EPM May 2014

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IN THIS ISSUE: Packaging & Anti-Counterfeiting Tabletting Equipment Spectroscopy Logistics & Distribution

European Pharmaceutical Manufacturer May 2014

Volume 14 | Issue 03

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IN THIS ISSUE

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editorial group editor lu rahman,

MANUFACTURING PRODUCTS

pages 5–19

lu.rahman@rapidnews.com editor elizabeth valero,

News

5–10

Case Study Laboratorio Sanderson reduces costs and boosts efficiency thanks to nitrogen generator News & Views… … From an Association Expert Tracking and Authentication — Both are Important!

By Ian M Lancaster, founding director of Reconnaissance International Ltd, member of the ISO committee, general secretary of the International Hologram Manufacturers Association and director of the Global Forum on Access to Safe Medicines.

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ellie@rapidnews.com publishers mark blezard, duncan wood

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production art samantha hamlyn production peter bartley

advertising robert anderton

Packaging & Anti-Counterfeiting Showcase

13–14

Comment Cracking the Code on Serialisation

By Heidi Vanheerswynghels, strategic account manager at Videojet Technologies.

Q&A… …With Scott Koehler, VP sales & marketing, Elizabeth Carbide Die Co., Inc.

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LABORATORY PRODUCTS

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Q&A… … With Scot Ellis, marketing manager — Raman spectroscopy and microscopy, Thermo Fisher Scientific, Inc.

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Spectroscopy Showcase

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Comment Applying Benchtop NMR Spectroscopy in the Pharma Lab

By John Paul Cerroti, director of sales, EMEA, at Magritek GmbH.

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INGREDIENTS & CONTRACT SERVICES

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News

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Comment Handling Pharma Recalls — A Test of Strength for the Customer-Brand Relationship

By Farzad Henareh, European managing director at Stericycle ExpertSOLUTIONS

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Logistics & Distribution Showcase

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Regulatory Affairs Eight Years of DCP

By Dr. Parvinder Puna, senior regulatory expert, EU and related markets, at ELC Group.

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European Pharmaceutical Manufacturer is published by Rapid Life Sciences Ltd. European Pharmaceutical Manufacturer is distributed in electronic and print formats to a combined readership of 14,000 pharmaceutical manufacturing professionals.

Volume 14 Issue 3 © May 2014.

While every attempt has been made to ensure that the information contained within European Pharmaceutical Manufacturer is accurate, the publisher accepts no liability for information published in error, or for views expressed. All rights for European Pharmaceutical Manufacturer are reserved and reproduction in part or whole without written permission is strictly prohibited.

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ISSN No - 2052-4811

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FROM THE EDITOR

A fond farewell until 2015 from me and over to you Lu!

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This is a somewhat ‘shared’ editor’s letter as this is my last issue this year; the reason being that I will shortly be on maternity leave and am passing the EPM reins over to Lu Rahman, editor of EPM’s sister publication Medical Plastics News.

Several mainstream stories have caught Lu’s and my attention this month, one in particular provoking quite a debate in our office and that I’d like to invite Lu to discuss. So, a fond farewell until 2015 from me and over to you Lu! Hi EPM readers, like the medical device sector, the pharma sector offers a continual source of news. There are common themes between the two and as 2013 saw a stream of merger and acquisition activity in the medical plastics world, this trend is making front page news in the pharma sector also.

Rumours have been circulating for months about Pfizer’s designs on AstraZeneca, and this week shares in AstraZeneca soared after Pfizer confirmed a multibillion pound bid for the UKbased drug maker. If the deal goes ahead, it will see the biggest ever takeover of a UK business by a foreign firm.

There has been much discussion over what this means for the UK, although I suspect not as much as there would be if we were talking about the takeover of a UK football club. Looking at it from an industry perspective, should we see the move as positive or negative? What will it mean for the sector and what effect will it have on the UK economy or say, investors in the business?

There have been reports that if the takeover goes ahead, it could have a detrimental effect on the development of

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new drugs in the UK. Industry experts have warned the move could be a ‘nail in the coffin’ for the UK drug sector and that mergers and acquisitions lead to lab closures, job losses and a threat to research output. With the UK holding a key position for world-leading drug R&D, is it ok to sit back and accept the takeover is a good move? When the UK has very little industrial output to call its own, should we be looking to protect the assets we have to a greater extent? The pharma sector is one of the UK’s most valuable assets. With this in mind — and the facts that it employs 68,000 people, contributes £210,000 to GDP per year, per employee, and invests £13.3 million a day in R&D — should we be more determined to ensure its security?

Then there is always the flip side.

Pfizer’s chairman has been quoted on his respect for AstraZeneca and industry players have highlighted the opportunities for Pfizer to develop AstraZeneca’s research facilities, creating a world-class pharma hub.

There is no doubt that the UK pharma sector makes a significant contribution to the economy. However, medicine sales dropped between 2004 and 2011.

According to the ABPI, which represents research-based biopharmaceutical companies, the UK has the lowest usage of innovative medicines compared with other comparable countries, despite having some of the lowest priced medicines in Europe. It says that if these trends continue, global pharma companies will think twice before investing in the UK. With this in mind, should we really be seeing Pfizer’s move in a more positive light?

It’s clear that there’s much discussion to be had and for those of you that have an opinion on the topic, please do get in touch as I’d be really interested to know what you think.

MANUFACTURING PRODUCTS 400,000+ hourly output of tablet press draws crowds at interpack Bosch Packaging Technology presented the new Manesty TPR 500 tablet press — equipped with die table, torque drive and tablet discharge chute as well as intuitive HMI — at this year’s interpack.

“With its novel design and high productivity, the Manesty TPR 500 underlines Bosch’s competence in tablet pressing and offers customers the highest machine quality combined with excellent usability,” said Christian Treitel, business development director, pharma product division at Bosch Packaging Technology. “Reduced maintenance efforts and overall ease of use lower the total cost of ownership and make the TPR 500 particularly suitable for customers with flexible requirements.”

The TPR 500 is equipped with a new 56-station die table and can produce more than 400,000 tablets per hour. The modular powder feeding system allows for more flexibility with a two-paddle design that can easily be upgraded to three paddles, depending on product properties and powder characteristics.

“Thanks to the scaled setting, all filling parameters can be easily reproduced, and the tablet press consistently

achieves high-quality yields,” explained Treitel.

To help ensure the smooth delivery of tablets, the new tablet discharge chute features an easy-to-clean pneumatic gate mechanism and optimised take-off angle for reducing product damage and increasing output, especially with shaped or friable tablets.

Connected directly to the turret, the new Siemens torque drive is said to achieve high torque at low revolutions per minute while saving space in the mechanical area. It generates little heat and has no wear and tear parts to allow customers to considerably reduce maintenance. The machine’s good overall accessibility promotes easy tool changes and cleaning. Turret removal is possible in ten minutes, while complete product changeover can be achieved in less than one hour.

Thanks to the hygienic design of the Manesty TPR 500, production is completely separated from the mechanical area, preventing powder contamination in the mechanical zone.

Beckhoff controls paired with an intuitive 21” HMI aim to ensure efficient

operations as well as easy machine setup.

“The reduced maintenance and cleaning efforts, as well as fast and easy changeovers, give our customers more

time for their actual production,” underlined Treitel.

Bosch Packaging Technology www.boschpackaging.com

Tablet tooling maintenance cuts downtime and costs The importance of maintaining punches and dies to help improve profitability should be a major consideration for any tablet manufacturer, says I Holland.

By following simple steps in tooling maintenance, press downtime can be limited, resulting in increased production.

As part of this process, I Holland introduced the 7 Step PharmaCare process, which has been adopted as a standard operating procedure by companies worldwide. By implementing the seven steps and simply maintaining tools, rather than replacing them, companies can extend the life of their

tablet tooling, without the expense of replacement. Correct maintenance is critical in obtaining maximum life from punches and dies, with a high proportion of problems being traced to poor handling and maintenance procedures.

As part of the 7 Step PharmaCare process, which includes the steps: clean, assess, repair, measure, polish, lubricate and store, I Holland has most recently introduced the MF40 automated punch and die polishing machine.

Automated polishing is one of the key steps in this process, which contributes towards maximising trouble-free tablet production by helping to keep tooling in

perfect condition. The MF40 has a 40 l media drum and punch holders, allowing a maximum of 51 B or 36 D punches to be polished per 20 minute cycle. To make the machine space- and cost-effective for manufacturers, the MF40 has a compact 940 x 750 mm footprint and uses single-phase power.

With regular use of an MF polishing machine, like the MF40, some sticking issues can be simply solved. The MF40 is said to use an easily accessible touchscreen software, which is available in several languages, and ensures consistent, repeatable polishing every time.

I Holland Ltd www.iholland.co.uk

Noxilizer provides rapid biodecontamination units for Weiler Engineering’s BFS Systems Noxilizer, the company advancing a room temperature, nitrogen dioxide (NO2) -based sterilisation process for life science manufacturers, and Weiler Engineering, a blow/fill/seal (BFS) equipment specialist, have embarked on an exclusive supply agreement.

Noxilizer will provide NOX FLEX rapid biodecontamination units for new Weiler Engineering BFS systems.

Today, BFS systems use steam or

sanitisation to decontaminate portions of the machine. The NOX FLEX units provide a sterilisation and depyrogenation process in a patentpending application for the shroud area of the new ASEP-TECH BFS machines.

This should result in improved manufacturing efficiency and process control.

“Weiler is a leader in the blow/fill/seal industry and we are excited to be

working with them,” said Lawrence Bruder, Noxilizer CEO. “This is another example of the important benefits of nitrogen dioxide in sterilisation, decontamination and depyrogenation for the pharmaceutical and biotech industry.”

“Providing the NOX FLEX rapid biodecontamination system to our customers demonstrates Weiler’s commitment to bringing innovation

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that leads to improved efficiency,” noted Carol Nowak, CEO and President of Weiler Engineering. “We are focused on the success of our customers.”

Noxilizer, Inc. www.noxilizer.com Weiler Engineering, Inc. www.weilerengineering.com

News

MANUFACTURING

Case Study: LABORATORIO SANDERSON REDUCES COSTS AND BOOSTS EFFICIENCY THANKS TO NITROGEN GENERATOR Building upon its successful experience with Atlas Copco’s compressed air solutions, Laboratorio Sanderson S.A., one of Chile’s leading pharmaceutical companies, has recently installed an NGP 92 nitrogen generator with pressure swing adsorption (PSA) technology to meet its growing demand for high purity nitrogen; by providing nitrogen at a purity between 95 and 99.999%, the NGP fully meets the pharmaceutical industry’s stringent purity requirements of 99.99%. “We have been using Atlas Copco’s compressors for over ten years to deliver both oil-free and oil-injected compressed air,” stated Marcela Cantillana, assistant manager for validations at Fresnius Kabi, Chile. “These compressors have always met our expectations and we feel that the new nitrogen generator is a perfect complement to our activities.”

Founded in 1942 and now part of the German group Fresenius Kabi, Laboratorio Sanderson specialises in the production and commercialisation of a range of injection products and other liquid substances for medical applications across the Latin American market. Its successful relationship with Atlas Copco started in 2003, when the company decided to replace its oilinjected load/unload air compressor with an energy-efficient oil-injected compressor with variable speed drive technology (GA 75 VSD FF) for the compressed air supply of its production plant; by adjusting the output of compressed air to the exact air demand at any given time, variable speed drive technology can save an average 35% of energy compared with load/unload compressors. In 2008, the company also bought an oil-free ZT55 VSD compressor with integrated MD dryer, achieving extremely positive energy savings.

Thanks to Atlas Copco, Laboratorio Sanderson has more recently also switched to on-site nitrogen generation.

Previously, the company purchased its nitrogen from an external supplier that delivered liquid nitrogen in cryogenic tanks. The nitrogen is now generated on

Gaining independence from external suppliers is a major benefit. Since the installation of the NGP 92, we do not have to rely on another organisation or company to ensure a constant and adequate supply of nitrogen.

site at the purity level required thanks to Atlas Copco’s installation of a ZT 18 IMD oil-free compressor and NGP 92 nitrogen generator with PSA technology.

“Gaining independence from external suppliers is a major benefit,” continued Cantillana. “Since the installation of the NGP 92, we do not have to rely on

Marco Contreras, Atlas Copco’s Industrial Air Division business line manager for Chile, and Marcela Cantillana, assistant manager for validations at Fresnius Kabi, Chile.

another organisation or company to ensure a constant and adequate supply of nitrogen.”

Based on PSA technology, with carbon molecular sieves selectively separating oxygen from nitrogen, Atlas Copco’s NGP nitrogen generation system provides a cost-effective, reliable and secure supply of nitrogen. By ensuring a continuous supply of nitrogen, the NGP unit eliminates the risk of production breakdowns and ensures low operating expenses, with no additional costs such as order processing, refills and delivery charges. In addition, the high purity of nitrogen is always guaranteed, with nitrogen purity rates ranging between 95 and 99.999%.

Fully aware of the efficiency and costsaving potentials of the nitrogen generator, Laboratorio Sanderson is now also considering installing Atlas Copco’s oxygen generator in the future.

Commenting on the company’s successful collaboration with Atlas Copco, Cantillana concluded: “Our relationship with Atlas Copco has always been one of mutual cooperation and we feel that Atlas Copco fully understands the importance of ensuring the proper functioning of its equipment through maintenance, support, documentation and certificates.”

