EPM April 2012 by EPM Magazine

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IN THIS ISSUE: Cleanrooms Tabletting Equipment Maintenance & Support Chromatography Aseptic Filling

European Pharmaceutical Manufacturer April 2012

Volume 12 | Issue 02

Front cover: Next Generation Tabletting Technology — Fette Compacting’s new FE55 follows the TRI.EASY Design for smooth handling. One turret can be used for all applications. Also, equipped with a coding ring, the turret prevents assembly errors.

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© April 2012. While every attempt has been made to ensure that the information contained within European Pharmaceutical Manufacturer is accurate, the publisher accepts no liability for information published in error, or for views expressed. All rights for European Pharmaceutical Manufacturer are reserved, and reproduction in part or whole without written permission is strictly prohibited.

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Welcome readers to the second 2012 issue of EPM, as we wave goodbye to the cold and dark winter and welcome in a warm and sunny spring — well, typically warmish and sunnyish in the UK — but enough about the weather and onto the all important contents of this magazine. This issue features two very topical case studies. The first, appearing in the Manufacturing Products and Equipment section on page 10, details Advanco’s installation of a traceability solution — which relies on a Cognex reader to de-code multiple 2D codes across a range of products — for a pharmaceutical customer in Turkey. 17 The second, which appears in the Ingredients & Contract Services section on page 28, has been provided by Quay Pharma and highlights the company’s codevelopment of a reportedly groundbreaking vaginal tablet that prevents the HIV virus from entering the bloodstream and will therefore help to prevent the spread of AIDS. On page 17 there is the second of a twopart instalment article on the subject of choosing cleanroom wipes, the first of which was published in the November/December issue. This second instalment highlights the additional benefits of using presaturated wipes. Finally, in his Regulatory Affairs column on page 30, Paolo discusses the timely topic of mandatory product data transmissions to the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD), advising on the 21 expected role of pharmaceutical manufacturers. The EPM team is currently gearing up to attend ACHEMA 2012, as I am sure many of you will be. I am in the process of collating exhibitors’ announcements for the ‘ACHEMA 2012 Exhibitors’ Preview’ in the next issue — this is intended to help you plan your time at this huge and rather diverse event effectively, so make sure you see the May issue prior to attending.

ADVERTISERS’ INDEX Company

Page

Emerson Fette

Müller

Natoli

Baxter

Frewitt

Optima

Canal

GEA Pharma

Rommelag

Sejong

Catalent

I Holland

Contec

L.B. Bohle

Elizabeth Carbide

Mediplas

Thomas Engineering

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 Process Understanding & Control, 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.

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SP Scientific

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eab members

from the editor

Henrik Broholm, Senior Specialist, H. Lundbeck A/S Henrik has been working in the pharmaceutical industry for the last 15 years, mainly in connection with finished goods packaging (blisters, ampoules and containers). At H. Lundbeck, he has gained valuable experience of working at both vendor and customer sites, further extending his pharmaceutical packaging expertise. Henrik is for the most part involved with user requirement specifications, machinery and process qualification and validation, the introduction of new products on packaging lines, and incorporating new features as required by authorities, e.g., 2D matrix coding with track and trace and child resistant blisters and packs.

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Grégory Poujol, Manufacturing Maintenance Manager, Sanofi Grégory is an ‘Arts et Métiers’ engineer, working for the wellknown French pharmaceutical company Sanofi. Grégory started working in one of the group’s injectable plants in 2003, before moving to a solid form plant as a Project Manager in 2004 to install new process equipment. He later moved to Spain and continues to lead new equipment installation projects at one of the group’s Spanish solid form plants and since 2009 has been in charge of process maintenance and improvements. 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

Research Project to Investigate Why Formulations Stick to Tablet Tooling As part of its ongoing study of the science behind tabletting, I Holland has launched a two-year ‘Tabletting Science Anti-stick Research’ (TSAR) project. The aim of this 24-month programme — carried out with the highly respected School of Pharmacy at The University of Nottingham — is to further investigate the root causes of why formulations stick to tablet tooling surfaces. Sticking is one of the biggest problems facing tablet manufacturers today and I Holland reportedly leads the way in developing new coatings to combat this issue. Formulation sticking to tablet tooling can be due to several parameters such as Van der Waals forces, capillary action, deformation mechanics and static electricity, to name but a few. It is these interactions that the TSAR project is designed to quantify, enabling I Holland customers to benefit from what it claims is a unique ‘optimum coating selector’ drawing on solid scientific research. Using many notoriously sticky excipients and APIs, including Ibuprofen, the TSAR project aims to analyse why one coating prevents sticking where another does not. I Holland regularly

solves these problems through scientific trials, but as these can take time and cost money, the company has chosen to innovate further by developing a predictive tool to speed up this process, ultimately benefiting the end user. TSAR will use a variety of highly advanced surface characterisation techniques, including: scanning electron microscopy; laser profilomitry; atomic force microscopy; adhesion mapping; xray photoelectron spectroscopy; raman spectroscopy and time of flight secondary-ion mass spectrometry (pictured). Heading up this high value project is Professor Clive Roberts, who has led previous research focused on quantitative measurements of the surface properties of pharmaceutical materials using a range of nano-scale techniques, leading to a Queen’s Award for Industry in 2011. Managing the

project for I Holland is R&D Manager Rob Blanchard with MD Chris Prideaux overseeing. TSAR builds on previous atomic force microscopy research and represents a significant further investment from I Holland that will ultimately benefit customers worldwide. I Holland expects to release progress reports throughout this two-year project. I Holland Ltd +44 115 972 6153 info@iholland.co.uk www.iholland.co.uk

Positive Displacement Pumps to be Highlighted at Interphex 2012 Almatec has announced that it will display Quattroflow positive displacement (PD) pumps at Interphex 2012, 1–3 May, New York, US, on Booth 2385. Quattroflow PD pumps incorporate a four piston-diaphragm technology with no mechanical seals that is driven by an eccentric shaft and motor. Available for multiple and single-use applications, Quattroflow PD pumps primarily serve the pharmaceutical and biotech industries that require high containment, purity and cleanability, and are best known for transferring shear sensitive media of aqueous solutions and biological products without

damage, ultimately ensuring product safety, efficiency and reliability. Quattroflow pumps feature wetted housing parts constructed with electropolished 316L (Basel Standard II, ferrite content <1%) stainless steel, while the valves are made of EPDM and the diaphragms of EPDM/PP compound. The Quattroflow product line consists of four sizes — QF150, QF1200, QF4400 and QF20K — with capacities of 2.6 to 333 lpm (0.7 to 88 gpm). In addition, Almatec will also display its BIOCOR and E-Series diaphragm pumps. BIOCOR pumps are ideal for applications with the highest purity, containment and cleanability requirements. Built to emulate and for use in the same applications as diaphragm valves, BIOCOR pumps are able to assure sterility and handle products containing protein solutions, cellular structures and other shearsensitive products. With no mechanical seals,

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rotors or stators, BIOCOR offers free passage for applications that require negative suction lift, self priming and dead head capability. Almatec solid block PTFE E-Series pumps are specifically designed for not only permanent applications, but also for single-use applications handling critical and even hazardous biopharmaceutical substances. The ESeries pumps are designed for use in advanced applications where high chemical compatability and full containment/leak-free design are required. Yet, the simplicity of design and operation makes the E-Series safe and economical for even single-use applications reportedly without compromising the highest standards. Almatec is an operating company within Dover Corporation’s Pump Solutions Group (PSG). Almatec Maschinenbau GmbH +49 2842 961 0 frericks@almatec.de www.almatec.de / www.quattroflow.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Multifunctional Milling System for Granulation of Heat-Sensitive Products A core component of Frewitt’s new mill, the OscilloWitt, is its oscillating rotor, which was borrowed from the previous model (MF line) in order to provide customers with the advantages of the company’s tried and proven oscillation process — less heat build-up and a milled product with more uniform grain size and minimal fine particles. It is possible to work in the oscillating as well as rotary mode when working with both the OscilloWitt-3 and the OscilloWitt-6, offering more flexibility, while lowering investment costs. Due to the new step-by-step readjustment of the oscillation amplitude, the unit requires less frequent maintenance, which in turn

lowers maintenance costs. The simple acceleration of the oscillatory motion by a variable angle and the simplified setting of the rotor/sieve distance also ensure greater ease of use. The OscilloWitt was specifically made for milling and dosing dry, moist and, in particular, heat-sensitive, hard-to-process products. The minimum necessary impact energy and the continuously variable rotor speed ensure that just the right amount of shearing and friction forces are exerted on the product in order to convey it gently through the sieve. This special process, which is complemented by the tight seals and the automatic cleanability of the system,

results in an exceptionally uniform and consistent product quality, which is equally important for processing ingredients in the pharmaceutical industry as it is for preparing flavourings, vitamins and proteins in the food industry, not to mention the diverse processes in the fine chemical industry that are based on gentle methods. As with all Frewitt equipment, the OscilloWitt is a tested and proven milling system with modern ergonomics. The OscilloWitt will be exhibited at Interphex 2012, 1–3 May, New York, US, on Booth 1845.

Versatile Tablet Weight Sorter Boasts up to 22,000 Hourly Rate

The new SADE SP440 offers sorting rates of up to 22,000 per hour and up to 500,000 per 24-hour period. It is a compact unit that combines four of CI Precision’s proven SADE SP sorting modules fed from just one, easy to fill, bulk hopper. The SADE SP440 offers around the clock operation, so once set up it can work for long periods of time without the need for operator intervention. A new feature of the SADE SP440 is a user selectable accuracy. It offers both +/- 2 and +/- 1 mg, enabling the operator to select the required accuracy level for the product being sorted. Simple to set up and use, the SADE SP440 can handle a wide range of shapes and sizes without the need for any change parts. It is also quick and easy to dismantle for cleaning. Key benefits of the SADE SP440 include: • 100% checkweighing of tablets or capsules for quality control; • saving of valuable product from weight rejected batches; • and rapid weight sorting of batches required for clinical trials. The SADE SP440 can be linked to a printer or a PC. With SP Connect, statistical reports are automatically saved as secure pdf files. For further information on the SADE SP440, SP240, SP140 and SP Benchtop or to discuss a specific application, contact CI Precision on the details provided below. CI Precision +44 1722 424100 sales@ciprecision.com www.ciprecision.com EPM 7

Frewitt SA +41 26 460 74 00 info@frewitt.com www.frewitt.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Experience Turnkey Filling Equipment in 3D at Interphex 2012 Optima Pharma is a leading turnkey supplier for pharmaceutical filling and packaging equipment. The process chain encompasses the complete upstream and downstream process, including e-beam decontamination, isolator technology and barrier systems, and freeze dryers with automatic loading and unloading systems. At Interphex 2012, 1–3 May, New York, US, on Booth 2233, Optima Pharma — with the help of the ExCube — invites visitors to an interactive, 3D virtual tour of three high-tech filling lines. The first of the three is a complete line for filling and closing ready-to-fill syringes with a gel-like product. Two different filling systems on the same machine is one of the highlights. The time pressure dosing system can be changed out with a rotary piston pump filling system as needed and vice-versa. Filling and stopper setting can both take place under vacuum. The line also utilises e-beam decontamination of tubs, while an open pressure regulated RABS ensures cleanroom class-A conditions in the filling and closing section. The line processes up to 36,000 syringes per hour and is operable with filling volumes from 0.5 to 10 ml. Diversity in vial processing is shown by a second line that is comprised of a

washing machine, sterilisation tunnel and filler with 100% in-process control. The liquid pharmaceuticals can be purged with nitrogen from filling right up to completed stoppering. A second operation mode allows for lyophilisation stoppers to be placed and the freeze drying process can be easily integrated. Returning from the freeze dryer, the vials re-enter the line in the opposite direction they exited and are directed to the capping unit and tray loader. Vials sizes 2R to 20R can be processed on the line at output rates of up to 12,000 vials per hour. A third machine shows another facet of Optima Pharma — machines for processing diagnostic products. The Linoline fills each of the 12 cavities in a cartridge with unique fill volumes and products. Twelve independently servodriven peristaltic pumps fill at 12 different stations. Each station has its own servo-driven nozzle movement. All parameters are freely programmable and can be stored and retrieved per format memory. Additionally, the line performs 100% in-process control on each cavity by using 13 weigh cells. OPTIMA packaging group GmbH +49 791 506 1410 sabine.gauger@optima-ger.com www.optima-ger.com

