EPM May 2013

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epmepm

IN THIS ISSUE: Anti-Counterfeiting Tablet Production Sample Preparation Contract Research

European Pharmaceutical Manufacturer May 2013

Volume 13 | Issue 03

GE Healthcare Life Sciences

Xcellerex adds full automation to the mix

Introducing the XDUO™ Quad™ Intelligent Single-Use Mixing System.

One of the first plug-and-play mixers in its class featuring powerful onboard automation. With XDUO, there’s no tedious manual titration and fewer process deviations. Just instant startup and effortless operation for automated mixing of buffer, media, product and intermediates, and other process fluids, upstream

www.gelifesciences.com/xcellerex

or downstream — plus full data capture for GMP batch records.

The XDUO even offers exclusive remote operation via our XDR™ single-use bioreactors or FlexFactory® biomanufacturing system.

For fully automated processing of viral inactivation, pH adjustment, formulation, and more, get XDUO in the mix today!

Download our white paper “Automated pH Adjustment in an Intelligent Single-Use Mixing Platform” at www.xcellerex.com/mixerpaper

GE, imagination at work, and the GE monogram are trademarks of General Electric Company. Xcellerex, FlexFactory, XDUO, Quad, and XDR are trademarks of Xcellerex, Inc., now a part of GE Healthcare. © 2013 General Electric Company — All rights reserved.

First published September 2012.

Front cover image: Fette's FE35 and FE55 tablet presses deliver technology, competence and service.

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editorial editor elizabeth valero, ellie@rapidnews.com publishers mark blezard,

in this issue

michael taylor

production art samantha hamlyn production peter bartley

advertising robert anderton

MANUFACTURING PRODUCTS & EQUIPMENT

pages 5–20

tel: +44 (0) 1244 680222, fax: +44 (0) 1244 671074, rob@rapidnews.com

REGULARS: 5–10 20

Latest News Roundup Corporate News & Events

subscriptions

SHOWCASES:

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16 17

Anti-Counterfeiting Solid Dose Inspection & Testing

qualifying readers

BUYERS’ GUIDES:

Europe - Free, ROW - £115

11 13

Bottling & Packaging Tablet Production

outside qualifying criteria

Q&A:

UK - £80, ROW - £115

14–15

I Holland’s R&D Manager Gives Lowdown on TSAR (Tabletting Science Anti-Stick Research) Project

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LABORATORY PRODUCTS & EQUIPMENT

pages 21–26 Address changes should be made on the original carrier sheet (address label) that came with this issue and then faxed to the publisher at +44 (0) 1244 671074. European Pharmaceutical Manufacturer is published by Rapid Life Sciences Limited.

REGULARS: 21–24 26

Latest News Roundup Corporate News

SHOWCASE: 25

Sample Preparation

INGREDIENTS & CONTRACT SERVICES

pages 27–33

REGULARS: Latest News Roundup Events Regulatory Affairs

27–31 33 33

SHOWCASE: 32

Contract Research

page 34

CLASSIFIEDS

European Pharmaceutical Manufacturer is distributed in electronic and print formats to a combined readership of 25,000 pharmaceutical manufacturing professionals.

Send address changes to European Pharmaceutical Manufacturer, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE, UK. © May 2013.

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.

ISSN No.: 2052-4811

EPM 3

“

Welcome to the May issue, almost halfway through the year already!

Since the last issue, we at EPM paid our first visit to the TechnoPharm and POWTECH show in Germany’s Nuremberg. The Nuremberg Messe was described by many exhibitors as a ‘well-organised’ and ‘compact’ venue, all halls consecutively linked in a circular setup, making it easily manageable for us visitors. You can find out more about our time at the show — who we spoke to and what we saw — on the EPM website ‘Blogs’ page.

Returning to this issue, not to be missed on page 14 is my Q&A with I Holland’s R&D Manager Rob Blanchard and Marketing Manager Clare Taylor, concerning the TSAR (Tabletting Science Anti-Stick Research) project. A two-year research collaboration with the University of Nottingham, 16 the aim of TSAR is to develop a ‘predictive tool’ that will enable I Holland to recommend the correct tablet tooling to avoid ‘sticking’ (product adhering to the tool face) straightaway, eliminating the need to carry out time-consuming and costly trial tooling runs at the customer’s facility. According to Rob and Clare, this is the first and only project of its kind and will therefore be a major differentiator for I Holland as of 24 January 2014 when it is scheduled to complete.

Also, for those of you whose organisations are gearing up for the 2016 FMD legislative obligations — though still some way off in 2016, the consensus is that to begin preparing earlier rather than later is highly advisable — the ‘AntiCounterfeiting’ Showcase on page 16 is worth a browse.

30 Finally, Dr. Biffignandi’s Regulatory Affairs instalment, ‘API GMP Requirements Update’, focuses on the Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients document; outlining what the impending Directive 2011/62/EU (for the prevention of falsified medicines entering the legal supply chain) means for API producers that choose to manufacture outside of the EU as well as summarising the ICH Q7 issues to be addressed in a forthcoming Q&A document.

Remember, you can keep abreast of the very latest pharmaceutical products and services news by visiting the EPM website and by following us on Twitter.

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eab members

from the editor

Henrik Broholm, Senior Specialist, H. Lundbeck A/S Henrik has been working in the pharmaceutical industry for the last 15 years, mainly in connection with finished goods packaging (blisters, ampoules and containers). At H. Lundbeck, he has gained valuable experience of working at both vendor and customer sites, further extending his pharmaceutical packaging expertise.

Henrik is for the most part involved with user requirement specifications, machinery and process qualification and validation, the introduction of new products on packaging lines and incorporating new features as required by authorities, e.g., 2D matrix coding with track and trace and child resistant blisters and packs.

James Cartwright, Global Granulation Leader, Particle Generation, Control & Engineering, GlaxoSmithKline James began working within the pharmaceutical industry in 1996.

During this time, he has been instrumental in developing and launching three products for various clinical indications spanning acute Otitis Media, Lymphatic Filiarisis and Type II Diabetes Mellitus.

James studied Chemistry and Chemical Engineering and is a Fellow of the Royal Society of Chemistry.

Dr. Dimitris Dogramatzis, RPh, PhD Dimitris is a registered pharmacist and pharmacologist, whose industry career encompasses medical affairs, marketing, country and regional management positions.

Dimitris has served as Regional VP — Northern Europe for SERONO and authored two textbooks entitled ‘Pharmaceutical Marketing: A Practical Guide’ (2001) and ‘Healthcare Biotechnology — A Practical Guide’ (2010).

Dr. Dave Doughty, Director of Pharmaceutics, GlaxoSmithKline In his 30 plus years in the pharmaceutical industry, Dave has a superb track record in leading teams to develop and commercialise products. This is underpinned by his expert knowledge of the science and mechanistic principles of dosage form design and processing, including PAT, manufacturing operations and GMP. Dave has co-authored product and process patents. Product innovations include oral and transdermal dosage forms.

Process innovations include compression and coating of tablets and continuous manufacturing methods and associated PAT. Continuous processes include feeding, mixing, granulation, drying, coating and a novel method of manufacturing low-dose, high-potency drugs.

John Gamble, Senior Research Scientist, Bristol-Myers Squibb After graduating from the University of Salford in 1998 with a degree in Chemistry with Industrial Experience, John began his career in quality control analysis of parental vaccines, later moving on to physical analysis of inhaled drugs, before arriving at his current position as Senior Research Scientist within the Powder Properties Optimisation group at Bristol-Myers Squibb.

John has a keen interest in understanding the interrelationships between the physical properties of drugs and excipients and their subsequent behaviour during formulation and manufacturing.

Aidan Mc Nabola, Engineering Director, UCB Group, SCHWARZ PHARMA Ltd Aidan is Engineering Director at Schwarz Pharma Ltd, based in Shannon Co. Clare, Ireland, and is responsible for site infrastructure, engineering systems — including capital projects — utilities, IT and automation on site.

Aidan holds a B. Eng Degree in Mechanical Engineering and has more than 23 years experience in primary and secondary manufacturing in the pharmachem and medical device industries.

Grégory Poujol, Manufacturing Maintenance Manager, Sanofi Grégory is an ‘Arts et Métiers’ engineer. He started working in one of Sanofi’s injectable plants in 2003, before moving to a solid form plant as a Project Manager in 2004 to install new process equipment.

In 2009, Grégory moved to one of the group’s solid form plants in Spain to lead new equipment installation projects as well as take charge of process maintenance and improvements. He returned to France in 2013 and continues with projects at one of Sanofi’s API production plants.

Grégory has experience of the most well-known providers of solid form equipment.

Kostas Saranteas, Senior Director, Process Chemistry and Engineering, Sunovion Pharmaceuticals Inc. Kostas is Senior Director of the Process Chemistry and Engineering Dept. at Sunovion’s R&D Division. He holds BS/MS/PhD degrees in Chemical Engineering and an MS degree in Environmental Engineering.

For 15 years, Kostas worked at Polaroid Corp., specialising in batch process equipment modelling, process optimisation and scale-up.

For 11 years, Kostas has been employed at Sunovion. He leads cross-functional teams, championing accelerated process development for drug substance and drug product synthesis from laboratory-scale to full-scale manufacturing.

MANUFACTURING PRODUCTS & EQUIPMENT Single Rotary Tablet Press Receives iF and red dot Seals of Approval Fette Compacting is shining on the international design stage again this year. A market leader in tablet presses, the company succeeded in impressing the international juries of two famous design prizes with the second model of the FE series, the FE35, launched at the ACHEMA 2012 trade fair in Frankfurt. A single rotary press, the FE35 can be fitted with up to 51 punch stations, permitting the production of up to 370,000 tablets per hour.

On 22 February 2013, the FE35 was awarded the iF product design award 2013 in the course of the Munich Creative Business Week (MCBW). It is amongst the products selected from a total of 3,011 entries. From July 2013, the FE35, together with all the other winning products, will be on virtual display in the new permanent exhibition at the HafenCity Hamburg, Germany.

The grant of the next prize was then announced at the beginning of March by selection for the red dot design award for product design 2013. At the awards ceremony on 1 July 2013, the FE35 will be honoured for its accomplishments in innovation, ergonomics and functionality.

Its design has therefore won through as one of 4,662 products entered.

“I am extremely happy that, following the success of the FE55, we have again

been given such high recognition for our second product in the FE series,” said Olaf J. Müller, CEO of Fette Compacting.

“Every year we not only manage to impress the market through technical innovation but we also set standards in product design and that is an impressive performance on the part of our entire team.”

The iF design award honours outstanding design as determined by an international jury of experts.

Manufacturers and designers from the product, communication and packaging design fields can enter the three disciplines of the competition.

World-famous firms as well as medium-sized companies, agencies and design consultancies take part. The iF design awards are amongst the largest and most important international design competitions.

The red dot design award is one of the largest and most well-known design competitions in the world. In 2012, about 1,800 companies and designers from 58 countries entered themselves for the red dot award: product design, taking the opportunity to demonstrate their design skills through international comparison with famous designers and emerging talents.

Fette Compacting GmbH +49 4151 12 473 tablet@fette-compacting.de www.fette-compacting.com

Comprehensive Range of Aseptic Filling Machines and Services rommelag manufactures and supplies bottelpack blow-fill-seal (BFS) machines for the aseptic-filling of sterile liquids, gels and pastes, as well as offers a spare parts service, stability tests and contract filling. bottelpack aseptic-filling machines have an included class A (US class 100) cleanroom with dark/white separation.

The machines are fully automatic, including CIP/SIP. The machine capacities vary depending on the product filled and the container design used but can handle up to 35,000 containers per hour, from 0.1 to more than 1,000 ml in size. Commonly used plastics are PE, PP, PET and others.

Using bottelpack CoEx machines, rommelag manufactures multi-layer containers with barrier layers for the packaging of sensitive products.

Customer training is provided in-house at the bottelpack Training Center and globally at customers’ sites by qualified service technicians.

The scope of supply also includes cap

welding units, high voltage leak detectors, mobile CIP units for cleaning and passivation, vial inspection machines for in-process control, plastic resin re-palletising units, modem and head camera systems for remote service, empty ampoule kits for stability trials, leachable and extractable studies for plastic resin, mould design, filling of

EPM 5

stability batches, qualification and validation services, etc. rommelag is certified according to the new standard DIN EN ISO 9001:2000. rommelag ag +41 62 834 55 55 mail@rommelag.ch www.rommelag.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Batch Mixer Boasts Exceptional Quality in Short Times Gebr. Lödige Maschinenbau introduced the Ploughshare FKM 2000 batch mixer at the recent POWTECH 2013 event.

The model, designed for the preparation of bulk material, is characterised by a low-maintenance mixer, short mixing times whilst achieving outstanding mixing quality as well as high batch reproducibility. Also, depending on the application, various equipment options are available, e.g., the mixer is available with humidification and granulation devices.

The batch mixer operates according to the process of the mechanically generated turbulent fluidised bed established by Lödige. In the batch mixer’s cylindrical drum, Ploughshare shovels rotate, subjecting the bulk material to a three-dimensional mixing movement and ensuring that the entire product is mixed both quickly and accurately. The product is handled with extreme care because, due to the special shape of the tools, the material to be mixed is taken off of the drum wall in a radial movement and thus the destruction of the particles is effectively prevented. This ensures short mixing times, exceptional mixing quality and high batch reproducibility. Moreover, the FKM 2000 is also characterised by a low-maintenance mixer concept with easy access to the mixer internal parts.

The batch mixer is equipped with various tools, depending on the mixing job. When special requirements are placed on the mixing process, it is possible to additionally support the mixing effect of the mixing element. For this purpose, separately driven

Single-Axis Robot Makes Packaging Flexibility Easy Research and development work on the TLM Transmodule continues unabated. Gerhard Schubert GmbH has announced enhancements to the freely programmable, single-axis robot that moves on a section of rail within TLM packaging lines. Among other things, the design is becoming more compact, the maximum acceleration is increasing to 8 m/s2 and wireless data transfer via WLAN will be twice as fast in the future. Development of the patented Transmodule follows the same principle as all TLM system components — less machinery and more intelligence ensure exceptional flexibility.

choppers rotating at high speed are installed. In combination with the mixing tools, they enable opening-up of agglomerates and targeted granulation during the mixing process. Additional available equipment options encompass a heated or cooled drum, head pieces and a shaft as well as various liquid addition devices. If necessary, the preparation of pumpable masses is also possible. Furthermore, the mixer can be equipped with highly wear-resistant surfaces, high-strength

constructional steels, stainless steels and special materials.

In accordance with the extensive application range of the FKM mixer series, the machines are available in various sizes with a 130 to 30,000 l drum capacity.

Gebr.Lödige Maschinenbau GmbH +49 5251 309 208 / 244 spittka@loedige.de www.loedige.de

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EPM 6

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The current development phase is complete and the new performance standard will be in place starting in the summer of 2013. This includes the conversion to the Uni 5 VMS controller generation. The individual Transmodule will still be 600 mm long.

Since its introduction in 2009, around 1,600 Transmodules have been in use in packaging machines across the globe. Despite the fact that creating solutions with the Transmodule has become routine for Schubert engineers, they continue to be surprised by what it makes possible. When transporting products and packaging, the Transmodule is not encumbered by mechanical equipment that is otherwise usually required for cycling in, buffering and backing up, for example. The autonomous robot can move on a section of path in sync and in coordination with the filling process and then proceed with the pick-and-place process continuously and in a controlled manner. The processes involved are optimally decoupled. It is possible to fill four boxes, erect two more and close another one in a section, all at the same time.