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Illustration of nitrogren separation.

NGP nitrogen generator.

Atlas Copco www.atlascopco.com/nitrogen

News

MANUFACTURING Bosch Packaging relocates inspection technology site in Japan Process and packaging technology solutions provider Bosch Packaging Technology has moved to a new location at Musashi, some 70 km north of Tokyo. Since the move in late March, over 100 associates have been developing and manufacturing inspection technology for the pharmaceuticals industry on premises covering 3,240 m2. A total of €1.6 million (£1.3/$1.4) was invested in the new site. Following relocation from Honjo to the much larger Musashi site, Bosch Packaging Technology now has considerably more space at its disposal for the development and assembly of its

machines. This investment in the Musashi site underscores the company’s commitment to Japan as a major market for pharmaceuticals inspection technology.

In the pharmaceuticals industry, demand is constantly rising for product safety and quality and therefore inspection solutions. The inspection technology unit was established in 2012 following the acquisition of Eisai Machinery, a Japanese company. It comprises manual, semi-automated and fully automated inspection machines, designed to identify particles in

pharmaceutical products. It also caters for the cosmetic inspection of containers or tablets in order to detect defects such as scratches or discolouration.

Musashi is one of four Bosch Packaging Technology sites in Japan.

Processing and packaging machines and robotics for the food and pharmaceuticals industries are developed and assembled at the

Funabashi site, located east of Tokyo, while the company also has a sales office in Tokyo and one in Osaka.

Bosch Packaging Technology www.boschpackaging.com

Pilot-scale freeze dryers prove worth in R&D and early production

The VirTis range of pilot-scale freeze dryers offers the user 0.142 to 2.13 m2 shelf areas in 1 to 15 shelf configurations and with 25, 35 and 50 l format condenser capacities. All systems are designed to occupy a compact footprint in a fully integrated, mobile framework.

According to manufacturer Biopharma Technology Ltd (BTL), with over 80 of these pilot-scale systems in successful operation across a diversity of applications throughout the UK and Ireland, they have proven their early production capability whilst still offering the flexibility required for R&D work.

The mechanical design options, choice of control systems and range of hardware and software options available aim to ensure a system tailored to specific requirements and that takes into consideration later scale up to larger production machines.

The 316L stainless steel chamber and shelf construction, materials and general construction comply with GMP and modern industry requirements, and all systems can be specified with control systems compliant with the latest regulatory requirements to 21 CFR Part 11 if necessary. As well as free-standing systems, VirTis designs include cleanroom compatible, through the wall systems to meet local space requirements and systems designed for use with isolators.

BTL provides full technical equipment support and also product analysis and process development services through its freeze drying laboratories.

Biopharma Technology Ltd www.intelligentfreezedrying.com EPM 8

News

MANUFACTURING Biodecontamination technology for aseptic systems Telstar has introduced the ionHP (ionised hydrogen peroxide) biodecontamination system for use in pharmaceutical aseptic enclosures, a technology that aims to resolve some of the traditional difficulties associated with H2O2 biodecontamination processes.

Unlike conventional systems, the ionHP technology, developed for application in aseptic isolators, increases the efficacy of the decontamination process and reduces degradation of construction materials by virtue of requiring a very low concentration of H2O2, says the company. Reduced biodecontamination cycle times should be possible since the process efficiency is not affected by temperature and humidity, and therefore there is no need to pre-condition the chamber prior to H2O2 injection.

This biodecontamination technology has been developed in response to increasing demand for the manufacture

of sterile potent drugs, which brings increased need for sterility testing. A biodecontamination system is an essential feature of all sterility test isolators, providing a reliable and repeatable method of sterility assurance.

Conventional decontamination systems use vaporised H2O2 to decontaminate the internal surfaces of the isolator and external surfaces of internal process equipment and product packages before testing begins.

Initial applications for ionHP had been in large warehouses, hospitals and airplanes and intended for single use, therefore the control systems requirements were basic. Over three years ago, following intensive research

by Telstar’s Technology Centre for Barrier Isolation Systems in the UK, the company identified an alternative decontamination system aimed at aseptic pharmaceutical processes that used ionHP. Telstar developed this

system for aseptic isolation technology, introducing a viable alternative to traditional systems. The ionHP system has been designed into the Telstar standard sterility test isolator range mechanically, electronically and through software; the result being a PLC-based integrated system. ionHP can be used in open air and, once ionised, acts like a gas as opposed to a vapour, which offers operational, commercial and environmental benefits.

According to Telstar, ionHP requires a significantly shorter decontamination process time than the traditional alternatives, and it has no requirement for special atmospheric conditions, eliminating the need for air conditioning units required with traditional systems.

At the same time, ionHP uses a base concentration of 7.5% volume, whereas traditional H2O2 systems use 30–35%.

This lower level of concentration is more conducive to shipping worldwide with it

being below the threshold level for transportation (especially air transport).

Hydrogen peroxide is the primary component used, which breaks down into oxygen and water at the completion of the decontamination process, making it one of the most environmentally friendly decontaminants available.

Telstar www.telstar.com

Additional MES capabilities bring production agility Life sciences companies have the dual task of maintaining flexible production lines to respond to changing market demands and cost-effectively managing compliance requirements. Rockwell Automation continues to expand the flexibility of its PharmaSuite v5.2 MES system to help manufacturers respond to these challenges and execute electronic batch records (EBRs) in more efficient ways.

PharmaSuite v5.2 is said to offer improved agility and production control as well as native integration with FactoryTalk Historian software and the OSIsoft PI system to help pharmaceutical and biotech companies optimise production, improve reporting and shorten development time.

“We’re aiming to set new performance standards for MES with the PharmaSuite v5.2 system,” said Martin Dittmer, PharmaSuite product manager, Rockwell Automation. “Empowering operators with agility and production

control, without sacrificing quality, delivers improved time to results. The PharmaSuite v5.2 system decreases the time required to produce, review and release each batch and speeds processes across production areas or individual lines for more efficient recipe execution.”

Recipe elements can be executed in parallel by multiple shop floor operators with PharmaSuite v5.2. On the production line, recipe tasks can be freely moved between electronic batch recording stations or fixed to a specific station by recipe design. This iteration should allow operators to define and control the level of execution freedom on the shop floor and increase the efficiency of electronic batch recording.

In addition, registration of devices like industrial laptops or tablets to a production line station is supported to enable worker mobility and collaboration in a more flexible but still secure manner.

The newest version of PharmaSuite also includes native integration with FactoryTalk Historian software and the OSIsoft PI system to increase insight into production by gathering and archiving actionable information into one deliverable. The purpose of FactoryTalk Historian is to automate the process of collecting historical data, developing trend charts and attaching this information to the batch record. This should reduce human error so operators can focus on production rather than reporting.

PharmaSuite v5.2 also has the ability to export production orders and EBRs for long-term archival using PDF and B2MML standards. With this, regulatory requirements for batch record retention can be efficiently supported.

Increased execution efficiency and completeness of batch records will help manufacturers to further reduce overall production costs and accelerate the return on investment.

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Rockwell Automation Ltd www.rockwellautomation.com

News

MANUFACTURING ICS Cool Energy to the rescue of pharma company With mounting pressures and a variety of hurdles thrown at the pharmaceuticals market — from escalating R&D costs right through to fiscal and governmental austerity measures — production schedules need to be tight and problems quickly rectified. A case in point is a

pharmaceutical development and manufacturing firm with bases in the UK and Europe that won a contract to develop a pharmaceutical drug for the MoD. Stringent targets were put in place to ensure that each element of the manufacturing process was managed with precision. However, one of the production lines was left out of action when a chiller failed whilst serving a granulation machine during manufacture of the drug. With order deadlines pressing, the company required immediate action and turned to ICS Cool Energy’s hire division for emergency cooling support.

Possessing an understanding of both the cooling equipment and fault, ICS Cool Energy acted fast and supplied a temporary TAEevo 351 chiller that,

thanks to the firm’s installation team, was installed to restore cooling overnight, ready for the business’ opening hours the very next day.

Following installation of the system, ICS Cool Energy hire division’s sales director Russ Baker commented: “Companies operating in the pharmaceutical sector need to ensure that the very best standard of temperature control is in place at all times. For tight production schedules such as this, downtime and delays can be detrimental, especially with competition in the sector being so high.

ICS Cool Energy’s hire division provides fast acting, comprehensive cooling and heating support, keeping businesses covered, if and when a breakdown occurs.”

The temporary cooling in place, and with minimum downtime and knock-on effect to the business, production was able to commence as normal.

ICS Cool Energy www.coolenergy.co.uk

Weigh module design enhances safety and service Mettler Toledo’s new weigh module, the SWB605 PowerMount, was designed to be easy to install and offers rugged construction, built-in safety features and continuous load cell monitoring. These design details — particularly standard POWERCELL load cell monitoring — are claimed to enable easier operation and maintenance for significant time and costsavings long term.

Without the kind of continuous monitoring offered by POWERCELL, errors such as load cell overload, poor

communication between modules, out-ofsymmetry errors and out-of-range temperatures can go unnoticed for long periods. When they do, out-of specification batches and poor quality product are the result. Significant costs and damage to company reputation can occur.

SWB605 PowerMount POWERCELLequipped load cells with on-board microprocessors should not only alert operators to performance degradation but also adjust the weighing signal to compensate for environmental changes

so accurate weighing is achieved regardless of the effects of temperature, linearity, hysteresis and creep.

In the unlikely event of load cell failure, SWB605 PowerMount’s design also makes individual load cells easier to replace. Global approvals are standard on SWB605 PowerMount POWERCELL, including OIML C3, C6 and C10 and NTEP 5000d and 10000d.

Mettler-Toledo Industry Weighing www.mt.com/ind-powermount

PTFE hose with stainless steel increases pressure capabilities AdvantaPure now offers its stainless steel overbraided PTFE hose in four styles.

The hose, called APFOS, provides the purity of PTFE fluoropolymer with the durability and enhanced pressure carrying capabilities of stainless steel.

APFOS is used in high-purity industries for critical fluid lines such as pharmaceutical batch, media and buffer transfer, hot and cold food and beverage conveyance and chemical lines.

The four versions include smooth core, convoluted core, silicone-jacketed smooth core and silicone-jacketed convoluted core. It is claimed that the smooth core options offer larger inside diameters than traditional nominal hoses and the maximum amount of flow during fluid transfer. The convoluted core styles are said to offer more hose flexibility and are less susceptible to stress cracking than metal counterparts. Both smooth and convoluted types are available with a layer of platinum-cured silicone over the stainless steel braid, offering two benefits: the silicone supplies heat protection, making the hose better able to withstand harsh environments and easier to handle in high temperature applications, and it provides a wipeclean smooth exterior to eliminate particle entrapment within the braid wires.

The cores of APFOS are manufactured from virgin PTFE fluoropolymer that is EPM 10

USP Class VI compliant and meets FDA 21 CFR 177.1550 and ISO 10993 sections 5, 6, 10 and 11. The cores are inert and aim to offer long flexural life, low permeability, non-flammability and the lowest coefficient of friction of any solid material. Overbraid material of 304 stainless steel wire permits higher pressure uses, improves flexibility, reduces kinking and protects the core.

APFOS handles temperatures ranging from -73 to 232˚C. APFOS sizes range from 1/4 through 3” nominal I.D., depending on style.

Custom options include conductive black PTFE, hose assemblies with crimped-on ends and identification solutions such as the AdvantaLabel silicone label attachment system.

Rubber-covered FEP fluoropolymer hose is stocked as well.

NewAge Industries AdvantaPure www.advantapure.com

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News & Views...

MANUFACTURING

...From an Association Expert

TRACKING AND AUTHENTICATION —

BOTH ARE IMPORTANT! Pharmaceuticals have become one of the most commonly — and most dangerously — counterfeited products, largely because it is so easy for a criminal to make something that looks right but has no — or inadequate — active ingredients. And while this problem is most prevalent in the poorest countries and developing nations, it is also an issue in developed nations. That is why the EU issued its Falsified Medicines Directive (FMD) and the US Congress recently enacted the Drug Quality and Security Act, both legislative attempts to establish stronger protective systems for medicines distributed in their respective jurisdictions.

However, it is not only counterfeit meds that are unsafe, as the WHO recognises with its cumbersomely-named Member State Mechanism on Substandard/ Spurious/Falsely-labelled/Falsified/ Counterfeit (SSFCC) Medical Products.

Spurious, falsely-labelled, falsified and counterfeit are all frankly synonyms for fakes, and substandard covers many other issues such as badly stored, out of date and so on. All of them are a cause of concern for patients and hence the need for careful supply chain control and monitoring and careful marking of legitimate pharmaceuticals; two complementary and necessary requirements that are often seen as the same thing.

ABOUT THE AUTHOR: Ian M Lancaster is a founding director of Reconnaissance International Ltd, which specialises in information about secured documents and products. He is a member of the ISO committee, which has drafted several authentication and anticounterfeiting standards, and is the general secretary of the International Hologram Manufacturers Association (IHMA). Ian is also the director of the Global Forum on Access to Safe Medicines (formerly on Pharmaceutical AntiCounterfeiting Solutions).

Monitoring and control of the medicines supply chain has become easier in recent years with the advent of low-cost track and trace systems, which allow every pack to be marked with a unique code that can then be read at key points in the distribution system.

