medical Ltd ProSys Containment and Sampling Technology

PUMPS CPI Technology Ltd Fisher Scientific Ireland Ltd Idex Pump Technologies (Ireland) Ltd Quitmann O’Neill Water Chromatography Ireland

QUALITY & COMPLIANCE A&C Your Global GMP Partner ABB Ltd Charles River Microbial Solutions Indaver Ireland Kuehne + Nagel McGee Pharma International Pharmalex ProSys Containment and Sampling Technology Veolia Weber Packaging Solutions Ltd

84

R&D A&C Your Global GMP Partner Almac Sciences Ltd Avara Shannon Pharmaceutical Services Charles River Microbial Solutions Euraxess Ireland ProSys Containment and Sampling Technology Protech Plastics Synthesis and Solid State Pharmaceutical Centre TopChem Pharmaceuticals Ltd

REACTORS CPI Technology Ltd Flexachem Manufacturing Ltd

RECRUITMENT Berkley Group Brightwater Chemishield ICDS Recruitment Consultants Thornshaw Scientific

REFRIGERATION / FREEZING Cross Technical Solutions CRS Pharma Solutions Daikin Europe Dawson Rentals Ireland Ltd Fisher Scientific Ireland Ltd Langanbach Services Ltd Q1 Scientific

RENEWABLE ENERGY ABB Ltd Callaghan Engineering Daikin Europe Indaver Ireland Sustainable Energy Authority of Ireland Veolia

RESEARCH FUNDING Science Foundation Ireland (SFI)

RESPIRATORY PHARMACEUTICALS Hovione Teva Pharmaceuticals Ireland Thornshaw Scientific

ROBOTICS Charles River Microbial Solutions Goliath Packaging Systems Ltd Labplan

SANITARY TUBING CPI Technology Ltd Flexachem Manufacturing Ltd

SCADA / DCS / MIS ABB Ltd Callaghan Engineering ProSys Containment and Sampling Technology

SCRUBBERS Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

SEALS & GASKETS Flexachem Manufacturing Ltd

SIEVING Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Particular Sciences Ltd WrenTech Ltd

SLEEVE / STRETCH WRAPPING Goliath Packaging Systems Ltd

SOFTWARE Charles River Microbial Solutions Chemishield

SOLVENT RECOVERY / SERVICES Carbon Group CPI Technology Ltd Indaver Ireland Soltec (Ireland) Ltd Veolia

STABILITY STORAGE Almac Sciences Ltd Corcoran Products Ltd CRS Pharma Solutions Dawson Rentals Ireland Ltd Eurofins Biopharma Product Testing Q1 Scientific

STABILITY TESTS Particular Sciences Ltd

STAINLESS STEEL / FITTINGS / PRODUCTS CPI Technology Ltd Henley Forklift Group Limited Interpac ProSys Containment and Sampling Technology Quitmann O’Neill WrenTech Ltd Weber Packaging Solutions Ltd

STEAM EQUIPMENT BS&B Safety Systems Ltd CPI Technology Ltd Flexachem Manufacturing Ltd

STERILITY TESTING Charles River Microbial Solutions

STORAGE / BUNDING CRS Pharma Solutions Dawson Rentals Ireland Ltd Interpac Kuehne + Nagel Quitmann O’Neill

STORAGE OF HAZARDOUS MATERIALS C&G Logistics Group Corcoran Products Ltd CRS Pharma Solutions Dawson Rentals Ireland Ltd Hazchem Training Ltd Indaver Ireland Kuehne + Nagel Veolia Irish PharmaChem | Industry Buyers Guide 2019


GENERAL SUPPLIERS STRAPPING EQUPMENT Goliath Packaging Systems Ltd

SUPPLY CHAIN MANAGEMENT C&G Logistics Group Chemco Ireland Ltd Cold Move GS1 Ireland Kuehne + Nagel KWE (Ireland) Ltd McGee Pharma International Quitmann O’Neill Solv-Echem Ireland Ltd Thornshaw Scientific

TABLETING EQUIPMENT Flexachem Manufacturing Ltd WrenTech Ltd

TANKS Celtic Forwarding Ltd Complas Packaging Ltd Flexachem Manufacturing Ltd Quitmann O’Neill

TEMPERATURE CONTROL Bord Gais Corcoran Products Ltd Cross Technical Solutions CRS Pharma Solutions Daikin Europe Dawson Rentals Ireland Ltd Eurolec Instrumentation Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd KWE (Ireland) Ltd Labplan Ocon Chemicals Ltd P.J. Bonner & Company Q1 Scientific

TEMPORARY LAB & OFFICE ACCOMMODATION Portakabin Allspace

TESTING SERVICES

TRAY HEAT SEALER Nelipak Healthcare Packaging

TUBE SETS / DISPOSABLES Langanbach Services Ltd Ocon Chemicals Ltd Quitmann O’Neill

VACUUM SYSTEMS BS&B Safety Systems Ltd CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Goliath Packaging Systems Ltd Particular Sciences Ltd WrenTech Ltd

VALVES BS&B Safety Systems Ltd CPI Technology Ltd Flexachem Manufacturing Ltd P. J. Bonner & Company WrenTech Ltd

VALIDATION ABB Ltd Almac Sciences Ltd Callaghan Engineering Charles River Microbial Solutions Chemishield CRS Pharma Solutions Dawson Rentals Ireland Ltd McGee Pharma International Pharmalex Pilz Ireland P. J. Bonner & Company

VENTILATION Callaghan Engineering Daikin Europe Pilz Ireland

VISION SYSTEMS Particular Sciences Ltd Weber Packaging Solutions Ltd

WAREHOUSE MANAGEMENT C&G Logistics Group Celtic Forwarding Ltd Cold Move Complas Packaging Ltd Henley Forklift Group Limited Kuehne + Nagel Portakabin Ireland Ltd Weber Packaging Solutions Ltd

WASHING EQUIPMENT Goliath Packaging Systems Ltd WrenTech Ltd

WASTE MANAGEMENT / BALERS / RECYCLING AQS Environmental Solutions Indaver Ireland Ocon Chemicals Ltd Quitmann O’Neill

WATER TREATMENT Carbon Group Charles River Microbial Solutions Chemco Ireland Ltd Chemifloc Ltd Flexachem Manufacturing Ltd Industrial Packaging Ltd Ocon Chemicals Ltd

weighing Fisher Scientific Ireland Ltd P.J. Bonner & Company Weber Packaging Solutions Ltd

wORKWEAR O’Flynn Medical Ltd

WORKWEAR MANAGEMENT DISPENSING MACHINE O’Flynn Medical Ltd

Almac Sciences Ltd Anecto CPI Technology Ltd Bemis Healthcare Packaging P. J. Bonner & Company

THERMAL IMAGING / THERMOGRAPHY Eurolec Instrumentation Ltd P. J. Bonner & Company

TOOLS Charles River Microbial Solutions

TRAINING Hazchem Training Ltd

TRANSPORT & LOGISTICS AQS Environmental Solutions C&G Logistics Group Celtic Forwarding Ltd Cold Move CRS Pharma Solutions Hazchem Training Ltd Kuehne + Nagel KWE (Ireland) Ltd Quitmann O’Neill Weber Packaging Solutions Ltd Irish PharmaChem | Industry Buyers Guide 2019

85


COMPANY LISTINGS

2 0 1 2

A

arran CHEMICAL COMPANY LTD

ABBVIE

Address: Tel: Address: Tel:

A Member of the Almac Group

ABBVIE Sligo – Manorhamilton Road.