High Performance Small-Scale Production Filtration and Drying

With a filtration area of 0.03 m2, Powder Systems Ltd’s (PSL’s) latest filter dryer provides a good solution for kilo laboratory application and commercial production of highly active product. The kilo lab filter dryer’s 0.03 m2 filtration area provides 15 l liquid volume, 6 l wet cake volume capabilities and an alloy 22 construction. PSL filter dryers provide optimal performance through high drying efficiency, complete heel removal, high containment operations and CIP systems. PSL’s high containment isolator allows product to be completely removed through a raking system and weighed and dispensed inside the isolator. The powder can be discharged into bags and transferred via an RTP or directly transferred into bags via a split butterfly valve. PSL’s client required an OEL test result of <1 µg/m3 8hr TWA. PSL’s philosophy is to exceed its client’s containment requirements and in this test significantly bettered its client’s needs by achieving an average of <50 ng during the sampling period. PSL provides total confidence that operations can be carried out without containment breach, ensuring full operator and product protection. PSL’s filter dryers can be simply scaled-up from 0.002 to 2.5 m2. Powder Systems Ltd (PSL) +44 151 448 7700 sales@powdersystems.com www.powdersystems.com

Easy to Operate Inline Moisture Sensor Offers Fast Payback

GEA Pharma Systems, in co-operation with NDC, has developed an inline moisture sensor for pharmaceutical drying systems that drastically simplifies moisture measurement, saves processing time, avoids unnecessary operator contact with toxic compounds and helps ensure exceptional product quality. The new moisture sensor, LHP-NDC 710e, which fits into a standard 2” port on the dryer, eliminates the need for complex chemical modelling techniques (chemometrics) to ascertain the moisture content of a product during the drying process. It extracts just the moisture content as a single piece of information and displays it simply for the operator. This speeds up the drying process and improves accuracy. Using standard techniques, samples of dried powder must be taken manually from each batch and tested offline in a laboratory to establish when the correct moisture contact has been achieved. This is time-consuming and runs the risk of the target moisture level being overshot, producing a product that is too dry and difficult to handle efficiently. The LHP-NDC 710e shows a continuous display of the actual moisture content on a display screen as the product dries. This allows the operator to monitor precisely the actual moisture content and to stop the drying at exactly the right point. There is no need to wait for results, no chance of over-drying the product and the operator never has to come into direct contact with the product. In addition, the standard technique only provides a snapshot of the condition of a limited amount of product (5–10 g). The inline moisture sensor is capable of monitoring the complete drying cycle. The total amount of analysed product during the process cycle is estimated to be more than 1,000 grammes. This will enable the operator to gain an understanding of the complete process cycle and so continuously improve the production process as well as anticipate unplanned events. The LHP-NDC 710e is simple to install and can be ready for calibration in just 20 minutes. It allows the moisture content of any powder product to be adjusted as required. GEA Pharma Systems Collette +32 3 350 1258 tomas.vermeire@geagroup.com www.geapharmasystems.com

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MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP CASE STUDY Within the pharmaceutical industry, stringent 2D CODE READING legislation exists to SOLUTION combat counterfeit goods by ensuring each product ENSURES PRODUCT can be traced throughout TRACEABILITY FOR the supply chain. In order PHARMA to achieve the required CUSTOMER IN levels of traceability, manufacturers are TURKEY increasingly reliant on printed 2D codes combined with advanced code reading technology. As a major international integrator of item level serialisation and tracking solutions, Advanco works together with some of the world’s largest pharmaceutical manufacturers installing automatic identification throughout the complete supply chain to ensure product traceability. As fulfilment of the second phase regulation of the Drug Tracking System and the Packaging

Tracking System as defined by the Ministry of Health of Turkey, Advanco recently installed a complete traceability solution for one of its key global manufacturers. With over 60 million medicine boxes manufactured and distributed each year from the facility in Turkey, accurate and reliable code reading were essential to achieve the required levels of traceability. Furthermore, the ability to read multiple codes within one field of view as well as any potentially blurred or distorted codes were challenging application requirements. Designed as a pre-shipment product traceability solution, Advanco had developed an Optical Box, comprising a Cognex In-Sight ID reader and an innovative light distribution system, to provide the most suitable environment for multiple code reading. Extensive research and testing had been carried out to analyse various code reading technology options involving both Cognex ID readers and other manufacturers’ products. The results reportedly concluded that Cognex was the only company to provide suitable ID readers with the advanced vision technology capable of consistently reading multiple codes within one field of view as well as distorted or blurred codes. Advanco’s workstation, including the Optical Box, was installed at the customer’s manufacturing facility and further testing carried out across the range of products to ensure the solution could maintain high read rates regardless of changes to product size or shape. Following a successful trial period, ten work-stations complete with Optical Box were integrated. Each medicine box has a 2D Data Matrix code printed onto the surface using an inkjet printer. The

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boxes are then shrink wrapped in batches of up to 25 and placed manually into the Optical Box. In just 1.4 seconds, the Cognex In-Sight 5615 ID reader decodes all 2D codes in a single action, the information is processed by Advanco’s ARC software and is displayed for the operator. Any defective products trigger the alarm and are removed. This procedure not only ensures all packages ready for shipment are fully traceable, but also leads to improved production processes for both code marking and wrapping operations as any defects can be addressed immediately. From the outset, the code reading solution has ensured high read rates for all products, even when the 2D codes have been obscured by the plastic shrink wrap. With these accurate and reliable read rates, the customer is now 100% satisfied that all 2D codes are fully readable before leaving the facility. Following the success of this project, further installations are currently planned with the customer. In addition, the Optical Box traceability solution is due to be rolled out to other pharmaceutical companies across Turkey and the rest of Europe. Dr. Olgun Yenersoy, Managing Director of Advanco commented: “Having tested many other vision cameras on the market, Cognex’s extensive range of cameras and ID Readers offers unrivalled code reading capabilities, with each product being both reliable and easy to integrate.” Cognex UK Ltd +44 1327 856040 www.cognex.co.uk

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Automatic Tablet Dosing Device Handles 3,000 Capsules Per Hour

Isopak, the UK's exclusive distributor for Dott.Bonapace, is expanding its already extensive range of pharmaceutical equipment with the addition of an automatic tablet dosing device. Fully compatible with all Dott.Bonapace capsule filling machines, the new automatic tablet dosing device is designed for applications involving the placement of tablets, oblongs and mini and micro tablets into capsules. Suitable for a wide range of projects, including clinical trials, R&D applications and blind trials, the automatic tablet dosing device can handle up to 3,000 capsules per hour. It is easy to use and has relatively inexpensive change parts needed for the accommodation of different tablets. A big feature of the dosing device is that Isopak can, if required, produce the change parts using just drawings, which is particularly useful where no tablet samples are available. Manufactured in high grade stainless steel, the unit can be supplied and fitted to new In-CAP capsule filling machines and also retrospectively to older Dott.Bonapace equipment. As a further bonus, no electrical connections are needed because the In-CAP capsule filling machine powers the automatic tablet dosing device. The unit is easy to operate and product changeovers can be made in a matter of minutes, thanks to the electro polished and laser marked format disc. Designed for disassembling without any tools, the full dosing cycle is controlled by a Siemens SPS that, thanks to a highly accurate laser beam, is precisely controlled. Operationally, the user can choose between the automatic dosing mode and manual production. The run cycle is straightforward and comprises the separation of the tablets, oblongs, mini or micro tablets into the feed hopper and the counting of these into the capsule body using a highly accurate laser sensor. The automatic tablet dosing device works with a cross-section of combinations, including tablets and powders, tablets and pellets, tablets with other tablets and also in combinations involving up to three of the different items. Supplied with a 12-month warranty, the automatic tablet dosing device is extremely well engineered and therefore highly unlikely to cause problems.

Customisable Machine Vision Capabilities to Meet Any Quality Inspection Requirements Astech Projects offers a complete design and build service within the machine vision and automated inspection fields. With its expertise in component handling, presentation and rejection, the company can successfully design and build custom automation solutions, while adhering to various industry regulations. Astech’s machine vision solutions are therefore ideal for customers with challenges including assembly verification, seal integrity, final product quality and primary/secondary packaging inspection. As a key process within many application areas, the design, manufacture and installation of a vision-

based inspection system enables automated and repeatable assessment of product assembly, quality and packaging. This is especially important in the healthcare industry, for example, where there are numerous safety regulations that need to be complied with in order to maintain the efficacy and safety of the product. Through the incorporation of Astech’s proven approach to the development of fully integrated, automated solutions, customers benefit from a quality turnkey machine design and building service. Furthermore, with its strong regulated industry knowledge, Astech can supply machine vision services that are

Isopak Ltd +44 1780 410093 mail@isopak.co.uk www.isopak.co.uk EPM 11

compliant with the key regulatory authorities. Anthony Moran, Director, Astech Projects, commented: “We are well known for our custom designed automation solutions for the laboratory automation and process/packaging arenas. We have been implementing machine vision solutions for many years. As such, we have direct experience within this field and are keen to continue with and expand on these successes.” Astech Projects +44 1928 571797 anthony.moran@astechprojects.co.uk www.astechprojects.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Colour Creativity in Pharmaceutical Packaging Colour can boost the on- and off-theshelf appeal of packaged medicines. Clariant is offering a globally-available MEVOPUR standard colour range of pre-tested ISO10933/USP 23 Part 87 and 88 colourants for pharmaceutical packaging. The range’s new MEVOPUR colours for TOPAS cyclic olefin (COC) polymers from Topas Advanced made their European debut at Pharmapack 2012 in Paris. Clariant’s pre-evaluated MEVOPUR colourants help to reduce customers’ development times and costs and minimise risk of change during the product lifecycle. Masterbatches and compounds utilising these colourants help to address the industry concern regarding drug adulteration caused by leaching of substances from the plastics packaging. By providing documentation on testing of ingredients using USP 23 parts 87, 88 and ISO10093 test protocol, Clariant supports converters and pharmaceutical companies to establish a basis for a clear extractable profile and simulation of potential leachables. Clariant’s MEVOPUR standard colourants are based on biologicallyevaluated ingredients using the test protocols of USP 23 parts 87, 88 for Class VI devices or ISO10993 parts 4, 5, 10, 11 and 18. In line with Clariant’s ‘Controlled, Consistent, Compliant’ approach for its medical and pharmaceutical customers, the colourants are manufactured at its three ISO 13485:2003 registered dedicated medical and pharmaceutical centres of competence based in the US, Europe and Asia. The standard colours are available on short leadtimes with supporting documentation to accelerate the development and approval process. Production from the same raw materials at all three sites supports customers’ global production and back-up requirements and helps to speed up development by eliminating the need for expensive and time-consuming revalidation. The MEVOPUR ISO10933/USP colour range introduced in 2011, with up to 17 colours for widely used polyethylene and polypropylene materials, has been further extended into newer materials of interest to packaging development engineers. Responding to the interest in glasslike polymers, the range was expanded to include the transparent polyester co-polymer Tritan for Eastman Chemical Company and new colours for TOPAS cyclic olefin (COC) from Topas Advanced. The TOPAS polymers offer glass-like clarity, temperature and chemical resistance, whilst providing the safety aspects of a tough polymer. The MEVOPUR colourants complement these properties by offering colours to differentiate the product or to block UV, thereby helping to protect UV sensitive pharmaceutical products.

Sealless Magnetically-Driven Pumps for Agressive Liquids Sealless magnetically-driven pumps are reportedly recognised as being the ideal solution for handling aggressive liquids and the T MAG-M pump from 3M is a good example of a pump that is ideally suited to challenging pumping applications. Available through Pump Engineering, the T MAG-M is a horizontal, sealless, magnetically-driven peripheral pump. It is particularly suited to applications involving low flows and high heads. T MAG-M pumps offer the important benefits of mag-drive pumping; long-life, reliable performance and lowmaintenance. Also, as a result of having no seals, the potential for leaks and emissions means optimum safety and reliability, even in the most challenging applications. Features of these pumps include: a high power, synchronous magnetic coupling that can operate at liquid temperatures up to 350°C (without the need for external cooling); an innovative hydraulic design with a self-balancing impeller that improves wear ring life; and

a sealing system with flat gaskets, preventing leakage to the atmosphere. Also, the rear shell is made in one single piece without welding and its ellipsoidal profile helps it to withstand higher pressures than traditional designs. The bearings are available in a choice of materials to suit specific applications, including silicon carbide, tungsten carbide, carbon to enable dry running and filled PTFE when carbon cannot be used. T MAG-M pumps are designed to deliver flows up to 12,000 l/hr at pressures up to 12 bar. Higher pressures versions are also available, which are capable of operating with a differential pressure of 50 bar on system pressures up to 150 bar. ATEX certified options are also available. 3M mag-drive pumps have numerous applications, for example, transferring

acids, alkalis, hydrocarbons, heat transfer oils, liquid gases, toxic and explosive chemicals in industrial and chemical industries. They are also suitable for pumping low viscosity surfactants, acids and CIP chemicals in pharmaceutical and cosmetic industries. Pump Engineering Ltd +44 1903 730900 sales@pumpeng.co.uk www.pumpeng.co.uk

Single-Use Tubing Assemblies Accommodate Flow Rates Over 100 L/Min Meissner’s BioFlex tubing assemblies provide secure and convenient fluid paths for use within single-use systems and will easily scale with a process, allowing for flow rates in excess of 100 l/min. The assemblies can also be used in conventional or hybrid facilities to connect single-use and stainless steel processing equipment. BioFlex assemblies are easily

customisable to end-user requirements and can integrate sterilising-grade through clarification-grade capsule filters. BioFlex assemblies are provided sterile and ready for immediate use, incorporating the end-user’s required tubing material, connectors, filters, pinch clamps and other specified components, effectively eliminating the cost and concern of on-site assembly.

