PharmaChem 2010

2010

Meeting the challenges of today’s industry: Outsourcing cGMP analytical testing.

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2 0 1 0 MINISTER’S FOREWORD Conor Lenihan TD, Minister for Science, Technology and Innovation, on the Government’s commitment to building the infrastructure to support a healthy, vibrant industry in the life sciences sector . . . . . . . . . . . . . . . . . . 3 SECTOR OVERVIEW Matt Moran, Director of Pharmachemical Ireland, explains the reasoning behind PharmaChemical Ireland’s Innovation and Excellence Strategy, focusing on how Ireland can become a centre of manufacturing excellence and innovation. . . . . . . . . 5 BIOTECHNOLOGY Michael Gillen, Irish BioIndustry Association, explains how Ireland can be central to creating a competitive, connected and greener economy. . . 10 MEDICAL TECHNOLOGY The massive success of Ireland’s medical technology sector has been no accident, but the result of a carefully planned strategy, writes Sharon Higgins, Director of the Irish Medical Devices Association. . . . . . . . . . . . . 14 COVER STORY Effective outsourcing of laboratory activities, such as that offered by Lancaster Laboratories, can allow biopharmaceutical companies to achieve improved operational performance. . . . . . . . . . . 18 REGULATIONS & COMPLIANCE Wesley O’Shea, Project Manager, Pilz Ireland, advises on how to choose the most effective and cost efficient route to compliance for your plant. . . . . . . . 21

SCIENCE FOUNDATION IRELAND Science Foundation Ireland is committed to building a world-class research environment in Ireland . . . . . . . . . . 34

CHROMATOGRAPHY Waters’ Corporation’s new ACQUITY UPLC H-Class System is designed to replace HPLC systems. . . . . . . . . . . 22 CLINICAL RESEARCH The recently launched Clinical Research Roadmap points the way for Ireland’s development as a centre for high quality, multi-centre clinical research . . 24 OUTSOURCING Outsourcing and not just ‘out-tasking’ your maintenance and facilities services can make perfect sense for the pharmaceutical sector, writes David Lyons, Client Operations Manager, Dalkia Ireland . . . . . . . . . . . . . . . . . . . . . . . 26 PATENTS Marie Walsh, Chartered and European Patent Attorney, writes on the use of Supplementary Protection Certificates in the extension of term of protection for medicinal products in Ireland. . . . . 29 COUNTERFEIT MEDICINES The European Federation of Pharmaceutical Industries and Associations recently unveiled a new medicine coding system to help address the growing risk of counterfeit medicines . . . . . . . . . . . . . . . . 31

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OPERATIONAL EXCELLENCE How the industry is responding to the crises arising from the challenges thrown up by failing R&D productivity and health care cost reforms, by management consultant Jim McKiernan. . . . . . . . . 36 HAZARDOUS WASTE RECYCLING In operation since 1994, Soltec has distinguished itself as a leader and innovator within the hazardous waste recycling industry. . . . . . . . . . . . . . . . . . 38 RECRUITMENT Joanna Houston, EMEA Operations Manager, Berkley Pharmaceutical and Life Sciences, reports on the wage stability and return to competitiveness of the pharmaceutical sector. . . . . . 40 PROCESS ANALYTICAL TECHNOLOGY Nessa Moyles, PharmaChemical Ireland, explains how Process Analytical Technology is playing an increasingly important role in Ireland’s pharmaceutical and chemical sectors. . . . . . . . . . . . 41 PHARMA NEWS scrubEx Launches in Ireland; Proposed Pharma Centre of Excellence; Merit Medical Expands Galway Plant. . . . . 42 Listings Chemical Suppliers. . . . . . . .

General Suppliers . . . . . . . . .

Company Listings . . . . . . . . .

Useful References . . . . . . . . .

43 45 53 64

Irish Pharmachem 2010 gratefully acknowledges the assistance of PharmaChemical Ireland in the production of this publication.

Every effort has been made to ensure the accuracy of the information contained in this publication, but the publisher cannot accept responsibility for errors or omissions.

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Minister’s Foreword

Securing a Bright Future for Pharmachem

T

he pharmaceutical industry is an extremely important industry and one that has enjoyed extraordinary success in Ireland, particularly over the past two decades. As a result, I am now very pleased to say that:

Technology and Innovation, published in 2006.

The Partnership Between Industry & Education

To achieve and sustain the goal we have set ourselves, a partnership approach • Ireland is a unique location for will be crucial. That is, the scientific pharma & biopharma investment; research community in our higher edu• We are the number one location in cation institutions must work closely Europe for life sciences projects; with their colleagues in industry for • Ireland is home to 8 of the top 10 the greater good of the economy and pharmaceutical companies in the Irish society. We have already seen world and employs approximately good progress in this regard with the 17,000 people in 83 facilities; nurturing and development of indus• Pharmaceutical exports are curtry/academic partnerships, largely Conor Lenihan TD, Minister for Science, rently valued at €29.7 billion annuon the back of Government funding Technology and Innovation. ally (40% of total manufacturing through Enterprise Ireland and Science exports); Foundation Ireland.

• Some 45,000 people are employed in life sciences; In the highly competitive and rapidly changing global • Six of the World’s top 10 drugs are made in Ireland; markets now evolving, success will go to those who use • There has been major progress in recent years in the knowledge to read trends and react first. Creative ideas, amount of R&D being undertaken in Ireland. new and better ways of working, innovative products and services, as well as improved ways of marketing and 30 years ago, the industry was almost non-existent in delivering goods to the world, will be the drivers of future Ireland. The work of our industrial development agencies success. and strong backing from Government has transformed that situation.

Global Competitiveness Today, the world-leading overseas companies with substantial overseas operations in Ireland include many of the Irish life science research continues to break new ground leading companies in the life sciences sector, encompassing in many areas and global competitiveness is already emergpharmaceuticals, biopharmaceuticals and medical devices. ing in fields such as molecular cell biology, human genetics, glycobiology, immunology and cancer. This extends Building a Healthy, Vibrant Industry beyond a strong base in fundamental basic research and has moved increasingly towards a highly productive interOver the past decade, the Government has strongly face with Ireland’s large industrial and pharmaceutical committed to building the infrastructure to support a sectors. healthy, vibrant industry in the life sciences sector. The Particularly encouraging progress has been made in establishment of the Programme for Research in Third areas that impact human health, including pharmaceutical Level Institutions focused on building world class research formulation technology, medical diagnostics and the underfacilities and capability under the National Development pinning science of biosensor research. A large number of Plan 2000-2006. In addition, Science Foundation Ireland research groups have also embraced new platforms for was established to promote world-class research activgenomic and proteomic research that are already facilitatity, initially focusing on biotechnology and ICT, and ing major strides in the study of a range of human diseases. more recently, through the extension of its remit, also on Sustainable Energy and Energy-Efficient Technologies.

Facing Up to the Challenges With these foundations in place, the Government has committed to further developing the life sciences sector Looking at the global market, we see that revenues from under the National Development Plan 2007 to 2013, to prescription drugs are valued at over $644 billion and implement its vision as set out in its Strategy for Science, projected to grow to €810 billion by 2010. Ireland is very 3

Minister’s Foreword

fortunate to have a major slice of this enormous market and to have shared in the substantial growth and success of the industry in recent years. There are approximately 90 blockbuster drugs on the market, that is, drugs achieving sales over $1bn per annum. Today, the top 10 drugs account for around 10% of total industry revenues. Of these top 10 drugs, six are manufactured in Ireland.

As regards global pharma industry challenges, it is clear that the traditional Pharma sector is experiencing somewhat slower growth, due to a combination of factors. Globally, there has also been some decline in R&D productivity.

Like all countries, we in Ireland are also facing huge challenges from the global credit crunch. Our ability to respond to this is strengthened by the fact that we are now ‘coming off the back of’ a period of 15-20 years where GDP expanded greatly and the employment base doubled, from 1.1m to 2m.

Nevertheless, the Government must of course strive to get banking and finance back to more normal operation, and to restore order to the Public Finances. On the industrial side, we remain committed to maintaining the Corporation Tax rate at 12.5%. We are determined that the business and regulatory environments will continue to be strongly pro-enterprise. We will continue to seek to strengthen our competitiveness, through addressing issues

on costs, infrastructure, education and training, and science, technology and innovation.

In these ways, we are determined to secure a bright future for industrial production in Ireland, to the benefit of all sectors, including, of course, the pharmaceutical sector.

Conor Lenihan TD, Minister for Science, Technology and Innovation.

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Sector Overview

Transforming the PharmaChem Sector Matt Moran, Director of PharmaChemical Ireland, explains the reasoning behind PharmaChemical Ireland’s Innovation and Excellence Strategy, focusing on how Ireland can become a centre of manufacturing excellence and innovation.

P

harmaChemical Ireland published a major strategy document in March 2010, entitled “Innovation and Excellence - PharmaChemical Ireland Strategic Plan”. The document, which was launched at the Drug Chemical and Allied Technologies (DCAT) meeting at the Waldorf Astoria, New York City, on March 16, outlines the industry response to the major challenges being faced by the global industry: DCAT attracts many of the key decision makers in the USA, an ideal audience for the plan.

comes off patent, revenues fall sharply - by up to 80%. Many commentators predict a drop in revenues of as much as €100 billion over the next five years. In the past, research pipelines provided replacement products for these drugs: unfortunately, such pipelines are now far less productive, meaning that companies will need to pursue alternative strategies to survive. An initial response by big pharma has been to merge: the recent Pfizer-Wyeth and Merck-Schering Plough mergers are examples of this, as companies seek to enhance their product and research portfolios.

This scenario presents a set of Background real challenges for the industry in Ireland as it prepares to absorb the Matt Moran, Director, PharmaChemical Ireland.

The global pharmaceutical, biophareffects of the first of these major patmaceutical and chemical industries ent expiries - that of Pfizer’s Lipitor face a challenging decade ahead. One of the major drivers in 2011. Exporting products valued at €47 billion in 2009, of this will the patent expiry of a number of blockbuster the sector is enormously important to the Irish economy: drugs manufactured in this country. Once a blockbuster therefore, it is paramount that the industry is well prepared for these challenges.

Fig. 1. Total Average Big Pharma* Revenue Decline Due to Scheduled Patent Expires %..

800

20.00%

700

15.00%

600

10.00%

400

6

0.00%

200

2009

10 8

300

2007 2008 Year

12

500

5.00% 2006

14

900

4 2

100

0

0

*Big Pharma average includes J&J, Novartis, Merck & Co., Abbott, Eli Lilly, Glaxo SmithKline, Pfizer, Sanofi, Bristol Myer Squibb and Roche. Source: Moody’s FM.

2001 2002 2003 2004 2005 2006 2007 2008 Sales

Growth

Linear (Growth)

Source: IMS Health Market Prognosis /(March, 2009)

5

% Growth yoy

25.00%

$ billion

% Revenue Decline

30.00%

Fig. 2. Global Pharma: Sales & Sales Growth 2001-2008

Sector Overview

Strategy Working Group In order to come up with a coherent and well thought-out response, PharmaChemical Ireland (PCI) established a group comprising industry heads to prepare a plan. They consulted widely among the sector here in Ireland, with other industry sectors such as med-tech and ICT, the research community and Government and its agencies.

This period of consultation prompted PharmaChemical Ireland to put this group onto a standing footing and to widen its membership to include strategic partners to the industry, such as IDA Ireland, Enterprise Ireland, Science Foundation Ireland, UCC, UCD, TCD, The Department of Enterprise, Trade and Innovation, NIBRT and Forfás.

This standing committee was responsible for the final strategy, which was published earlier this year. The same committee is responsible for the execution of the strategy.

Future Shape

• Companies need to strive to be regarded as lean by closely monitoring and benchmarking those key indicators that allow them to track their own efficiency and productivity.

• The industry must persuade companies to invest in on-site innovation – this should include process optimisation, product development and clinical trial manufacture, scale up and technology transfer.

• The industry must establish a rationale for conducting or co-ordinating clinical trials out of Ireland. An industry taskforce comprising PharmaChemical Ireland, IPHA, HRB, representatives from the clinical research community, ICRIN, IPPOSI, and IBIA, should be established to examine its feasibility.

• In collaboration with the Government and the research community, industry should prepare a comprehensive marketing plan for an Irish life sciences cluster. The plan would address all components of a successful cluster, such as industry, research centres, Government agencies and all other supporting cluster components.

Consideration should be given to positioning the country as a bridge between the US and Asia.

• Companies and their supply bases must reduce their operating costs across the board in order to recover relative competitiveness within their own corporate networks. All cost components, including labour, energy, cost of capital, waste treatment, local authority charges, etc, need to be controlled.

• The Chemical and Pharmaceutical Report from the Technology Foresight Exercise recommends a rapid response regulation strategy. This strategy recognises the need for Ireland to be the most favourable global location to meet the properly stringent national and international regulatory requirements. It covers all forms of regulation, including quality, health, safety and environment. It makes reference to a number of regulatory bodies including the Irish Medicines Board (IMB), the European Medicines Agency (EMEA), the FDA, the Health and Safety Authority (HSA) and the Environmental Protection Agency (EPA).

• The Technology Foresight Report also identifies the benefit to industry of quickly meeting regulatory

of the industry in Ireland

The membership of PCI have defined what characteristics each site must possess if it is to survive in the long term - the so-called ‘factory of the future’. These are summarised below: • Highly-efficient, cost-effective manufacturing with the full implementation of the principles of lean manufacturing and operational excellence; • Best practice in regulatory management, including principles of quality by design and process analytical technology; • On-site process and product development capabilities fully integrated into manufacturing; • Site of choice for transfer of all new entities to market; • Flexible and adaptable production facility; • On-site pilot plant facilities; • An on-site unit aimed at training the workforce in the latest principles of Lean, Six Sigma, etc; • Fully networked and research infrastructure; • Best practice in systems and information management; • Best in class in all aspects of environment and health and safety (EHS) management; • A fully-integrated development network for overall corporate structure; • Capacity and capability for clinical trials manufacture; • Regional HQ status for supply chain components, where it makes economic sense to concentrate them at one location; • A strong local management team; • A flexible workforce that can facilitate change on an ongoing basis.

How Can

the Industry

Achieve

this?

PCI has clearly identified a range of measures that need to be taken by companies themselves if they are to become factories of the future. A number of companies are already well on the way to attaining this status and becoming strategically relevant within their own corporate networks.

These are summarised below: 6

Sector Overview

• The high-level group on manufacturing identified a number of measures to support business at the level of the firm. These include the establishment of a manufacturing forum, support for productivity improvement, benchmarking and support for R&D and training. It is important that the Government implements these recommendations and ensures that the pharmachemical sector has access to them.

• The Government should actively support the recommendations of the European Commission high-level group on chemicals.

• The Government has committed to fund the National Bio-processing Research and Training Centre. This is a welcome development and will provide valuable support to the bio-pharmaceutical sector. However, if the pharmachemical sector as a whole is to broaden its remit to embrace process development in a meaningful way, it will be necessary to expand the centre to support the chemical and the specifically pharmaceutical part of the industry, commonly referred to as ‘small molecule’. It would provide expertise in such areas as organic synthesis, drug formulation, reactor design and green chemistry. The need for such a facility was identified by the Irish Council for Science Technology and Innovation and Forfás in their statement, titled ‘Embedding the PharmaChem Industry in Ireland’.

requirements. In the case of a medicine, this can result in significant financial savings for the company. It is essential that the industry ensures that the necessary expertise is available in Ireland. Moreover, companies need to actively invest in up-to-date regulatory approaches, such as those which have been identified by the FDA in its 21st Century Initiative, including Quality by Design, Process Analytical Technology, etc. It is important that companies apply these principles rigorously to achieve real efficiencies and cost savings through reduced testing and regulatory track streamlining.

What Can Government Do? Given the strategic importance of the sector to the economy here - over 50% of all merchandise exports are pharmachem related - it is vital that Government works closely with the industry to assist it in achieving its aims. PCI has set a clear set of recommendations which should be well within the capacity of Government to deliver. These are: • It is imperative that the Government continues to endorse the 12.5% rate for corporate tax.

• The Government must stimulate investment by enhancing the R&D tax credit scheme. It should be a purely volume-based scheme and, in addition, companies should be permitted to write off R&D expenditure against operational costs.

• The Government must ensure that Ireland is an attractive location for highly-skilled employees. It should consider tax breaks for overseas employees to encourage them to locate here. They in turn will then promote Ireland as a location for future investment and attract more similarly skilled people.

• The Government must prioritise support for the teaching of physical sciences at second level. The recommendations of the Task Force on Physical Sciences need to be implemented in full.

• Enterprise Ireland and the IDA need to develop an integrated strategy for industry development and actively promote interaction between foreign-owned and indigenous firms.

• The Enterprise Strategy Group recommended that public funding for applied research and in-firm R&D should be progressively increased to match that provided by the Department of Enterprise Trade and Employment for basic research. This includes support for in-firm capability, development, commercialisation, and cluster-led academic research and innovation partnerships. There are some notable examples of how this approach has already paid dividends through the Science Foundation Ireland (SFI) sponsored Centres for Science, Technology and Engineering (CSETs) and the Strategic Research Cluster in crystallisation, recently established at the University of Limerick.

The Government needs to ensure that this activity is prioritised and that the level of investment in applied research at least matches that in fundamental research.

• The Government must ensure that adequate infrastructural supports are in place, with a waste disposal infra7

Sector Overview

placement were integrated into courses in physical sciences and chemical engineering. This would expose graduates to the world of industry, provide them with an insight into an industrial environment and promote future collaboration.

• The Government has invested significant amounts into the research sector via the HEI-backed Programme for Research into Third Level Institutes (PRTLI), which in turn has invested in a major infrastructure programme. The Government has also committed major funding to the research base via SFI, prioritising life sciences. It is critical that this work takes account of pharmaceutical, biopharmaceutical and chemical supply sector needs, where applicable, in conjunction with SFI funding objectives. PRTLI centres should be promoted to the industry by the relevant research institutions and, where applicable, provide research support and services to the sector.

structure, including provision for thermal treatment of hazardous waste.

• The Government must avoid adding to the cost base through excessive charges for its services or those delivered via local authorities, examples of which include commercial rates, development levies, waste and water charges etc.

• The sector is highly regulated by a number of state bodies including the IMB, HSA and EPA. Additionally, the industry is subject to regulatory oversight from the US-based FDA and European EMEA. It is critical that the regulatory burden placed upon the sector in Ireland does not place the industry at a relative competitive disadvantage to its competitors for investment.

The Role

of

Conclusion If Ireland is to sustain its leading position as a global supplier of pharmaceutical and biopharmaceutical and chemical products, the pharmaceutical, biopharmaceutical and chemical supply sectors will have to transform. This transformation will take place at company level, with the Government, its agencies and the research sector playing a key collaborative role in this process.

Manufacturing alone will not be enough to ensure the long-term presence of the industry in Ireland. Research, development and innovation will drive the transformation process forward. Many factors present hurdles, including: expiry of patents on blockbuster drugs manufactured in Ireland; a rising cost base; competition from Asia and other locations; and the further consolidation of supply-chains.

These factors will erode the country’s manufacturing base unless action is taken.

Companies need to embrace the concepts of manufacturing and supply-chain excellence, as well as those of onsite innovation, such as process and product development.

Ultimately, If Irish sites achieve this goal and the country can become a global centre of excellence for development and manufacturing, they will be well positioned to participate meaningfully in discovery-related activities. Also, opportunities for indigenous companies in areas such as high-end synthesis, biotechnology, contract research, specialist centres and contract manufacturing will inevitably emerge. Hence, a much more embedded, integrated and sustainable sector will emerge.

In order to achieve these goals, it is necessary that stakeholders are aligned in a collaborative manner. Ireland does not have the time or resources to duplicate its effort. Now is the time to be smart and agile. The existing Government support network and the local management of pharmachemical companies in this country are strong and integrated. It should be more than possible to build upon this strong history and for this country to move on to become a centre of manufacturing excellence and innovation.

Research

Central to the PCI strategy is the growth of development activities within the sector, thereby anchoring manufacturing along the so-called development + manufacturing (D+M) model and positioning Irish sites to be the sites of choice for new product launches, bringing them more centre stage in global supply chains. Therefore, it is vital that the industry collaborates actively with the research community in order to build this type of capability, both on site and in the research infrastructure. Hence, the strategy contains some recommendations for the research community, developed in consultation with them: • It is important that Higher Education Institutes (HEIs) ensure that industry is aware of their research programmes, thereby enabling collaboration at an early stage. HEIs should ensure that they have well-funded and dynamic translational research programmes in place, in addition to fundamental research programmes.

• HEIs must ensure that proper systems are in place to identify and exploit intellectual property (IP) as it arises. They should be open to innovative approaches to exploitation of IP, which may entail licensing to industry. They should ensure that effective IP units are in place, reflecting and promoting best practice, as outlined in the Forfás guides on IP. • Interaction between the HEI sector and industry could be further enhanced if a six-month period of industrial 8

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Biotechnology

Biotech: Building a Brighter future Michael Gillen, Director, Irish BioIndustry Association and Senior Executive, Pharmachemical Ireland, explains how Ireland can be central to creating a competitive, connected and greener economy.

T

he EU Strategy for 2020 • Understanding from a public that is envisages an economy based well-informed about how biotechnolon smart, sustainable growth ogy is helping to create a healthier, – a powerful, ultra-efficient greener, more productive, and more engine, driving high levels of employsustainable economy. ment, productivity and social cohesion.