071 913 6600 ABBVIE Cork - IDA Business & Technology Park, Carrigtohill, Co. Cork. (021) 488 1400

Business: Pharmaceutical

A&C Your Global GMP Partner Address:

Tel: Fax: Email: Web: Contact: Business:

Questum, Cahir Road, Ballingarrane, Clonmel, Co. Tipperary, E91 V239.

(formerly BioClin Research Laboratories) Address:

IDA Technology & Business Park, Garrycastle, Athlone, Ireland, N37X061.

Tel: +353 (0)90 646 0200 Fax: +353 (0)90 646 0210 Email: almacanalytical@almacgroup.com Web: www.almacgroup.com Business: Analytical services provider in GMP / GLP environments across UK, Europe and US with significant experience in the analysis of both small and large molecules. Our state-of-the-art labs support drug substance (API) and drug product (finished product) analytics across all phases of clinical development and into commercial release. Contact: Business Development: Mary Manny

+353 52 614 8880 +353 52 614 8880 www.acggp.com Sales & Marketing Director: Gearoid O’Rourke Global GMP manufacturer of excipients, buffers, process solutions and a small number of APIs that has been servicing the life science industry since 1966. A&C services are to provide custom solutions, custom products and custom packaging to client specific problems in the pharmaceutical and biopharmaceutical markets.

Address: Monksland, Athlone, Co. Westmeath. Tel: (090) 649 5000 Web: www.alkermes.com Business: Global Biopharmaceutical Company. Contact: Vice President & Athlone General Manager: Kevin Brady

allsop europe ltd Address: Industrial Park, Waterford. Tel: +353 51 355091 Fax: +353 51 377717 Email: noel.kinsella@allsop.eu Web: www.allsopmould.ie Business: Injection moulding products. Contact: Manufacturing & Quality Manager: Noel Kinsella

ARRAN CHEMICAL COMPANY Address: Monksland Industrial Estate, Athlone, Co. Roscommon, N37 DN24, Ireland. Tel: +353 906 445700 Email: info@arranchemical.ie Web: www.arranchemical.ie Business: Fine chemical company specialising in the manufacture of products for Pharma, Healthcare, Flavour/ Fragrance & other specialised chemicals & industrial applications. Contact: Gareth Maguire, Business Development Manager

PANTONE GREEN 361c PANTONE BLACK CMYK GREEN: c: 78.8 m:11.5 y: 100 k:1.5 CMYK BLACK: K 100% RGB GREEN: r: 52 g: 160 b: 44 RGB BLACK: r: 35 g: 31 b: 32 HEX GREEN: #34A02C HEX BLACK: #231F20 Font: Myriad Pro

ASSOCIATED CHEMICALS LTD

euro@acggp.com

Alkermes Pharma Ireland Limited

86

Almac Sciences Ltd.

AQS ENVIRONMENTAL SOLUTIONS

Address: Castletown, Galmoy (via Thurles), Co. Kilkenny. Tel: +353 (0)504 57800 Freephone: 1800 500 020 Email: info@aqssolutions.ie Web: www.aqssolutions.ie Business: Provider of drainage, industrial cleaning, waste management and processing services. Contact: Commercial Director: Stan O’Reilly

Address: 16D Euro Business Park, Little Island, Co. Cork, Ireland. Tel: +353 21 4351014 Fax: +353 21 4351015 Email: info@acl.ie Web: www.acl.ie Business: Chemical Supplies Contact: Managing Director: Sylvester Cotter

Avara Shannon Pharmaceutical Services Limited Address: Shannon Industrial Estate, Shannon,

Co. Clare, V14 FX09, Ireland.

Tel: 00353-61-714114 Fax: 00353-61-714101 Email: wjkunz@avara.com Web: www.avara.com Business: US / European based CDMO for API, Bulk Drug Product, Finished Product, Packaging and Distribution. Contact: Mr. Werner Kunz: VP & Site Director

Irish PharmaChem | Industry Buyers Guide 2019


COMPANY LISTINGS B

C

B. Braun MEDICAL BEMIS HEALTHCARE PACKAGING Address: Kilbeggan Road, Clara, Co. Offaly, R35 F583. Tel: (057) 933 1888 Fax: (057) 933 1887 Email: bhpeu@bemis.com Web: www.bemis.com/healthcare-packaging Business: Contract Packing Services, Medical and Pharmaceutical Packaging, Test Laboratory Services.

Address: Mobile: Fax: Email: Web: Business: Contact:

3 Naas Road Industrial Park, Dublin 12. 086 833 9836 +353 (0)1 709 1889 robert.bannon@bbraun.com www.bbraun.ie OEM manufacturing. Sales Consultant: Robert Bannon

BETCO MARKETING LTD Address: Exham House, The Fingerpost, Douglas, Co. Cork. Tel: (021) 436 4999 Fax: (021) 436 5739 Email: dhalpin@betco.ie Web: www.betco.ie Business: Agent and distributors in Ireland for Cargill Starches and Sweeteners Europe and Cargill Texturising Solutions. Contact: Managing Director: Diarmuid Halpin

P.J. BonNer & Company INSTRUMENTATION & CONTROL SOLUTION SPECIALISTS Address:

35 Western Parkway Business Centre, Ballymount Drive, Ballymount, Dublin 12.

Tel: (01) 450 5050 Fax: (01) 450 5183 Email: contact@bonner.ie Web: www.bonner.ie Business: Instrumentation, Measurement and Control Solutions including Calibration, Maintenance, Temperature Mapping and Automation systems. Instrumentation product sales from international manufacturers Contact: Managing Director: Patrick M Bonner Service Manager: Roddy Jefferson Control Solutions: Vernon Smit

Irish PharmaChem | Industry Buyers Guide 2019

I

P

BERKLEY GROUP Address: Dublin: 509 The Capel Building, Mary’s Abbey, Dublin 7. Cork: Mill House, Carrigrohane, Co. Cork. International Offices: Singapore, London & Dubai. Tel: (01) 872 4666 (021) 428 9600 Email: sgreenwood@Berkley-group.com Web: www.berkley-group.com Contact: Steve Greenwood

CALLAGHAN ENGINEERING Dublin Address: Wentworth House, 19/20 Hogan Place, Lower Grand Canal St, Dublin 2. Cork Address: Suite 201, Building 1000, Units 1201& 1202, City Gate, Mahon, Cork. Tel: (01) 661 4420 Fax: (01) 661 4424 Email: mail@calleng.ie Web: www.calleng.ie rIsh hem Business: harma Multi-discipline consulting engineering and project managment company.