In addition to the transport of products and packaging, the Transmodule is essential for another Schubert development. During a fully automatic tool change, it transports the tools back and forth. The Transmodule also enables great flexibility in the TLM filling line presented in 2012. Among other things, it plays a decisive role in the gravimetric filling process.

The possibilities of solving known challenges of primary and secondary packaging (and beyond) in a new and intelligent way are nowhere near being exhausted, according to Gerald Schubert. In response to inquiries from the assembly department, he said: “The history of the Transmodule is still being told. I’m sure there are many more very exciting chapters to come.”

Gerhard Schubert GmbH +49 7951 400 0 info@gerhard-schubert.de www.gerhard-schubert.com

Design‌ more than skin deep Service‌ at the heart of everything we do Because we understand that service is everything.

Visit www.iholland.co.uk or telephone +44 (0) 115 972 6153 @ihollandtooling #TabletTooling I Holland I Holland Ltd

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Leak Detection Whitepaper Advocates Use of Laser Testing Device A new whitepaper by a leading packaging expert from the University of Ulster, Dr. Dorian Dixon, into the integrity of pharmaceutical packaging has established that existing methods for testing the seal integrity of blister packs are not as accurate as newer technology-based test equipment. In particular, Dr. Dixon found that the laserbased Blisterscan was capable of detecting 15% more product defects than traditional blue dye test methods used by the majority of the pharmaceutical market.

In his whitepaper study, Dr. Dixon compared the ability of Blisterscan and the blue dye test to detect defective pockets in blister packs with 12 or 20 µm

12 µm Hole (%)

15 µm Hole (%)

20 µm Hole (%)

Defect Free (%)

Blisterscan detection accuracy

99

100

100

100

Blue Dye detection accuracy

90

85

99

100

sized holes that were laser drilled in the packs to create defective packs. Ninety pockets were tested for each of the three sample types investigated (defect free, 12 or 20 µm holes). The current industry standard for testing blister pack integrity

is blue dye testing, which consists of placing a selection of packs into blue stained water, subjecting the packs to a vacuum of typically 40–600 mBar for several minutes and then removing the vacuum, which allows any defective

pockets to take up the dye. Blisterscan is a dry, nondestructive technique, which uses a laser to measure changes in the pack profile that result from applying a vacuum. The lidding material of defective pockets will respond in a different manner to a perfectly sealed pocket when a vacuum is applied.

Building on Dr. Dixon’s initial study where 100% of 15 µm holes were detected, Blisterscan went on to detect 100% of the 20 µm holes and 99% of the 12 µm holes in the final whitepaper study.

Conversely, blue dye testing was only capable of detecting 85% of the 15 µm holes, 90% of the 12 µm holes and 99% of the 20 µm holes.

Commenting on the results of the whitepaper, Dr. Dixon said: “Blisterscan testing is a rapid non-destructive test method, which can detect the presence of 12 µm, 15 µm and 20 µm sized defects in pharmaceutical blister packaging with a higher degree of reliability than conventional blue dye testing.” Dr. Dixon went on to conclude that: “The non-subjective nature of Blisterscan testing removes the possibility of human error and reliance on operator judgement, which is a key element in the correct identification of small holes using traditional blue dye testing.”

Sepha Ltd +44 2890 484848 paul.kelly@sepha.com www.sepha.com

Ultra-Low Profile Sifter Fits Tight Spots Kason has introduced an ultra-low profile, 101.60 cm diameter Flo-Thru Vibroscreen sifter, with flat dust cover that fits tight spots between storage and process equipment.

The sifter employs two imbalancedweight gyratory motors mounted on opposing exterior sidewalls of the unit, instead of one motor positioned beneath the screening chamber, reducing overall height significantly. The design also allows vertical alignment of the top inlet and bottom outlet, causing on-size material to descend through the screen in a straight-through path at high rates.

Oversize material is ejected through a spout at the periphery of the screen.

The unit is intended for installation above or below storage vessels, bulk bag and drum unloaders, bag dump stations, blenders, mixers and other process equipment, and can be installed with minimum alteration to existing layouts.

All material contact surfaces are stainless steel, with continuous welds polished to cGMP, 3-A, USDA and FDA standards.

The company also manufactures other circular vibratory screeners as well as centrifugal separators and circular fluid bed dryers, coolers and moisturisers.

Kason Corporation Europe +44 1782 597540 sales@kasoneurope.co.uk www.kasoneurope.co.uk EPM 8

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Two High-Speed Liquid Filling Machines Extend Successful Product Line Romaco has extended its Macofar LF 200 product family with two more models for filling liquids into glass and plastic bottles at high speeds. The new Macofar LF 200 FD and LF 200 FS series were specially developed for bottling pharmaceutical liquids. The LF 200 family comprises five different models for filling a variety of applications of almost any viscosity gently and efficiently.

The new Macofar LF 200 FD is used for high-speed filling of pharmaceutical sprays, nose and ear drops as well as ophthalmics and syrups. The machine boasts a maximum output of 12,000 bottles per hour, with a filling volume of

up to 100 ml. The LF 200 FD is equipped with two closing stations and is capable of handling a wide range of closure types, including pipettes, droppers, dosing cups, spray pumps, plugs, plungers and screw caps. The dual closure system is extremely flexible and facilitates many different combinations. The bottles are filled continuously, speeding up the filling process. The movement of the swivelling dosing systems is synchronised with the bottle transport through the machine. The LF 200 FD is suitable for glass and plastic containers 16 to 80 ml in diameter and 35 to 200 ml in height, with a filling volume of 0.5 to

500 ml. The transport system that transfers the packaging can be adjusted to different container dimensions quickly and easily.

The Macofar LF 200 FS is another new model belonging to the same family as the Macofar LF 200 FD. Romaco’s FS machines were specifically designed for applications with a single closure system such as pump, pilfer-proof, child-proof, screw or press-on caps. The Macofar LF 200 FS likewise fills the containers in a continuous process at a maximum rate of 12,000 bottles per hour. It is particularly suited for processing pharmaceutical liquids that are orally

administered or applied to mucous membranes. Servo-controlled processes assure safe and reliable handling throughout the filling and closing operations.

Romaco Group +49 721 4804 0 susanne.silva@romaco.com

Multi-Page Label Booklets Incorporate More Pages

1.

Objective Test Results

4.

Denny Bros is an independent, specialist print company and the originator of Fix-a-Form multi-page labels. Committed to supplying fault-free solutions on time, every time, the company’s multi-page labels are used extensively within the pharmaceutical and clinical trial markets. Vital product descriptions, dosage and user guidelines, including safety messages, can be applied and relayed to endusers in a multitude of languages.

Owing to the development of using 45 gsm paper, Denny Bros is now able to provide an increased number of pages within a booklet format, allowing the company to push the boundaries further with a choice of either 80- or 120-page double booklets.

As a pharmaceutically accredited company, to the new PS9000 2011 standard, Denny Bros’ processes and staff are monitored and assessed continually to ensure the development of effective, dependable products, thus delivering an exceptional level of customer care.

Denny Bros continuously develops products that meet the industry’s needs but also works with clients to create bespoke products specific to their requirements. In an ever-evolving world, the company’s R&D team keeps an open mind when tailoring new packaging solutions.

It is not only the products that make Denny Bros an ideal packaging provider but services such as the provision of alpha numeric and unique random codes and quick response (QR) codes that can now include uniform resource names (URNs) and Braille.

Denny Bros Ltd +44 1284 701381 fix-a-form@dennybros.com www.dennybros.com

Quality Assurance 2.

Reduced Costs

3.

Non-Destructive Testing

€

THINK SMARTER ABOUT BLISTER PACK INSPECTION Objective Test Results

Reduced Costs

Non-Destructive Testing

Quality Assurance

Remove operator subjectivity from testing pharmaceutical blister packs with pharma specific test equipment that utilises modern technology to deliver objective, repeatable results.

Blisterpack test procedures are completely nondestructive enabling good product to be returned to the line. Significant return on investment and cost savings can be achieved.

Laser and high resolution inspection technologies ensure that no product or pack damage is incurred during the test process. Our equipment will detect weak seals, pin holes, capillary leaks and other pack defects down to 7 micron.

Our technology has been developed specifically for the pharmaceutical industry. Test results are objective, reliable, repeatable and enable significant improvements in accuracy compared to destructive test methods.

The global leader in non-destructive leak detection technology for blister packs.

www.sepha.com

+44 (0)28 9048 4848 marketing@sepha.com

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MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Easy-to-Use Dust Measurement Device Allows for On-Site Calibration The new CEL-712 Microdust Pro from Casella CEL is a rugged, handheld data logging instrument for the real-time detection of airborne dusts, fumes and aerosols during the pharmaceutical manufacturing process. According to the company, it boasts the highest measurement range of any device of its kind currently available and features a unique filter that enables on-site calibration not possible with competitor units.

The risk of occupational exposure to chemicals during the manufacture of pharmaceutical products includes inhalation of volatile organic compounds (VOCs) from recovery, isolation and extraction activities and handling of wet cakes in drying operations and during wet granulation, compounding and coating processes. Risks also arise from uncontained filtration equipment as well as fugitive emissions from leaking

pumps, valves and manifold stations, e.g., during extraction and purification steps.

Additional sources of inhalation exposures include chemical synthesis and extraction operations and sterilisation activities (e.g., germicides such as formaldehyde and glutaraldehyde and sterilisation gases like ethylene oxide) plus exposure to synthetic hormones and other endocrine disrupters. In secondary pharmaceutical manufacturing, workers may be exposed to airborne dusts during dispensing, drilling, milling and mixing operations.

The easy-to-use CEL-712 Microdust Pro is ideal for occupational health monitoring as well as industrial process monitoring, testing air filtration efficiency, site boundary monitoring, environmental measurement and research activities.

Featuring a large colour display and

colour-coded screens to ease navigation, plus graphical facility, it provides immediate details of when and where excessive dust levels are occurring.

The CEL-712 Microdust Pro comes factory calibrated to internationallyrecognised ‘standard’ dust but userdefined dust-type settings may be obtained by using an optional TUFF air sampling pump and gravimetric adaptor.

This means that the user can calculate a correction factor for the actual type of dust being measured and ensures maximum accuracy for the application.

Further benefits include just three simple steps to take a measurement and a large memory capable of up to 500 measurements that can be downloaded into Casella Insight data management software where it can be stored and analysed.

Casella CEL +44 1234 844100 www.casellameasurement.com

Checkweighers Sort Profitably for Pharma Customers Around Globe CI Precision has secured orders for its new SADE SP440 tablet and capsule weight sorter from clients around the world, including the US, Brazil, Australia and Poland.

The SADE SP440 is used for 100% weight checking of tablets and capsules to ensure each tablet or capsule in the batch complies with the specified weight, saving on the cost of reject batches and ensuring 100% quality.

As one of CI Precision’s customers remarked: “We would recommend the SADE SP sorters to other companies because they are easy to handle, clean and set up. In addition, the software is user friendly.”

CI Precision +44 1722 424100 sales@ciprecision.com www.ciprecision.com

Tablet Design Software Eliminates Common Manufacturing Issues

Purity through innovation Global sieving and filtration specialists ng 5 pi EL m O cla ing nt ed vid e nt ro m te p ain Pa em ont st c sy

Improve your product quality with the Russell Compact Airlock Sieve™ ...

With a large, easy to fill 150 l hopper feeding the four weighing channels, the SP440 can sort up to 22,000 items per hour at an accuracy of ±2 mg.

The SP440 sorts tablets of most shapes and sizes up to 2 g, including coated and non-coated tablets, tablets with break points and dusty tablets.

The unit also handles hard shell capsule sizes 00 to 6 as well as most softgel forms. All without any size or format specific parts.

High containment check screening for the pharmaceutical industry

What makes us specialists..?

Customized solutions - Applying innovation to meet your requirements Comprehensive customer service - Technical support & global stocking Specialized testing facilities - Trial your products for total peace of mind

Call us on: +44 (0) 20 8818 2000 EPM 10

I Holland is offering tablet manufacturers a tablet design software that aids the design and calculation of key tablet parameters whilst also performing stress analysis for round and shape tool tips in three easy steps.

Custom designed by experts in the I Holland design team, iTAB incorporates decades of tablet tooling design experience and knowledge to give users an extensive piece of software that can calculate basic tablet parameters and stress analysis when designing tablets. iTAB results in 2D drawings ready for production and automatically generated design reports. The software is easy to use and requires no formal training.

Steve Osborn, Design Manager, said: “iTAB was specifically designed to be user-friendly so anyone within tablet manufacture can use it. It features a simple three-step process. Step one involves the selection of a specific tablet profile and modification of key parameters. There is a safety zone that ensures any unfeasible designs would be flagged up so only quality tablets are produced.

“Step two runs a real-time, integrated finite element analysis (FEA) simulation against the design, giving a punch tip maximum force calculation, and finally, step three produces a report summarising the key design data that can be emailed directly to us for further analysis, design work and tooling production.

“At the click of a button, iTAB can quickly and simply help in tablet design and reduce the amount of time and money usually spent on this process.”

By using iTAB, tablet manufacturing problems such as punch tip breakage can be eliminated from the beginning.

Accurate punch tip loads calculations and 3D rotation of punch tip stress allow for instant decision making on design issues. iTAB is Microsoft Windows-based, compatible with modern, commonplace PC specifications and operating systems and features a calculation of tablet design parameters in real time (volume, mass, density and surface area) as the user modifies key tablet dimensions (diameter, cup depth and radii, etc.). Key statistics, including volume, mass, density and surface area, are also automatically included in the final report.

I Holland Ltd +44 115 972 6153 info@iholland.co.uk www.iholland.co.uk

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West Pharmaservices Ltd, UK +44 1202 870890 sales@westpharmaservices.co.uk www.westpharmaservices.co.uk

Sepha Ltd, UK +44 2890 484 848 sales@sepha.com www.sepha.com

rommelag ag, Switzerland +41 62 834 55 55 mail@rommelag.ch www.rommelag.com

Romaco Pharmatechnik GmbH, Germany +49 721 4804 0 info@romaco.com www.romaco.com

Robert Bosch GmbH, Germany packaging-ph@bosch.com www.boschpackaging.com

Phillips-Medisize, Switzerland +41 44 8383939 eu_sales@phillipsmedisize.com www.phillipsmedisize.com

OPTIMA pharma GmbH, Germany +49 791 94950 info@optima-pharma.com www.optima-pharma.com

Nuova Ompi, Italy +39 049 9318111 nuovaompi@stevanatogroup.com www.nuovaompi.it

IMA Safe Srl, Italy +39 051 6514111 franciar@ima.it www.ima.it

Gerhard Schubert GmbH, Germany +49 7951 4000 info@gerhard-schubert.de www.gerhard-schubert.de

Fix-a-Form International Ltd, UK +44 1284 723 144 enquiries@fix-a-form.com www.fix-a-form.com

Bausch+StrĂśbel Maschinenfabrik Ilshofen, Germany +49 7904 701 0 info@bausch-stroebel.de www.bausch-stroebel.com

Bausch Advanced Technology Group, US +1 860 304 6456 ego@bausch-group.com www.bausch-group.com

bottling & packaging

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Syringe Filling Equipment Syringes Tube/Fill Seal Equipment Unit Dosing Machines Unit Packaging Equipment Vacuum Packaging Equipment Vial Pack Process Equipment Wrapping Machines

Bespoke machinery designed, manufactured and installed.

Blow-fill-seal machines.

Counting equipment.

Glass vials, ampoules, cartridges and syringes.

Counting equipment, palletisers and tray packers.

Packaging robots.

Multi-page labels.