These systems take serialisation to a new level of functionality, using encoded numbering systems such as data matrix codes to carry critical information about the item that they are on. That information can include the unique identifier for the item, manufacturing place and date and intended destination market. The unique identifier is stored on a central database so that when the code is read at key distribution, dispensing or selling points, it can be checked against the database to make sure that the item is in the intended place at the expected time. Also, when it is dispensed or sold, then the record can be appropriately marked.

More sophisticated systems, such as the e-pedigree aspiration of US legislation, aim to write back to the item the action that has been performed on it, noting what, when, where and by whom.

But these systems are still more dream than reality, because the write/read/write infrastructure is very expensive, as is the chip or other method of receiving the updated data on to the item. Data matrix and other methods of encoding serialisation are here and now, as demonstrated by GS1’s healthcare marking standards.

All of these enhance supply chain monitoring and inventory recording, both of which help to keep fakes from being insinuated into the supply chain.

However, they do not provide the other essential component of ensuring delivery

of safe medicines to patients — authentication.

In 2012, the International Standards Organization published its standard 12931, titled Performance requirements for authentication solutions in the field of material goods, the first international standard to prescribe such requirements. That standard makes a case for the complementarity of tracking and authentication, stating that ‘track and trace on its own does not provide authentication (of material goods)’.

Why not? If the supply chain can be controlled and each item tracked from factory to patient, why does this not mean that the medicine as taken by the patient is always genuine? The answer lies in a human being’s inability to read a data matrix code, the vulnerability of network-based systems and the fact of the existence of parallel supply chains (those set up by the counterfeiters or other criminal suppliers).

It is generally accepted these days by product or brand protection managers and others in the authentication community that the most effective way to combat the efforts of counterfeiters is to use a combination of different types of functional feature. This is captured in ISO 12931, which recommends the use of overt and covert features, with the facility for forensic analysis, all complemented by track and trace methods. Overt features are readable by one or more of the human senses, while covert features require some kind of tool to become readable, whether by revealing something to a person or to a machine. In either case, they are independent of network connections and databases at the other end of a telecoms link, thus they work in adverse

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conditions as long as the person doing the examining is properly equipped with the right tool and a reference feature to compare with.

Also, network-based systems are vulnerable to interruptions, hacking and other attacks. Neither a human eye nor a reading device can tell whether a data matrix or similar code has been copied, with a link to a cloned website (think of all those phishing emails that link to a cloned bank website) so that the item is seemingly validated as the authentic product.

And while pharmaceutical company supply chains are tightly controlled, this control does not extend to the parallel supply chains through which fake medicines are sent from a factory (often but not always in China) to the street market or bazaar in an African, SE Asian or other vulnerable country. Or, indeed, to a pharmacist in Europe or the US. The fake products in these supply chains may well have a code on them, but it is a code that is linked to a false website, and that assumes that the code will be used, which is most often not the case.

A linked overt/covert authentication feature is the only way to demonstrate the genuineness of a product in the supply chain or on a counter or stall at the pharmacist or street trader, but the best combination is to link that feature to the encoded serialisation feature. This can be done through separate features, each operating independently, or they can be combined, for example, in a hologram or colour-shifting ink that incorporate a data matrix code. In this way, they become inseparable, the one validating the other and providing the best supply chain control and authenticator of the item.

Showcase

MANUFACTURING

PACKAGING & ANTI-COUNTERFEITING Standalone serialisation solution debuts at interpack There is an increasing demand for serial numbers to be printed on secondary drug packaging. Superior reliability and efficiency in this context can be achieved only if printer, camera and transport modules, as well as the serialisation software, are perfectly coordinated.

Atlantic Zeiser has developed a standalone system for serial numbering flat carton boxes, the DIGILINE Single 450, presented for the first time at this year’s interpack fair. According to the company, with the optional Atlantic Zeiser MEDTRACKER software, it not only ensures the utmost dependability when generating and printing codes but also offers the best possible functional protection in case of an operator error.

The DIGILINE Single 450 system is designed for sheets and flat carton boxes measuring from 80 x 100 mm to 450 x 500 mm (W x L) and offers a print width of 36 to 210 mm. Equipped with an Omega UV inkjet printer, the system

delivers deep black, high-contrast codes. The ink is said to put an end to short de-capping time and greyish tones, both defects being a constant source of complaints with cartridgebased ink systems. Furthermore, the special UV ink is highly resistant to water, alcohol and other solvents, which the company says rules out accidental smearing of the codes after printing.

Depending on the printer, the system offers a transport speed of 30 to 60 m per minute, which corresponds to approximately 120 to 240 pharmaceutical cardboard boxes a minute. The rugged transport system, developed by machine manufacturer Kohmann, is designed for longevity and stability. Its feeder aims to allow short setup times and format changes. The configurable elements of the DIGILINE Single 450 encompass not only the transport and printing systems but also the intermix and verification cameras. A

label unit and a second printer for a helper code are available as options.

DIGILINE Single 450 can be operated without MEDTRACKER software, enabling manual production data assignment for a limited number of number ranges for different products.

However, for applications with a large number of different products, MEDTRACKER can provide the required audit proof security. The software is said to manage any quantity of number ranges and data files, automatically converting the data from the incoming

format to the required production format. It also permits simultaneous production on two or more lines and allows production to be switched from one machine to another quickly and securely. The production results are recorded and made available for auditing purposes.

Atlantic Zeiser www.atlanticzeiser.com

Non-destructive inspection, blister recovery and packaging technologies make European debut Three new products aimed at meeting the changing demands of global pharmaceutical companies have been launched by Sepha at this year’s interpack.

The first machine, BottleScan, is claimed to be the world’s first tool-less, non-destructive leak detection instrument for testing multiple inductionsealed bottles simultaneously. It incorporates force decay technology in order to test induction-sealed bottles for holes and weak seals without destroying the contents. Ahead of its European debut, Bottlescan had already attracted orders from several of Sepha’s Asian and North American customers.

Press Out Universal Mini is a lowvolume, rapid product changeover deblistering unit that enables product to be recovered from all blister pack types, particularly child resistant, peelable and senior friendly packs. The unit has been

developed to reflect changes in the pharmaceutical manufacturing market, where manufacturers are focusing on shorter runs of more bespoke, highvalue drugs in child resistant or senior friendly blister packs.

Finally, EZ MedPak extends Sepha’s EZ range of low-volume, package development units into the wider

medical packaging market. It is aimed specifically at medical device and packaging development teams looking to take control of their own pack designs and develop bespoke packs for small devices and pre-filled syringes.

Sepha’s head of sales and marketing, Paul Kelly, said: “Sepha is focusing on innovation by investing in new

technologies and developing our product offering in line with market demand. Our new equipment extends our range into new markets and will meet the changing demands of our global pharma clients.”

Sepha Ltd www.sepha.com/en/home

CO2 laser marking systems boost productivity by improving line integration As line speeds increase to cope with more demanding production targets, manufacturers need easier, more efficient laser marking to print highquality codes consistently on their products. Videojet Technologies has therefore advanced its range of CO2 laser marking systems with the Videojet 3330 30 watt and the Videojet 3130 10 watt lasers.

Aiming to deliver superior code quality across a range of marking speeds and suitable for a wide array of substrates, the 3330 and 3130 lasers are said to mark simple and complex codes while providing easy integration for virtually any application. When speed is the priority, manufacturers can utilise the dot font mode, enabling print

speeds up to 150,000 products per hour.

Videojet offers over 20,000 standard configurations within its CO2 laser marking line, including 21 mark window options and three laser wavelengths.

“We know from experience that line integration in certain cartoner and labeller applications in the pharmaceutical, beverage and food industries is challenging due to space restrictions,” explained Markus Vetter, laser business unit manager at Videojet Technologies. “The available configurations give Videojet the flexibility to match the physical integration needs of the packaging line, and the mark window options help

ensure we can deliver the marking performance our customers need.”

With three available laser wavelengths, the Videojet CO2 lasers can mark on a range of substrates including PET bottling, plastic labels, laminated cartons and a host of plastic materials common in consumer packaging.

To meet the increasing demands for traceability marking, the 3330 and 3130 are suitable options for serialised coding applications.

“With the US Drug Quality and Security Act and the EU Falsified Medicines Directive, our customers are looking for high-quality alphanumeric and datamatrix marking,” added Vetter.

“The high-resolution marking head on the 3330 and 3130, when supported

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with good material handling and proper line integration, can deliver consistently high-quality datamatrix codes.”

Complementing the 3330 and 3130, Videojet offers a range of fume extraction systems and filter options, helping to remove smoke and particulate debris and improving uptime by keeping the laser lens clean.

Videojet Technologies www.videojet.co.uk

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MANUFACTURING

PACKAGING & ANTI-COUNTERFEITING Sanner exceeds €55 million mark Manufacturer of plastic packaging and components for pharmaceutical, medical and healthcare products Sanner topped the €55 million (£45/$76 million) mark and set a new sales record in 2013 (up from €50.6/£41.7/$70.2 million in 2012).

This development was supported by a clear brand positioning with the new slogan Sanner. Protecting Health and substantial national and international investments.

“2013 was full of positive changes for our company,” explained Sanner CEO

Holger Frank. “Our business continued to grow with a 10% increase in sales to €55.5 million. We also managed to further strengthen our market leadership.” The focus here is on market segments that require the use of desiccants.

Sanner. Protecting Health, the company’s new slogan, introduced to the public in 2013, signified a clear brand positioning for Sanner. The new product divisions — pharma desiccant, teststrip, effervescent and pharma & medical packaging, as well as eye care and ready-to-fill syringes — underline the strategic orientation. The packaging specialist also claims to be setting new standards in the development of new packaging concepts, having been awarded a number of new patents in the past year.

As part of its strategic realignment, Sanner invested in extensive reconstruction at its headquarters in Bensheim, Germany, and took important steps toward doubling production capacity at its plant in Kunshan, China.

The company is also continuously expanding its market presence in India.

As in previous years, the Asian markets — especially China — proved to be major sales drivers.

“Our high-quality manufacturing operations and ongoing investments in plants and equipment give Sanner a positive outlook for the future,” Frank underlined.

Along with an increase in sales, Sanner is also growing in terms of its workforce.

The company added 60 new employees last year.

“We are planning for further growth this year. We are counting on the sales of new products in different segments as well as on specific customer projects for which we are developing tailormade packaging solutions,” concluded Frank.

Sanner GmbH www.sanner-group.com

Labelling solutions meet stringent requirements of pharma and chemical sectors Over the last few months, Faubel has expanded its product portfolio with a new instant access index label, a damage resistant synthetic label, a child resistant and senior friendly (CRSF) label and tamper proof blinding solutions, all of which the company highlighted at this year’s interpack.

“The pharmaceutical and chemical industries require our products to meet high standards of quality. These requirements make us more innovative, which results in highly specialised and customised labelling solutions,” explained Reinhard Kuge, CEO at Faubel.

The multi-page, coloured index label provides an alternative to an ordinary table of contents. The thumb index should make it easier for users to

instantly access important information inside the booklet.

Made of synthetic paper, the FaubelCompact label benefits from the positive properties of plastic material. It is tearresistant, waterproof and resistant to grease and chemicals, making it suitable for a multitude of applications, says Faubel.

The CRSF label is said to offer an effective way of making standard blister packs childproof during downstream processing yet still guarantee packaging that is senior-friendly. The safety element is suitable for machine processing and is certified to DIN EN 134375 and US 16 CFR 1700.20 (F1) standards.

Webinar polls show packaging solutions offer ideal way to meet FMD challenges The results from polls taken at a recent webinar attended by representatives from the pharmaceutical sector highlight the industry’s progress in meeting the requirements of the Falsified Medicines Directive (FMD).

Organised by Essentra Packaging, the webinar was entitled Meeting the Packaging Needs of the EU Falsified Medicines Directive & Beyond.

Participants were taken through some of the key challenges facing companies looking to meet the demands of the FMD, in addition to the technologies on offer to address them.

Three polls were taken during the webinar to measure the level of engagement with the issue, its challenges and possible solutions.

In response to the question asking how many attendees’ companies had taken steps towards meeting the serialisation requirements of the FMD, only 50% said they were already engaged with this. Also, when asked if they had undertaken activity to meet the tamper evidence requirements of the FMD, just 58% replied positively.

Simon Wildash, head of marketing at Essentra Packaging, said: “Whilst we were delighted to hear how many of our webinar attendees were actively addressing the requirements of the FMD and looking for packaging products to help achieve this, our polls showed there is still a way to go for many.”

Polling also highlighted that the preferred products to achieve tamper evidence included closure labels, glued

cartons and perforations as the top solutions being considered or implemented.

Wildash commented: “At Essentra, we have a range of cost-effective tamper evident and authentication options that can deliver secure solutions for the healthcare market.

“As our survey shows, packaging really does offer a way to overcome regulatory challenges, ranging from gluing cartons and incorporating labels to a more integrated view of security options including elements such as holography, overt, covert and forensic technologies as well as security design and print.”

Essentra Packaging www.essentrapackaging.com

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Lastly, Faubel blinding solutions are products that are used for single- or double-blind clinical trials. Vials, bottles, pots, tubes and blister packs can be fully covered and protected against tampering.