This echoes the strategy outlined by the Indeed, a proper strategy to foster Irish Government in 2008. However, biotechnological innovation is vital achieving these ambitious goals requires to achieving Ireland’s and the EU’s not just addressing today’s most pressing economic, ecological and social goals challenges – healthcare affordability, our for the coming decade. Encouraging ageing demographics, economic instabilbiotech helps create economic growth, ity, climate change, energy security and provides incentives to innovate to busithe global food supply – but also buildnesses both small and large, and boosts ing a lasting framework that will allow industrial and agricultural outputs, Europe and, by extension, Ireland to while reducing their impact on the prosper over the long term. environment.

Biotechnology already plays an invaluable role in this agenda. No other Smart Economy industrial sector sits so comfortably Michael Gillen, Director, Irish BioIndustry Association and Senior Executive, at the intersection of enhancement of Biotechnology offers smart, efficient Pharmachemical Ireland. quality of life, knowledge, innovation, answers to today’s economic, social and productivity and environmental protecenvironmental challenges. Healthcare tion. From new drugs that can address unmet medical providers can offer personalised, innovative, safe and needs and fight epidemics and rare diseases, to industrial effective biotech diagnostic medicines and therapies that processes that use renewable feedstocks instead of crude improve quality of life without overwhelming government oil, to drought-resistant crops that allow farmers in third budgets. But the benefits spread beyond healthcare to the world countries to feed more people under ever-harsher economy as a whole. climatic conditions, biotechnology can and will pay ecoMany biotechnology companies are SMEs, and are nomic, social and environmental dividends. thus the backbone of European business and innovation.

These bold technologies – and the ones still on the In the EU, SMEs comprise approximately 99% of all firms drawing board or in the pipeline – promise a brighter and employ more than 100m people. Biotech SMEs are future for Ireland and the world, but they don’t simply knowledge-based enterprises that provide the high valuehappen by themselves. They require: added jobs that will help the EU achieve its goal of becoming the foremost knowledge-based economy in the world.

• Sound policies that supports innovation and entrepreHealthcare offers a vivid example of how setting smart neurial risk-taking; policy today will pay big rewards down the road. By 2015, healthcare biotechnological knowledge is likely to be used • Regulatory structures that reward long-term investin the development process for all new pharmaceuticals. ment in research and development over short-term gain Through smart partnerships between companies of all and quick consumption; sizes, and also between the public and private sectors, 10

Biotechnology

Ireland originates in this sector (in excess of €44 billion in 2008).

However, while healthcare biotechnology can support governments in their efforts to enhance the sustainability of their healthcare systems, cost containment measures can also have the perverse effect of hampering innovation and access for patients by delaying or limiting entry into market of new technologies. Often short-term by nature, these measures, including stricter Health Technology Assessments (HTAs) or pricing and reimbursement processes, should ensure that patients benefit in the long-term from these healthcare innovations.

The Issue

of

Sustainability

Faced with global warming and limited fossil fuel resources, we need to encourage the development of new biological processes and the use of agricultural waste streams and renewable raw materials derived from plants, crops and trees. Using these processes and materials to produce biobased fuel, innovative materials and chemicals, has the potential to enhance quality of life while reducing negative environmental impact and thus reducing our eco-footprint.

Making the transition from a fossil fuel to a biobased economy will reduce the dependency of future generations on fossil fuels for energy and industrial raw materials.

Biobased products play a valuable role in contributing to a more sustainable society, with the potential to reduce greenhouse gas emissions, generate less waste, and use less fossil fuels and water.

innovation in healthcare biotech pushes the frontiers of science, increasing our understanding of the mechanisms of diseases daily and addressing unmet medical needs.

Fast Facts: Healthcare Biotechnology • More than 350m patients have benefited from medicines manufactured through biotechnology.

• Biotech medicines are estimated to account for more than 20% of all marketed medicines and half of all medicines in the pipeline.

Fast Facts: Industrial Biotechnology

• Biotechnology is enabling the development of therapies for rare diseases affecting 20-30m Europeans and their families, and has a major impact on the provision of safe and effective vaccines against infectious diseases.

• Industrial Biotechnology uses enzymes and micro-organisms to make bio-based products in sectors as diverse as chemicals, food and feed, detergents, paper and pulp, textiles and bioenergy.

By doing so, it provides patients with newer, safer, more effective and targeted therapies for a wide range of major diseases such as cancer, diabetes and stroke. New preventive tools such as predictive diagnostic tests or vaccines can already address diseases even before they affect patients. Biotechnology will also contribute to national healthcare services by, for example, replacing hospital stays with new treatments, or by altering the type of medical intervention, for instance by replacing long-term drug therapies with cures due to gene or stem cells therapies.

• It transforms agricultural products or organic waste into other substances, in the same way as crude oil is used as a feedstock in the production of chemicals.

Highly Skilled Jobs

• It enables the EU to produce about 75% of the world’s enzymes.

• It can save energy in production processes and lead to significant reductions in greenhouses gas emissions - between 1 billion and 2.5 billion tonnes of CO2 equivalent per year by 2030.

• Industrial Biotechnology is an industry in which Europe is a world leader.

Healthcare biotechnology is also a source of highly skilled jobs, increasing the competitive value of the sector in Europe. Nowhere is this more pronounced that in Ireland.

Approximately 50,000 people are employed, both directly and indirectly, in the life sciences sector (this includes pharmachemical, medical devices and biopharmaceutical in Ireland). Indeed over 50% of the value of exports from

The benefits of biotechnology are repeatedly reaffirmed by scientific studies and reports, such as the OECD’s report on the application of biotechnology to industrial sustainability and, most recently, by the World Wide Fund for Nature (WWF) report on the potential of industrial bio11

Biotechnology

technology to cut CO2 emissions and help build a greener economy. The WWF report concludes that the full climate change mitigation potential of biotechnology processes and bio-based products ranges from between 1 billion and 2.5 billion tonnes of CO2 equivalent per year by 2030. To put this in context, this represents more than Germany’s total reported emissions in 1990.

Creating

a

More Inclusive World

The EU Strategy for 2020 is about more than just boosting Europe’s competitiveness. It is about creating a more inclusive world and in this context, biotechnology will be a major part of the new global vision of Europe’s strategy for economic growth, sustainability and inclusion.

Industrial biorefineries will, thanks to their optimal location, add skilled jobs in rural areas. A growing market for sustainable biotech products benefits the agricultural, rural and healthcare economies, and will create new skilled and green jobs in Europe and around the world.

Biotechnology will be an indispensable tool in the effort to feed the world’s growing demand for food, even as we endeavour to reduce the impact of agriculture on our climate. The Food and Agriculture Organisation of the United Nations (UN FAO) has estimated that we will have to produce 70% more food for an additional 2.3 billion people by 2050. Green biotechnology will allow us to increase yields and help meet these market demands, while promoting sustainable agricultural practices and mitigating and adapting to the impact of climate change.

tion, build a knowledge-based economy and to speed up the transition towards a low-carbon economy. It also fits in perfectly with building a smart economy in Ireland. But it will not happen unless we take action.

Creating a sustainable and competitive bio-economy requires an integrated action plan, based on a holistic approach by the European Commission and the individual Member States, including Ireland. It must also offer real partnerships between businesses – including the pharmaceutical, medical devices and diagnostic industry, civil society including patient advocacy groups, national governments, the scientific community, consumers and the agricultural and forestry sectors – within the EU as well as between the EU and less industrialised nations.

A key element of any strategy for the development of an innovative, knowledge-based, sustainable economy must be a focus on R&D (and subsequent manufacturing) for the benefit of society and the economy. To achieve this will require the various stakeholders to:

Fast Facts: Agricultural Biotechnology • Agricultural biotechnology increases yields by up to 30% on the same amount of land, helping to protect biodiversity and conserve wildlife.

• It offers protection against insect damage, resulting in a decrease in pesticide spraying.

• It also helps reduce fuel use and CO2 emissions by requiring less tillage, and helps farmers grow more food, reliably, in harsher climatic conditions.

• Agricultural biotechnology produces food and feed containing fewer natural toxins such as mycotoxins.

• It helps to meet the Millennium Development Goals on reducing poverty.

1. Concentrate funds on targeted research, training and innovation programmes.

• It also protects soils from erosion and compaction, and increases the efficiency of water usage

Call

to

2. Design projects with clear objectives and a compulsory transfer to end products by working with industry, academia and policymakers.

Action

3. Secure the implementation of R&D in Europe through a solid reward system: i.e. via a competitive patent system and data exclusivity regimes.

The development of a biobased economy fits perfectly with the aims of the EU Strategy for 2020 to support innova12

Biotechnology

4. Promote translational research projects – from bench to market – via public-private partnerships, particularly in the field of genomics and pharmacogenomics.

Moving forward, it will be important that the private sector plays an increasingly active role in steering these partnerships towards the development of products and applications according to society’s demand.

• Create a predictable and coherent EU regulatory framework adapted to the current paradigm shift in healthcare biotech – the so-called personalised medicine approach.

• Promote national pricing and reimbursement processes that incentivise innovation and foster future access to innovative biotech therapies and personalised medicine products and services in particular.

5. Foster the development of processes for the validation and approval of biomarkers to ultimately improve patient outcomes.

• Improve the existing regulatory framework in which orphan medicinal products (OMPs) are approved to increase the successful rate of OMPs available to treat and cure rare diseases.

6. Implement the industry recommendations formulated during the revision of the Clinical Trials Directive to ensure that trials conducted in the EU remain safe, effective, competitive and adapted to emerging technologies.

• Support the coordination between Member States to establish truly patient-centred healthcare systems, placing long-term patient benefits at the heart of all industry and healthcare policies.

7. Nurture and promote coherent pro-growth and predevelopment policies that do not discriminate against promising technologies.

• Develop competitive, biobased markets via innovation support, demo-projects (such as bio-refineries) and legislation that secures the market development for biobased products.

8. Design schemes to support the funding of innovative SMEs to strengthen the climate for these groups during their capital intensive, long pathways to sustainability and towards the commercialisation of biotech products, retaining value and jobs within the EU.

Such an integrated and fully harmonised strategy is the only way that the bio-economy can develop in a sustainable manner and help drive the EU toward its EU 2020 economic, environmental and social goals. Ireland is well positioned to be at the centre of this innovative, knowledge-based and sustainable economy.

Greater Integration In addition, the establishment of a sustainable knowledge based bioeconomy will require greater integration with a variety of initiatives to:

Michael Gillen’s article is adapted from a EuropaBio position paper, published June 24, 2010.

• Inform citizens about the technologies, their safety, their advantages and the existing regulatory framework.

13

Medical Technology

Med-Tech Standing Tall The massive success of Ireland’s medical technology sector has been no accident, but the result of a carefully planned strategy, writes Sharon Higgins, Director of the Irish Medical Devices Association (IMDA).

I

reland’s medical technology sector has evolved into one of the leading clusters for medical device and diagnostic products globally, so much so that today, companies design, develop and manufacture medical devices and technology platforms that are exported across the world. The success has been truly exceptional, so that now, the country boasts a thriving multinational and a rapidly growing indigenous sector that continues to attract investment to the point where:

• Exports of medical device and diagnostic products during 2009 increased by over 9% over 2008 to €6.8 billion.

• 95% of medical devices and diagnostic products made in Ireland are exported around the world.

• Ireland is the second largest exporter of medical products in Europe, second only to Germany.

• Medical technology companies in Ireland directly employ 25,000 people.

• Ireland continues to be the highest employer, per capita, of medical technology personnel across Europe.

Pictured at the IMDA AGM in November 2009 are (l-r): Gerry McDonnell, VP Operations, Stryker Orthopaedics; Sharon Higgins, Director, Irish Medical Devices Association, and Pat Gallagher, General Manager of Baxter Manufacturing in Ireland.

• A recent survey by the Irish Medical Devices Association found that 40% of companies expect to increase staff numbers in the third quarter of this year and that a similar number intend retraining existing staff.

Announcements of note so far in 2010 include:

(TRIL) Centre. GE Healthcare is invested $3m in the TRIL Centre.

January: Creganna acquired Avalan Medical Sciences in a deal that could increase the Irish company’s revenues by 50%. The company, now known as Creganna-Taxt Medical, becomes one of the top 10 global providers of technologies and services to minimally invasive device companies.

June: Biotrin to create 40 new jobs in Dublin in a project that will establish the site as corporate headquarters for the molecular diagnostics research and development of Italian parent company Diasorin.

March: Veryan closed a €4m round of investment led by Dublinbased venture capital firm Seroba Kernel. The company has developed a coronary stent product.

July: Merit Medical to invest of €6.7m and 100 new jobs at their Galway facility, now designated as its European centre.

July: Taoiseach Brian Cowen officially opened a European Services Centre in Dublin for Covidien, a multinational medical supplies company.The company announced plans to invest €1.8m in medical technology research, and into a development project with three Irish academic institutions. But the details will not be announced until later this year. 200 people are employed at the European Services Centre.

March: Clearstream signed a contract for the distribution of its catheters in a number of Latin American and Caribbean territories.

April: GE Healthcare joined Intel and leading Irish Universities at world-class Technology Research for Independent Living

14

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Medical Technology

The success of the sector has not been accidental but an integral part of a 40-year strategy that successive Governments and agencies in Ireland have adopted and refined to attract internationally mobile investment and grow indigenous companies. The taxation model, skills pool, proximity to Europe, availability of high quality services, regulatory infrastructure, and operational excellence knowledge and R&D supports that exist enable the country to continue to compete for investment.

Nonetheless, as an export driven industry, the future success of the industry here is highly dependent on international events. A general analysis of both the global and domestic economies throws up more positives than negatives. Forecasts for global GDP growth have been revised upwards with the IMF now expecting growth of over 4% in both 2010 and 2011.

In Ireland, data for Q1 shows that GDP grew by 2.7% relative to Q4 2009. The trading sector benefited from the international recovery and export growth in the first quarter at 6.9% was very strong. Improving international demand and the significant weakening of the euro over recent months has provided a much more positive environment for Ireland’s export sector.

However, pressures on healthcare systems have resulted in a greater focus on enhanced efficacy of treatments and cost reduction. There is no sense of complacency across the sector in Ireland, where industry and Government alike are constantly looking for new ways to enhance competitiveness, develop new capabilities and ultimately generate new sustainable growth.

As outlined above, one of the key recommendations in the report includes the establishment of an industryled Life Sciences Alliance to drive and influence the implementation of the actions identified in the report as necessary to support the growth and evolution of the sector in Ireland. The Alliance, chaired by Paul Duffy, Head of Irish Manufacturing, Pfizer, is made up of industry representatives, the enterprise development agencies, and representatives of the health sector in Ireland. The Irish Medical Devices Association has significant representation on this important national group.

The Irish Medical Devices Association (IMDA) strategy is built around four pillars:

Influencing National Policy

Manufacturing and Operational Excellence: Consolidate the substantial manufacturing base of the medical technology industry in Ireland and grow investment in manufacturing and operations by delivering higher value to investors than that available in competing locations globally.

A recent report, The ‘Health LifeSciences in Ireland – an Enterprise Outlook’, published in November 2009, concludes that Ireland is well positioned to take advantage of global trends in the sector, including convergence products and devices, functional foods, and remote diagnostics and healthcare delivery. It goes on to say that investments made in R&D in areas directly relevant to the sector, together with our depth of capabilities in ICT and engineering, will continue to serve us well as we shift towards increasingly innovative and research intensive activities. The specific recommendations made in the report are:

Innovation, Research, Development and Commercialisation: Exploit innovation and R&D opportunities in the medical technology sector by nurturing strong interdisciplinary and cross sectoral collaboration(s), and thereby maximise the potential for commercialisation within Ireland.

• Harnessing the proactive engagement of a wide range of contributors for enhanced collaboration;

Global Business Services/ Shared Services: Increase the footprint of and value generated in medical technology companies operating in Ireland by attracting significant levels of global business/ shared services investment.

• Putting in place the necessary infrastructures and supports in translational medicine; • Building on our international reputation for excellence in manufacturing and process R&D;

Skills and Knowledge: Continuously develop the Irish medical technology sector’s greatest asset - our highly educated, talented and skilled workforce – who are key to meeting the future needs of the rapidly changing global industry as science technology and healthcare delivery systems advance.

• Creating, developing and attracting talent; • Underpinning the opportunity areas in physical infrastructure.

16

Medical Technology

Other

gave a review of recent developments at the SFDA, as well as upcoming changes to the Saudi regulatory framework. Discussions also took place regarding advanced regulatory training and a number of options in this regard were discussed.

topics relevant to the sector include:

The Late Payments Directive is currently being recast and is expected to come into force in early 2012 (co-decision process). The European Parliament IMCO voted on April 28, while MEPs will vote in September.

IMDA has and continues to be in correspondence with MEPs Crowley and Gallagher and the Department of Enterprise Trade and Innovation on this matter. The Irish position calls for:

Irish Medtech QA/RA Conference The IMDA are in the final stages of preparing for the flagship Irish Medtech QA/RA Conference IMDA’s biennial Global Access 2010 Conference. The event will be held on September 29 & 30 2010 in the Strand Hotel in Limerick. The programme will feature influential international speakers, including Tim Ulatowski (Director, Device Compliance, FDA), Christy Foreman (Acting Director, Device Evaluation, FDA), and Alberto Gutierrez (Director, Office of In Vitro Diagnostic Device Evaluation and Safety, FDA), Pat O’Mahony (CEO of the Irish Medicines Board) and Ann O’Connor (Director of Human Products Authorisation and Registration, IMB), Jesús Rueda (Regulatory Affairs Manager, EDMA), John Brennan (Director of Regulatory Affairs, Eucomed).

• Inclusion of public hospitals within the scope of this Directive; • Inclusion of a maximum payment period (30 days) to secure on-time payment; • Support for the European Commission’s proposal to include a lump sum compensation of 5% of the amount due to be paid by the creditor after the first day of late payment, which would strongly incentivise public authorities to pay in time. This proposal has not received any support at Parliament level; Scope of the directive should not include business-tobusiness transactions. IMDA believes that the inclusion of such provisions by the European Parliament shifts the focus away from what the European Commission had found to be the most significant area of concern, which are - public authorities to private business late payment.

Irish Industry Delegation Meet FDA A delegation of senior regulatory affairs representatives travelled as part of an IMDA delegation to Washington DC to meet with the US FDA in July. The delegation met with Centre Directors from the FDA’s Centre for Devices and Radiological Health (CDRH).

Topics for discussion include: an Overview of CDRH’s structure, roles and responsibilities; the CDRH’s FY 2010 strategic priorities; the FDA’s requirements for post-approval studies; annual reports for Premarket Applications (PMA) and 30-day Notices; and the status of CDRH’s review of the 510k process.

The day before the FDA meeting, the delegation also met with senior representatives from the US trade association AdvaMed to discuss regulatory issues of mutual concern.

IMDA

meet

Operational Excellence Training

for Industry

The IMDA have been funded to build on the achievements of the successful outgoing Manufacturing Excellence Skillnet, and broaden the programme offering to appeal to pharmaceutical, biopharmaceuticals, chemical, food and drinks manufacturers. The successful new “Life Science Skillnet” application was submitted with the support of PharmaChemical Ireland (PCI) and Food and Drink Industry Ireland (FDII). The network will build on the core programme of Lean/Six Sigma training for manufacturers (accredited at FETAC 5), and will develop a new NQF level 6 programme/qualification aimed at supervisors and technicians working in a manufacturing environment.

SFA FDA

The Irish Medical Devices Association (IMDA) met with Abdullah Abdulmohsin Al Rasheed from the Saudi Food and Drug Authority (SFDA) on June 10. Mr. Rasheed 17

Cover Story

Lancaster Excels in Outsourced Solutions Effective outsourcing of laboratory activities, such as that offered by Lancaster Laboratories, can allow biopharmaceutical companies to achieve improved operational performance.

M

eeting the changing demands of development, commercialisation and manufacturing activities as part of a global organisation is a significant challenge and is key to the success of Ireland’s biopharmaceutical operations.

Outsourcing laboratory activities enables access to extended capabilities and capacity without commitment to additional fixed costs to manage both routine and exceptional demands on GMP operations. Progressive outsourced GMP service providers now present flexible solutions to allow access to resources both within their own GMP operations and those of the client, and are becoming an increasingly strategic component of the pharmaceutical operational modus operandi.

The biopharmaceutical industry in Ireland has changed significantly in recent times. Economic factors have accelerated the actions of global Pharma to rationalise its activities.

Implications of patent expiration are forcing the industry to achieve more efficient development and commercial supply chain operations.

Companies no longer rely on pipelines being fed by selfdiscovered entities and the demands of acquired product candidates, combined with a shift towards large molecule technology, means operations need the ability to accommodate changing requirements, while under the continual pressure to focus their fixed resources on high value activities.

More than ever, the realisation that commitment to costs cannot be long term obligations is changing the way global biopharma views what is core and which activities can be delegated to service providers.

Lancaster Laboratories’ Pennsylvania facility.

their responsibilities are evolving to support technical disciplines to create more flexible operations. “They need not only to avoid fixed costs and create a more demand-orientated variable cost base, but also to ensure that operations are not exposed to risk and that delegated or outsourced activities are optimised,” explains Mark Glass, Business Development Manager at Lancaster Laboratories. “This means more focus on how service providers are utilised, ensuring interactions are seamless and activities are planned rather than reactionary, so value for money is optimised in both the short and longer term.”