b renntAG ireLAnd Brenntag Ireland

Address: Unit 405, Greenogue Address: Unit 405, Business Park, Rathcoole, Greenogue Business Dublin 24. Park, Rathcoole, +353 (0) 1 401 3500 Tel: Dublin 24. Fax: +353 (0) 1 401 3599 Tel: (01) 401 3500 Email: dublin.sales@brenntag.ie Fax: (01) 405 3501 Web: www.brenntag.ie Email: dublin.sales@brenntag.ie Business: Chemical Suppliers & Web: www.brenntag.ie Distributors Contact: cormac.mccarthy@brenntag.ie Contact: Sales Desk

b riGhtwAter BS&B SAFETY SYSTEMS LTD

Address: 36 Merrion Square, Address: Raheen Business Park, Dublin 2. Raheen, Co. Limerick. Tel: (01) 662 1000 Tel: (061) 484 700 Mobile: (086) 8385556 Fax: (01) 662 3900 Email: sales@bsb.ie Email: e.moloney@brightwater.ie Web: www.bsbflamearrester.ie Web: www.brightwater.ie www.bsb.ie Contact: Eileen Moloney

Business: Flame Arresters, Detonation Arresters, Breather Vents, and bs&b sAfety systems Ltd Pressure/Vacuum Vents, Address: Raheen Business Park, Pressure Relief Safety Devices. Contact: Raheen, Ireland Direct Sales Co. Limerick. Manager: Patrick Murphy

Tel: Fax: Email: Web: Business: Contact:

C

(061) 484 700 Emergency Delivery: 086 241 0615 Direct Line: 086 838 5556 (061) 352 240 sales@bsb.ie www.bsb.ie Pressure relief devices. Sales Manager: Patrick Murphy

C

Building 1000, Units 1201& 1202, City Gate, Mahon, Cork. Tel: (021) 240 9099 Fax: CAMIDA LTD(021) 240 9009 Email: mail@calleng.ie Address: New Quay, Clonmel, Web: Co.www.calleng.ie Tipperary, E91 YV66, Ireland. Business: +353 Multi-discipline Tel: 52 6125455 consulting engineering Fax: +353 52 6125466 Email: info@camida.com and project managment Web: www.camida.com company.

Contact:

Company Secretary: Deirdre McGrath

cAmidA Ltd

Address: Tower House, New Quay, Clonmel, Co. Tipperary. Tel: (052) 612 5455 Fax: (052) 612 5466 carbon group Email: info@camida.com Address: Factory Cross, Web: Co. Cork. Ringaskiddy, www.camida.com Tel: +353 (0)21 437 8988 Contact: Company Secretary: Mobile: 086 2612 485 Deirdre McGrath Fax: +353 (0)21 437 8950

Email: carol.deegan@carbon.ie sales@carbon.ie Web: www.carbon.ie Business: Pharma/biopharma chemicals. Contact: Area Sales Manager: Carol Deegan

cArbon Group

Address: Factory Cross, Ringaskiddy, Co. Cork. Tel: +353 (0)21 437 8988 Mobile: River 086 2612 485 Charles Microbial Fax: +353 (0)21 437 8950 Solutions International Email: carol.deegan@carbon.ie Ltd sales@carbon.ie Address: 49, Greenogue Business Park, Jordanstown Web: Ave, Jordanstown, www.carbon.ie Rathcoole, Co. Dublin, D24 NF21, Business: Pharmachemicals. Ireland. Contact: Area Sales Manager: Email: askcharlesriver@crl.com Web: criver.com/microbial Carol Deegan

Business: Micro QC

cAtALent phArmA soLutions

Address: Unit 26, www.irishpharmachem.com

cALLAGhAn enGineerinG Address:

Dublin: Wentworth House, 19/20 Hogan Place,

2012

Cherry Orchard 87 Industrial Estate, Dublin 10. Tel: (01) 620 0600 Fax: (01) 626 2815 Email: diarmuid.wilson@catalent.com

Contact:

ceLtic fo Address:

Tel: Fax: Email: Web: Business: Contact:

c + G Lo Address: Tel: Fax: Email: Web: Contact:


COMPANY LISTINGS

Charles Tennant & co Ltd Address: 71 Cookstown Ind Estate, Belgard Road, Tallaght, Dublin 24. Tel: (01) 451 4099 Fax: (01) 451 4702 Email: jgrehan@ctennant.ie Web: www.charlestennant.com Business: Chemical and Packaging supplier. Contact: Chemical Manager: Jim Grehan

Chemishield Address: Arc Labs, Carriganore, Waterford. Tel: +353 (0)51 576 025 Email: info@chemishield.com Web: www.chemishield.com Business: Software & Life Sciences Consultancy. Contact: Commerical Director: James Steele

CPI technology ltd

Address: Unit 5 Link Road, Business Park, Ballincollig, Co. Cork. Tel: (021) 487 4142 Fax: (021) 487 8764 Email: info@cpitechnology.com Web: www.cpitechnology.com Business: Providers of Process Equipment. Contact: Managing Director: Adrian Giltinan

COLD MOVE LIMITED Address: Tel: Email: Web: Business: Contact:

Chemco Ireland Limited Address: Unit 2, Stadium Business Park, Ballycoolin, Cappagh, Dublin 11, D11 X205. Tel: +353 (0)1 8293600 Fax: +353 (0)1 8855029 Email: info@chemco.ie Web: www.chemco.ie

Glenascaul Industrial Park, Oranmore, Co. Galway, Ireland. (091) 792926 info@coldmove.ie www.coldmove.ie Logistics & Distribution Jason Mallon

complas packaging ltd Address: Naas Industrial Estate, Dublin Road, Naas, Co. Kildare. Tel: (045) 874 088/9 Fax: (045) 874 090 Email: sales@complas.ie Web: www.complas.ie

CROSS TECHNICAL SOLUTIONS Address: 9/10 Broomhill Road, Tallaght, Dublin 24. Tel: (01) 405 6777 Fax: (01) 413 6932 Email: jmcgrath@ctsolutions.ie Web: www.crosstechnicalsolutions.ie Business: Refrigeration Technical Director: Contact: Jonathan McGrath General Manager: Jason Keating

CORCORAN CHEMICALS LIMITED Chemifloc Group: Chemifloc, GI Chemicals, Chemilabs Address:

Smithstown Ind Est, Shannon, Foynes Port, Limerick.