Faubel & Co. Nachf. GmbH www.faubel.de

Comment

MANUFACTURING

CRACKING THE CODE ON

SERIALISATION In 2011, the anti-piracy consortium Business Action to Stop Counterfeiting Piracy (BASCAP) of the International Chamber of Commerce estimated that the annual cost of counterfeiting and piracy was $775 billion (£463 billion/€561 billion) and is expected to reach $1.7 trillion (£1 trillion/€1.2 trillion) by 2015. BASCAP points out that the costs of counterfeiting extend far beyond the lost revenue opportunity to include the impact on consumer safety, lost government revenues and an estimated destruction of 2.5 million jobs globally. The pharmaceutical industry is a frequent target of counterfeiting and according to the 2011 Report on EU customs enforcement of intellectual property rights (IPR), medicines represented the single highest product category detained by EU customs agencies for suspected IPR infringement.

Combatting the proliferation of counterfeit drugs is a complex topic, yet serialisation of the individual unit of sale remains a critical tool in the fight to protect consumers and IPR holders. Its effectiveness against these threats is evident in the recent passage of regulations across the globe mandating serialisation, including DRC-54, The System for National Control of Medicines in Brazil, the EU Falsified Medicines Directive and the recently passed Drug Quality and Security Act in the US. Serialisation has clear implications for the integration of data and physical product flows both at the packaging lines and downstream in the supply chain. And while the complexities of generating unique codes, managing aggregations and supporting downstream product movement and authentication receive significant attention, it is easy to overlook the role that coding and marking need to play in an effective serialisation programme.

Data matrix codes have become the predominant ‘code carrier’ for the majority of pharmaceutical regulations.

Besides the obvious advantages of machine readability with low-cost optical imagers, Data matrix codes have a high data carrying capacity and embedded error correction, which allows for some

ABOUT THE AUTHOR: Heidi Vanheerswynghels is a strategic account manager at Videojet Technologies Inc., a manufacturer of marking and coding systems.

She leads a defined group of the company’s global pharmaceutical key accounts and carries responsibility for all medical and pharmaceutical business in EMEA.

code damage while maintaining readability.

While most coding and marking suppliers have Data matrix marking capability, packaging professionals need to consider a broader set of supplier capabilities to identify the right coding and marking partner for their serialisation needs. At the packaging line, the success of any serialisation project requires the integration of software, printers, cameras and material handling. Identifying a coding and marking supplier with a track record of working with serialisation software providers to successfully communicate unique code data between the software system and the printer has obvious benefits.

Another critical element is the printing technology breadth of the chosen coding and marking partner.

Pharmaceutical manufacturers often produce a range of products utilising different packaging substrates that require specific printing technologies.

Opting for a partner with a range of printing technologies ensures that the packaging professional can evaluate options and consider future packaging line requirements including throughput and substrate flexibility.

Lastly, the ideal coding and marking partner should be proactive in offering suggestions on the proper integration of the printing solution with the material handling solution. The interaction of these two elements can be overlooked with implications on code quality, throughput and the overall efficiency of the packaging processes.

Pharmaceutical packaging teams are now literally racing against the clock to get serialisation systems in place before the legislated deadlines. And while these projects are complex, these teams can eliminate one dimension of complexity by teaming with a qualified coding and marking supplier. Properly-integrated printers, generating high quality Data matrix codes, are a foundational element to any successful serialisation programme.

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Q&A...

MANUFACTURING

...With Scott Koehler, VP SALES & MARKETING, ELIZABETH CARBIDE DIE CO., INC. Since its establishment in 1954, Elizabeth has grown to become a global supplier of compression tooling, rotary tabletting services and blister packaging tooling/feeding solutions. The company’s range of technologies encompasses Elizabeth Carbide Die compression tooling, Elizabeth Scheu & Kniss replacement parts and services, Elizabeth-Hata tablet presses and Elizabeth-Europe blister feeding solutions.

Q:

was on display for the first time at this month’s interpack tradeshow in Düsseldorf.

What does your role involve?

A:

I’m responsible for global sales and marketing leadership.

Q:

Elizabeth is involved in a range of sectors — including pharmaceutical, battery, powdered metal, energy and power, automotive and metal forming — how important and what percentage of business is pharma?

A:

The pharma and nutritional sectors are very important to our business, representing roughly half of annual turnover. Many innovations are driven by our interactions with pharma and nutritional customers focusing upon their product assurance and total cost of operation.

Q:

What has been the latest product launch for the pharmaceutical market?

A:

We recently introduced Eliza-Press, a new series of manually operated tablet presses. Eliza-Press offers a simple,

I think the biggest challenge for our pharma customers is meeting global demand for costeffective medicines, delivered securely and timely to every corner of the world.

Q:

What are the current tablet tooling trends?

A:

reliable and cost-effective way to produce R&D- and medium-scale batches. Eliza-Press is borne from our three decades’ experience with highspeed Hata rotary tablet presses. Our new Eliza-Press 400 double-sided press

More for less.

Elizabeth is routinely working with customers to improve their production yields and production rates and extend useful lifetime of their tooling.

Through CIP (continuous improvement project) efforts, our engineering and customer service staff identify opportunities to enhance performance in any or all three areas.

While design improvements directly impacting performance may seem clear, the pathway to implementation is not always direct as we comprehend and support customer change control obligations.

Another recent trend involves the stricter federal agency guidelines concerning the use of functional tablet bisects. Tablet bisects are no more simply product trade-dress but must serve an intended purpose of dose partitioning. Again, our engineering staff collaborates with pharma manufacturers to design the necessary level of tooling precision yet with an eye towards operational robustness.

Q:

How does Elizabeth ensure that pharma customers’ needs are consistently met? (for example, what are the biggest issues faced by tabletting customers and what role does Elizabeth play in helping to solve these?)

A:

Combo Feeder.

I think the biggest challenge for our pharma customers is meeting global demand for cost-effective medicines, EPM 16

Eliza-Press 400. delivered securely and timely to every corner of the world. Our customers endeavour to provide incredible value in terms of patient quality of life and treatment outcomes yet need to respond to the fiscal constraints driven by consolidated supply chains and governmental initiatives to expand access to quality care.

Q:

What do you believe Elizabeth is able to offer its pharma clients over its competitors?

A:

In the simplest term, Elizabeth offers passion — we are passionate about our customer relationships, we are passionate about our customers’ success, and we are passionate about our integrity. Elizabeth celebrates its 60th anniversary in 2014 and we are globally positioned to service our customers from manufacturing facilities on three continents.

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TABLETTING EQUIPMENT LOCATOR

•••

•

•• ••• • • • •••

• TABLET TOOLING Adamus

Elizabeth

+48 91 45 99 100 www.adamus.com.pl

+1 412 829 7700 www.eliz.com

R&D TABLET PRESSES

I Holland

Natoli

Elizabeth

MedelPharm

+44 115 972 6153 www.tablettingscience.com

+1 636 926 8900 www.natoli.com

+1 412 829 7700 www.eliz.com

+33 478 9762 13 www.medelpharm.com

Thomas Engineering

Yener Kalip

Natoli

Riva

+1 800 634 9910 www.thomaseng.com

+90 216 451 6876 www.yenerkalip.com

+1 636 926 8900 www.natoli.com

+54 11 4653 2000 www.rivasa.com

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•

•• • ••

•

TABLET PRESSES ACG-Pam

Bosch Packaging Technology

Elizabeth

Fette

+91 22 3078 0701 www.acg-pam.com

+44 151 547 8000 www.boschpackaging.com

+1 412 829 7700 www.eliz.com

+49 4151 12 0 www.fette-compacting.com

GEA Courtoy

IMA

Kilian

Korsch

+32 2 363 83 00 www.gea.com

+39 051 6514111 www.ima-pharma.com

+49 221 7174 100 www.kilian-tableting.com

+49 30 435760 www.korsch.com

Natoli

PTK

Sejong

SVIAC

+1 636 926 8900 www.natoli.com

+82 31 987 2300 www.ptk4u.com

+82 32 508 1281 2 www.sjpmt.com

+33 1 55 59 91 11 www.sviac.com

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LABORATORY PRODUCTS Seward ramps up blender bag manufacturing Manufacturer of Stomacher paddle blenders used in sample preparation for microbiological analysis Seward has increased production capacity for its blender bags. By locally manufacturing its range of Stomacher 400 and 3,500 ml bags at its UK facility, Seward claims to have reduced delivery lead times for its European customers and minimised its environmental footprint.

Seward already strives to ensure rapid supply of Stomacher products to customers worldwide through local bag manufacture and stocking from regional sites in the US and Singapore. As well as reducing delivery times, this policy for local manufacture and stocking should help minimise the impact of rising material and transportation costs on product price. Furthermore, this complies with Seward’s environmental policy to minimise material and energy wastage and promote the use of

recyclable and renewable materials. In doing this, the company aims to achieve the ISO 14001 environmental management standard by mid-2014.

Since starting manufacturing bags in the UK, Seward reports that it is now recycling 85% of all its plastic and cardboard material production waste, contributing to an overall 40% reduction in general company waste.

“We are committed to operating our business in a manner that is sensitive to the needs and concerns of the people and surrounding environment; bringing our manufacturing processes in line with our environmental policy is just one of a number of measures that we have adopted to achieve this,” said Dan Crothers, general manager, Seward. “We are particularly keen to talk to customers who have similar environmental policies to us and are interested in collaborating to reduce the environmental impact of

laboratory testing. We can also discuss OEM manufacturing requirements.”

Seward’s Stomacher bag range has been designed to fulfill applications from sample blending, straining and storage, including bags designed for extensive blending (processes requiring more than 15 minutes on the machine) and small samples for life science applications.

Made from high-quality food grade virgin LDPE granule extruded to 65 µm film thickness, Stomacher blender bags are designed to withstand extensive blending without tears or perforations.

According to the company, this provides a low-cost option for sample preparation with no risk of cross contamination between samples. All Stomacher blender bags are irradiated sterile and a certificate of irradiation is available for all bag products upon request.

Seward www.seward.co.uk

Screen saving concept delivers improved LIMS audit trail operability

Freeze drying microscope provides clearer images for easier analysis

The OneTime configuration tools provided with the Matrix Gemini LIMS not only allow the system to be configured without the use of custom programming but also provide an audit trail each time a display screen for the system is updated or modified, says Autoscribe. If a screen is being altered, no one else can modify it until it goes live again. Each version is saved with a version number so the audit trail allows the possibility of returning to an earlier version if required.

A visual workflow screen editor shows the screen in edit mode along with all the options and control properties associated with that screen. Screens can be linked together and information transferred between them without programming. New screens can be created by copying and modifying existing screens from the screen library.

In addition, the screen and menu files can be e-mailed between the user and the Matrix support group at Autoscribe, allowing experts to review any proposed changes and provide advice on the implementation. Proposed changes can be developed in a training/development database and once approved can be copied into the live database for immediate use.

More screen technology is said to be available within Matrix Gemini with its

Biopharma Technology Ltd (BTL) has released the Lyostat4, its latest freeze drying microscope. Freeze drying microscopy (FDM) is a much used technique for establishing the point of collapse, the most important critical temperature for developing safe and robust freeze drying cycles. Essentially operating as a micro freeze dryer, FDM enables freezing and drying of a real sample to be observed in real time.

As FDM analysis is based on visual identification rather than thermal data, it is of the utmost importance to ensure maximum image clarity and resolution.

According to BTL, the Lyostat4 provides the latest generation LED light source for an even sharper image; it is brighter than the previous Halogen illumination but at the same time generates significantly less heat. This is accomplished by combining the LED source with an efficient, customdesigned electronics module. It is claimed that the LED system also provides superior longevity with a maintenance-free lifetime of more than 60,000 hours and nominal electrical power consumption for operation savings and green credentials.

Lyostat4 is compact, saving 20 x 21 cm bench space over Lyostat3. Used with the new stand, which eliminates trailing cables, the footprint can be reduced to

ability to migrate existing LIMS desktop applications developed in previous versions of Matrix to become web enabled. According to Autoscribe, this ensures that any screen that has been configured for use on the desktop is immediately available, with appropriate security, to a user running a web browser, without the need for programming, java or esoteric scripting languages.

Matrix Gemini is a pure Microsoft.NET/C# product and not a mixture of other technologies. It is said to offer the benefits of close integration between the Windows operating system and web technology so that just a single configuration is needed for both desktop and web use with no further modification, effort or cost.

Autoscribe Ltd www.autoscribe.co.uk

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just 45 x 30 cm (not including vacuum pump).

Biopharma Technology Ltd www.intelligentfreezedrying.com

News

LABORATORY Metallic lab nutsche filter dryer extends capabilities in drug discovery and development The GFD nustche filter dryer, launched four years ago, can now be found in many pharmaceutical and drug discovery laboratories around the world.

Since the 19th century, chemists have used the commonly known method of Buchner filtration, followed by the use of a vacuum dryer or other method, to complete the drying phase. The GFD technology combines filtration, cake washing and drying all in one step and product is fully recovered through the filtration basket.

Owing to its direct scale-up abilities, this vacuum laboratory filtration and drying unit is suitable for feasibility studies and trials, prior to investing in a large-scale nutsche agitated filter dryer.

To take the unit’s scalability a step further, a new addition has been launched this year to satisfy even more laboratory requirements, the metallic vessel GFD. The rising demand for higher pressure requirement and exact replicate of pressured ANFD drove Powder Systems Ltd (PSL), the

manufacturer, to develop an alternative technology to its best-seller, the laboratory glass filter dryer. The GFD laboratory filter dryer is now available in glass borosilicate 3.3, stainless steel 316L and alloy C22.