Additional

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Aseptic Disconnector Makes Tubing Disconnection Easy

Chinese Pharma Company Invests in Vision Inspection Machine with Integrated HSA

Sartorius Stedim Biotech has launched new sizes XS and S of the Clipster aseptic disconnector, in addition to the existing size L. This single-use device allows an aseptic disconnection of silicone (Pt) as well as thermoplastic elastomer (TPE) tubes in biopharmaceutical manufacturing processes. It is safe, quick, easy to use and available as a standalone product or pre-mounted on single-use transfer lines and bag assemblies.

Seidenader Maschinenbau has sold its first machine with integrated head space analysis (HSA) to China. HSA is a complementary inspection technology used to check the integrity of pharmaceutical containers. For one Chinese customer, HSA has recently been integrated as one single module within a Seidenader MS series vision inspection machine.

Leak tightness of pharmaceutical containers is one of the most important safety criteria for parenterals. Besides the penetration of oxygen and its possible reaction with the product, the loss of sterility is the most serious threat to the health of patients.

With HSA, the pharmaceutical manufacturers have their products checked in line and with a nondestructive test, by verifying the pressure in the headspace of containers. Parenteral products are usually filled under partial vacuum; in other cases an inert filling gas is added.

The HSA gives information about the absolute pressure as well as, for example, the water partial pressure within the container and, after comparison with the appropriate set values, about its leak tightness.

Depending on the handling system and head space gas characteristics, up to 600 vials per minute and 100 measurements per container can be analysed.

The challenge of the Chinese project was the small size of the containers and the limited space for the additional leak test module on the MS inspection platform. 2R vials filled with lyophilised product are inspected for particles and cosmetic defects by several camera stations at a speed of 400 vials per minute. The Seidenader solution for a complete HSA leak test has been implemented in one small module that is installed in an available spare position of the vision inspection carousel. In addition to the measurement path, this module contains a reference path to compensate for ambient air influences in the measurement path.

The precisely positioned vials pass the laser head. The laser beam, tuned over a certain wavelength range, is sent

The Clipster Aseptic Disconnector is used after a fluid transfer to disconnect transfer lines and bag assemblies. The disconnection of tubes can be performed in non-classified and classified environments while maintaining product sterility. It is performed with a handheld tool that ensures easy execution in various space requirements. The Clipster Aseptic Disconnector XS, S or L can be applied to multiple tubing material (silicone and TPE) and sizes from 1/8 x 1/4” up to 1/2 x 3/4”.

The validation of this key single-use device has been carried out under the most stringent test regimes. Biological and physical tests have been combined to provide data representing a variety of process conditions, including critical applications.

Sartorius Stedim Biotech S.A. +49 551 308 3615 karin.kleist@sartorius.com www.sartorius.com

through the headspace of the vial. A photo-sensor receives the transmitted light. After balancing this signal by means of the reference signal, the absorption profile of the headspace gas is determined. The analysis of this profile results in precise information about the absolute pressure and, for example, the water partial pressure. The obtained data are compared with

threshold values to generate pass/fail decisions. The PLC tracks each product and activates the reject gate to separate defective from good products.

Seidenader Maschinenbau GmbH +49 8121 802 183 julia.palka@seidenader.de www.seidenader.de

Checkweighers Awarded Fire Safety Seal of Approval Mettler-Toledo Garvens’ checkweighers have now received Underwriters Laboratories (UL) 508A listing, guaranteeing automatic compliance with stringent US fire safety legislation, as well as the country’s National Fire Protection Association (NFPA) voluntary 70 and 79 guidelines. Food, beverage and pharmaceutical manufacturers looking to expand into US and international markets can now harmonise their global production lines by sourcing checkweighing technology that meets local safety standards while ensuring compliance with international regulations. This will enable them to benefit from the same high-precision weighing technology across all facilities whilst safeguarding the welfare of employees.

UL is an independent global organisation based in the US that

inspects manufacturing technology for fire safety approval. Approved by the US federal agency Occupational Safety and Health Administration (OSHA), the company also performs safety testing on industrial and domestic equipment. UL 508A deals specifically with fire safety for industrial control panels (IPCs), ensuring the risk of fire is minimal. The fire safety listing requires the use of insulating

materials in manufacturing equipment and stipulates that the control panel and power supply meet the design criteria described by OSHA. The receipt of UL 508A listing means that Mettler-Toledo Garvens has demonstrated that the control panel on its checkweighers has been assembled according to specific construction and production principles, including the use

EPM 12

of insulation to shield production line operatives from the unlikely event of an electric shock. The listing also requires that sufficient overcurrent protection is included in checkweigher control panels to minimise damage to the machine and harm to operatives from power surges.

“Mettler-Toledo Garvens is dedicated to ensuring its technology always complies with the latest safety standards to help manufacturers protect their staff and production line from the harm and damage caused by fire, helping to maintain profits and grow their business,” said Kerstin Bernhart, Marketing Manager, Mettler-Toledo Garvens.

Mettler-Toledo Garvens GmbH +49 5121 933 131 kerstin.bernhart@mt.com www.mt.com/pi

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Tablet Tooling Inspection Systems/Analysis Software

Tablet Dedusters

Tablet Coaters

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Elizabeth-Europe, France +33 2 54 90 21 20 service@epmo.com www.elizeurope.com Fette Compacting GmbH, Germany +49 4151 12 0 tablet@fette-compacting.com www.fette-compacting.com GEA Pharma Systems — Courtoy, Belgium +32 2 363 83 00 courtoy@geagroup.com www.gea-ps.com I Holland Ltd, UK +44 115 972 6153 sales@iholland.co.uk www.iholland.co.uk IMA S.p.A., Italy, IMA Kilian GmbH & Co KG, Germany +39 051 6514111 behrensm@ima.it www.ima.it KORSCH, Germany +49 30 435 76 0 berlin@korsch.de www.korsch.de Natoli Engineering Company, Inc., US +1 636 926 8900 sales@natoli.com www.natoli.com Sejong Pharmatech Company, Korea +82 32 508 1280 sales2@sjpmt.com www.@sjpmt.com Thomas Engineering Inc, US +1 800 634 9910 sales@thomaseng.com www.thomaseng.com

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Exchangeable Die Disc (EDD) and Exchangeable Compression Module (ECM).

Tablet tooling troubleshooting training and tablet tooling cleaning, repair, measurement, polishing, lubrication and storage equipment.

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Tablet Compression Accessories Catalog, tablet tooling and die segment storage solutions and ultrasonic kits.

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Müller GmbH - 79 618 Rheinfelden (Germany) Industrieweg 5 - Phone: +49 (0) 76 23 / 9 69 - 0 - Fax: +49 (0) 76 23 / 9 69 - 69 A company of the Müller group info@mueller-gmbh.com - www.mueller-gmbh.com EPM 13

Q&A I Holland’s R&D Manager Gives Lowdown on TSAR Project

In January 2012, tablet tooling specialist I Holland and the University of Nottingham’s School of Pharmacy launched the two-year TSAR (Tabletting Science Anti-Stick Research) project to investigate and solve the most common tabletting issue of formulation ‘sticking’ to the tool face, which frequently results in long periods of downtime and substantial losses of product.

EPM’s Editor, Elizabeth Valero, talked to I Holland’s Rob Blanchard, R&D Manager, and Clare Taylor, Marketing Manager, about how TSAR will be used to help customers in the future to eliminate sticking and therefore protect productivity and profitability.

How many people are involved in the TSAR project and what are their roles?

Rob: There are six core people involved; four from I Holland and two from the University of Nottingham. From I Holland, there’s Chris Prideaux, the Managing Director, who is chairing the project, myself, the project lead, and Tim Sefton, an R&D engineer. All three of us have our own defined roles within the project, with Chris and I using Tim as a resource for carrying out compression trials and helping with the analysis of formulations and mechanical testing.

We also draw on other resources as and when needed, for example, the manufacturing team was instrumental in producing the samples that we’ve used for the project. Then there’s Dr. Abdennour Bouhroum, who is the associate from the University employed

by I Holland as part of the project team.

He is completing the analytical research for us. He’s planning and project managing the resources that are available to us at the University.

Also from the University, there’s

Professor Clive Roberts, the academic lead, and Professor Morgan Alexander.

They both have their own different skill sets and areas of expertise that are complimentary to the project.

Professor Roberts is Chair of the Pharmaceutical Nano Technology group and Director of the Nottingham Nano Technology Science Centre, both part of the Faculty of Science at the University.

Clive has a fantastic reputation in the field of particle adhesion; he’s carried out many different studies looking into different kinds of adhesion. We’ve been working with Clive since 2009, so it’s not a new relationship.

Professor Alexander is Professor of Biomedical Services and Head of the Division of Biophysics at the Surface Analysis group, one area of his expertise and focus is on understanding surface interactions.

What are the factors that cause sticking and how is it currently dealt with?

Rob: TSAR is not the start of our antistick research as we began using advanced techniques such as atomic force microscopy to understand all the factors for sticking back in 2009.

There are several factors that we know have a major influence on sticking. I will start with the main ones. First to consider is Van der Waals forces or molecular attraction, which is when elements within the formulation are naturally attracted to elements within the tablet punch material.

These forces are very low and can only be measured in nanonewtons but in bulk behaviour, when lots of these forces interact on the face of a tablet, they can cause sticking.

Another major influencer of sticking is capillary action, which can be linked to high moisture content. If moisture is present, there’s the potential for sticking in both direct compression or wet granulation. On the other hand, if the granules are very dry, you can get Laboratory of Biophysics and Surface Analysis group.

static electricity, also a major cause of sticking.

Those are the three main ones but there are others. You’ve also got the roughness or the morphology of the contact, or in other words, the punch tip face used to compress the powder. How that surface face interacts with the granule is critical.

Then you’ve got the deformation mechanics of the granule itself. Under compression, the granule is either elastic or plastic, which will have an influence again on sticking. So the characteristics of the granule itself under compression are also very important.

There’s also the environment that you are compressing in and that comes back to capillary action because if you have a very humid environment, then you’re going to get capillary action causing sticking.

Also linking back to Van der Waals forces, different chemistries on the punch tip face can influence sticking.

For example, if Van der Waals forces are causing sticking where you’ve got chromium, the structure of the chemical coating can be changed so that the element is no longer present.

Understanding what factors cause sticking is what we did in 2009 to develop our PharmaCote range of coatings, way before TSAR started. The objective was that if we could understand what causes sticking, our R&D team could tailor the development of coatings for punch tip faces that prevent sticking. That’s what we’ve been doing since 2009 and as a result we’ve got a proven range of anti-stick solutions based on that research, but the one thing that could be improved across the industry is the ability of the tooling manufacturer to select the right coating solution straightaway and that leads into what TSAR is really about.

Clare: At present, when a customer presents us with a sticking problem, we have to do a lot of testing in the field to select the right coating solution for their specific problem. This involves taking time out of their production schedule to run test punches on their tablet presses, then we have to analyse the results before getting back to them with a recommendation.

We released a case study regarding an anti-stick trial we did with Pfizer five years ago and that took a good few weeks’ worth of preparation and testing at both I Holland and their facility. TSAR will help us eliminate the need for that costly in-the-field testing process.

Rob: This type of testing is a successful way of identifying the right solution but

EPM 14

R. Blanchard, R&D Manager, I Holland.

C. Taylor, Marketing Manager, I Holland. it’s very costly, very slow and therefore doesn’t offer the most efficient customer service.

Are you able to offer an insight into the project’s findings so far?

Rob: What we’re developing with TSAR is a predictive tool, which will comprise data on a range of parameters such as surface chemistry, temperature, humidity and size of the granule, whether it’s elastic or plastic for example. We obviously won’t release the final parameters to be included in the model until the end of the project. The predictive tool will allow us to enter parameter information and straightaway provide an exact answer as to what the customer requires. It’s completely different to what anyone else is doing and will eliminate the need for the costly and slow in-the-field testing for the customer.

The project is based around two main elements. Firstly, we’re compressing the final formulation and creating tablets with various excipients and APIs using all of our anti-stick coatings (a couple of which are still in development) as well as our PharmaGrade range of raw materials. The results of this testing are then being put to one side and will be used to validate the predictive tool at the end of the project.

The second part consists of five substages, starting with the initial research into our PharmaCote and PharmaGrade material solutions and their surface characteristics.

Secondly, we carried out a case study by testing the well-known formulation Ibuprofen. This proved that the analytical techniques used to predict the correct solution matched what actually happened in the tablet press, which validates the concept of our predictive tool. Having obtained the desired results

from the Ibuprofen trial, we moved onto conducting compression trials with different formulations supplied by our international customer base. From these tests, we have built up a database of results that will also be used to validate the results of the predictive tool. We’ve just finished the compression trials and at the end of the project we will enter the details of all formulations compressed into the predictive tool and see whether it gives us the result we got in the tablet press.

As well as carrying out compression trials, we’re also doing a lot of analysis using very complex techniques such as atomic force microscopy (AFM) and time-of-flight secondary ion mass spectrometry (ToF-SIMS). There’s a long list of different pieces of equipment and techniques that we are utilising and are key to helping us develop the predictive tool.

Next, we move on to adhesion mapping, which is where we use techniques like AFM and ToFSIMS to look at particles that are stuck to a punch tip and analyse exactly what they are chemically, thus working out what those interactions are.

Once we’ve completed the adhesion mapping stage, we’re onto the development of the predictive tool, which we’ve just started. The predictive tool is going to take some time to develop because of the utilisation of complex techniques.

We’re using principle component analysis (PCA) to understand the key

interactions that are causing the formulation to stick to the punch tip faces.

What will the results ultimately mean for I Holland customers?

Clare: The main advantage for the customer will be that by using the predictive tool we can recommend the right punch material or coating solution very quickly based on proven scientific knowledge of how the different elements within their formulation behave and interact to cause the sticking. The aim is that they will no longer have to buy a test set of tooling and take time out of their production schedule to ascertain which solution is right for their specific problem.

What we’re trying to get across to our customer base is yes, we’re known for producing excellent quality punches and dies, however we’re not just an engineering business turning out the core product. Our headline brand is ‘tabletting science’ and that’s what we offer to customers. All this research is essentially free added value that we provide to customers throughout our entire product and service portfolio.

Rob: The TSAR project is totally unique, we’re the first tablet tooling manufacturer to do anything like this.

We began our anti-stick research and developing our anti-stick coatings

back in 2004 and we really started to understand what caused sticking in 2009, now here we are in 2013 over half way through developing a predictive tool that will allow us to use that research and those products that we have developed already in a much more efficient way.

What does I Holland’s recent HSBC Global Connections competition funding win mean for the project?

Rob: We’ve won the regional final, which has given us a nice financial reward and some kudos that we’re a wellperforming business.

We’re now through to the national final in June.

PharmaCote coated We’re not normally a tool samples. company that enters award competitions but with this one there was a financial benefit for our customers, I Holland Ltd allowing us to invest further in our R&D +44 115 972 6153 programme and thus our customer info@iholland.co.uk service offering. www.iholland.co.uk

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SHOWCASE ANTI-COUNTERFEITING Pharma Packaging Specialist Launches Tamper-Evident Labelling System Travtec has extended its range of equipment capable of meeting the requirements of the recent EC Falsified Medicines Directive (FMD) with the introduction of a new, tamper-evident labelling system.

The Travtec Labello 3 applies nonresealable clear labels to both openings of a carton and also has the capacity to affix the special bollini or vignette labels required for pharmacist dispensed drugs in the Italian and French markets respectively.

The system comprises a precision multi-belt conveyor with a synchronised top hold-down belt that keeps cartons firmly in place while they are presented to the label applicators.

A series of label heads then places the clear labels over each opening and any additional label on the front face of the pack.