Lancaster Laboratories has been in operation, supporting the biopharmaceutical industry for 50 years. In 2007, it established its EU operations base in Dungarvan, County Waterford, through acquisition of Microchem Laboratories, which has been supporting the industry in Ireland for 25 years. The creation of a harmonised global service organisation enables the support of common requirements and demands of operations located in the US, Puerto Rico, Ireland and other industry regions in the UK and mainland Europe. Analytical expertise, methods and support models can be transferred between the US and EU as the demands of their customers dictate, ensuring best practice is accessed and set-up activities are not duplicated.

The pressure from the emergence of new markets and locations in Asia and Eastern Europe accentuated the need to provide flexible service models to enable facilities to meet the demands of their global organisations. GMP service providers have evolved to meet these needs. “This has led to in- and out-sourced service solutions, allowing access to technology and human resources to optimise short, medium and long-term operational needs,” notes Glass. “In many cases, adoption of continuous improve-

Lancaster Laboratories’ EU operations base at Dungarvan, County Waterford, Ireland.

Increasing Flexibility Procurement is now a key discipline within the operations of Irish facilities. Initially tasked with reduction in cost, 18

Cover Story

and systems established to support activities but have a constraint on headcount. Often, temporary contracts are deployed to fill this interim or contingent need. This approach can create challenges for the incumbent management team, supporting training and induction needs and backfilling the often higher attrition rate of temporary staff. PSS enables more effective access to trained staff with on-site management and remote oversight, ensuring that more effective training, deployment and performance management of in-sourced teams is achieved. Lancaster has deployed PSS teams into biopharmaceutical operations in Ireland and the UK. This is often implemented to allow allocation of permanent staff onto high value or core activities.

PSS Teams are a proven solution to more efficient environmental monitoring operations where key process learning from the contract environment has been successfully applied to enhance in-facility testing operations.

PSS can also be utilised to augment functional units which need to flex as business needs change. This can be achieved by the provision of a pool of trained staff that can join development or QC testing teams as required to accommodate work loads. An on-site supervisor analyst coordinates the allocation of resources to the various client functions being supported.

ment frameworks, such as Lean, are on parity with client organisations. Concerns over financial security and access to capital for investment to meet client requirements no longer exist, as many are part of global diversified corporations, with the ability to respond to industry needs.

“These factors are critical in allowing operating facilities to rely on third parties to support development, manufacturing and supply chain activities. However, successful delivery of facility performance is dependent on the appropriate selection of the right service provider. Investment in that relationship is critical, so that appropriate service models can be utilised, working processes optimised, and waste and cost avoided. The effective supply of therapeutic products into the global supply chain is paramount.”

Biopharma organisations must take a risk-based approach in selecting their service partners. Outsourcing is not a new concept or practice in global industry, but only in recent times has it become part of biopharma strategy.

This is due to the emergence of robust and progressive outsourced service providers whose competencies enhance their clients’ operations.

In a manufacturing dominated environment, contract analytical services present a valuable tool set to enhance both the variable demands of production facilities and assurance of quality and compliance. Here are some key factors to consider when evaluating in- and out-sourced scenarios.

Service Models: Several tiers of support exist with activities undertaken either at the service provider location or within client facilities.

Fee for Service: This is the traditional, transactional outsourcing method, which is still optimal for many sporadic or short term capacity or technology needs. Client organisations request a defined test or service which is delivered and invoiced.

Raw material testing is often managed under this arrangement because of the inconsistent stream of samples which client facilities are increasingly reluctant to support themselves, so avoiding maintenance of costly laboratory infrastructure for this ‘non-core’ testing activity.

Global Presence

with the

Ability

to Invest

It is important that service organisations have comparable financial stability and global footprint to their clients.

Many pharmaceutical companies have operations in the US, Europe and increasingly in Asia. “As part of Thermo Fisher Scientific’s Biopharma Services Division, Lancaster has established operations in both the US and Europe and can invest to meet the needs of the evolving industry,” explains Mark Glass. “Large Molecule product testing, UPLC, Genotypic Microbial Identification and a global LIMs platform are examples of capability investment to meet the needs of a changing landscape. This infrastructure and capability allows Lancaster to provide parallel services to their clients’ global locations, enabling alignment of best working practices.”

This diversity of locations, service models and client base allows varied technical and ancillary career development. Contract Analytical Services combines the need for

Full Time Equivalents (FTEs): When projects are longer term and analysts can be dedicated to a single assignment, utilisation of FTEs can be a more cost effective way to sub-contract laboratory projects.

Clear deliverables and project milestones must be defined and regular interactions between supplier and client to ensure performance metrics are delivered and the project is on track. Longer term project based work such as process development, method remediation, stability programs and cleaning validation studies often lend themselves to the FTE service model.

Professional Scientific Staffing (PSS) Models: Many pharmaceutical operations have the facilities 19

Cover Story Safety Engineering Services excellent scientific expertise with those of client services and project management, quality assurance, IT and business development. Lancaster’s employees have the opportunity to combine their technical training with important client facing skills, working within their own facilities and those of their clients.

Communication

and

Process Safety • Project Management • IEC 61508/61511 • HAZOP • LOPA • SIL • Safety System Design • System Implementation • Validation • ATEX/EPD

Continual Improvement

How organisations work together to ensure objectives are met and processes are improved is core to successful outsourced relationships. The service providers must be experienced in managing the communication task with dedicated client services and project management functions.

The use of performance metrics to allow objective assessment of how well activities are being expected is essential to implement continual improvement initiatives and drive efficiencies throughout laboratory service operations.

Quality

and

Machinery Safety • Project Management • Risk Assessment • Safety Concept • Safety Design • System Implementation • Validation • CE Marking • International Compliance • Plant Assessment

Compliance

Only by having an in-depth, experienced-based understanding of GMPs in the major regulatory zones can service providers meet the expectations of global biopharma.

Many of Ireland’s operations supply global markets, so a strong inspection history with the Irish Medicines Board and the Food and Drug Administration is essential.

Safety Training • HAZOP/LOPA • SIL • ATEX • IEC 61508/61511 • CE Marking • EN ISO 13849 • Electrical Safety • Safety Design • Machinery Regulations

In Conclusion Outsourcing of GMP analytical services and the access to contingent technical staff is becoming an important part of the GMP facility tool set. World class outsourced service providers have emerged to meet these needs and now form a growing part of the industry, both in Ireland and globally.

To support the biopharmaceutical client base, outsourcing partners need to have the corporate stability and access to resources to ensure capital investment and staff development continue to meet the ever increasing demands of the industry. Experience with the industry regulators and a track record of continual improvement will ensure effective relationships with operational and quality counterparts across client and service provider organisations.

“Whether the challenge is to manage the variable demands of globally compliant raw materials testing, drive efficiency in environmental monitoring operations or to access analytical expertise to support in process or finished product testing,” concludes Glass, “the GMP service industry has the capacity and capability to enable you to achieve operational success.”

Pilz Ireland Business & Technology Park, Model Farm Road, Cork T (021) 4346535 F (021) 4804994 E sales@pilz.ie W www.pilz.ie/services

For more information on outsourced solutions and Lancaster Laboratories, visit www.lancasterlabs.com or contact Mark Glass on +353 58 48300.

Your Projects are in Safe Hands.

20

Regulations & Compliance

A Total Compliance Approach

P

Wesley O’Shea, Project Manager, Pilz Ireland, advises on how to choose the most effective and cost efficient route to compliance for your plant.

rocess Safety, Machine Safety, EMC, ATEX and Pressure Equipment are all commonly used buzzwords within the Industrial Safety Community. Depending on the application, the installation and the hazards present, varying approaches and techniques have been developed to cater for the identification of hazards and the reduction of risk posed by plant and equipment.

Organisations now have a choice of techniques including Risk Assessment, HAZOP, SIL Determination, Basis of Safety Analysis, Electrical and Mechanical Integrity Reviews etc., along with a range of legislation; Machinery Directives new 200642-EC or old 98-37-EC, Process Safety EN 61508 or EN 61511, Safety Category or Safety Integrity Level.

So how does an organisation choose the most effective and cost efficient route to compliance?

The Road

to

Case Study

To demonstrate this Total Compliance approach, we will take the example of a customer in the pharmaceutical industry. During the planning stages of an upgrade project, whereby a batch manufacturing area was due to undergo a full control system retrofit, incorporating the purchasing of new auxiliary process equipment, it was decided a Total Compliance Approach was necessary in order to manage the project from both a process safety and machinery safety aspect. The combination of Machine CE Marking, Process Control Hazards, Functional Safety Requirements and Explosion Protection was proving a significant challenge to the plant engineering and EHS departments. The challenge was how to best address all mandatory requirements of relevant legislation in a timely and cost effective manner. The traditional approach of having several teams working on HAZOPs, Machine Risk Assessment, SIL determination and Explosion Protection would have paralysed the project, both from a cost and time perspective.

The Total Compliance Assessment team systematically reviewed the plant compliance status in a single assessment. So rather than having a HAZOP, then a Risk Assessment, then a SIL meeting, a single combined assessment covered all areas. The Total Compliance Assessment team analysed E&I drawings, P&IDs, PFDs, Hazardous Area Classifications, machinery requirements, Safety Critcial Loops and EMC and noise implications for surrounding personnel and equipment.

Following the onsite assessment, a single report was delivered to the customer. This report provided an identification of all risks, along with a single prioritised action listing. As a result of this integrated approach, the customer estimated that the duration of this project stage was reduced by approximately 40%, with a comparable saving on resource requirements.

As part of our Safety Engineering Services, Pilz offers our ‘Total Compliance Assessment’. This assessment offers our customers a one stop solution for all plant and equipment whether new or old. No longer does the customer need to decide between Machinery Directive or ATEX Directive, between HAZOP or Risk Assessment: our ‘Total Compliance Assessment’ covers all areas in a combined multidisciplinary approach; Several Areas - One Assessment: Total Compliance.

Total Compliance

Whether purchasing new plant or equipment, making modifications or upgrades, the target must be ‘Total Compliance’. In trying to achieve total compliance, the customer is faced with the unenviable task of defining all legislation and standards applicable to his/her project and then determining how to coherently identify and address all risks across a range of engineering and organisational disciplines. Traditionally, plant and equipment were defined as either a machine or a process and subsequently a machine risk assessment or HAZOP would follow. However, the defining line is not so clear and often hazards and compliance requirements were only partially addressed or even missed. The industry is now moving towards Total Compliance via a more holistic approach.

This holistic approach promotes the use of a standalone team with the internal competency to carry out a full Compliance Assessment of the plant/machine/equipment. The Compliance Assessment encompasses hazard and operability, machine safety, explosion risk, functional safety etc., carried out by a single team, through a single assessment and delivered in a single report. It is easy to imagine the savings achievable by this approach when we consider the potential for reduction in meetings, documentation review cycles, action prioritisation and so on.

21

Chromatography

HPLC Simplicity with UPLC Performance Waters Corporation has introduced the new Waters ACQUITY UPLC H-Class System, incorporating the proven, robust and reliable performance of ACQUITY UltraPerformance LC (UPLC) with the operational familiarity of traditional high performance liquid chromatography. This combination of performance, simplicity and flexibility is designed to help more laboratories realise the scientific and business benefits of sub2-μm (micron) particle column technology by making it more accessible to a broader range of industries, applications and operators.

With systems currently installed in Waters’ demonstration laboratories worldwide, the ACQUITY UPLC H-Class is ready for customer shipping today.

“Working closely with our customers, it became obvious that the immediate next step for UPLC was to more closely link UPLC and HPLC to improve data quality, increase sample throughput, and reduce cost per analysis across a broader range of markets and entire enterprises,” said Art Caputo, President of the Waters Division. “Based on conversations with some of our key accounts, the introduction of the ACQUITY UPLC H-Class is the right system at the right time.”

Waters’ Corporation’s new ACQUITY UPLC H-Class System is designed to replace HPLC systems and accelerate UPLC adoption among HPLC users.

ogy platform that makes the future transition from HPLC to UPLC-based methods straightforward and practical - from product discovery through to product release testing.

“Having proven itself in the market under the most rigorous situations for the most demanding applications, UPLC technology has experienced a prolific adoption rate,” continued Caputo. “So much so, that today’s HPLC users, many of whom are currently unable to or prefer not to change their approach to LC, are looking for the benefits from UPLC technology, but on their terms.”

High Separation Efficiency The answer to achieving UPLC performance and benefits without fundamentally modifying HPLC workflows came in the form of the ACQUITY UPLC H-Class’ new quaternary solvent manager (QSM) and sample manager (SM-FTN), with flow-through needle design, thereby mimicking traditional HPLC system workflow. The featured QSM and SM-FTN on the ACQUITY UPLC H-Class combine to enable the chromatographer to achieve high separation efficiency using sub-2-μm (micron) particle separations at high pressures. The result is seamless upgrade of chromatographic capabilities.

Backed by a range of ACQUITY UPLC columns that include three particle substrates in 11 chemistries, all of which are scaleable between HPLC and UPLC particle sizes, the ACQUITY UPLC H-Class introduction is complemented by new ACQUITY UPLC Method Transfer kits. These new kits contain both UPLC and HPLC columns, with specified chemistry, and an ACQUITY UPLC Columns Calculator, all designed to take the guess work out of method transfer. In addition, Method Development and Method Validation kits are available to ensure efficient method development and robustness.

For more information on the ACQUITY UPLC H-Class, please visit www.waters.com/hclass.

Seamless Method Transfer Beyond improving chromatographic performance when running UPLC columns, as well as fully supporting HPLC columns, the ACQUITY UPLC H-Class system closely emulates HPLC workflows, making method transfer from HPLC to UPLC easier or more seamless. Furthermore, the introduction of ACQUITY UPLC H-Class allows organisations to standardise their approach to LC with a common technol22

WE HAVE ONE WORD FOR THOSE STILL USING HPLC METHODS.

INTRODUCING ACQUITY UPLC® H-CLASS. ULTIMATE PERFORMANCE FOR EVERY LABORATORY. Sign up for a demonstration at waters.com/hclass

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Clinical Trials

The Future for Clinical Research

T

The recently launched Clinical Research Roadmap points the way for Ireland’s development as a centre for high quality, multi-centre clinical research.

he launch of the Clinical Research Roadmap for Ireland has been widely welcomed as a significant step towards the further development and enhancement of Ireland’s clinical research infrastructure and an important contribution towards the country’s economic renewal.

The Clinical Research Roadmap highlights the strategic and operational changes needed to improve Ireland’s capacity to undertake high quality, multi-centre clinical research. These changes are needed to develop new medicines, diagnostics, therapeutics and medical devices and to allow Ireland to participate in European research initiatives.

The Roadmap, developed by the Irish Clinical Research Infrastructure Network (ICRIN), looks at how we can create a coordinated, networked clinical research system in Ireland, bringing together the ideas and knowledge of the best minds in clinical research - regulators, funders, researchers, industry associations, hospitals, universities and patient organisations.

Pictured at the launch of the Clinical Research Roadmap are (l-r): Professor Larry Egan, Clinical Director of ICRIN; Dr Ruth Barrington, CEO of MMI; Dr Damian O’ Connell, Chair of MMI; Mary Harney TD, Minister for Health & Children; John Mc Cormack, Chair of Medical Research Charities Group; and Enda Connolly, CEO of Health Research Board.

vene the key players in clinical research in Ireland in a series of workshops to develop a comprehensive set of recommendations in the form of a Roadmap for the development of clinical research in Ireland, which was launched in June 2010.

Speaking at the launch of the Clinical Research Roadmap, Dr Damian O’Connell, Chair of Molecular Medicine Ireland, announced that the MMI partners would work together to increase the number of multi-centre clinical studies in Ireland and in particular, to improve the experience of industry in conducting clinical trials in Ireland.

Background Ireland has the potential to be a leading country for quality clinical research, including clinical trials, to be a partner of choice in multi-national clinical trials and to generate innovative products to improve health and reduce disability.

The Irish Government is committed to providing the infrastructure for clinical research in Ireland, as evidenced by large-scale investment in recent years in facilities and expertise, the policy commitments in the Renewed Programme for Government, the Health Research Action Plan (HRAP) and the prioritisation of clinical research for funding in the Strategic Business Plan 2010-14 of the Health Research Board (HRB).

The Development

of

Strong Alliances Between Third Level Institutions The recently published Report of the Innovation Task Force endorses the need for strong alliances between third level institutions that focus on innovation. It highlights the opportunities for this country to capture innovation from convergent technologies in the pharmaceutical and biotech sectors and from our strengths in research on food and health and our expertise in medical device technologies.

The Report also stresses that “the development of a clinical trials research system is critical for the future growth and development of this sector in Ireland (both indigenous and MNCs) and to ensure that we leverage investments in research and development - translating from bench to bedside”.

ICRIN

The Irish Clinical Research Infrastructure Network (ICRIN) was created in 2006 by University College Dublin, Trinity College Dublin, University College Cork, National University of Ireland, Galway, and the Royal College of Surgeons in Ireland, and operates as a business unit of Molecular Medicine Ireland (MMI). Its preparatory phase is funded by the HRB and the Health Service Executive (HSE) and its goal is to promote harmonisation of training, processes and practice in all aspects of clinical research in Ireland in order to support academic and industry sponsors of research.

ICRIN was tasked by the HRB and the HSE to con-

Funding Clinical Research Dr Damien O’Connell, who is also Vice President for Research and Development with Pfizer, spoke about 24

Clinical Trials

need here. When this is in place, Ireland will be in a much better position to absorb new innovations and support high performance in our health system. This will improve people’s health, as well as attracting industry investment.”

John McCormack, Chair of the Medical Research Charities Group and CEO of the Irish Cancer Society, also welcomed the Roadmap, noting how “There are great opportunities to improve health outcomes for Irish people through clinical research. There is also great potential for patients to avail of the latest treatments for their conditions by taking part in clinical studies. If the recommendations of the Roadmap are implemented, the benefits of clinical research will be made more widely available.”

the changes in the way the pharmaceutical industry funds clinical research and what Ireland has to do to become a core site again for clinical trials. A combination of logistical problems and financial pressures has led companies to reduce the number of countries in which they conduct clinical trials as a strategy to increase the speed of study execution and reduce costs, while maintaining quality.

“At an operational level, industry – both global and indigenous - wants a rapid assessment of the feasibility of a study, no undue delays between the decision to conduct the study and the recruitment of the first patients and the target patient population recruited within the agreed timescale,” noted Dr O’Connell. “Industry wants predictable costs and a high level of regulatory compliance and it wants to be able to navigate the system of clinical research easily.

“As a small country, we cannot be good at everything, so we must prioritise and map our clinical research strengths and our health needs. Building the patient registries and bio collections linked to those priorities, coupled with a much improved capacity to undertake clinical trials, will be of interest to industry and will generate more clinical research and more jobs in Ireland.”

Recommendations of the Roadmap The Roadmap made a number of recommendations, which include: - An urgent priority is to reform the structure and operation of ethical review of clinical research.

- The Minister for Health and Children should establish 6-8 national research ethics committees to provide a multi-site single opinion review for all categories of clinical research involving the recruitment of participants through the health service.

- The Minister for Health and Children should establish a Central Office for Research Ethics Committees, with the necessary legal underpinning for the oversight and support of ethics committees in Ireland.

- All clinical research conducted in Ireland should be carried out within appropriate governance structures and with the assurance of compliance to the highest international standards. The ability to demonstrate that Irish researchers have the appropriate structures and skills in place to enable sponsorship and oversight of research activities is crucial to being able to lead on Irish research ideas that require the participation of multiple sites and multiple countries. This means we must develop more robust arrangements for research governance in our hospitals and universities and between those institutions.

- The Irish clinical research system should develop as a component of the emerging European biobanking and clinical research infrastructures, which are being developed as part of the European Research Area.

- An effective research infrastructure should be organised so that it improves all processes related to the design, approval, start-up, enrolment and completion of clinical trials and other research programmes with a measurable impact on productivity and research outcomes for industry and academic driven research programmes.

ICRIN Working Group The MMI Board has endorsed the creation of an ICRIN Working Group that, before the end of 2010, will address the issues identified as critical to building a clinical research infrastructure in Ireland. The ICRIN Working Group is chaired by Professor Larry Egan, Acting Clinical Director of the NUI Galway CRC at University College Hospital, Galway. Its members include leading clinical researchers responsible for the CRCs in place or planned in Dublin, Cork and Galway.

In launching the Roadmap, Mary Harney TD, Minister for Health and Children said that the Government is committed to building capacity for clinical research in Ireland and acknowledged the Roadmap as an important contribution in this regard.

Professor Lawrence Egan, Clinical Director of ICRIN and Interim Director of Galway Clinical Research Facility, said, “Our vision is to incorporate clinical research into the everyday care of patients”. Referring to the importance of partnership, he emphasised that, “ICRIN’s Clinical Research Roadmap represents an opportunity for funders, researchers, industry and the health service to build together an Irish clinical research system that will achieve this vision”.

The Roadmap was also welcomed by Enda Connolly, Chief Executive at the Health Research Board, who said, “The HRB is driving the growth of clinical research in Ireland. Developing a strong coherence across the Irish health and research systems is central to this. We have supported ICRIN to develop this Roadmap because it will help create the vibrant, co-ordinated clinical research system we

Copies of the Clinical Research Roadmap may be ordered through infor@molecularmedicineireland. ie (€6 per copy, including postage) or may be downloaded from www.molecularmedicineIreland.ie.