The full range uses the same accessories, including control box and drive system for the agitator, allowing flexibility between the different vessels.

The GFD products range from the smallest size mini lab GFD with 0.002 m2 filtration basket for a total volume of 0.3 l, which can filter a cake volume up to 0.1 l; this is a suitable piece of equipment for laboratory-scale trials.

Then the lab GFD size includes a removable filtration basket of 0.01 m2 for a cake volume around 0.5 l for smallscale synthesis and the maxi lab GFD is used in the kilo-laboratory for a cake volume of 5 l with 0.05 m2 filtration area.

How it works is firstly the slurry enters the vessel through one of the nozzles located on the vessel lid. During the filtration phase, vacuum is pulled at the

bottom of the vessel whilst the filter basket collects the product. It is then possible to wash the cake, again using a nozzle of choice on the lid to introduce the solvent and the heated vessel jacket if required.

It is common practice to apply pressure to the top of the filter cake during filtration whilst the bidirectional motor is running in a clockwise direction to smooth the cake. Optimal filtration is achieved in this way as the operator can pressure filter with no cracks in the cake.

The heated jacket is then used to heat the vessel for the drying phase. The vessel is rated to temperatures between -25 and 150˚C, and it is not uncommon for the GFD to be also used for the filtration of unstable products at low

Mini lab GFD filter dryer. temperatures. The bi-directional motor is lowered into the cake during this phase and is now used in the anti-clockwise direction to dig into the cake, resulting in the homogeneous drying of the product.

Powder Systems Ltd www.powdersystems.com

Water purification unit proves popular with pharma sector According to Purite, a range of pharmaceutical manufacturers are benefiting from its Select Fusion water purification system. This compact product has been developed specifically for cost-effective, long-term use in a variety of laboratory and small-scale pharmaceutical applications.

The Select Fusion, which produces two grades of purified water, forms part of Purite’s range of modular, standalone water purification units. It is capable of producing up to 50 l per day of laboratory grade purified water and ultrapure water up to 18.2 MΩ.cm that exceeds current British (BP), European (EP) and US (USP) pharmacopoeia water quality specifications, making it suitable for laboratory users operating in the highly regulated pharmaceutical industry.

The constituent that is the most abundant in the majority of pharmaceutical formulations is typically referred to as aqua or purified water, which is used in a range of product development processes, including testing and analysis, product development and cleaning production machinery. Although manufacturing processes require different grades of water purity, in nearly all cases, owing to very strict industry requirements, water must be purified, so a reliable and cost-effective purification system is often critical.

The Select Fusion, designed to produce consistently high-quality purified water that meets pharmacopoeia and laboratory standards and at a competitive cost, incorporates pretreatment filtration, reverse osmosis, UV

irradiation, ion exchange and sub-micron filtration technology in a single, robust enclosure. The unit can be wall or bench mounted and includes an integral 20 l purified water storage tank to minimise use of valuable workbench space.

The use of low-energy, reverse osmosis semi-permeable membranes, combined with the use of the automatic recirculation pump, help to maintain water quality and minimise power consumption, especially during periods of low demand. In addition, all of the consumables have been developed to be easy to change and to give a long and consistent operating life.

The Select Fusion water purification unit can be set up quickly, is said to be easy to operate and has a built-in colour LCD touchscreen, which shows system status, including water quality, TOC,

temperature and flow rates. Visual and audible alarms are also included and the system is supported by Purite’s global network of sales and distribution partners.

Purite Ltd www.purite.com

Dissolution line meets scientists’ needs today and tomorrow The ability to flexibly respond to change in today’s fast-paced pharmaceutical environment can make the difference between success and failure. Fast time-to-market requirements — outsourcing, relocations, shift of manufacturing capacities and short return on investment considerations — ask for equally flexible testing solutions in R&D and QC laboratories. According to the SOTAX Group, its new, fully modular and scalable Xtend dissolution line

concept is 100% based on this basic premise and allows laboratory scientists to tailor dissolution testing to both their current and future needs, making their investment future-proof.

This concept consists of new individual and standardised Xtend modules such as the AT dissolution bath, the CP pump, the FS filter station and the SAM sample manager, which can be combined for different automation requirements, from manual bath to semi- and fully automated dissolution system.

Irrespective of the chosen configuration, all modules and components of the Xtend dissolution line are robust as they are designed for the most demanding conditions of a fully automated system running 24 hours per day.

The Xtend dissolution line also aims to simplify method transfer, to make scale-up from R&D to QC with different throughput requirements and changing workloads easier. From qualification to writing SOPs, scientists can keep in place what is already used, described and validated.

SOTAX AG www.sotax.com

Merck Millipore and VWR extend western European distribution agreement Merck Millipore, the Life Science division of Merck, has announced a new, non-exclusive preferred distribution agreement for western Europe with VWR, a global provider of laboratory supplies, equipment and services. The contract includes a range of Merck Millipore products and reagents for chemical and microbiological analysis, which are mainly used in QC solutions for the pharmaceutical, food and beverage and chemical industries as well as

products for research in the field of organic synthesis and biosciences.

“The new contract continues an important relationship with one of Merck Millipore’s largest distributors and reinforces our commitment to providing our existing customers easy access to high quality products,” noted Robert Yates, head of Merck Millipore. “We will give VWR access to more Merck Millipore products and expect, with VWR’s wide geographic coverage across western Europe, we will be able to reach a larger customer base.”

The contract replaces an exclusive chemical distribution agreement between Merck Millipore and VWR covering western Europe, originally signed in 2004.

Under the new agreement, Merck Millipore is free to engage with other organisations, but VWR will remain the distributor of choice through December 2018.

“VWR is proud to renew its agreement with Merck Millipore to provide customers with high-quality chemical and analysis products,” said Peter Schuele,

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president European lab business, VWR. “We enable science with our assurance of supply through an excellent logistic infrastructure and our ability to combine the chemical offering with consumables, equipment, instrumentation and our rapidly growing service business. Merck Millipore is a very important part of our chemical portfolio and the high value we can bring to our customer base.”

Merck Millipore www.emdmillipore.com

Q&A...

LABORATORY

...With Scot Ellis, marketing manager — RAMAN SPECTROSCOPY AND MICROSCOPY, THERMO FISHER SCIENTIFIC, INC. Thermo Fisher Scientific offers a complete line of handheld and laboratory Raman instrumentation.

The company’s latest benchtop Raman product, the Thermo Scientific DXRxi Raman imaging microscope, uses imagecentric software to quickly produce high-definition chemical images.

Q:

What is the DXRxi Raman imaging microscope typically used for?

A:

The DXRxi microscope allows rapid chemical imaging of solid dosage forms, including tablets and HME (hot melt extrusion) drugs. It provides powerful characterisation of drug materials, profiling content uniformity, calculating component concentrations, even finding and identifying contaminants or unexpected components. The system provides a rich visual display of the information and eliminates the learning curve once associated with Raman spectroscopy. The speed provided through the combination of workflow and system performance allows characterisation of batch-representative numbers of tablets in very short times.

Q:

Is there a particular pharmaceutical development challenge that Thermo Scientific Raman spectroscopy products have helped customers overcome?

Customers can expect to see more solution-oriented products both in individual instrument design and combinations of technologies combined into workflow solutions.

A:

Q:

In a highly competitive market, how does the company aim to stay ahead of its competitors?

A:

We work hard to understand customer problems and their impact and

design products to solve them. Our instrument designs transcend measurement technology and complement how our customers have to work. For example, with the DXRxi, we went well beyond making a fast Raman imaging system and concentrated on time to results, users who may not be spectroscopists and uptime and reliability.

The result is a product that provides immediate business value rather than technology that must be learned and maintained with limited productivity and high operating cost.

We’ve been working with a number of customers who are developing new drug forms using polymer extrusion processes to improve bioavailability by controlling the state of the API and the polymer it’s embedded in. We’ve provided a unique solution that includes our Thermo Scientific Pharma 16 hot melt twin extruder for product and process development, our Thermo Scientific Antaris NIR analyser for continuous process monitoring and the DXRxi Raman imaging system to verify final content uniformity and dosage. This complete solution makes process development and validation robust by bringing manufacturing equipment and advanced characterisation tools together to control, optimise and verify at each step of the development and manufacturing process.

Q:

Thermo Fisher is currently holding spectroscopic solutions workshops in the US, are there plans to stage workshops in Europe?

A:

There are indeed. On 17 June in Copenhagen, Denmark, and 18 June in Gothenburg, Sweden, we will be holding the Imaging Solutions for Advanced Materials Characterization seminars. For anyone working in the rapidly expanding field of the development of advanced materials, these free seminars will illustrate how our new technologies can help them achieve the results they need.

There will be a comprehensive programme of presentations covering the exciting developments in: Raman

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imaging for materials science, X-ray photoelectron spectroscopy, FT-IR spectroscopy for materials analysis and using electron microscopy as a powerful analytical tool for materials analysis.

Then there is the L’innovazione nella Filiera dei Polimeri per la Produzione di Packaging (Innovation in the Polymers chain for Packaging production) workshop, taking place on 20 May in Napoli, Italy.

The workshop aims to collect contributions from the whole polymer chain, from manufacturers of instrumentation, companies producing plants and polymers, up to companies transforming them. The planned presentations interventions will be organised during the day, with the afternoon dedicated to hands-on sessions. (For more information on any of the seminars, please email info.spectroscopy.eu@thermofisher.com)

Q:

What next for the Raman spectroscopy product family?

A:

Customers can expect to see more solution-oriented products both in individual instrument design and combinations of technologies combined into workflow solutions. We have a long history of working closely with the pharma industry to understand needs and problems related to drug development, manufacturing and distribution as well as develop solutions across the drug product lifecycle. For example, our Raman products have been implemented as specific solutions in raw material verification for manufacturing, polymorph determination for patent protection at the development stage and tablet imaging for content uniformity and troubleshooting and anti-counterfeiting efforts in commercial support. We will continue to tailor our product designs and workflows as those needs evolve.

Showcase

LABORATORY

SPECTROSCOPY Material ID handheld Raman analyser boasts improved performance and ease-of-use Rigaku Raman Technologies has introduced its next generation handheld analyser, the Progeny, designed to deliver comprehensive and accurate materials identification, improved ease-of-use, adaptability and reliability.

At Progeny’s core is an advanced, miniature, VPG-based 1064 nm optical engine offering benchtop quality analytical performance in a rugged, ergonomic and IP-68 sealed enclosure. Its fully customisable workflow software is 21 CFR Part 11 compliant and a smartphoneinspired user interface (UI) shortens the learning curve, allowing rapid implementation of material ID methods, and improves return on investment.

“As the first company to bring a 1064 nm handheld Raman analyser to market, Rigaku has once again leveraged its deep understanding of Raman spectroscopy and handheld designs to achieve breakthrough technological and design advancements,” said Bree Allen, general manager. “Progeny will reset customer expectations in the market because when compared to other

handhelds available today, it offers a level of functionality and performance that simply has not been achievable in the past.”

Progeny is aimed at inspectors, chemists and scientists in the pharmaceutical, chemical manufacturing and academia markets. According to the company, key benefits of the new system are: • 1064 nm excitation laser delivers improved speed and sensitivity of analysis and minimises fluorescence interferences, broaden the range of materials that can be measured • 512-pixel InGaAs detector enables better resolution, analytics and signal to noise, handling challenging mixture analyses • quad-core processor manages demanding search and quantification algorithms without requiring remote desktop work • sampling accessories and adjustable focus increase sensitivity and aim to ensure confidence in results from a broad range of samples

• advanced ergonomics and sleek shape provide single-hand entry into industrial barrels/drums to allow users to view the screen while the instrument is in a downward orientation • sealed system (IP-68) guards against moisture and dust to enable rugged warehouse use and easy cleaning while lessening cross contamination risk • multi-touch, high-contrast screen and large-sized hard buttons to help ensure a shorter learning curve • remote connectivity using both Wi-Fi and Bluetooth • integrated digital camera for barcode entry and sample snapshots to improve workflow efficiency and data tracking • optional docking station for charging, data synchronisation, security and benchtop use • intuitive user interface for development of new applications and adaptation of current workflows • running of simple or advanced chemometric applications directly on board the analyser for both qualitative and quantitative method development

• patent-pending, wavelets-based spectral match algorithm ensures maximum confidence in sample identification.

Rigaku Raman Technologies www.rigakuraman.com

Raman system for API and excipient analysis now available in UK and Ireland

Terahertz optical sampling system for R&D lab applications

Analytik has announced the UK and Ireland release of the SciAps Inspector 500 SWIR Raman system for the pharmaceutical analysis of APIs and excipients, including cellulose-based materials like microcrystalline cellulose (MCC), croscarmellose, nutrients like folic acid and other complex molecules.

The Inspector 500 features shortwaveinfrared Raman technology as well as a 1030 nm laser and detector. According to Analytik, the laser suppresses fluorescence, allowing for even highly fluorescing compounds to be easily analysed, including those complex APIs and excipients that traditional 785 nm lasers cannot analyse. MCC is a particularly good example because it can be modified to different degrees of crystallinity, usually in the range of 40 to 60%. The Raman peaks from MCC that have a higher proportion of amorphous material (i.e. less crystallinity) will be broader with the 785 nm laser, thus requiring the 1030 nm Inspector 500 for verification.