Clariant International Ltd +41 61 469 6363 stefanie.nehlsen@clariant.com www.clariant.com

EPM 13

For applications requiring sterile filtration, pre- and post-use integrity testing procedures can be accommodated. Meissner Filtration Products, Inc. +1 805 388 9911 leads@meissner.com www.meissner.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Full Software Solution and Specialist Support Services Offer Fast Route to Meeting XEVMPD Mandate ELC Group has announced the launch of a new subsidiary, Pharma eReport, a software and services company that delivers a comprehensive EudraVigilance Medicinal Product Dictionary (EVMPD) compliance solution for pharmaceutical regulatory professionals. Pharma eReport offers a total package for Marketing Authorisation Holders (MAHs) seeking to meet the 2 July 2012 deadline for mandatory EudraVigilance Medicinal Product Dictionary (EVMPD/XEVMPD) data submissions. With its flagship Centrality software suite and specialist EVMPD services — delivered by a Key Support Services team of qualified chemists — Pharma

eReport provides a comprehensive EVMPD solution, including complete outsourced data-gathering and compilation of Structured Substance Information (SSI) libraries. The Centrality software is available as an on-demand software-as-a-service (SaaS)/cloudbased solution — accessed via a standard web browser — or it can be installed as a standalone software application. Centrality is offered via a transparent pricing model that has been in full general availability since March 2012. Prospective users are invited to sign up online now for priority product demonstrations. Pharma eReport’s Centrality software

tool allows MAHs to quickly and effortlessly convert existing medicinal product information into an XML Schema Definition (XSD)-compliant format and seamlessly upload the required data as a EudraVigilance Product Report Message using an approved submission mechanism. The software is secure, easy to use and custom-engineered for flexible implementation, including development support for bespoke interfaces to provide full harmonisation with customers’ existing systems. Pharma eReport’s Centrality platform provides an intuitive product license management system for database-wide pharmacovigilance updates, tracking,

organising and managing product and substance information, and ensuring continuing European Medicines Agency (EMA) regulatory compliance. Centrality can be coupled with specialist Key Support Services, including data collation, organisation and mapping capabilities, plus complete SSI library compilation services to enable customers to extract maximum value from substance data. Pharma eReport is co-founded by the management of ELC Group and former executives from electronic design automation software company Synopsys, Inc. Pharma eReport harnesses the reportedly unparalleled industry knowledge of its regulatory expert founders and combines this with a worldclass software development team to deliver a total solution for EVMPD compliance and beyond. To sign up online for a priority demonstration, visit www.pharmaereport.com. ELC Group +42 22 491 00 00 ajain@elc-group.com www.elc-group.com

Stand Aids Single-Use Fluid Transfers Meissner offers the stainless steel FlexCessory stand to secure and support FlexFill single-use fluid transfer assemblies during use. Reportedly adding an unprecedented level of user convenience, the FlexCessory stand secures the FlexFill assembly and provides the luxury of one-handed liquid transfers. Compact in design, the FlexCessory stand interfaces seamlessly with the FlexFill assembly inside of a laminar flow hood to facilitate aseptic fluid transfer. Sterile bottled liquids can be conveniently transferred to FlexFill for enhanced flexibility and security when adding fluids to either single or multi-use bioreactors. Excess fluid can be stored in the FlexFill biocontainer on the FlexCessory stand for future dispensing. The FlexCessory stand is fully adjustable and can accommodate the full range of FlexFill biocontainer assemblies from 500 ml to 6 l. Meissner Filtration Products, Inc. +1 805 388 9911 leads@meissner.com www.meissner.com EPM 14

Water Purification Systems

Ultrafiltration Equipment

Ion Exchange Systems — Continuous Process

Superheaters

Filtration Systems — Ion Exchange

Stills

Filter Presses — Automatic

11 12 13 14 15 16

Steam Generating Systems

Pasteurisers

Filtration Systems — UF

Dewaterers

Depyrogenation Systems

Distillation Equipment

Bacteria Control Systems

Additional

Custom-made OEM filter devices and disposable disc filters.

Powder Systems Ltd (PSL), UK +44 151 448 7700 sales@powdersystems.com www.powdersystems.com

Wychwood Water Systems, UK +44 1993 892 211 sales@wychwood-water.com www.wychwood-water.com

Meissner Filtration Products, US +1 805 388 9911 info@meissner.com www.meissner.com

Sefar Ltd, UK +44 161 765 3530 ross.nuttall@sefar.co.uk www.sefar.com

Helapet Ltd, UK +44 1582 501980 sales@helapet.co.uk www.filterdevices.co.uk

Russell Finex Ltd, UK +44 208 818 2058 marketing@russellfinex.com www.russellfinex.com

Filtration Systems — RO

GEA Process Engineering Ltd, UK +44 1925 855702 david.dubbin@geagroup.com www.geaprocess.co.uk

Filtration Systems — MF

Axium Process Ltd, UK +44 1792 883 882 gale.rudd@axiumprocess.com www.axiumprocess.com

Laboratory and Manufacturing

purification & filtration

Manufacturing

buyers’ guide

Filter dryer (liquid/solid separation), lab glass filter dryer, vacuum/pressure filter — the simplefilter.

Textile filter media and precision synthetic mesh for sieving and sifting.

EPM 15

15 16

BMM Weston Ltd, UK +44 1795 533441 gpinks@bmmweston.co.uk www@bmmweston.co.uk

10 11 12 13

Sterilisers — Dry, Heat, Electric

Sterilisers — Dry, Heat, Gas

Sterilisers — Gas (ETO)

Sterilisers — Ionising Radiation

Sterilisers — Laboratory

Sterilisers — Membrane Filtration

Sterilisers — Oxone

Getinge Infection Control, UK +44 1623 510033 stephen.morley@getinge.com www.getinge.com

IMA S.p.A. - IMA LIFE division, Italy +39 051 6514111 mktg.life@ima.it www.ima-pharma.com

Waterwise Technology Ltd, UK +44 1844 215570 info@waterwise.co.uk www.waterwise.co.uk

11 12 13

Cleaning equipment (washers), isolators for sterility testing and steam generators.

Cycle development, D & Z value studies, EN285, HTM2010, HTM01-05.

Teknomek Ltd, UK +44 1603 788833 mail@teknomek.co.uk www.teknomek.co.uk

Synergy Health plc +44 8456 88 99 77 assistance@synergyhealthplc.com www.synergyhealthplc.com/sterilisation

Additional

Honeyman Group Ltd +44 1833 696425 enquiries@honeyman.co.uk www.honeyman.co.uk

Sterilisation Equipment Servicing

Sterilising Tunnels

Sterilisers — UV Radiation

Sterility Indicators

Steriliants — Liquid

Manufacturing

Etigam, The Netherlands +31 55 5211721 info@etigam.nl www.etigam.nl

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

Both

Laboratory

sterilisation

Sterilisers — Autoclaves

buyers’ guide

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Sealer and Sterile Welder Machines Available for Biopharma Grade Tubing AdvantaPure has introduced the AdvantaTube Sealer and the AdvantaTube Sterile Welder. The two machines, specifically designed for biopharmaceutical process applications, are preprogrammed to seal and weld the company’s biopharmaceutical grade TPE (thermoplastic elastomer) tubing AdvantaFlex. Pharmaceutical manufacturers typically use silicone or TPE tubing for single-use fluid transfer applications. Their processes involve disposable moulded manifolds, tubing assemblies, peristaltic pumps and the need to retain product samples. Silicone has been a popular choice for years because of its cleanliness, performance properties and suitability in pumps, but presents a problem when it comes to sample retention. Sections of tubing must be permanently and securely sealed off — a task silicone cannot manage. Tubing also needs to be welded, open end to open end, which is another function not possible with silicone. TPE tubing like AdvantaFlex, however, is sealable and weldable. It also works well in peristaltic pumps, may be moulded to form sampling and batch filling assemblies and exhibits low levels of extractables. AdvantaFlex has become a practical selection for pharmaceutical and biopharmaceutical processing applications and with the availability of the AdvantaTube Sealer and Sterile Welder, manufacturers have the benefit of one tubing material — TPE — that meets their sealing and welding requirements. The AdvantaTube Sterile Welder produces tubing

welds, where two open ends of tubing are heated and joined to form a leak-free, single length of tubing, easily and quickly using an automated process. The welder maintains the sterility of wet, dry or fluid-filled tubing and works with gamma irradiated and autoclaved AdvantaFlex. It is a rugged, tabletop unit that features an average cycle time of three minutes. The AdvantaTube Sealer is also simple to operate. Its convenient 3.1 m cord connects to a base and allows users to bring the remote sealing head to the tubing; operation is not restricted to a specific location as with other tabletop based tubing sealers. The unit uses heat and compression to securely seal fluid-filled or unfilled tubing in one-and-one-half to two minutes. The AdvantaTube Sealer and Sterile Welder work with tubing wall thicknesses from 0.2 to 0.3 cm thick and are designed for tubing with an O.D. of up to 1.9 cm. EPM 16

AdvantaPure +1 215 526 2151 sales@advantapure.com www.advantapure.com/advantatube-welder.htm / www.advantapure.com/advantatube-sealer.htm

MANUFACTURING PRODUCTS & EQUIPMENT ARTICLE

Successful Wiping Studies have shown that wiping is the most effective method of cleanroom cleaning. Presaturated wipes especially, are highly suitable for capturing and removing particles and dirt, disturbing biofilms and removing residues. The removal of particles is especially key, not only to pick up dirt and particles, but to trap them in the wipe and physically remove them from the cleanroom. The ability of a wipe to retain and remove a particle or fibre depends on the structure of the wipe and the size of the contaminant. Dry or wetted wipes for cleaning? Some manufacturers have developed proprietary surface treatments to dry wipes in order to enhance particle removal and retention. Particle Attraction Technology (PAT) enhances the ability of the wipe to attract and retain fine particles, less than 10 microns. This improves the wipes ability to clean surfaces, thereby leaving surfaces cleaner. It is a permanent treatment that molecularly bonds to the fabric fibres and is in fact actually enhanced in the presence of a solvent. Wetting the wipe significantly enhances particle entrapment and removal. Using a wetted wiper provides an overpowering bias for the particles to remain with the wipe, since capillary hydroscopic forces from the moisture on the wipe provide the mechanism for the particles removed from the surface to remain with the wipe. Once the wipe is removed from the environment, the particles go with it, resulting in the most effective method for removing particles from a cleanroom surface. The amount of fluid used to pre-wet the wipe is critical: if the wipe is over saturated then particles are re-deposited on the surface and simply moved around, not picked up into the wipe1.