Tel: 061 708699; 021 4911643 (GI) Fax: +353 61 708653 Email: info@gichemicals.ie; info@chemilabws.ie Web: chemifloc.ie; gichemicals.ie Business: Chemifloc: Water Treatment Chemicals; GI: Industrial Chemicals, Chemilabs: Laboratory Technical Services Contact: Fergal Lawless, Tom Kelly (GI) Director, GM (GI)

88

Address: 17 Parkgate Street, Dublin 8. Tel: (01) 633 0400 Fax: (01) 679 3521 Email: info@corcoranchemicals.com Web: www.corcoranchemicals.com Business: Distributors of polymers & raw materials for the food, pharmaceutical & chemical industry. Contact: Sales Department

CORCORAN PRODUCTS LIMITED Address: Tel: Email: Web: Business: Contact:

Unit 12, Northern Cross Business Park, Finglas, Dublin 11. (01) 864 4422 info@corcoranproducts.com www.corcoranproducts.com Suppliers of packaging to the Food, Retail, Industrial, Agri & Pharmaceutical Industries. Derek Lennon

CRS Pharma Solutions Address: Tel: LoCall: Email: Web: Business: Contact:

Dublin, Belfast, London, Manchester. +353 46 943 5000 1890 929 824 info@crspharmasolutions.ie www.crspharmasolutions.ie GxP compliant pharmaceutical portable temperature controlled storage solutions, chamber temperatures range from -65°C to +60°C. Close control temperature and humidity stores, stability chambers, incubators, Atex cold stores, dual redundant cooling systems with integral back-up generators, blast freezers, freezers for fast freezing of phase change materials (Eutectic plates and gel packs). Technical Director: Patrick Tyrrell

Irish PharmaChem | Industry Buyers Guide 2019


COMPANY LISTINGS

D

flexachem manufacturing ltd

Daikin Europe Address:

Unit 1, Orchard Business Centre, Orchard Avenue, Citywest, Dublin 24.

Tel: (01) 642 3430 Email: chillers@daikin.ie Web: www.daikin.ie Business: HVAC manufacturer

Eurofins BioPharma Product Testing Address: Clogherane, Dungarvan, Co. Waterford, X35 T628 Ireland. Tel: +353 (0) 58 48300 Email: pharma@eurofins.com Web: www.Eurofins.com/Biopharma

Address:

Unit JB Beech Avenue, Newhall, Naas, Co. Kildare

Tel: 045 448810 Fax: 045 448811 Email: aidanmccauley@ dawsongroup.ie Web: www.dawsongroup.ie Business: Temperature Controlled Solutions Contact: Managing Director: Aidan McCauley

eurolec instrumentation ltd Address: Tel: Fax: Email: Web: Business:

Technology House, Cluan Enda, Dundalk, Co. Louth. (042) 933 3423 (042) 933 1758 info@eurolec-Instruments.com www.eurolec-instruments.com Electronic instrumentation.

F

festo ltd

E

ENDRESS+HAUSER (IRELAND) LTD. Address: Tel: Email: Web: Business: Contact:

Exchequer House, Embassy Office Park, Kill, Co. Kildare. (045) 989 200 info@ie.endress.com www.ie.endress.com Leading supplier of products, services and solutions for industrial process measurement and automation industry. Sales Manager: Brian O’Connell

EURAXESS IRELAND Address: C/O Irish Universities Association, 48 Merrion Square, Dublin 2. Tel: (01) 676 4948 Fax: (01) 662 2815 Email: jennifer.cleary@iua.ie Web: www.euraxess.ie Contact: Euraxess Ireland Manager: Jennifer Cleary

Irish PharmaChem | Industry Buyers Guide 2019

Web: Business: Contact:

Donnybrook, Commercial Centre, Douglas, Co. Cork. (021) 461 7200 / (021) 4617209 (021) 489 1297 sales@flexachem.com tim.quigley@flexachem.com www.flexachem.com Manufacturer/ Distributor. Operations Manager: Tim Quigley

G

Dawson Rentals Ireland Ltd

Address: Tel: Fax: Email:

Address: Tel: Fax: Email: Web: Business:

Unit 5, Sandyford Park, Sandyford Industrial Estate, Dublin 18. (01) 295 4955 (01) 295 5680 sales_ie@festo.com/ie www.festo.com/ie Automation company specialising in factory and process automation.

FISHER SCIENTIFIC f isher scientific IRELAND LTD Address: Suite 4, Plaza 212,

GOLIATH PACKAGING SYSTEMS LTD Address: Well Road, Nenagh, Co. Tipperary. Tel: (067) 37893 Fax: (067) 34794 Email: info@goliath.ie Web: www.goliath.ie Business: Supply & installation of End of Line Automation Systems, Materials Handling Equipment & Industrial Washing Machinery.

IrIsh Pharma Chem 2011 Goodbody Stockbrokers Address: Ballsbridge Park, Ballsbridge, Dublin 4. Tel: (01) 667 0400 Fax: (01) 667 0230 Email: goodbody@goodbody.ie Web: www.goodbody.ie Business: Markets, GoLiAthCapital pAckAGinG Investment Management, s ysteMs Ltd Wealth Management.

Address: Beechwood, Nenagh, Address: Suite 6, Plaza 212, Blanchardstown, Blanchardstown Co. Tipperary. Corporate Park 2, Tel: (067) 37893 Corporate Park, Ballycoolin, Dublin 15, Ballycoolin, Fax: (067) 34794 Goulding chemicals ltd D15 VY66. Tel: Dublin 15. Email: info@goliath.ie (01) 885 5854 Address: Centre Park Road, Tel: (01) 885 5854 Web: www.goliath.ie Fax: (01) 899 1855 Marina, Email: fsie.sales@thermofisher.com Fax: (01) 899 1855 Business: Cork City.Supply & Web: www.ie.fishersci.com Tel: (021) 491installation of 1611 Email: fsie.sales@thermofisher.com Business: Laboratory supplies, Fax: (021) 491packaging equipment 1660 Web: www.ie.fishersci.com Chemicals, Consumables, Email: kellyt@gouldings.ie Business: Reagents, Equipment & Laboratory and materials Instruments. Web: www.gouldings.ie Contact: supplies. handling systems. Commercial Business: Chemical distributor. Contact: Product Marketing Contact: Director: Manager: GerryManager: Fitzmaurice George O’Leary Gerry Fitzmaurice

fLexAcheM MAnufActurinG Ltd Address:

Donnybrook Commercial Centre,

GouLdinG cheMicALs Ltd89 Address: Tel: Fax:

Centre Park Road, Marina, Cork City. (021) 491 1611 (021) 491 1660

H

hAzch

Addres Tel: Fax: Email: Web: Contac

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Addres Tel: Fax: Email: Web: Busine


COMPANY LISTINGS

Graham Hart (Process Technology) Ltd Address: Friars Industrial Estate, Bradford Road, Idle, Bradford, BD10 8SW, UK. Tel: (0044) 1274 617021 Fax: (0044) 1274 618614 Email: sales@graham-hart.com Web: www.graham-hart.com Business: Chemical Engineers Design and Manufacturers of Heat Exchangers and Process Plant.

