EPM August 2013

www.epmmagazine.com

epm

IN THIS ISSUE: Blow-Fill-Seal Cleanrooms Incubators Clinical Trials Coatings & Capsules

European Pharmaceutical Manufacturer August 2013

Volume 13 | Issue 05

Front cover image: With the newly-developed FILL-O-Matic, customers can increase the product output or the capacity with a wide array of products up to 100%.

www.epmmagazine.com

epm head office Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE. Tel. +44 (0) 1244 680222 Fax. +44 (0) 1244 671074 Web: www.epmmagazine.com

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

in this issue

production art samantha hamlyn production peter bartley

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

MANUFACTURING PRODUCTS & EQUIPMENT

pages 5–20

subscriptions subscriptions@rapidnews.com

REGULARS: 5–15 19–20

Latest News Roundup Industry News & Events

qualifying readers Europe - Free, ROW - £115

SHOWCASE: 16

Blow-Fill-Seal

outside qualifying criteria UK - £80, ROW - £115

BUYERS’ GUIDE: 14

Cleanrooms

please subscribe online at www.epmmagazine.com

LABORATORY PRODUCTS & EQUIPMENT

pages 21–26

European Pharmaceutical Manufacturer is published by Rapid Life Sciences Ltd.

REGULARS: 21–24 26

Latest News Roundup Industry News & Events

European Pharmaceutical Manufacturer is distributed in electronic and print formats to a combined readership of 14,000 pharmaceutical manufacturing professionals.

SHOWCASE: 25

Incubators

INGREDIENTS & CONTRACT SERVICES

pages 27–34

REGULARS: Latest News Roundup Events News Regulatory Affairs

Address changes should be emailed to subscriptions@rapidnews.com.

27–28 34 34

SHOWCASE:

Volume 13 Issue 5 © August 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.

29 31

Clinical Trials Coatings & Capsules

BPA Worldwide Membership

page 35

CLASSIFIEDS EPM 3

ISSN No - 2052-4811

“

Welcome to your fifth 2013 instalment of EPM. Unexpectedly inundated with news for August, we have been busily collating this issue in temperatures a good few degrees higher than last year, reaching 30˚+ some days. High quality content and sun at last, a surely winning combination!

The Manufacturing Equipment & Products section includes three, yes three, case studies, all naming the customers and therefore reinforcing their credibility. The first has in fact been supplied by the customer, CDMO Haupt Pharma, and is an appraisal of GEA Pharma Systems - Courtoy’s MODUL rotary tablet presses, in use at the company’s Münster site in Germany. The facility ‘meets a design occupational exposure limit (DOEL) of 0.01 µg/m3’

and ‘all equipment has been selected based on its containment performance’. Haupt Pharma Münster has therefore thoroughly assessed the containment performance of the MODUL presses during production and exclusively shares its findings on page 6.

The second of these case studies concerns 6 pharmaceutical manufacturer MEDICE Arzneimittel’s deployment of OYSTAR IWK’s FP 18-1 tube filling machine at its Iserlohn factory in Germany. The machine is used to package MEDICE’s popular Soventol HC Creme and Soventol Gel wound and skin treatment products in nine different tubes after the decision was made to bring their manufacture back in–house. Reiner Pöstges, Head of Production and Technology at MEDICE, gives his six-month verdict on page 9.

Our third customer story on page 15 has been 9 provided by contamination control flooring specialist Dycem Ltd. Client Takeda Pharma Sp. z o.o., a medicinal products and dietary supplements producer, sought Dycem’s help in reducing the spread of dust caused by footwear and forklifts in production areas. Three months after the installation of contamination control flooring in key locations identified by a Dycem representative’s site survey, Takeda Pharma reports that the spread of dust has significantly reduced.

15 Last but not least, in his Regulatory Affairs contribution on page 34, Dr. Biffignandi discusses the draft guideline on non-clinical and clinical development of biosimilars containing low-molecularweight heparins (LMWHs) announced by the EMA on 31 January. Biffignandi highlights the main differences between this revised guideline and the one currently in place, i.e. “the non-clinical section of the previous guideline [having] been revised to reflect that a risk-based approach can be followed” and “the clinical section of the previous guideline [having] been revised to reflect that a dedicated efficacy study may now ‘be waived in exceptional situations.’”

Before I sign off, we at EPM are beginning to prepare for the all-important, main pharmaceutical ingredients event CPhI Worldwide (and associated shows ICSE, InnoPack and P-MEC Europe). As is custom, the September issue will feature a preview section, so is not to be missed if you are looking for a heads up on exhibitors’ plans for 22–24 October.

EPM 4

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 Fully Qualified Tabletting Equipment Technicians Provide End-to-End Service Without comprehensive training, service work on complex machine engineering technology is not feasible, but at Fette Compacting, all of the approximately 50 service technicians working worldwide are trained as electricians/system engineers and mechanics. Thanks to this dual qualification, these experts can provide an overview of the entire system during inspection, maintenance or calibration — essential in order to maintain the machines in perfect condition.

A practical example is the initial installation of a new machine. The service technician is on–site and monitors the delivery into the workshop and ensures the safe handling of the machine being lifted out of the crate. “It

is extremely important to us that our specialists monitor the entire process from the beginning,” Bernd Klingenhof, Director of Field Services at Fette Compacting explained. As a result, they are responsible for every detail during installation — the electrical connections, the installation of the compression dies, the operational testing and the basic instruction. “When our specialists are finished, we guarantee a fully functioning and perfectly calibrated machine,” Klingenhof confirmed.

Other important aspects are the geographic proximity of the service

technician to the client. “Not only do we operate globally, we also have trained technicians in all the relevant markets who originate from the respective regions,” Klingenhof added.

Fette Compacting GmbH +49 4151 12 427 tablet@fette-compacting.de www.fette-compacting.com

Webinar Explains How to Establish and Maintain Accurate Weighing Results A new, on-demand webinar from Mettler Toledo explains how to ensure accurate weighing results in any pharmaceutical quality management system. Out-ofspecification results can slow down a production process. Inaccurate weighing results can lead to accidental acceptance of unacceptable products.

These two issues can be easily eliminated by controlling the weighing risk and knowing the minimum weight and measurement uncertainty of each weighing instrument in the process.

The right weighing instrument for a process will guarantee the best results.

The free webinar explains the cornerstones for evaluating and selecting an appropriate weighing system based on measurement and uncertainty and minimum weight. Upon

completion of the webinar, participants should be able to understand the correlation between consistent quality, risk management and efficiency improvement, prove compliance by knowing and documenting the accuracy of their weighing equipment and avoid surprises during audits.

Additionally, the webinar describes the principles of good weighing practice (GWP), the global weighing standard, and how these can be used to establish and maintain sustainable quality and accurate results in the weighing process. It also defines concrete

measures for optimising and documenting accuracy.

To register for the webinar, visit www.mt.com/GWP_Webinar_OOS_Chem Pharma.

Mettler Toledo Ltd +44 116 234 5005 www.mt.com

Online Information Advantage to Increase Plant Competitiveness A new website — www.IntelliMill.com — in support of Hosokawa Micron’s Performance Improvement Solutions service, offers engineers and plant operators a wealth of practical, step by step solutions to plant optimisation, a free downloadable diagnostic app and case study evidence and information for those seeking more from their existing plant. Browse the website by mobile phone, tablet or PC for information at a glance.

The site demystifies the jargon of process optimisation and its role in meeting lean manufacturing targets and achieving Six Sigma performance.

It reveals how Hosokawa’s established Performance Improvement Solutions service can help processors operate their existing plant at full potential to exploit

production opportunities and achieve rapid return on investment.

With three simple stages — ‘Understand’, ‘Monitor’ and ‘Control’ — Hosokawa Micron’s phased approach to performance improvement and plant optimisation offers engineers clear indicators and defined actions for continuous strategic performance improvement.

Hosokawa Micron’s Performance Improvement Solutions combine the strength of Hosokawa Micron’s technical and practical processing expertise with the latest plant performance monitoring equipment and analysis software from XpertRule Software Ltd to achieve benefits including increased production yield, improved product quality, increased plant availability and reduced emissions across a range of industries.

EPM 5

Hosokawa Micron Ltd +44 1928 755100 info@hmluk.hosokawa.com www.hosokawa.co.uk

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP CASE STUDY In response to increasing demand for the HAUPT PHARMA processing of highly potent APIs, Haupt RATES USE OF Pharma has — at its ROTARY PRESSES Münster, Germany, site AT HIGH POTENCY — cultivated a centre of excellence for this FACILITY application.

Compression of tablets is, from a containment as well as a processing point of view, one of the most challenging unit operations in solid dose manufacturing.

The rapidly increasing demand in recent years for contract manufacturing, particularly in the solid dose sector, has meant that CMOs need to have an even greater ability to produce a huge variety of products at an economical speed, even when they consist of challenging formulations. Additionally, specific health and safety challenges arise when potent APIs are processed, requiring the use of equipment that combines very high flexibility with high productivity and an appropriate containment performance. GEA Courtoy’s MODUL rotary presses meet these criteria at Haupt Pharma’s Münster site.

Haupt Pharma and Haupt Pharma Münster With nine sites in Germany, Italy, France and Japan, Haupt Pharma is one of the largest European companies for pharmaceutical contract development and manufacturing. A full range of services — from pharmaceutical development, materials procurement and production and packaging to logistics and distribution, including the possibility of customised solutions — is offered for almost all dosage forms. In addition to the processing of conventional APIs, Haupt Pharma develops and produces various specialty products such as cytotoxics, hormones, beta-lactam antibiotics (penicillin/cephalosporin) and narcotics.

The Haupt Pharma Münster site specialises in the production of highly effective and low-dose preparations such as oral contraceptives, thyroid hormones and narcotics. Batches from 1 to 400 kg can be handled. Services range from development activities via scale up and clinical trial supplies to routine manufacturing. More than 2.5 billion single unit doses per year, including tablets, film-coated tablets and sugar-coated tablets, are produced. The facility meets the current FDA requirements applicable to medicinal products in the US market.

Containment concept at Haupt Pharma Münster As most of the APIs handled require special attention from a health and safety point of view, the entire site was designed according to EU Directive 89/391 EEC. Among other requirements, this implies that containment is assured purely by engineering methods, and personal protective equipment (PPE) is only used in the case of an emergency, as a last resort. This philosophy is seamlessly taken from dispensing all the way through to compression and coating.

The factory has been built to meet a design occupational exposure limit (DOEL) of 0.01 µg/m3.

The DOEL was selected based on the mix of products to be processed. This includes sex hormones such as ethynyloestradiol (EE). All equipment was selected based on its containment performance according to standardised measurement of equipment particulate airborne concentration (SMEPAC) tests.

While most pieces of equipment performing the required unit operations such as granulation and drying or blending are tight enough by their design and operational principle, all transfer steps are a potential area of concern. Haupt Pharma opted for Müller drums in combination with GEA MC split

Packaging line for highly potent solids.

Closed-containment v-processor.

High-containment tablet press for the production of highly potent solids. butterfly valves. Due to its mechanical complexity, the tablet compression process demanded special attention, therefore Haupt Pharma decided on Courtoy MODUL presses.

MODUL press range The MODUL is Courtoy’s flagship product. It combines typical Courtoy features such as extended dwell time, which enables the compression of difficult formulations at reportedly unbeaten speeds, with the exchangeable compression module (ECM) concept. The ECM is completely isolated from the remainder of the machine, contains all product contact parts and can be easily removed from the press in a contained way to perform an off-line washing process. This means that the press itself remains powder-free and requires no cleaning. Benefits include the possibility of fast changeover, especially important when new products need to be processed, plus excellent containment performance.

Haupt Pharma Münster’s experience of MODUL presses The Haupt Pharma Münster site has assessed containment performance of its two MODUL S presses intensively by measuring particle load in the production environment under operating conditions. The two presses produce a huge number of tablets. When the turret of the singlesided press is equipped with BB tooling, it is able to produce up to one million tablets per hour, having been fitted for up to five-fold multi-tip tooling.

Additionally, the presses can be turned over in less than two hours to accommodate a change of product. For a product changeover, all product-

EPM 6

contact parts are removed in a contained manner.

Owing to the high containment performance, cleaning of the remainder of the press and room is not required. A second ECM and second set of peripheral equipment are brought to the compression area and allow production to resume in under two hours. The first set of parts is then cleaned off-line in a dedicated washing area, with no interference to manufacturing.

After a successful placebo-based site acceptance test (SAT), the presses were taken into verum production and air samplings were performed for an assessment of their containment capability.

Sampling heads were placed close to the most critical areas that had been identified by a risk analysis. A series of tests has been performed, taking into consideration the full range of products.

Seven series of tests were carried out, consisting of a total of 26 individual measurements. Out of these, 23 results were below detection limit, which is 0.001 µg/m3. In three cases, product was detected but the amounts found were well below the DOEL. Haupt Pharma Münster GmbH Dipl.-Ing. Heinz Schulte-Brochterbeck +49 251 2855 446 heinz.schulte-brochterbeck@haupt-pharma.de Günter Nykamp, Ph.D. +49 251 2855 201 guenter.nykamp@haupt-pharma.de www.haupt-pharma.com GEA Pharma Systems Harald Stahl, Ph.D. +49 6349 927 706 harald.stahl@gea.com www.gea-ps.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Handheld Particle Counter Makes Regular Environmental Monitoring Affordable Manufacturers across many sectors use ISO classified cleanroom environments to conduct critical processes that demand protection from harmful contamination. The only way companies can ensure they are consistently meeting ISO classification parameters is to regularly monitor the environment.

However, despite the critical process and expensive investment in a cleanroom, many companies rely solely on their annual or bi-annual validation visit from contractors to check that the cleanroom is meeting its specified ISO classification parameters.

Every day, contamination risks are presented by production staff, processes and products that may not be present during the annual validation visit, such as filter blockages, too low airflow rate, poor operator practice and product/packaging. These risks have the potential to increase product failure rates and expensive recalls. For pharmaceutical, medical or food

markets, contamination issues could even be fatal.

Regular environmental monitoring promotes cleanroom class confidence to satisfy internal or external audits. It also allows organisations to detect and address contamination sources quickly, before they cause issues.

The good news is that particle counters are no longer too expensive, too large or too inaccessible for organisations to invest in.

Cleanroomshop.com has recently launched a new range of particle counters that offer great value. The online cleanroom supplies specialist confidently claims that the three-channel particle counter from Airy Technology offers the best value on the market, owing to its low price, accuracy, functionality and ease of use.

ISO 14644-1 specifies maximum limits for a range of particle sizes, which is why this particle counter monitors three channels simultaneously:

• Channel 1 — Choice of 0.3 and 0.5 µm • Channel 2 — Choice of 0.5, 1.0, 2.0 and 2.5 µm • Channel 3 — 5.0 µm.

For users monitoring ISO Class 7 or 8 cleanroom environments, the most popular channel combination is 0.5, 1.0 and 5.0 µm. This particle counter is easy to use with a colour display and saves up to 8,000 data set records, which is higher than average for a handheld unit.

When ISO mode is selected, this three-channel particle counter automatically calculates average, standard deviation and upper control limit (UCL), speeding up the process and improving accuracy by reducing manual calculations. ISO 21501-4 calibration with ongoing calibration service is offered and a carrying case is included to protect the investment.

To offer a higher level of environmental monitoring, Cleanroomshop.com also

offers a six-channel particle counter that calculates minimum sampling locations and minimum sampling time as well as simultaneously monitors six channels.

Connect 2 Cleanrooms & Cleanroomshop.com +44 1524 813022 info@cleanroomshop.com www.cleanroomshop.com

Plastic Packaging Supplier Launches Healthcare Website Due to a growing demand for healthcare products, M&H is launching a new website specifically focussed on the healthcare sector. In addition, a dedicated Healthcare division has been set up, spearheaded by Shaun Catchpole and Catherine Wardell, both with extensive experience in the packaging arena.