The transparent labels feature a special adhesive that securely seals the carton but which becomes inactive once the label is peeled back for the first time to provide effective visual evidence if a product has been interfered with during the distribution process. This meets the second key requirement of the FMD, which also specifies that all packs must include a serialised 2D Datamatrix code.

The new Travtec Labello 3 can operate in conjunction with the company’s newly-launched

Pharmacarton Elite to provide a one-stop solution to meet the Directive. Equally important, the compact dimensions of the equipment mean both models can be easily retrofitted into existing packing lines.

“Our two systems have been designed to enable companies to satisfy these legal requirements quickly and costeffectively,” commented Travtec Managing Director Harry Thomason.

Travtec Ltd +44 1942 677664 info@travtec.co.uk www.travtec.co.uk

Marking Solution with Detachable Label Parts Raises Hurdle for Counterfeiters

Schreiner MediPharm develops customised, reliable means of marking pharmaceutical products to enhance protection against piracy and tampering.

The Pharma-Comb label offers a wide range of security features that address

parts. Equipped with integrated security features, the label becomes an effective means of providing pharmaceuticals with customised authenticity protection.

Overt features like holograms or colourshifting security inks are combined with covert features such as the void effect or the LaserSecure specialty pigment into multi-level security systems, depending on the requirements.

Complex holograms confront potential counterfeiters with big hurdles. The holograms can be customised and with their distinctive designs are easily recognisable. Furthermore, due to their high-grade appeal, holograms enhance the value of the label.

Colour-shifting inks generate a specific colour perception, depending on the angle of vision or lighting conditions.

Due to worldwide controls imposed on the supply of security inks, their availability is limited. Colour-shifting security inks thus provide a high level of counterfeit protection. The effect is visible by the naked eye or means of special filters.

An integrated void effect reliably indicates that a label has been detached.

This is achieved by a visible message or

the specific needs of pharmaceutical manufacturers and meet the requirements of EU Regulation 2011/62/EU for prescription drugs.

The Pharma-Comb label is a versatile marking solution with detachable label

Latest Version of ID and Data Verification Software Enables Serialisation Cognex has announced a new version of the In-Sight Track & Trace identification and data verification solution for healthcare serialisation. A follow-up to successful deployments of In-Sight Track & Trace 1.0, this version includes enhancements that address additional requirements for pharmaceutical and medical device manufacturers to achieve unit-level product traceability.

Customers can use In-Sight Track & Trace 2.0 with multiple networked InSight vision systems to decode human-readable text along with 2D and 1D barcodes, including Data Matrix, GS1-128, GS1 DataBar, securPharm and Pharmacode.

“In-Sight Track & Trace is an off-theshelf label verification and serialisation software supplement for our pharmaceutical customers required to comply with GS1 and FDA regulations and similar laws worldwide,” said Herbert Lade, Vice President and Business Unit Manager, Vision Systems. “In the newest version, we incorporated bundling reading support, secondary authentication capability and our OCRMax tool for the highest read rates in the industry. This new feature provides superior read rates of human-readable dates, lot codes and serial numbers.”

The pre-programmed add-on software package needs little set up

through a touchscreen or HMI. In-Sight Track & Trace can be easily integrated into third-party serialisation software or MES with industrial protocol support and built-in I/O controls. The technical controls needed for FDA 21 CFR Part 11 validation, including secure user authentication and automatic audit trail generation, are also included.

Cognex Corporation +1 877 264 6391 pr@cognex.com www.cognex.com/tracktrace

EPM 16

image that irreversibly emerges from a solid-coloured area. Even if the seal should be accurately reapplied, the previously triggered ‘warning’ message remains.

Due to their customised formulation, LaserSecure colour pigments represent an optical fingerprint and offer clear proof of authenticity. The nano pigments are integrated into the label and make authentication possible by means of a special reader.

The Pharma-Comb label provides government authorities, pharmacists and healthcare staff with an easy means of authenticating pharmaceuticals while protecting patients against counterfeit and inferior products. At the same time, the pharmaceutical manufacturer benefits from a tailored solution that can be integrated into the existing corporate and brand design while complying with the high approval requirements of the EU’s Falsified Medicines Directive (FMD).

Schreiner MediPharm, a business unit of Schreiner Group GmbH & Co. KG +49 89 31584 5400 info@schreiner-medipharm.com www.schreiner-medipharm.com

SHOWCASE SOLID DOSE INSPECTION & TESTING X-Ray Spectrometer Offers Standardless Analysis and Non-Destructive Testing of Solid Dosage Forms

PANalytical’s Epsilon 3 benchtop EDXRF spectrometer with a PCA cluster analysis showing a clear visualisation of different polyolefin types.

Epsilon 3 is a PANalytical benchtop energy dispersive X-ray fluorescence (EDXRF) spectrometer for elemental analysis in industry process control and R&D. It is a highly flexible elemental analysis tool, suitable for a wide variety of sample types and shapes. Examples include whole tablets and packaging materials. The Epsilon 3 can accommodate large and irregular shaped materials. Advanced spectrum processing and quantification algorithms ensure accuracy and precision.

There are two software modules — Omnian provides advanced easy-to-use elemental quantification analysis without the need for calibration standards and FingerPrint readily identifies counterfeit materials.

According to PANalytical, the Omnian module enables users to achieve the

Brochure Showcases Upgraded Solids Dosage Testing Range A new brochure from Copley Scientific, ‘Quality Solutions for the Testing of Pharmaceuticals’, provides a wealth of information for those seeking help with the interpretation and application of regulatory guidance as well as highlights new additions to the company’s extensive range of solids dosage testing equipment.

New products include the DissoMate dissolution media preparation station, the DissoFract dissolution off-line fraction collector, new accessories for testing semi-solids and upgrades to the popular range of dissolution and disintegration testers. Furthermore, an expansion of the range of easy-to-use tools now supports the calibration of

dissolution testing apparatus according to the very latest USP and FDA specifications. The brochure covers tablets and capsules, suppositories, powders, transdermals, creams and ointments and is freely downloadable from the Copley Scientific website where the digital version can also be viewed online.

Copley Scientific places strong emphasis on manufacturing durable, well-designed equipment in the UK and supports this offering with education and training that help to maximise productivity. The new brochure exemplifies this approach. It highlights changes and additions to the pharmacopoeias and regulatory

best possible analysis when dedicated methods or certified standards do not exist. A standardless analysis package, Omnian incorporates state-of-the-art software and setup samples that deliver fast and reliable results regardless of sample type or matrix.

The FingerPrint software module is ideal for material testing when analysis speed is important but the actual composition is not of interest.

FingerPrinting generally involves little to no sample preparation and is nondestructive. It provides positive material identification and authentification.

Sophisticated yet easy to use, FingerPrint software incorporates outstanding statistical analysis procedures and easy to understand pass/fail reporting.

PANalytical’s XRF technologies offer

guidance and explains in straightforward, easily understood language how to develop and apply effective testing strategies.

The new range of easy-to-use calibration tools supports compliance with the recently introduced enhanced USP and FDA specifications for tablet dissolution apparatus based on enhanced mechanical calibration (EMC).

The upgrades to the dissolution and disintegration testers also feature new digital heaters capable of heating to target rapidly without overshoot; controlling temperature to within a tolerance of ±0.1˚C. This enhancement helps to support accurate maintenance of the 37˚C ±0.5˚C applied during testing.

non-destructive analysis with very high sensitivity and simple or no sample preparation. Elemental analysis using the Omnian standardless analysis package can be performed on just milligrammes of sample. Instrument qualification (IQ) and operational qualification (OQ) procedures, originally designed for the pharmaceutical industry, validate instrument performance. Finally, audit trail and enhanced data security functionality record the sample analysis and data processing history in accordance with FDA 21 CFR Part 11.

PANalytical B.V. +31 546 534444 www.panalytical.com

Copley Scientific Ltd +44 115 961 6229 m.copley@copleyscientific.co.uk www.copleyscientific.com

Compact X-Ray Unit Simultaneously Checks All Capsule Quality Features

Simple Device for Routine Checks of Tablet Hardness Tester Functionality

Based on X-ray technology, the inspection unit KKX 3900 for capsules serves as a system for comprehensive and 100% weight and quality control. It is equipped with soft X-ray technology and a sensor for image creation.

“The KKX 3900 is universally applicable and apart from filling weight control provides further advantages,” said Melanie Beck, Product Manager at Bosch Packaging Technology. “For the first time, an inspection unit is capable of simultaneously checking all quality features like weight, foreign particles, deformation of capsule top and bottom as well as length.”

The KKX 3900 is used for the inspection of filled hard capsules. It can be installed downstream of any capsule filling machine and achieves an output of up to 220,000 capsules per hour.

Besides filling weight information, the system also measures the length of capsules. Additionally, foreign particles in the filling product or capsule material

Measuring product breaking force is a standard procedure in every tablet manufacturing facility. Like all instrumentation, regular qualification of a hardness tester is mandatory. In order to ensure that the instrument is functioning within specifications, SOTAX has developed the MT, a simple device that is designed for frequent routine verifications of the functionality of tablet hardness testers between qualifications.

Supplier-independent, the MT mechanical tablet is designed to work with all hardness testers. The tablets are engineered so that a predetermined amount of force triggers a mechanical breaking point that is recorded by the hardness tester.

MTs are manufactured at five different breaking forces with an accuracy of ±0.5 Kp or better (5, 10, 15, 20 and 30 Kp). They can also verify six different physical dimensions ±0.03 mm (5, 10, 14, 15, 20 and 30 mm).

The devices are all calibrated, verified and tested according to a strict quality process using a NIST traceable

are detected. Therefore, capsule quality is examined comprehensively and in one single process step. Capsules that are not in line with desired requirements are discharged individually. The real-time image evaluation resists vibration, air flow and dampness.

The KKX 3900 is reportedly the first capsule inspection unit to check different process-relevant data in real time.

Bosch Packaging Technology +49 711 811 57255 melanie.beck@bosch.com www.boschpackaging.com

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calibration instrument. A full internal test report, along with a calibration certificate, is provided with each MT. SOTAX AG +41 61 487 54 54 info@sotax.com www.sotax.com

We pack your product: Regardless of what you process, TLM packaging machines can be adjusted to work with any product. This is made possible with the technology

Closing

www.gerhard-schubert.com

Gerhard Schubert GmbH Packaging machines Industriegebiet Suedost

Filling

Hofaeckerstrasse 7 74564 Crailsheim / Germany

of the sub-machines; the TLM components and the TLM Vision System. Changeover can be fully automatic. TLM – the compact machine which leaves nothing to be desired in terms of flexibility.

TOTAL, Birmingham 04 – 06 June 2013 Hall 5 | Booth H70 Welcome!

Orienting

Phone +49 - 7951 / 400-0 Fax +49 - 7951 / 85 88 info @ gerhard-schubert.de

Unpacking

Corporate News & Events

Cleanzone 2013 to Focus on Technology and Life Sciences The second Cleanzone, 22–23 October 2013, Messe Frankfurt, Frankfurt Am Mein, is off to a promising start with a stronger profile. Last year, the trade fair and congress made a successful debut as the new international industry meeting point for cleanroom technology.

It is targeted towards all companies and sectors in which industrial production is taking place under cleanroom conditions today and tomorrow.

The 2013 trade fair will therefore be focusing even more precisely on visitors coming from two important industrial sectors. ‘Technology & MicroTechnology’ is targeted towards the micro-electronics, micro-system technology, semi-conductors, aerospace technology, optical and laser technology, automotive, electronics and precision engineering markets. ‘Life Sciences’ is aimed at pharmaceuticals, cosmetics, sterile production of food, medical research, pharmacies and biotechnology. Overlaps can be found in the areas of medical technology and packaging solutions.

Many companies have already confirmed their attendance as exhibitors.

The flexibility of the overall concept, which allows exhibitors to present their products and services very individually, is particularly popular. “The industry welcomes our concept of showing cleanrooms in their various areas of application, explaining their use in practical terms. This applies both to the exclusive speaker programme on our Cleanzone Plaza stage area as well as to the exhibitors’ stand presentations. We are excited about the early announcement of a number of exhibitors to bring interactive and attractive exhibits to Cleanzone,” said Johannes SchmidWiedersheim, Director of New Events at Messe Frankfurt Exhibition.

Cleanzone is the new international cross-sector meeting place for cleanroom technology. It is organised by Messe Frankfurt and supported by its marketing and content partner ReinraumAkademie Leipzig. Participants from 13 countries made their way to Frankfurt for the debut in October 2012

and both the trade fair and congress earned top marks: 89% of visitors and 84% of exhibitors were ‘satisfied’ or ‘very satisfied’ with the event’s debut, 46% of visitors were from top management and 88% stated that they were able to influence purchasing and procurement decisions in their companies.

Both the international scope and thematic range of the trade fair and

congress are to be expanded in the second year. In 2013, Cleanzone will be held in Hall 1, alongside the CPhI Worldwide pharmaceutical ingredients event.

Messe Frankfurt Exhibition GmbH +49 221 16 99 59 30 kerstin.maenner@messefrankfurt.com www.cleanzone.messefrankfurt.com

Hydroflex Names UK Distributor for Cleanroom Mopping Systems

Partnership to Share Materials Characterisation and Processing Expertise

Hydroflex, a specialist supplier of cleanroom cleaning equipment, has appointed Connect 2 Cleanrooms as the main UK distributor of its range of cleanroom cleaning equipment.

Hydroflex realises the importance of strong service expertise and orientation to bring its high-tech solutions to the customer.

Malvern Instruments Ltd, UK, a materials and biophysical characterisation company, and NETZSCH Grinding & Dispersing, headquartered in Selb, Germany, a worldwide manufacturer of industrial wet and dry grinding, mixing, dispersing and kneading equipment, have entered into a cooperative marketing agreement. Both organisations serve a broad range of market sectors from pharmaceuticals, ceramics, nano-technology applications, food and surface coatings through to mining metals and minerals.

The global agreement, initially in place for three years, will harness the strength of each company’s brands and expertise in materials characterisation and materials processing. Under the terms of the agreement, NETZSCH will standardise on Malvern’s particle sizing and characterisation equipment, primarily the Mastersizer 3000 laser diffraction particle size analyser.

Customers and prospective customers of each company will gain access both to the extensive milling knowledge of the NETZSCH teams and to the particle sizing know-how of Malvern Instruments.

This combined approach supports the further development of solutions and services to meet increasingly specific individual customer needs.

Initially, Malvern Mastersizer 3000 systems will be installed in NETZSCH demonstration and test laboratories in key territories around the world — Germany, the US, Brazil, China, Korea, India and Russia. All trials, demonstrations and toll-production

Hydroflex mopping systems are designed to make cleaning processes more efficient, with savings of up to 55% on detergents and 20% in preparation time when compared with traditional methods. Options available include a plastic mopping package suitable for ISO 14644–1 areas from Class 7+ and GMP C/D cleanrooms along with a stainless steel mopping package suitable for ISO 14644–1 Class 5+ and GMP A/B cleanrooms. The company also provides a full range of mop heads (sterile option available) as well as wipes, frames and trolley systems to suit a wide range of cleaning requirements.

“We look forward to working with Connect 2 Cleanrooms, an excellent

and qualified partner that has the same mindset and is able to offer the expertise and service level that the market requires,” said Edward Becker, Product Management at Hydroflex. “Our customers will also profit from Connect 2 Cleanrooms’ flexibility as a mediumsized, well-run business that can react to their needs quickly and efficiently.”

Connect 2 Cleanrooms will promote the Hydroflex range through its fully transactional, global website www.cleanroomshop.com (a division of Connect 2 Cleanrooms). The company also has a specialist team of professionals that is able to advise clients on cleanroom products and protocols.