25

Outsourcing

The Benefits of Outsourcing Outsourcing and not just ‘out-tasking’ your maintenance and facilities services can make perfect sense for the pharmaceutical sector, writes David Lyons, Client Operations Manager, Dalkia Ireland.

I

n the pharmaceutical market of today, companies are striving to reduce costs, maximise efficiencies and at the same time, research and develop new products. The daily running of a modern pharmaceutical plant requires not only process knowledge and manufacturing know-how, but a team of skilled people to operate and maintain the peripheral building services and utilities required to create and sustain the manufacturing environment, as well as energy management and essential, non-manufacturing services such as cleaning, building maintenance, catering and a host of others.

Outsourcing of these peripheral, non-manufacturing services can offer savings and efficiencies to pharmaceutical companies, allowing them to concentrate solely on the business of developing and manufacturing product.

However, before looking at what advantages outsourcing of these functions can bring, it is important to understand what is meant by outsourcing, and to differentiate it from ‘out-tasking’.

But what if the maintenance and operation programme itself, to include regular preventative and predictive as well as corrective tasks and technical support, were contracted out? Now the client is moving into the outsourced model, where a whole function, rather than a specific task, is being contracted out, and it is in this scenario that savings and efficiencies can be made.

Outsourcing of utility services within the pharmaceutical industry in most cases will include clean systems such as high purity water, clean steam, and clean HVAC systems, as well as typical plant services such as chilled water, plant steam, compressed air, waste systems etc. Facilities services will typically include building fabric maintenance, cleaning, general building services administration and possibly security as well. A well defined scope and clear objectives should be agreed between client and service provider, encapsulated in a Service Level Agreement (SLA) between provider and client.

Ensuring Client Satisfaction

Outsourcing Vs Out-tasking

Using a risk-based approach, the scope and responsibility of the service provider can be built up over time, thus ensuring client satisfaction and confidence, particularly around regulatory compliance. It is important, particularly in this regard, that the client doesn’t relinquish all responsibility, as ultimate regulatory responsibility lies with the product manufacturer. Appointing key subject matter experts (SMEs) to liaise with the service provider and designing escalation and process flows for change controls, equipment deviations and the like, will ensure adherence to quality and regulatory systems. This is the area that poses most risk to the pharmaceutical manufacturer, but with the proper approach and with good systems in place, this ceases to be an issue.

For the service provider, customer satisfaction is a primary focus and all experienced providers will recognise that adherence to quality systems in a highly regulated industry can ‘make or break’ any outsourced agreement in this sector.

Many client companies will use third party vendors or contractors to carry out various maintenance tasks, for example maintenance on specialist equipment such as Water-For-Injection (WFI) stills, compressors and boilers, and many see this as ‘outsourcing’ these maintenance functions. However, responsibility for quality and scope of work and internal documentation still remains with the client, so in essence it is the specific maintenance task that is being contracted out: in other words, these activities are being ‘out-tasked’.

Key Performance Indicators Apart from strict regulatory concerns, there are other key areas where successful delivery of service can be judged: for example, safe systems of work, system availability, performance against schedule, to name but a few. These can be captured as Key Performance Indicators (KPIs) in 26

Outsourcing a performance scorecard, which can then be linked financially to the service agreement contract.

Each line item can be linked to a performance metric, each metric can be weighted and scoring criteria agreed, and on a periodic basis (monthly, quarterly), the metrics are reviewed and scored.

Linking the score to contract payments (for example, withholding an agreed percentage each quarter pending an agreed KPI score), drives performance from the service provider point of view and if properly chosen, ensures client satisfaction. As the relationship between provider and client matures, the KPIs can be reviewed and changed as either the client-supplier relationship develops, or as

business needs change, possibly changing the scope of the original agreement – this would be particularly important in longer term agreements.

Reducing Costs Outsourcing maintenance and facilities allows the client to reduce costs by reducing direct company head-count, and as the pharmaceutical company essentially becomes the customer of the service provider, it is much easier to drive change and continuous improvement within the facilities function. It also allows him to focus almost all of his resources on the core business of developing and manufacturing product, without having an internal team dedicated to the non-manufacturing activities involved in facilities engineering.

For the service provider, successful delivery of service means more business, particularly in an industry where reputation counts for so much.

For further reading, see ‘Maintenance and Facilities Outsourcing Excellence’ – An Industry Case Study – Padraig Liggan, ISPE Pharmaceutical Engineering Magazine, July/August 2009, Vol 29, No. 4 - http:// www.dalkia.ie/docs/doc148.pdf

27

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St James Hospital has recently purchased two scrubEx machines for our Theatre Department through our Linen provider, Celtic Linen. The implementation ® of scrubEx machines has proved very successful in terms of traceability, and elimination of non return of scrub suits. The system is supported by technology that offers a suite of reports which ensures adequate stock coverage at all times and a track and trace functionality. ® Due to the success and cost savings achieved to date, St James Hospital is now implementing scrubEx system to all Clinical Departments that require Scrub Suits.

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Patents

The Use of SPCs Marie Walsh, Chartered and European Patent Attorney, MacLachlan & Donaldson, writes on the use of Supplementary Protection Certificates in the extension of term of protection for medicinal products and plant protection products in Ireland.

P

atent proprietors make use of various strategies to extend the term of their monopoly position for medicinal products. One of these strategies is the use of Supplementary Protection Certificates (SPCs). The purpose of SPCs is to compensate patent proprietors for the time period that elapses between the filing of an application for a patent for a new medicinal product and the authorisation to place that medicinal product on the market.

Protection Provided

by an

SPC

A Supplementary Protection Certificate (SPC) does not prolong the term of the basic patent itself. Instead, an SPC comes into effect when the basic patent expires and provides the same protection as that afforded by the patent but the SPC protection extends only to the product covered by the Marketing Authorisation.

Marie Walsh, Chartered and European Patent Attorney, MacLachlan & Donaldson.

Relevant Regulations

protection product for which an authorisation to place the product on the Irish market has been issued and in respect of which an Irish patent is in force.

‘Medicinal Product’ means the active ingredient or combination of active ingredients of a medicinal product, being a substance (or combination of substances) for treating or preventing disease in humans or animals, including a substance (or combination of substances) administered for diagnostic purposes or for restoring, correcting or modifying physiological functions.

‘Plant Protection Product’ means active substances and products containing them intended to (a) protect plants or plant products against all harmful organisms; (b) influence the life process of plants, other than as a nutrient; (c) preserve plant products, in so far as such substances or products are not subject to special Council or Commercial provisions on preservatives; (d) destroy undesirable plants; or (e) destroy parts of plants, check or prevent undesirable growth of plants.

An SPC may be sought for each qualifying product, provided that only one SPC is available for a given active ingredient or combination of active ingredients. If the

Council Regulation (EEC) No. 1768/92 for Medicinal Products and Council Regulation (EC) 1610/96 for Plant Protection Products came into effect in the European Union States on January 2, 1993, and February 8, 1997, respectively. Following several amendments, Regulation No. 1768/92 was consolidated into Regulation (EC) No. 469/2009 effective from July 6, 2009.

Under the Regulations, a Supplementary Protection Certificate (SPC) for a medicinal product or a plant protection product can be sought in any European Union (EU) state subject to a first authorisation to market the product having been obtained. SPCs are also available for the following countries: Iceland, Norway and Liechtenstein.

The main provisions of the relevant Regulations relating to SPCs, with particular reference to Ireland are discussed here.

Product

for which an

SPC May

be

Sought

An SPC can be applied for any medicinal product, including a pharmaceutical or veterinary product, or a plant 29

B i o tPeacthennot sl o g y

patent covers more than one authorised product, then an SPC can and should be sought for each qualifying product.

Who May Seek

SPC

an

An SPC may be sought only by the proprietor of the basic patent. The basic patent is the patent which protects the product per se, a process for manufacturing the product or an application (use) of the product.

When

to

Seek

an

SPC

An application for an SPC must be filed within six months of the date on which the authorisation to place the product on the market in Ireland is issued, unless such authorisation is given prior to granting of the basic patent, in which case the time for filing the application is six months from the date of grant of the patent. No application for an SPC may be filed if the basic patent has expired.

Calculating

the

Duration

of an

SPC

An SPC becomes effective on the day following the expiry of the basic patent. The maximum duration of an SPC is restricted to five years, subject to payment of annual renewal fees at the same level as the renewal fee for the 20th year of a patent. The actual duration of any SPC is the period between the date of the application for the basic patent and the date of the first EU authorisation for the product, less five years. Of course, the term is limited by the five year maximum term.

Paediatric Use Extension

of

Term

of

SPC

Extension of the term of an SPC for a medicinal product is available where steps are taken to determine the suitability of the product for paediatric use.

Regulation (EC) No. 1901/2006 on medicinal products for paediatric use was implemented in Ireland by way of Statutory Instrument No. 307 of 2008. Regulation (EC) No. 1901/2006 (as amended by Regulation (EC) No. 1902/2006) partially came into effect on January 26, 2007.

Since January 26, 2009, this regulation is fully in effect.

Under the provisions of this Paediatric Regulation, the duration of any SPC for a medicinal product can be extended by six months on application to the Irish Patents Office, provided that certain measures have been taken relating to determining the suitability of the medicinal product for paediatric use.

To be able to obtain this extension of an SPC’s term, a Paediatric Investydion Plan (PIP) must be approved and completed, and the result applied to the marketing authorisation for the product. The outcome of the paediatric studies is irrelevant to the granting of an extension.

The product must be authorised in all Member States of the European Union. An application for an SPC term extension may be made, together with an application for an SPC or after granting of the SPC, but not later than

two years prior to the normal expiry of the SPC. During a transitional period, which ends on January 26, 2012, an application for an SPC term extension can be filed up to six months before the normal expiry date of the SPC. In addition to details concerning the SPC, an application for an extension of the term of an SPC must include a copy of the statement indicating compliance with an agreed completed PIP and proof of authorisation to place the product on the market in all Member States.

Further Information For specific information about applications for SPCs or SPC term extensions in Ireland or other European Union States, please contact Marie Walsh at walshm@ maclachlan.ie or Dr. Yvonne McKeown at mckeowny@ maclachlan.ie.

This article provides general information only and does not purport to provide legal advice. Specific advice should be sought as relates to particular circumstances.

30

Counterfeit Medicines

Countering the Counterfeiters The European Federation of Pharmaceutical Industries and Associations recently unveiled a new medicine coding system to help address the growing risk of counterfeit medicines.

E

FPIA (The European Federation of Pharmaceutical Industries and Associations), the voice of the research-based pharmaceutical industry in Europe, recently unveiled its pilot project to verify medicines and so help reduce the risk of counterfeit medicines being dispensed to patients.

The coding pilot project, launched in September, involves testing a pharmacy-based verification system using a small data matrix on each medicine pack dispensed. This will run for approximately four months in 25 pharmacies, and will assess more than 100,000 packs.

The project uses a two-dimensional barcode, similar to those found on airline boarding passes. This contains a unique product identifier, allowing pharmacists to verify the status of every pack in the pilot at the time of dispensing. Scanning the data matrix code with a simple barcode reader will also allow the pharmacists to automatically detect the product expiry date and the batch number. This will increase confidence that the product being dispensed is safe.

Background

to the

other measures are also required.

To eliminate counterfeits and protect public health means having a comprehensive series of measures. These include harmonised product serialisation, the universal use of safety features and a ban on repackaging.

Ensuring Product Integrity The use of safety features on the packaging, to show the pack has not been opened or tampered with, along with verification at the point of dispensing, will ensure pack integrity. Where existing safety features have been removed, it becomes easier for counterfeits to enter the supply chain undetected. The simplest method of avoiding this would be a ban on repackaging, as this would help guarantee that the integrity of the original packaging has been preserved throughout the entire distribution chain and the product has not been tampered with. However, to date the Commission does not wish to see such measures.

EFPIA strongly believes that, should repackaging be allowed to continue, robust inspection and audits by regulatory authorities are required to ensure that this activity is strictly controlled and scrutinised.

EFPIA Pilot

An Optimum Approach

The project is a response to the European Commission’s Draft Directive on counterfeiting, aimed at reducing the risks of counterfeit medicines entering the legitimate supply chain. The proposals set out a legal basis for ensuring that safety features are obligatory on packs, allowing them to be authenticated and traced.

The logic of the Commission’s proposal is indisputable.

Europe’s citizens need to be protected from the infiltration of counterfeit medicines, for their own safety, as well as to maintain confidence in the legitimate supply chain.

Improved identification of medicine packs entering the pharmacy and being dispensed to patients will make a valuable contribution to tackling this threat.

However, this cannot wholly eradicate the problem:

to

Product Verification

Of the measures proposed, a product verification system at the point of dispense (i.e. pharmacy or hospital) offers good scope for improving both supply chain security and patient safety. The Commission has not set out how they envisage traceability working, but there are clear criteria required to ensure success.

Paramount is that the system is harmonised and interoperable across Europe. If the free movement of medicines across borders is to be safe, a coordinated approach to identification and verification is essential. This needs all national coding systems to be interoperable and based on common standards, such as those defined by GS1.

This way, any pharmacist in any country can verify whether a pack with the same serial number has been 31

Barcode Verification

Scan First Time - Everytime !

The accurate scanning of barcodes is fundamental for effective supply chain management. Barcodes that do not scan properly result in wasted time and money for retailers and suppliers.

The GS1 Ireland Verification service checks the likely scanning performance of your barcodes and how they conform to international (ISO) standards and the GS1 General Specifications.

Benefits of Verification

Risk of failed scans greatly reduced

More efficient supply chain

Faster product to market

Faster order to cash cycle

Improved customer relationships

More accurate orders, deliveries & Invoices

ATRIX M A T A 2D D ICATION VERIF AILABLE AV NOW

Scanning v’s Verification A simple scan is no substitute for verification. Barcode scanners differ from wands to lasers to cameras, from manually operated to automatic. Lighting conditions, surface reflectance, print contrast and the scanner maintenance all vary.

Verification is a scientific measurement of each individual bar and space. Symbol placement and contrast, data structure, check digit validation as well as the amount of light reflected back are all precisely measured.

Verification is the “bridge between printing and scanning”.

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GS1 Ireland will provide you with a full verification report indicating the likely compliance of your barcode when it is printed on your consumer unit or product packaging. If necessary we will suggest where you may need to make changes to meet GS1 and/or industry specifications.

For more information on services offered by GS1 Ireland visit www.gs1ie.org or call Membership Services on 01-208 0660.

www.npp.ie

Nationwide Delivery Service

Counterfeit Medicines

Pharma Manufacturer

Wholesaler

Wholesaler

Pharmacist/ Hospital

Patient

Product Flow

Unique Serialization

Verification Verification

Dispensing

2D Data Matrix on 2o pack

Data Transfer

Product Serialization Database

dispensed before, irrespective of its country of origin.

Accredited full-line wholesalers would also be able to have the option to access the database to check the status of the product at any time if in doubt, either before sending a product to the pharmacists or upon return of the product by the pharmacists.

Without standardisation and interoperability, there is a risk that the national identification and verification systems will be fragmented. This will limit verification of a product’s provenance to national product codes and create the problem of identifying counterfeit products crossing borders.

With parallel trade accounting for around 10% of all pharmaceutical sales in Europe, the ability to verify products that have moved cross-border is essential.

Furthermore, the solution needs to garner the support of all stakeholders by addressing their needs effectively.

Imposing high-end or expensive solutions throughout the supply chain is likely to generate resistance. The proposed EFPIA solution is realistic, proportionate and costeffective. This pilot project encompasses both wholesalers and retail pharmacies in the trial process, and will generate learnings from all actors.

counterfeit medicines in the supply chain continues to increase, while Member States initiate potentially incompatible solutions at different speeds, without addressing the needs for interoperability and standardisation.

The EFPIA project will provide proof of concept; a system using proven technology that can be deployed rapidly. It will also address the key requirements of interoperability and standardisation in a proportionate and affordable manner. This is a practical solution to the challenge of implementing unique pack verification that all actors can embrace.

It will not offer the total protection that a ban on repackaging would provide, but offers a practical, pragmatic and achievable approach that provides citizens with additional protection from this threat.

Preliminary Results The pilot project will not be completed until the end of the year but early results have been very encouraging: • No operational problems reported by pharmacies; • New scanners are well accepted by pharmacists; • More than 1,000 packs verified and dispensed during work days; • Pharmacy log file entries show that the majority of pharmacies do not have any significant issues; • Ca. 9900 packs sold (as of 5 Oct) which is ca. 9 % of packs coded; • Excellent system response times, 99 % of transactions completed in < 1.0 sec.

A Timely Solution Finally, the solution needs to be timely. The Commission proposals mean that Member States will have to embrace mass serialisation, but without setting timelines or guidelines on the appropriate technology.

This could create a situation where the numbers of 33

Science Foundation Ireland

Research for Ireland’s Future Science Foundation Ireland (SFI) is committed to building a world-class research environment in Ireland, investing in research teams to generate new knowledge, leading edge technologies and competitive enterprises in the fields of science and engineering.

S

FI was set up 10 years ago when it became clear that Ireland needed to develop its research capacity and that Ireland needed highly skilled people available to carry out research and to support the industries coming here for manufacturing purposes.

In recent years, Ireland, through substantial Government investment, has made significant progress in building its scientific research capacity. Last December, the Irish Government reiterated this commitment, through the publication of its strategy for economic recovery, ‘Building Ireland’s Smart Economy: A Framework for Sustainable Economic Renewal’, and more recently, in the Irish Government’s Infrastructure Investment Priorities for the period 2010-2016. The plan has, at its core, a sustained commitment to innovation, to attracting world-class researchers to Ireland, and to harnessing opportunities from diverse research areas.

• Biotechnology (BIO); • Information and communication technology (ICT); • Sustainable energy and energy efficient technologies (ENERGY).

The ultimate goal of the Government investment through SFI is that economic benefit should, in due course, arise from the actions and projects funded.

SFI now directly supports 3,225 researchers in the higher education sector (up 15% from 2008). SFI researchers have leveraged further funding from other sources to effectively double this community to over 6,000 active researchers.

Total expenditure/payments on SFI funding awards in 2009 amounted to €171m, with over 251 new awards to 19 research bodies being approved across its suite of award programmes.

Substantial benefits have already arisen from this investment:

Utilising Human Capital

• SFI Researchers have reported publishing 4,057 peer reviewed publications in 2009 (up 26% on 2008). This has contributed significantly to Ireland’s on-going ascent from below EU average volumes of scientific output to OECD levels. Ireland has moved up the international rankings in terms of scientific quality – Ireland now ranks in the top 20 nations, up from 36th in 2003.

• Academic-industry partnerships have grown extensively. SFI Researchers collaborate with 389 distinct companies/organisations, including 184 multinational corporations (MNC) and 165 small-medium enterprises (SME).

• Academic-academic collaborative networks expanded, growing Ireland’s scientific networks/international reputation. 1,967 academic-academic collaborations were reported (up from 1,338 in 2008). 46% of these are with partners outside the European Union (EU); 32% with rest-of-EU partners outside Ireland and 24% with Irish partners.

• The SFI community produce 4,057 scientific publications, representing a 26% increase on 2008.

• An increase in the number of SFI-supported Post Doctoral Researchers to 846 (up from 688 in 2008) and an increase in PhD students to 1,344 (up from 1,156 in 2008).

Ireland is one of the key players in the global life sciences sector. Despite the current economic climate, the sector continues to attract foreign investment by investing in research and development, and education with links to industry. The aim is to ensure that Ireland remains a key location for leading edge research and development, and the quality jobs it can deliver.

The focus is essentially about the utilisation of human capital – the knowledge, skills and creativity of people – and our ability and effectiveness in translating the outputs into valuable processes, products and services.

It is clear that successful economies of the future will be those that embrace knowledge and learn how to use it. For Ireland, this involves bringing together our best scientists, educators, engineers and entrepreneurs to work across sectors and industries.

Investing

in the

Future

SFI is investing in high quality investigators and research teams, who are most likely to generate new knowledge, leading edge technologies and competitive enterprises in the fields of science and engineering which underpin the broad areas of: 34

Science Foundation Ireland

• In 2009, 76% of academic collaborations engaged in by SFI researchers were outside of Ireland, spanning 56 different countries.

• SFI leaders won €159m worth of research investment from non-SFI sources such as the EU’s framework programme, Enterprise Ireland and the Wellcome Trust.

Developing Links

SFI Strategic Research Clusters (SRC’s) – Life Sciences • Reproductive Biology Research Cluster, Dr Alexander Evans, UCD; • The Irish Drug Delivery Research Network (IDDN), Prof. David Brayden, UCD; • Network of Excellence for Functional Biomaterials (NFB),Prof. Abhay Pandit, NUIG; • Solid State Pharmaceuticals Cluster, Prof. Kieran Hodnett, UL; • Immunology Research Centre (IRC), Prof. Kingston Mills, TCD; • Advanced Biomimetics for Solar Energy Conversion, Prof. James MacElroy, UCD; • BioNanoInteract, Prof. Kenneth Dawson, UCD; • Alimentary Glycoscience Research Cluster (AGRC), Prof. Lokesh Joshi, NUIG; • Irish Separation Science Cluster, Prof. Brett Paull, DCU; • Molecular Therapeutics for Cancer Ireland (MTCI), Prof. John Crown, DCU

with Industry

In order to bring about real and meaning for economic benefits from investment in scientific research, it is crucial for SFI and its funded researchers to develop strong links with industry. It will be key industry partners who pose the questions and, through partnership with academic researchers, find the solutions to technological, environmental, medical and economical issues. It is these industry partners who, in association with SFI-funded projects, will commercialise the outputs of the research and bring about smaller incremental changes in the existing operations, thereby increasing the competitiveness of business in Ireland.