The M&H portfolio includes a wide

range of containers suitable for healthcare products from liquids, tablets and powders, to creams, gels and ointments. The company recognises that functionality and safety are key factors and has a range of products that includes tamper-evident and child-proof closures.

M&H has a full-time QA team working to ensure the effective implementation of

EPM 8

its Certified Integrated Management System, embracing quality management, environmental management and health and safety management.

M&H Plastics +44 1502 715518 sales@mhplastics.com www.mhplasticshealthcare.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP CASE STUDY The pharmaceuticals enterprise MEDICE Arzneimittel recently started producing its MEDICE gel for burns and wounds and its semi-solid Soventol products in its own factory. For this purpose, the company invested in a new, high-performance filling system: the FP 18-1 by OYSTAR IWK. It would be hard to find a neighbourhood pharmacy in Germany that does not sell the proven wound and skin treatment products by Iserlohn-based MEDICE. Whether for scrapes, insect stings, allergic reactions or minor burns, the applications for Soventol et al are manyfold. The manufacturer’s quality criteria for its products are equally high. This led MEDICE to take the decision last year, as part of its strategic realignment, to put an end to the contract packaging of its Soventol HC Creme and Soventol Gel products and bring it in-house. However, the old facility was only capable of handling around three million tubes per year, so it was not nearly big enough. The search began for a new, more powerful tube filling system.

The answer was found in the FP 18-1 by OYSTAR IWK, a leading, international supplier of tube filling machinery. The system meets all of MEDICE’s needs to a T, with state-of-the-art technology, a GMP-compliant design and access from all sides for thorough cleaning. In addition, the FP 18-1 is easy to use and needs few operators.

TUBE FILLING MACHINE MEETS HIGH THROUGHPUT DEMANDS OF MEDICE ARZNEIMITTEL’S MANUFACTURING FACILITY

Intuitive menu navigation “We have been running the FP 18-1 for six months now and we are completely satisfied,” said Reiner Pöstges, Head of the Production and Technology business unit at MEDICE. The operators especially

The FP 18-1 can fill metal, plastic and laminate tubes from 10 to 60 mm in diameter and 60 to 250 mm in length.

appreciate the intuitive menu navigation and ergonomics of the TEOS HMI touch panel, developed by the OYSTAR Group. “Each individual process step is clearly displayed on the 15.4” widescreen display,” explained Pöstges. “In addition, it is a simple thing to manage the format data, and the quick access to batch protocols and recipes are of great help to us in process validation.”

Switching product is quick and simple because most format parts can be changed without tools and the transporter rises or lowers automatically. “It only takes three tubes for the system to set the

FP tube filling system The FP 18-1 by OYSTAR IWK can fill metal, plastic and laminate tubes from 10 to 60 mm in diameter and 60 to 250 mm long. This equates to a fill volume of 1.5 to 400 ml of product. Up to 120 tubes per minute can be filled and sealed. This reportedly makes the FP 18-1 the fastest single head tube filler currently available on the market.

In addition to producing various tubes, the filling system can be used for other cosmetic applications, such as filling bottles or jars.

Control technologies based on servomotors ensure technical precision during filling. It can also integrate the lobe pump dispensing system. Using lobe pumps will further reduce the set-up and cleaning time.

The FP 18-1 is supplemented with five other FP-series models that can handle up to 300 tubes per minute.

Applications for the semi-solid Soventol products are manifold.

exact fill weight for a new format,” reported Torsten Ebel, a fitter at MEDICE. “In order to find the precise fill weight so rapidly, the tube filler software automatically calibrates the servomotor-driven piston stroke.”

Four products in nine formats Altogether, the FP 18-1 at MEDICE is packaging four different products (creams and gels) in nine different tube formats ranging from 15 to 100 g. The system fills aluminium tubes with threefold seams at a rate of up to 100 tubes per minute and then automatically packages them into collapsible boxes using the OYSTAR IWK SC 5 cartoning machine.

A production campaign consists of up to four tonnes of bulk goods. These are filled into the socalled inliner in batches of 1,000 kg each. Inliners are multi-layered plastic bags that are stored in an intermediate bulk container (IBC) and placed next to the tube filling machine during filling. A feeder consisting of a progressive cavity pump and a 10 l accumulator then moves the product to a dispensing station.

“By switching to inliners, we are breaking completely new ground,” explained Martin Becker, Head of Packaging at MEDICE. “However, the entire system has run stably and seamlessly since we started it up. We have already nearly doubled our efficiency in filling and packaging tubes compared to before.

“We also skip the complex process of cleaning containers that come into contact with the product and validating that cleaning. Furthermore, we minimise the risk of contamination and save space needed for storage.”

Steps have also been taken for the further expansion of production. The FP 18-1 is designed to be outfitted with modules such as a heat welding station and a cutting station to allow for the additional processing of plastic and/or laminate tubes.

MEDICE Arzneimittel Pütter GmbH & Co. KG +49 2371 9370 info@medice.de www.medice.de

“We have been running the FP 18-1 for six months now and we are completely satisfied,” said Reiner Pöstges, Head of the Production and Technology business unit at MEDICE.

EPM 9

OYSTAR IWK Verpackungstechnik GmbH +49 7244 9680 info-pharmapackaging@oystar-group.com www.oystar-group.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Ceiling Solutions Significantly Reduce Noise Levels in Cleanrooms and Manufacturing Plants Saint-Gobain Ecophon has added two new sector specific ranges to its product offering that will help manage the different acoustic demands of industrial and cleanroom environments.

In manufacturing plants or factories where noise levels can be very high, protecting the welfare of workers is extremely important (as per the HSE Noise at Work Regulations). Providing the correct acoustic treatment will reduce dB levels and, as a result, decrease stress levels and create a more comfortable working environment.

Three new Ecophon Industry ceiling solutions are ideally suited for areas that require high levels of sound absorption.

Offering flexibility in terms of the type of installation, Industry Modus and Industry RTP have visible grids with demountable tiles, while Industry Ambit has a concealed grid with nondemountable tiles. The RTP system also has the added benefit of impact resistance.

Ecophon has also created two new acoustic ceiling solutions for laboratory, cleanroom or healthcare environments.

In areas that have strict hygiene and cleaning requirements, Hygiene Labotec Ds C1 and Hygiene Labotec Air A C1 offer wall-to-wall sound-absorption. Both are suitable for areas where there are demands for low particle emission and

where occasional wet wiping and/or disinfection is required.

While the Ds system has only vertical joints that minimise dirt traps, Labotec Air ensures optimised air permeability and limits air leakage through the ceiling.

Andy Holler, Key Application Manager at Ecophon, said: “To be able to offer such sector specific acoustic ceiling solutions is a real benefit. Both ranges of products have been designed with the unique demands of those environments in mind. This allows architects and specifiers to create the best possible

acoustic environment for workers, helping to safeguard their wellbeing.”

All the new solutions have a core of high density glass wool, which utilises Ecophon’s innovative 3RD technology as well as painted Akutex finishes.

Saint-Gobain Ecophon Ltd +44 1256 850977 marketing@ecophon.co.uk www.ecophon.com

Laminar Flow Booth Removes Dust Particles to Protect Operator and Prevent Contamination

Flextraction has introduced a laminar flow booth to its extensive range of products. A modular unit in 2, 4 or 6 m widths, ideally suited to those environments where dust generation is unavoidable, cannot be contained or collected at source, it is designed to be used in conjunction with a full width, standard height (900 mm) work bench.

The unit provides laminar air flow across the operator, extracting airborne respirable dust particles towards the rear of the booth, away from the operator’s breathing zone, and preventing contamination of the surrounding area.

Using three stages of disposable filtration to remove the dust, with the final stage being through a HEPA filter, the air is re-circulated back into the working environment via a diffuser, offering the added benefit of saving on heat loss.

The unit comes fitted with three visual indicators to enable monitoring of the condition of the filters. Whilst designed for the extraction of dust, there is an option for the unit to be adapted for the removal of fumes, either through ventilation to atmosphere or via an activated carbon, enabling recirculation of the clean air back into the workplace.

Flextraction Ltd +44 1664 410641 lkd@flextraction.co.uk www.flextraction.co.uk EPM 10

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Leading Pharma Manufacturer Orders High Specification Vibratory Sieve

One Machine Offers HV Leak Detection and Vision Inspection of Syringes

The pharmaceutical industry requires the highest standards of design, usability and performance from all processing equipment. Working closely with leading pharmaceutical manufacturers for the past 75 years, Russell Finex has continually carried out extensive research to ensure these high standards are met.

When approached by a key pharmaceutical customer for an upgrade to an existing Russell vibratory sieving machine, Russell Finex supplied a customised Finex 22 vibratory sieve to better suit that customer’s changing needs. The Finex 22 has remained one of the most popular choices in the pharmaceutical industry for over 30 years and is ideal for check-screening and grading pharmaceutical powders and pellets.

For this particular application, a double deck Finex 22 was supplied fitted with a 1600 µm mesh on the top deck and a 800 µm mesh on the bottom deck. This allowed the customer to grade small batches of product. The bottom mesh included a scroll frame to ensure a better flow of the material across the entire screening area is achieved. An easy-clean, mirror polished magnetic separator was also fitted to the bottom deck to ensure any ferrous contamination is removed before the material progresses further down the process line. The machine was supplied in high quality 316L stainless steel and was fully mirror polished to a documented 0.2–0.6Ra value.

As the machine needed to be a certain height to fit in with the existing process line, the sieve was supplied on a stand.

However, owing to regulations, the stand cannot exceed a certain height. To ensure the machine was of the height requested by the customer, an extended base was also added. An enclosed system was needed to transfer the product from the sieve to the next stage in the process, so the discharge from the outlet was angled downwards and fitted with a tri-clamp assembly to enable

Seidenader Maschinenbau claims to have combined visual inspection with high voltage (HV) leak detection in an automatic syringe inspection machine for the first time.

In addition to camera-based inspection of parenterals, in recent years Seidenader has been focusing increasingly on complementary inspection technologies — including the use of HV, polarimetric inspection or near-infrared spectroscopy (NIRS) to check for leaks and integrity of containers — to identify the product or to avoid cross contamination. These technologies are provided either on their own platform as a standalone machine or integrated as a module into a high-performance inspection machine.

Such integration offers enormous advantages in terms of lower initial costs, easier handling and maintenance, smaller footprint and reduced training requirements for operators.

The MS-S machine has two carousels that are linked by a turn-over starwheel in order to ensure optimal conditions for both camera-based inspection and HV inspection.

For visual inspection, the syringes are transported vertically in the carousel with finger grip down. Doing so, particles hidden in the syringe cone are brought into motion and become detectable for the camera. In the HV inspection station, however, presentation of the syringes in needledown position is preferable, because in this orientation the complete surface of the inner wall of the syringe can be wetted by rotation. This is especially

the material to pass straight to a drum via a flexible connector to the drum. As the machine was to be used within different processing lines, a blanking assembly was also added to the outlet to enable the customer to close the oversize outlet when required. A final modification was the addition of a viewport to enable operators to inspect the material as it is being screened.

Prior to despatching the machine, a factory acceptance test (FAT) was carried out where the customer visually inspected the machine at the Russell Finex factory. With the FAT passed, a comprehensive documentation pack was then issued, which included the full FAT report, mill certification, certificates of conformity and FDA declaration letters to ensure faster validation during commissioning.

Russell Finex Ltd +44 208 818 2000 enquiries@russellfinex.com www.russellfinex.com

EPM 11

important for the syringe cone, which is the most critical part for leak detection, thereby creating conditions for optimal HV inspection.

To prevent accidental flashovers, discharges, electrical leakage or interference fields at the HV inspection station, the product grippers, which retain the syringe by the finger grip, are electrically non–conductive owing to a special, extremely durable plastic. In addition, appropriate insulation paths have been established between the HV electrodes and the electrically conductive parts of the machine. These structural modifications led to the construction of a syringe inspection machine on a MS-S platform that combines visual inspection for particles and cosmetic defects with HV inspection for integrity of syringes, with a throughput of up to 24,000 products per hour.

The HV inspection module is designed for a capacity of 36,000 syringes per hour and therefore can also be integrated into the Seidenader highspeed inspection machine VI-S. Seidenader Maschinenbau GmbH +49 8121 802 486 heidrun.sing@seidenader.de www.seidenader.de

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Bag Tester Detects Single-Use Bioreactor Leaks Post-Installation Sartorius Stedim Biotech (SSB) has launched the new Sartocheck 4 plus Bag tester, the latest addition to its wellestablished Sartocheck line. According to the company, the new system is the first device allowing reliable pre-use testing of single-use bioreactors after installation, based on the proven pressure decay measurement method.

The Sartocheck 4 plus Bag tester directly responds to the market needs for increased security and quality assurance when single-use components are used. Designed for cell cultivation, single-use BIOSTAT CultiBag STR bioreactors with working volumes of 50 and 200 l can now be conveniently tested by this new system. Later this year, the newly developed technology of

this device will be extended to permit testing of 500 and 1,000 l BIOSTAT CultiBag STR systems.

The Sartocheck 4 plus Bag tester performs a pre-use test of the entire bioreactor, including tubing. This device is capable of detecting typical leaks that might have been caused by operator handling errors upon installation of a bioreactor. Therefore, the bag tester is ideal for eliminating the risk of filling a defective single-use bioreactor with expensive cell cultures. The reason is its patented fleece, which is inserted between the plastic film of the BIOSTAT CultiBag STR and the bag holding device of the tester. This fleece acts as a porous spacer, preventing direct contact between the bag and the smooth

stainless steel surface of the holder. In addition, the fleece substantially reduces environmental heat transfer and, most importantly, eliminates the effects of masking any potential pinholes. The high accuracy of the Sartocheck 4 plus Bag tester in measuring the pressure drop, along with its patented fleece technology, provides outstanding reliability and reproducibility for testing.

The Sartocheck 4 plus Bag tester is an important contribution

by Sartorius Stedim Biotech towards enhancing risk mitigation for single-use equipment in biopharmaceutical manufacturing.

Sartorius Stedim Biotech S.A. +49 551 308 0 www.sartorius.com

White Paper Explains How Intelligent Analytical Measurement Solutions Reduce Documentation Burden Creating and managing standard operating procedures (SOPs) to meet quality control system requirements necessitates a great deal of pharmaceutical company staff’s time and effort. There is therefore an understandable reluctance to update SOPs whenever a company’s production department wishes to alter a process.

However, technical advances in analytical measurement equipment offer improved sensor operations that lead to greater production efficiency. These benefits can outweigh the workload of updating SOPs and should not be ignored. In addition, modern process analytical systems actually simplify SOPs, as explained in Mettler Toledo’s new white paper.

Pharmaceutical production is one of the world’s most regulated activities.

Consequently, creating and maintaining documentation in a quality control

system to satisfy regulatory requirements is a considerable task for drug companies. SOPs are an essential component of most quality control systems and must document precisely all activities involved in drug production.

Mettler Toledo’s Intelligent Sensor Management (ISM) is a digital technology for analytical measurement solutions. ISM improves sensor handling and increases process reliability and production uptime, leading to greater productivity. It also simplifies sensorrelated SOPs. Kurt Hiltbrunner, pharmaceutical industry market specialist at Mettler Toledo, provided an example: “When a technician is calibrating a conventional analogue pH probe, they must read the sensor’s serial number printed on the sensor body and update the history for that probe in their data, for example, the number of exposures to CIP/SIP cycles and operating hours.

the X65 doubles the speed of previous FlexLink conveyor generations, significantly reducing cost per produced unit.