“We believe that the appointment as distributor of Hydroflex products offers a real opportunity for the cleanroom and healthcare community within the UK and internationally,” said Joe Govier, Managing Director of Connect 2 Cleanrooms and cleanroomshop.com.

“We are excited to add the Hydroflex precision mopping systems and trolley systems to our extensive range of products, enabling us to achieve one of our more important company objectives — offering our customers choice and quality cleanroom consumable products at affordable prices.”

Connect 2 Cleanrooms & cleanroomshop.com +44 1524 812899 info@connect2cleanrooms.com www.connect2cleanrooms.com / www.cleanroomshop.com

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At POWTECH 2013, Paul Walker (left), Managing Director of Malvern Instruments, and Dimitrios Makrakis, Managing Director of the NETZSCH Grinding & Dispersing Business Unit, announce an agreement to cooperate.

carried out by NETZSCH on customers’ materials in NETZSCH facilities will be routinely tested using Malvern instrumentation, with Malvern’s applications experts in each territory available to support the understanding and interpretation of data as required.

Jointly organised seminars and other initiatives will be targeted at key market sectors to deliver valuable information and support to customers and potential customers of either or both companies.

Malvern Instruments Ltd www.malvern.com NETZSCH Grinding & Dispersing www.netzsch.com/gd

LABORATORY PRODUCTS & EQUIPMENT

Discussion of Analytical Toolkit for Biopharma Applications Available Online A recent Malvern Instruments sponsored webinar, presented by specialists from the company, examined the need for specific analytical tools for biopharmaceutical applications. The recording of the live event, which attracted more than 600 registrants, is now available to view online at http://bit.ly/MALOTACB. In the presentation, Mark Pothecary and Paul Clarke, Product Manager and Product Group Manager respectively for Nanoparticle and Molecular Characterisation at Malvern Instruments, discuss a variety of the analytical technologies that are available for the growing biopharmaceutical industry.

They provide fresh insights into the use of a number of well-established characterisation techniques, including light scattering and size exclusion chromatography (GPC/SEC) and illustrate the use of these techniques in combination, showing how they can provide a wide range of complementary information useful to protein scientists.

The continued shift within the industry towards biopharmaceuticals has resulted in the need for analytical instrumentation that can quickly deliver compelling solutions to meet rapidly evolving

analytical and regulatory challenges. In particular, the move towards drugs using biomolecules as the active has stimulated advances in new analytical procedures. As well as traditional techniques, such as GPC/SEC and dynamic light scattering (DLS), which can be performed separately or in combination (SEC-DLS), new technologies including microrheology and resonant mass measurement are rapidly becoming essential components of the analytical toolkit.

Within Malvern Instruments, the company’s global Bioscience Development Initiative recognises the unprecedented pace of development in biopharmaceuticals and the onus this places on analytical instrumentation companies to quickly deliver solutions to a host of rapidly evolving analytical and

regulatory challenges. Malvern’s Bioscience Development Initiative is focused specifically on the requirements of the biopharmaceutical sector, most notably the biochemical and biophysical characterisation needs relating to formulation and product development.

Malvern Instruments Ltd +44 1684 892456 salesinfo@malvern.com www.malvern.com

Loop Filling Module Enables Automated Combinatorial Flow Chemistry The FlowSyn Auto-LF loop filling module from Uniqsis is a powerful and highly efficient module that allows chemists to automatically perform in sequence combinatorial flow chemistry experiments. Each experiment can be run under different conditions and utilise a different set of reagents or monomers.

Incorporating a separate liquid handler and fraction

collector, FlowSyn Auto-LF enables sample loop filling in preparation for the next experiment to take place before the current experiment has finished, thereby reducing overall reaction run-times. Additionally, the module has no injection ports to leak or block and the fully integrated, robust wash protocols minimise the risk of crosscontamination. Sampler calibration ensures that reagent plugs are positioned precisely in the loops to ensure volumetrically accurate partial loop filling that avoids wasting precious starting materials when performing reactions with different stoichiometries.

The powerful PC software included with FlowSyn Auto-LF makes real-time reaction monitoring and data logging straightforward. Data can be saved as a log file for each experiment to give an audit trail.

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The Uniqsis FlowSyn is a compact, integrated continuous flow reactor system, designed for easy, safe and efficient operation. The FlowSyn range includes models for performing single or multiple homogeneous or heterogeneous reactions, either manually or automatically.

The range of chemistries that can be explored with Uniqsis’ integrated and modular flow chemistry systems grows ever wider and is exemplified by the growing number of applications published both in the academic press and in Uniqsis’ own application notes.

Uniqsis Ltd +44 845 864 7747 info@uniqsis.com www.uniqsis.com

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Spectrometer and Photometer Extend Measurement Capabilities of Detection Range

LC Syringes Exhibit Minimal Carryover and Low Adsorption Effects

With the new BioSpectrometer and BioPhotometer D30, Eppendorf has extended its family of easy-to-use detection instruments that combine effective hardware with powerful software solutions. The new instruments offer additional measurement capabilities and features.

The detection instrument portfolio of Eppendorf is supported by accessories and consumables such as the UVette, a UVtransparent disposable cuvette, and the new semi-micro and macro Vis cuvettes. Additional accessories include reference filter sets and a microvolume measurement cell, the µCuvette G1.0, to measure sample volumes of only 1.5 µl.

“Eppendorf continues a longstanding tradition with over 60 years of experience in the field of photometry,” said Dr. Tanja Musiol, Global Product Manager Detection at Eppendorf AG. “From the very beginning, the focus was on obtaining maximum benefits while using the simplest handling methods. This philosophy has remained unchanged to this day. With the current product portfolio, Eppendorf allows the customer to select the optimal combination of devices and

With Hamilton X-Type syringes, a new generation of high-performance injectors for liquid chromatography (LC) will soon be available from CTC Analytics. X-Type syringes, developed in collaboration with CTC analytics, boast an extremely long life with minimal carryover and low adsorption effects. These syringes are suitable for analysing sticky samples and have been specifically developed for use in CTC PAL autosampler systems.

As the actual separation process starts when the sample volume is injected into the chromatographic system, injectors are the starting point in LC and the syringe is at the heart of this process. The injection is especially critical in the field of high throughput LC used in pharmaceutical analytics where highly efficient, long-life injection syringes are needed, as chemical inertness is a basic prerequisite. Since extremely small sample amounts are being measured, minimal carryover of sample substances and low adsorption effects is a must.

X-Type syringes are developed by Hamilton in collaboration with CTC Analytics and fully comply with all the requirements of a CTC system. Even in high throughput processes, the chemically inert syringes offer an extended product life. To prevent adsorption and minimise carryover of sample substances, the internal surfaces of the glass barrel have been smoothed

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accessories from a large, rapidly expanding range of products. From fluorescence-based applications to microvolume measurements, anything is possible.”

The Eppendorf detection family is used in a broad range of life science applications, including kinetic and fluorescence measurements as well as microvolume measurements. The combination of Eppendorf instruments, accessories and consumables enables users to perform many different tasks with variable sample volumes and concentrations in a flexible way.

Eppendorf UK Ltd +44 1438 735 888 sales@eppendorf.co.uk www.eppendorf.co.uk

by a special inorganic coating. The inside and outside of the needle are also coated to eliminate sample-to-surface binding.

The goal of minimising carryover drives the syringes’ construction, as the needle and glass barrel are directly attached to each other. Thanks to this adhesive-free and chemically inert bond, dead volumes are eliminated, leaving no voids where sample residues can remain and be carried over to the next injection. To achieve high mechanical stability even in the most demanding processes, the plunger tip is made of a specially formulated PTFE polymer.

This new syringe generation is well suited for handling sticky samples such as proteins, peptides, phospholipids and amino acids. X-Type syringes are available in volume sizes of 25 and 100 µl.

Hamilton Bonaduz AG +41 81 660 67 41 mnipius@hamilton.ch www.hamilton.ch

Pumps that Meet the

Speed-To-Market Challenge

Quattroflow™ positive displacement quaternary (four-piston) diaphragm pumps offer high purity, containment and one of the highest turn up/down capabilities in biologics and pharmaceutical production applications.

• • • • • •

Scale-up capability assures pump operation does not adversely affect results Constant flow rates from 1 L/hr (0.0047 gpm) to 20,000 L/hr (88 gpm) Gentle transfer of shear-sensitive biological products Self-priming and risk-free dry running Ensures product safety, efficiency and reliability Available in Single-Use and Multi-Use head options

ALMATEC Maschinenbau GmbH Carl-Friedrich-Gauß-Str. 5 47475 Kamp-Lintfort, Germany O: +49/2842/961-0 F: +49/2842/961-40

www.quattroflow.com

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LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Aspiration System Guarantees Safe Disposal of Liquids in Biosafety Level Labs The VACUSAFE laboratory aspiration system from INTEGRA is designed to provide simple, reliable and safe aspiration of hazardous waste liquids in microbiological and biomedical laboratories.

The essential elements of the four biosafety levels for activities involving infectious microorganisms and laboratory animals have been laid down by the US Center for Disease Control (CDC). The levels are designated in ascending order, by degree of protection provided to personnel, the environment and the community. The CDC guidelines dictate that in biosafety level 2 and 3 areas that laboratory equipment should be routinely decontaminated as well as after spills, splashes or other potential contamination. Moreover, vacuum lines/devices must be protected with HEPA filters or their equivalent. Filters must be replaced as needed.

The VACUSAFE enables biosafety level 1, 2 and 3 laboratories to comply with the stringent user safety guidelines for handling contaminated solutions while maximising productivity and minimising noise and operational inconveniences.

The VACUSAFE is a dedicated standalone product for the convenient and safe disposal of almost any

Evolving High Content Screening with Inverted Microscope Frame

biological liquid waste. The VACUSAFE has a range of important safety features, including a dependable liquid level sensor to prevent overfilling of the shatterproof waste bottle, an easy-toreplace hydrophobic filter that blocks potentially dangerous aerosols from entering the laboratory workspace and fully autoclavable components to protect staff from biohazards.

For total containment of hazardous liquids, the compact VACUSAFE includes an integrated pump with vacuum control, thereby eliminating the risk of contaminating house vacuum pipelines and reducing environmental impact caused by evaporation of volatile elements. The air outlet can be connected to silicon tubing to direct exhaust air into a safety hood or through an additional HEPA filter to produce a totally closed system. Self-closing quick connectors prevent the escape of drops or aerosols when disconnecting the waste bottle and tubing. A sturdy handle makes the carrying and emptying of the VACUSAFE waste bottle really simple and effortless.

Operating the VACUSAFE is straightforward — simply switch on, set the desired vacuum and start working.

The integrated pump is switched off automatically when the vacuum is established in the bottle and is switched on again when the vacuum is used; this way, unnecessary noise is avoided and the pump’s lifetime increased. With a wide range of VACUBOY adapters included, removal of liquids is possible from virtually any container or microplate.

INTEGRA Biosciences AG +41 81 286 9530 info@integra-biosciences.com www.integra-biosciences.com

The scan^R 2.4 high content screening station is the latest addition to the growing collection of microscopy systems based upon the new IX3 high-end inverted microscope frame. Thanks to its open source design concept, the IX3 is offering a completely modular and flexible approach to live cell imaging. Built around a swappable deck design, optical modules can be easily exchanged into the accessible infinite light path, moulding the IX3 microscope to the diverse requirements of the user. The updated Olympus scan^R 2.4 high content screening station can now be incorporated with the most advanced model of the IX3 range, the fully automated IX83, combining benefits of a modular frame design with increased scan speed. This new system delivers quantitative expert results in a vast array of high content screening of cellbased assays, from gene expression to bacterial infection assays.

Keeping pace with the IX3 platform, the scan^R 2.4 software capabilities have also been extended, including fully supported multi-core analysis and kinetic analysis for advanced

microscopy techniques. Furthermore, cell population data can be easily exported so users can jointly benefit from all the flexibility offered by complex experiments in the Olympus xcellence imaging software. The workflow-orientated graphical user interface has also been updated, allowing the advanced capabilities of the scan^R 2.4 station to be operated in a straightforward and intuitive manner, for routine and highly complex assays alike.

These new features build upon the performance of the scan^R stations’ high-speed image acquisition and analysis. The dedicated real-time controller ensures precise timing of image capture, avoiding photobleaching and phototoxicity while maintaining the optimum scan speed.

Designed to be flexible to user requirements, the scan^R 2.4 station is optimised for many different assay formats, including multi-well plates, slides and custom-built arrays.

Olympus Europa Holding GmbH +49 40 23773 5913 microscopy@olympus-europa.com www.microscopy.olympus.eu

Quality. Performance. Serrvvice. v

Flexible

Scalable

Improved Yields

For more information, ormation,, pplease visit 3M.ie/filtration/biotechnology or contact one of our filtration specialists on +353 (0)1 2803555

3M Zeta Plus Encapsulated System Scale-up Capsule Filters ™

™

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LABORATORY PRODUCTS & EQUIPMENT ROUNDUP High-End Biological Safety Cabinets Offer Low Noise and Power Consumption Telstar has launched its latest range of high quality Class II biological safety cabinets, reportedly designed to provide the highest level of protection for operator, product and environment by minimising hazards inherent to working with agents assigned to biosafety levels 1, 2 and 3. BioVanguard Series is comprised of two different models: BioVanguard and BioVanguard B. BioVanguard is designed for microbiological research with biological agents (bacteria, viruses, etc.) and allergens. BioVanguard B (with additional first stage HEPA filtration) is designed for high risk microbiological and highly toxic applications, such as the production of cytotoxic medicines.

According to the company, the BioVanguard Series has been designed in accordance with the highest

standards of quality, biological safety, reliability, ergonomics and usability.

Possessing all the features of an ergonomic, high quality and performance cabinet, the BioVanguard Series is designed to offer low sound level, low energy consumption and low maintenance costs. In terms of energy efficiency, this range of cabinets has Green Line EC fans, resulting in lower energy consumption (about 30% less than the average biological safety cabinet).

Characteristic features of the BioVanguard Series are the ergonomic sloped front window, easy-to-clean sliding/hinged front window, ultra-safe multi-shell construction, UV light and gas valve safety control, worktop with air slots, maintenance reducing pre-filter and drip tray, filter clogging

compensation and patented 4F System (Fast, Friendly and eFFicient) to support replacement of the filters.

Furthermore, downflow velocity can be set up to 0.45 m/s (according to GMP Annex 1 and PIC regulations) and connections are available for particle count sensor, pressure sensor and temperature/relative humidity sensor.

Today, Telstar is one of the world’s top five manufacturers of biosafety cabinets and one of the top three manufacturers of laboratory freeze dryers. The company holds a 15% share of the world market for biosafety cabinets for laboratories.

Telstar +34 93 736 16 00 marketing@telstar.eu www.telstar.eu

Software Provides Reliable Tracking System for Irreplaceable Samples With laboratory regulations becoming increasingly tight, it has never been more important for scientists to be able to track and validate their systems. Pro-curo Software assists in meeting these stringent standards through its comprehensive tracking and reporting software package, which includes powerful search functions, automatic printing of 2D barcodes and a multi-level location structure. Fully compliant with the FDA’s 21 CFR Part 11 requirements, Pro-curo software stores a complete history of every sample transaction for future traceability, meaning users can be sure that irreplaceable samples are monitored and that they always have access to historical reports.

Having a complete audit trail with full traceability is essential in studies involving the use of human material.

However, there are many laboratories still using traditional paper systems or nonspecialist software packages, such as Excel, to track their samples. This creates considerable scope for error and exposes laboratories to the risk of losing samples, with potentially serious consequences for their research. Also, the inability to prove the source and movement of samples could lead to the confiscation of materials, with severe financial implications for institutions.