An integral part of SFI investment is to focus research in areas of strategic importance to Ireland. The SFI Strategic Research Clusters (SRCs) and Centres for Science Engineering and Technology (CSETs) encourage collaboration with industry around strategic areas of research.

A large number of the SRCs exist within the life sciences space, including the Solid State Pharmaceuticals Cluster (SSPC) in Limerick, the Network of Excellence in Functional Biomaterials (NFB) and Glycoscience Research Clusters in Galway and the Irish Drug Delivery Network and BioNanoInteract Clusters at University College Dublin.

Between them, these clusters alone have over 30 industry partnerships with a diverse range of international companies, including Medtronic, Boston Scientific, Pfizer and GlaxoSmithKline.

SFI’s most significant awards are CSETs. Currently, SFI supports nine CSETs – three in the Life Sciences and six in the ICT sector.

Examples of these collaborative SFI CSETs in the Life Sciences include:

affect the quality of people’s lives worldwide over the coming decades. The diagnostic devices and sensors will aim to detect minute concentrations of disease related molecules in biological samples like blood, saliva and breath. Collaborating Partners: Åmic AB (recently acquired by J&J Ortho-Clinical Diagnostics), Analog Devices Inc., Becton Dickinson and Co., Biosurfit S.A, Enfer Technologies Ltd., Hospira Inc., Inverness Medical Innovations Inc.,Millipore.

Systems Biology Ireland, University College Dublin - www.ucd.ie/sbi Systems Biology Ireland will build the foundations of the science through the development of platforms and expertise in systems biology by focusing on defined scientific projects. In an effort to solve critical biological and biomedical problems, SBI research projects will be driven by the need to address biological questions for tangible benefits. In order to achieve a systems level understanding, the conceptual framework to rationalise complex biological relationships will come from mathematical modelling.

Collaborating Partners: NUI Galway and industry partners Hewlett Packard, Servier, Agilent Technologies, Siemens Ireland, Ark Therapeutics and Protagen AG.

Alimentary Pharmabiotic Centre (APC) at University College Cork - www.ucc.ie/research/apc The goals of the APC include investigating the means by which intestinal bacteria influence health and disease; developing new therapies for debilitating gastrointestinal diseases (such as gastroenteritis, C. difficile, ulcerative colitis and Crohn’s disease); exploring commercial opportunities in both the pharma and functional food sector; and positioning Ireland at the forefront of this exciting new area. Collaborating partners: Alimentary Health, GlaxoSmithKline and Teagasc (the Irish agriculture and food development authority).

Maintaining Momentum Over the coming years, SFI intends to maintain the momentum and to firmly establish Ireland as a centre for excellent research in leading areas of science and technology. SFI activities have become increasingly relevant to the economy and this trend will continue, in the belief that high-quality scientific research and researchers are the drivers needed to develop Ireland into a high-value, knowledge-based economy.

For more information about the research SFI supports and details of up coming calls, see www.sfi.ie.

Biomedical Diagnostics Institute (BDI), Dublin City University - www.bdi.ie BDI is carrying out cutting-edge research to develop the next generation of biomedical devices that will directly 35

Operational Excellence

The Prescriptions for Future Success How the industry is responding to the crises arising from the challenges thrown up by failing R&D productivity and health care cost reforms, by management consultant Jim McKiernan of McKiernan Associates GmbH.

T

hese days, the pharmaceutical industry is relentlessly pursuing a drive to reduce costs as it tries to maintain competitiveness and, at the same time, retain its historical attractiveness to the investment community. Profitability has been significantly challenged as traditional blockbuster products lose patent protection and the industry has no like-for-like replacements.

The traditional model is under severe threat with the pressures of healthcare cost containment, the widespread adoption of generic products and more targeted treatments based on genomic profiling and demands for a clearer link between cost and therapeutic benefit.

The growing cost of health care is leading insurers and governments to demand greater use of generic substitution and enforced price cuts on medicines. For long neglected by corporate headquarters as of little consequence to the overall cost paradigm, manufacturing and supply chains are under the microscope like never before. Historically high costs (CoGS – Cost of Goods Sold) and poor levels of efficiency were unimportant in the past since margins were comfortably high.

Smart Ideas

but

Little New Under

the

ing over a century ago. (There was a scientific reason behind the “any colour as long as it’s black” approach – Henry Ford’s approach to customer service!

In fact, black paint dries faster than any other colour, thus improving processing time on his newly introduced assembly lines, a classic lean concept.)

What’s

different though?

The differences between, say, the Total Quality and Re-Engineering movements of the ’80s and ’90s that make lean and six sigma more compelling are now understood. Amongst other things, Operational Excellence demands: • A strong focus on defining and understanding customers as a starting point; • Insistence on senior management sponsorship and commitment; • Ideas flowing bottom-up from those closest to the ‘coal-face’; • A strict definition of project scope and timelines using the 5-step DMAIC (Define, Measure, Analyse, Improve, Control) methodology; • Tracking of benefits and improvements linked to economic value to the business; • A proactive approach to the use of culture change as a driver of improvement.

The journey to operational excellence is seen as a neverending quest for perfection, whereas individual projects typically last no longer than four to six months, ensuring focus and quick returns. All of these factors combine to provide a winning formula for success and sustainability.

Sun

As a response to these cost pressure and, indeed, to try to guarantee survival of in-house manufacturing, companies are now implementing management approaches long since used in other industries such as Lean and Six Sigma. Using the umbrella term of Operational Excellence, we can also consider techniques and practices such as Continuous Improvement (Kaizen), Risk Management and Design for Manufacturing.

Whereas Six Sigma was developed fairly recently (the US electronics company, Motorola developed it as a statistically-based analysis of variation in the mid-’80s), other practices have been around for much longer. There is evidence of process flow in the way in which the Italian navy built ships in Venice in the 11th Century, while Henry Ford was well ahead of his peers in lean think-

Does Ireland

have a

USP?

These new approaches present both risks and opportunities for Irish sites, as global companies continue to rationalise their manufacturing networks, following patent expirations and major mergers.

In two cycles of benchmarking conducted by PharmaChemical Ireland over the past five years, it is clearly seen that most Irish pharma sites have embarked 36

Operational Excellence

on operational excellence programs and major benefits have been demonstrated in terms of reduced throughput times, reduced inventory levels and more productive use of expensive capital assets - all 35 sites benchmarked have such initiatives under way.

When we look at the industry, both internationally and in Ireland, three classes of site emerge in terms of maturity in the adoption of Operational Excellence: • Leaders: clearly stretching their levels of achievement but also actively looking outside the industry for examples of best practice across other sectors such as electronics, automotive and aerospace; • Followers: some four or five years behind the leading sites but beginning to implement important new performance measures such as OEE (Overall Equipment Effectiveness) and process capability; • Beginners: sites only recently starting on their excellence journey but keen to leap-frog ahead by learning from their more advanced colleagues and avoiding mistakes made by the pioneers.

Fig 1 – Combining Strategic Relevance with Operational Excellence

less after the fact inspection and greater use of in-process control and right first time quality (Quality at source and Design for Manufacture). Active ingredient manufacturers are looking at innovative scientific solutions to the traditional batch-driven approach, which will allow continuous processing and a much greater emphasis on flow.

Looking

of

Future

Nobody could have predicted the changes we have lived through in the past decade and equally, we cannot be certain of what the future holds. Nevertheless, there are encouraging signs that Ireland’s response to recent challenges are beginning to bear fruit. Recent announcements about manufacturing site rationalisation have not left the country unscathed but this is not surprising, given the breadth of our manufacturing footprint.

What has been encouraging are the announcements in which Irish sites’ strategic importance has been recognised and this has been reinforced by additional investments and research collaborations. We must continue to leverage these successes and in this operational excellence will play a central role in ensuring the future competitiveness of Irish sites.

Ireland’s USP is its talent pool, combined with an active industry network, supported by IBEC (PharmaChemical Ireland) as well as IDA and government initiatives which seek to combine solid operational excellence with the appropriate economic, scientific and skills environment.

Breaking Out

to the

Pharma’s Cultural Gravity

Historically, pharma manufacturers have been constrained by what we term “Cultural Gravity” (Fig 1). This is seen in the traditional response to ideas from outside - “This won’t work here; we’re a regulated industry”, “We’re not Toyota”, “We have SOPs to follow”. And yet industry leaders with insight recognise that ensuring their manufacturing sites survive and thrive in the future will demand game-changing strategies which have never been seen in the industry before.

Organisations are being turned sideways as companies adopt process-oriented structures with minimised hierarchical layers. In the past, it was common to find quality departments with up to one quarter of a site’s headcount – these numbers are being drastically scaled back as quality at source becomes the norm, with much

Jim McKiernan is MD of McKiernan Consultants GmbH, a professional services firm, offering management consulting to the pharmaceutical and life sciences industries and professional development training and coaching to management across all sectors. For more information, contact McKiernan Associates GmbH, Aeschenvorstadt 71, CH-4051 Basel, Switzerland. Web: www.mckiernan.ch. Email: info@mckiernan.ch. Tel: +41 61 225 4264.

37

Hazardous Waste Recycling

Soltec: Making Waste Work In operation since 1994, Soltec has distinguished itself as a leader and innovator within the hazardous waste recycling industry. As innovators, Soltec are always looking for new cost-friendly solutions to their customersâ&#x20AC;&#x2122; ever-changing needs.

A

s leaders in hazardous waste recycling, Soltec ensure excellence in all areas of operation and their ISO 9001:2008 accreditation and EPA Licensed Facility are a credit to that fact.

Soltec take pride in the fact that their company offers a fully traceable waste collection service from point of collection to point of recovery or disposal. As a customer, you can be confident that any waste collected by Soltec will be treated and disposed of in accordance with all environmental, Health and Safety legislation, and that all relevant documentation will be available to you as proof of this for your own records and for audit purposes.

Waste is collected by the operator in the red polypropylene lined HazBin. This process ensures that only hazardous waste is placed in the easily identifiable colour coded bags, thus eliminating the possibility of general waste been sent along with the hazardous waste, a situation which would increase disposal costs unnecessarily. Full bags of waste are then removed from the bin, tied and transferred to either the bulk HazBox or HazBag.

HazBin

Reducing Costs

As innovators, Soltec are always looking for new costfriendly solutions to their customersâ&#x20AC;&#x2122; ever-changing needs.

These solutions need to be effective, easy to implement but more importantly, remain in line with the companyâ&#x20AC;&#x2122;s quality ethos.

An example of such innovation is evident in their HazBin, a new addition to their range of Haz products.

The HazBin is a Certified Fire Retardant Bin (Cert No SII210/2) which is suitable for wipes, oily rags, air filters and contaminated Personal Protective Equipment and can hold up to 90 Litres.

Used predominantly to collect hazardous waste from production lines or labs, the HazBin performs an integral role in the collection process and can help reduce costs when used in conjunction with the HazBag or HazBox.

The HazBag and HazBox are FIBC containers pioneered

by Soltec for the disposal of solid hazardous waste. The unique feature of these two products is that they can hold up to five times the amount of an ordinary 200-litre open top barrel, resulting in a reduced need for repeat purchase for barrels and thus, reduced costs.

As leaders and innovators within the hazardous waste recycling industry, it is easy to see why major pharmaceutical manufacturers trust Soltec with their hazardous waste disposal and are keen to implement the cost-saving measures, outlined above, into their current waste management plan.

Interested in reducing your hazardous waste disposal costs? Soltec are always happy to share their expertise for those seeking assistance with any waste management queries.

Contact Details: For more information, or to find out how Soltec can help reduce your hazardous waste disposal costs, visit www.soltec.ie. Tel: 044 93 35133.

Email: info@soltec.ie.

38

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Recruitment

Positive Outlook for Pharmachem Sector

T

he last year has seen a remarkable change in the pharmaceutical recruitment landscape and most importantly, we are seeing positivity returning to it, particularly over the last six months.

Organisations took a lean approach to the way they recruited by utilising more combined recruitment models at favourable rates and engaging niche service providers, who could deliver accurate candidates in a streamlined manner. Berkley found that it was important to be able to offer clients flexibility that allowed them to ramp up and down as required to suit the business needs.

With niche skills being in demand and organisations concentrating on talent management on a global basis, we have seen the value in providing an international service that allows unique skills to brought into Ireland where needed, as well as providing a consistent recruitment service across global teams.

It is increasingly becoming the case that all service providers in engineering and resourcing have to be regional and global. With all the consolidation within the industry, increasingly companies want universal suppliers, local input and decision powers are being centralised.

In 2010 to date, Berkley has seen additional requests from European and Asian colleagues to present short-lists for key management roles internationally, while in a local context, we have found a lift in the number of organisation considering operations here, with an increase in the requests for due diligence information for new builds or expansion programmes.

Joanna Houston, EMEA Operations Manager, Berkley Pharmaceutical and Life Sciences, reports on the wage stability and return to competitiveness of the pharmaceutical sector.

recent survey has also revealed that 52% of people are still open to moving roles, while 46% are happy to retain their current salary rates. Salary inflation is not as common when moving to a new role or seeking an internal promotion, so wage costs are increasingly stable as a result.

In analysing the Irish market in global terms, Berkley compared the current rates and cost factors that their clients are working with. Over the past 12 months, the competitiveness and normalisation of the Irish market has been dramatic. While the economic factors at a corporate level are always attractive, the wage inflation and expectations of the workforce were becoming un-sustainable.

When the weakness of the US dollar was also taking hold, projects and costs were soaring. The US dollar has now retreated almost 15-18%, the project costs are more competitive, while added to this, salaries have adjusted 10-15%.

Realism

in the

Market

When you add the third component of wage increase expectation, Ireland is the lowest in the global league of expectation, i.e. we expect lowest percentage of increases, if any. In fact, 65% of Irish candidates are more flexible on salary, a genuine show of realism in the market.

Take all of this into account, we are now once again, dollar for euro, more cost effective. While a lot of resources have taken up roles internationally in the contract engineering sector, most are awaiting the opportunity to return for new projects in Ireland.

About Berkley

Stabilising Labour Supply

Berkley Group have been providing resourcing and engineering solutions in the Irish, European and Asian markets for over 15 years. For more information, contact Joanna Houston, EMEA Operations Manager, Berkley Pharmaceutical and Life Sciences. See www.berkley.ie or call +353 (0)1 8724666 / +353 (0)21 4289600.

The labour supply has stabilised, with a lot of restructuring at the low level and middle management functions.

Organisations were faced with triple and quadruple applications for certain skill sets, however, the need for direct headhunting increase for critical roles and proactive searches are still required to extract specialist skills. Our 40

Process Analytical Technology

P

PAT: Measuring Its Impact

rocess Analytical Technology (PAT) is a term used to describe the application of a variety of different analytical methodologies inline, on-line or at-line to allow timely measurement of product attributes during manufacturing and the use of this data to increase the level of process understanding and control.

PAT is a set of tools which can be applied to achieve a goal, not a goal in its own right. The goal is to reduce variation in a process and achieve RFT (Right First Time) manufacturing. It provides a window to enhance process understanding and is applied based on comprehensive process risk assessments. It can be used to enhance process safety and enable a more cost effective manufacturing operation. PAT facilitates the development of knowledge during development and maintenance of control during manufacturing.

Nessa Moyles, Senior Executive, PharmaChemical Ireland, explains how Process Analytical Technology is playing an increasingly important role in Ireland’s pharmaceutical and chemical sectors.

• •

•

• •

• • •

•

Perception of regulatory obstacles Transition from development application to manufacturing Appropriate GMP quality oversight Openness to new technology Corporate support –selling PAT to senior management - can be difficult to show positive payback Technical challenges Implementation infrastructure Handling regulatory change post filing, developing high level skills Time and cost associated with creating methods

Much of the Irish pharma sector has already begun or is in the process of implementing PAT. PAT technology in use on Irish sites includes: • MS dryer monitoring; • IR reaction monitoring; • Feasibility on NIR for blending to monitor assay and CU; • Optical particle size; • Raman rxn cell, lasentec, reactir, drying; • NIR id and IPT; • FBRM, NIR, pH, conductivity, RI; • NIR, MS, turbidity.

PAT: The Benefits & Challenges

As with most things in life, there are both benefits and challenges when it comes to PAT. Benefits include: • Real time window on process • Root cause determination Sharing Information Nessa Moyles, Senior • Increase in process knowledge and underExecutive, PharmaChemical standing While there is much shared content on the Ireland.

• Ability to reduce process variability subject, the majority of information is not at • Sampling, testing, product contact reducthe working/practitioner level. Therefore, this tion limits the ability of Irish entities to leverage the combined • Attribute based endpoints experience of the Irish pharma sector in terms of end-user needs and interaction with regulatory authorities. In order • Process control to address this deficit, Irish pharma sites have come together • More agile manufacturing operations in 2010 and formed a PAT group, the aim of which is to • Tackling inefficiencies and reducing in process testing • Increased process understanding to determine key facilitate candid sharing between PAT practitioners of both attributes that impact on product quality successes and failures. The group will focus on the follow• Elimination of OOT/OOS results ing objectives: • Increased efficiency • Identify implementation opportunities and risks; • Improved throughputs, efficiency, reduced costs • Identify and address skills deficiencies (work with • Process optimisation, reduced time to market, consistacademia); ency of product, data generation for CAPAs • Identify infrastructure / technology opportunities • Use PAT to assist in implementation of QBD (work with vendors); • Improved quality and reduced costs through driving • Enable Ireland to be a recognised PAT centre of innovation excellence.

Challenges to PAT are: • Technology robustness • Cost • New skill sets needed across functions • Reluctance to change

PAT is playing an increasingly important role in quality systems and has an invaluable role to play in process understanding and deviation reduction. Going forward, PAT will be an integral part of how sites evaluate and establish product quality.

41

Pharma News

scrubEx

Launches in Ireland

Recently launched into the Irish pharmaceutical market

by O’Flynn Medical, scrubEX is an easy to operate gown management system which can be customised to suit individual plant requirements. Employees simply swipe their security badge/ID and the relevant protective clothing is dispensed/returned. scrubEx encourages cGMP and lowers operating costs. It is setting the benchmark standards in gowning by using modern technology in an innovative and traceable approach to the prevention of instances of contamination through the misuse of protective clothing; working in conjunction with an easy-to-use management computer and software system, which allows for multi site usage.

The system has already proved popular in the Irish healthcare market, with Limerick Regional Hospital describing scrubEX as “probably the most effective piece of equipment that I purchased in the past few years...it has made life so much better!! I would recommend it to everyone.”

Tadhg O’Flynn, MD of O’Flynn Medical, pictured with the new scrubEx gown management system.

Quitmann O’Neill Have Packaging Covered Quitmann O’Neill Packaging Ltd is one of the leading suppliers of specialist packaging products and services to the pharmaceutical, chemical, hazardous waste and food industries.

Quitmann O’Neill Packaging is based in the midlands with easy access to all major routes. They operate a modern transport fleet that meets the latest European pollution standards.

Quitmann O’Neill Packaging provides tailored services to customers’ packaging requirements. Their range includes steel, plastic and fibre drums, IBCs, FIBCs, tin plate containers, buckets, bottles, pots and UN corrugated boxes.

The company recently launched their plastic bucket and small pot range. For further details, please contact Shane McEnroy at 085 8022626 or smcenroy@ quitmannoneill.com.

Proposed Pharmaceutical Centre of Excellence

Merit Medical Expands Galway Plant

IRELAND could soon have a global pharmaceutical centre of excellence in Tralee if a group, headed by Corkbased Pharmadel, have their way. The proposed centre of excellence would offer “the largest single employment placements on the island of Ireland”, with 4,800 jobs, and would become one of the largest research and development centres in the world.

The group behind the proposal are in constant contact with the Department of Enterprise and if given the green light, the new centre could be open by September 2012, employing 116 leading academic professionals, 321 corporate management executives and more than 4,300 graduates.

Merit Medical is to invest €6.7m in an expansion of its plant in Galway, which will allow for the creation of 100 new jobs. The firm is to enter the surgical pre-pack business in Europe and establish Galway as its European centre. Merit Medical Ireland Limited (MMIL) established in Galway in 1994, manufacturing guidewires and inflation devices used in hospitals worldwide. The chairman and chief executive of Merit Medical, Fred P. Lampropoulos, said: “Merit employs 250 people in Galway and when it was decided to venture into the surgical pre-pack market in Europe, a number of location options were considered.

The success of Merit’s established operation in Ireland and the skills set of the existing Irish management team made Ireland Merit’s location of choice.”