The factory environment is a concern for manufacturers and FlexLink has made considerable effort to reduce noise and improve operator safety. In most common applications, the noise level of the X65 is on par with a typical office.

For automated, single-piece flow applications, the X65 offers high quality production at low cost. The X65 pallet system stands out with its exceptional design and standardised functions for the handling of products up to 1 kg. The pallets and functions are prepared for the integration of process control systems such as track and trace and MES. FlexLink Group +46 31 337 31 00 info@flexlink.com www.flexlink.com

the SOP burden and is available at www.mt.com/PRO-SOP Mettler Toledo Process Analytics Solutions +41 44 729 6273 santare.rukaite@mt.com www.mt.com/pro

PLM Solution Improves Global Operational Efficiency and Accelerates Drug Launch Process

Conveyor Platform Increases User Value in Three Key Areas Sophisticated conveyor systems are major elements in production logistics solutions, enhancing the total efficiency in production, testing and packaging lines.

The requirements on the equipment are increasing over time, typically in terms of additional processing, flexibility for new products, higher capacity and lower operating costs. With the launch of the X65 conveyor, FlexLink reportedly takes the performance of conveyors to new and higher levels, offering a lower total cost of ownership, drastically lower noise level and futuristic design.

According to the company, the X65’s design offers twice the strength of today’s standards, thereby doubling maintenance intervals. Göran Abbestam, Product Manager at FlexLink, explained: “The doubled conveyor strength has a dramatic effect on the service life and maintenance intervals of systems installed. In addition, the layouts can be made simpler as fewer drives and transfers are required for a given layout due to the increased maximum conveyor length. To the user, this has a substantial, positive impact with less complexity and a lower cost of installation.”

In addition, FlexLink is introducing new high-efficiency drive technology to further reduce power consumption. Dependent on the application and choice of drive unit, power consumption is 8–44% less compared with previous high efficiency drive units from FlexLink. At 120 m/min,

They then need to decide, based on the sensor’s history, if the probe can be used again or should be disposed of.

“ISM simplifies these operations as all relevant sensor data, plus valuable sensor diagnostics data, is stored on the sensor. When an ISM sensor is connected to our iSense software, this information is automatically transferred to the software, which then updates its database for that particular probe. iSense also displays the sensor diagnostics, allowing technicians to easily see what, if any, maintenance the sensor requires or if it has reached the end of its reliable lifetime. ISM therefore not only simplifies sensor-related SOPs by providing sensor diagnostics, it also increases process integrity.”

Mettler Toledo’s new white paper ‘Simplified Compliance — SOPs for Intelligent Sensors’ explains how ISM measurement systems can help reduce

Dassault Systèmes has launched a new industry solution experience for pharmaceutical and biotech companies, Licensed to Cure for BioPharma. Based on Dassault Systèmes’s 3DEXPERIENCE platform, it is claimed that the new solution transforms the way biotech and pharmaceutical companies manage product and process complexity by smoothing drug variation, enabling easier and faster expansion into new markets, all while managing increasing regulatory requirements.

In an environment of expiring patents, more stringent regulations and increased development costs, companies are increasingly turning to drug variations to drive growth. With one API yielding as many as 1,000 finished products, a biopharmaceutical company must have a business platform that not only manages product knowledge complexity but also simultaneously drives collaboration, innovation and compliancy.

Licensed to Cure for BioPharma boosts compliance strategies and creates a structured approach to manage product and process complexity, resulting in faster delivery of product variations to new markets. With the holistic view of all product-related information, pharmaceutical executives can analyse changes independently of their organisational origins in order to

EPM 12

make fully informed decisions in strategic context. It results in global operational efficiency improvement, including maximising supply chain opportunities and enforcing efficient and compliant execution.

Alan Louie, Ph.D., Research Director, IDC Health Insights, commented: “The pharmaceutical industry is facing significant pressure to perform and deliver new therapies that provide strong returns both financially and efficaciously.

When dealing with product variants, companies are typically resistant to change given the regulatory implications and significant potential added cost. The ability to visualise a comprehensive holistic view of the full product portfolio is incredibly valuable. Systematically analysing the likely impact of proposed changes prior to investing time and money has the potential to deliver valuable insights to management that aren’t available today. This approach to product management is much more than just expanded traditional information management. It is a crossindustry best practice that requires full organisational buy-in starting at the CEO and extending all the way to the lab bench.”

Dassault Systèmes +33 1 6162 6162 www.3ds.com/solutions/life-sciences

Ceiling, Floor and Wall Panels

Cleanroom Cleaning Service

Cleanrooms Design and Construction

Garments

Hand Tools, e.g., Clamps, Pliers, Forceps and Knives

5

6

Clean Modules Ltd, UK +44 1332 696970 enquiries@cleanmodules.co.uk www.cleanmodules.co.uk

1

Cleanroom Design & Construction Ltd , UK +44 1562 881420 lbreckles@cdcltd.co.uk www.cleanroomdesign.co.uk

2

3

1

Clean Room Construction Ltd, UK +44 1634 295111 slawton@crc-ltd.co.uk www.crc-ltd.co.uk Connect 2 Cleanrooms, UK +44 1524 812899 info@connect2cleanrooms.com www.connect2cleanrooms.com

13

17 18 19

19

10

2

3

4

6

1

2

3

4

6

7

9

10

12

Wipes and Sponges

10 11

Transport Carts/Trolleys

6

4

Mops/Mop Heads

19

1

18 19

12

ADDITIONAL

Design and installation of ACDP Cat. 2,3 and 4 labs and test environmental facilities, plus cleanroom and lab validation.

Powder coated, stainless steel multi-product dispensers (particularly good for storing gloves).

17

Powder dosing valves, tablet valves and high containment filling systems.

13

Dycem Ltd, UK +44 1179 559921 carlos.mourelle@dycem.com www.dycem.com

Contamination control flooring.

4

Helapet Ltd, UK +44 800 0328 428 sales@helapet.co.uk www.helapet.com

7

1

9

3

15

9

11

16

18

14

Maintenance.

1

2

4

6

10

18

Process Components Ltd, UK +44 1625 412000 kieran.grey@pro-components.com www.pro-components.com Shield Medicare — a division of Ecolab, UK +44 2920 854390 info@shieldmedicare.com www.shieldmedicare.com

16

10

6

CO.RA s.r.l/Adrian Cameron Agent UK & Ireland, UK +44 161 485 5494 adrian.cameron@acprocess.co.uk www.acprocess.co.uk

Precision Cleanrooms Ltd, UK +44 845 3013110 wbeard@precisioncleanrooms.co.uk www.precisioncleanrooms.co.uk

15

9

4

Contec Inc., France +33 2 97 4376 98 fcostanzo@contecinc.com www.contecinc.com

Powder Systems Ltd (PSL), UK +44 151 4487700 sales@powdersystems.com www.powdersystems.com

14

Workstations and Workbenches

Cabinets

4

Building Projects (UK), UK +44 1457 861702 ajbell@buildingprojectsuk.com www.buildingprojectsuk.com

10 11 12

Sterile Packaging, e.g. for Ready-to-Use Components

9

Restricted Access Barrier Systems

8

Sterile Components, e.g., Stoppers, Syringes, Caps and Plungers

7

Product Handling and Transfer Solutions

6

Mixing and Storing Vessels

5

Lighting

4

Isolation Technologies, e.g., Gloveboxes and Ports

3

Air Monitoring Equipment

cleanrooms

2

Air Handling Equipment

buyers’ guide

1

Powder dosing valves, tablet valves and gland sealing solutions (temporary sealing of service pipework or tubing).

13

Sterile disinfectants.

7

12

15

18

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Pre-Configured Content Packages Speed Up MES Project Timelines Werum Software and Systems offers ‘out of the box’ content packages for its customers to enable best practice based configuration of the PAS-X manufacturing execution systems (MES) software.

When setting up PAS-X, the customer no longer needs to start with an empty application but can instead utilise preconfigured content targeted to the specific processes of pharmaceutical and biotech companies. The new content packages, with their GMPcompliant templates, ensure an easy set-up of the system and speed up the overall project timeline. They are based

on the best practices of Werum customers and driven by the PAS-X user community PFU. One of these content packages is the PAS-X User Rights and Roles Content Package. It is available for the configuration of PAS-X user rights based on global profiles targeted to GMP compliance and pharmaceutical manufacturing. The already included user profiles, with predefined rights, are designed for defined roles in a GMP organisation. Examples include Shop Floor Operator or MBR Designer. These roles can be combined with each other, if needed. In line with Werum’s project

experiences, the descriptive names of the profiles make it clear which user these roles are assigned to.

The User Rights and Roles Content Package considerably simplifies the configuration and maintenance of PASX’s highly flexible user rights capability.

Based on the clear and well-structured documentation of the rights and profiles, system administrators and project team members can save up to 95% of the time usually required for the initial configuration and testing of rights.

“The pre-configured content, along with supporting consulting services, clearly defines a new standard and

EPM 14

facilitates harmonisation in the industry,” said Torsten Isenberg, Director Head of Department Consulting & Training, Werum Software & Systems AG. Werum Software & Systems AG +49 4131 8900 689 dirk.ebbecke@werum.com www.werum.com / www.pas-x.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP CASE STUDY Dycem is a world leading manufacturer and supplier of FLOORING SYSTEM contamination control CONSIDERABLY floor solutions for LIMITS SPREAD OF critical environments.

The products produced CONTAMINATION AT are solely manufactured TAKEDA PHARMA in the UK at its Bristol site and are sold globally in more than 50 countries to many of the world’s leading corporations.

Today, thousands of cleanrooms, critical areas and controlled environments are protected by Dycem polymeric contamination control flooring, enabling all organisations to reduce particle counts by up to 99.9%. This contributes to eradicating contamination and cross contamination and therefore increases product yields and ultimately profit.

Dycem has been manufacturing contamination control zones since 1966, with headquarters in Bristol, UK, Warwick, Rhode Island, US, and Santa Rosa, Philippines, and was this year recognised for its manufacturing excellence by being nominated as a finalist for the South West exporter of the year. The company also manufactures to all relevant international standards, with the minimum carbon footprint.

Dycem has a commitment to quality, total customer satisfaction and product development, which has earned the company recognition across the globe.

The company’s user base of thousands includes blue chip companies such as Sony, GlaxoSmithKline, Lilly, Abbott, Johnson and

Johnson, Motorola, Roche, IBM, Pfzer, Rolls Royce, Nestle, Bombardier, Intel, Seagate, Takeda, Nokia, Honda, BMW, Heinz and Texas Instruments. Dycem is suitable for the smallest to the largest company as it is flexible, versatile and can be bespoke installed to individual needs.

In addition, with a continuous improvement management strategy, Dycem has developed and improved the design and ability of its materials to trap and retain particles down to the nano scale.

Takeda Pharmaceutical Company and Takeda Pharma Sp. z o.o.

Headquartered in Japan, Takeda Pharmaceutical Company Ltd is a global, research-based organisation with its main focus on pharmaceuticals.

Takeda Pharma Sp. z o.o. in Poland produces, distributes and trades in medicinal products and dietary supplements; these drugs are produced for both domestic and foreign markets.

installed in the production corridor under door openings leading to the weighing room. There were further installations in the cloakrooms/changing areas for male and female employees in Takeda’s grey clean zone.

Challenge faced by Takeda Pharma: Takeda was searching for a solution that would prevent the spreading of dust by the footwear of employees and forklift trucks in dusty production areas such as weighing rooms.

Furthermore, Takeda was looking to reduce the spread of contamination under the footwear of employees entering from production areas to the cloakroom/changing areas and back in the other direction.

Verdict Three months after their installation, Takeda has reported that ‘Dycem flooring systems have considerably limited the spread of contamination by employees moving from the production area to the cloakrooms/changing areas. The installation of Dycem has resulted in a sizeable reduction of the quantities of dust transported by employees exiting dusty areas, i.e. the weighing rooms. Finally, the installation of Dycem has reduced floor contamination and also the effort required and costs of maintaining cleanness of the remaining production areas’.

Placement of Dycem contamination control flooring After a site survey by Dycem’s contamination control representative, Dycem flooring systems were

Dycem Ltd +44 117 9559921 contact@dycem.com www.dycem.com

EPM 15

SHOWCASE BLOW-FILL-SEAL

BFS Machines Specialist Offers Range of Models to Suit Variety of Requirements According to Weiler Engineering, its corporate focus is to provide the most advanced aseptic liquid processing technology available through the application of customised Asep-Tech blow-fill-seal (BFS) machinery and integrated services. Weiler’s manufacturing facilities and corporate offices are conveniently located near Chicago’s O’Hare International Airport.

Asep-Tech BFS machines are designed and manufactured in the US, at a 13,006 m2 manufacturing plant located near Chicago, Illinois.

The Weiler design incorporates the three-step process of blow moulding, aseptic filling and hermetic sealing of liquid products in one sequential operation on a compact machine frame.

The entire Asep-Tech product line is

optimised for sterile production of liquid pharmaceuticals.

The Asep-Tech Model 628 BFS machine has the flexibility to produce sterile, liquid filled, tamper-evident containers ranging in size from 0.5 to 500 ml, in full-scale production quantities. It comes complete with an integral product buffer tank and all digital controls, designed to meet tight fill tolerances.

The versatile Model 628 features a twopiece stepped base design for easy maintenance and convenient product discharge. The design allows quick, efficient tooling changeovers for multiple container formats. Additionally, all existing Model 624 tooling (moulds, fill systems and parison heads) can be used on the Model 628 machine,

making it an attractive upgrade for current users.

An all-electric model is available, reportedly offering the ultimate in green processing, minimising the carbon footprint and enhancing the quality of the processing environment through highly reduced particulate generation.

The all-electric option is ideal for injectable and heat sensitive applications.

Additional machine models are offered to fulfill higher output and/or larger container size requirements.

Weiler Engineering, Inc. +1 847 697 4900 solutions@weilerengineering.com www.weilerengineering.com

BFS Machinery Range Reduces Waste and Lowers Costs Automatic Liquid Packaging Solutions, LLC (ALPS), in the US, is a supplier of blow-fill-seal (BFS)/form fill seal (FFS) sterile filling machines. ALPS possesses over 30 years of expertise in design, manufacturing and marketing of BFS machines around the world.

The BFS process is recognised as an advanced aseptic process by the FDA, designed for sterile liquid packaging applications.

ALPS manufactures new machines as well as supplies like new refurbished machines, with custom designed machinery tooling for aseptic liquid packaging applications such as the filling of plastic vials/bottles with parenterals, ophthalmics, nutraceuticals and biologics. ALPS’s green approach to designing its machinery and packaging has reduced plastic consumption by up to 10–20% in the flash wastage area.

ALPS offers R&D services for new prototype mould development of vials and bottles; sizes can range from 100 µl to 1.5 l.

ALPS +1 847 264 5349 ar@alp-solutions.com www.alp-solutions.com

An ALPS BFS machine with insertion-isolation technology to produce multiple product configurations.

CIP Unit Provides GMP-Compliant Cleaning of BFS Equipment in Tight Spaces The cleaning and passivation of rommelag’s bottelpack blow-fill-seal (BFS) systems and other pharmaceutical machines need to be carried out in accordance with validated procedures. This can be done in an automated, reproducible, safe and economic manner with the company’s recently launched CIP unit.

The CIP unit can be used to clean standard products and biotech products (with alkaline and acid solutions, tensides, etc.). Other applications of the CIP unit include passivation and derouging with standard chemicals for the pharmaceutical sector.

The mobile CIP unit can be used for

several systems and guarantees a GMPcompliant process control that can be validated. rommelag ag +41 62 834 55 55 mail@rommelag.ch www.rommelag.com

BFS Produces Pre-Filled Syringes at Reduced Cost There is an upward trend in the use of pre-filled syringes and healthcare professionals recognise that pre-filled syringes are distinctly advantageous because of: lower overfill; increased patient compliance; reduced risk of contamination and dosage error; and reduced possibility of reuse and hence cross infection.