Wipe with PAT

Wipe without PAT

Advantages of presaturated wipes Presaturated wipes can offer many benefits over bottled IPA and dry wipes for cleanroom use. Presats were first introduced to cleanrooms in IBM in 1988 by Contec Inc, to reduce solvent utilisation and increase convenience in hand wiping. Because they provide exceptional solvent control, presaturated wipes were soon adopted by the aerospace, semiconductor, automotive and other industries in order to meet increasingly stringent VOC emission and solvent reduction regulations. However, one of the quickest adopters of these products was the medical device industry, which saw the productivity improvements and process controls the technology offered. Sterile presats for the pharmaceutical industry were introduced in 1990 and are now one of the fasting growing consumable products used in pharmaceutical cleanrooms due to the benefits they provide. Solvent reduction and lowering of VOCs Based on feedback from end-users, a comparison of common methods of applying cleaning solutions to wipes showed that solvent usage can be reduced between 15 and 50% depending on the method of saturation. The majority of pharmaceutical cleanrooms use 70% alcohol solutions for transfer disinfection as it is fast acting and leaves no residue. For instance, if IPA is the alcohol of choice, it has a low work exposure limit (UK TWA 400 ppm eight hours) and this limit can be very easily breached when spraying for long periods of time during transfer disinfection. The use of presaturated wipes can eliminate the need for costly remedial work to install ventilated transfer hatches. Process control and repeatability In all cleanrooms there is a need for repeatable and validated processes. The spraying of a dry wipe with a solvent to a predefined saturation level is not a repeatable process. Each operator has a different view on when a wipe feels wet. Add to this that the operator is probably wearing two pairs of gloves and the tendency is to over wet the wipe as they cannot actually feel how saturated (or not) the wipe is. Even the same operator on different days probably does not saturate a dry wipe in the same way. In the case of disinfection, the objective is to leave a visible film of disinfectant on a surface for a defined contact time. The wipe needs to be saturated enough to leave behind enough disinfectant, but not be so wet that the benefits of controlled application of the fluid are lost. Also, the validated process of disinfection relies on the correct amount of disinfectant being applied by each operator to get the expected log reduction in microorganisms. If insufficient disinfectant is applied, the disinfectant may dry before the validated contact time is reached. In the case of cleaning, the saturation levels are even more crucial. A groundbreaking study by Mattina et al2 showed that a wipe saturated beyond its ability to hold solution, left a surface with more contaminants than with any other level of saturation. Indeed, saturation levels below the saturation limit (i.e. a less wetted wipe) consistently resulted in fewer particulate contaminants remaining on the wiped surface. A wipe with excess solution will leave some solution behind on the wiped surface and with it any contamination within the solution. Validation Having a validated cleaning process requires documentation of both the process and the products

EPM 17

used in the process. The use of a presaturated wipe reduces time and costs as only one product, the presaturated wipe, needs to be qualified and validated as opposed to two products, the wipe and the spray. Using presaturated wipes simplifies the writing of SOPs as the process of validating the spraying of the wipe is removed. This saves time, but more importantly provides a process that is more easily audited by internal and external agencies. Disinfection Another more recent study also came to a groundbreaking conclusion. A study published in Letters in Applied Microbiology3 compared the spread of microbial contamination on surfaces cleaned with dry wipes that were sprayed with alcohol with those cleaned with presaturated wipes. This independent study concluded that wiping with presaturated wipes minimised the spread of contamination: “The dry wipes sprayed with alcohol demonstrated minimal effect at reducing the bacterial bioburden on a surface and were able to transfer viable micro-organisms between surfaces… However, the continuous transfer of bacteria following the use of the dry wipes sprayed with alcohol is of concern. …our results clearly demonstrated, in a quantitative manner, that alcohol pre-impregnated wipes are more effective at reducing surface bioburden than dry wipes sprayed with alcohol.” Conclusion Cleaning and disinfection in a pharmaceutical cleanroom is a critical process to protect patient safety and product quality. More effective and consistent hand cleaning and disinfection will result in greater consistency, quality and safety in the overall process and the resulting product. Damp wiping to a validated procedure is a proven method of effective surface cleaning versus other techniques. The use of presaturated wipes brings additional benefits in improved productivity, reduced validation, increased process control and repeatability, improved safety and VOC reduction. For life science cleanrooms, the use of alcohol presaturated wipes versus wipes wet at point of use is even more beneficial as it has been proven that they are more effective at reducing surface bioburden. References 1. Wiping Surfaces Clean Vicon Publishing 2004: H Siegerman Ph.D. 2. The cleanliness of wiped surfaces: particles left behind as a function of wiper and volume of solvent used. C F Mattina, J McBride, D Nobile Cleanroom East Proceedings 1996. 3. Evaluation of alcohol wipes used during aseptic manufacturing. The Society for Applied Microbiology, Letters in Applied Microbiology 48 648-651. M.N. Panousi, G.J. Williams, S. Girdlestone, S.J. Hiom and J.Y. Maillard (2009). The author would like to acknowledge the input of Jack McBride and Dave Nobile of Contec Inc. in compiling this article.

Author: Written by Karen Rossington, freelance marketing consultant to contamination control specialist Contec Inc., www.contecinc.com.

SHOWCASE CLEANROOMS Thermal Aerosol Generator for Testing HEPA and ULPA Filtration Systems

Gland Seal Solution for Cleanrooms The MUCON Iris Diaphragm Valve (IDV) has proved itself to be one of the most versatile flow control valves for dry bulk solids. When fitted with an elastometric diaphragm, the valve is capable of closing around lumps of products or even foreign bodies trapped during closure, whilst still providing an effective seal to smaller particles and dust. It is this reportedly unique feature that has enabled the MUCON IDV to be used for a variety of unusual valving applications. One of these applications is sealing around service tubes between cleanrooms. The problem — The transfer of material from one ‘condition’ to another, for example, between light and dark rooms or rooms with a pressure differential. Should cleanrooms operate at a slight over pressure, with one being at a higher pressure than the other, problems or pressure loss can occur on a regular basis. The need — Operators require an effective, hygienic and reliable way of sealing around the tubes passing ‘through the wall’, separating one condition from another, such as

temporary sealing of service pipework or tubing, for example, CIP and gas pipes. The solution — The MUCON high hygiene K-Series Iris Diaphragm Valve, with quick-disconnect flanges, brings the tubes together and closes tightly around them. The material flows freely without pressure leakage or damage to the tubes. The one-piece moulded diaphragm also acts as the valve gasket. In addition, both the diaphragm and the valve itself can easily be removed without tools. Process Components Ltd +44 1625 412000 sales@pro-components.com www.pro-components.com

DOP Solutions’ DOP2200 Micro Aerogene is a very compact and easy to carry thermal aerosol generator for use in cleanroom and containment systems for testing HEPA and ULPA filtration systems. It is also used for airflow visualisation, recovery rate determinations and containment leak testing in the clean air and containment industry sectors. Oil is propelled through the heat exchanger using an inert gas (normally CO2) and is vapourised. The vapour condenses in the ambient air to provide a dry dense aerosol smoke of specific particle size distribution. The precision control dial allows for accurate and repeatable control of the aerosol output. The aerosol may be easily directed to the point of use using DOP Solutions’ Positive Injection Pump (PIP). The PIP also allows the aerosol to be injected into positive pressures. Using the company’s Sparge Pipes, the aerosol may be distributed within an air duct or plenum using the PIP, thus reducing the required mixing distance for upstream challenges.

The vernier control is located on the top panel and turning it anti-clockwise allows more oil into the heat exchanger, increasing the aerosol output. Fifteen full turns from closed to open provides accurate control of the aerosol concentration required for the test. The Micro Aerogene covers the main range of output concentrations required for testing small safety and clean air cabinets up to HVAC and multi-filter cleanroom installations. DOP Solutions Ltd +44 1462 676446 sales@dopsolutions.com www.dopsolutions.com

Anti-Slip Colour Match Tray Drain Cover

Cleanroom Manufacturer Re-Brands and Launches Range to Meet EN ISO 14644

In specialist environments where appearance is nearly as important as a non-slip, hygienic and safe floor finish, the new ASPEN Resin Filled Drain Cover is perfect. Now available in two standard sizes, the ASPEN Resin Filled Tray Drain Cover can be filled with a resin to match the colour, finish and functionality of the surrounding floor surface. This new product from the forward thinking ASPEN team creates a durable, hardwearing floor finish, with anti-slip protection and looks to match. As the UK-based designer and manufacturer of all ASPEN stainless products, Canal Engineering is able to offer complete drainage systems and bespoke stainless steel equipment and can customise any standard product to suit its environment.

Following successful business expansion, cleanroom manufacturer Panel Projects has rebranded as Gilcrest Manufacturing and announced the launch of its Puracore range of cleanrooms specifically designed by application to meet EN ISO 14644 requirements. The improved range has the option of a pre-selected cleanroom package to meet individual ISO and application requirements or offers the flexibility to select individual components to customise the customer’s cleanroom solution to their specification. The extensive range includes a variety of

View Canal Engineering’s full range of industrial stainless steel products online or contact the company’s specialist engineers to discuss bespoke requirements. Canal Engineering Ltd +44 115 986 6321 aspen@canalengineering.co.uk www.aspen.eu.com

EPM 18

cleanroom panel cores and finishes, as well as doors, windows and ceilings. Gilcrest Manufacturing +44 117 316 7003 zrogers-lewis@gilcrestmanufacturing.com www.gilcrestmanufacturing.com

SHOWCASE TABLETTING EQUIPMENT MAINTENANCE & SUPPORT Exceptional Customer Service and 24/7 Spare Parts Online Facility IMA is oriented to the continuous improvement of its own products and services and considers customer service to be of the utmost importance. According to the company IMA Integrated Maintenance contracts are the most effective solution to keep equipment performances at the highest level while at the same time reducing maintenance shutdown to a minimum and with activities always planned beforehand. On time maintenance intervention, combined with mechanical upgrades using IMA original spare parts, can increase the longevity of the equipment and result in higher efficiency. MyIMA Spare Parts is a new online

service that allows the customer access to IMA’s SAP system, 24 hours a day, seven days a week. Customers can check the availability and the price of IMA spare parts in stock, issue quotations and place orders by quickly navigating through the spares catalogues and easily identifying the parts. The benefits of this service are the issuing of immediate quotations, overviews of the customer’s particular machines, the simple identification of parts through tables and exploded views, different levels of authorisation for users and no time limit on the system’s availability. For process optimisation, the IMA Pharma Service Laboratory has been in

operation for more then 30 years and boasts an archive of more then 3,500 tests. Ten test rooms, which are staffed by qualified pharmacists and supported by skilled engineers, are at the customer’s disposal for product testing and process set-up. Training courses can be organised at IMA’s site or the customer’s plant. They are designed for personnel from production, R&D, process transfer and maintenance departments.

IMA Active division +39 051 6514111 mktg.soliddose@ima.it www.ima-pharma.com

Dedicated to providing the pharmaceutical industry with quality products at fair prices, the Natoli Tablet Compression Accessories Catalog is a leading resource for tablet compression accessories. According to Natoli, it is the world’s premier manufacturer and supplier of tablet compression tooling, accessories, presses, parts and services for the pharmaceutical, nutraceutical, veterinary, industrial, confectionary and chemical industries. Reportedly, Natoli’s dedication to excellence, innovative thinking and commitment to providing the best customer service has propelled the company to the forefront of the tablet compression industry.

Natoli Engineering Company, Inc. +1 636 926 8900 catalog3@natoli.com www.natoli.com

3D Tablet Compression Accessories Catalogue Natoli Engineering Company has announced the launch of a new interactive tablet compression accessories catalogue. Featuring more than 1,500 items, the 184-page, fullcolour catalogue is a complete accessory guide for tablet compression in the pharmaceutical, nutraceutical, veterinary, industrial, confectionary and chemical industries. “The online catalogue is a fun way to research tablet compression accessories,” said Rachel Krafft, Marketing Coordinator, Natoli Engineering. “Customers will be able to request quotes at their own pace by simply clicking on a part number and

adding the item to their cart.” In addition, the catalogue can be forwarded to a friend or downloaded directly to the user’s computer for easy reference. Other features of the online catalogue include user bookmarks, personal notes, informational videos and more. The new online Tablet Compression Accessories Catalog features new products in every section from ‘Set-Up’ to ‘Storage’, to suit a variety of needs. The ‘Room Design’ section offers a wide range of furniture and equipment that can be used to help customers design their own rooms, using the online Room Layout Tool.

Seven Simple Steps to Total Tooling Protection It makes good business sense — maintain and store punches and dies correctly and expect to produce a better product for longer, reduce costs and enhance profitability. 85% of punch and die problems and damage can be conclusively traced back to an unsuitable aftercare procedure and inappropriate handling. I Holland’s PharmaCare range of equipment has been designed to allow users to follow the 7-Step Process and meet all of their maintenance and storage requirements. It is a planned, professional aftercare programme that will contribute more than it costs to a company’s turnover. The PharmaCare 7-Step Process: 1. Clean — tooling should be cleaned and dried to remove any oil or product residue. 2. Assess — visually inspect tooling for signs of obvious damage and establish if maintenance is required. 3. Repair — light surface corrosion and damage can be polished out and repaired. 4. Measure — measuring is essential after repair to ensure that critical tooling dimensions have stayed within tolerance. 5. Polish — polishing should result in a smooth mirror finish. 6. Lubricate — lubrication is important to protect, preserve and aid the smooth operation of tooling. 7. Store — storage cabinets should be specially designed to maximise security and safety and minimise damage to tooling during transportation. I Holland runs regular training seminars on ‘The 7-Step Process’ at its facility in Nottingham, UK, and at various venues around the world.