Hovione Ltd HENLEY FORKLIFT GROUP LIMITED Address: Henley Industrial Park, Killeen Road, Dublin 10. Tel: (01) 620 9200 Fax: (01) 626 5406 Email: phammett@henley.ie Web: www.henley.ie/pharma Business: Forklift and warehousing equipment, sales, service, hire, parts, driver training, thorough examinations. Contact: Director: Brian O’Connell boconnell@henley.ie

GS1 Ireland Address: Tel: Fax: Email: Web: Business: Contact:

Second Floor, The Merrion Centre, Nutley Lane, Donnybrook, Dublin 4. (01) 208 0660 (01) 208 0670 healthcare@gs1ie.org www.gs1ie.org/healthcare Global Supply Chain Standards Body. Chairman: Thomas Shortall Vice Chairman: Pat Tracey Chief Executive Officer: Mike Byrne

H

hazchem training ltd Address: G10, Maynooth Business Campus, Maynooth, Co. Kildare. Tel: (01) 629 1800 Fax: (01) 629 1822 Email: info@hazchem.ie Web: www.hazchem.ie Business: Training Contact: Manager: Michelle Cleere

90

Address: Tel: Fax: Email: Web: Contact:

Loughbeg, Ringaskiddy, Co. Cork, Ireland. +353 21 451 2856 +353 21 437 8697 hello@hovione.com www.hovione.com General Manager: Dr. Paul Downing

I

ICDS Recruitment Consultants Address: Connacht House, 24 Upper Fitzwilliam Street, Dublin 2. Tel: +353 1 632 1200 Email: info@icds.ie Web: www.icds.ie Business: Specialist Recruitment Consultants to the Pharmaceutical, Life Science, Chemical, Medical Device, Food and Technology sectors.

HETEROCHEM DIST LTD Address: Tel: Fax: Email: Web: Business: Contact:

Unit 49, Robertson House, Baldoyle Industrial Est., Dublin 13. (01) 839 3127 (01) 832 5746 info@heterochem.com www.heterochem.com Chemical Distributors & Raw Material Specialists. Managing Director: Kim Doran kim@heterochem.com

Holfeld Graphics

Address:

Unit 3, Jamestown Industrial Estate, Kylemore Way, Dublin, D08 PF1C.

Tel: Email: Web: Business: Contact:

01 285 5233 rory@holfeldgraphics.com www.holfeldgraphics.com Manufacturer of Flexo plates for Hapa Blister printers, Agents for Axicon, ISO Barcode Verifiers (GS1 128, GS1 Datamatrix, etc.,) Managing Director: Rory Connaughton

IDA IRELAND Address: Wilton Park House, Wilton Place, Dublin 2. Tel: (01) 603 4000 Email: idaireland@ida.ie Web: www.idaireland.com Business: Investment Promotion & Development Agency

idex pump technologies (ireland) ltd Address: R79, Shannon Industrial Estate, Shannon, Co. Clare. Tel: (061) 471933 Email: vsicsipti@idexcorp.com Web: www.blagdonpump.com www.vikingpump.com Contact: Customer Services: Ann O’Gorman

Irish PharmaChem | Industry Buyers Guide 2019


IrIsh PharmaChem 2012 ComPany LIstIngs

COMPANY LISTINGS www.labplan.ie

irish Lift trucks Address: Clonlara Avenue, Baldonnell Business Park, Baldonnell, Dublin 22. Tel: (01) 403 4100 Fax: (01) 403 4183 Email: info@irishlifttrucks.ie Web: www.irishlifttrucks.ie Business: Materials Handling Equipment / Hyster INDAVER IRELAND Forklifts / Lancer Address: 4th Floor, Block 1, Sideloaders West Pier Business Campus, Old Dunleary Contact: General Manager: Road, Conal McCourt Dun Laoghaire,

Co. Dublin.

nAtionAL (01) 280 4534 iTel: rish AccreditAtion bFax: oArd , t(01) he280 7865 Email:

info@indaver.ie

Address: Wilton Park House, Web: www.indaver.ie Business: Hazardous Wilton Place, & nonhazardous waste Dublin 2. disposal and recovery Tel: (01) 607 3003 ensuring full compliance. Fax: (01) 607 3109 Email: inab@inab.ie Web: www.inab.ie Business: Provides accreditation interpac of laboratories, Address: certification & 67E Heather Road, Sandyford Estate, Industrial inspection bodies. Sandyford, Dublin 18. Contact: Information Officer: Tel: (01) 294 0600 Fax: Orla Doyle (01) 294 0602

Email: ian@interpac.ie Web: www.interpac.ie Business: Supplier of packaging to the pharmaceutical, hazardous J AvA cLinicAL reseArch Ltd waste, food and dairy industries. Address: Fitzwilliam Buiness Contact: Director: Ian Sutton

J

Centre, 26 Upper Pembroke St, Dublin 2. Tel: 01 637 3903 invest northern ireland Fax: 01 637 3907 Address: Bedford Square, Bedford Email: info@javacr.com Street, Belfast, BT2 7ES. Web: www.javacr.com Tel: (048) 9069 8601 Business: Clinical Research Fax: (048) 9043 6536 Email: patricia.oneill@investni.com Contact: Managing Director: www.investni.com Web: Ruth Nallen Business: Economic development agency.

Web: Business:

Johnston LoGistics Ltd

Address: Blackchurch Business K Park, Rathcoole, Co. Dublin. Tel: + 353 1 401 3333 Fax: + 353 1 458 8015 Email: info@jol.ie Kuehne + Nagel niallh@jol.ie IRELAND Web: www.johnstonlogistics.ie Address: Unit D2 Horizon Logistics Park, Business: Logistics & distribution Harristown, Swords, Co. Dublin, K67(Complete Supply Y954. Tel: 01Chain Management). 823 9777 Email: Alison.moore@kuehne-nagel.com Contact: Business Development Web: www.kuehne-nagel.ie Manager: Logistics & Supply Chain Business: Niall Hickey Contact:

K

Marketing & Communications Manager: Alison Moore Mob: +353 86 4104241

Address: 28 Merrion Square, Dublin 2. Tel: (01) 661 2182 Fax: (01) 661 2315 Email: niallstobie@irishexporters.ie Web: www.irishexporters.ie Business: Life Sciences Ireland is Industry Grouping with the Irish Exporters Association. Contact: Manager Life Science Ireland: Niall Stobie. 52,63 Company Listings 2012.indd 7

Irish PharmaChem | Industry Buyers Guide 2019

LAnGAnbAch services Ltd

Address: Unit 4, Cedar Estate, Killarney Road, Bray, Co. Wicklow. Tel: (01) 276 2510 LIMERICK PACKAGING Fax: (01) 276 2472 Address: Eastlink Business Park, Email: Ballysimon Rd., Limerick. sales@langanbach.ie Tel: (061) 400 035 Web: www.langanbach.ie Fax: (061) 400 036 Business: Supply of laboratory Email: info@lmkpkg.ie equipment and Web: www.limerickpackaging.ie manufacturers, Business: Packaging diagnostic tests. Distributors, Designers Infection control and Auditors. products for human Contact: Sales Director: Mike Boland and animal health. Contact: Sales and Marketing Director: Jim Woods