This task can be made simpler and safer if the solvent is packed and supplied in pre-filled syringes. Most of these syringes are supplied in nests or a matrix of a few tens up to hundreds of sterile ready to be filled syringes, which are associated to filling machines; each manufacturing step increases risk of contamination, not to mention the high cost of production.

Pre-filled syringes are not widely used in reconstituent applications, mainly due to their high cost. However, main solvents used for reconstituting lyophilised (freeze dried) product are sodium chloride (NaCl) and water for injection (WFI). At present, most of these solvents are packed and supplied in ampoules. A sterile syringe is then required to draw the solvent from the ampoule and mix it with the lyophilised drug contained in the vial for reconstitution.

An ageing population, the global financial meltdown and an increasing number of producers of generic drugs are all drivers for reducing production costs. A several-fold reduction in cost can be achieved if these pre-filled

elimination of tungsten presence; and reduced silicon-related problems. syringes are produced using blow-fillseal (BFS) technology, which offers: reduced production steps; elimination of secondary packaging cost; tighter tolerance and reduced ovality;

EPM 16

Brevetti Angela S.r.l. +39 0444 474200 info@brevettiangela.com www.brevettiangela.com

Corporate News & Events

Tablet Tooling Specialist Announces Management Changes at UK Headquarters As a result of growing global markets, I Holland has announced the key appointment of a Sales and Marketing Director and the changing role of the Business Development Director to focus on the development of the cross functional Customer Service Group (CSG). These new roles reflect the company’s commitment to building and maintaining a strong and dynamic management team and delivering outstanding customer service.

Formerly Business Manager and Sales Director at Linx Printing, part of the Danaher Group, Andrew Priestley has taken on the role of Sales and Marketing Director. With a first class honours degree in Marketing and Engineering and a

diploma from the Institute of Marketing, Priestley joins I Holland with a wealth of experience. Together with his main board responsibilities, Andrew will be responsible for leading and developing all sales and marketing activity.

Commenting on Priestley’s appointment, Chris Prideaux, Managing Director of I Holland, said: “I Holland has implemented a strategic programme to drive the company forward and Andrew’s appointment will be central to increasing our sales and marketing activities worldwide. Andrew is highly qualified and experienced and we look forward to working with him.”

Priestley said: “I am very pleased to be a part of a company that has established

itself to be a leader in its field. I relish the exciting opportunity to apply myself to building on the sales and marketing of the company and helping to grow the company globally.”

The other change to the management structure is Steve Deakin’s new role of overseeing the development of I Holland’s cross-functional CSG. The CSG is made up of all customer facing employees in the business, including sales, marketing and manufacturing.

Deakin will help to push I Holland forward in achieving a high level of customer service and will concentrate on meeting the challenges presented by customers.

He will also facilitate the continuing improvements of I Holland’s processes

Andrew Priestley, Sales & Marketing Director.

and products, an essential part of the company’s strategy to offer a first-class service.

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

Conference to Focus on Future Requirements for Successful Pharma Manufacturing Facilities ISPE has announced its latest European conference, a two-day event taking place in Brussels, Belgium, on 30 September– 1 October 2013, will bring together leading industry experts and regulators to discuss methods for achieving adaptable production facilities and meeting the challenge of operational flexibility.

Thomas Zimmer, Conference Chair, Senior Vice President, Boehringer Ingelheim GmbH, said: “Megatrends in the pharmaceutical industry are in front of us. There is an increased focus on

quality risk management, good compliance practices, flexible facilities using modular concepts, the use of disposables for quality risk management and on the right implementation of quality by design — not to mention the important topic of supply chain integrity and the upcoming new GDPs. More and more, these topics need to be addressed with a cross-functional approach.”

The three conference tracks — Operations, Facilities and Plants and IT and Automation — will explore the implications of flexible and adaptable

Coding and Marking Equipment Specialist Revamps Corporate Image Allen Coding Systems has unveiled its new corporate image to mark the company’s next phase of growth and development and promote consistency and synergy across the ITW European Coding & Marking Business Unit.

The new corporate image includes revamped logo and website and was created to reflect the company’s professional standard and reputation as a leading European operation with highly respected products and expertise as well as its enterprising business strategy and vision.

A corporate identity guide sets standards for the mission, vision, core values, logo, colours, typography, images and many marketing materials.

The Allen Coding logo was redesigned as part of the corporate image launch to give it a more modern and dynamic look, while a new Allen Coding website — www.allencoding.com — acts as a gateway to each of the business unit member’s websites.

Steve Ryan, UK Sales & OEM Manager, commented: “The new corporate image was introduced to standardise branding and marketing

material across the ITW European Coding & Marking Business Unit, which also comprises Allen Spain and Allen Germany. It also helps reinforce our position across Europe and signals the start of a new phase of energetic growth and development. The re-designed logo and website emphasises our service, quality and innovation, plus gives us the formula for continuing to impress our customers with robust solutions.”

Allen Coding is part of the ITW Coding & Marking Division, which also comprises Allen Spain, Allen Germany, Norwood, Diagraph and Trident.

Allen Coding Systems +44 1438 347 770 info@allencoding.co.uk www.allencoding.com

manufacturing for pharmaceutical production, including: • supply chain requirements • the use of disposables in aseptic manufacture • lean production • portable equipment and modular plants • innovative technologies and control strategies • process data applications.

The conference will also cover the expected changes to the GMP chapters 3 and 5 and their impact on facility

design and production as well as recommendations to avoid cross contamination in a shared production facility.

For more information on this conference, including detailed agendas and registration information, visit: www.ISPE.org/2013-Flexible-FacilitiesEU-Conference.

ISPE European Operations +32 2 743 15 53 sabine.dupont@associationhq.com www.ispe.org

Award-Winning Robotics and Automation Supplier Comes of Age Astech Projects celebrated its eighteenth anniversary on 18 July 2013. The company was started with the founders’ vision to be ‘recognised as one of the world’s best’ in the design and supply of custom robotics and automation for use in advanced manufacturing industries, including pharmaceutical, medical device, consumer healthcare, petrochemical and chemical. This has largely been achieved by providing exceptional automation solutions tailored to the customer’s individual requirements.

Astech has gone from strength to the strength with an increasing sized workforce, two relocations to larger premises and a Queen’s Award for Enterprise: Innovation. Astech Director Anthony Moran commented: “This is a significant milestone for us and we hope it reinforces our reputation for quality and longevity. We have ambitious plans to broaden our product portfolio and to keep offering valuable solutions to our customers. We are committed to being best-in-class and, if we continue to improve, we can only become even more successful. In addition to thanking our dedicated Astech team for all their hard work and commitment over the last 18 years, we would like to thank our many clients who have entrusted Astech

EPM 19

to provide them with innovative and intelligent design solutions.”

To celebrate its anniversary, Astech is currently offering a free consultation and proposal of its turnkey approach to automation, which can consist of four key steps: (1) consultation and proposal, (2) concept design study, (3) proof of concept(s) and (4) detailed design, manufacture and testing. Simply complete the online form at www.astechprojects.co.uk/company/selfappraisal.php and one of Astech’s specialist Business Development Managers will be in touch.

Astech Projects Ltd +44 1928 571797 info@astechprojects.co.uk www.astechprojects.com

Corporate News & Events

Coding Specialist Bolsters Sales and Customer Service with Dual Appointment Domino has reaffirmed its commitment to customer service after promoting Mike Hurst to the role of UK Sales Director and appointing Ian Cockett to the position of UK Service Manager.

In his new role, Hurst will ensure that Domino UK is organised in the way that best responds to the needs of British manufacturers for coding, marking and printing solutions that have a low total cost of ownership and help to boost efficiency and minimise downtime. He will lead Domino UK’s team of area and regional sales managers, business development managers and key account manager.

Hurst, whose previous roles at Domino during his 19-year tenure include Director of Sales Channel Development and Product Director, said: “My key activities over the next few months will include developing a better understanding of the shape of the UK market and the different sectors that we serve. I want to ensure that we fully

understand our customers’ needs, how we serve them and why we serve them in the way that we do.”

Cockett, who took up his new post earlier this year, leads Domino’s team of field-based service engineers and the headquarters-based technical team, which both provide specialist support to the manufacturer’s diverse customer base.

Cockett joined the company from Bosch UK, where he was responsible for the after sales team within its heating division. In his new role at Domino, he will further develop the UK service team to support Domino’s growing portfolio of coding, marking and digital printing solutions and ensure high levels of customer service. Cockett will also implement system enhancements, aiming to ensure customers are offered the right solution the first time.

Customers will also benefit from training by Domino engineers, both

onsite and at Domino UK's Cambridge headquarters.

This will ensure they are empowered with the knowledge to diagnose and fix any basic technical issues without having to wait for a service engineer to arrive, helping to minimise downtime.

Cockett said: “I believe that one of Domino’s key Ian Cockett, Domino UK differentiators is how they Service Manager. support their customers in Mike Hurst, Domino UK the field. I think the critical Sales Director. factors in delivering worldclass customer service include having challenging and demanding an absolute understanding of what environment, not just when a customer customers want and striving to deliver a installs one of our products but all the service that exceeds their expectations.” way through that product’s lifecycle.”

Will Edwards, Domino UK General Manager, said: “The appointments of Domino UK Mike and Ian will help us move to the +44 1954 782551 next level in terms of offering our christoper.thorpe@domino-uk.com customers the best possible service in a www.domino-printing.com

Continuous Powder to Tablet Line Wins Annual Innovation Award GEA Pharma Systems has won the GEA Innovation Award for its revolutionary continuous direct compression technology, ConsiGma DC (CDC). CDC takes ingredients from powder to tablet in one step.

The GEA Innovation Award is an annual competition designed to celebrate and reward innovation throughout the organisation. Entrants are judged for their practicality and commercial potential with the winners being awarded additional funding to help with the development and promotion of the technology.

The CDC is a compact, all-in-one, tablet production line for direct compression formulations. It is a highyield system that is sufficiently flexible to be able to handle bespoke production of small volume, high-value products and

high-volume generic products on the same machine. It combines accurate feeding, blending, tablet compression and process analytics, all using patented GEA technologies.

Richard Steiner, Business Development Manager Continuous Processing for GEA Pharma Systems, recently presented the CDC concept to the GEA Board’s judging panel. The judges were impressed by the technology’s commercial benefits and business potential, recognising that the system provides the flexibility the pharmaceutical industry needs to meet growing volumes owing to an increase in generics and a simultaneous increase in the demand for specialist medicines.

“We were all so pleased to win,” said Jan Vugts, Managing Director of GEA Pharma Systems in Wommelgem, “It will

Jürg Oleas, Chief Executive Officer of GEA Group Aktiengesellschaft, Richard Steiner, Business Development Manager for Continuous Processing of GEA Pharma Systems, Jan Vugts, Managing Director of GEA Pharma Systems, Belgium, and Anders Wilhjelm, President and CEO of GEA Process Engineering Segment. make a real difference to our plans to roll out the CDC worldwide. It’s exactly the right technology at exactly the right time.”

GEA Pharma Systems +32 3 350 12 88 kris.schoeters@geagroup.com www.geapharmasystems.com

Processing Equipment Specialist Acquires Tablet Presses Supplier International Process and Packaging Technologies GmbH (IPPT) is buying Kilian GmbH & Co. KG. IPPT, based in Karlsruhe, Germany, is a portfolio company of Deutsche Beteiligungs AG (DBAG) and owner of the Romaco Group.

The official contract of sale has been signed by the German IPPT and the Italian IMA Group. The final completion of the contract is conditional, amongst other things, on the approval of the antitrust authorities. The transaction is expected to be concluded in the late summer.

IPPT is the parent company of the Romaco Group, with production sites in Germany, Switzerland and Italy as well as Sales & Service centres in the US,

Spain and Brazil. Kilian will be a sister company of the Romaco Group.

Kilian is a leading international supplier of tablet press machines residing in Cologne, Germany, with reported sales of approximately €45 million in 2012. The manufacturer’s technologies are used in the pharmaceutical, food and chemical industries both in serial production and on a laboratory scale. Apart from a wide range of tablets for pharmaceutical use, stock cubes, dishwasher tabs and pressed dextrose and sweetener products are just a few of the many applications. The portfolio encompasses a variety of services in addition to classic machines and lines.

Kilian offers outstanding prospects in

national and international markets alike.

Demand for equipment from European OEMs is especially high in the rapidly expanding pharmaceutical markets of Asia, Eastern Europe and South America, owing partly to the sharp rise in generics production worldwide. Kilian was established in Berlin in 1875 as a family-owned business. The firm moved to Cologne after the Second World War, by which time numerous patents relating to tablet press design and manufacture were already in its possession. Kilian was acquired by the IMA Group in 2000 and currently employs some 150 staff at its Cologne headquarters.

“Kilian is a seasoned company and a leader in the field of tablet press

EPM 20

technologies. It has an excellent reputation in key pharmaceutical and food production markets around the globe,” explained Paulo Alexandre, CEO of IPPT. “Pharmaceuticals and food in general are characterised by stable growth, which is significantly stronger in the emerging countries. Our acquisition of Kilian will enable us to extend the Romaco Group’s portfolio of machinery and services with an important new segment in solid dose applications, giving a crucial boost to our growth strategy.”

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

LABORATORY PRODUCTS & EQUIPMENT

Lab Press Introduces Additional R&D Capabilities In business for more than 40 years, Natoli Engineering offers high-quality tablet compression tooling, parts and accessories, as well as tablet presses that range from full-size industrial machines to benchtop laboratory presses.

Natoli has now launched the NP-RD20, a single station laboratory press that presents new opportunities for pharmaceutical R&D. Ideal for use during formulation development, the NPRD20 produces product in small quantities to test and simulate dwell time and compaction on a production press. This significantly reduces product loss and can provide multiple benefits as production is scaled up.

This automated, mobile press allows the operator to program aspects of

tablet production, including precompression parameters and dwell time, on a colour touchscreen display.

Hydraulics allow for automatic tablet compression and ejection.

The NP-RD20 also has data acquisition capabilities that can be used to collect and track test results, including compression curve and elasticity in single and bi-layer tablets.

Other features include quick tooling changeover and acceptance of both TSM and EU tooling in sizes B, D and F in standard, core rod or multi-tip configuration.

The NP-RD20 is CE compliant and can run on 110 or 220v power.

Standard safety features include Lexan guards and two-hand, no-tie-down controls.

Natoli Engineering Company, Inc. +1 636 926 8900 info@natoli.com www.natoli.com

Flexible Filling Device Facilitates DoE and Easy Scale-Up to Production With the new FHM 1000 series, Bosch Packaging Technology introduces semiautomated, modular laboratory devices for liquid pharmaceutical filling operations. The first prototype of the series was presented to an expert audience at the Crailsheimer Pharmatag in May 2013. The new development is particularly suited to pharmacists and for application in laboratories and early clinical trials. Its filling parameters can be easily scaled-up to production systems; all relevant parameters are measured and specified in the laboratory and can then be transferred to production machines without further settings.

The development of the FHM 1000 prototype was based on early involvement of customers and end-users in the process. “Our goal is to offer our customers compact and modular laboratory filling systems that support their everyday working processes,” said Joachim Brenner, Site Manager at Bosch Packaging Technology’s Crailsheim facility and responsible for the pharmaceutical liquid product portfolio worldwide. The FHM series significantly facilitates design of experiments (DoE) for customers. Recording parameters makes it possible to precisely determine cause-effect relationships between influencing factors and target variables

by involving customers’ experience.