Box for Safe and Economical Protection of Tooling Elizabeth Carbide Die Co. provides a pharmaceutical tooling storage box for the safe, convenient and economical storage of pharmaceutical tablet punches and dies. Designed to accomodate both B and D Tooling, the pharmaceutical tooling box offers the following features: • removable tray that holds up to 72 punches and 36 dies (B Tooling) and 48 punches and 24 dies (D Tooling); • head supports that elevate the punch from the tray for easy removal; • moulded keyways and guides that provide secure storage of individual punches and prevent collisions between tools; • die storage on top of the tray for immediate access; • deeply recessed handles for secure handling; • and a stackable and easy to clean design. Dimensions of the pharmaceutical tooling box are 45.7 (l) x26.7 (w) x 18.4 cm (h). The Elizabeth Companies’ Elizabeth Carbide Die Co., Inc. +1 412 751 3000 ryank@eliz.com www.eliz.com

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

EPM 19

Corporate News & Events

Mixers and Homogenisers Partnership Announced by Process Equipment Supplier S3 Process has announced a new partnership with Zoatec, a manufacturer of high quality mixers and homogenisers for the pharmaceutical, biopharmaceutical, cosmetics and food processing industries. Located in the south of Germany, Zoatec is part of the AZO Group, one of the largest engineering companies in the process industry. With highly knowledgeable people with years of experience with mixing, dispersing and homogenising, Zoatec is fast building a reputation for sound process understanding, state-of-the-art engineering and high build quality and has supplied to leading pharmaceutical, food and cosmetic companies. Zoatec’s BG Speed Line Mixers and Homogenisers consistently provide users with a high-quality product and reliable batch times. The vessels are simple to operate and easy to clean and maintain, lowering operating costs. The BG type vacuum process plants

have been ingeniously designed in modular assembly groups, allowing configuration to meet a wide range of liquid to cream-like applications. A number of different agitator combinations are available, allowing different optimisations of the mixing process depending on the product characteristics and improving heat exchange for shorter batch times. CIP times are also shorter due to the improved turbulence. Other mixing elements like dissolvers and a jet stream homogeniser can be integrated. The vessels are designed within a frame, allowing all components to be easily accessed for cleaning and maintenance. The four frame legs allow easy integration of loadcells for exceptionally high accuracy. S3 Process Ltd +44 845 50 53 53 0 dbetteley@s3process.co.uk www.s3process.co.uk

ACHEMA 2012 to Provide Global Forum for Process Engineering in Pharma Production

With c.3,800 exhibitors and 173,000 visitors, ACHEMA is the world forum of the process industry, chemical engineering, environmental protection and biotechnology. From 18–22 June, the latest trends in pharmaceutical manufacturing, laboratory equipment, process development and packaging and labelling will be presented in Frankfurt, Germany. Exhibition and congress will cover current issues such as single-use technologies, secure labelling and process automation. The organiser of ACHEMA 2012 is very positive about the outlook on the event and with good reason — exhibition groups such as measurement and controlling and pharmaceutical, packaging and storage technologies show significant growth even four months before the start and some of the halls are close to being sold out. The ACHEMA exhibition covers the complete value chain of pharmaceutical manufacturing, from the culturing of microbes to the fermentation vessel, from analytical equipment to the packaging line. While the exhibition shows the latest novelties from the market, the congress offers a glimpse of

what will be possible in the near future. With c.900 lectures and sessions on pharmaceutical production, laboratory technology, measurement and controlling and bioprocessing continuously throughout the week, this is the place to develop new concepts, discuss innovative ideas and learn best practices from leading global experts. A broad range of guest and partner events complements the lecture programme. At the Technology Transfer Days, SMEs and research institutions present their newest market-relevant developments and showcase potential new products and services. For the first time, a Partnering platform open to all exhibitors and visitors supports participants in making the most of the five days in Frankfurt. Information on exhibitors, the lecture programme, guest and special events and organisational details is available on the website. DECHEMA e.V. +49 69 756 4277 achema@dechema.de www.achema.de

Finalisation of Papers for Pharma and Medical Packaging Conference The programme for Pharmaceutical and Medical Packaging 2012, 22nd Annual International Conference — which takes place on 1–2 May, in Copenhagen, Denmark — has been finalised. Ten expert speakers will share their knowledge on subjects that will be of benefit to professionals involved with the packaging of healthcare products. Dieter Mössner — Convenor of CEN/TC 261/SC 5/WG12 Marking, Heidenheim/Brenz, Germany — will present one of of the key roundtable topics ‘Tamper Verification Features for Medicinal Product Packaging’, addressing: • legal background — EU falsified medicines directive; • technical solutions for tamper evident packaging; • European standard tamper verification features for medicinal product packaging EPM 20

• and current status and outlook on next steps. For further information about the papers to be presented and to register, please visit the website. Hexagon Holding ApS +45 33 11 41 22 hexagon@hexagon.dk www.hexagon.dk

LABORATORY PRODUCTS & EQUIPMENT

Latest Version of Powder Characteristics Tester Offers Complete Characterisation Hosokawa Micron has announced the launch of the Hosokawa Powder Characteristics Tester, type PT-X, the latest version of the well-known laboratory unit that is used to determine powder characteristics when designing powder handling and processing systems. The PT-X has been updated with a number of features to make it easier to use and more operator friendly. The new design allows the unit to be used in conjunction with computers for data recording, delivering a clear visual display of analysis results that enable the operator to evaluate the results simply and quickly. In 1965, Dr. R.L Carr developed seven powder characteristics to help in the design and control of powder handling and processing systems. These seven characteristics can be measured by the PT-X unit: Angle of Repose, Compressibility, Angle of Spatula,

Cohesion, Angle of Fall, Dispersibility and Angle of Difference. In addition, three auxiliary values— Aerated Bulk Density, Packed Bulk Density and Uniformity — can also be evaluated by the Hosokawa Powder Characteristics Tester to determine valued results for flowability and floodability of dry powders. The new PT-X looks very different from previous versions and is more compact in design. The unit offers computer control via a touchscreen 12.5” tablet PC using a core i5 processor with Windows 7 Professional operating system, which can reduce analysis time. Reduced operator intervention ensures analysis accuracy and repeatability. The unit’s inner wall forms part of the structure, making the PT-X easier to

clean, and an optional integrated HEPA filter for dust protection is available, as is a vacuum cleaner. The Hosokawa Powder Characteristics Tester PT-X offers complete powder characterisation in a single instrument. Hosokawa Micron Ltd +44 1928 755100 info@hmluk.hosokawa.com www.hosokawa.co.uk

Purification Systems Provide Reliable Pure Water Quality for Clinical Analysers Merck Millipore, the Life Science division of Merck, has announced the introduction of its AFS 10E and AFS 15E water purification systems. The new systems are designed to provide an economical and reliable pure water solution for clinical analysers. The Merck Millipore AFS 10E and AFS 15E water purification systems integrate

patented Elix electrodeionisation (EDI) technology, along with several other complementary water purification techniques (for example, pretreatment, reverse osmosis, UV lamp treatment and final 0.22 µm filtration) in order to produce clinical laboratory reagent water (CLRW) with consistently pure and reliable water quality. Elix EDI technology, which uses ion exchange resins that are permanently selfregenerated, ensures low, predictable running costs for users. “For clinical laboratories that need a reliable and economical source of pure water, the new AFS 10E and AFS 15E systems are the perfect solution,” said Lab Water Product Manager Maryse Gauthey. “Systems are designed to produce clinical laboratory reagent water that complies with the Clinical and Laboratory Standards Institute guideline — efficently and with low, predictable running costs.” The new AFS 10E /15E range includes models that provide pure water flow rates of 10 or 15 l per hr and daily production capacity of up to 300 l. The high-quality pure water produced by the systems

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has resistivity values typically exceeding 15 MΩ·cm at 25˚C, less than 30 ppb of TOC (Total Organic Carbon) and bacteria levels of less than 1 cfu/mL. The AFS E systems are robust and intuitive controls make system operation simple. The display shows only the necessary information, and system messages are highlighted by the new backlit LCD screen that changes colour to indicate message importance. Systems are low-maintenance, with a new ergonomic purification pack locking system to facilitate pack changes, as well as other automatic selfmaintenance functions. AFS 10E and AFS 15E systems have adaptable configurations that enable users to make optimal use of laboratory space. The systems’ small footprint allows easy installation on the wall, on or under the bench, or on a cart; if necessary, production capacity can be increased by adding an Elix system in duplex. A full range of high-quality polyethylene reservoirs (10–350 l) is available for use with the systems. Merck Millipore +33 1 30 12 71 46 axelle.defoucaultmercier@merckgroup .com www.merckmillipore.com/millipore

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Benchtop Instrument Provides High-Resolution Moisture Sorption Isotherms in Just Two Days

Electronic Version of Air Jet Sieve With Highly Reliable Particle Analysis

Labcell, the UK distributor for Decagon Devices, is introducing the AquaLab Vapor Sorption Analyzer (VSA) that generates complete moisture sorption isotherms in just two days. Thanks to patented technology, this instrument produces high-resolution, accurate adsorption and desorption isotherms with over 100 points for each curve — whereas isotherms generated using conventional methods typically have fewer than a dozen points and take weeks of work. Despite its outstanding performance, the AquaLab VSA is a compact benchtop instrument that is simple to use and affordable for researchers and formulators in the food and pharmaceutical industries. It is also a powerful tool for use when troubleshooting moisture-related problems that arise during production. Using the AquaLab Vapor Sorption Analyzer, which incorporates patented Dynamic Dewpoint Isotherm (DDI) technology, scientists can gain a far better understanding of the water interactions within the ingredient or product being analysed. This enables users to set specifications for water activity so that products remain adequately stable for their required shelf life, and they can predict how abuse conditions — such as high humidity and temperature — will affect

The new ergonomic design of the Alpine Air Jet Sieve e200 LS leads to faster and simplified operations with a much higher analysis reliability. It now comes complete with a range of innovative accessories to complement the three software packages available — eControl Basic, Professional and Ultimate — which cover the entire range of particle size analysis and in doing so fulfils all users’ high specifications and expectations. Samples of around 10 grammes are placed into the Air Jet Sieve where they are fluidised by a revolving jet stream, producing very accurate separation for sieving. The fine particles are sucked through test screens available in a range from 10 to 2 mm. An added feature of these certified test sieves is that they come fitted with an RFID chip for fully automatic sieve recognition to eliminate possible operator errors. The new e200 LS uprated electronic version of the Alpine Air Jet Sieve has an integrated mini-computer with a high resolution 6.4“ touchscreen, which regulates, monitors and controls the entire sieving process, leading to reduced QC operating times and more enhanced repeatability. It is the choice software packages and the comprehensive range of accessories that set the new version apart from its predecessors. The software can be upgraded to a higher version at any time with easy and

shelf life. Ingredients and recipes can also be investigated to see how they will respond to changes in formulation. If problems such as moulding occur during production or storage, the AquaLab Vapor Sorption Analyzer can help users to establish why and what action will prevent a recurrence. In addition to generating isotherms, the AquaLab Vapor Sorption Analyzer also enables the humidity in the sample headspace to be controlled while monitoring the sample mass. Users can therefore study rates of vapour exchange and crystallisation. For those companies unable to justify the purchase of their own instrument, Labcell offers a cost-effective Isotherm Generation Service in which clients’ samples can be analysed within one week. Labcell Ltd +44 1420 568150 mail@labcell.com www.labcell.com

intuitive operation thanks to an easily understandable menu structure. Other features include: individual language selection; automatic identification of the test sieve mesh; information regarding the system data and settings; and direct connection of a laboratory balance via an interface. USB, Ethernet and RS232C data interfaces are standard and there is a 1 GB analysis protocol memory. A range of accessories is available, including a high performance vacuum cleaner for reliable cleaning of the working air, a small filter for active dedusting of the process air, a high precision laboratory balance, an ultrasonic test sieve cleaning unit and a high performance cyclone for reliable and clean recovery of fines. Hosokawa Micron Ltd +44 1928 755100 info@hmluk.hosokawa.com www.hosokawa.co.uk

Economical Purification Systems Ensure Consistently Pure Water Quality Merck Millipore, the Life Science division of Merck, has announced the addition of its Elix Essential systems to its existing range of Elix water purification equipment. The new systems integrate patented Elix electrodeionisation (EDI) technology along with several other complementary water purification techniques (e.g., pretreatment, reverse osmosis and UV lamp treatment) in order to produce Type 2 pure water with consistently pure and reliable water quality.