LISTER MACHINE TOOLS LTD Address:

KWE (Ireland) Ltd GDP Wholesale Licence) Holder kwe (ireLAnd Ltd

Dublin Head Office & Temperature Controlled Address: Dublin: Unit 4 Warehouse Facility Horizon Logistics Address: Horizon Logistics Park, Park, New Naul Rd, Harristown, Swords, Co. Dublin. (01) 823 9600 Tel: Harristown, Fax: (01) 836 1111 Swords, Co. Dublin. Email: kwedub@kwe.com dubsls@kwe.com Cork: Unit 4&5, Web: www.kwe.com South Ring & Warehouse Facility Cork Regional OfficeWest Business Pk, South Ring West Business Park, Address: Tramore Road, Tramore Road, Cork. Co. Cork. Tel: (021) 497 5722 Tel: (01) 823 9600 Fax: (021) 497 5727 Email: (021) 497 5722 kweork@kwe.com Fax: (01) 836 1111 (021) 497 5727 Email: kwedub@ea.kwe.com L kweork@ea.kwe.com LABPLAN www.kwe.com Web: Address: Allenwood Enterprise Park, Contact: Sales Manager: Allenwood, Naas, Co Kildare. Karl O’Reilly Tel: (045) 870 560 Fax: (045) 870 811 Email: info@labplan.ie Web: www.labplan.ie Business: Lab supplier of analytical LAbpLAn instrumentation, services, Address: Allenwood Business technical support.

L

irish exporters association - life sciences ireland

Contact:

Laboratory supplier to pharmaceutical businesses. Managing Director: Aidan Smyth

PO Box 838, Bluebell Industrial Estate, LAncAster LAborAtories Dublin 12. Address: IDA Business Park, Tel: (01) 450 8866 Fax: (01) 450 9836 Clogherane, Email: sales@listermachinetools.com Dungarvan, Web: www.listermachinetools.com Co. Waterford. Business: Sales and service of Machine Tel: (058) 48 300 Tools and related accessories, Fax: (058) 42 855 consumables and metrology Email: info@lancasterlabs.com equipment.

Web: www.lancasterlabspharm.com Business: Contract Analytical M Services Contact: Business Development maclachlan & donaldsonDirector: Address: 47 Mark Glass Merrion Square, Dublin 2. Lennox LAborAtory Tel: (01) 676 3465 suppLies Ltd Fax: (01) 661 2083 Email: Address: mail@maclachlan.ie John F. Kennedy Web: www.maclachlan.ie Drive, Naas Road, Business: Intellectual Property Dublin 12. Attorneys. Tel: (01) 455 2201 Contact: Dr. Yvonne McKeown

Fax: Email: Web: Business:

(01) 450 7906 sales@lennox.ie greg@lennox.ie www.lennox.ie Laboratory suppliers.

Park, Allenwood, Naas, Co. Kildare. lennox laboratory Tel: (045) 870 560 supplies ltd Fax: (045) 870 811 Address: John F. Kennedy Drive, Email: info@labplan.ie Naas Road, Dublin 12. 58 2201 Tel: (01) 455 Fax: (01) 450 7906 Email: sales@lennox.ie greg@lennox.ie Web: www.lennox.ie Business: Laboratory suppliers.

30/05/2012 16:57

91


COMPANY LISTINGS

micro Address: Unit 2003 Orchard Avenue, Citywest Business Campus, Dublin 24. Tel: (01) 463 9100 Email: info@mirco.ie Web: www.micro.ie Business: High Purity hose, manifolds / tube sets, disposable solutions for the Bio-Pharma Industry. Contact: Ralph Fitzsimons

MSD Ireland Address:

Oak North Rd, South County Business Park, Leopardstown, Dublin 18.

Tel: +353 (0)1 299 8700 Email: info@msd.ie Web: www.msd.ie Business: MSD Ireland is one of the country’s leading healthcare companies, having first established here over 50 years ago. We currently employ over 1,900 employees, across four sites in Ballydine, Co. Tipperary, Brinny, Co. Cork, Carlow and Dublin and operate substantial Human Health and Animal Health businesses. Early in 2018 the decision was made to base a new biotechnology facility – known as MSD Biotech, Dublin - in Ireland with the expected creation of up to 350 new jobs. Contact: Ger Brennan MSD Ireland (Human Health) LTD

N

Nelipak Healthcare Packaging Address:

Unit 6D, Mervue Business Park, Mervue, Galway.

Tel: Email: Web: Business: Contact:

(091) 757 152 info@nelipak.com www.nelipak.com Cleanroom manufactured rigid custom thermoform plastic packaging for the healthcare market serving the medical and pharmaceutical sectors. Director of Global Marketing: Sean Egan

npp group ltd Address: Unit 509, Mitchelstown Road, Northwest Business Park, Ballycoolin, Blanchardstown, Dublin 15. Tel: (01) 880 9299 Email: sales@npp.ie bmcmahon@npp.ie Web: www.npp.ie Business: Flexible packaging suppliers & distributors.

O

OBEECO LTD Address:

Annaville Avenue, Blackrock, Co. Dublin.

NATIONAL CHEMICAL COMPANY Address: NCC House, 42 Lower Leeson St., Dublin 2, D02 FX39. Tel: (01) 613 1400 Fax: (01) 634 0132 Email: sales@ncc.ie Web: www.ncc.ie Business: Supply Chain Partner Life Sciences Industry Contact: Christy Smith, Sales Director.

Tel: Fax: Email: Web:

(01) 278 2323 (01) 278 2374 sales@obeeco.ie www.obeeco.ie

OCON CHEMICALS LTD Address: Unit 5, South Cork Industrial Estate, Vicars Road, Pouladuff, Co. Cork. Tel: (021) 431 8555 Fax: (021) 431 8560 Email: info@oconchemicals.com Web: www.oconchemicals.ie

www.irishpharmachem.com 92

Irish PharmaChem | Industry Buyers Guide 2019


COMPANY LISTINGS

pilz ireland

o’flynn medical ltd Address:

The Old Creamery, Tanyard, Millstreet Town, Co. Cork, Ireland.

Tel: Fax: Email: Web: Business: Contact:

(029) 21 799 (029) 70 191 info@oflynnmedical.com www.oflynnmedical.com Distributor of Scrubex “Automated Protective Clothing Distributor”. CEO: Tadhg O’Flynn

Address: Tel: Fax: Email: Web: Business:

Cork Business & Technology Park, Model Farm Road, Co. Cork. (021) 434 6535 (021) 480 4994 sales@pilz.ie www.pilz.ie Process and machinery safety engineering services and training.