This user experience approach has already been successfully implemented within the Bosch Group. In the electromobility sector, for instance, the very early involvement of potential customers in the design and development process led to a quick marketability of several products. “Our new development was a good occasion to transfer this internal knowhow to the pharmaceutical area,” said Andreas Groß, Product Manager at Bosch Packaging Technology. “An interdisciplinary team of development and market experts successfully implemented the user experience approach for our new laboratory device FHM 1000.”

The FHM 1000 series currently consists of four different modules: human machine interface (HMI), filling module, weighing module and needle movement.

All automatic processes are operated from the HMI, which is the centrepiece of the device. The filling process, with its filling needle movement and in-process control (IPC) weighing, is parameterised via the HMI, whereas input and output of the packaging is done manually. “The recorded results and parameters can be

EPM 21

scaled-up and transferred, for example, to high-performance lines,” Groß explained.

The prototype operates with a peristaltic pump. Further filling modules are planned, for instance with a rotary slide piston pump. According to demand, the different filling systems can then be flexibly exchanged. The integration of a closing module is also planned, enabling packaging to be equipped with different types of stoppers. A protective housing for both the filling module and the needle movement ensure product and operator safety. All modules conform to the EU Machinery Directive 2006/42/EG. Bosch Packaging Technology +49 7951 402 472 www.boschpackaging.com

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP LC-MS System’s Tri-Configuration Enables Outstanding Depth of Analysis Thermo Fisher Scientific has introduced the Thermo Scientific Orbitrap Fusion Tribrid liquid chromatography-mass spectrometry (LC-MS) system, integrating its three mass analysers — quadrupole, Orbitrap and linear ion trap — in a Tribrid architecture that offers a significant increase in depth of analysis of complex biological samples.

One way the Orbitrap Fusion system addresses throughput challenges is through tandem mass tags (TMT). This technique enables mass spectrometers to determine relative quantification of proteins in multiple samples simultaneously. The Orbitrap Fusion’s depth and quality of data allows for exceptional TMT results. According to Thermo Fisher, the new platform takes advantage of MS3 selectivity to improve quantitative accuracy and can collect twice as many MS3 scans per unit time at significantly greater sensitivity than previously possible. New TMT reagents are also available, allowing comprehensive, simultaneous analysis of up to 10 samples.

At the heart of the Orbitrap Fusion LCMS is a configuration of three different

mass analysers that work together to raise analytical performance: • a quadrupole for precursor selection at isolation widths down to 0.4 amu for excellent sensitivity and selectivity • an ultra-high-field Orbitrap offering resolution in excess of 450,000 and scan rates up to 15 Hz for exceptional selectivity and speed of analysis • an ion routing multipole followed by dual-pressure linear ion trap providing MSn HCD, CID and ETD fragmentations and fast, sensitive mass analysis with scan rates of up to 20 Hz. This Tribrid configuration allows users to positively identify large numbers of low-abundance proteins incredibly fast.

Its architecture enables simultaneous precursor isolation, fragmentation and data acquisition in both the Orbitrap and linear ion trap mass analysers. More high-quality data can be collected, expanding the range of possible experiments.

The ability to choose between fragmentation modes at any stage of MSn analysis with detection by the Orbitrap or linear ion trap analyser reportedly makes possible a range of

Thermo Scientific Orbitrap Fusion Tribrid LC-MS with Thermo Scientific Dionex UltiMate Series UHPLC.

novel experiments to achieve a new level of structural information from metabolites, glycans, post-translational modifications and sequence polymorphisms.

In typical metabolomics experiments, scientists frequently encounter unknowns along with target compounds.

To identify the unknowns, the sample must be rerun on an LC-linear ion trap instrument to obtain MSn data, although it is difficult to match chromatography retention time on the second run,

introducing substantial uncertainty. With its three mass analyser configuration, the new Orbitrap Fusion Tribrid LC-MS addresses this problem, offering users the ability to transform many small molecule experiments by conclusively identifying unknowns as they are encountered.

Thermo Fisher Scientific Inc. +1 408 965 6408 stu.matlow@thermofisher.com www.thermofisher.com

Fast Lyophilisation Methodology Enables Routine Generation of Powder Samples from HPLC Fractions

Programmable Peristaltic Pump Dispenses Wide Range of Volumes with Speed and Accuracy

Genevac has reported that its HT Series II Evaporator, using the fast lyophilisation or LyoSpeed process, is enabling a growing number of pharmaceutical laboratories to routinely dry HPLC fraction samples to a powder form, such that the samples can then be accurately weighed, easily sub-sampled and redissolved.

When working with certain HPLC solvents, such as water and acetonitrile, a fully dried result can be hard to achieve owing to interactions with the dissolved sample, resulting in the formation of a gum or oil.

To provide a rapid, high-throughput alternative to freeze drying HPLC purification fractions, Genevac developed its proprietary fast lyophilisation (LyoSpeed) methodology for use on the HT Series II Evaporators.

While LyoSpeed works well for most hydrophilic samples, difficulties may arise where the sample cannot dissolve in only water. In such situations, when the organic solvent is removed, the sample crashes out, forming an oil that until now required further processing to achieve the desired dry powder form.

For such samples and to improve LyoSpeed results generally, Genevac developed the SuperCool 75, which

The DOSE IT peristaltic pump from INTEGRA makes dispensing easy.

With different application methods and different tubing, the DOSE IT can be set up to accurately and rapidly dispense into almost any labware.

DOSE IT is an intuitive programmable peristaltic pump that simplifies the dispensing of cell culture media, buffers and other solutions for volumes ranging from 0.1 to 999 ml. DOSE IT features a very small footprint and weighs only 3.5 kg, making it a perfect device for benchtop or in-hood dispensing applications. Programming DOSE IT is fast and easy through a multilingual user interface (English, Spanish, German, French, Italian and Japanese). The instrument’s pump head accommodates the use of 1–8 mm tubing diameters, allowing a wide range of volumes to be dispensed with outstanding speed and precision. A built-in print capability supports the capture of program details for record keeping and quality control. Many accessories are available to support a variety of dispensing applications.

For more complex liquid handling procedures, the DOSE IT CUSTOMIZE

chills to -75˚C and reportedly operates at higher power than any other commercially available condenser.

Customer trials have shown that the Genevac HT Series II Evaporator/SuperCool 75 combination produces powdered lyophilisation samples using the LyoSpeed methodology from even the most difficult to handle samples with a success rate as high as 95%.

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

Microplate Design Eliminates Well-to-Well Crosstalk To address performance limiting well-towell crosstalk inherent in most assay plates, Porvair Sciences has developed the Krystal 2000 microplate range.

Incorporating individual clear cups moulded into either a black or white polypropylene matrix, crosstalk is eliminated and the sensitivity, photometric accuracy and repeatability of users’ bottom reading absorbance, fluorescence and luminescence measurements markedly improved.

Maintaining industry standard 96-well microplate dimensions, the Krystal 2000

range is fully compatible with all commercially available plate readers, robotic sample processors and automated liquid handling systems.

Constructed in ultra-pure grade polystyrene, Krystal 2000 microplates are available in opaque white, solid black and black and white combination formats. For sensitive fluorescence measurements, the black plate provides the all-absorbing background needed to minimise background interference. The opaque white plate maximises reflectivity, enabling even weakly

emitting luminescence assays to be routinely undertaken.

In addition to optimised luminescence and fluorescence measurements, the design offers improved cell binding efficiency and allows the convenience of direct measurements on bottom reading spectrophotometers and inverted microscopes.

Porvair Sciences Ltd +44 1978 666240 int.sales@porvair-sciences.com www.porvair-sciences.com

EPM 22

software mode allows users to create their own personalised liquid handling protocols. Up to 20 consecutive dispensing and aspirating steps can be defined. A wide range of settable parameters, such as volume, flow rate and repetitions, can be assigned to each step. In addition, the flow rate can be set to ramp up or down to the target speed, thus avoiding foaming, splashing or unwanted turbulences during dispensing.

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

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Large Chamber Autoclaves Accommodate Bulky Items

The Priorclave RSC range of autoclaves, with taller, large rectangular steam sterilising chambers, has become a popular choice for laboratories undertaking high-volume throughput or that are frequently tasked with handling taller and bulkier items. Despite their large practical chamber size, these autoclaves require only a relatively small floor area.

To suit a diverse range of applications in food and drink, dairy, pharmaceutical, agriculture, education, healthcare and research laboratories, Priorclave is able to supply RSC autoclaves with a choice of steam generation (electrical or direct steam heated), or they can be fitted with an in-house steam generator, ideal where continuous sterilising applications take place.

Five standard chamber sizes are available — 230, 285, 350, 450 and 700 l — and each model is fitted with one of the most advanced microprocessor control systems to guide operators through simple setup procedures. This ensures that laboratories optimise the autoclave performance in relation to the media being processed, helping to reduce running costs.

All RSC autoclaves are equipped with a patented, large hand-wheel door closure system for the easy and safe opening/closing of the robust hinged door. An inherent feature is the fitting of a thermal and pressure lock system to the lower hand-wheel, which prevents the door opening at load temperatures above 80˚C and pressures above 0.2 bar, thus averting potential accidents through discharge of hot, high-pressurised steam.

The autoclaves are fitted with an automatic water-fill as standard, however Priorclave is able to incorporate a number of options into the standard steriliser framework of these high-capacity sterilisers such as water cooling jackets, a pre-cycle vacuum, enabling multiple vacuum stages to be programmed with interspersed heating to achieve greater steam penetration of difficult media as well as post cycle drying.

All Priorclave autoclaves feature an antimicrobial exterior finish. By adding Biomaster Protection to the exterior epoxy coating on body panels and frames, a highly effective and permanent treatment for control of harmful bacteria has been achieved, providing durable lifelong protection against the threat of cross contamination. This tough finish is proven to reduce bacterial growth by up to 99.99% and is highly effective against MRSA, E.coli, Listeria, Legionella, Campylobacter, Salmonella, Pseudomonas and over 50 other species.

Peristaltic Cased Tube Pump Ensures Contamination-Free Transfer The Verderflex Vantage 3000 range of tube pumps offers highly accurate, repeatable dosing for low to medium flow.

They are ideally suited for pharmaceutical and laboratory applications.

The compact Vantage 3000 may easily be used on a benchtop and is ideal for the transfer, dosing or metering of abrasive, shear sensitive and highly viscous fluids. It operates at pressures of 2 Bar and is available to the end-user in three drive options: B Model — standard on/off, left/right function C Model — remotely controlled analogue operation P Model — dispensing, programmable and remote operation.

A key feature of the Vantage 3000 is the easy tube load head, which can be changed in just three simple steps without any tools in seconds, therefore reducing downtime. Additional pump heads can be simply fitted to the pump for simultaneous multiple dosing from a single pump.

Peristaltic tube pumps contain the liquid in the tube, eliminating the risk of contamination. This makes a peristaltic pump the perfect choice for aseptic applications where hygiene and sterility are critical to the process.

Additionally, a favourite feature is the Verderflex Vantage 3000’s programmable timed dosing option. This reliably dispenses a preset liquid volume, offering accurate and repeatable dosing up to ± 0.5%, with no product slip, providing piece of mind dosing and dramatically speeding up this process.

The Verderflex Vantage 3000 peristaltic pump has proven remote control capabilities; with inputs for both a remote stop/start and a 4 to 20 mA speed control, it is easily integrated into a manufacturer’s equipment.

Subject to material compatibility, the Verderflex Vantage 3000’s tubing is certified to FDA CFR 21, EC 1935/2004, USP class VI and NSF and can be sterilised by autoclaving, gamma irradiation or ethylene oxide (EtO).

Verderflex +44 1924 221033 paul.dale@verder.co.uk www.verderflex.com

Website and Magazine Serve as Comprehensive Resources for Biomedical Products Panasonic Biomedical has launched a comprehensive, easy to navigate, new website that reflects the full incorporation in April this year of its healthcare and biomedical products into a single branded division.

With its streamlined new design, the revamped website allows visitors to easily and quickly access the information they need to make purchasing decisions. Resources

available on the site then help them right through to ongoing maintenance, service and support. Launched to coincide with the new website is the new Panasonic Biomedical magazine, a half-yearly publication that provides additional information on key product lines.

Readers can further their knowledge with articles on product applications, such as the use of Panasonic Biomedical freezers in biobanking, and coverage of topics that include best practice and sample security.

The new Panasonic Biomedical website is conveniently structured and quick to navigate, with an increased array of product information accessible via a specific downloads area.

Here, users can access a time-saving search function

Priorclave Ltd +44 20 8316 6620 sales@priorclave.co.uk www.priorclave.co.uk EPM 23

that quickly and easily locates brochures, fliers, instruction manuals and part lists. A series of short service movies will eventually accompany this wider range of product information, addressing topics from basic problem solving to instrument best practice.

Users of the new Panasonic Biomedical website can complete quotation and validation forms online and have them sent straight to their local distributor, shortening processing and response times and enhancing customer service.

The English language version of Panasonic Biomedical’s new website and supporting magazine are available now, with Dutch, French, German and Russian sites scheduled for later in 2013.

Panasonic Biomedical Sales Europe B.V. +31 76 543 38 33 biomedical.export@eu.panasonic.com www.biomedical.panasonic.eu

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Life Science Imaging and Analysis Software Features Customisable Interface Focusing on ease of use for routine applications, the latest cellSens software release, version 1.8, offers flexible and user-centric imaging, processing, analysing and reporting. New and enhanced functions include a fully customisable user interface, precise frame-by-frame sample navigation and easy one-button switching between wells.

For a wide range of life science applications, cellSens provides easy control of the workflow. The software binds together Olympus frames, cameras and high-quality optics to form complete, highly precise and user-friendly microscopy systems.

The new ‘My Functions’ window allows users to build their own personal interface by selecting and freely grouping software commands and icons according to individual needs. In addition, the

creation of flexible workflow toolbars facilitates repetitive operations. The ability to display only the functions needed on the toolbar and to group common operations in a single tab, enables quick and easy access to the most frequently used tasks while providing a display free from clutter and confusion.

A ‘Well Navigator’ solution for rapid and intuitive setup of multi-well imaging studies includes customisable pre-sets for a wide range of plate formats. The software also features panoramic individual well imaging that composes a single montage as the user moves across the specimen. As focusing can be an issue when moving across large multi-well plates, the ‘Well Navigator’ can be used in conjunction with the Olympus Z-Drift Compensation (ZDC) unit to ensure that focus is automatically

maintained. The new version also supports one-button direct movement between wells and precise frame-byframe navigation, replacing cumbersome joystick control.

The updates complement existing cellSens functions such as extended focus imaging (EFI), 2D deconvolution and high dynamic range (HDR). EFI records image data while focusing through the sample to automatically generate a final all-focus image, whereas HDR captures at different exposures to create even final images for samples that contain both low and high light intensity areas. 2D deconvolution applies a true deconvolution to a single image to enable better focusing on thick and complex specimens.

These combined features make cellSens ideal for a broad range of

routine applications, enabling any user to generate expert results, regardless of experience.

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

Vision-Based Multispectral Imaging Analyser Provides Fast Screening for OOS Products

Mixer-Reactor Chip Improves Control of Rapid Highly Exothermic Reactions

Analytik has released the VideometerLab 3, an easy-to-use multispectral imaging and automated visual measurement system for fast and accurate determination of surface colour, texture and chemical composition of manufactured and natural products.

Based on high-intensity and homogeneous sample illumination using light emitting diodes (LEDs) and an integrating sphere, in combination with a high-resolution camera, the well-defined and diffuse illumination enhances and highlights very small colour variations of samples.

Multispectral imaging can be described as affordable hyperspectral imaging but with a trade-off sacrificing of some spectral resolution to increase spatial information, giving a snapshot of the combined bulk properties of a sample, handling natural variation and inhomogeneity. The technique offers a rapid solution to screening for out of specification (OOS) tablets, capsules, granules and contaminated pharmaceutical powders, including assessment of shape, colour, impurities, foreign bodies, chipping and cracks.