Equally important, the detector operates with very low power consumption so no fans or ultralight batteries are required. The result is a lightweight Raman analyser that may be used all day long. It is easily cleaned to avoid sample contamination or cross contamination. The Inspector 500 is claimed to be the world’s first and only 1 µm laser system to offer so many user benefits: it defeats fluorescence, is light weight, has easy one-handed operation and is environmentally sealed.

Engineered specifically for the analysis of high-fluorescence samples, for

Advantest has introduced a new terahertz optical sampling system, the TAS7400TS. The flexible design of the new system allows the user to freely configure the terahertz source and detector modules. It can be paired with a variety of terahertz source modules covering three different spectral ranges within the terahertz frequency band.

The terahertz range of frequencies spans 0.1–10 THz on the electromagnetic spectrum.

With recent advances in the stable generation and detection of terahertz waves, the technology is attracting interest for non-destructive analysis and high-speed communication uses, while research into a host of further applications also gathers momentum, says Advantest.

The TAS7400TS aims to provide stable, highly accurate terahertz measurement functionality at an affordable price. An addition to the Advantest’s low-cost, multi-purpose terahertz spectroscopy TAS7400 Series, the system is said to allow users to configure their own platform by connecting THz source and detector modules to the mainframe with optical fibre pigtails. The modules can be freely positioned for a flexible measurement area. In addition, accessories for sample heating or automated sample handling may be configured into the measurement environment, which could open up new possibilities for terahertz researchers and developers of future applications for this technology.

example those samples with complex molecules or many contaminants as encountered in a pharmaceutical laboratory, the Inspector 500 supports advanced chemometric algorithm processing, which is required for materials that are difficult to discriminate.

To summarise, the Inspector 500 expands the number of samples that can be identified; is capable of rapid response times thanks to on-board processing; can support advanced algorithms and large library processing; features a 4.3” TFT LCD touchscreen display; offers a jog wheel option for menu selection; and provides multiple sampling options (the vial holder for powders and liquids supports multiple sized vials and incorporates the NuScope adapter for Raman microscopy).

Analytik Ltd www.analytik.co.uk

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The TAS7400TS is intended to bring terahertz technologies within reach of many R&D researchers, creating a broader user base in a wide range of sectors, from pharmaceuticals and biotechnology to new materials R&D. Like the TAS7500TS, Advantest’s highend terahertz wave spectroscopy and analysis platform, the new system relies on a low-jitter fibre laser and analogue signal analysis technology to deliver measurement stability. Measurements are reproducible to within ±0.03%.

Three separate source modules are available for TAS7400TS platform configuration. Each covers a separate waveband: the TAS1110 for 0.1–4THz (basic type), the TAS1120 for 0.03–2THz (low-frequency type) and the TAS1130 for 0.5–7THz (broadband type). These modules are also interchangeable with the TAS7500TS platform.

Advantest Europe GmbH www.advantest.de

Comment

LABORATORY

APPLYING BENCHTOP NMR SPECTROSCOPY IN THE PHARMA LAB The latest analytical technology to move to the benchtop is nuclear magnetic resonance (NMR) spectroscopy. High-end, high-cost instrumentation has dominated the NMR sector for many years, with both the initial purchase price and annual running costs putting the technique beyond the reach of almost all individual laboratories. Specialist is the word that would come to mind. A special room with special supplies and, not least, a specialist to run and interpret the data produced.

This might be compared with how mass spectrometry was twenty years ago, but look where it is today — buyers have a choice of many benchtop footprint instruments from multiple suppliers. The last twelve months has seen the world of NMR make similar strides, with the arrival of several new instruments and suppliers.

The world of organic chemistry is the principal beneficiary from the advent of benchtop NMR spectrometers. Whether the user is in academia or in research, in the chemical or pharmaceutical industry, a key goal of any synthetic chemist is to be able to quickly and reliably identify exactly what has been made at each stage of the process. NMR is the ultimate technique for this. While mass spectrometry, infrared (IR) and ultraviolet (UV) spectroscopies are widely used, organic chemists agree that NMR provides the most definitive information about the structure of an organic compound.

In academia, benchtop NMR is now being used for both teaching and research at institutes including the group of Professor Magid Abou-Gharbia at the Temple University School of Pharmacy and in the NMR labs of Professor Joseph Hornak at the Rochester Institute of Technology.

ABOUT THE AUTHOR: John Paul Cerroti is director of sales, EMEA, at Magritek GmbH, a nuclear magnetic resonance (NMR) and magnetic resonance imaging (MRI) solutions provider.

Cerroti has worked in analytical instrumentation for nearly thirty years.

With a background in materials science, he has held senior sales and marketing roles for many of the leading innovators in spectroscopy tools, including PerkinElmer, Renishaw and Oxford Instruments.

For organic chemists, proton (1H) and carbon-13 (13C) NMR form the backbone of routine molecular analysis. For the first time, 1D and 2D proton-carbon NMR is available in a benchtop instrument — Magritek’s Spinsolve Carbon spectrometer — that meets the needs of synthetic chemists, academics focused on organic chemistry education, pharmaceutical and medicinal chemists and researchers working on the structure elucidation of organic molecules, without the use of cryogens or special facilities.

Users of benchtop systems have found them to be particularly convenient and robust to use. Ease of operation makes them perfect for bench chemists and analysts who need immediate results. To get answers in the lab in a couple of minutes beats sending samples away for analysis.

A long-held aspiration of synthetic chemists and chemical engineers is an NMR instrument that can both monitor reactions and be deployed to synthetic laboratories and pilot plants. Now it is possible to bring the NMR to the synthesis instead of having to bring the synthesis to the NMR. The key ability to monitor reactions by tracking reactants, products, intermediates and by-products and to determine end-points is now available. Such work has recently been reported at the BAM Institute in Berlin where the process analytical technology group works on the development and validation of analytical online and at-line methods.

A simple acetalisation reaction, using a flow cell passing through the spectrometer, illustrates this reaction monitoring capability:

The acetalisation reaction of acetaldehyde.

In the photo (top right), the software has been configured to take a 1D proton NMR spectrum every 30 seconds, and the reaction is followed for just over one hour. This application takes advantage of the inherently quantitative nature of NMR, enabling chemists to follow the reaction as it is occurring, without the need for chemometrics or other complex

An experimental setup for online, real-time reaction monitoring with NMR; a pump (left) provides a continuous flow of reactants to the NMR spectrometer via a flow tube that goes from the top to the bottom of the spectrometer.

The acetalisation of acetaldehyde monitored by a benchtop NMR spectrometer using continuous flow measurements of the reaction in real time. The three sets of green rectangles show the integration regions displayed next.

The three integration regions from the image above plotted against time, showing the quantitative measurement of reactant and product concentrations measured in real time by NMR. analysis methods that are so often necessary when monitoring reactions using other analytical techniques.

In conclusion, it has been demonstrated that benchtop NMR is

EPM 26

suited to both teaching and use in an industrial laboratory environment. It will continue to grow as a technique, creating new opportunities for timely and cost-effective analysis.

INGREDIENTS & CONTRACT SERVICES Aesica introduces serialisation services at Italian finished dose site Serialisation services have been introduced for a multinational client’s two anti-allergy product lines at Aesica’s manufacturing and packaging site in Pianezza, Italy. The packaging lines and associated serialisation services are for one of Aesica’s strategic partners’ dedicated supply to the Chinese market. The implementation took under six months to complete.

The joint collaboration called for Aesica personnel at Pianezza to use their knowledge and skills to deliver serialisation packaging methods and processes that fully comply with stringent State Food and Drug Administration regulations set by the Ministry of Health of China and dovetailed with the partner’s coding requirements. As a consequence of the partnership, Aesica is one of the first

CDMOs in Italy to have successfully implemented serialisation for a pharmaceutical product.

The serialisation technology uses special digital techniques to check the linear barcode 128 and 20 digit serialised numbers. The code check is in full compliance with international ISO 15416 standards. The check system provides a reliable instrument for checking products and batches all the way through the packaging and distribution process.

The platform has capability for both thermal transfer and thermal inkjet printers for printing stickers with e-codes and variable data with 2D bar codes respectively. According to Aesica, high quality variable programming, inks suitable for a multiplicity of applications and ribbons that comply with the latest legislative and environmental standards

have all been part of the installation.

Paolo Pizzorni, senior director at Aesica Pianezza, commented: “We are delighted that our strategic partnership model has seen the successful development of two robust serialisation packaging lines. For our customer, this means improved patient safety with a reduced risk of competition from counterfeit products and the ability to detect expired drugs automatically. The end-users are now able to verify the integrity and authenticity of the products dispensed to patients using a simple scan.”

He added: “China is a key geographic market that Western

pharma companies seek to export to.

We are delighted to be providing serialisation services to enable one of our customers to meet the technical and complex serialisation regulations in this market.”

Aesica Pharmaceuticals Ltd www.aesica-pharma.com

Haselmeier announces launch of Sanofi half-unit insulin pen Suitable for all Sanofi insulin types, the new and reusable half-unit insulin pen JuniorSTAR is now available in Germany. It provides individual dosage, which can be corrected easily.

Furthermore, it has a large display to ensure the correct dosage and is a lightweight companion during the day, especially for young people with diabetes.

“The launch of JuniorSTAR marks another milestone of a long-term partnership with Sanofi,” said Sandra de Haan, director project management at

Haselmeier and project manager responsible for the JuniorSTAR. “After the single unit pen TactiPen, the portfolio is now complete with the halfunit pen JuniorSTAR. The JuniorSTAR delivers 1 to 30 units in steps of 0.5.

Thanks to the close cooperation of both teams, we were able to develop an excellent pen that meets current, very high quality requirements.”

“The JuniorSTAR expands our portfolio for people suffering from diabetes,” said Hamit Oualali, global device manager for reusable pens at Sanofi. “Being

flexible and easy to handle, it is especially suitable for young people with type 1 diabetes. The close and excellent cooperation with Haselmeier was important for the successful development of the JuniorSTAR.” The pen comes in red, blue and silver for easy differentiation of various insulin types.

The Chicago Athenaeum Museum of Architecture and Design has already honoured the JuniorSTAR pen for its new and fully developed technology with the Good Design Award.

Haselmeier GmbH www.haselmeier.com

HME extends Molecular Profiles’ technologies portfolio Molecular Profiles, a subsidiary of Columbia Laboratories, Inc., has invested in GMP hot melt extrusion (HME) technology along with further milling equipment, enabling the company to accelerate formulation development for its clients.

Dr. Rob Harris, chief technical officer at Molecular Profiles, said: “Over the years, our company has gained a strong reputation in advanced characterisation, formulation development and dealing with complex molecules. We have been working in this space for nearly a decade, bringing a high level of understanding to, for instance, the stability and failings that occur in HME.

“Expanding our in-house equipment is all about complementing this expertise by bringing on board an even more diverse range of enabling technologies to assist clients in developing challenging compounds.

“Supported by our world-class suite of processing and characterisation tools, our new enabling technologies division forms the backbone of our early formulation development services.

Utilising a science-led approach, this team is primarily focused on screening formulation options for challenging molecules, quickly developing effective formulations and finding solutions to our clients’ product development requirements.”

This is the latest significant venture for Molecular Profiles, which opened its new clinical production site last July following a successful inspection from the MHRA. Dovetailing with its development capabilities, the organisation manufactures a range of dosage forms for clinical trials spanning solids, liquids, semi-solids and inhaled products, including potent compounds.

Extending both its GMP and development equipment further strengthens the company’s ability to formulate a broader range of dosage forms that are able to deliver the drug substance more effectively.

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The company recently hosted a two-day conference focused on overcoming biological barriers in drug development.

The event was attended by dozens of pharmaceutical executives, scientists and leading academics from across the globe.

Molecular Profiles www.molprofiles.co.uk

News

INGREDIENTS Technical service lab for pharma polymers in Shanghai expands Evonik has expanded its technical service laboratory for pharmaceutical polymers in Shanghai from 130 to 750 m2 in response to Chinese pharmaceutical market growth.

“The expansion was based on our excellent reputation in the region as a provider of controlled drug release solutions and the strategic decision to add to our R&D activities in Asia,” said Axel Bergt, vice president healthcare Asia-Pacific, Evonik, during the opening ceremony.

The expanded laboratory serves both as a technical service laboratory and as centre of excellence for contract development of oral drug delivery

systems. The free services offered to customers who use EUDRAGIT products include training on the handling of pharmaceutical polymers. With the help of Evonik experts, customers can also simulate the actual manufacturing process in the service laboratory and see how coating, tabletting or granulation works.

Furthermore, Evonik offers paid formulation services for pharmaceutical companies, where scientists develop drug delivery systems on the basis of an active substance and a specified release profile.

On request, they can also supply all data required for product approval and provide support with the approval process.

Laboratory head Henry Han used the opportunity of the expansion to further improve the technical equipment of the laboratory, both for analytical services and drug product manufacturing.

“We are now able to simulate the first scale-up step in our laboratory,” he explained. “This simplifies the subsequent transfer of the production process to the customer.”

Representatives of around 30 pharmaceutical companies in China were present at the opening ceremony

to find out more about the new services available at Xinzhuang Industry Park.

Evonik Industries AG www.evonik.de

Lucideon opens pharma QC testing labs Provider of materials development, testing and assurance Lucideon, formerly known as Ceram, has invested £1.5 million in pharmaceutical chemistry QC testing laboratories, at its headquarters in Stoke-on-Trent.