Pro-curo software can track samples from multiple research projects. It also has functions to remotely book samples

in and out and supports 2D barcoding. According to Pro-curo Software, its tracking and reporting solution is the most comprehensive possible and can be incorporated into a variety of existing systems across a range of laboratory types.

Every Pro-curo software user has complete access — by phone, email or live chat — to the company’s 24-hour customer support service for round-the-clock security.

Latest Microplate Reader Range Meets Requests of Scientists Biochrom has announced the launch of its EZ Read range of microplate readers, developed to meet the specific application needs of scientists.

Biochrom has created the EZ Read microplate reader range by matching its expertise in absorbance measurement with requests from scientists and technicians to make their experimental workflow easier and more effective.

Biochrom’s focus on scientists’ requirements has resulted not only in a dedicated range of instruments but also in the development of outstanding data acquisition and analysis software; Galapagos for EZ Read.

Measurement of ELISA assays is a

major application of absorbance-based microplate readers. Biochrom offers a comprehensive solution for scientists running ELISA assays using Galapagos software’s intuitive ‘click and drag’ approach for setup and analysis as well as offering a shaker/incubator and a microplate washer to complete the ELISA workflow. Biochrom’s EZ Read range offers a broad range of ELISA microplate readers so that scientists can choose the right instrument for their laboratory environment.

For research scientists, Galapagos software for EZ Read enables quick setup of data analysis, making it just as easy to analyse data as to export to

Excel. The extensive EZ Read instrumentation range enables scientists to measure all their absorbance assays such as ELISA, total protein and cell viability assays, without the need to buy and install extra filters.

The EZ Read range builds on the success of the EZ Read 400, which was launched in 2011 and is now relied upon by scientists in ELISA labs globally. The EZ Read 800 provides the same reliability and flexibility as the EZ Read 400 but is faster, making it an excellent choice for high throughput laboratories.

The EZ Read LED also provides fast measurements of ELISA assays but uses LEDs for reduced energy consumption and reduced maintenance. For the greatest range of versatility, the EZ Read 2000 has flexible wavelength selection, allowing scientists to choose any wavelength from 340 to 800 nm.

Tristana von Will, Product Marketing Manager at Biochrom, commented: “This new range of microplate readers and software builds on our 40-year heritage in providing high-quality scientific instruments and has been developed to meet the needs of both ELISA labs and research scientists using microplate readers for their experiments.”

Biochrom Ltd +44 1223 427 813 tristana.von.will@biochrom.co.uk www.biochrom.co.uk

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Pro-Curo Software Ltd +44 1403 788807 info@pro-curo.com www.pro-curo.com

Microplate Barcoding Service Helps Ensure Traceability Porvair Sciences has announced a new barcoding service for its complete range of 24-, 48-, 96- and 384-well microplates. Highquality barcode labels can be affixed to any side of a Porvair microplate to assist in ensuring sample traceability. Porvair’s barcoding services offer a nonrepeatable barcode sequence to prevent label duplication.

The barcode labels have been tested for optimal readability as well as solvent resistance and prolonged exposure to temperatures ranging from -80 to +80˚C. Flexible, customisable barcoding options include CODE 39 (3 of 9), CODE 128, 12/5 and PDF417 symbologies, with or without human-readable text and a choice of label position on the microplate. Advice on which barcode symbology is best is available from Porvair’s technical support team.

Porvair Sciences Ltd +44 1372 824290 int.sales@porvair-sciences.com www.porvair-sciences.com

SHOWCASE SAMPLE PREPARATION

NTA Characterises Drug Carrier Polymer Nanoparticles at Saarland University Eppendorf has introduced four new rotors for 5804/5804 R and 5810/5810 R centrifuges, which are defined as true workhorses of the laboratory with their renowned quality, reliability and versatility.

Two new swing-bucket rotors increase the capacity of Centrifuge 5804/5804 R to one litre and Centrifuge 5810/5810 R to three litres. The new three-litre swingbucket rotor (4 x 750 ml) reportedly makes the Centrifuge 5810/5810 R the smallest three-litre centrifuge available and contains options for round and plate buckets, either of which can use new aerosol-tight Eppendorf QuickLock caps for one-handed operation. Also, the new aerodynamic round bucket

design allows for energy savings up to 36% (compared with rotor A-4-81).

In addition, there are two new fixedangle rotors now available for both 5804/5804 R and 5810/5810 R. These rotors include aerosol-tight Eppendorf QuickLock lids, which require only a quarter turn. The new 48 x 1.5/2 ml rotor (FA-45-48-11) has a max speed of 19,083 x g. Also available is a high-capacity fixed-angle rotor for 15 ml conical and glass tubes (F-35-48-17), with capacity for 40 x 15 ml conical tubes and max speed up to 5,050 x g.

Eppendorf UK Ltd +44 1438 735 888 sales@eppendorf.co.uk www.eppendorf.co.uk

Life Science Products Distributor Provides Microzone PCR and DNA Reagents Cambio is able to supply its customers with a selection of reagents by Microzone. MegaMix, microLYSIS and MicroCLEAN are each specifically designed as convenient and efficient solutions for PCR, DNA release and DNA clean-up respectively. By incorporating these reagents into their procedures, life scientists can save time that would otherwise be spent creating their own mixes as well as reducing risk of contamination. Thanks to their standardised formulation, the Microzone reagents also dramatically increase the reproducibility of DNA amplification, giving researchers the upmost confidence in their methods and therefore their results.

MegaMix is a PCR master mix containing all the fixed components needed for PCR amplification, including

an enzyme cocktail consisting of two Taq polymerases, dNTPs, MgCl2, reaction buffers and enzyme stabilisers. All these components are optimised to maximise yield with minimal non-specific background and the product is exceptionally easy to use — the MegaMix just has to be thawed, the recommended volume drawn and DNA and primers added. MegaMix can survive multiple freeze/thaw cycles without deterioration of either product or function. MegaMix is also available with dye to allow easy visualisation and double concentrated for added convenience.

In addition, Cambio also supplies Microzone’s MicroCLEAN and microLYSIS products. MicroCLEAN is a rapid, one tube, one and a half spin DNA reagent, which cleans up any double

stranded DNA from reaction buffers, enzymes, primers or dNTPs. The versatile reagent has no limit on the size or volume of the target DNA and requires no additional manipulation such as phenol extractions or spin columns.

Finally, microLYSIS and microLYSIS-Plus are reagents designed for use as a pre-step to PCR. When combined with rapid heating and cooling of thermocyclers, the mycroLYSIS formulation effectively lyses the cells and enables users to reach the PCR stage in less than 15 minutes. For tougher cell samples, such as those found in plant and some animal tissues,

High-Performance Benchtop Freeze Dryer Offers Long-Term Versatility The new VirTis BenchTop Pro freeze dryer range from SP Scientific has been designed to be highly affordable, yet meet the needs of the most demanding research laboratories. Each system can be configured to meet present and future needs.

Condenser refrigeration packages of -55, -75, -85 and -105˚C meet the demands of both aqueous or aqueous solvent based formulations. Systems can be configured for smaller sample numbers or to process a relatively heavy workload with condenser size choices of 3, 8 or 9 l. This built-in flexibility maximises use of the freeze dryer and eliminates paying for unnecessary capacity or refrigeration.

Manifolds are available in a variety of easily interchangeable styles. In applications where inorganic solvents are being utilised or the customer is rack

drying and wants to ensure visibility, an acrylic manifold is the option of choice.

For laboratories tasked with organic solvent applications, the stainless steel manifolds will provide a lifetime of use.

Traditional time losses incurred from lengthy condenser defrost and clean-up procedures are minimised with the new hot-gas defrost facility on the BenchTop Pro. Designed for both the occasional user and freeze drying expert, the BenchTop Pro Omnitronics controller simplifies freeze drying and makes the system easy to operate. One-touch startup and shutdown ensure that product and freeze dryer are protected from inadvertent operational procedures. An intuitive graphic display provides users with at-a-glance understanding of the status of the freeze dryer and whether or not appropriate freeze drying conditions

exist. Audible alarms help notify the user of potential problems with the system and hence, with the product.

All Omnitronics controllers come complete with a trending screen that allows the user to watch critical parameters on an ongoing basis if required. Utilising optional ethernet control, the freeze dryer can be connected to a network and be monitored and controlled from any other location on the network. The ethernet option also allows printout in a batch record, alphanumeric type report.

Genevac Ltd +44 1473 240000 salesinfo@genevac.co.uk www.spscientific.com

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microLYSIS-Plus can still offer the same impressive results.

Cambio Ltd +44 1954 210200 support@cambio.co.uk www.cambio.co.uk

Corporate News

Applications Invited for 2013 Royal Pharmaceutical Society Science Award Applications are invited for the 2013 Royal Pharmaceutical Society Science Award. The winner will receive a Commemorative Award, £1,000 in prize money and an invitation to present the RPS Award Lecture on their work at the Academy of Pharmaceutical Sciences UKPharmSci annual meeting on 2 September 2013.

Applications are welcome from scientists worldwide who are working in a pharmaceutical or allied discipline in industry or academia. With no more than 10 years’ experience at postdoctoral level, applicants must have a proven record of independent research

and published work that shows outstanding promise.

Applicants are invited to submit the following details by 31 May 2013: • Full CV detailing personal information, past and present appointments, research responsibilities and published work.

• List of research students who have worked for the applicant and their thesis titles and dates, plus any other instances of research collaborations.

• Details of research grants awarded and the candidate’s role.

• Invitations to speak at conferences in the UK and overseas, lecture or

Powder Characterisation Company Announces Applications Team Appointment Freeman Technology has employed Doug Millington-Smith in the role of Applications Specialist. Educated to PhD level, Millington-Smith has a background in chemistry and considerable experience in supporting the use of high-precision scientific instrumentation.

He is based at Freeman Technology’s headquarters in the UK and will be involved in supporting users of the FT4 Powder Rheometer right through from initial installation and training to ongoing education and applications support.

Welcoming Millington-Smith to the team, Managing Director Tim Freeman said: “FT4 users around the world know

D. Millington-Smith, Applications Specialist at Freeman Technology.

symposium titles and names of awards.

• A brief resume of two pages should also be submitted with the CV, indicating discoveries made (please note, copies of publications are not required).

Applications should be made to Prof. Jayne Lawrence, preferably by email to: jayne.lawrence@rpharms.com/ or by post to: Prof. Jayne Lawrence, Chief Scientific Advisor, Royal Pharmaceutical Society, 1 Lambeth High Street, London, SE1 7JN.

Royal Pharmaceutical Society +44 207 572 2737 jayne.lawrence@rpharms.com www.rpharms.com

Autoclave and Steriliser Manufacturer Opens US Business

they can call on the expertise and experience both of our representatives on the ground and the team working at our UK headquarters. The FT4 Powder Rheometer is now used in a diverse range of industrial situations and we are growing our teams to ensure that we continue to develop the customer support excellence for which we are known.”

Millington-Smith will be involved in installing instruments at user sites and providing initial user training. Users will then be able to turn to him for remote advice and continued support in all areas, including analysis and data interpretation if needed.

“The fact that Freeman Technology demonstrates the potential of its products through meaningful research makes it a very attractive company to work for,” said Millington-Smith. “I am delighted to now be part of such a successful team and am enjoying helping people across many different areas of powder characterisation to make the most of their experience with our instruments.”

Freeman Technology Ltd +44 1684 851 551 pr@freemantech.co.uk www.freemantech.co.uk

Astell Scientific has announced the opening of its US subsidiary, Astell Inc, in Charlotte, North Carolina. With Astell Scientific in the UK currently having great success exporting to more than 60 countries worldwide, the company is confident that its new base in America will further contribute to the significant overseas growth it has seen in recent years.

The opening of this new office will enable the Astell brand to gain further recognition in the US market. Over the last four years, Astell’s export sales team has been cultivating strong relationships with US companies, so setting up a North American subsidiary was the obvious next step to ensuring a strong foothold and presence in the US sterilisation market.

Rich Apolinar, the newly appointed CEO of Astell Inc, said: “The development and expansion of Astell’s business into the US is a very exciting opportunity. Our in-house knowledge and experience, combined with the many technical advantages and costeffective advantages that Astell can offer over the competition, should ensure our success and growth in the evolving US markets.” Apolinar has over 25 years’ experience in the sterilisation industry, having worked in various engineering

and business development positions globally. Along with his expertise, he has developed the management skills, market knowledge and in-depth technical expertise to support successful growth.

Whilst Astell Scientific products speak for themselves in terms of quality and application, having an in-house expert in the US will prove invaluable to customers. Astell Inc will ensure that US customers receive exceptional practical advice and specific application assistance when choosing an autoclave or steriliser. Professional after-sales service and support will also be provided, ensuring customer and satisfaction during the lifetime of the product.

Astell Inc +1 704 455 0456 info@astellinc.com www.astellinc.com

Life Sciences Centre of Excellence to Open in Portsmouth Pall Corporation has confirmed plans for a Life Sciences Centre of Excellence at its new Harbourgate site in Portsmouth, UK. The Centre of Excellence (COE), which will open in mid 2013, will offer a full suite of capabilities, including cell culture, purification, analytical solutions, protein characterisation and microbiological tools. This latest COE will complement recently announced Life Sciences Centres in the US (Westborough, Massachusetts, and Menlo Park, California) as well as investments

previously announced in China, Singapore and India.

“The announcement of Pall’s new Portsmouth Centre of Excellence provides another example of our commitment to meeting the diverse needs of our life sciences customers across the globe,” said Yves Baratelli, President, Pall Life Sciences.

“Portsmouth represents an important life sciences hub for Pall. By upgrading and expanding our capabilities at the site, we are not only enhancing our ability to service our customers but also

creating a multi-disciplinary and responsive environment in which Pall scientists and engineers can thrive and innovate.”

The new Portsmouth COE will include a dedicated 4,000 m2 scientific area with a connected walkway to another recently opened facility that houses an additional 2,000 m2 for life sciences technical support and training, R&D engineering and product management.

Manufacturing and test areas will remain at the current Walton Road site in Portsmouth.

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In addition to customer service support, COE offerings will include the development, testing and validation of a wide range of products that now form part of Pall’s portfolio. According to the company, there will also be an extensive range of scale-up technology on hand for applying industry-leading standards to match demands for fully representative and rapid drug development.

Pall Corporation +1 516 801 9944 doug_novarro@pall.com www.pall.com

INGREDIENTS & CONTRACT SERVICES

Successful FDA Inspection for UK Contract Laboratory Company Wickham Laboratories — a specialist GMP contract analytical services provider, based in Hampshire, UK — has reported a successful conclusion to its recent FDA inspection at its Hoeford Point facility in Gosport. In March 2013, the inspector spent three days at the laboratories reviewing quality systems and evidence of consistent application of documented procedures as well as test data generated by the microbiology and toxicology departments relating to specified products.

According to Wickham Laboratories, no 483s (written non conformances) were raised and verbal feedback received from the inspector commented on the quality of the excellent facilities, staff expertise and GMP systems.

Wickham Laboratories has been established for 50 years in the south of England and is now reportedly recognised as the UK’s largest single site GMP microbiology contract

organisation, serving UK and overseas clients in both pharmaceutical and medical device industries. It remains a privately-owned company.

Dr. Lee Humpheson, Business Development Manager at Wickham Laboratories, commented: “The positive outcome of our first FDA inspection since relocating to our new facility is justification for the time, money and energy our company has invested over the past 18 months. This latest regulatory inspection compliments the positive feedback given by the UK MHRA in May 2012 and numerous Wickham Laboratories clients who have visited and audited our facilities over the past year.”