The Elix Essential system range includes models with flow rates of 3, 5, 10 or 15 l of pure water per hour and daily production possibilities of up to 300 l. The high-quality pure water produced by the systems has resistivity values exceeding 5 MΩ·cm at 25˚C (typically 10–15 MΩ·cm at 25˚C) and less than 30 ppb of TOC (Total Oxidisable Carbon). Product water is recommended for a variety of uses: feed to laboratory equipment (e.g., Milli-Q Type 1 ultrapure water systems,

weatherometers, autoclaves, glassware washers and dissolution testing units); preparation of microbiological media, buffer and pH solutions; histology; chemical reactions run in water; and manual glassware rinsing. Users of Elix Essential systems have full control over pure water quality, thanks to the systems’ high-precision monitoring equipment that measures key water quality parameters. In addition, RFID technology provides traceability for the Progard pretreatment cartridges.

Productivity Gains Using Particle Size Analyser in Raw Materials Testing Particle size analysis of raw materials is often a necessary but routine task where speed and efficiency are critical to decision-making and the smooth operation of a manufacturing process. The Mastersizer 3000 from Malvern Instruments supports improved productivity through fast, fully automated measurement and cleaning, combined with instrument and data analysis software that streamlines every aspect of the instrument’s use. In-built intelligence supports each measurement, from the outset through to a successful conclusion. The result is robust and reliable data produced with ease and efficiency and minimal operator input.

The Mastersizer 3000 harnesses robust and proven laser diffraction technology to deliver a particle sizing instrument that is highly suited for raw material and commodity handling requirements, and can be used by operators with different backgrounds and experience. It measures particles across a wide size range from 10 nm to 3500 µm, efficiently analysing both wet and dry samples. Measurement is rapid and robust, even for polydisperse materials. Switching between sample types is simple with auto-locking dispersion cells and automatic system initialisation. System software plays a crucial role in lightening the analytical workload.

Real-time feedback during method development accelerates the optimisation of every measurement, with a developed method then locked down as a standard operating procedure to secure validatable performance. An inbuilt Data Quality Expert alerts and guides the user in the event of a problem during analysis, while an editin-place report designer allows the tailoring of results so that data is presented in the most appropriate form for every application. Malvern Instruments Ltd +44 1684 892456 salesinfo@malvern.com www.malvern.com

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Elix Essential systems have a small footprint and can be installed on or under the bench, as well as on a wall, letting users optimise laboratory space. A full range of high-quality polyethylene reservoirs (30–100 l) is available to match users’ required water volumes. Merck Millipore +33 1 30 12 71 46 axelle.defoucaultmercier@merckgroup .com www.merckmillipore.com/millipore

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Release of 2012–13 Prepared Media Price List Cherwell Laboratories has announced the availability of its 2012–13 price list for its Redipor Prepared Media product portfolio. To request a copy, go to www.cherwell-labs.co.uk/contactform.html. Cherwell manufactures Redipor ready-to-use culture media in a variety of formats, including petri dishes, contact plates, bottled media, broth bags and ampoules, plus an extensive selection of gamma irradiated media. The range is suitable for a wide array of applications, including environmental monitoring, sterility testing of products, operator validation and process validation. The Redipor price list includes a selection of the most commonly requested media types, many of which are available from stock for next day delivery. Cherwell’s ISO9001 accredited manufacturing processes can also produce custom media varieties, quantities and packaging solutions to order. Each batch of

Redipor prepared media passes through extensive quality control testing prior to being released to customers, to assure Redipor’s suitability for use within critical areas. “We have many years of expertise in developing and manufacturing microbiological media, over this time our Redipor brand has built a strong reputation for providing high quality products with a flexible and efficient service,” said Andy Whittard, MD at Cherwell. “Specific customer requirements can be made to order, with short lead times and small minimum order requirements, allowing

Intelligently Dose Chemical Reactors at High Flow Rates with Atlas Syringe Pump

us to best meet the needs of individual customers.” Cherwell Laboratories Ltd +44 1869 355500 andrew.barrow@cherwell-labs.co.uk www.cherwell-labs.co.uk

Free Trial of Reaction Screening Tool Bibby Scientific’s STEM Integrity 10 Reaction Station has already proven to be the product of choice for practically all of the top 20 pharmaceutical companies, being used in investigative research, screening tests, quality testing and production monitoring. Within its 10 reaction positions, the user can run 10 independent experiments simultaneously, with precise and independent stirring and temperature at each position from 30°C to 150°C. The STEM Integrity 10 maps the progress of each reaction on its user-friendly touchscreen and automatically records all the data gathered, so that it can be left running overnight unattended. It is small enough to be portable around the laboratory on a trolley, supports lean laboratory working and increases the

throughput of any laboratory by up to 20-fold, as a 24-hour, round-the-clock workhorse. Not only is the STEM Integrity 10 state-of-the-art for accuracy and control, it is reportedly the most economical reaction station of its kind on the market. Bibby Scientific is offering a free trial of its STEM Integrity 10 unit to selected universities, companies or organisations, as the company claims that once a customer has tried working with the STEM Integrity 10, there will be no going back. Bibby Scientific Ltd +44 844 9360234 info@bibby-scientific.com www.bibby-scientific.com

Reaction Monitoring Instrument Enables Precision Process Transfer at Any Scale Mettler Toledo has announced the availability of its new ReactIR 45P. Next-generation ReactIR 45P technology allows reaction scale-up to be studied under actual process conditions. The key information it provides ensures critical yield and product purity are maintained, saving time and money while enhancing safety and compliance in sensitive manufacturing processes. Designed to operate in the laboratory as well as classified areas, ReactIR 45P uses preferred in situ monitoring to study the formation and consumption of starting materials, intermediates and other species in reaction. However, because of its size and reportedly unique instrumentation, the same machine can be used as the process is scaled, eliminating the difficulty of transferring calibration data between analysers. Not only does this enhance time-savings, but chemists and engineers develop a direct process understanding and continue monitoring as the process is scaled.

This results in fewer reaction surprises and an easier transfer of precision processes from laboratory to plant. Using proved sampling technology, ReactIR 45P, which replaces the Mettler Toledo MonArc instrument, has successfully monitored hundreds of chemistry reaction classes, including hydrogenations, Grignard reactions, lithiations, halogenations and acidchloride reactions. iC series software, including iC IR and iC Process, effortlessly turns this reaction data into chemical information for rapid analysis. Desired reaction goals are reached in less time, allowing companies to compete in today’s fast-paced global market. These robust iC software packages come as standard on ReactIR 45P, along with detailed audit and event logs to enhance compliance. A hardened interferometer with multilevel vibration insolation, purge and pressurised NEMA 4X stainless steel enclosure, Thermo Electric (TE) cooler and DS Series Sampling Technology

Syrris has created the reportedly unique Atlas Syringe Pump XL, which is extremely chemically resistant and allows automated volumetric dosing from 100 µl/min to 200 ml/min, providing ultimate flexibility for automated chemistry applications. The Atlas Syringe Pump XL features two syringes that can be independently controlled or combined to enable continuous flow at pressures up to 6 bar. Its embedded computer and range of accessories allow it to independently automate sophisticated additions, sample into vials at user-defined intervals or automatically dose acids or bases to maintain a user-defined pH, with built-in safety features to pause the process in the event of an exothermic reaction exceeding a predefined temperature. For even greater control, it can be connected to an Atlas Base Unit, Reactor Master or PC to allow coordination of automated dosing/sampling with other process parameters such as heating and stirring.

Syrris Ltd +44 1763 242 555 info@tecan.com www.syrris.com/batch-products/ atlas-syringe-pump

ensure enhanced reaction protection and environmental control. Full support for distributed control systems via industry standard protocols such as Modbus and OPC UA offer robust communication options as well. Mettler-Toledo AutoChem, Inc. +1 410 910 8486 patricia.hicks@mt.com www.mt.com/reactir45p

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LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Replacement Cooled Incubator Range Offers Improved Energy Efficiency

UK manufacturer LTE Scientific has recently launched an improved family of cooled incubators to replace its Qualicool range. The stylish new 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 of just 3. This, coupled 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˚C and +50˚C. Three sizes are available and all models can be supplied with either a

white epoxy coated or stainless steel exterior finish. Additionally, the IC200 and IC400 models can also be supplied with double-glazed glass doors. Interiors have a durable ABS construction and are high impactresistant. The entire range also has a onepiece 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 of 80 l, which makes it one of the largest underbench cooled incubators available. In addition, the IC200 range can be stacked, thus making good use of floor area in the laboratory. The IC400 has an impressive 277 l capacity, yet it only takes up 595 x 640 mm of floor space. 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.

Sterilisation Resistant and Computer Printable Laboratory Labels

Perfect for all demanding sterilisation processes, laboratory-labelling specialist CILS has launched high-performance labels that stay attached during repeated autoclave sterilisation, radiation exposure, chemical sterilisation and extreme temperatures (-196°C to +388°C), providing failsafe labware identification. The ultimate durable label range is fully computer printable and variable data

(batch numbers, barcodes, etc.) can be added in minutes, straight from a standard laser, inkjet or thermal transfer printer, perfect for on-demand or mass batch label printing. CILS International +44 1903 219000 info@cils-international.com www.cils-international.com/content/ cils-laboratory-labelling-division

Downloadable Paper Considers Particle Size Metrics for Orally Inhaled Products

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

Partnership to Produce Fully Integrated QC Kit for Liquid Handling Workstations Tecan has partnered with Artel — a worldwide leader in liquid handling quality assurance — to offer the QC Kit, a fully integrated performance verification solution for its Freedom EVO liquid handling workstations. The QC Kit incorporates Artel’s proprietary Ratiometric Photometry technology within the Freedom EVO system, enabling collection of precision and accuracy performance data regarding the volumes delivered by every channel of a liquid handling arm, with results fully traceable to international standards. This new tool provides clinical, pharmaceutical and forensic laboratories with a simple and reliable way to meet increasing quality and regulatory demand for performance verification. The QC Kit comprises an Infinite F50 or Infinite 200 PRO microplate reader, a calibrator plate, shaker, barcode scanner and a Freedom EVOware software addon, plus a range of cobranded consumables, including characterised verification microplates and colour dye solutions. All colour dye solutions are traceable to international reference standards, allowing direct comparison of results between different sites and instruments. The liquid handling performance results can be obtained automatically in just 10 to 30 minutes — depending on the workstation configuration — without the need for a carefully controlled testing environment,

sample preparation or standard curve generation. “Artel’s mission is to solve liquid handling quality, productivity and compliance challenges for our customers and, by partnering on this project with Tecan, the world’s leading supplier of liquid handling instruments, we are a step closer to achieving our mission,” said Kirby Pilcher, President of Artel. “With the regulatory burden for analytical laboratories increasing yearon-year, it is fantastic to be part of a team helping to reduce the complexity of ensuring regulatory compliance.” Frederic Vanderhaegen, Head of Life Sciences Business at Tecan, added: “We are delighted to have entered into this partnership with Artel, enabling us to bring a turnkey solution to Tecan’s broad customer base for liquid handling performance verification testing.” The QC Kit product line will be offered to Tecan’s global customer base through Life Sciences Business and Partnering Business channels. Artel will continue to promote and sell its technology within its existing Multichannel Verification System and Liquid Handling Performance Verification Service brands. Tecan Group Ltd +41 44 922 81 11 info@tecan.com www.tecan.com/qckit

Copley Scientific has added a new, freely available download to its extensive library on the company website. ‘Calculating particle size distribution metrics for inhaled product characterization’ is a recently published paper authored by Mark Copley, Sales Director of Copley Scientific, and David Lewis from 3DI Solutions. It provides a review of the data processing techniques used to generate relevant aerodynamic particle size distribution (APSD) metrics for orally inhaled products (OIPs). A valuable reference for anyone working in the development and QC of this important class of pharmaceuticals, the paper can be downloaded at http://bit.ly/COPNWP. Particle size is critical for OIPs because of its influence on the efficiency of drug delivery. The authors discuss this need for particle size data and how to efficiently derive key metrics from the substantial amount of data produced when using cascade impaction. Cascade impaction is the mandatory technique for measuring APSD measurement in all OIPs. Cascade impaction involves size

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fractionation of a delivered dose. This enables the generation of an APSD specifically for the API, rather than the entire formulation. Each sample is separated into around seven or eight fractions, each of which is analysed by HPLC. Processing the resulting data to produce meaningful metrics is essential, but can be complicated and potentially time-consuming. Beginning with an introduction to cascade impaction, ‘Calculating particle size distribution metrics for inhaled product characterization’ focuses on the calculation of mass median aerodynamic diameter (MMAD), comparing the different data regression techniques that can be applied in its determination. The simplicity, effectiveness and validity of direct linear interpolation is emphasised and there is more general discussion of current efforts towards streamlined data analysis. Copley Scientific Ltd +44 115 961 6229 m.copley@copleyscientific.co.uk www.copleyscientific.com