42

Chemical Suppliers Acids & Alkalis ABB Ltd Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Corcoran Chemicals Ltd Enva Ireland Ltd Fisher Scientific Goulding Chemicals Ltd National Chemical Co. Ltd P.K. Chemicals Ltd SciChem - Cork SciChem - Dublin Sigma-Aldrich Ireland Ltd Univar Ltd

Biochemicals Associated Chemicals Ltd Camida Ltd Carbon Group Corcoran Chemicals Ltd Fisher Scientific National Chemical Co. Ltd Sigma-Aldrich Ireland Ltd

Biocides ABB Ltd Brenntag Ireland Camida Ltd Fisher Scientific Univar Ltd

Catalysts Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Corcoran Chemicals Ltd P.K. Chemicals Ltd

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44

General Suppliers Actuators Festo Ltd Flexachem Manufacturing Ltd Norgren Ireland Ltd Petrochem Pipeline Supply Ltd Tyco Valves & Controls Ireland Ltd

Aerators Flexachem Manufacturing Ltd Manotherm Ltd WrenTech Ltd

Agitators Fisher Scientific Flexachem Manufacturing Ltd Quitmann Oâ&#x20AC;&#x2122;Neill Packaging Ltd WrenTech Ltd

Air Filtration/Monitoring / Pollution Control Norgren Ireland Ltd SciChem - Cork SciChem - Dublin

Alarms P.J. Boner & Co. Ltd

Aluminium Products Topchem Laboratories Ltd

Analysis Services Anecto Catalent Pharma Solutions Lancaster Laboratories

Analytical Equipment P.J. Boner & Co. Ltd Calibration Technology Carbon Goup Fisher Scientific Petrochem Pipeline Supply Ltd PPD Inc. Sartorius Mechatronics Ltd

SciChem - Cork SciChem - Dublin Sigma-Aldrich Ireland Ltd Waters Chromatography Ireland Weber Labelling & Coding

Associations Irish Exporters Assoc.-Life Sciences Irl.

Autoclaves Fisher Scientific Goliath Packaging Systems Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

Automation P.J. Boner & Co. Ltd Bosch Rexroth Ltd Festo Ltd Flexachem Manufacturing Ltd Goliath Packaging Systems Ltd Norgren Ireland Ltd Pilz Ireland Weber Labelling & Coding

Barriers Safety WrenTech Ltd

Biotechnology Catalent Pharma Solutions Flexachem Manufacturing Ltd Idex Pump Technologies (Ireland) Ltd PM Group SciChem - Cork SciChem - Dublin Sigma-Aldrich Ireland Ltd

Blenders Fisher Scientific Flexachem Manufacturing Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

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45

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Chemical Consultants Enva Ireland Ltd Hazchem Training Ltd Johnston Logistics Ltd Pilz Ireland Topchem Laboratories Ltd

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Cleanrooms Pilz Ireland PM Group WrenTech Ltd

Clinical Reasearch Organisation

Cold Chain Packaging Catalent Pharma Solutions Cross Technical Solutions CRS Mobile Cold Storage

Compressed Air/ Compressors Festo Ltd Flexachem Manufacturing Ltd Idex Pump Technologies (Ireland) Ltd Norgren Ireland Ltd

Computer Systems O’Flynn Medical Ltd

Condensors Cross Technical Solutions Flexachem Manufacturing Ltd

Condition Monitoring P.J. Boner & Co. Ltd Flexachem Manufacturing Ltd Dalkia

Construction Management PM Group

Conveyors

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P.J. Boner & Co. Ltd Manotherm Ltd Waters Chromatography Ireland Weber Labelling & Coding Zenith Technologies

Dehumidifiers Cross Technical Solutions

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Dispersers Ocon Chemicals Ltd WrenTech Ltd

Distillation Soltec (Ireland) Ltd WrenTech Ltd

Driers Complas Packaging Ltd Flexachem Manufacturing Ltd GEA Process Technologies Ltd WrenTech Ltd

Drums/Containers

Bosch Rexroth Ltd Flexachem Manufacturing Ltd Goliath Packaging Systems Ltd Weber Labelling & Coding WrenTech Ltd

Environmental Consulting PM Group

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Cleaning Services / Equipment

Data Acquisition

Cooling Systems Cross Technical Solutions Graham Hart (Process Technology) Ltd Waters Chromatography Ireland

Carbon Goup Complas Packaging Ltd Flexachem Manufacturing Ltd Indaver Ireland Industrial Packaging Ltd Interpac Quitmann O’Neill Packaging Ltd Soltec (Ireland) Ltd WrenTech Ltd

Dry Ice Carbon Goup

Economic Development Agency Invest Northern Ireland

46

Education & Training Ann McGee Calibration Technology Festo Ltd Hazchem Training Ltd Henley Forklift Group Ltd Irish Exporters Assoc.-Life Sciences Irl. Pilz Ireland PM Group Waters Chromatography Ireland

Effluent Monitoring/ Treatment Axium Process P.J. Boner & Co. Ltd Carbon Goup Enva Ireland Ltd Flexachem Manufacturing Ltd Lancaster Laboratories Norgren Ireland Ltd

Electrical Cross Technical Solutions

Electronic Components Cross Technical Solutions Pilz Ireland

Energy Efficiency / Management Cross Technical Solutions ESB Independent Energy Flexachem Manufacturing Ltd Irish National Accreditation Board PM Group Sustainable Energy Authority of Ireland

Engineering Services Berkley Group P.J. Boner & Co. Ltd Croom Precision Medical Cross Technical Solutions Flexachem Manufacturing Ltd GEA Process Technologies Ltd Henley Forklift Group Ltd Pilz Ireland Festo Ltd Nederman Ltd PM Group

Environmental Consulting Ocon Chemicals Ltd Pilz Ireland

Environmental Services/ Equipment P.J. Boner & Co. Ltd Cross Technical Solutions Enva Ireland Ltd Idex Pump Technologies (Ireland) Ltd Ocon Chemicals Ltd Pilz Ireland PM Group Quitmann O’Neill Packaging Ltd Soltec (Ireland) Ltd

Filling Equipment Flexachem Manufacturing Ltd Idex Pump Technologies (Ireland) Ltd Quitmann O’Neill Packaging Ltd Weber Labelling & Coding WrenTech Ltd

Filters Axium Process Carbon Goup Fisher Scientific Flexachem Manufacturing Ltd Idex Pump Technologies (Ireland) Ltd Nederman Ltd Norgren Ireland Ltd

Filtration

Evaporators Cross Technical Solutions Fisher Scientific Flexachem Manufacturing Ltd GEA Process Technologies Ltd

Explosion Proofing BS&B Safety Systems Ltd Flexachem Manufacturing Ltd Gunnebo Ireland Ltd Henley Forklift Group Ltd Norgren Ireland Ltd Pilz Ireland Sartorius Mechatronics Ltd

Explosion Protection / Panels BS&B Safety Systems Ltd Henley Forklift Group Ltd Pilz Ireland

Axium Process Enva Ireland Ltd Flexachem Manufacturing Ltd GEA Process Technologies Ltd Idex Pump Technologies (Ireland) Ltd Nederman Ltd Norgren Ireland Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

Flow Control P.J. Boner & Co. Ltd Fisher Scientific Flexachem Manufacturing Ltd GEA Process Technologies Ltd Idex Pump Technologies (Ireland) Ltd Manotherm Ltd Norgren Ireland Ltd Petrochem Pipeline Supply Ltd Tyco Valves & Controls Ireland Ltd

Fluid Handling

Extruders WrenTech Ltd

Facility Design PM Group

Facilities Management Goliath Packaging Systems Ltd Hochtief Facility Management 47

Fisher Scientific Flexachem Manufacturing Ltd GEA Process Technologies Ltd Idex PumpTechnologies (Ireland) Norgren Ireland Ltd Petrochem Pipeline Supply Ltd SciChem - Cork SciChem - Dublin Tyco Valves & Controls Ireland Ltd WrenTech Ltd

G e n e r a l S u pp l i e r s

Irish PharmaChem 2010

Irish PharmaChem 2010 G e n e r a l S u pp l i e r s

Fume Cupboards Fisher Scientific Nederman Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

Furnaces Fisher Scientific SciChem - Cork SciChem - Dublin

Gas Detection Fisher Scientific SciChem - Cork SciChem - Dublin

Gauges P.J. Boner & Co. Ltd Fisher Scientific Flexachem Manufacturing Ltd GEA Process Technologies Ltd Manotherm Ltd Norgren Ireland Ltd Petrochem Pipeline Supply Ltd

Glassware Fisher Scientific Flexachem Manufacturing Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin Sigma-Aldrich Ireland Ltd

Hazardous Waste Disposal/Treatment Enva Ireland Ltd Hazchem Training Ltd Indaver Ireland Idex Pump Technologies (Ireland) Ltd Interpac Quitmann O’Neill Packaging Ltd Soltec (Ireland) Ltd

Health & Safety/First Aid Fisher Scientific Hazchem Training Ltd Pilz Ireland

Heat Exchangers Axium Process Cross Technical Solutions Flexachem Manufacturing Ltd GEA Process Technologies Ltd Graham Hart (Process Technology) Ltd Petrochem Pipeline Supply Ltd ProSys Containment and Sampling Technology Tyco Valves & Controls Ireland Ltd WrenTech Ltd

Homogenisers Fisher Scientific Flexachem Manufacturing Ltd GEA Process Technologies Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

Hoses Flexachem Manufacturing Ltd Henley Forklift Group Ltd Micro Hydraulics Ltd/Micro Industries Ltd Nederman Ltd Norgren Ireland Ltd

Humidity/Humidifiers P.J. Boner & Co. Ltd Cross Technical Solutions Fisher Scientific Interpac Manotherm Ltd

Hydraulics

Inspection Equipment P.J. Boner & Co. Ltd Flexachem Manufacturing Ltd Sartorius Mechatronics Ltd Weber Labelling & Coding

Instrumentation P.J. Boner & Co. Ltd Carbon Goup Cross Technical Solutions Fisher Scientific Flexachem Manufacturing Ltd Manotherm Ltd Petrochem Pipeline Supply Ltd SciChem - Cork SciChem - Dublin Tyco Valves & Controls Ireland Ltd Waters Chromatography Ireland Weber Labelling & Coding Zenith Technologies

IT Brightwater Weber Labelling & Coding

Investment Glanbia Estates Science Foundation Ireland (SFI)

Investment Promotion Agency IDA Ireland

Lab Equipment/Supplies

Bosch Rexroth Ltd Henley Forklift Group Ltd Micro Hydraulics Ltd/Micro Industries Ltd

Incineration Indaver Ireland Ocon Chemicals Ltd

Incubators Fisher Scientific SciChem - Cork SciChem - Dublin 48

P.J. Boner & Co. Ltd Calibration Technology Carbon Goup Fisher Scientific Ocon Chemicals Ltd ProSys Containment and Sampling Technology Quitmann O’Neill Packaging Ltd Sartorius Mechatronics Ltd SciChem - Cork SciChem - Dublin Sepha Ltd Sigma-Aldrich Ireland Ltd Waters Chromatography Ireland Weber Labelling & Coding WrenTech Ltd

Legal/Financial/ Insurance MacLachlan & Donaldson Matheson Ormsby Prentice

Logistics C+G Logistics Group Celtic Forwarding Ltd Johnston Logistics Ltd KWE (Ireland) Ltd One Stop Handling Weber Labelling & Coding

Lifts & Hoists Goliath Packaging Systems Ltd Gunnebo Ireland Ltd Henley Forklift Group Ltd Norman Lauder Ltd WrenTech Ltd

Machine Tools Idex Pump Technologies (Ireland) Ltd Lister Machine Tools Ltd Soltec (Ireland) Ltd

Maintenance Cross Technical Solutions Festo Ltd Flexachem Manufacturing Ltd GEA Process Technologies Ltd Goliath Packaging Systems Ltd Gunnebo Ireland Ltd Lister Machine Tools Ltd Sartorius Mechatronics Ltd

Materials Handling/ Forklifts/Pallet Trucks Goliath Packaging Systems Ltd Henley Forklift Group Ltd Interpac Johnston Logistics Ltd One Stop Handling Waters Chromatography Ireland WrenTech Ltd Toyota Material Handling Ireland Ltd

Mechanical Engineering Services Axium Process Croom Precision Medical Cross Technical Solutions Flexachem Manufacturing Ltd GEA Process Technologies Ltd Henley Forklift Group Ltd Goliath Packaging Systems Ltd Pilz Ireland

Mechanical & Process Engineering Axium Process Flexachem Manufacturing Ltd GEA Process Technologies Ltd Norgren Ireland Ltd Pilz Ireland WrenTech Ltd

Medical Device Manufacture B.Braun Medical Croom Precision Medical

Membrane Filtration Systems

Microscopes Fisher Scientific Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

Milling Flexachem Manufacturing Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

Mixers Fisher Scientific Flexachem Manufacturing Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

Noise/Odour Control Flexachem Manufacturing Ltd

OEM Manufacturing Flexachem Manufacturing Ltd Idex Pump Technologies (Ireland) Ltd GEA Process Technologies Ltd Sigma-Aldrich Ireland Ltd

microfiltration

Axium Process Fisher Scientific GEA Process Technologies Ltd nanofiltration

Axium Process Fisher Scientific GEA Process Technologies Ltd ultrafiltration

Axium Process Fisher Scientific GEA Process Technologies Ltd

Meters P.J. Boner & Co. Ltd Fisher Scientific Flexachem Manufacturing Ltd GEA Process Technologies Ltd Manotherm Ltd Petrochem Pipeline Supply 49

Packaging/Design Anecto Catalent Pharma Solutions Charpak Medical Chesapeake Complas Packaging Ltd Industrial Packaging Ltd Interpac Measom Freer NPP Group Ltd PrimePac Ltd Quitmann O’Neill Packaging Ltd Smurfit Kappa Ireland Weber Labelling & Coding

G e n e r a l S u pp l i e r s

Irish PharmaChem 2010

Irish PharmaChem 2010 G e n e r a l S u pp l i e r s

Packaging/Machinery Chesapeake Goliath Packaging Systems Ltd Interpac NPP Group Ltd Quitmann O’Neill Packaging Ltd Sepha Ltd Weber Labelling & Coding WrenTech Ltd

Pallets Complas Packaging Ltd Goliath Packaging Systems Ltd Henley Forklift Group Ltd Interpac Johnston Logistics Ltd Quitmann O’Neill Packaging Ltd Smurfit Kappa Ireland WrenTech Ltd

Pharmaceutical Fabrication Axium Process Catalent Pharma Solutions

Pipes/Cores Flexachem Manufacturing Ltd Industrial Packaging Ltd Petrochem Pipeline Supply Ltd Smurfit Kappa Ireland

Plastic Containers Chesapeake Fisher Scientific Flexachem Manufacturing Ltd Industrial Packaging Ltd Measom Freer Ocon Chemicals Ltd PrimePac Ltd SciChem - Cork SciChem - Dublin Soltec (Ireland) Ltd WrenTech Ltd

Plastic Cores / Tubes

Pneumatics

Pressure Relief

Bosch Rexroth Ltd P.J. Boner & Co. Ltd Festo Ltd Fisher Scientific Flexachem Manufacturing Ltd Idex Pump Technologies (Ireland) Ltd Norgren Ireland Ltd

Pollution Control Nederman Ltd O’Flynn Medical Ltd

Powder Handling Carbon Goup Flexachem Manufacturing Ltd GEA Process Technologies Ltd Goliath Packaging Systems Ltd Idex Pump Technologies (Ireland) Ltd ProSys Containment and Sampling Technology Quitmann O’Neill Packaging Ltd WrenTech Ltd

Power Supply ESB Independent Energy

Pressure Measurements/ Switches/Vessels Axium Process P.J. Boner & Co. Ltd BS&B Safety Systems Ltd Cross Technical Solutions Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd Manotherm Ltd Norgren Ireland Ltd Petrochem Pipeline Supply Ltd

Pressure Vessels Flexachem Manufacturing Ltd Petrochem Pipeline Supply Ltd

Fisher Scientific Flexachem Manufacturing Ltd Measom Freer Sigma-Aldrich Ireland Ltd Smurfit Kappa Ireland 50

BS&B Safety Systems Ltd Flexachem Manufacturing Ltd GEA Process Technologies Ltd Manotherm Ltd Norgren Ireland Ltd Petrochem Pipeline Supply Ltd Pilz Ireland Tyco Valves & Controls Ireland Ltd

Process Control Axium Process P.J. Boner & Co. Ltd Flexachem Manufacturing Ltd GEA Process Technologies Ltd Manotherm Ltd Norgren Ireland Ltd O’Flynn Medical Ltd Petrochem Pipeline Supply Ltd Pilz Ireland Sartorius Mechatronics Ltd Weber Labelling & Coding Zenith Technologies

Process Design GEA Process Technologies Ltd Pilz Ireland PM Group Weber Labelling & Coding

Process & Mechanical Engineering Contractors Axium Process Pilz Ireland GEA Process Technologies Ltd

Project Management Axium Process Cross Technical Solutions GEA Process Technologies Ltd Glanbia Estates Goliath Packaging Systems Ltd Johnston Logistics Ltd Pilz Ireland PM Group Zenith Technologies

Protective Clothing/ Apparatus Fisher Scientific O’Flynn Medical Ltd

Pumps Fisher Scientific Flexachem Manufacturing Ltd GEA Process Technologies Ltd Idex Pump Technologies (Ireland) Ltd ProSys Containment and Sampling Technology

Quality & Compliance

Renewable Energy ESB Independent Energy Sustainable Energy Authority of Ireland

Sanitary Tubing Flexachem Manufacturing Ltd Micro Hydraulics Ltd/Micro Industries Ltd Petrochem Pipeline Supply Ltd

SCADA/DCS/MIS P.J. Boner & Co. Ltd Cross Technical Solutions Zenith Technologies

Ann McGee Consulting Ltd

Reactors Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

Recruitment Berkley Group Brightwater ICDS Recruitment Consultants Lancaster Recruitment Matrix Recruitment O’Loughlin Partnership Science Recruitment Ireland Zenith Technologies

R&D Axium Process Lancaster Laboratories PPD Inc. SciChem - Cork SciChem - Dublin Topchem Laboratories Ltd WrenTech Ltd

Refrigeration/Freezing Cross Technical Solutions CRS Mobile Cold Storage Dalkia Fisher Scientific GEA Process Technologies Ltd SciChem - Cork SciChem - Dublin

Scrubbers Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

Seals & Gaskets Flexachem Manufacturing Ltd GEA Process Technologies Ltd Micro Hydraulics Ltd/Micro Industries Ltd Quitmann O’Neill Packaging Ltd

Stainless Steel/ Fittings/Products Festo Ltd Fisher Scientific Flexachem Manufacturing Ltd GEA Process Technologies Ltd Idex Pump Technologies (Ireland) Ltd Interpac Micro Hydraulics Ltd/Micro Industries Ltd Petrochem Pipeline Supply Ltd Quitmann O’Neill Packaging Ltd

Steam Equipment Flexachem Manufacturing Ltd Manotherm Ltd Petrochem Pipeline Supply Ltd

Storage/Bunding C+G Logistics Group CRS Mobile Cold Storage Interpac Johnston Logistics Ltd SciChem - Cork SciChem - Dublin

Supply Chain Management Catalent Pharma Solutions Carbon Goup C+G Logistics Group Chesapeake Johnston Logistics Ltd KWE (Ireland) Ltd

Sieving Fisher Scientific WrenTech Ltd

Software O’Flynn Medical Ltd Sartorius Mechatronics Ltd Waters Chromatography Ireland Weber Labelling & Coding Zenith Technologies

Solvent Recovery/ Services Associated Chemicals Ltd Indaver Ireland Soltec (Ireland) Ltd

51

Sustainability PM Group

Tableting Equipment Flexachem Manufacturing Ltd GEA Process Technologies Ltd Goliath Packaging Systems Ltd Sepha Ltd WrenTech Ltd

G e n e r a l S u pp l i e r s

Irish PharmaChem 2010

Irish PharmaChem 2010 G e n e r a l S u pp l i e r s

Tanks Axium Process Celtic Forwarding Ltd Complas Packaging Ltd Enva Ireland Ltd Flexachem Manufacturing Ltd GEA Process Technologies Ltd Micro Hydraulics Ltd/Micro Industries Ltd Quitmann O’Neill Packaging Ltd WrenTech Ltd

Temperature Control P.J. Boner & Co. Ltd Cross Technical Solutions Flexachem Manufacturing Ltd Johnston Logistics Ltd Manotherm Ltd Petrochem Pipeline Supply Ltd

Testing Services Anecto P.J. Boner & Co. Ltd Flexachem Manufacturing Ltd GEA Process Technologies Ltd Irish National Accreditation Board Lancaster Laboratories PPD Inc.

Thermal Imaging/ Thermography

Vacuum Systems Fisher Scientific Flexachem Manufacturing Ltd Nederman Ltd Norgren Ireland Ltd WrenTech Ltd

Valves Axium Process P.J. Boner & Co. Ltd BS&B Safety Systems Ltd Flexachem Manufacturing Ltd GEA Process Technologies Ltd Manotherm Ltd Micro Hydraulics Ltd/Micro Industries Ltd Norgren Ireland Ltd Petrochem Pipeline Supply Ltd ProSys Containment and Sampling Technology Tyco Valves & Controls Ireland Ltd

Validation

C+G Logistics Group Celtic Forwarding Ltd Hazchem Training Ltd Irish Exporters Assoc.-Life Sciences Irl. Johnston Logistics Ltd KWE (Ireland) Ltd Quitmann O’Neill Packaging Ltd

Tube Sets/Disposables Fisher Scientific Micro Hydraulics Ltd/Micro Industries Ltd

GEA Process Technologies Ltd Goliath Packaging Systems Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

Waste Management/ Balers/Recycling Axium Process Goliath Packaging Systems Ltd Indaver Ireland Idex Pump Technologies (Ireland) Ltd Interpac Ocon Chemicals Ltd Quitmann O’Neill Packaging Ltd Soltec (Ireland) Ltd reverse osmosis

Axium Process

Water Treatment

Ann McGee Consulting Ltd Carbon Goup Cross Technical Solutions GEA Process Technologies Ltd Pilz Ireland PM Group PPD Inc. Waters Chromatography Ireland Zenith Technologies

Manotherm Ltd

Transport & Logistics

Washing Equipment

Ventilation Cross Technical Solutions Nederman Ltd

Vision Systems Lister Machine Tools Ltd Weber Labelling & Coding

Warehouse Management Celtic Forwarding Ltd Complas Packaging Ltd Goliath Packaging Systems Ltd Johnston Logistics Ltd Zenith Technologies

52

ABB Ltd Associated Chemicals Ltd Axium Process Carbon Goup Flexachem Manufacturing Ltd Norgren Ireland Ltd PM Group

Weighing P.J. Boner & Co. Ltd Calibration Technology Fisher Scientific Goliath Packaging Systems Ltd Sartorius Mechatronics Ltd SciChem - Cork SciChem - Dublin Weber Labelling & Coding WrenTech Ltd

Irish PharmaChem 2010

A Abb Ltd

Address: Belgard Road,

Tallaght, Dublin 24.