Since the response of the test material is measured almost simultaneously at up to 20 different wavelength bands, very subtle changes in composition can be detected and differences automatically flagged.

This test is entirely non-destructive, requiring only a sub-sample of the product under test to be placed in a petri dish before analysis is carried out.

Uniqsis has demonstrated how its proprietary glass static mixer-reactor chip technology can be used to perform highly exothermic reactions more conveniently at higher temperatures with useful throughputs under continuous flow-through conditions.

To achieve high reproducibility and facilitate scale up, it is important to control both mixing and temperature, particularly for highly exothermic or rapid mixing-dependent reactions (Type A reactions).

Where the diffusional mixing provided by simple T-piece mixers is too slow to afford good control and reproducible reaction outcomes, Uniqsis has introduced a range of ingenious glass static mixer blocks (chips) that incorporate channels with active mixing geometries to provide efficient turbulent mixing throughout the reaction vessel whilst also functioning as very efficient heat exchangers.

Uniqsis offers both conventional two input one output static glass mixerreactor chips for combining two reagent streams, useful in nitration chemistry for example, and a three input one output chip, which is particularly useful for reactions requiring a quench input. The chips are easy to incorporate into the reaction flow path and use conventional threaded connectors that require no tools to attach and achieve leak-free seals over a wide temperature range.

Precision machined from chemically

Much improved colour determination compared with traditional RGB technology and the ability to produce a multispectral analysis in less than six seconds makes VideometerLab 3 an ideal instrument for microbiological culture monitoring and automation, distinguishing multiple live colonies from each other as well as foreign matter or air bubbles and auto identification of pathogens.

The system could also be used to identify counterfeit pharmaceuticals through analysis of packaging (ink, lacquer, printing and substrate) as well as the actual finished dosage forms.

Analytik Ltd +44 870 991 4044 ksenia.semina@analytik.co.uk www.analytik.co.uk

inert borosilicate glass, these chip are tested to operate efficiently at up to 40 bar pressure and from -80 to +150˚C. Metalations are typically performed at very low temperature (often -78˚C) in batch with slow addition of the organometallic base in order to control the highly exothermic nature of such reactions.

Uniqsis mixer-reactor chips in combination with a FlowSyn column module, Cold Coil or Polar Bear reaction station offer a convenient and reliable solution to the control of mixing and temperature in chemical synthesis.

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

Bioreactor Combines Proven Glass Design and Single-Use Efficiency Sartorius Stedim Biotech (SSB) has presented the UniVessel SU, the second generation of its successful laboratory bioreactor. This single-use stirred tank bioreactor can be operated in a choice of working volumes ranging from 0.6 to 2 l and is suitable for the cultivation of mammalian cells, including stem cells, insect cells and plant cells. Typical areas of application for the UniVessel SU are process development and optimisation as well as production of seed cultures and cell banks.

Fast and flexible for efficient management of peak workloads despite

challenging timelines, UniVessel SU combines the proven design of conventional glass vessels with the efficiency and flexibility of single-use systems. Supplied as a completely preassembled and presterilised unit, this laboratory bioreactor is instantly ready to use right out of the box. It eliminates the need for labour-intensive steps, such as autoclaving or installation of probes, minimising the time needed for preparation. The new UniVessel SU can be used interchangeably with glass vessels to help laboratories better manage peak workloads despite challenging timelines.

Each UniVessel SU is equipped with integrated single-use sensors for pH and dissolved oxygen measurement. This proven single-use sensor technology, which SSB also uses in its BIOSTAT RM and BIOSTAT STR disposable bioreactors, measures the pH and DO values non-invasively, therefore eliminating time-consuming autoclaving and risk-prone insertion of probes in the culture vessel.

UniVessel SU is compatible with SSB BIOSTAT controllers and can also be operated with nearly any other brand of bioreactor controller. This saves

EPM 24

customers from having to buy expensive new equipment. The new UniVessel SU Connection Box enables the integrated single-use sensors of UniVessel SU to be used with existing controllers. Up to four bioreactor controllers can be interfaced per Connection Box. The sensor calibration data can be read in easily by a barcode scanner in an errorfree manner.

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

SHOWCASE INCUBATORS

Critical Considerations for CO2 Incubator Selection The CO2 incubator is one of the most widely used items of laboratory equipment in any typical cell culture laboratory. It is commonly used for the following applications: cell culturing, tissue engineering, neuroscience, cancer research, in-vitro fertilisation, embryonic stem cell research, stem cell research and other mammalian cell research and cultivation of mammalian cells.

The perfect in vivo environment (conditions required inside the CO2 incubator inner chamber) that is most commonly used for cell research and cell cultivation is typically 37.0˚C, 5.0% CO2 and 88% RH (relative humidity). It is therefore very important to take time

in deciding selection criteria before purchasing a CO2 incubator and to consider some very important and critical factors such as uniformity and control and fastest CO2, humidity and temperature recovery without overshoot.

Esco CelCulture CO2 incubators combine direct heat technology with an air jacket and forced convection to reportedly achieve the most stabile, homogenous and accurate chamber conditions for cell cultivation.

VentiFlow forced convection offers reduced disturbance to cell culture. The blower automatically stops when the door is opened to minimise mixing of chamber and room air. As a result,

recovery of the chamber air to ISO Class 5 cleanliness after the door closes is less than 13 minutes to prevent contamination. Filtered air circulates across the water pan to accelerate the humidifying process.

According to Esco, it has undertaken a great deal of market research, analysed many competitors’ CO2 incubators, listened to its customers and made every effort to produce the best quality CO2 incubator range in today’s market.

Esco Gb Ltd +44 1725 514 555 info@escogb.com www.escogb.com

Cooled Incubator Range Offers Four Sizes with 2 to 50˚C Temperature Range LTE Scientific has recently launched a brand new and improved family of cooled incubators to replace its Qualicool range. The stylish IC range combines contemporary cabinet design with solid, reliable performance. In addition, all models use refrigerants R290 and R600a, which have a global warming potential (GWP) of just 3. This, together with lower energy consumption, will help lower running costs whilst reducing carbon footprint.

Accurate temperature performance and space-efficient storage capacities are key features of the new IC range. All IC cooled incubators incorporate a quiet and effective fan circulation system that

distributes the air evenly throughout the chamber. All models are designed to operate between 2 and 50˚C. Four sizes are available and all models can be supplied with either a white epoxy coated or stainless steel exterior finish. Additionally, all models can also be supplied with doubleglazed glass doors. Interiors are high impact-resistant and durable ABS. The entire range also has a one-piece door seal that can be easily removed, making the whole cabinet extremely easy to clean.

A major feature of the benchtop/underbench IC200 model is its impressive usable chamber capacity

CO2 Incubators Ensure Sample Security with Outstanding Environmental Control Increasingly stringent regulation and the need for absolute sample security when working with human materials heightens the need for laboratory instrumentation that performs to the highest standards.

Panasonic MCO-19 CO2 cell culture incubators deliver outstanding environmental reliability. Through the incorporation of the company’s patented Direct Heat and Air Jacket system, together with dual wavelength infrared CO2 control, incubator temperature and CO2 concentrations are constantly monitored and closely controlled.

Additional O2 concentration control is also available as part of the range’s multigas incubators.

Panasonic’s Direct Heat and Air Jacket guarantees precise, uniform temperature control, which safeguards the incubator and its contents from any fluctuations in ambient temperature. The dual wavelength infrared CO2 control system is exceptionally accurate, simultaneously measuring both sample and reference wavelengths to provide continuous autozero calibration. Panasonic’s highly effective SafeCell UV contamination

IC400 has an impressive 294 l capacity yet it only takes up 595 x 640 mm floor area.

For easy manoeuvrability, IC400 and IC600 models are supplied on castors as standard.

IC cooled incubators are controlled via an electronic PID controller, providing close temperature control and variation throughout the chambers. For added safety, over-temperature protection is provided via a class 2 limiter. of 92 l, which makes it one of the largest under-bench cooled incubators available. In addition, the IC200 range can be stacked, therefore making good use of floor area in the laboratory. The

LTE Scientific Ltd +44 1457 876221 info@lte-scientific.co.uk www.lte-scientific.co.uk

Cooled Incubators with Two Technology Options to Suit Variety of Applications

control is built in, together with InCu saFe, a copperenriched stainless steel alloy interior and decontamination system, so users can be confident that their samples are safely maintained in the optimum environment.

Importantly, ongoing support from the dedicated team of Panasonic Service Specialists maximises the potential and lifespan of all Panasonic instruments.

Panasonic is committed to providing customers with exceptional service, right from helping with purchase through to the maintenance of equipment.

Panasonic Biomedical Sales Europe B.V. +31 76 543 38 33 biomedical.export@eu.panasonic.com www.biomedical.panasonic.eu

More and more, today’s customers require complex, versatile solutions.

Each application demands to be handled in its own individual way, with the logical inference that the range of products will cater to the specific needs of the application. For this reason, BINDER has added cooled incubators with two different technologies to its range. These are traditional units with either Peltier modules — the KT Series, or compressor technology — the KB series.

Cooled incubators belong in every laboratory where cell biology, microbiology or molecular biology methods are used, such as in the biology, medicine, pharmaceutical research and food industries. They create a constant microclimate for the development and growth processes of microorganisms and cell cultures.

Peltier technology creates new possibilities for cooling in special applications. Peltier units are particularly cost- and energy-efficient when operated at or around ambient temperatures. In addition, they operate more quietly and with less vibration and are very

EPM 25

environmentally friendly because refrigerants are not required.

In contrast, compressor-drive cooling systems have greater performance reserves for higher temperature dynamics and show their strengths at low operating temperatures with greater efficiency.

Both technologies have their specific advantages and between them cover the complex application fields for cooled incubators.

BINDER GmbH +49 7462 2005 632 dorothea.fichter-fechner@binderworld.com www.binder-world.com

Corporate News & Events

Lab Equipment and Chemicals Supplier Triumphs in Medilink East Midlands Business Awards Scientific Laboratory Supplies (SLS) has walked away with the award for Outstanding Achievement in this year’s Medilink East Midlands Business Competition. The company collected the prize at the Innovation Day awards dinner, held on 13 June 2013, at the Radisson Blu Hotel, East Midlands Airport, UK. Based on the Wilford Industrial Park on the outskirts of Nottingham, SLS is reportedly the largest independent supplier of laboratory equipment, consumables, chemicals and life science products in the UK. The award recognises the company’s achievement in winning a major contract to supply the Nuclear Decommissioning Agency, which commended the technical quality, flexibility and innovative approach shown in the SLS proposal. The commercial impact for SLS has been significant; not least the adoption of safety and quality standards and a drive to implement higher level quality

procedures throughout the whole company.

Peter Lister, Operations Director, said: “SLS were shortlisted for two Medilink awards, including the Export Achievement Award, which is recognition in itself. Winning the Outstanding Achievement Award is a brilliant accomplishment for the SLS team, as is the recognition within the East Midlands Life Science community.”

The Outstanding Achievement Award is sponsored by Morningside Pharmaceuticals Ltd. CEO Dr. Nik Kotecha said: “Exceptional achievement in the life sciences sector is something we believe in, which is why we sponsor this award. It provides the recognition that high achieving companies deserve.

It is good to see independent companies like SLS making excellent progress in a marketplace dominated by a few large companies. The award recognises drive, innovation and commitment to quality that is good for

the whole sector, as it sets a standard for others to emulate.”

Speaking after the awards were announced, Dr. Darren Clark, Chief Executive of Medilink East Midlands, commented: “SLS has shown great tenacity and drive in winning a major new client and using this in turn to drive internal development as well as create new jobs for the city. We congratulate them on their continuing success, which illustrates that quality of service and customer care still set a company apart from the competition.”

SLS is automatically entered into the Medilink UK National Awards, which will take place in early 2014.

The Awards ceremony took place on the evening following the Medilink East Midlands Innovation Conference, which was supported by the Healthcare and Bioscience iNet project (part-financed by the European Regional Development Fund (ERDF)). This year’s conference theme, ‘Revolutionising Healthcare —

Dr. Nik Kotecha, CEO of Morningside Pharmaceuticals, with Peter Lister, Operations Director at SLS. What part will you play?’ attracted over 200 of the region’s leading businesses and academics in the sector.

Scientific Laboratory Supplies Ltd +44 1482 649665 www.scientificlabs.co.uk

Company Museum Presents History of Analytical Measuring Technology Analytik Jena’s company museum presents the exciting history of analytical measuring technology in Jena to visitors, customers, business partners and interested guests over 70 m2 and showcases the successful continuation of instrument development at Analytik Jena up to the present day. More than 40 exhibits are on display from the three business units of Analytical Instrumentation, Life Science and Optics, including many historical instruments from the time before Analytik Jena was founded in 1990 — starting in the 1960s and 1970s and stretching into the 1990s. A variety of instruments ranging from spectrophotometers, atomic absorption spectrometers, thermal cyclers, automatic pipetters and refractometers to small reflex sights from the Optics unit are on display.

Klaus Berka, Chief Executive Officer of Analytik Jena, commented: “Analytik Jena

is one of the most innovative companies in the world for modern analytical measuring technology. The foundations of our success were laid in April 1990 when three former Zeiss employees established Analytik Jena. With the acquisition of lab analysis technology from Carl Zeiss — including product portfolio, patents and employees and their expertise — in December 1995, the long-standing tradition, which was on the verge of coming to an end, was continued with great success in Jena. We are still strongly committed to the historical achievements of Ernst Abbe and Carl Zeiss today.”

Following a six-month conception and design phase, Analytik Jena now presents an impressive overview of outstanding technologies from the area of optical spectroscopy on the ground floor of the company’s headquarters on Konrad-ZuseStrasse in Jena-Göschwitz, Germany. For

instance, with the AAS 5 EA (pictured), the company demonstrates a spectrophotometer in the area of atomic absorption spectrometry (AAS), which was a global first with its transverse-heated graphite furnace applications and the possibility of direct solid sample analysis in graphite tubes and represented a technologically important link in continuing later R&D work at Analytik Jena.

Berka added: “Individual exhibit items still work after many years and many are still being used in laboratories around the world because of their excellent quality.

We remain committed to this legacy of quality in our products today. Our one-ofa-kind contraAA technology still has a unique global technological position after more than eight years on the market.”

The industrial manufacture of the first

analytical instruments in the world began at Jena, in the optical workshop of Carl Zeiss, founded in 1846. Carl Zeiss launched the world’s first spectrometer in 1874; Ernst Abbe had provided the scientific basis for producing optical measuring instruments effectively.

Analytik Jena AG +49 36 41 77 70 info@analytik-jena.com www.analytik-jena.com

analytica 2014 to Offer More Highlights and Exhibitors analytica will feature a new attraction when it opens in April 2014. For the first time, there will be a special show on occupational health and safety in the laboratory. Successful concepts such as Live Labs and the renowned analytica Conference will also be continued.

Susanne Grödl, Exhibition Director for analytica, explained: “Whether in research or industry, the safety of laboratory employees is extremely important. Until now, none of the world’s trade fairs for analysis and laboratory technology featured a special show on the topic.” But the 2014 fair will cover it in live demonstrations that are part of Live Labs. With some 3,000 visitors, they were the highlight of last year’s fair. In 2014, the Live Labs will be located in Halls B1,

B2 and A3 again and will focus on topics such as food and water analysis, plastics analysis and the life sciences.

Currently, 580 companies have registered for the fair (compared with 553 in 2011) and nearly two-thirds of the space in the five halls is occupied. Those companies include industry leaders such as Agilent, Analytik Jena, Beckman Coulter, Becton Dickinson, Bruker, Büchi, Carl Zeiss, Eppendorf, GE Healthcare, Horiba, Julabo, Metrohm, Perkin Elmer, Thermo Fisher Scientific, Shimadzu and VWR International.