The investment is part of the company’s multi-million pound commitment to develop new services in both the UK and US for its clients in the construction, healthcare/pharmaceutical and power generation sectors.

Officially opening in April, the facilities will, on completion, include both chemistry and microbiology laboratories and be staffed by a team with many years’ experience. Services will include QC (batch release) testing, method development and validation, raw material

analysis, pharmacopoeial testing (BP, Eur. Ph. USP, JP), client methods, residual solvent testing and stability storage. Full microbiology testing including sterility testing will also be offered.

Dr. Richard White, head of testing, said: “Thanks to the work we do with many blue-chip healthcare companies worldwide, healthcare is now one of our biggest sectors. Pharmaceutical testing complements the already extensive array of materials characterisation, analysis and development that we do, something which clients will be able to benefit from.

We don’t just churn out numbers, we work hard to provide solutions, whether that is during product development, manufacturing or failure.”

Supporting the expenditure on new

laboratories, which includes the first commercially installed 7900 ICP-MS (Inductively Coupled Plasma Mass Spectrometer) in the UK, there is also a parallel investment in staff. The new pharmaceutical and microbiology team is headed up by Parmjit Bilan, who has over 25 years of analytical chemistry experience and has spent many years testing for the pharmaceutical industry. In total, the team has nearly 100 years of experience.

Parmjit said: “There are many pharmaceutical laboratories out there, but I believe we’re unique in that we don’t just offer routine pharmaceutical testing, we also provide a vast range of back-up analytical services such as surface analysis. This, together with the

Parmjit Bilan, business and technical manager, pharmaceuticals.

materials development work, for example, in the area of inorganic controlled release technologies, can only help our clients to optimise their products, processes and their profits.”

Lucideon Ltd www.lucideon.com/pharma

Penn Pharma staff completes potent compound safety training certification Penn Pharma has announced the completion of potent compound safety training and certification by its staff through Affygility Solutions.

Penn Pharma officially opened a new, purpose-built contained manufacturing facility in September 2013 and the training and subsequent certification of its staff was a critical factor milestone to achieve.

Penn Pharma selected Affygility Solutions to complete the training certification based on the company’s specific expertise in potent compound safety. Affygility Solutions also offered a

flexible webinar format that allowed Penn Pharma staff to attend from multiple global locations.

The training was extremely comprehensive and included: introduction to potent compound safety, toxicology, industrial hygiene, banding and control strategies and the manufacturing of highly potent compounds.

This comprehensive programme, along with the flexibility of training, made Affygility Solutions the perfect partner for Penn Pharma.

Penn Pharma COO Mark Dean

Netscher commented: “We are extremely pleased to have our staff complete the potent compound safety training certification process. This is an important component of our continued commitment to employee safety and operational excellence in Penn as we continue to demonstrate leadership of the handling, development and manufacturing of potent products in our contained manufacturing facility.”

Penn Pharma www.pennpharm.com

Capsugel enters agreement with Chiasma for scale-up manufacture of oral ocreotide acetate Capsugel has announced an agreement with Chiasma, Inc., wherein Capsugel’s dosage form solutions (DFS) business unit is scaling up manufacturing for what is claimed to be the only investigational oral form of octreotide in clinical development.

The drug candidate is in Phase 3 clinical trials for the treatment of acromegaly, a disorder that develops when a person's pituitary gland produces too much growth hormone.

This agreement extends the companies’ existing product-development relationship, which dates back four years, and sets the stage for them to continue to collaborate on commercial manufacturing preparation.

Scale-up activities for the drug are underway at Capsugel’s FDA- and MHRA-accredited site in Livingston,

Scotland, UK, which became part of Capsugel’s DFS network when it acquired Encap Drug Delivery in March 2013. Capsugel DFS has already manufactured several clinical batches of the compound, including those needed for the NDA registration. Commercialscale batches are expected to be validated during fourth quarter 2014 or first quarter 2015.

“Capsugel was the best choice of partner because of its combined capabilities in liquid-fill and capsule coating as well as its track record in scale-up and commercialisation of pharmaceutical liquid-filled products,” said Roni Mamluk, PhD, CEO at Chiasma. “We have been impressed by Capsugel’s ability to quickly transfer the technology and scale-up for Phase 3 manufacturing.”

Capsugel has invested heavily in its capability to optimise and accelerate formulation scale-up at the Livingston site. The company recently installed commercial-scale milling equipment and associated containment equipment, inhouse printing facilities and large-scale capsule coating equipment. The facility modifications and equipment installations were successfully completed at the end of first quarter 2014, with initial commercial-scale manufacture now in progress.

“We are pleased to partner with Chiasma to manufacture this oral drug to help those living with acromegaly,” said Stephen Brown, PhD, managing director of Capsugel DFS’ Encap Drug Delivery.

“Our expertise in liquid-filled hard capsule development, advanced enteric drug delivery technologies and handling

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of hormonal products offers our clients solutions to help bring new medicines to market quickly.”

Octreotide acetate is the lead candidate for Chiasma, a privately owned biopharmaceutical company that develops oral drugs previously only available by injection using its TPE (Transient Permeability Enhancer) system. Chiasma and Roche will develop and commercialise the product.

The scale-up agreement with Capsugel marks an important milestone in the product’s development. If approved, oral octreotide acetate will offer the first oral alternative for the treatment of acromegaly.

Capsugel www.capsugel.com / www.encapdrugdelivery.com.

News

INGREDIENTS Theorem takes centre stage at 2014 CRO Leadership Awards Theorem Clinical Research has won recognition in all five categories of the 2014 CRO Leadership Awards: quality, productivity, reliability, innovation and regulatory.

“Theorem is committed to retaining therapeutic thought leaders and expert support staff to build tightly integrated partnerships with our clients and provide expert guidance and thorough communication,” said John Potthoff, Theorem president and CEO. “We are proud to have been recognised by our peers for our work in clinical research.”

The CRO Leadership Awards are presented by Life Science Leader

magazine and based on industry research conducted by Nice Insight.

Companies receiving scores in the top 20th percentile in each category were recognised for their achievements.

Unlike other industry awards that are based on a subjective nomination and voting process, the CRO Leadership Awards are based on objective research conducted among pharmaceutical and biopharmaceutical companies utilising contract research services. The awards provide pharmaceutical companies with additional information to use to vet potential partners.

Specifically, the awards recognised Theorem’s abilities to deliver agreed objectives and to meet timelines.

Theorem was also recognised for treating clients’ projects as if they were their own, for enhancing clients’ inhouse capabilities through new ideas and for being reputable and compliant.

“These awards recognise the hard work and dedication of the entire Theorem team,” Potthoff said. “I couldn’t be prouder of their accomplishments.”

Theorem Clinical Research Inc. www.theoremclinical.com

Internship programme offers opportunities for postdoctoral researchers and Camargo Camargo Pharmaceutical Services, a drug development organisation specialising in the 505(b)(2) approval pathway, is adding expertise to its projects and helping postdoctoral researchers gain real-world experience through an internship programme.

In January 2014, four postdoctoral researchers joined the Camargo team at its Durham, North Carolina, US, location. Partnering with academic organisations, including Duke University, the internship creates hands-on opportunities across the drug development process. The interns assist research scientists during various stages of their work, including feasibility assessments and the design and conduct of non-clinical programmes and Phase I-IV clinical trials as well as FDA regulatory preparation and filings of INDs and NDAs. “This experience provides an opportunity for postdoctoral interns to gain experience in the regulated environment of drug development, offers a fresh perspective to our research scientists by contributing to the therapeutic breadth and ultimately helps Camargo expand our efforts,” said Gary Barnette, vice president of drug development for Camargo.

The internship can also act as a gateway to a career. In the last 20 years, there has been an increase in Ph.D. graduates countered by a decrease in academic appointments.

More and more graduates with a Ph.D. are looking for positions beyond academia, including positions in pharmaceutical research.

“Historically, Ph.D. students and postdoctoral researchers were training for tenured faculty positions, but now only 20% of graduates with a Ph.D. will go on to tenured academic appointments,” said Molly Starback, director of Duke’s postdoctoral services office. “Today, these postdoctoral researchers are applying for the same positions as established professionals.

It has become a very competitive field, but internship programmes like Camargo’s are helping some of them get their foot in the door.”

Camargo Pharmaceutical Services www.camargopharma.com EPM 29

News

INGREDIENTS

HCPC recognises Noven Therapeutics and Depomed for compliance prompting calendarised packaging Packaging Coordinators, Inc. (PCI) has congratulated Noven Therapeutics and Depomed, Inc. for their recent awards in the Healthcare Compliance Packaging Council’s (HCPC’s) 2013 Compliance Package of the Year Awards competition.

HCPC recognised Noven as the overall winner for the Brisdelle compliance prompting design at the RxAdherence conference on patient adherence in Florham Park, New Jersey, US, on 8 April, while also recognising Depomed for the Gralise starter pack as first runner up in the competition.

Submitted by PCI on behalf of Noven and utilising the MWV Dosepak design, Brisdelle is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. The Brisdelle compliance design features calendarised dosing for 30 days of therapy, with a designated area for the patient to note the starting

date of the therapy. The Brisdelle package graphics highlight that the patient should take one capsule each day at bedtime. The calendarisation of the product also highlights the need to refill the prescription in the final week of the packaged product. Package graphics demonstrate the push and pull mechanism for accessing the child resistant protection for the package. The Prescribing Information and Medication Guide is conveniently located in the 5th panel of the package.

Also submitted by PCI on behalf of Depomed, Gralise is indicated for 24-hour pain control for patients with after-shingles pain, also known as post-herpetic neuralgia or PHN. The Gralise starter pack is designed as a titration therapy, bringing patients from an initial dose of 300 mg on day one, progressing to the maintenance dose of 1800 mg by day thirty. Patients take a

single 300 mg tablet on day one, a 600 mg tablet on day two, a combination of 300 mg and 600 mg for days three through six, two 600 mg tablets and a single 300 mg tablet on days eleven through fourteen and three 600 mg tablets for days fifteen through thirty. The pack features extensive dosing instructions to help guide the patient through the dosing schedule. Patients are also encouraged to take Gralise with

food, clearly identified on the pack labelling along with the opportunity to write the start date of the medication.

The multipanel wallet style card also includes a medication guide located in a convenient pocket. The corresponding prescribing insert is adhered to the back of the folded package.

Packaging Coordinators, Inc. www.pciservices.com

Vetter Pharma implements serialisation to support track and trace efforts Significant progress has been made with Vetter Pharma’s product packaging solution, which is designed to support the prevention of product counterfeiting.

This development is in response to expanded requirements by official regulatory agencies that require manufacturers to have clear identification of drugs on packaging.

Vetter is successfully implementing its IT solution and will offer its customers a range of serialisation services as a basis for track and trace programmes by the end of 2014.

Drug counterfeiting is a serious problem facing the industry and continues to grow unabated worldwide.

To combat this issue, regulatory agencies have been seeking and implementing new methods to thwart the counterfeiters. Serialisation of

packaging has been considered one of the most effective solutions so far by many countries. The US, South Korea and Brazil, as well as regions including the EU, will be following suit in the coming years.

In this regard, Vetter, a CDMO with extensive packaging experience, has designed an effective solution for its customers: a flexible serialisation service that forms the basis of track and trace programmes. With this offer, the company is extending its existing services. These services include, for example, printing of global trade item numbers (GTINs) on packages, which has been requested by France and is expected to be requested by the US in 2015. Following the successful implementation of an initial IT solution, Vetter began implementing an

capabilities, particularly in expanding its portfolio of non-IP services to improve bioavailability and solubility of drugs.

“We are delighted that Alison has brought her extensive expertise to Quay Pharma,” commented CEO Maireadh Pedersen.

“We pride ourselves on our bespoke approach to each client project, understanding the nature of a particular drug, its properties, what needs to be achieved and devising a tailored solution. Nano dispersion technology will widen our options when it comes to the challenges of poor solubility and drug bioavailability and will provide a valuable additional benefit to all our clients.”

Quay Pharma www.quaypharma.com

Vetter Pharma International GmbH www.vetter-pharma.com

LGC launches stability testing service

Senior appointment widens Quay Pharma’s capabilities Pharmaceutical outsourcing specialist Quay Pharma has further extended its technical expertise with the appointment of Dr. Alison Foster as project manager to establish an in-house capability for nano dispersion technology.

As co-founder and pharmaceutical programme director of IOTA NanoSolutions Ltd, Dr. Foster has over seven years’ experience in the formulation of nanoparticles of poorly soluble drugs using a proprietary technology that was promoted across Europe and the US. Her previous roles have also encompassed project management of a variety of pharmaceutical development projects, with customers ranging from leading multinationals to small speciality companies.

Quay Pharma has an established reputation in formulation work and the development of highly effective drug delivery mechanisms for the pharmaceutical and biotech industry.

The availability of nano technology within the business should further enhance the company’s formulation

engineering platform for serialisation that is expected to be operational by the end of 2014. The service will support pharmaceutical and biotech companies in implementing their own track and trace programmes for a secured and controlled supply chain.

“The Vetter serialisation service will support growing customer and regulatory demands in the area of track and trace in the struggle against counterfeiting,” said Thomas Otto, managing director. “This service, which we expect to have implemented by late 2014, is based upon a comprehensive concept study that we undertook. With our serialisation service, the packages will include the unique identification necessary to support product security and supply chain efficiency.”