Tel: (01) 405 7300 Fax: (01) 405 7327 Email: marketing@ie.abb.com Web: www.abb.com Type of Business: Lifescience

solutions.

Anecto

Address: Mervue Business

Park, Co. Galway.

Tel: (091) 757 404 Fax: (091) 757 387 Email: sales@anecto.com Web: www.anecto.com Type of Business: Dangerous goods

packaging testing

laboratory.

ATC Automation ltd Address:

Tel: Fax: Email: Web:

Unit B7, Centre Point Business Park, Oak Road, Dublin 12.

(01) 460 7070 (01) 461 0771 automationsales@atc.ie www.atc.ie

Axium Process Address:

Tel: Fax: Email: Web:

Hendy Industrial Estate, Hendy, Swansea, SA4 0XP. (0044) 1792 883882 (0044) 1792 886049 info@axiumprocess.com www.axiumprocess.com

Address: Unit 63, Grange

Close, Baldoyle

Industrial Estate,

Baldoyle, Dublin 13.

Tel: (01) 832 5948 Fax: (01) 832 5949 Email: info@annmcgee.com Web: www.annmcgee.com Type of Business: Pharmaceutical

Quality, Compliance

and Training

Specialists.

Contact: Office Manager:

Jane Lyons

Associated Chemicals Ltd

Address: 16D Euro Business

Park, Little Island,

Co. Cork Tel: (021) 435 1014 Fax: (021) 435 1015 Email: info@acl.ie Type of Business: Chemical Supplies Contact: Managing Director:

Sylvester Cotter

Address:

Tel: Fax: Email: Web: Type of Business:

Berkley Group Address:

Tel:

Email: Web: Contact:

Dublin: 509 The Capel Building, Mary’s Abbey, Dublin 7.

Cork: Mill House, Carrigrohane, Co. Cork.

(01) 872 4666 (021) 428 9600 pharma@berkley.ie www.berkley.ie Joanna Houston

Betco Marketing Ltd

B BASF Ireland Ltd

Ann McGee Consulting Ltd

Company Listings

Company Listings

Bracetown Business Park, Clonee, Co. Meath.

(01) 825 5701 (01) 825 2038 yvonne.mullins@basf.com www.basf.com Distributor of chemicals.

B. Braun Medical

Address: 3 Naas Road

Industrial Park,

Dublin 12.

Tel: (01) 709 1801 Fax: (01) 709 1889 Email: bill.proctor@bbraun.com Web: www.bbraun.com Type of Business: OEM

manufacturing.

Contact: Business Unit

Manager: Bill Proctor

53

Address: Exham House,

The Fingerpost,

Douglas, Co. Cork.

Tel: (021) 436 4999 Fax: (021) 436 5739 Email: dhalpin@betco.ie Web: www.betco.ie Contact: Managing Director:

Diarmuid Halpin

P.J. Boner & Co. Ltd Instrument & Weighing Specialists Address:

Tel: Fax: Email: Web: Type of Business: Contact:

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

(01) 450 5050 (01) 450 5183 info@pjboner.com www.pjboner.com Instrument & weighing specialists.

Managing Director: Patrick M. Boner Sales Executive: Rory Keane

Irish PharmaChem 2010 Company Listings

Carbon Group

Bosch Rexroth Ltd

Address: Unit 6, Lismard

Business Park,

Timahoe Road,

Portlaoise,

Co Laois.

Tel: (057) 867 8200 Fax: (057) 867 8201 Email: info@boschrexroth.ie Web: www.boschrexroth.ie Type of Business: Engineering Contact: Regional Sales

Manager:

John Doran

Brenntag Ireland Address:

Tel: Fax: Email: Web:

Contact:

Unit 405, Greenogue Business Park, Rathcoole, Dublin 24.

(01) 401 3500 (01) 405 3501 bill.maher@brenntag.ie www.brenntag.ie General Manager: Bill Maher

Brightwater

Address: 36 Merrion Square,

Dublin 2.

Tel: (01) 662 1000 Fax: (01) 662 3900 Email: e.moloney@brightwater.ie Web: www.brightwater.ie Contact: Eileen Moloney

BS&B Safety Systems Ltd

Address: Raheen Business

Park, Raheen,

Co. Limerick.

Tel: (061) 484 700

Emergency Delivery:

086 241 0615

Direct Line:

086 838 5556 Fax: (061) 352 240 Email: sales@bsb.ie Web: www.bsb.ie Type of Business: Pressure relief

devices.

Contact: Sales Manager:

Patrick Murphy

C Calibration Technology

Address: Innovation Works,

National Technology

Park,

Co. Limerick.

Tel: (061) 503 132 Fax: (061) 338 065 Email: service@calibrationtech.ie Web: www.calibrationtech.ie Type of Business: Accredited

calibration of all

makes of laboratory equipment.

Camida Ltd Address:

Tel: Fax: Email: Web: Contact:

Tower House, New Quay, Clonmel, Co. Tipperary.

(052) 612 5455 (052) 612 5466 info@camida.com www.camida.com Company Secretary: Deirdre McGrath

54

Address:

Tel:

Fax: Email:

Factory Cross, Ringaskiddy, Co. Cork.

(021) 437 8988 UK Local Lo-Call: (0044) 8708 504 831 (021) 437 8950 cdeegan@indigo.ie sales@carbon.ie Web: www.carbon.ie Type of Business: Pharmachemicals.

Contact: Area Sales Manager:

Carol Deegan

Catalent Pharma Solutions Address: Unit 26,

Cherry Orchard

Industrial Estate,

Dublin 10.

Tel: (01) 620 0600 Fax: (01) 626 2815 Email: diarmuid.wilson@catalent.com Web: www.catalent.com Type of Contract manufacturing Business: capabilities as well as

packaging and printed

components to the

pharmaceutical

industry.

Contact: Director of Business

Development:

Diarmuid Wilson

Celtic Forwarding Ltd

Address: Dublin:

Celtic House,

30 Marlborough

Street,

Dublin 1.

Waterford:

Belview Port,

Slieverue,

Co. Waterford.

Limerick:

2 Church Street,

Johnâ&#x20AC;&#x2122;s Square,

Co. Limerick.

Tel: (01) 865 6000

(051) 851 821

(061) 467 969 Fax: (01) 874 6745

(051) 851 823

(061) 467 972 Email: info@celticfwd.ie Web: www.celticfwd.ie Type of Business: Shipping.

Contact: Director:

Finbarr Cleary Sales Manager:

Gerald Kiernan DGSA

Tank Division

Manager:

Patty deCourcey

C + G Logistics Group Address:

Tel: Fax: Email: Web: Contact:

Westpoint Business Park, Navan Road, Mulhuddart, Dublin 15.

(01) 820 8455 (01) 820 8457 info@cglogistics.ie www.cglogistics.ie General Manager/ Director : Patrick Wogan

Charpak Medical Address:

Tel: Fax: Email: Web:

30 St. Peters Road, Huntingdon, Cambs. UK. 0044 1480 434434 0044 1480 434545 sales@charpak.co.uk www.charpakmedical.com

Chemco Ireland Ltd.

Address: Unit 2,

Stadium

Business Park,

Ballycoolin Road,

Cappagh,

Dublin 11 Tel: (01) 829 3600 Fax: (01) 885 5029 Email: sales@chemco.ie Web: www.chemco.ie Type of Business: Chemical

Distribution.

Contact: Sales Director:

Peter Fitzgerald

Chemtek Sales Ltd Address:

Tel: Fax: Email: Web:

Estuary House, New Street, Malahide, Co. Dublin.

(01) 845 3766/63 (01) 845 3172 sales@chemtek.ie www.chemtek.ie

Cross Technical Solutions

Chesapeake

Address: Enterprise Way,

Hightown Industrial Estate, Newtownabbey,

Belfast, BT36 4EW. Tel: (0044) 2890 804 000 Fax: (0044) 2890 804 301 Email: sales.pharma@chesapeakecorp.com Web: www.chesapeake.com/pharma Type of Business: Pharmaceutical and

healthcare packaging

(cartons, labels,

leaflets and more).

Complas Packaging Ltd Address:

Tel: Fax: Email: Web:

Naas Industrial Estate, Dublin Road, Naas, Co. Kildare.

(045) 874 088/9 (045) 874 090 sales@complas.ie www.complas.ie

Corcoran Chemicals Ltd

Address: Kingsbridge House,

17-22 Parkgate

Street, Dublin 8.

Tel: (01) 633 0400 Fax: (01) 679 3521 Email: info@corcoranchemicals.com Web: www.corcoranchemicals.com Type of Business: Distribution.

Contact: Sales Department

Croom Precision Medical

Address: Enterprise Centre,

Croom,

Co. Limerick.

Tel: (061) 397 744 Fax: (061) 397 639 Email: info@croomprecision.ie Web: www.croomprecision.com Type of Business: Medical device

manufacture.

Contact: Managing Director:

Patrick Byrnes 55

Address: Unit 24,

Cookstown Industrial

Estate,

Cookstown,

Tallaght,

Dublin 24 Tel: (01) 405 6777 Fax: (01) 413 6932 Email: jmcgrath@cross

technicalsolutions.ie Web:

www.crosstechnical

solutions.ie Type of Business: Refrigeration.

Contact: Technical Director:

Jonathan McGrath

General Manager:

Jason Keating

CRSâ&#x20AC;&#x2C6;Mobile Cold Storage Address: Arctic House,

Carnisle,

Kildalkey,

Co.â&#x20AC;&#x2C6;Meath Tel: (046) 943 5000 Fax: (046) 943 5068 Email: enquiry@crs.ie Web:

www.crs.ie Type of Business: Cold storage,

pharmaceutical

storage, bespoke

refigeration Contact: John Tyrell

Company Listings

Irish PharmaChem 2010

Irish PharmaChem 2010 Company Listings

D

F

ESBâ&#x20AC;&#x2C6;Independent Energy

Dalkia

Address: 145 Lakeview Drive,

Airside Business Park,

Swords,

Co. Dublin Tel: (01) 870 1200 Fax: (01) 870 1201 Email: info@dalkia.ie Web: www.dalkia.ie Contact: Managing Director:

Pat Gilroy

Industrial Director

Pharmaceutical & Health:

Fergus Elebert

Dionex Ireland Ltd

Address: Unit 9A, Suite 3C,

Plato Business Park,

Damastown,

Dublin 15.

Tel: (01) 644 0064 Fax: (01) 885 1673 Email: ireland.info@dionex.com Web: www.dionex.com Type of Business: Scientific analytical

equipment.

E Enva Ireland Ltd

Address:

Tel: Fax: Email: Web:

Raffeen Industrial Estate, Ringaskiddy, Co. Cork.

(021) 438 7200 (021) 438 7299 cork@enva.ie www.enva.ie

Address: Dublin:

Woodford Business

Park, Santry,

Dublin 17.

Belfast:

Forsyth House,

Cromac Square,

Belfast, BT1 8LA Tel: (01) 862 8300

(048)â&#x20AC;&#x2C6;9051 1246 Fax: (01) 862 8350

(048) 9027 8400 Email: info@esbie.ie Web:

www.esbie.ie Contact: Marketing Manager:

John Conlon

Customer Operations

Manager:

Susan Kinane

Commerical Manager:

Derek Russell

Festo Ltd

Eurolec Instrumentation Ltd

Address: Suite 4, Plaza 212,

Blanchardstown

Corporate Park 2,

Ballycoolin,

Dublin 15.

Tel: (01) 885 5854 Fax: (01) 899 1855 Email: fsie.sales@thermofisher.com Web: www.ie.fishersci.com Type of Business: Laboratory

supplies.

Contact: Marketing

Manager:

Gerry Fitzmaurice

Address: Technology House,

Cluan Enda,

Dundalk,

Co. Louth.

Tel: (042) 933 3423 Fax: (042) 933 1758 Email: eurolec@esatclear.ie Web: www.eurolec-instruments.com Type of Business: Electronic

instrumentation.

Contact: Sales/Marketing

Executive:

Chris Mears

Fisher Scientific

Flexachem Manufacturing Ltd

Address: Donnybrook

Commercial Centre,

Douglas, Co. Cork.

Tel: (021) 461 7200 Fax: (021) 489 1297 Email: sales@flexachem.com Web: www.flexachem.com Type of Business: Manufacturer/

Distributor.

Contact: Commercial Director:

Agnes Mullins

Environmental Protection Agency Address:

Tel: Fax: Email: Web:

Address: Unit 5,

Sandyford Park,

Sandyford Industrial

Estate,

Dublin 18.

Tel: (01) 295 4955 Fax: (01) 295 5680 Email: sales_ie@festo.com Web: www.festo.com/ie Type of Business: Automation

company specialising

in factory and

process automation.

Contact: Sales Manager:

Diarmaid Cowhie

PO Box 3000, Johnstown Castle Estate, Co. Wexford.

(053) 916 0600 (053) 916 0699 info@epa.ie www.epa.ie 56

G

H

GEA Process Technologies Ireland Ltd Address:

Tel: Fax: Email: Web: Contact:

Ash House, Lime Tree Avenue, Millennium Park, Naas, Co. Kildare.

(045) 981 200 (045) 981 232 postbox@geapt.ie www.geapt.ie Business Development Manager: Adrian Field

Hazchem Training Ltd Graham Hart (Process Technology) Ltd Address:

Tel: Fax: Email: Web: Contact:

Friars Ind. Estate, Bradford Road, Idle, Bradford, BD10 8SW, UK. (0044) 1274 617021 (0044) 1274 618614 sales@graham-hart.com www.graham-hart.com Sales Director: Stephen Hart

Goliath Packaging Systems Ltd

Address: Beechwood, Nenagh,

Co. Tipperary.

Tel: (067) 37893 Fax: (067) 34794 Email: info@goliath.ie Web: www.goliath.ie Type of Business: Supply &

installation of

packaging equipment

and materials

handling systems.

Contact: Director:

George Oâ&#x20AC;&#x2122;Leary

Goulding Chemicals Ltd

Address: Centre Park Road,

Marina, Co. Cork.

Tel: (021) 491 1611 Fax: (021) 491 1660 Email: pollockm@gouldings.ie Web: www.gouldings.ie Type of Business: Chemical

distributor.

G10, Maynooth Business Campus, Maynooth, Co. Kildare.

(01) 629 1800 (01) 629 1822 info@hazchem.ie www.hazchem.ie Director: Michelle Cleere

Henley Forklift Group Ltd

Glanbia Estates

Address: Glanbia House,

Ring Road,

Co. Kilkenny.

Tel: (056) 777 2288 Email: gmullally@glanbia.com Web: www.kilmeadenfields.com Type of Business: Property Business

Unit of Glanbia PLC. Contact: CEO: Ger Mullally

Address:

Tel: Fax: Email: Web: Contact:

GS1 Ireland Address:

Tel: Fax: Email: Web: Contact:

The Nutley Building Merrion Road, Dublin 4.

(01) 208 0660 (01) 208 0670 info@gs1ie.org www.gs1ie.org Member Support Services: Karen Murphy

Gunnebo Ireland Ltd

Address:

Tel:

Fax:

Email: Web:

Dublin: 601 Western Industrial Estate, Dublin 12.

Cork: Unit 4, Hillview Campus, Euro Business Park, Little Island, Co. Cork.

(01) 458 4836 (021) 452 4940 (01) 458 4835 (021) 452 4409 noel@gunnebolifting.com bryan@gunnebolifting.com www.gunnebolifting.com

57

Address: Henley Industrial

Park, Killeen Road,

Dublin 10.

Tel: (01) 620 9200 Fax: (01) 626 5406 Email: fwilson@henley.ie

phammett@henley.ie Web: www.henley.ie Type of Business: Forklifts & Warehousing

Equipment.

Specialists in

flameproof forklift

trucks.

Contact: Director:

Mark Kenny

Director:

Brian Oâ&#x20AC;&#x2122;Connell

Company Listings

Irish PharmaChem 2010

Irish PharmaChem 2010 Company Listings

HOCHTIEF Facility Management

Address: Ireland:

HOCHTIEF Facility

Management

Ireland Ltd.,

Landscape House,

Landscape Road,

Churchtown,

Dublin 14.

UK:

HOCHTIEF Facility

Management UK Ltd,

HOCHTIEFâ&#x20AC;&#x2C6;House,

2 Ibis Court,

Centre Park,

WarringtonWA1 1RL Tel: (01) 215 7000

+44 1925 404 500 Fax: (01) 215 7070

+44 1925 404 598 Email: contactus@hochtief-fm.com Web: www.hochtief-fm.ie www.hochtief-facilitymanagement.co.uk

Type of Business: Facilities

Management.

Contact: Region Operations

Manager:

Ray Casey

H.R. Holfeld (Hydraulics) Ltd Address:

Tel: Fax: Email: Web: Type of Business: Contact:

2-4 Merville Road, Stillorgan, Co. Dublin.

(01) 288 7361 (01) 288 7380 pumps@holfeld.ie www.holfeld.ie Process Pump Supplier.

Business Development & Key Accounts: Emmet Connelly

I ICDS Recruitment Consultants Address:

Tel: Fax:

24 Upper Fitzwilliam Street, Dublin 2.

(01) 632 1200 (01) 676 2079

Email: info@icds.ie Web: www.icds.ie Type of Business: Recruitment

consultants.

Contact: Recruitment

Director:

Anthony McLoughlin

IDA Ireland

Address: Wilton Park House,

Wilton Place,

Dublin 2.

Tel: (01) 603 4000 Email: idaireland@ida.ie Web: www.idaireland.com Type of Business: Investment

promotion agency.

Contact: Global Head of Life

Sciences:

David Shanahan

Idex Pump Technologies (Ireland) Ltd

Address:

Tel: Fax: Email: Web: Contact:

R79, Shannon Industrial Estate, Shannon, Co. Clare.

(061) 471 933 (061) 475 046 chennessy@idexcorp.com www.blagdonpump.com www.vikingpump.com Customer Service Administrator: Carmel Hennessy

Indaver Ireland

Address: 4 Haddington Terrace,

Dun Laoghaire,

Co. Dublin.

Tel: (01) 280 4534 Fax: (01) 280 7865 Email: info@indaver.ie Web:

www.indaver.ie Type of Business: Hazardous & non-

hazardous waste

disposal and recovery

ensuring full

compliance.

58

Industrial Packaging Ltd

Address: Killarney Road,

Bray, Co. Wicklow.

Tel: (01) 286 4010 Email: mail@industrialpackaging.ie Web: www.industrialpackaging.ie Type of Business: Manufacturer of

fibre drums.

Contact: Managing Director:

Norman Lee

Interpac

Address: 67E Heather Road,

Sandyford Industrial

Estate, Dublin 18.

Tel: (01) 294 0600 Email: ian@interpac.ie Web: www.interpac.ie Type of Business: Packaging.

Contact: Managing Director:

Ian Sutton

Invest Northern Ireland

Address: Bedford Square,

Bedford Street,

Belfast, BT2 7ES. Tel: (048) 9069 8601 Fax: (048) 9043 6536 Email: patricia.oneill@investni.com Web: www.investni.com Type of Business: Economic

development agency.

Contact: Patricia Oâ&#x20AC;&#x2122;Neill

Irish Exporters Association Life Sciences Ireland Address:

Tel: Fax: Email:

28 Merrion Square, Dublin 2.

(01) 661 2182 (01) 661 2315 raulmolina@ irishexporters.org Web: www.irishexporters.org Type of Business: Life Sciences

Ireland is Industry Grouping within the

Irish Exporters

Association.

Irish National Accreditation Board, The

Address: Wilton Park House,

Wilton Place,

Dublin 2.

Tel: (01) 607 3003 Fax: (01) 607 3109 Email: inab@inab.ie Web: www.inab.ie Type of Business: Provides

accreditation

of laboratories,

certification &

inspection bodies.

Contact: Information Officer:

Orla Doyle

J

Java Clinical Research Ltd

Address: Fitzwilliam Buiness

Centre, 26 Upper

Pembroke St,

Dublin 2.

Tel: 01 637 3903 Fax: 01 637 3907 Email: info@javacr.com Web: www.javacr.com Type of Business: Clinical Research Contact: Managing Director:

Ruth Nallen

Johnston Logistics Ltd

Address: Blackchurch Business

Park, Rathcoole,

Co. Dublin.

Tel: + 353 1 401 3333 Fax: + 353 1 458 8015 Email: info@jol.ie

chrisf@jol.ie Web: www.johnstonlogistics.ie Type of Business: Logistics & distribution

(Complete Supply

Chain Management).