P

particular sciences ltd Address: 2 Birch House, Rosemount Business Park, Ballycoolin Road, Finglas, Dublin D11 T327. Tel: (01) 820 5395 Fax: (01) 822 8813 Email: sean@particular.ie Web: www.particular.ie Business: Supply and Service Laboratory Equipment. Contact: Managing Director: Sean Quilty

Address: Tel: Fax: Email: Business: Contact:

IDA Business Park, Carrigtohill, Co. Cork, Ireland, T45AP82. +353 21 4853900 +353 21 4853866 Michael.Hennessy@prosysgroup.com www.prosysgroup.com Head of Global Sales: Michael Hennessy

Q1 SCIENTIFIC Portakabin Ireland Ltd Address:

Pharmalex Suite 2, Stafford House, Strand Road, Portmarnock, Co. Dublin, D13 H525.

Tel: +353 1 846 4742 Email: Victor.cowper@pharmalex.com Web: www.pharmalex.com/ireland Business: An award winning EU and US Quality, Technical & Compliance consultancy to the life science industry. Contact: Client Services Manager: Victor Cowper

Irish PharmaChem | Industry Buyers Guide 2019

Unit 23, Sandyford Office Park, Blackthorn Avenue, Sandyford Industrial Estate, Foxrock, Dublin 18. (01) 295 6977 (01) 295 8338 graeme@pkchemicals.com Chemical Distributor Managing Director: Graeme Locke

Address: 2 Eastgate Avenue, Little Island, Cork. Tel: (021) 435 5762 Fax: (021) 435 5907 Email: dmurphy@protechplastics.org Web: www.protechplastics.net Business: Design, development and manufacture of injection moulded packaging, for use in food and pharma.

Q

Address: Tel: Fax: Email: Web: Contact:

Protech Plastics PK CHEMICALS LTD

Address:

ProSys Containment And Sampling Technology

Roseville Business Park, Turvey Avenue, Donabate, Co. Dublin.

Tel: 01 808 5055 Email: greg.maher@portakabin.com Web: www.portakabin.ie Business: Modular and portable building solutions. Contact: Marketing Manager: Greg Maher

PPD, Inc. Address: Building C, Athlone Business & Technology Park, Garrycastle, Athlone, Co. Westmeath. Tel: (0906) 460 300 Fax: (0906) 460 301 Email: susan.neenan@ppdi.com Web: www.ppdi.com Business: Contract Research Organisation.

Address: Tel: Email: Web: Business: Contact:

87 Westside Business Park, Co. Waterford. (051) 355977 info@q1scientific.com www.q1scientific.com Stability Storage (ICH/GMP) Louise Grubb, CEO

Quitmann O’Neill Packaging Ltd Address: Tel: Fax: Email: Web: Business: Contact:

St. Brendan’s Road, Portumna, Co. Galway, H53 HX51. (090) 974 1148 (090) 974 1459 sales@quitmannoneill.com www.qonpack.com Packaging Disributor and Stockist. Managing Director: David O’Neill

93


COMPANY LISTINGS

SOLV-ECHEM IRELAND LTD

S

Science foundation ireland (SFI) Address: Wilton Park House, Wilton Place, Dublin 2. Tel: (01) 607 3200 Fax: (01) 607 3201 Email: info@sfi.ie Web: www.sfi.ie Business: Government funding agency for research. Contact: Director - Strategy and Communications: Dr. Ruth Freeman

Address: Tel: Email: Web: Business: Contact:

Great Island Industrial Park, Ballincollig, Co. Cork. (021) 487 7066 tony@solvechem.com www.solvechem.com Chemical distribution, chemicals, solvents, water treatment, warehousing. Director: Tony Murray

Source BioScience Address:

SK Biotek Address: Watery Lane, Swords, Co. Dublin. Tel: 01 813 9000 Email: skbiotekmarketing@sk.com Web: www.skbiotek.ie Business: Contract Development Manufacturing Organisation. Contact: Brian Fairley, Director Business Development & Marketing

SMURFIT KAPPA IRELAND Address: Ballymount Road, Walkinstown, Dublin 12. Tel: (01) 409 0000 Fax: (01) 456 4506 Email: info@smurfitkappa.ie Web: www.smurfitkappa.ie www.skpackaging.ie Business: Packaging.

SOLTEC (IRELAND) LTD Address: Tel: Email: Web: Business: Contact:

94

Zone A, Mullingar Business Park, Mullingar, Co. Westmeath. (044) 933 5133 info@soltec.ie www.soltec.ie Soltec is Ireland’s only commercially operated solvent recycling plant. Solid hazardous waste collections also provided. Business Development Manager: Michael Corcoran

1 Orchard Place, Nottingham Business Park, Nottingham, NG8 6PX, United Kingdom.

Tel: Web:

+44 (0) 115 855 2528 www.sourcebioscience.com

SUSTAINABLE ENERGY AUTHORITY OF IRELAND Address: Glasnevin, Dublin 9. Tel: (01) 836 9080 Email: info@sei.ie Web: www.sei.ie Business: Energy advice & information.

SSPC, THE SFI PHARMA RESEARCH CENTRE Address: University of Limerick, Limerick, Ireland. Tel: +353 (0)61 234629 Web: www.sspc.ie Business: Research Centre Contact: General Manager: Dr Denise Croker

T

teva pharmaceuticals ireland Address: Unit 301, IDA Industrial Park, Waterford. Tel: (051) 331 331 Web: www.teva.ie Business: Respiratory Pharmaceutical R&D and Manufacture. Contact: Managing Director: Andy Crowley

Toyota Material Handling Ireland Ltd Address: Killeen Road, Dublin 12. Tel: (01) 419 0200 Web: www.toyota-forklifts.ie Business: Forklift and Warehouse Supplies. Contact: Noel Foley

TWi Address: West Building, Carrigaline Industrial Park, Carrigaline, Cork, Ireland. Tel: +353 (0)21 242 8800 Email: info@technicallywriteit.com Web: www.technicallywriteit.com Business: Technical writing, information design, and documentation solutions service provider. Contact: Emmet Kearney, Business Development Manager Irish PharmaChem | Industry Buyers Guide 2019


COMPANY LISTINGS

W

U

Weber Packaging Solutions Ltd

Univar Address: Tel: Email: Business: Contact:

536 Grants Crescent, Greenogue Business Park, Rathcoole, Co. Dublin. (01) 401 9800 irelandsalesoffice@univar.com Chemical Distribution Key Account Manager: Carla Byrne

Address: Kilcannon Industrial Estate, Old Dublin Road, Enniscorthy, Co. Wexford. Tel: (053) 923 3778 Fax: (053) 923 3284 Email: sales@weberireland.com Web: www.webermarking.ie

Westbourne Global IT Solutions Limited Address: The Atrium, Blackpool, Co. Cork Tel: 021 431 4310 Email: sales@westbourne.ie Web: www.westbourne.ie Business: Outsourced Service Desks for Labs and IT. Contact: Sales Manager: James Symington

V

Veolia Address: Suite 18, Plaza 256,

Tel: Fax: Email: Web: Business: Contact:

Blanchardstown Corporate Park 2, Blanchardstown, Dublin 15, D15 TR96

+353 (0)1 870 1200 +353 (0)1 870 1201 ie.info@veolia.com www.veolia.ie Energy, Water and Waste Management Solutions. Business Development Director: Sean Molloy

wRENTECH LTD Address: Eversley, Church Bay Road, Crosshaven, Co. Cork. Tel: (021) 483 2644 Fax: (021) 483 1363 Email: smurray@wrentech.ie Web: www.wrentech.ie

NOTES

Irish PharmaChem | Industry Buyers Guide 2019

95


USEFUL REFERENCES ACADEMY OF CLINICAL SCIENCE AND LABORATORY

ELECTRICITY SUPPLY

INSTITUTE OF CHEMISTRY

IRISH PATENTS OFFICE

BOARD

OF IRELAND

Tel: (056) 772 0111

MEDICINE

Tel: 1850 372 757

E-mail: info@instituteofchemistry.org

E-mail: patlib@patentsoffice.ie

Tel: (01) 905 9730

E-mail: esbnetworks@esb.ie

Web: www.instituteofchemistry.org

Web: www.patentsoffice.ie

E-mail: mail@acslm.ie

Web: www.esb.ie INTERNATIONAL SOCIETY

IRISH PHARMACY UNION

ENTERPRISE IRELAND

FOR PHARMACEUTICAL

Tel: (01) 493 6401

Tel: (01) 727 2000

ENGINERING (ISPE)

E-mail: info@ipu.ie

E-mail: client.service@enterprise-ireland.com

Tel: +1 (813) 960 2105

Web: www.ipu.ie

Web: www.enterprise-ireland.com

E-mail: ask@ispe.org

Web: www.acslm.ie ADVISORY COUNCIL FOR SCIENCE, TECHNOLOGY & INNOVATION Tel: (01) 631 2858 E-mail: firstname.surname@djei.ie Web: www.sciencecouncil.ie AN BORD PLEANALA Tel: (01) 858 8100 LoCall: 1890 275 175 E-mail: bord@pleanala.ie

IRISH VENTURE CAPITAL

Web: www.ispe.org

ASSOCIATION

ENVIRONMENTAL HEALTH ASSOCIATION OF IRELAND

INVEST NORTHERN IRELAND

Tel: (01) 276 4647

Tel: (01) 276 1211

Tel: (01) 865 1885

E-mail: secretary@ivca.ie

E-mail: info@ehoa.ie

E-mail: dublin@investni.com

Web: www.ivca.ie

Web: www.ehai.ie

Web: www.investni.com MANDATE TRADE UNION

ENVIRONMENTAL

IRISH BUSINESS &

Tel: (01) 874 6321

PROTECTION AGENCY

EMPLOYERS

E-mail: mandate@mandate.ie

Tel: (053) 916 0600

CONFEDERATION (IBEC)

Web: www.mandate.ie

LoCall: 1890 335 599

Tel: (01) 605 1500

E-mail: info@ibec.ie

E-mail: info@epa.ie

E-mail: info@ibec.ie

Web: www.biopharmachemireland.ie

Web: www.epa.ie

Web: www.ibec.ie

CHAMBERS IRELAND

HEALTH AND SAFETY

IRISH CLEANROOM

Tel: (01) 400 4300

AUTHORITY

SOCIETY

E-mail: info@chambers.ie

Tel: 01 614 7000

Tel: 087 958 8045

Web: www.chambers.ie

LoCall: 1890 289 389

E-mail: info@cleanrooms-ireland.ie

E-mail: wcu@hsa.ie

Web: www.cleanrooms-ireland.ie

Web: www.pleanala.ie BIOPHARMACHEM IRELAND Tel: (01) 605 1500

COMPANIES REGISTRATION OFFICE Tel: (01) 804 5200 LoCall: 1890 220 226 E-mail: info@cro.ie

Web: www.hsa.ie

Web: www.cro.ie

NATIONAL INSTITUTE FOR TRANSPORT & LOGISTICS (NITL) Tel: (01) 402 3000 E-mail: nitl@dit.ie Web: www.nitl.ie PARENTERAL DRUG ASSOCIATION (PDA) Tel: +1 (301) 656 5900 E-mail: info@pda.org

IRISH COSMETICS, HEALTH PRODUCTS

DETERGENT & ALLIED

REGULATORY AUTHORITY

PRODUCTS ASSOCIATION

Tel: (01) 676 4971

Tel: (01) 605 1671

PHARMACEUTICAL

E-mail: info@hpra.ie

E-mail: siobhan.dean@ibec.ie

SOCIETY OF IRELAND

Web: www.hpra.ie

Web: www.icda.ie

Tel: (01) 218 4000 E-mail: info@psi.ie

HEALTH RESEARCH

IRISH EXPORTERS

Web: www.thepsi.ie

BOARD

ASSOCIATION

Tel: (01) 234 5000

Tel: (01) 661 2182

E-mail: hrb@hrb.ie

E-mail: iea@irishexporters.ie

Web: www.hrb.ie

Web: www.irishexporters.ie

HIGHER EDUCATION

IRISH MEDTECH

AUTHORITY

ASSOCIATION

Tel: (01) 231 7100

Tel: (01) 605 1500

E-mail: info@hea.ie

E-mail: info@irishmedtechassoc.ie

Web: www.hea.ie

Web: www.irishmedtechassoc.ie

& LOCAL GOVERNMENT

IDA - INDUSTRIAL

IRISH NATIONAL

Tel: (01) 888 2000

DEVELOPMENT AGENCY

ACCREDITATION BOARD

LoCall: 1890 20 20 21

Tel: (01) 603 4000

Tel: 1890 289 389

Tel: (01) 716 1825

E-mail: qcsofficer@housing.gov.ie

E-mail: idaireland@ida.ie

E-mail: info@inab.ie

E-mail: chemical.eng@ucd.ie

Web: www.housing.gov.ie

Web: www.idaireland.com

Web: www.inab.ie

Web: www.ucd.ie/chembioeng

Web: www.pda.org

DEPARTMENT OF COMMUNICATIONS, CLIMATE ACTION AND ENVIRONMENT Tel: 01 678 2000 E-mail: customer.service@dccae.gov.ie Web: www.dccae.gov.ie DEPT. OF Business, ENTERPRISE & INNOVATION Tel: (01) 631 2121 LoCall: 1890 220 222 E-mail: info@dbei.gov.ie Web: www.dbei.gov.ie

REPAK Tel: (01) 467 0190 E-mail: info@repak.ie Web: www.repak.ie SCIENCE FOUNDATION IRELAND Tel: (01) 607 3200 E-mail: info@sfi.ie Web: www.sfi.ie

DEPT. OF HOUSING, PLANNING

96

UCD SCHOOL OF CHEMICAL & BIOPROCESS ENGINEERING

Irish PharmaChem | Industry Buyers Guide 2019


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