The analytica Conference boasts 22 symposia, full lecture halls and 1,700 participants, which is an increase of 40% compared with 2010. Well-known scientists from Germany and abroad will

report on the current state and growth potential of the analysis sector again.

Presentations will revolve around innovative methods and techniques as well as new potential applications and processes. Analysts from nearly every application sector will present their findings, from pharmaceutical analysis, bioanalysis and food analysis to clinical and medical diagnostics and environmental, water and material analysis. The conference is organised by Forum Analytik, Germany’s three leading scientific associations — the German Chemical Society (GDCh), the Association for Biochemistry and Molecular Biology (GBM) and the German Society for Clinical Chemistry and Laboratory Medicine (DGKL).

EPM 26

Owing to strong demand in the past, training and consulting company Klinkner & Partner will offer an expanded programme of seminar events. Besides scientific know-how, participants can discover the latest knowledge in laboratory and quality management. As in the past, organisers are also planning to hold analytica Job Day, Finance Day and practice-oriented lectures for laboratory users in analytica’s Biotech and Laboratory & Analytics Forums.

Messe München GmbH analytica +49 89 949 114 88 info@analytica.de www.analytica.de

INGREDIENTS & CONTRACT SERVICES

CDMO Invests £3 Million in Additional Tabletting Capacity Penn Pharma has announced its latest plans to invest in additional specific tablet manufacturing and coating capacity to meet customer demand.

This investment is in addition to the £14 million recently invested in a solid dose contained manufacturing facility to handle potent APIs. Penn Pharma Chief Executive Officer Richard Yarwood commented: “We are making this additional significant investment to meet our growing customer demands. It is fuelled by our demonstrated ability to provide pragmatic and timely solutions for their needs. At a time when many businesses are struggling, we are continuing to grow the Penn business and our recent investments give us the platform to provide even better services to our customers.”

The new £3 million investment follows the recent completion of Penn Pharma’s new 1,394 m2 site for the clinical and commercial manufacture of tablets and capsules. The facility will deliver both the clinical and commercial contained manufacturing needs of its clients.

Penn Pharma Chief Operating Officer Mark Dean-Netscher also commented: “Again, we at Penn are demonstrating our commitment to our customers and our growth as a business. This additional investment will ensure we deliver to our customers and exceed expectations.”

Penn Pharma has been providing pharmaceutical services for over 30

years and employs 275 staff at its two sites in South Wales, UK. It has twice won the prestigious Queen’s Award for Enterprise in recognition of the work it provides to export markets including the US and Japan.

Penn Pharmaceutical Services Ltd +44 1495 711 222 www.pennpharm.co.uk

FDA Inspection Opens Door for Increased Production of User-Friendly Solid Dosage Forms at Wolfratshausen Facility Hermes Pharma, a division of Hermes Arzneimittel GmbH, recently completed a successful inspection by the FDA of its production facility in Wolfratshausen, Germany. The inspection stemmed from Hermes Pharma’s status as a manufacturer of food supplement products to the US and marks the first routine inspection of a Hermes Pharma facility by the FDA. The Wolfratshausen facility, coupled with a production facility in Wolfsberg, Austria, enables Hermes Pharma to support global customers looking to license in user-friendly dosage forms for distribution and sale in the US. The two plants are equipped with very similar production lines to ensure that there will be no interruption to supply. The service has proven very popular with the pharmaceutical industry, with 10 of the top 15 global pharmaceutical companies currently working with Hermes Pharma.

User-friendly dosage forms such as instant drinks, orally disintegrating granules, lozenges, effervescent and chewable tablets represent a rapidly growing opportunity in the food supplement market, especially for patients who find swallowing pills difficult. They are also gaining significant traction in the pharmaceutical sector as companies seek to better meet the needs of patients, while diversifying their

product portfolio, strengthening their brands and extending product lifecycles.

“As a developer of pharmaceuticals and food supplements, we work on a global basis and understand and value compliance to assure quality and adherence for our customers,” said Dr. Thomas Hein, Director of Sales & Business Development, Hermes Pharma. “This represents an important milestone for Hermes Pharma as the company steadily increases its manufacturing support for pharmaceutical companies around the world, especially those that seek access to the US marketplace or are already operating in the country.”

The inspection covered thorough reviews of general systems, including training, equipment calibration and qualification, standard operating procedures (SOPs), protocols and methods. It also appraised Hermes Pharma’s hazard analysis and critical control point (HACCP) system, which is designed to identify and control specific hazards to ensure the safety of food products. Upon completion, the FDA investigator reported no adverse findings and did not issue a Form 483.

EPM 27

Wolfratshausen plant.

More than 800 million effervescent and chewable tablets are manufactured annually in Hermes Pharma’s production plant in Wolfratshausen. Opened in 1994, the plant is optimised for the manufacture of moisture-sensitive effervescent tablets as well as chewable tablets. Weighing, granulating, mixing, tabletting and packaging take place in automated, closed systems spreading across 12,400 m2. Rigorous Quality Control ensures compliance with all GMP requirements, regulatory demands and client specifications.

Hermes Arzneimittel GmbH Division Hermes Pharma +49 89 79102 261 www.hermes-pharma.com

INGREDIENTS & CONTRACT SERVICES ROUNDUP CDMO’s Commercial Facility Passes MHRA Inspection SCM Pharma’s new £6 million contract manufacturing facility has been given the go ahead for commercial production following a successful inspection from the Medicines and Healthcare products Regulatory Agency (MHRA).

The UK-based CDMO will use its new 7,925 m2 site for the supply of licensed commercial products and to complement its nearby clinical manufacturing facility for projects requiring clinical scale-up.

Based in North-East England, the site is able to handle highly potent, flammable and toxic products along with controlled drugs. It houses technology for aseptic filling and terminal sterilisation capabilities and is equipped for ampoule filling, vial filling and syringe filling.

Dianne Sharp, Managing Director at SCM Pharma, said: “The official MHRA approval of our new facility is a huge landmark in the history of our company and heralds in a new era for our team.

I’d like to thank all those involved in the planning, design and construction of SCM Newburn as the end result is what I believe to be one of the finest contract manufacturing facilities of its type in Europe.

“We are planning an event to officially open the doors this summer before Newburn becomes a hub for the production and supply of licensed drug products.”

Independently-owned, SCM Pharma specialises in the sterile production of

drug products that require high containment. Most of the CDMO’s contract filling projects assist companies requiring products for clinical trials or licensed drugs needed in niche commercial markets such as orphan drugs.

With commercial-scale cleanrooms, which include a potent suite, dedicated commercial suite and Grade C/D rooms, the new site massively increases SCM Pharma’s current and future capability and capacity.

The site includes a range of packaging and labelling areas, temperature controlled warehousing, raw materials and engineering preparation, visual inspection and leak testing. A dedicated,

enclosed cleanroom suite has also been built, which houses an automated syringe filling and packaging line with full track and trace capability.

SCM Pharma Ltd +44 1661 833 693 info@scmpharma.com www.scmpharma.com

R&D Centre Expands Bioavailability Enhancement and Oral Dosage Formulation Capabilities

Merck Millipore, the life science division of Merck, has announced the opening of its new Research & Development Center for Formulation in Darmstadt, Germany. The Center for Formulation combines formulation, analytical and synthetic laboratories and a fullyequipped customer training centre in a single facility. It will accelerate growth of the company’s portfolio of technologies and products that overcome bioavailability and formulation challenges and will provide hands-on support to assist customers in their drug development.

“To better address the needs of our pharmaceutical customers, we are expanding our capabilities for bioavailability enhancement,” said Burghard Freiberg, Senior Vice President, Pharma Chemicals Solutions.

“There is a clear market need for a comprehensive set of innovative products and technologies to support bioavailability enhancement. At our new Center for Formulation, we can help customers overcome formulation-related challenges, such as insufficient API performance due to poor solubility and lifecycle management developments, in a more effective and efficient manner.”

Expertise offered by Merck Millipore includes oral dosage formulation development and drug delivery systems.

Core areas are inorganic carriers, solid dispersion formulation techniques and development of other excipients and excipient systems. Technologies include granulation, tabletting, film coating, direct compression and freeze drying.

When requested by customers, formulated products can be analytically characterised in the new laboratory.

Merck Millipore +1 781 533 5336 pegeen.dossantos@emdmillipore.com www.merckmillipore.com EPM 28

SHOWCASE CLINICAL TRIALS Clinical Manufacturing Site Gains MHRA Approval UK-based contract research and manufacturing organisation Molecular Profiles has opened the doors of its new facility following a successful inspection from the Medicines and Healthcare products Regulatory Agency (MHRA). The Nottingham-based, £9 million pharmaceutical production site will offer drug development companies across the world access to its clinical manufacturing capabilities.

Designed to handle a range of nonsterile dosage forms such as solids, liquids, semi-solids and inhaled products, Molecular Profiles’ new 2,787 m2 facility marks a significant expansion for the company that started life as a spin-out from Nottingham University over 15 years ago.

The investment adds six GMP suites, new laboratories and a dedicated clinical packing area to support clients’

Phase I and II clinical trial projects. The facility also allows for the manufacture of highly potent compounds up to OEB 4 level, with a manufacturing batch scale of up to 30 kg.

Nikin Patel, CEO at Molecular Profiles, said: “Receiving the license from the MHRA for our new site is probably the biggest milestone for our business since we set-up shop so is naturally a very exciting time for everyone involved.

“From a commercial perspective, we are very much open for business and have already received significant interest from companies looking to use our manufacturing capabilities to assist with their clinical trial requirements.

“We have enjoyed a sustained and gradual period of growth over the last decade, driven by our consulting, formulation development and analytical services, but we are expecting our

expanded manufacturing facilities to take us to the next level by helping us better compete on a global scale.”

The official approval of the company’s cGMP-compliant facility follows a recent high-profile visit from the Honourable Nick Clegg, Deputy Prime Minister of the UK Government, which provided £1.6 million towards the expansion through the regional growth fund grant.

Having a dedicated manufacturing site complements Molecular Profiles’ established formulation development expertise. Furthermore, it supports its strategic alliance with Onyx Scientific, which is aimed at delivering end-to-end pharmaceutical development services from initial drug discovery through to the later phases of clinical development.

Founded by a group of scientists, Molecular Profiles now works with

Nikin Patel, CEO at Molecular Profiles, in front of the company's new UK-based clinical manufacturing facility. leading pharmaceutical companies across the globe and specialises in advanced characterisation, R&D and manufacturing services.

Molecular Profiles +44 115 871 8888 enquiry@molprofiles.co.uk www.molprofiles.co.uk

Packing and Distribution Facility Further Enhances Clinical Trials Offering 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

Packaging Solutions Provider Strengthens Clinical Trials Business with Senior Appointment PCI has announced the appointment of Tim Roberts to Associate Director of Clinical Trials. The changes follow the restructure of its global management announced last year and recent acquisition of AndersonBrecon.

Formerly in Business Development for PCI, Roberts will now lead the implementation of the Clinical Trials strategy and will oversee the UK Clinical

Trials Project Management and Treforest Storage and Distribution teams. He will report to Bob Misher, Global Head of Clinical Trials.

Responding to the changing demands of customers and the evolution of the pharmaceutical industry, the restructure reinforces the company’s commitment to providing end-to-end global packaging services.

Commenting on the appointment, Misher said: “We have an ambitious growth strategy for our Clinical Trials business and Tim’s appointment will help us to achieve this strategy. Having been with the organisation for some time, he brings with him the expertise and knowledge needed to drive this part of the business forward.”

Roberts added: “I’m very excited to

Clinical Services Sites Introduce Contained Drug Handling and Bottling Capabilities Almac’s Clinical Services business unit has expanded its service offering for dispensing and bottling solid dosage products by introducing enhanced containment equipment and processes at its EU and US headquarters.

Dr. Robert Dunlop, Managing Director of Almac Clinical Services, commented: “In recent years, we have experienced an increase in demand for facilities

equipped to handle compounds of a higher potency. As a customer orientated company, Almac saw an opportunity to meet the needs of its client base. This development at our European and North American Headquarters is the latest example of how Almac constantly strives to advance its service offering to reflect the needs of the drug development industry.”

Following successful installation and validation, the facilities are now operational and Almac welcomes packaging discussions with companies that have potent products in their pipelines.

Almac Group Ltd +44 28 3833 2200 info@almacgroup.com www.almacgroup.com

EPM 29

take on this new role at PCI at such an important time in the company’s journey.

I’m looking forward to helping to deliver the world-class services our customers expect whilst achieving our growth targets.”

Packaging Coordinators, Inc. +1 215 613 3600 www.pciservices.com

SHOWCASE COATINGS & CAPSULES Pigmented Film Coatings Help Reduce Medication Mix-Ups In-Line and In-Use Nutritional, brand and generic pharmaceutical manufacturers today are striving to design drug products that enable safe and compliant use. Many of them are finding novel ways to differentiate their products through the use of pigmented film coatings and unique tablet designs.

It is a well-established fact that film coating tablets can enhance product performance by making the tablets less friable and protecting them against light, oxygen or humidity degradation.

However, plain white or clear film coated tablets are not distinguishable or memorable. They do little to aid in compliance, boost brand loyalty or help avoid medication mix ups.

Film coating with pigments, however, opens up a whole new world to manufacturers, especially those who wish to assure regulators and insurers that their products are developed to help improve compliance and avoid medication errors.

Combined with unique tablet shapes and debossed, embossed or printed

surfaces, pigmented film coated medications are readily identified by consumers, especially the geriatric population. Easy identification helps to minimise the chances for production line mix-ups as well as possible dispensing errors by healthcare practitioners, patients and caregivers alike.

There is a misconception that generic companies always follow the innovator, so that what starts out as a plain white, uncoated tablet must remain a plain white, uncoated tablet. However, there are many cases where generic manufacturers have changed the shape/colour and/or logo, which differentiated their product from the innovators’. In addition, there are a number of examples where those branded generics actually enjoy a higher market share today than their plain, white tablet counterparts.

Colorcon has been supplying pigmented film coating systems to the pharmaceutical brand and generic and nutraceutical industries for over fifty years. Recognised for exceptional

products, technical support and regulatory support, the company is helping organisations around the world reduce costs from their business.

Today, Colorcon provides a tablet design service, also known as Brand Enhancement service, which helps companies evaluate visual alternatives for their brands and evaluate the competitive landscape. Companies using this service are quickly realising the advantages of differentiating products within their own product portfolio between various dosage sizes and between immediate or modified release profiles. They also have access to valuable research provided through the service on currently marketed products by therapeutic category and information on medications that may be used in combination with their brand.

Incorporated into an overall brand strategy designed to help reduce medication errors, Colorcon’s tablet design service is helping manufacturers pave the way to improved product recognition, optimised branding and increased patient compliance.

Colorcon Ltd +44 1322 293000 colorcon_communications@colorcon. com www.colorcon.com

Coating Systems Allow Customers to Create Own Colours Kollicoat IR coating systems possess excellent flow properties and can be redispersed quickly and easily. The seven globally approved base colours can be combined to create hundreds of shades.

In addition, faster and more straightforward production makes for reduced energy costs and lower carbon emissions. According to BASF, thanks to a combination of the monographed and proven water-soluble film former Kollicoat IR, a new manufacturing process and an innovative colour concept, coating is now more flexible and efficient than ever.

The seven base colours, comprising of pigments registered around the world, can be used to create a large number of shades. Individual, instantly recognisable tablets can be produced, even at short notice, while reducing inventories.

Creating colour samples is easy and there is no need to disclose proprietary colour information. The supply chain becomes streamlined, and the customer is no longer constrained by lead times, ensuring their agility and responsiveness within a fast-moving market.