Adding to the drug development services delivered from its Fordham, Cambridgeshire site, LGC has launched a stability testing service, said to enable continuous recording and monitoring of essential data on the impact of environmental factors such as temperature and humidity on the quality of a pharmaceutical product.

LGC provides on-site stability storage at a range of ICH (International Conference on Harmonisation) and nonstandard conditions for long-term stability, accelerated stability and photostability assessment of clinical trial materials, actives and finished products.

According to LGC, the conditions in the stability chambers are continuously monitored by automated systems and benefit from full back-up power supplies.

With method development, validation and cGMP analytical testing capabilites, LGC aims to manage stability programmes to provide an integrated service to meet requirements.

Jeremy Cook, managing director, laboratory and managed services, LGC, said: “We are delighted to be able to offer stability testing, which further extends our drug development portfolio.

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In doing so, we can establish either a retest period for a drug substance or a shelf life and recommended storage conditions for a manufactured product, which are all essential to minimising market risk and helping us towards our vision of using our science for a Stability cabinet. safer world.”

With the acquisition of the leading bioanalytical business from Quotient Bioresearch in December 2012, LGC now has more than 50 years’ experience in high-integrity analytical science and expertise spanning small and large molecules, biomarkers, molecular biology and microbiology.

LGC Ltd www.lgcgroup.com

Comment

INGREDIENTS

HANDLING PHARMA RECALLS — A TEST OF STRENGTH FOR THE CUSTOMER-BRAND RELATIONSHIP Pharmaceutical products and medical devices are among the most highly regulated and most thoroughly tested products in the world. In the UK, the MHRA (Medicines and Healthcare Products Regulatory Agency) is responsible for ensuring that all medicines and medical devices work correctly and are safe for consumption.

Despite thorough testing, there is always a chance that issues can develop and the health and safety of customers can be called into question. In this case, recalls become a necessity. In addition to this, customers are now more discerning than ever before, resulting in companies choosing a more cautionary approach and withdrawing products before they are required to do so by public demand or national bodies. Companies are now looking further ahead and pre-empting mandatory action, complying with regulations, removing immediate dangers and protecting their valuable customer relationships.

Not only is the customer-brand relationship more fragile than ever before, but brand loyalty is also declining significantly. A less stable customerbrand-relationship leads companies to focus on enhancing brand image and

ABOUT THE AUTHOR: Farzad Henareh is European managing director at Stericycle ExpertSOLUTIONS, a business unit of Stericycle that specialises in product recalls, retrievals, returns, audits and sustainability services to aid companies in protecting and enhancing their brands.

the overall customer experience. In addition to that, more complex supply chains make it difficult for manufacturers to ensure continuously high quality standards.

So, what should a company do if there is a problem with a product and the concerned product must be removed from the market as quickly and efficiently as possible? In case of pharmaceutical recalls, preparation is key. This means either having an internal plan ready or having an external provider on standby.

As a first step in the recall process, all relevant channels and stakeholders need to be informed, including the local health authorities. Depending on the nature of the recall, the public needs to be made aware of the reasons and consequences of the recall as well as any harm associated with the product. Establishing lines of communication and assigning responsibilities beforehand ensures an efficient and comprehensive operation.

A particular challenge in recalling pharmaceutical products is the administrative and logistical element. As up to 100% effectiveness can be required, accurate and detailed documentation of production, testing, distribution and partners is key. This can save a lot of time and ultimately money, as a recall will only then be deemed complete if the authorities are convinced that all regulations have been followed and all threats to public health and safety have been eliminated. Rigorous preparation, comprehensive documents and attention to detail help keep the possible negative implications of recall to a minimum.

A company failing to handle a recall successfully risks damaging the brand.

However, companies that are prepared and offer a comprehensive end-to-end solution will ultimately emerge stronger.

In the end, effective recall management has one goal — protecting the public and the brand.

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Providing a positive customer experience, taking their concerns into account and showing commitment to resolving the situation can, in fact, help increase brand loyalty. It is the way the situation is handled by the company that can make or break a customer relationship.

Showcase

INGREDIENTS

LOGISTICS & DISTRIBUTION UPS expands healthcare network to simplify Latin American market access UPS held a ribbon-cutting ceremony in the state of Mexico on 4 April, celebrating the addition of three healthcare-dedicated facilities to address high-growth medical device and pharmaceutical consumption markets throughout Latin America. Over the coming months, UPS will open and expand new facilities near Mexico City, Mexico, São Paulo, Brazil, and Santiago, Chile, highlighting its continued investment in the region.

With these expansions, UPS’ network in the region reaches nearly 70% of the total healthcare consumption and manufacturing markets in Latin America.

The region includes two of the top 15 healthcare consumer markets worldwide and the UPS facilities are located in the largest consumption cities in these countries, enabling efficient market access.

“Latin America represents a strong growth opportunity for healthcare companies and providers who rely on

UPS’ network of dedicated facilities, air freight and safety and compliance expertise to support their business goals,” said John Menna, UPS vice president, global healthcare strategy.

“These facilities offer greater access to the best-in-class logistics solutions for pharmaceutical, biotech and medical device companies serving Latin America, giving global healthcare customers the confidence they need.

The growing middle-class is said to be driving increased healthcare demand across emerging markets worldwide, including Latin America. Reaching new markets was identified by nearly 80% of healthcare executives in UPS’ most recent annual Pain in the (Supply) Chain study, which measures decision makers’ concerns in healthcare logistics.

Specifics of the healthcare expansions include: Mexico — Located in Cuautitlan Izcalli, state of Mexico, this new multi-client

facility serves what is claimed to be the second largest medical device and pharmaceutical consumption market in the region. The existing building now includes nearly 7,246 m2 of healthcarededicated space. UPS has been operating in Mexico since 1989.

Brazil — Brazil is said to be the largest pharmaceutical consumption market in Latin America and this is UPS’ second healthcare-dedicated facility in the country. This new location in São Paulo will open in the third quarter of this year and includes 7,432 m2 of space. UPS has been operating in Brazil since 1989.

Chile — Scheduled for completion this fall, this expansion will include 1,951 m2 of healthcare-dedicated space in Santiago, Chile, a manufacturing country for many healthcare multinational corporations. UPS has been operating in Chile since 1991.

Each facility is compliant with global, regional and local regulations and

designed to support ambient healthcare products for both pharmaceutical and medical device companies. UPS healthcare clients can also take advantage of a single global IT platform, intended to provide a seamless experience and end-to-end supply chain visibility.

UPS www.ups.com/healthcare

70% growth in temperature controlled pharma airfreight volumes for Yusen Logistics Yusen Logistics has reported seeing major growth in temperature-controlled pharmaceutical volumes to and from Japan and Oceania as well as increased demand for international cross trade products. Volumes for 2013/14 are up 73% on the previous year, says the company.

API manufacturers are increasingly looking for bespoke airfreight solutions as part of their total supply chains for these extremely valuable and temperature-sensitive products. They run the risk of significant stock write-offs from temperature excursions in the airport and air. Yusen Logistics is now providing solutions for a number of global API manufacturers, helping to ensure these essential products reach destinations throughout Europe as well as the US, China, North Africa and Brazil.

David Young, business development manager and global airfreight specialist at Yusen Logistics, commented: “We’re seeing major increases in demand for

specialist shipments for temperaturecontrolled pharmaceutical products including APIs from areas such as Japan and Oceania.

“It’s all about attention to detail throughout the supply chain, refining every step of the process. Yusen Logistics provides specialist, dedicated pharmaceutical warehousing on airport and bespoke thermal protection for pharmaceutical products as part of its solutions. Through this approach, Yusen is achieving industry leading quality in terms of temperature range compliance accuracy.”

Yusen Logistics’ pharmaceutical offering is based around its healthcare superhighway control tower, offering clients of all scales a single centre to manage their global supply chain flows, together with a full range of customs and fiscal services linking into Yusen Logistics offices around the world. Such airfreight movements are managed by the Yusen Logistics airfreight teams globally, with coordination from the

control tower. A range of carriers and airports are utilised according to the specific solution requirements of the client.

The company’s European gateways in Amsterdam, Frankfurt and Heathrow, linked to its fully temperature controlled, GDP-approved distribution centres in the UK and Belgium, provide a platform for cost-effective airfreight export and import services.

Yusen Logistics’ European

pharmaceutical superhighway carried over one million pallets last year and this growth is continuing as more manufacturers buy into its high security services. The service provides crossborder, temperature-controlled coverage, with flexible GDP compliant solutions, ensuring complete product integrity and legislative compliance.

Yusen Logistics www.eur.yusen-logistics.com

ByBox helps supply materials to pharma sales teams Having recently expanded its locker network to over 1,500 drop boxes across the country, ByBox is aiming to bring about a new way of delivering equipment and marketing collateral to pharmaceutical representatives. Currently working with GSK, ByBox is helping to deliver materials in a more efficient way to sales staff based across the UK. By offering a pre-8am pick-up service for members of GSK’s sales teams, reps can pick up items integral to their jobs from local locations such as petrol stations or supermarkets. This is

intended to negate the need to visit a warehouse or local office at the start of a day, making more time for reps to carry out their crucial commercial roles. In addition to this, they also have the option of returning items by the same method, dropping collateral that is no longer needed into one of ByBox’s iBoxes, ahead of it being returned to the warehouse.

This supply chain structure aims to remove the need for sales teams to be based around a specific location or stay at home until the tools they need to

undertake their job have been delivered.

Creating a more effective sales structure is the end goal of the strategy, says ByBox managing director Mark Garritt: “The classic method of supplying sales teams with materials, involving deliveries to and from specific addresses and a local warehouse, is not sustainable in this day and age. Technology is enabling us to create a more efficient and convenient network for businesses that expect speed, reliability and effectiveness, something that iBoxes are bringing to the pharmaceutical industry.”

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ByBox www.bybox.com

Regulatory Affairs

INGREDIENTS EIGHT YEARS OF DCP

This issue’s contribution has been provided by Dr. Parvinder Punia, senior regulatory expert, EU and related markets, at pan-European regulatory affairs organisation ELC Group. With a decade of regulatory experience — which included roles in two EU health agencies — Dr. Punia is an RA expert in the EU and other regulated region procedures. Responsible for managing worldwide submissions, she has expertise in regulatory strategy development, budgeting preparation and scientific and regulatory documentation. From dossier preparations and conversions for devices and medicines, she regularly employs her extensive working knowledge of European licensing procedures (mutual recognition and decentralised). Her background includes working as a project manager at the National Authority of Medicines and Health Products (INFARMED, I.P.) in Portugal and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. When the decentralised procedure (DCP) was implemented in 2005, I was employed by an agency. It was a time of great change in the EU directive and a sense of anticipation accompanied its introduction. Previous to this, there were only two possibilities: the centralised procedure (CP) or the national procedure (followed by mutual recognition). The system had required an overhaul and a new perspective. The DCP changed the way the EU introduced new medicinal products. The basic premise is that if an MA does not exist anywhere, a new application can be filed simultaneously to multiple member states. They will then simultaneously evaluate the application and grant approval at the same time.

The concept of the reference member state (RMS) and concerned member state (CMS) from the mutual recognition (MR) was carried over to the DCP. This allowed flexibility without the associated costs of the CP. In the early days, there was a

significant amount of experience gathering to be done. The Coordination Group for Mutual Recognition and Decentralised Procedures — Human (CMDh) began working to iron out any flaws noted in the procedure and, to this day, continues to evolve to improve the DCP. However, at the beginning, only a few agencies were active as RMS. Germany, the Netherlands, the UK and Denmark dominated as RMS in the early years, then after 2010, other agencies — significantly Portugal and Sweden — also contributed to the RMS work. These six agencies remain the most active today, although all agencies have now participated as RMS in a DCP. Another significant change that came about with the DCP was the referral system. The DCP has served to highlight the large discrepancies in expert opinions within the EU, and previously these would be referred automatically to the Working Party (WP) or Committee for Medicinal Products for Human use (CHMP) for resolution. Now, a versatile

interim has been provided and utilised extensively, where 60 days are given after the closure of a DCP for agencies to discuss such matters. This has resulted in a reduced burden of work being passed to the CHMP and increased awareness of technical issues amongst agencies. Additionally, such discussions have resulted in a proactive approach to harmonisation of summaries of product characteristics (SPCs) in the EU, as the procedure is well-used by the generics industry.

There are still areas for improvement, for example, the national phase after the DCP approval that could benefit from the same examples set by the procedure itself. Other areas that could be improved are the active substance master file (ASMF) assessments and GMP inspections. However, it is noted that all these aspects and more are being reviewed and work is being done to include these in the DCP. The CMDh continues to work tirelessly in order to keep the high standard that

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the DCP has already set. As well as being in control of procedural aspects, it is also involved in ensuring that all aspects run smoothly. This includes, but is not limited to, respecting timetable timelines, managing referral processes, bridging the gap between industry and agency, consulting with EMA experts to gain experience and opinions, interpretation of legislation and guidelines and harmonisation as well as being available for all matters of consultation and public speaking events.

The CMDh has been at the core of the success that has followed the DCP until today.

Having seen the DCP from three perspectives — agency, industry and consultant — my opinion is that the EU can boast the highest level of marketing authorisation application (MAA) coordination not yet seen in any other regulated region. It could be used as an example of how different languages, opinions and histories can work together towards a uniform regulating procedure.

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