SHOWCASE CHROMATOGRAPHY High Quality TLC and HPLC Glassware Kimble Chase designs and manufactures glass products for preparative scale-up, thin layer chromatography (TLC) and HPLC. Researchers have a source for high quality chromatography glassware, designed to provide convenience, economy and efficiency. Kimble Chase offers a portfolio of chromatography glassware that includes columns, tanks, sample vials and its reportedly unique solvent handling system with Ultra-Ware reservoirs. For preparative scale-up applications, chromatographers use borosilicate glass CHROMAFLEX and FLEX-COLUMN or polypropylene DISPOSAFLEX chromatography columns. Columns are supported with available fittings, flow adaptors and packing reservoirs. For analytical separations, Kimble Chase manufactures glass gravity columns in several configurations along with reservoirs and adaptors. For custom

chromatography columns, the Custom Glass Shop at Kimble Chase offers design and fabrication services. Kimble Chase offers optically clear, ruggedly durable TLC Developing Tanks in several configurations, including rectangular and cylindrical. Microcaps are ingenious borosilicate glass capillary tubes, designed for precise TLC plate spotting. Other accessories include TLC reagent sprayers, a plate streaker and labelling templates. Kimble Chase offers Ultra-Ware HPLC Mobile Phase Handling Systems to improve retention-time reproducibility and baseline stability by reducing contaminant background noise levels. These airtight and chemically resistant systems eliminate exposure to ambient air contaminants while maximising the effectiveness of helium sparging. The plastic safety coating used on UltraWare reservoirs minimises

photochemical degradation of the mobile phase by blocking virtually all ultraviolet radiation below 385 nm. The systems provide completely integrated filtration, sparging/degassing and delivery of solvents. Reservoirs, with their patented conical bottoms, are available in sizes ranging from 250 ml to 20 l. For chromatography sample management, Kimble Chase offers chromatography and sample storage vials in various styles, with attached closures, printed volume measurement lines and closures with multiple cap and liner combinations in a choice of materials. Kimble Chase’s vials are manufactured in US-based, ISO-9001 compliant facilities. Kimble Chase, LLC +1 865 717 2600 ext. 2684 k.williams@kimble-chase.com www.kimble-chase.com

Syringe Filters Enhance Sample Preparation

Thermo Fisher Scientific has launched the Thermo Scientific Titan3 and Target2 ranges of single-use syringe filters for sample preparation. These more robust syringe filters significantly enhance sample preparation workflow by accommodating greater burst pressures and providing exceptional flow-through characteristics. Previously supplied as the SUN-Sri TITAN2 and National Scientific Target ranges, these filter units have been enhanced by Thermo Fisher to offer improved reliability and performance, including an improved housing design that prevents leakage during filtration. The premium Titan3 range provides further confidence with colour-coded housings for easy membrane selection

Multi-Detection GPC/SEC for More In-Depth Data

and an integral ring that withstands even greater burst pressures, with 30 mm models resistant to pressures of up to 120 psi. Both the Titan3 and Target2 filter ranges are fully HPLC-tested and incorporate low extractable membranes and housings. Titan3 and Target2 syringe filters are available in a wide range of filtration membrane types and porosities and are suitable as a high-quality filtration solution for a range of chromatography filtration applications.

Malvern Instruments’ Viscotek product range incorporates complete separation and detection systems, and detector combinations that can be added to an existing Gel Permeation Chromatography/Size Exclusion Chromatography (GPC/SEC) system. Multi-detection GPC/SEC is a simple, yet practical technique for characterising proteins, natural and synthetic polymers, copolymers and other complex macromolecules. Benefits include: • absolute molecular weight of small and large polymers without extrapolation, protein stability and protein aggregation using 90 degree and low angle light scattering (RALS/LALS); • protein and polymer structural information such as branching using intrinsic viscosity detection; • molecular size in terms of hydrodynamic diameter and Rg; • and copolymer composition using single or multi-wavelength UV detection. By combining light scattering, refractive index (RI), intrinsic viscosity

Thermo Fisher Scientific Inc. +1 408 965 6022 stephanie.kubina@thermofisher.com www.thermoscientific.com/ syringefilters

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and even ultra-violet (UV) detection in a single measurement, the Malvern Viscotek method of GPC/SEC maximises the data gathered about the macromolecules under investigation. Additionally, by measuring molecular weight directly, multi-detection GPC/SEC systems avoid the requirement to calibrate the system using a molecular weight correlation based purely on the retention volume. Viscotek multi-detection systems, such as the TDAMax, are 21 CFR Part 11 compliant and incorporate an autosampler to increase throughput and improve repeatability. Additional features include simple to use but comprehensive functionality software, a full suite of calibration and GPC/SEC calculation types and 3D absorption plot for chemical identification of each component. Malvern Instruments Ltd +44 1684 892456 salesinfo@malvern.com www.malvern.com/viscotek

Events

Training Courses in Laboratory Freeze Drying SP Scientific has announced new summer and fall dates for its popular hands-on laboratory training courses in freeze drying and cycle optimisation techniques. The training courses, due to take place in June and October, will focus on the freeze drying process from formulation and thermal analysis to cycle development and optimisation, packaging and troubleshooting. The Course Director is Dr. Jeff Schwegman and equipment demonstration and use is provided by industry experts including TA Instruments, McCrone Microscopes and Metrohm. The new extended four-day training courses have been designed to enable people involved with lyophilisation, at all levels of experience, to gain considerable benefit and to reinforce their classroom training with extensive laboratory work.

Scientists to Benefit from Free Flow and Automated Process Chemistry Workshops

The training will be held in the newly designed Warminster, Pennsylvania laboratory, on 5–8 June and 23–26 October. In order to provide the best possible learning experience, the course is limited to approximately 16 attendees. SP Scientific Inc. +1 845 255 5000 shireen.scott@spscientific.com www.spscientific.com

Building on last year’s success, Syrris is again inviting scientists to attend a free programme of flow chemistry and automated process chemistry workshops and seminars, which will be held at the Dinslaken premises of German distributor YMC Europe GmbH, on 21–25 May. Delegates attending the flow chemistry workshop will acquire an understanding of the theoretical and practical aspects of flow chemistry — including reaction optimisation — and learn how the technique can provide faster, safer and cleaner reactions. Participants will also receive specialist application training, enabling them to adapt established batch chemistry processes to suit a more efficient flow chemistry format. The automated process chemistry workshop provides scientists with an opportunity to learn how to calculate reaction power and enthalpy, generate real-time kinetic data and understand

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the safety implications of increasing the scale of a chemical reaction. New crystallisation techniques that enable narrower particle size distribution, cleaner particles and better selectivity of polymorphs will also be demonstrated. To register, or to find out more about the workshops, email workshop@syrris.com. Syrris Ltd +44 1763 242 555 www.syrris.com

INGREDIENTS & CONTRACT SERVICES

360 Degree Virtual Tours of Worldwide Custom Manufacturing Locations Lonza, a leading custom manufacturer of chemical and biological therapeutics, has announced the launch of its new 360 Degree Virtual Tours. The new digital tours provide a comprehensive view of Lonza’s global custom manufacturing facilities, including a wide range of technologies, common areas and support functions. The complete online viewing system allows customers to explore the copmpany’s state-of-the-art development and manufacturing facilities first hand, while avoiding costly travel expenses. “Our new virtual tours provide our customer with a high level of transparency, allowing them to fully experience and explore our facilities globally, on their own schedule and from their own location,” said Dr. Karin Maag, Senior Director of Marketing, Lonza Custom Manufacturing. “We value the importance of a strong global presence in today’s market, while

Catalent can offer an unparalleled range and scale of services to the development and testing of large and small molecules,” commented Graeme Lowe, Director of Analytical Solutions for Catalent in Swindon. “The enhanced facilities here in Swindon are complimented by Catalent’s acquisitions of Aptuit’s Clinical Trials Supply business and the full ownership of the Eberbach softgel facility. We are now offering a broader range of pharmaceutical and biopharmaceutical testing services from five locations in the US, UK and Germany. We have the expertise and the global reach to help our customers bring more products to market faster,” said Christine Dolan, VP and GM of Catalent’s Development and Analytical Solutions.

Hovione has announced the appointment of Dr. Colin Minchom as VP of its Particle Design Business Unit. Dr. Minchom was most recently employed by Patheon, as VP, Pharmaceutical Development Services for North America. Based in East Windsor, New Jersey, Dr. Minchom will report to Guy Villax, Hovione’s CEO. “Dr. Minchom is an excellent addition to our management team; he will be responsible for innovating Hovione’s pharmaceutical particle design offerings to meet the development and commercial supply needs of the formulator with poorly bioavailable or otherwise challenging molecules,” said Villax. “I look forward to building on what has been achieved by Hovione to date in its creation of solutions for customers needing particle design for improved bioavailability and also specialist delivery by non-oral routes,” said Dr. Minchom. Dr. Minchom’s 29-year career includes extensive experience in the process, science and global regulation of drug development with emphasis on dosage forms and drug delivery. Prior to his role at Patheon, Dr. Minchom was Head of Pharmaceutical Sciences at Cerebrus Ltd, a UK, privately held pharmaceutical company, and has also held positions of increasing scientific and management responsibility at Eli Lilly and E.R. Squibb, in formulation and product development, project management and product management. Dr. Minchom is chair of the American Association of Pharmaceutical Scientists (AAPS) 2012 Annual Meeting Planning Committee for Chicago. He also serves as a volunteer at the United States Pharmacopoeia (USP), as member of an Expert Committee addressing small molecules. Dr. Minchom was until recently an advisor at the Medical and Related Sciences Discovery District (MaRS) incubator in Toronto, Canada. Trained as a pharmacist at the Leicester School of Pharmacy in the UK, he holds a PhD in Industrial Pharmacy from the University of Wales College of Cardiff.

Catalent Pharma Solutions +44 7580 041073 chris.halling@catalent.com www.catalent.com

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

understanding the limitations on travel for preliminary visitations.” With the services of Enrich Media, a visual media company, Lonza was able to capture the daily development and production operations of its global custom manufacturing locations. The digital interface has been designed to mimic the newly created Lonza website and allow for simple and efficient customer navigation. Each site tour can be filtered by technology and service for detailed viewing. With widespread reduction in travel budgets across the industry, Lonza has created a system for customers everywhere to explore its facilities at their leisure. For further information and access to the tours, please visit www.lonzavirtualtours.com. Lonza Group Ltd +41 61 316 8798 dominik.werner@lonza.com www.lonza.com

Development and Analytical Services Expansion in Swindon Catalent Pharma Solutions has announced the completion of new Development and Analytical Solutions laboratories at its facility in Swindon, UK. From this laboratory suite, Catalent will offer expert analytical testing, development support and regulatory services to pharmaceutical and biopharmaceutical companies. The laboratory suite incorporates expanded, state-of-the-art facilities for the storage and testing of controlled and cytotoxic substances. Catalent’s new Swindon laboratories offer a comprehensive range of development and analytical services. These services include European import testing, Qualified Person (QP) and regulatory consulting services, methods development and microbial, sterility and stability testing for a range of advanced dose forms including for inhaled and orally administered substances. “This additional capacity, coupled with our international network, means

API Manufacturer Appoints VP for Particle Design Business

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INGREDIENTS & CONTRACT SERVICES ROUNDUP CASE STUDY In association with its client, Quay Pharma has developed a reportedly novel vaginal tablet that rapidly and completely forms a gel containing a potent microbiocide that blocks HIV from entering the bloodstream. Of the 16,000 people around the world contracting HIV every day, the majority are infected by unprotected sex, with the greatest incidence being in subSaharan Africa and India. While work continues into the development of new drugs and vaccines, the use of microbiocides formulated as gels is currently considered the best chance yet of controlling the spread of AIDS; a recent finding suggested that a gel, applied inside the vagina, may reduce the chances of women contracting HIV by a third. A key benefit is that it offers an opportunity for women to protect themselves against infection where their partners are unwilling to use any form of protection. Quay’s client, a large, private, non-profit corporation in the US, has a long-established research programme into methods of reducing the incidence of HIV sexual transmission. Following the screening of a large number of acceptable pharmaceutical compounds, the company found a compound that had good in-vitro activity against HIV and also had pronounced in-vivo efficacy