The polymers possess outstanding mechanical properties, creating a robust film with a distinct appearance.

The highly elastic coating increases tablet stability and provides effective protection for the active ingredients.

In comparison with conventional coatings, Kollicoat IR coating systems are nearly dust-free. The pigments form a solid dispersion in the polymer matrix and can be re-dispersed using a low shear mixer within 20 minutes.

Owing to the coating suspension’s low viscosity, it is possible to prepare and spray coat suspensions with a high solids content up to 30%.

Pigments disperse evenly and without lumping. The coating suspension is easy to spray and evenly covers the tablet; the film is not tacky. It can even be applied at temperatures below 25˚C, making it ideal for coating products with thermo-sensitive active ingredients.

Kollicoat IR coating systems make for a more efficient and environmentallyfriendly manufacturing process because by accelerating production, they help reduce energy consumption and associated carbon emissions. Because of Kollicoat IR’s high elasticity, there is

no need for additional plasticisers.

Furthermore, equipment can be cleaned quickly and easily using just warm or cold water.

BASF SE +49 621 60 76536 nils.rottmann@basf.com www.pharma-ingredients.basf.com

Aqueous Controlled Release Coatings Simplify Tablet and Capsule Manufacture Edible coatings provider MantroseHaeuser Co., Inc. has extended its proprietary line of controlled release coatings designed for the nutritional supplements and pharmaceutical industries.

The Certiseal 700 Series is a family of high-performance and economical aqueous coating systems formulated with 100% generally recognised as safe (GRAS) ingredients, incorporating a natural film forming resin. They provide improved dissolution and disintegration, an attractive glossy appearance and excellent adhesion and barrier properties.

Certiseal 700 Series products are stable, robust coating systems, designed for use

on tablets and soft gelatin capsules, and superior alternatives to synthetic and solvent based systems.

The Certiseal 700 Series offers reproducible performance for tablets and capsules. This product family of controlled release coatings ensures fast film build and low tack time using standard equipment including side vented pans, fluidised bed systems with top, bottom or tangential spray nozzles or conventional pans. Certiseal 700 coatings are fully supported by Mantrose-Haeuser’s world-class technical team.

Mantrose-Haeuser offers a wide range of certified pharmaceutical glazes

meeting USP, EP and JP monographs, Certiseal aqueous glazes and Mantrocel and Mantroclear cellulose ethers for an extensive list of demanding immediate, controlled or enteric release applications.

Through its dedication to advanced pharmaceutical and supplements coating technologies, MantroseHaeuser’s controlled/extended release coatings provide reliable release and simplify the design and manufacturing process for tablets and capsules.

EPM 31

Mantrose UK Ltd +44 1488 648988 orders@mantrose.co.uk www.mantroseuk.com

EPM 32

EPM 33

Events REGULATORY AFFAIRS PROPOSED GUIDELINE ON LMWHS IN BIOSIMILARS

Written by Dr. Paolo Biffignandi, Advisory Board member of the panEuropean pharmaceutical regulatory affairs organisation ELC Group and former President of TOPRA (The Organisation for Professionals in Regulatory Affairs).

The European Medicines Agency (EMA) announced on 31 January 2013 that it had released a draft guideline to revise the agency’s current guideline on biosimilars containing low molecular weight heparins (LMWHs), a type of medical product often used in surgical settings as an anticoagulant and incorporated into a wide range of products. The draft guideline was released for a six-month public consultation period (bit.ly/EMAdraftguidelinesLMWHproducts).

LMWHs are prepared from unfractionated heparin by various chemical or enzymatic depolymerisation processes. Thus, the starting material of LMWHs is of biological origin (mainly from porcine intestinal mucosa) and the manufacturing process defines the characteristics of the drug substance. LMWHs are used as anticoagulants for the treatment of thrombotic and cardiovascular disorders. The complexity of LMWHs results largely from the nature of the starting material, the extraction, the fractionation and the production processes.

The proposed guideline lays down the non-clinical and clinical requirements for biosimilars containing LMWHs and claiming to be similar to a LMWH that is already marketed. The revised guideline would replace the current guideline (EMEA/CHMP/BMWP/118264/2007), which came into effect in October 2009.

The non-clinical section of the previous guideline has been revised to reflect that a risk-based approach can be followed. In vivo studies will not be required as part of the comparability exercise if physicochemical and biological characterisation of the biosimilar and the reference LMWH has been performed with a high level of resolution and have convincingly demonstrated close similarity. Otherwise, in vivo models are required and should include either an appropriate pharmacodynamics model or a suitable animal venous or arterial thrombosis model. From a toxicological standpoint, the EMA said it will generally not require separate repeated dose toxicity studies, but the need for such studies in specific cases such as the introduction of novel excipients should be assessed on a case-bycase basis.

Clinical studies represent something of a challenge to sponsors, the EMA explained: ‘Due to the heterogeneity of LMWHs, conventional pharmacokinetic studies cannot be performed. Instead, the absorption and elimination characteristics of LMWHs should be compared by determining pharmacodynamic activities (including anti FXa and anti-FIIa), as surrogate markers for their circulating concentrations.”

The clinical section of the previous guideline has been revised to reflect the fact that a dedicated efficacy study may now ‘be waived in exceptional situations’. The revised guideline states that biosimilars manufacturers would not have to conduct trials to show comparable efficacy to a reference product if similar efficacy can be ‘convincingly deduced’ from comparison of physiochemical characteristics, biological activity and potency and pharmacodynamic fingerprint profiles. The guideline does mention, however, that this scenario would be the exception to the rule, as the amount of ‘reassurance from analytical data and bioassays would be considerable’. Most sponsors, then, will need to conduct a clinical trial in which they focus on therapeutic equivalence of the two products. The most sensitive trials model used to show equivalency would include surgical patients — and especially those undergoing major orthopaedic surgery — who have a high risk of developing venous thromboembolisms (VTEs), more commonly known as blood clots. VTEs can cause serious and fatal adverse events if they break free, so any differences between the similar biological product and the reference product could cause clinically significant differences as well.

Safety data will also be required, and regulators said that sponsors should compare the type, frequency and severity of any adverse events occurring in the studied patients. Sufficient reassurance should also be provided that the biosimilar is not associated with excessive immunogenicity compared with the Dr. Paolo Biffignandi paolo@elc-group.com reference product.

CPhI Worldwide 2013 to Attract More Than 30,000 Pharma Professionals The global pharmaceutical market is constantly changing and distinct trends and shifts are being witnessed, with more companies are seeking outsourcing services to strengthen their position in areas such as formulation development and R&D. With this in mind, CPhI acknowledges the need to form solid contacts and build relations with other companies in order to vastly enhance growth within the industry.

CPhI Worldwide returns on 22–24 October 2013, to Messe Frankfurt, Germany, alongside co-located ICSE, InnoPack and P-MEC Europe. The shows will provide an exceptional platform for driving innovation and augmenting growth within the industry.

The event expects to attract more than 30,000 senior pharmaceutical professionals from over 140 countries and therefore is a great platform to make new business connections.

Highlights of CPhI Worldwide 2013 are: • Pre-Connect Conference (21 October): Comprised of six modules, featuring topics such as API sourcing and drug delivery systems, offering the exclusive opportunity to join senior executives and influential speakers from across the pharmaceutical industry.

• Global Meetings: Enabling suppliers and buyers to maximise time by

bringing them together with the most relevant business contacts. Participants will have access to the most suitable pre-selected buyers, who can meet and discuss valuable business proposals.

• Speaker’s Corner: Hear first-hand from exhibitors about industry trends, their latest products, innovations, services and more.

• Pharma Awards: Recognising thought leadership on a global scale, unveiling top pharma innovators to global trade.

To learn more or submit an entry, visit: www.cphi.com/pharma-awards.

To register for CPhI Worldwide, visit: https://cphi2013.registerbynet.com.

UBMi B.V. CPhI Worldwide 2013 +44 845 218 6020 cphi@ubm.com www.cphi.com

Pharma Integrates 2013 Organiser Announces Latest Agenda Topics and Speakers At this year’s Pharma Integrates, 26–27 November, Riverbank Park Plaza, London, over 200 strategy level pharmaceutical executives will gather to debate ‘Strategically transforming pharma business relationships’, examining how such collaborations are evolving and supporting innovation, productivity, differentiation and profitable growth.

Subjects to be addressed include: Exploring the ‘tougher’ side of integration — what part should regulators and patients play? This session will bring together key stakeholders in patient advocacy, NHS, government, regulators and industry innovators to explore the issues and opportunities in creating a fully integrated healthcare system of world class proportions.

Facilitated by: Hedley Rees, Managing Director of Biotech PharmaFlow and Global Advisory Board Member at Marken.

Panellists include: James Christie, Head of Manufacturing, Oxford BioMedica, and Ramaswami Ramanan, Clinician/Cardiac Surgeon & Assessor and Judge, Innovation Den, Technology Strategy Board.

Biosimilars: Big pharma and generics treading on each other’s toes. As we near the first monoclonal antibody biosimilar approval in Europe, it seems that biosimilars (at least in Europe) will become a key enabler in reducing healthcare costs and will foster a new product category. Who is placed to win in EPM 34

a biosimilars world? This panel will discuss the key factors for success in a biosimilars world from the two perspectives of big pharma and generics.

Facilitated by: Jo Pisani, Partner Pharmaceuticals and Lifesciences Strategy, PricewaterhouseCoopers.

Panellists include: Michael Tzimas, Director of New Generic Products, Teva Pharmaceuticals and Mohit Singh, Portfolio Director International Markets, Global Commercial Operations, AstraZeneca and Fritjof Linz, VP Global R&D/PD, DSM Biologics.

The future of the generics industry. The traditional generics industry is coming under threat, however, the volume of generics is increasing as healthcare economies strive to cut costs and the patent cliff continues. Is there room for a pure generics player in this new world and what will the new success factors be?

Facilitated by: Asa Cox, Chief Executive Officer, Generic Pharma.

Panellists include: Chanelle McCoy, Director Medical Business, Chanelle Medical, Michael Tzimas, Director of New Generic Products, Teva Pharmaceuticals, Alan Sheppard, Principal, Global Generics, Thought Leadership, IMS Health, and Kim Kjornas, Senior Director Sales & Marketing Rx/Gx Europe, Actavis.

Life Sciences Index Pharma Integrates 2013 +44 20 8667 2117 miranda.zouheir@lsi-uk.com www.lifesciencesindex.com

EPM CLASSIFIEDS

To advertise here, please contact Rob Anderton: Tel: +44 (0) 1244 680222 Email: rob@rapidnews.com

CLEANROOMS EQUIPMENT & SERVICES

GRINDING AND GRANULATION EQUIPMENT & SERVICES

CONTAINMENT

DIOSNA Dierks & Söhne GmbH

Telstar Life Sciences

Tel: +49 (0) 541 331 040 Email: info@diosna.de Web: www.diosna.de

Tel: +34 (0)937 361 600 Email: sales.pharma@telstar.eu Web: www.telstar-lifesciences.com

HOSOKAWA ALPINE Aktiengesellschaft Tel: +49 (0) 821 5906-0 Email: pharma@alpine.hosokawa.com Web: www.alpinehosokawa.com

MIXING & BLENDING EQUIPMENT AND SERVICES

CONTAMINATION CONTROL Helapet are a leading supplier of cleanroom disposables for hospital, pharmaceutical, electronic and laboratory cleanrooms providing solutions for contamination control in critical environments.

Freephone: 0800 0 328 428 Email: sales@helapet.co.uk Web: www.helapet.com

MATERIAL/POWDER HANDLING

Supply of our quality range of SteriClean® sprays, offering an effective mix of alcohols, biocides and neutral detergents aiding disinfection measures in controlled environments.

WET GRANULATION EQUIPMENT

Müller GmbH

Russell Finex Ltd

Tel: +49 (0) 76 23 969 0 Email: info@mueller-gmbh.com Web: www.mueller-gmbh.com

Tel: +44 (0)20 8818 2000 Email: enquiries@russellfinex.com Web: www.russellfinex.com

PACKAGING & BOTTLING EQUIPMENT AND SERVICES INDUSTRIAL SERVICES

Gerhard Schubert GmbH

CHEMICAL CLEANING

Tel: +49 (0) 7951 400-0 Email: info@gerhard-schubert.de Web: www.gerhard-schubert.de

Transflow Industrial Services Limited

DESIGN & INSTALLATION

The Passivation Specialists

Refurbishment, Decontamination, De-rouging, Passivation, Sterilization of your Stainless Steel & Pharmaceutical Plant on or off-site T: +44 (0)20 8591 3875 E: enquiries@transflow-industrial.com W: www.transflow-industrial.com

LABORATORY & R&D PRODUCTS AND SERVICES

Fritsch GmbH

Weiler Engineering Inc

Tel: +49 (0) 67 8470146 Email: info@fritsch.de Web: www.fritsch.de

FURNITURE

Tel: +1 847 697 4900 Email: solutions@weilerengineering.com Web: www.weilerengineering.com

Teknomek Industries Ltd ENVIRONMENTAL/STABILITY ROOM

Tel: +44 (0)1603 788833 Email: sales@teknomek.co.uk Web: www.teknomek.co.uk

PURIFICATION & FILTRATION PRODUCTS AND SERVICES

LTE Scientific Ltd Tel: +44 (0)1457 876221 Email: info@lte-scientific.com Web: www.lte-scientific.com

COATING EQUIPMENT & SERVICES

PARTICLE SIZE ANALYSIS

Bosch Packaging Technology

Whitehouse Scientific Ltd

Tel: +44 (0)151 547 8000 E-mail: info.packaging-kny@Bosch.com Web: boschpackaging.com

Tel: +44 (0)1244 33 2626 Email: info@whitehousescientific.co.uk Web: www.whitehousescientific.co.uk

QUALITY AND COMPLIANCE SPECIALISTS

WEIGHING

Glatt GmbH Tel: +49 (0)7621 664 0 Email: info@glatt.com Web: www.glatt.com

Mettler Toledo Tel: +44 (0)116 2345074 Email: enquire.mtuk@mt.com Web: www.mt.com/quantos

L.B. Bohle GmbH MANUFACTURING ANCILLARIES

Tel: +49 (0)25 24 93 230 Email: info@lbbohle.de Web: www.lbbohle.de

TABLET PRESS SUPPLIERS

ELECTRONIC DRIVE & MOTOR REPAIRS

CONTRACT STERILISATION & TESTING

PUMPS

Fristam Pumpen F. Stamp KG Tel: +49 (0) 40 725 56 0 Email: info@fristam.de Web: www.fristam.de

EXCIPIENTS HPMC FILM COATING

Peristaltic pumps accurately transfer fluid through a sterile and fully validated tube from source to delivery.

BE HERE FOR A YEAR Call Rob on 01244 680222 or email rob@rapidnews.com

Tel: +44 (0) 1326 370370 Email: info@wmpg.co.uk

Web: www.wmpg.co.uk

ADVERTISERS’ INDEX Company

Page

3M Brevetti Angela S.R.L. Canal Engineering Capsugel

11 17 15 32, 33

Contec Dycem Esco GB Fette Goa-Pharma I Holland

13 15 23 1 28 7 EPM 35

Natoli Penn Pharma Sejong Rommelag Weiler

36 2, 30 8 10 18

Working Together to Perfect Your Tableting Process There are a number of factors that can affect tablet quality, and failing to address them could cause serious production problems. Choosing a tooling provider who has the experience and foresight to avoid such costly mistakes can be critical to your success.

The tableting experts at Natoli have decades of experience and know just what to look for to prevent common production problems. When you invest in quality Natoli tooling you gain instant access to ďŹ rst-class customer service, extensive technical resources and expert support to help make production problems a thing of the past.

Contact us today to begin a partnership with endless possibilities.