Contact: Sales Executive:

Chris Fogarty

K

Lianco

KWE (Ireland) Ltd Address:

Tel:

Fax:

Email:

Web: Contact:

Dublin: Unit 4 Horizon Logistics Park, New Naul Rd, Harristown, Swords, Co. Dublin.

Cork: Unit 4&5, South Ring West Business Pk, Tramore Road, Co. Cork.

(01) 823 9600 (021) 497 5722 (01) 836 1111 (021) 497 5727 kwedub@ea.kwe.com kweork@ea.kwe.com www.kwe.com Sales Manager: Karl O’Reilly

L

Address:

Tel:

Fax: Email: Web: Type of Business:

Rathclaren, Kilbrittain, Co. Cork.

(023) 49681 087 260 5447 (023) 49677 lianco@iol.ie www.lianco.net Powder drying, processing, conveying, and containment.

Lister Machine Tools Ltd

Address: PO Box 838,

Bluebell Industrial

Estate,

Dublin 12.

Tel: (01) 450 8866 Fax: (01) 450 9836 Email: sales@listermachinetools.com Web: www.listermachinetools.com Type of Sale of machine Business: tools & associated

equipment.

M

Lancaster Laboratories

Address: IDA Business Park,

Clogherane,

Dungarvan,

Co. Waterford Tel: (058) 48 300 Fax: (058) 42 855 Email: info@lancasterlabs.com Web: www.lancasterlabs.com Type of Business: Contract Analytical

Services Contact: Business Development

Director:

Mark Glass

Lennox Laboratory Supplies Ltd

Address: John F. Kennedy

Drive, Naas Road,

Dublin 12.

Tel: (01) 455 2201 Fax: (01) 450 7906 Email: sales@lennox.ie

greg@lennox.ie Web: www.lennox.ie Type of Business: Laboratory suppliers.

59

MacLachlan & Donaldson

Address: 47 Merrion Square, Dublin 2.

Tel: (01) 676 3465 Fax: (01) 661 2083 Email: mail@maclachlan.ie Web: www.maclachlan.ie Type of Business: Intellectual Property Attorneys Contact: Dr. YvonneMcKeown

Manotherm Ltd

Address: 4 Walkinstown Road,

Dublin 12.

Tel: (01) 452 2355 Fax: (01) 451 6919 Email: info@manotherm.ie Web: www.manotherm.ie Type of Business: Distributors of controls and instrumentation.

Contact: Managing Director:

R.C. Gilbert

Company Listings

Irish PharmaChem 2010

Irish PharmaChem 2010 Company Listings

Matheson Ormsby Prentice

Address: 70 Sir John

Rogerson’s Quay,

Dublin 2.

Tel: (01) 232 2000 Fax: (01) 232 3333 Email: helen.middleton@mop.ie Web: www.mop.ie Type of Business: Law firm

Matrix Recruitment

Address: Dolphin House,

George’s Street,

Waterford Tel: (051) 850 206 Fax: (051) 850 530 Email: waterford@matrixrecruitment.ie Web: www.matrixrecruitment.ie Type of Business: Recruitment Agency Contact: Managing Director: Kierán McKeown

Measom Freer

Address: 37-41 Chartwell

Drive, Wigston,

Leicester, LE18 2FL,

UK. Tel: (0044) 1162 881588 Fax: (0044) 1162 813000 Email: sales@measomfreer.co.uk Web: www.measomfreer.co.uk Type of Business: Manufacturer.

Contact: Sales Director:

Mark Freer

Micro Hydraulics Ltd/ Micro Industries Ireland

Address: Dublin:

2003 Orchard

Avenue, Citywest

Business Campus,

Dublin 24.

Cork:

Unit 6/7 Cherrywood

Business Park,

Little Island,

Co. Cork.

Tel: (01) 463 9000 Fax: (01) 410 5609 Email: info@microhydraulics.ie Web: www.microhydraulics.ie Type of Business: Sanitary hose,

tube & accessories.

Contact:

Sales Representative: Ralph Fitzsimons Sales Representative: Dave O’Donavan

NPP Group Ltd

N National Chemical Co. Ltd

Address: NCC House,

42 Lower Leeson St.,

Dublin 2.

Tel: (01) 613 1400 Fax: (01) 634 0132 Email: info@ncc.ie Web: www.ncc.ie Type of Business: Distributor.

Contact: Sales Director:

Christy Smith

Nederman Ltd Address: Premier Business

Centre,

3013 Lake Drive,

Citywest Business

Campus,

Dublin 24.

Tel: (01) 469 3729 Fax: (01) 469 3321 Email: ciaran.wilkinson@

nederman.ie Web: www.nederman.ie Type of Business: Fume, Dust &

Materials Handling.

Norgren Ireland Ltd

Address: 137 Slaney Close,

Dublin Industrial

Estate, Glasnevin,

Dublin 11.

Tel: (01) 830 0288 Fax: (01) 830 0082 Email: dublin@norgren.com Web: www.norgren.com Type of Business: Fluid and motion

control. ‘Pneumatics’

automation

components.

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 Type of Business: Flexible packaging

suppliers &

distributors.

Contact: Commercial Director:

Ken Martin

O Ocon Chemicals Ltd Address:

Tel: Fax: Email: Web: Contact:

Unit 5, South Cork Industrial Estate, Vicars Road, Pouladuff, Co. Cork.

(021) 431 8555 (021) 431 8560 info@oconchemicals.com www.oconchemicals.com Managing Director: Frank Mulcahy

O’Flynn Medical Ltd

Address: Westend, Millstreet,

Co. Cork.

Tel: (029) 21 799 Fax: (029) 70 191 Email: info@oflynnmedical.com Web: www.oflynnmedical.com Type of Business: Distributor of

Scrubex “Automated

Protective Clothing

Distributor” Contact: Managing Director:

Tadhg O’Flynn

O’Loughlin Partnership Address:

Tel: Fax: Email: Web: 60

1 Rowan Park Ave, Blackrock, Co. Dublin.

(01) 280 0430 (01) 696 1029 info@olpartners.com www.olpartners.ie

Type of Business: Executive search,

selection & interim

management.

One Stop Handling Ireland Ltd Address:

113 Millennium Trade Park, Ballycoolin

Dublin 15 Tel: 00353 1 864 9008 Fax: 00353 1 864 9028 Email: info@onestophandling.ie Web: www.onestophandling.ie Type of Business: OSHI supply Materials Handling Solutions & Lifting Equipment to industries as wide ranging and diverse as Electronic, Computer, Packaging and Woodworking, Metal, Food, Drinks, Pharmaceutical: literally all industries.

We can also modify and manufacture non standard equipment for special

applications.

Contact: Paul Parkes

P Pegler & Louden Ireland

A Division of BSS (Ireland) Ltd Address: Dublin:

301 South Circular

Road, White Heather

Industrial Estate,

Dublin 8.

Tel: (01) 416 5170 Fax: (01) 416 5175 Email: jmelinn@pli.ie

jgeraghty@pli.ie Web: www.fcx-pli.com

Cork: South Link Park,

Ballycurreen Road

Grange, Co. Cork.

Tel: (021) 497 7128 Fax: (021) 491 5213 Email: Cork:

p.obrien@pli.ie

p.cronin@pli.ie Web: www.fcx-pli.com

Petrochem Pipeline Supply Ltd

Address: Unit 14, Euro

Business Park, Little

Island, Co Cork.

Tel: (021) 435 1300 Fax: (021) 435 1166 Email: sales@petrochem.ie Web: www.petrochem.ie Type of Business: Supplier of

stainless pipes, fittings,

flanges, fastners, valves, instrumentation and

controls to the Irish

Pharmaceutical and

biotech markets.

Contact: Sales Manager:

Dave Ahern

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 Type of Business: Contract Research

Organisation Contact: Director, GMP Labs,

Europe:

Susan Neenan

PrimePac Ltd Pilz Ireland

Address: Cork Business &

Technology Park,

Model Farm Road,

Co Cork.

Tel: (021) 434 6535 Fax: (021) 480 4994 Email: sales@pilz.ie Web: www.pilz.ie Type of Business: Process and

machinery saftey

engineering services

and training.

Contact: Sales Manager:

Andrew Donnelly

MD: John McAuliffe

PM Group

Address: Cork: Loughmahon

Technology Park,

Blackrock, Co. Cork.

Dublin: Killakee

House, Belgard Square,

Tallaght, Dublin 24.

Tel: (021) 435 8922 (01) 404 0700 Email: info@pmg.ie Web: www.pmg.ie Contact: Billy Oâ&#x20AC;&#x2122;Neill

Paul Hallam

Business Development

Marketing Executive:

Vicki Shanahan 61

Address: Unit 2,

Caulside Drive,

Newpark Industrial

Estate,

Antrim,

BT41 2DU. Tel: (0044) 2894 428 188 Fax: (0044) 2894 428 177 Email: sales@primepacltd.com Web: www.primepacltd.com Type of Business: Manufacturer &

supplier of plastic

containers.

Contact: Director:

John McGahon

ProSys Containment And Sampling technology

Address: Rosehill Business

Centre, Ballinacurra,

Midleton,

Co. Cork.

Tel: (021) 461 3890 Fax: (021) 461 3891 Email: mmcl@prosys.ie Web: www.prosys.ie Type of Business: Design and

maunfacture of

sampling and

isolators for the

pharmaceutical and

chemical industries.

Contact: Managing Director:

Michael McLoughlin

Company Listings

Irish PharmaChem 2010

Irish PharmaChem 2010 Company Listings

Q

Quitmann O’Neill Packaging Ltd

Address: St. Brendan’s Road,

Portumna,

Co. Galway.

Tel: (090) 974 1148/9 Fax: (090) 974 1459 Email: sales@quitmannoneill.com Web: www.qonpack.com Type of Business: Packaging stockist

& distributors.

Contact: General Manager:

David O’Neill

S Sartorius Mechatronics UK Ltd

Address: Unit 41, The Business

Centre, Stadium

Business Park,

Ballycoolin Road,

Dublin 11.

Tel: (01) 808 9050 Fax: (01) 808 9388 Email: info.ireland@

sartorius.com Web: www.sartorius.ie Type of Business: Laboratory &

process technology

provider. Sales &

service of laboratory

& process weighing

equipment.

Contact: Nick Parsons

SciChem - Cork

Address: Unit 14,

Barryscourt Business

Park, Carrigtwohill,

Co. Cork.

Tel: (021) 488 2388 Fax: (021) 488 2389 Email: cork@scichem.com Web: www.scichem.com Type of Business: Laboratory

Suppliers.

Contact: Branch Manager:

John Molloy

SciChem - Dublin

Address: Greenhills Industrial

Estate, Walkinstown,

Dublin 12.

Tel: (01) 450 4077 Fax: (01) 450 4328 Email: dublin@scichem.com Web: www.scichem.com Type of Business: Laboratory

Suppliers.

Contact: Branch Manager:

Seamus Amond

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 Type of Business: Government

funding agency

for research.

Contact: Head of Industry -

Research Development:

Dr. Paul Dodd

Contact:

testers & deblistering machines for the pharmaceutical industry.

Account Manager UK & Ireland: Tanya Kilfeather

Sigma-Aldrich Ireland Ltd

Address: Vale Road,

Arklow, Co. Wicklow.

Tel: (0402) 203 70 Fax: (0402) 203 75 Email: eircustsupport@sial.com Web: www.sigma-aldrich.com Contact: Business Unit Manager:

Nicola McCarthy Type of Business: Chemical /

Pharmaceutical

Smurfit Kappa Ireland

Science Recruitment 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 Type of Business: Packaging.

Contact: Marketing Manager: Mark Munnelly

Sepha ltd

Soltec (Ireland) Ltd

Address: 40 Grand Canal

Street Upper, Dublin 4.

Tel: (01) 667 5008 Fax: (01) 667 6714 Email: info@sri.ie Web: www.sri.ie Type of Business: Specialist science

recruitment agency.

Contact: Managing Director:

Helen McGardle Address: Unit 25,

Carrowreagh

Business Park,

Carrowreagh Road,

Dundonald,

Northern Ireland,

BT16 1QQ. Tel: (048) 9048 48 48

+44 (0) 2890 48 48 48 Fax: (048) 9048 08 90

+44 (0) 2890 48 08 90 Email: info@sepha.com Web: www.sepha.com Type of Business: Manufacturer of

laboratory scale

blister packers,

non-destructive leak 62

Address: Zone A, Mullingar

Business Park,

Mullingar,

Co. Westmeath.

Tel: (044) 933 5133 Email: info@soltec.ie Web: www.soltec.ie Type of Business: Soltec is Ireland’s

only commercially

operated solvent

recycling plant. Solid

hazardous waste

collections also

provided.

Contact: Business Development

Manager:

Michael Corcoran

Sustainable Energy Authority of Ireland

Address: Glasnevin,

Dublin 9.

Tel: (01) 836 9080 Fax: (01) 837 2848 Email: info@sei.ie Web: www.sei.ie Type of Business: Energy advice &

information.

T TopChem Laboratories Ltd

Address: 70 Western Parkway

Business Park,

Ballymount Drive,

Dublin 12.

Tel: (01) 460 8818 Email: sales@topchemlabs.com

dwalsh@topchem.ie Web: www.topchem.ie Type of Business: Chemical synthesis.

Contact: Managing Director:

Dr. Donal Coveney

U

Weber Labelling & Coding

Univar Ltd

Address: 536 Grants Crescent,

Greenogue Business

Park, Rathcoole,

Co. Dublin.

Tel: (01) 401 9800 Fax: (01) 401 9142 Email: pharma.sales@

univareurope.com Web: www.univareurope.com Type of Business: Ingredients pharma industry

including APIâ&#x20AC;&#x2122;s,

excipients, process

chems, solvents &

intermediates.

Contact: Account Manager:

John McCluskey

W

Toyota Material Handling Ireland Ltd

Address: Killeen Road,

Dublin 12.

Tel: (01) 419 0321 Fax: (01) 419 0325 Type of Business: Forklift and

Warehouse Supplies.

Contact: Sales Manager:

Robert Oâ&#x20AC;&#x2122; Reilly

Tyco Valves & Controls Ireland Limited

Address: Victoria House,

Beaumont Avenue,

Churchtown,

Dublin 14.

Tel: (01) 295 1101 Email: tkilbane@tyco-valves.com Web: www.tycoflowcontrol-eu.com Type of Business: Industrial valves &

controls.

Contact: General Manager:

Tony Kilbane

Address:

Tel: Fax: Email: Web: Contact:

Kilcannon Ind. Est., Old Dublin Road, Enniscorthy, Co. Wexford.

(053) 923 3778 (053) 923 3284 sales@weberireland.com www.weberireland.com Operations Manager: Patrick Hughes

WrenTech Ltd Address:

Tel: Fax: Email: Web: Contact:

Wrentech House, Crosshaven Hill, Crosshaven, Co. Cork.

(021) 483 2644 (021) 483 1363 smurray@wrentech.ie www.wrentech.ie Sales Administrator: Siobhan Murray

Z Zenith Technologies Waters Chromatography Ireland

Address: Unit 3.1 Woodford

Business Park,

Santry,

Dublin 9.

Tel: (01) 448 1500 Fax: (01) 448 1510 Email: ireland@waters.com Web: www.waters.com Type of Business: The company

designs, manufactures,

sells and services

HPLC, UPLC,

mass spectrometry

instrument systems

and support products,

including chemistry

consumables and

post-warranty

service plans.

Contact: National Sales

Manager:Joe Kildunne

63

Address:

Tel: Email:

Portgate Business Park, Ringaskiddy, Co. Cork (021) 437 0200 peter.sheehan@ zenithtechnologies.com Web: www.zenithtechnologies.com Contact: Sales & Marketing

Manager:

Peter Sheehan

Zetes

Address: National

Technology Park,

Plassey,

Co. Limerick.

Tel: (061) 333 188

1890 252 869 Lo-call Email info@ie.zetes.com Web: www.zetes.ie Type of Business: Zetes provides

innovative solutions,

improving efficiency,

productivity and

tracebility through

the supply chain.

Company Listings

Irish PharmaChem 2010

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I r i s h P h a r m a C h e m 2010

Useful References ACADEMY OF MEDICAL LABORATORY SCIENCE Tel: (01) 677 5602 E-mail: mail@amls.ie Web: www.amls.ie

ENVIRONMENTAL HEALTH OFFICERS’ ASSOCIATION Tel: (01) 276 1211 E-mail: amanda@ehoa.ie Web: www.ehoa.ie

Advisory Council for Science, Technology & Innovation Tel: (01) 607 3162 E-mail: firstname.surname@forfas.ie Web: www.sciencecouncil.ie

ENVIRONMENTAL PROTECTION AGENCY Tel: (053) 916 0600 LoCall: 1890 335 599 E-mail: info@epa.ie Web: www.epa.ie

AN BORD PLEANALA Tel: (01) 858 8100 LoCall: 1890 275 175 E-mail: bord@pleanala.ie Web: www.pleanala.ie CHAMBERS IRELAND Tel: (01) 661 2888 E-mail: info@chambers.ie Web: www.chambers.ie

DEPT. OF CHEMICAL ENGINEERS, UCD Tel: (01) 716 1825 E-mail: chemical.eng@ucd.ie Web: www.ucd.ie/chembioeng

HEALTH AND SAFETY AUTHORITY Tel: 1890 289 389 E-mail: wcu@hsa.ie Web: www.hsa.ie

DEPT. OF ENTERPRISE, TRADE & EMPLOYMENT Tel: (01) 631 2121 LoCall: 1890 220 222 E-mail: info@entemp.ie Web: www.entemp.ie

HEALTH RESEARCH BOARD Tel: (01) 234 5000 E-mail: hrb@hrb.ie Web: www.hrb.ie

ENTERPRISE IRELAND Tel: (01) 727 2000 E-mail: client.service@ enterprise-ireland.com Web: www.enterprise-ireland.com

IRISH BUSINESS & EMPLOYERS CONFEDERATION (IBEC) Tel: (01) 605 1500 E-mail: info@ibec.ie Web: www.ibec.ie

FAS - TRAINING & EMPLOYMENT AGENCY Tel: (01) 607 0500 E-mail: info@fas.ie Web: www.fas.ie FORFAS Tel: (01) 607 3000 E-mail: firstname.surname@forfas.ie Web: www.forfas.ie

ELECTRICITY SUPPLY BOARD Tel: 1850 372 372 E-mail: esbnetworks@esb.ie Web: www.esb.ie

IRISH BIOINDUSTRY ASSOCIATION Tel: (01) 605 1584 E-mail: firstname.surname@ibec. ie Web: www.ibec.ie/ibia

BIOTECHNOLOGY IRELAND Tel: (01) 727 2692 E-mail: editor@biotechnologyireland.com www.biotechnologyireland.com

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

DEPT. OF THE ENVIRONMENT, HERITAGE & LOCAL GOVERNMENT Tel: (01) 888 2000 LoCall: 1890 20 20 21 E-mail: press-office@environ.ie Web: www.environ.ie

INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINERING (ISPE) Tel: +32 2 743 4422 E-mail: ispe@associationhq.org Web: www. ispe.org

IRISH CLEANROOM SOCIETY Tel: 087 285 9679 E-mail: info@cleanrooms-ireland. ie Web: www.cleanrooms-ireland.ie IRISH COSMETICS, DETERGENT & ALLIED PRODUCTS ASSOCIATION Tel: (01) 605 1584 E-mail: siobhan.murphy@ibec.ie Web: www.icda.ie IRISH EXPORTERS ASSOCIATION Tel: (01) 661 2182 E-mail: iea@irishexporters.ie Web: www.irishexporters.ie IRISH MEDICAL DEVICES ASSOCIATION Tel: (01) 605 1529 E-mail: firstname.surname@ibec. ie Web: www.ibec.ie/imda

HIGHER EDUCATION AUTHORITY Tel: (01) 231 7100 E-mail: info@hea.ie Web: www.hea.ie

IRISH MEDICINES BOARD Tel: (01) 676 4971 E-mail: imb@imb.ie Web: www.imb.ie

IDA - INDUSTRIAL DEVELOPMENT AGENCY Tel: (01) 603 4000 E-mail: idaireland@ida.ie Web: www.idaireland.com

IRISH NATIONAL ACCREDITATION BOARD Tel: (01) 607 3003 E-mail: info@inab.ie Web: www.inab.ie

INSTITUTE OF CHEMISTRY OF IRELAND E-mail: info@instituteofchemistry.org www.instituteofchemistry.org

IRISH PATENTS OFFICE Tel: (056) 772 0111 E-mail: patlib@patentsoffice.ie Web: www.patentsoffice.ie

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IRISH PHARMACY UNION Tel: (01) 4936401 E-mail: firstname.surname@ipu.ie Web: www.ipu.ie IRISH VENTURE CAPITAL ASSOCIATION Tel: (01) 276 4647 E-mail: secretary@ivca.ie Web: www.ivca.ie INVEST NORTHERN IRELAND Tel: (048) 9023 9060 E-mail: eo@investni.com Web: www.investni.com MANDATE TRADE UNION Tel: (01) 874 6321 E-mail: mandate@mandate.ie Web: www.mandate.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 Web: www.pda.org PHARMACHEMICAL IRELAND Tel: (01) 605 1584 E-mail: pharmachemicalireland@ ibec.ie Web: www. pharmachemicalireland.com Pharmaceutical society of Ireland Tel: (01) 218 4000 E-mail: info@pharmaceuticalsociety.ie Web: www.pharmaceuticalsociety.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