Wickham Laboratories +44 1329 226600 mail@wickhamlabs.co.uk www.wickhamlabs.co.uk

Agreement to Co-Promote Technology for Improved Drug Solubility and Stability Hovione has announced a co-promotion and collaboration agreement with Ligand Pharmaceuticals to provide Hovione’s customers with efficient access to Captisol technology.

Captisol, a chemically modified cyclodextrin, is proven to improve the solubility and stability of drugs and is currently used in six marketed products.

Hovione offers particle engineering technologies to improve the solubility of modern drugs. The agreement allows Hovione to use Captisol technology in its solubilisation programmes, which include amorphous solid dispersions, crystal design and size reduction and

control of particle size. By adding this new technology, it increases the likelihood of solving the molecule’s bioavailability challenges.

“Hovione is delighted to announce the ability to provide access to Captisol.

There is no single solution to improving bioavailability and for a customer to access diverse options with a single supplier provides for greater probability of success and speedier outcomes,” said Dr. Colin Minchom, Hovione’s Vice President of Particle Design.

“Hovione has manufactured Captisol for more than a decade and we are very pleased to expand our partnership to

help customers succeed. Providing for greater access to Captisol should efficiently enable the successful development of more poorly soluble molecules and further increase our Captisol partnership portfolio,” said Mathew W. Foehr, Ligand’s Executive Vice President and Chief Operating Officer.

Hovione +351 21 982 9362 ipina@hovione.com www.hovione.com

CDMO’s Fontaine Site Receives Approval for Supply of Manufactured Products to Japan Recipharm’s solid dose facility in Fontaine, France, has been approved for supply of manufactured products to the Japan’s pharmaceuticals market following a recent inspection by the PMDA, the Japanese drug agency.

The product dossier was presented by an existing contract manufacturing customer, also securing regulatory approval for its supply to Japan.

The Fontaine site is one of Recipharm’s solid dose forms sites and until 2009 was owned by Solvay Pharma (now Abbott). The facility is also approved to supply to the US. In addition to manufacturing, the site also has a distribution centre for delivery to pharmacy level within France.

As a consequence of this latest regulatory approval, Recipharm now supplies an extensive range of products to the Japanese, the US and European markets from a number of its facilities

located in Europe. Indeed, the development marks a further significant step forward in the company’s international drive to access and expand its reach into a multitude of key geographic regions and countries.

Stéphane Guisado, Recipharm Fontaine’s General Manager, commented: “We are very pleased to have secured this approval. Supplying products to Japan involves carrying out a substantial number of additional activities and meeting stringent requirements for enhanced quality control and we have met these challenges head on. We were also able to draw upon experience from other Recipharm sites that are already supplying this key market. As a result of this approval, we are now in a good

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position to further support other customers with their plans to penetrate and expand sales in specific pharmaceutical markets within Japan.”

Recipharm AB +46 8 602 52 00 info@recipharm.com www.recipharm.com

INGREDIENTS & CONTRACT SERVICES ROUNDUP cGMP Biopharma Manufacturing Operation Opens in Brisbane we are already seeing flow-on benefits from local alliances.”

The DSM operation will provide cGMP mammalian cell culture contract manufacturing services from process development through to commercial manufacturing. DSM Biologics operates with all standard technologies and also has a portfolio of proprietary technologies for the optimisation of DSM Biologics Brisbane (centre), adjacent to the Translational biopharmaceutical Research Institute of Queensland. manufacturing, reducing the cost and risk of DSM Pharmaceutical Products mammalian cell culture. The facility has +1 973 257 8160 an annual output capability of 500 kg guy.tiene@dsm.com and has expansion space available for www.dsmbiologics.com / www.dsm.com further capacity utilisation.

DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM, has announced that its new cGMP custom biopharmaceutical manufacturing ‘biologics plant of the future’ will open in June 2013.

The DSM facility was built with cooperation from the Queensland and Commonwealth Governments of Australia. Karen King, President of DSM Biologics, the biopharmaceutical manufacturing business of DSM Pharmaceutical Products, said: “We are thrilled to announce the June opening of our new cGMP facility in Brisbane. This operation combines DSM’s 25 years of experience and high quality track record in mammalian cell culture manufacturing with a state-of-the-art commercial and development facility. Our partnership with the Government of Queensland and the Commonwealth of Australia has led

to this important addition to the Australian biotechnology industry and will be a key contributor to the entire Asia-Pacific region.”

Australia has a vibrant biotechnology industry but previously had no custom mammalian-based biopharmaceutical manufacturing operation in country. The Queensland Government formed BioPharmaceuticals Australia (BPA), which has partnered with DSM to bring this new facility and operation to Brisbane.

David Hughes, CEO of BioPharmaceuticals Australia, said: “The opening of this facility satisfies a national capability gap. Our partnership gives Australia and the wider region access to DSM’s extensive experience, expertise and ongoing commitment to developing improved bioprocessing technologies.

DSM’s operations are a good strategic fit with Australia’s existing capabilities and

Packing and Distribution Facility Further Enhances Pharma Outsourcer’s Offering

Commercial Filling Line Ready for cGMP Filling with First Customer Project Underway

Quay Pharma is adding to its range of services to support clinical trials with the establishment of a dedicated packing and distribution facility at its Deeside, UK, headquarters. The new £100,000 MHRA (UK Medicines and Healthcare Products Regulatory Agency) approved area will give Quay the flexibility to respond to client requirements for bulk delivery of product and to meet increasing demand for just in time deliveries to support randomised and blinded studies.

Quay offers the filling of primary packs, including bottles, tubes, blister packs, sachets and oral dosing syringes, followed by secondary packing. As well as providing multi-language labelling, blinding and randomisation, working with its sister company Chester Medical, a commercial packaging provider, Quay can provide individually designed patient packs that are optimised to aid patient compliance and assist in trial success.

Quay also supports cold chain management, including shipping and storage to ensure product quality and security are maintained throughout the distribution process. The inclusion of tamper evident seals and code break labels can be incorporated as part of the packing process.

The new facility is the latest development for Quay’s purposedesigned £2.5 million factory in Deeside, which was opened in June 2010 and offers a wide range of specialist services, including formulation development, drug delivery design, analytical method development and clinical trial manufacture.

“Quay has developed this service to assist a number of our clients for whom we have developed products, as they move through to Phase II and Phase III clinical trials,” commented Quay Pharma Chief Executive Maireadh Pedersen.

“This is an important enhancement to our client offering, enabling us to continue to support our customers throughout their development phase.”

Quay Pharma +44 151 203 9800 enquiries@quaypharma.com www.quaypharma.com

Vetter’s new award-winning filling line at the company’s Ravensburg Vetter South facility is fully validated and ready for cGMP filling, after successful media-fill completion. One customer project is underway, with more in the wings. The line’s capacity ranges from mid- to largevolume batch sizes, with a maximum filling speed of 800 pre-sterilised syringes per minute. The line currently fills 1 ml standard-format syringes, with additional formats to be added in the near and long terms. Featuring technologies that enhance safety and maximise API yield, it was designed to exceed cGMP requirements.

Highlights of the new commercial line, which features both speed and flexibility, include: • Minimal human contact to enhance safety.

• Fully automated transfer of sterile packed tubs from preparation room to Class-A cleanroom and throughout the filling process. Includes a reportedly novel approach to zonal transition when moving tubs to higher cleanroom classes.

• Use of RABS. • Exceptional disinfection techniques.

• A special spray disinfection tunnel for bagged tubs, co-developed by Vetter and the equipment manufacturer.

• Optimised personnel and material flows.

• One-way design to minimise potential for product mix-up and contamination risk.

• Advanced track and trace.

• An end-to-end track-and-trace system with integrated scanners and printers, including automated disposal of rejects and sample removal following the filling process.

• Techniques and technology to maximise API yield.

• Optimised routing that shortens the distances between the compounding area and filling station.

• 100% fully automated in-line control of syringe closures using a 3D scanner prior to filling to minimise API loss and reduce risk of contamination.

• In-line monitoring of filling quantities using an automatic weighing system.

Peter Soelkner, Vetter Managing Director, noted: “With our launch of the new filling line, Vetter continues to expand its prefilled-syringe capabilities due to increased customer demand.

Whether our customers require smallbatch clinical fills or high-volume commercial fills, we can accommodate their needs.”

Vetter Pharma International GmbH +49 751 3700 3023 prnews@vetter-pharma.com www.vetter-pharma.com

CDMO Supports Clinical Scale-Up for Varicose Veins Treatment SCM Pharma will assist BTG in preparation for the commercial launch of Varisolve (polidocanol endovenous microfoam (PEM)), after providing clinical development consultancy for the product for several years.

The UK-based CDMO has worked with specialist healthcare company BTG since 2005, assisting with clinical studies through to the recent pivotal Phase III clinical trial supply.

PEM is being developed by BTG as a comprehensive treatment for the appearance and symptoms of varicose veins. In the US alone, over 40 million patients suffer from varicose veins.

To date, SCM Pharma has supported BTG with process development, sterile manufacturing, packaging and distribution to trial sites in the US. The CDMO will now be named on the New Drug Application (NDA) for PEM as a commercial supplier and is prepared to further support BTG throughout the NDA review process.

Dianne Sharp, Managing Director at SCM Pharma, said: “We are very proud to be supporting BTG with its NDA for Varisolve, as it is a product that we have helped them develop for many years.

“The complexities involved in developing, processing and producing this product illustrates the type of work we do here at SCM Pharma. Working with D. Sharpe, Managing Director, SCM Pharma. novel products, difficult processes and applications and often commercial facility that will reinforce its dangerous substances and APIs at expertise in vial, ampoule and syringe relatively smaller scale is very much our filling, particularly when dealing with sweet spot.” highly potent and toxic products that SCM Pharma is an award-wining require aseptic filling. manufacturer specialising in the sterile production of products for clinical trials SCM Pharma Ltd along with the supply of licensed drugs +44 1661 833 693 in niche markets. It is currently gearing info@scmpharma.com up for the opening of its new www.scmpharma.com

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Medical Plastics Manufacturing Injection Moulding Medical Materials Extrusion & Thermoforming Automation & Robotics Process Control Prototyping Cleanroom Regulation Design

R E T S REGI .. .

N OW

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25-26 September 2013 NEC, BIRMINGHAM, UK

www.mediplasuk.com

INGREDIENTS & CONTRACT SERVICES ROUNDUP Market Alerted to Explosive Properties of Reclassified Reagent Novasep’s R&D team has discovered and characterised the explosive properties of the Togni reagent II and intermediates at the Novasep Leverkusen site in Germany. The findings have been published in the March edition of the journal Organic Process Research and Development.

Togni reagent II (1-(trifluoromethyl)-1,2benziodoxol-3(1H)-one, 1) is a versatile reagent for the electrophilic introduction of trifluoromethyl groups. It is used in pharmaceutical manufacturing. It is also widely used by universities.

Novasep conducted a Koenen test on a sample of Togni Reagent II prepared in its kilolab, in which the reagent was

Novasep operating Koenen test.

shown to be highly explosive. Another critical property of the Togni Reagent II clarified by the Novasep team is its fast combustion when ignited. The combustion factor was measured as BZ6, the same classification as black powder.

This discovery has resulted in a revised classification for handling and transportation of the Togni reagent II, which must now be approved by national competent authorities. Novasep has also informed companies known to market the compound, which will relay the safety measures required to handle the reagent.

Tests were conducted at the Novasep Leverkusen plant. The plant has German government authorisation to handle energetic materials and operate hazardous reactions from the laboratory to thousands of tonnes scale. This has enabled Novasep to develop reliable and cost-efficient processes that satisfy regulatory requirements whilst maintaining safety for technical staff and its plants.

The skill developed by Novasep includes managing large-scale reactions that use sodium azide, reactive metals, diazomethane and diborane (both in gaseous form), hydrazine, ozone and nitroalkanes. These chemical reactions are often more direct and cost-efficient than traditional routes of synthesis. They generally create fewer by-products and have a high yield and productivity.

Novasep Leverkusen site in Germany.

“Novasep has used our 140 years’ experience and the knowledge of our R&D team in highly energetic reagents and reactions as well as our specialised equipment to be able to identify another set of dangerous properties of a commonly used compound,” said Dr. Jan Haller, Senior Scientist, Process Development, Novasep. “We consider it very important to share this knowledge with scientific, manufacturing and regulatory communities to ensure that this compound is treated in a safe manner.”

“The work completed by Novasep regarding the Togni Reagent II will contribute to a more deliberate and responsible handling of the reagent used by so many research groups,” said Professor Togni, Professor of Organometallic Chemistry at the Laboratory of Inorganic Chemistry, ETH Zürich, Switzerland, and inventor of the reagent.

Groupe Novasep +33 383 49 70 00 customer.services@novasep.com www.novasep.com

Formulation Development and Clinical Testing Solution Extends into Non-Oral Routes of Delivery Quotient Clinical, part of Quotient Bioresearch (Quotient), has announced that three new pharmaceutical and biotech clients have selected its RapidFACT (Rapid Formulation development And Clinical Testing) service to support the development of optimal drug products for pulmonary, transdermal and ocular administration.

This marks a key extension in the

application of RapidFACT across a wide range of dosage forms and delivery routes.

RapidFACT is underpinned by a translational pharmaceutics platform that integrates formulation development, real-time GMP product manufacturing and clinical testing. Compared with conventional development processes, RapidFACT shortens development

timelines, lowers costs and also reduces the consumption of drug substance by up to 90%.

Mark Egerton, Managing Director of Quotient Clinical, said: “We are delighted that RapidFACT has been selected to support the development of these exciting new products. To date, RapidFACT has been deployed on over 30 programmes that have focused on

oral delivery or intranasal delivery. These new programmes further demonstrate the broad utility of RapidFACT and our belief that it can be used to support the development of molecules for any route of delivery.”

freight teams based at Heathrow, UK, Amsterdam, the Netherlands, Frankfurt, Germany, and Milan, Italy, with coordination from the Healthcare Superhighway Control Tower. A range of carriers and airports are utilised according to the specific requirements of the client.

The Control Tower offers clients of all sizes 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.

Quotient Clinical +44 115 974 9000 www.quotientbioresearch.com/clinical

Contract Logistics Provider Enhances EMEA Healthcare Coverage Yusen Logistics is enhancing its coverage of the EMEA region in response to demand from pharmaceutical manufacturers. The company’s European Pharmaceutical Superhighway is already contracted to carry over one million pallets this year and this growth is set to continue as more manufacturers buy into this high security service. The service provides cross border, temperature controlled coverage, with flexible GDP compliant solutions, ensuring complete product integrity and legislative compliance.

Healthcare manufacturers are on an increasing scale searching for innovative solutions to move their products to those geographic areas that have previously proved challenging whilst maintaining a stringent temperature regime at all times.

Maximising availability of stock and minimising risk in the supply chain are behind the growing demand for bespoke solutions to specialist requirements.

David Young, Business Development Manager and Global Airfreight Specialist, commented: “We’re seeing increased demand for specialist shipments for temperature controlled pharmaceutical export product, recent examples being to

Afghanistan and African countries such as Ghana, South Africa and Uganda.

Maintaining quality and avoiding temperature excursions at all times is key, with specialist passive packaging from small boxes to multiple pallet shipments being utilised.”

Such airfreight movements are managed by the Yusen Logistics air

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Yusen Logistics +44 1604 748500 claire.sivills@uk.yusen-logistics.com www.eur.yusen-logistics.com

INGREDIENTS & CONTRACT SERVICES ROUNDUP Hot Melt Coating Enables Rapid and Cost-Effective Production of User-Friendly Dosage Forms

Drug Development Services Provider Announces Two Executive Leadership Team Members

With over 40 years of experience, Hermes Pharma is an expert in developing and manufacturing userfriendly solid oral dosage forms such as effervescent tablets and orally disintegrating granules (ODGs).

Designed to start dissolving before ingestion, e.g., in a glass of water, or be directly applied in the mouth, they are easier to ingest Particle with HMC layer. than conventional tablets, boosting patient API is covered with a molten, lipid-based compliance and treatment effectiveness. mixture at carefully controlled However, as ODGs spend more time in temperatures, which then solidifies to the mouth and are tasted, they must be form a homogeneous coating. However, skilfully coated to maintain stability and such coatings are sometimes unstable deliver the desired release profile. or can exhibit unpredictable API-release Traditional coating requires that the API properties, making lipid-characterisation and excipients be first dissolved in a and stability-projection important liquid and then sprayed onto a seed prerequisites for successful HMC. particle. However, organic solvents can “Our data shows that we have found a be expensive, toxic and flammable, while way to effectively circumvent these using water increases drying times and issues and can formulate stable, costs. Therefore, Hermes Pharma is pleasant-tasting products with the currently conducting research into hot desired API-release profile. We look melt coating (HMC) as an alternative forward to making this know-how technology. accessible to our customers.”

Dr. Detlev Haack of Hermes Pharma said: “HMC removes the need for Hermes Arzneimittel GmbH solvents while offering shorter +49 89 79102 261 processing times and lower production www.hermes-pharma.com costs. During HMC, the solid core of the

Aptuit has appointed two new members to its Executive Leadership team. Kurt Dinkelacker has been named Executive Vice President and Chief Financial Officer and Kevin Duffield has been promoted to Vice President, Sales and Business Development.

As Executive Vice President and Chief Financial Officer, Dinkelacker is reporting directly to Stuart Needleman, Aptuit’s President and COO. Dinkelacker brings substantial experience in managing global financial operations in growth-focused corporations. Previously, he was Executive Vice President and CFO at Retrievex, also a Welsh, Carson, Anderson & Stowe portfolio company.

Before that, he held leadership positions at Financing Alternatives, TeleSpectrum Worldwide and IKON Office Solutions. A graduate of Drexel University where he earned a BA in Accounting and an MBA in its Executive graduate programme, Dinkelacker is the recipient of the University’s 1998 Alumni Award.

Duffield takes on new responsibilities as Aptuit’s Vice President, Sales and Business Development. He will be handling global sales and marketing, also reporting directly to Needleman.

While the coordinated sales effort continues to be focused at the site function level, under Duffield’s leadership, all sales efforts will be

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leveraged. Under his supervision, cross selling initiatives and new opportunities from Aptuit’s vast range of capabilities and disciplines are anticipated. Duffield has more than 25 years’ experience in pharmaceutical contract manufacturing services. He has held several leadership positions in sales, business development and operations of cGMP development and manufacturing facilities. Before he joined Aptuit, Duffield gained diverse experience while he was employed at Eastman Fine Chemicals, ChiRex and NovaSep. Duffield holds a Bachelor’s Degree in Chemistry from Illinois State University.

In discussing these new appointments, Needleman said: “We congratulate these professionals and look forward to their contributions to our Executive Leadership team.

We’ve put a great deal of effort in finding the people who represent our ‘uncommon expertise’ across a range of disciplines. These two proven pros are valuable additions to our team, ready to implement a strategy that will help steer Aptuit to its position as a market-leading provider of early to mid-phase integrated drug discovery and development.”

Aptuit LLC +1 203 422 6600 info@aptuit.com www.aptuit.com

SHOWCASE CONTRACT RESEARCH Assisted Early Product Development Accelerates Time to Market Before any drug can go to market, factors such as chemical stability, solubility, dosing and the practicality of a proposed formulation must all be assessed. Early phase work can be extremely challenging and potentially demanding of time and resources, given all the unknowns that there are at the start of every project.

Most early phase projects are likely to involve elements of new method development, validation and stability. An experienced contract laboratory is often better placed and better resourced to carry out this work because of the balance of skills it can offer — science with compliance, project management, pragmatism in the laboratory and having experience of working with a wide variety of chemistries and formulations.

Good communication, quality and flexibility of service are key in choosing the right contract laboratory.

Developing a stability-indicating method is never straightforward, especially for NCEs; reference materials and impurity markers are not always commercially available and the method developer has to be adept enough to

Tailored Outsourcing Solutions Deliver Better Outcomes

provide the best ‘fit for purpose’ method under the constraints of time and cost.

As an experienced contract laboratory, RSSL can support these decisions and understands that choices made during development can have a major impact on time taken to market and potentially a lasting impact on sales and success.

The company has helped accelerate time to market for many new products and enabled its customers to meet regulatory obligations with the minimum of fuss.

Reading Scientific Services Ltd (RSSL) +44 118 918 4000 enquiries@rssl.com www.rssl.com

As the pharmaceutical industry continues its pursuit of more successful outcomes at all stages of the pharmaceutical pipeline, greater value is coming from outsourcing strategies that provide more comprehensive, adaptable and tightly integrated solutions that are tailored to the industry’s evolving challenges. By selecting an outsourcing provider that has experienced process chemists as well as the ability to integrate small-scale, non-GMP supply with slightly larger scale GMP projects, the outcomes needed by the healthcare and related industries can be met.

GMPs are a foundation of the AMRI SMARTSOURCING philosophy. The scale and range of capabilities at AMRI’s European site places it at the heart of the complete AMRI SMARTSOURCING range of offerings, from discovery to large-scale manufacture. The site has kilo lab-, pilot plant- and large-scale manufacturing capabilities that can scale batch sizes from tens of grammes to hundreds of kilos. This includes preclinical and Phase I–III product development and commercial manufacturing for approved products.

AMRI is a global contract research and manufacturing organisation that provides services in North America, Europe and Asia. The company’s UK-based site in Holywell offers a combination of process research, process development and

commercial manufacturing services, which are co-located with the supporting disciplines of organic chemistry, analytical chemistry and chemical engineering to ensure maximum flexibility and rapid response. In addition, the close integration of facilities and strategically positioned leadership drive synergies between all of AMRI’s manufacturing locations to improve quality, efficiency and delivery of APIs for customers.

Albany Molecular Research, Inc. (AMRI) +1 518 512 2512 www.amriglobal.com

High Pedigree Pathology Team Delivers Quality and Speed

CRO Reports Successful Start to Year

Harlan Laboratories Contract Research Services (CRS) has further strengthened its service offering in histopathology with the creation of a new multi-discipline team that offers clients high levels of knowledge and support in tissue processing, histopathology slide production, assessment and project delivery for safety evaluation.

Following the arrival of Wendy Henderson as Global Head of Pathology last summer, a major recruitment drive has led to the appointment of a strong team of pathologists and technicians from a wide range of backgrounds that between them have in excess of 100 years’ experience and expertise, gained at a variety of companies, including Novartis and Charles River.

Supported by new processes based on Six Sigma methodology, along with ongoing investment in the latest equipment and a modern approach, the new team will deliver a fast-response, high-quality service in the production of slides and interpretation of data. The multi-national, multi-lingual team is based at Harlan’s facility in Itingen, Switzerland.

In addition, the company’s operations in Spain and the UK, with their own histology and necropsy services, constitute a harmonised operational platform that allows maximum flexibility across all sites for the delivery of projects on time and on budget.

PAREXEL has had a positive year so far with several key announcements. In April, the company’s technology subsidiary, Perceptive Informatics, a leading eClinical solutions provider, released an enhanced version of its comprehensive IMPACT clinical trial management system (CTMS).

The developments include improved data entry as well as site management and monitoring capabilities designed for pharmaceutical and biotechnology companies of all sizes. The system has more than 26,000 users in studies of up to tens of thousands of subjects and millions of visits. Perceptive’s enhanced version is a customisable platform that gives managers the flexibility to define the information that is most important to their clinical trial and configure it accordingly.

PAREXEL also recently received the ‘Three-Star Special Employer Brand Award’ in Berlin’s Best Employers Competition. The award is sponsored by the Helmut Schmidt University, the IMWF Institute for Management and Economic Research and the Berliner Morgenpost.

The competition evaluated the brand and reputation of the 160 largest employers in the Berlin metropolitan area, Germany. PAREXEL was recognised for its deep commitment to

To further enhance the quality of its offering, Harlan has also expanded its external Pathologist Panel with an additional three expert members who will work with the Harlan teams in order to provide pathology read-outs.

“Two areas are vital for an effective histopathology service — quality of production and data and speed of throughput and response — and these are what our new team will deliver,” commented Dr. Ciriaco Maraschiello, Director Global General Toxicology, Harlan Laboratories CRS. “We have been able to attract the very best talent from both the CRO and pharma industries and this will enable us to meet our commitment of delivering a quality service.”

Harlan Laboratories Ltd +44 1332 792896 www.harlan.com

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PAREXEL accepts the ‘Three-Star Special Employer Brand Award’. fostering a positive workplace, instilling corporate values and creating an open culture that encourages contribution and attracts global talent.

Lastly, PAREXEL’s latest research report, Strategic Partnerships 2013, is the first to explore the current outsourcing landscape and examine the value that strategic partnerships provide to biopharmaceutical companies of all sizes. According to the report, executives believe this more integrated approach to clinical development reduces their level of oversight, decreases fixed costs and provides access to capabilities not found internally.

PAREXEL International +1 781 487 9900 www.parexel.com

Events

Conference to Focus on Optimising Drug Supply and Ensuring Security ISPE (the International Society for Pharmaceutical Engineering) will hold the World Class Supply End-to-End conference, highlighting key challenges and opportunities in the pharmaceutical supply chain, on 13–14 June 2013, in Prague, the Czech Republic. Delegates will gain insights into anti-counterfeiting issues, packaging fraud, pharmacovigilance and effective recall.

Legalities around falsified medicines and new obligations for manufacturers and distributors of medicinal products will be covered by an MHRA, Expert GMP/GDP Inspector.

Preliminary results of the global survey on Drug Shortages that ISPE is currently conducting will be introduced during the event. The survey goal is to gather data on the technical, scientific, manufacturing, quality and compliance issues that have resulted in this complex problem.

Jim McKiernan, CEO, McKiernan Associates, conference chair, said: “The industry has made tremendous strides forward in the past decade to improve its supply chain efficiency. However, compared with other sectors, pharma still has a long way to go to achieve truly

world-class performance. This conference will allow attendees to hear examples of best practice and gain insights on moving their business forward.”

This two-day conference will provide an opportunity for supply chain and production plant managers, clinical supply professionals, CROs, CMOs, anticounterfeiting officers and technology transfer specialists to be updated on the latest technological and regulatory developments in pharmaceutical supply chain operations. More than 30 industry and regulatory speakers from

organisations such as MHRA, NHS Scotland, Napp, Boehringer Ingelheim and Cemafroid will share their experiences.

ISPE European Operations +32 2 743 15 53 sabine.dupont@associationhq.com www.ispe.org/2013-supply-chain-euconference

Community Website to Analyse Pharma Industry in Monthly and Annual Reports CPhI Worldwide, a division of UBM Live, and its sister brand Pharma Evolution (www.pharmaevolution.com) will introduce annual and monthly reports covering key trends in the global pharmaceutical industry.

CPhI, which hosts a number of successful and well-respected pharmaceutical conferences and exhibitions around the world, will leverage its longstanding independent position within the industry to analyse trends identified by its attendees and a group of expert advisors. Together with content partner Pharma Evolution, a new peer-to-peer community website, CPhI will examine key topics and issues and promote online discussion.

The first monthly report, covering Formulation & Ingredients, will be released in May and subsequent reports will examine such topics as outsourcing, biopharmaceutical development and manufacturing and generic drug development.

The first annual report, which will review the current state of the global pharma industry, will be released in September, one month before the CPhI Worldwide conference in Frankfurt in

mid-October. It will feature insights from thought leaders in key sectors of the industry, evaluating current practices and projecting near- and long-term trends as well surveying all CPhI attendees, providing an aggregated view of the industry from its most senior people for the first time.

The monthly reports will be developed and data collected by Pharma Evolution, a joint venture with UBM DeusM, launched on 25 February, which aims to promote direct online sharing between professionals in pharmaceutical R&D, manufacturing, supply chain management and quality. On Pharma Evolution, industry insiders share bestpractices, self-assessment tools, technical articles, webcasts and more designed to help professionals to improve results and envisage more innovative approaches to R&D and manufacturing. Instead of focusing on journalist-written content, Pharma Evolution showcases content written by industry experts and those who work in the industry, providing a safe and secure online environment where peers can share the best non-proprietary practices, troubleshoot problems and openly discuss challenges and issues.

UBM realised the need for a community as well as greater access to analysis and best practices within the drug industry. “For pharmaceutical professionals today there’s an enormous pressure to innovate and manufacture more efficiently, with fewer resources, improving product safety and quality at the same time,” said PharmaEvolution.com Editor Agnes Stanley. “There’s a real need for better risk management and a more scientific approach to quality assurance and control.”

By diversifying its content through the new partnership and moving into industry research and analysis, CPhI aims to define and share best practices across the global pharmaceutical industry.

CPhI Worldwide/Pharma Evolution cphi@ubm.com www.pharmaevolution.com

REGULATORY AFFAIRS API GMP Requirements Update

Written by Dr. Paolo Biffignandi, Advisory Board member of the pan-European pharmaceutical regulatory affairs organisation ELC Group and former President of TOPRA (The Organisation for Professionals in Regulatory Affairs), in collaboration with Chetan Javia, Senior Project Manager at ELC Group in India.

In order to ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess, the Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7) was developed by the International Conference on Harmonization (ICH) in November 2000. This document provides guidance regarding GMP for the manufacturing of APIs under an appropriate system for managing quality and has been accepted as the reference guidance by most of the countries across the world, including the EU. The European Legislation does not require mandatory routine GMP inspections for active substance manufacturers, unless the manufacturer performs sterilisation and subsequent aseptic handling of the active substance, since, as per Article 46(f) of Directive 2004/27/EC, the responsibility for only using active substances that have been manufactured in accordance with GMP is placed on the holders of a marketing authorisation.

In recent times, the GMP requirements for APIs have come back into limelight with the introduction of Directive 2011/62/EU, which will come into force from July this year. In order to prevent the entry of falsified medicinal products into the legal supply chain, all APIs manufactured outside the EU that are being imported into the EU will have to be accompanied by a ‘Written Confirmation’, unless they are being imported from a country that has been assessed by the EU Commission and is considered to have equivalent rules for GMPs to those in the EU. The ‘Written confirmation’ is to be issued from the regulatory authority of the country where the manufacturing site is located and must confirm that the active substance that is being imported into the EU has been manufactured in compliance with standards of GMP of the EU or ICH Q7.

Further, based on the practical experience of implementation of ICH Q7, the following issues have been identified so far and will be addressed by a Q&A document on ICH Q7: • Output from the review of existing Q&As (e.g., from PIC/S Expert Circle on APIs, from initial Regulatory/PDA training 2002) that is currently underway by PIC/S teams will be considered for endorsement.

• Technical issues for clarification such as application in the supply chain control, contractor/supplier management (outsourcing), monitoring of impurity profiles, quality systems, applicability to biologicals/biotech and relationship with Q5D and GMP expectations in the development phase (manufacturing for clinical trials).

• Impact of the implementation of ICH Q8/Q11, Q9 and Q10 on Q7.

The final concept paper for ICH Q7 was endorsed by the ICH Steering committee on Dr. Paolo Biffignandi 17 October 2012 and Step 2/4 is expected to paolo@elc-group.com be in 2014.

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