GEL-FORMING VAGINAL TABLET TO HELP CONTROL SPREAD OF AIDS

against HIV challenge vaginally in animal models. In order for the compound to be evaluated in clinical trials, Quay’s client needed an effective means for its intra-vaginal administration. A variety of different methods were tried unsuccessfully, with particular problems being that many of the excipients used in the formation of creams and gels proved an irritant to the sensitive vaginal mucosae or did not provide entire mucosae coverage and therefore protection. Quay was approached to develop a novel vaginal tablet that, once administered, would be able to gel very quickly to produce a clear, non-irritant, barrier layer that was undetectable by the male partner during intercourse. The requirement was for the tablet to rapidly and completely gel within less than two minutes in 2 mls of simulated vaginal fluid and to develop mucoadherent properties within five minutes, and to ensure that the gel remained in the vagina during intercourse. Additionally, the gel formed from the tablet needed to have an acidic pH of 3–5 and remain acidic (pH of <6) when mixed in-vitro with a volume of semen typical of a human ejaculate. Using Quay’s expertise in tablet formulation development, many possible formulations were proposed and tried out experimentally, using various acceptable and non-irritant swellable polymers. Ensuring that a complete gel was formed quickly and completely was made even

£9 Million Facility to Increase Manufacturing Capabilities for Phase I and II Clinical Trials Molecular Profiles has announced the commencement of construction of a manufacturing facility. This £9 million investment will allow Molecular Profiles to expand its current manufacturing capabilities while strengthening its existing expertise in the drug development field. The new GMP facility, planned to open in late 2012, will provide an additional 2,787 m2 of space. The investment marks a significant expansion of scale for the company, with six new GMP suites, new laboratories and a clinical packing suite. The new facility is designed to the latest specifications, enabling flexibility of use and the manufacture of highly potent compounds up to OEB 4 level. Designed to handle a range of dosage forms — including solids, liquids, semi-solids and inhaled products — the expanded capability allows Molecular Profiles to comprehensively cover phase I and II clinical trial requirements with a manufacturing batch scale of up to 30 kg. The new build at Molecular Profiles’ site in Nottingham will complement the existing GMP facility and research laboratories, providing increased productivity across the company’s complete portfolio of drug development services. The investment will enable expansion across all services, including formulation development, polymorph and salt selection, analytical services, materials characterisation and clinical trial manufacturing. This significant investment further

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

Partnership to Provide Development to Commercialisation Solution for Hormone Eluting Drug/Device Combination Products

demonstrates Molecular Profiles’ commitment to providing its pharmaceutical customers with a complete formulation and manufacturing capability in a single location. The UK government has provided its support through the allocation of a regional growth fund grant of £1.6 m. Nikin Patel, CEO of Molecular Profiles, commented: “The construction of significantly larger manufacturing and laboratory facilities is a strategic decision based on customer demand. Our strategy for expansion is well underway and securing the regional growth funding is a clear endorsement of our strategic growth plans. Following our double win of the Queen’s Award in 2007 and 2011 in the category of innovation, we have once again affirmed our ambition and continuous development.” Molecular Profiles +44 115 8718888 info@molprofiles.co.uk www.molprofiles.co.uk

more difficult by the requirement that the gel had to be formed with only very small amounts of water present (2 mls). The formulation finally selected and progressed was the one that could be compressed most easily into vaginal tablets. Patent filings have now taken place for the selected tablet, which is planned to be assessed in extensive clinical trials. “This has been a very exciting and challenging project and we are very proud to have made such a significant contribution,” commented Mike Rubinstein, Quay Pharma’s Chief Executive. “We believe this development will be a very significant milestone in the battle to protect people against HIV/AIDS infection and will be especially welcomed in developing countries as an inexpensive and culturally acceptable method of protection.”

Particle Sciences Inc. (PSI), a leading pharmaceutical CRO, and CHEMO, a multinational and pharmaceutical company with strong industrial capacities for APIs and FinishedDosage-Forms (FDF), have formed a partnership to offer complete contract product development and commercial manufacturing of hormone-eluting devices. Particle Sciences is a world leader in the formulation, testing and scale up of drug/device combinations and has been working with CHEMO for several years on a number of hormone-based polymeric combination products. Mark Mitchnick, CEO of Particle Sciences, commented: “In our work with CHEMO and others, it became clear that there was no complete solution for companies wishing to develop and commercialise hormone-based combination products. CHEMO is basic in many hormones, a well-respected global supplier and has strong global marketing capabilities in WHC. Particle Sciences has the intellectual property, infrastructure and development capabilities to rapidly get such products into the clinic. By combining our efforts, CHEMO and Particle Sciences now offer the only complete solution for combination product development. CHEMO has proven to be an excellent partner and this is consistent with our business model of making sure that our clients are positioned in the best possible competitive situation, in this case by providing a rapid, cost efficient

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path to commercialisation.” Under the agreement, the two companies will leverage each other’s strengths to provide a start to finish contract solution for those looking to develop and market hormone eluting devices. Particle Sciences will carry out the development work, establishing design, performance, scale up parameters, analytic and QC methods and producing clinical trial materials in its cGMP facility. CHEMO will assume production and fulfillment roles in mid to late clinical testing and through to commercialisation. The companies are already successfully working on several products under this model, with the first ones having already entered the clinic last year. Lucas Sigman, CEO of CHEMO’s US Subsidiary, stated: “Particle Sciences has a top tier technical team and an excellent facility. This relationship is yet another step in CHEMO’s global technology-based expansion. As an API supplier and FDF manufacturer, bringing in hormonebased combination product capabilities is a natural step and one that we are very enthusiastic about.”

Particle Sciences Inc. +1 610 861 4701 info@particlesciences.com www.particlesciences.com

INGREDIENTS & CONTRACT SERVICES ROUNDUP Pharma Services Company Announces £14 Million Investment in High Containment Operations

REGULATORY AFFAIRS On 5 March 2012, the European Medicines Agency (EMA) published the updated set of mandatory requirements for Marketing Authorisation Holders (MAHs) to comply with Article 57(2) — one of the key measures of the new pharmacovigilance legislation — also known as the XEVMPD (Extended EudraVigilance Medicinal Product Dictionary). By 2 July 2012 at the latest, MAHs must electronically submit to the EMA information about all valid (authorised or suspended) medicinal products, independently from the authorisation procedure. Due to a number of key concerns raised by the pharmaceutical industry (including the short timeline and the fact that views on content are currently not always harmonised by all pharmaceutical industry associations, especially for structured information), the EMA has considerably reduced the number of data fields that will be initially required. In particular, the socalled Structured Substance Information (SSI) will no longer be required by 2 July and the EMA will now work with the EU regulatory network and the European pharmaceutical industry associations on developing a plan for SSI submission after July 2012. The major issue inherent in this activity for MAHs is certainly not the electronic submission of data itself, but the collection and collation of data to be submitted in a structured and effective manner. Detailed guidance has been published by the EMA about the future mandatory data set for SSI. This will involve a major effort from manufacturers, since not only specifications on the active ingredients, but on excipients also, have to be provided. The expertise required and the data mining of this information will continue throughout the product lifecycle since, following a variation, the XEVMPD will have to be updated within 15 calendar days. Thus, this new revolutionary pharmacovigilance legislation will have a significant impact on all sectors of the pharmaceutical industry, involving both regulatory professionals and quality experts at the same time.

EMA UPDATES REQUIREMENTS AS EVMPD DEADLINE DRAWS NEAR

Dr. Paolo Biffignandi paolo@elc-group.com

Dr. Paolo Biffignandi, MD, PhD, QPPV, FTOPRA, former President of The Organisation for Professionals in Regulatory Affairs (TOPRA), is an advisory board member of the pan-European pharmaceutical regulatory affairs organisation ELC Group. He is a renowned physician who graduated in Medicine with PhDs in Endocrinology and Pharmacology. Dr. Biffignandi started his highly successful career in the pharmaceutical industry after a period at the University of Torino, Italy, and in 1989 he became an independent consultant in medical and regulatory affairs. He is the author of more than 160 scientific articles and co-author of three books on

European Regulatory Affairs and a member of several scientific societies, including DIA, RAPS and TOPRA. From 2003, he was a member of the Board of Directors of TOPRA, of which he was President in 2009–10. In 2009, he was appointed Fellow of The Royal Society of Medicine, in the UK.

Penn Pharma has announced a £14 million investment in its South Wales, UK, facility to strengthen its offering for international supply and further build on the company’s established high tech manufacturing capabilities. The investment sees the 33-year-old company expand its specialist high containment facilities with a 1,394 m2 new development and commercial manufacturing unit for tablets and capsules meeting the highest international Quality Standards. The new facility will enable the team at Penn to further build upon its established expertise in the manufacture of specialist drugs for the worldwide market. Speaking on the announcement, Chief Executive Dr. Richard Yarwood (pictured) said: “We are delighted to announce this significant investment in the UK pharmaceutical manufacturing sector at a time when the established industry remodels itself and outsourcing is on the increase. “This investment is the catalyst required to enable us to build on the services that we are currently offering our clients and ensure that we are able to react to the evolving market place. We have seen a growth in the number of highly potent compounds coming through the pharmaceutical early phase pipeline and in response to this we are investing in an expansion of our existing resources to meet this growing demand.” Penn Pharma has a wealth of experience in successfully providing an integrated range of services for the development, manufacture and distribution of medicinal products to the global pharmaceutical market. This new facility will see the team at Penn build on its success in the oncology and orphan drug sector and allow for more frequent and larger scale project delivery. Due to the company’s location, in the Welsh market town of Tredegar, the pharmaceutical firm

has been fortunate in securing additional funding and training support from the Welsh Assembly Government. Business Minister Edwina Hart has welcomed the news, saying: “The Welsh Government continues to provide support in areas of Welsh industry where we can help secure specialist, skilled jobs. We are particularly pleased to be able to support Penn in this significant investment and it’s always good to hear of companies in our key industry sectors investing and expanding, despite challenging economic conditions.” Wanting to keep high skilled jobs within Wales, Yarwood believes that the passion and positive attitude that sits with all staff at Penn is testament to the company’s ongoing success. He said: “Over recent years we have witnessed strong growth in our development and manufacturing services, we are expecting this to continue at an increasing rate post completion of the new facility. We wouldn’t have achieved such great year on year success if it wasn’t for the hard work of our skilled personnel.”

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

API and Formulated Products Supplier Acknowledged with Two Industry Awards Aesica is celebrating following the presentation of two awards from NEPIC at its annual awards dinner, which recognised the achievements of two individuals within the company. Dr. Susan Daly was recognised with the Young Achiever Award for the pharmaceutical industry and CEO Dr. Robert Hardy was presented with the Outstanding Contribution Award. The NEPIC (Northeast of England Process Industry Cluster) Annual Awards are designed to recognise the success and achievements of members operating in the hi-tech manufacturing marketplace, including the chemical, pharmaceutical, petrochemical and biotechnology sectors among others. The awards provide a platform from which to celebrate the vital contribution the manufacturing and process industries are making to the regional, national and global economy. Dr. Hardy was honoured for his contribution to the pharmaceutical industry throughout a career that has spanned three decades and seen him play a pivotal role in the success of BASF before founding Aesica in 2004. With Dr. Hardy’s expertise and leadership, Aesica is now one of the UK’s fastest growing companies and in the last five years has doubled its turnover and its workforce. With 1,300 staff across ten sites in the UK, Europe, Asia and America, the company’s long-term vision is to be the number one supplier of APIs and formulated products to the pharmaceutical industry, which is being seen through a combination of organic growth and strategic acquisitions. Dr. Hardy commented: “I am extremely proud to have been honoured with the Outstanding Contribution Award. The last eight years since forming Aesica have been the most exhilarating of EPM 30

my career and I am delighted that we are recognised as one of the fastest growing companies in the North East and the UK as a whole. I am accepting the award on behalf of every member of our team around the world, as without their dedication, expertise and drive, my initial vision would not have been realised.” Dr. Daly, now a Product Manager, was acknowledged for her contribution to the sustained growth of Aesica. She joined Aesica having graduated in Medicinal Chemistry and completed a Ph.D in Synthetic Organic Chemistry. Dr. Daly’s career at Aesica began as a chemist in the development laboratory, working on process improvement and new product development and later focusing on environmentally-friendly manufacturing. By supporting the company’s community work in the North East, She has helped inspire local school children and aspiring chemists to follow her path into the science and technology arena. Speaking of her award, Dr. Daly said: “To have been recognised by NEPIC and my industry peers is a great honour and I am delighted to have received the award. I joined Aesica upon completion of my PhD and have been fortunate to work across a range of areas in the business from the lab through to my current role in the commercial team. It has been this diversity, coupled with Aesica’s dynamic vision and approach, that has inspired and motivated me to succeed.” Aesica Pharmaceuticals Ltd +44 191 218 1960 info@aesica-pharma.com www.aesica-pharma.com

SHOWCASE ASEPTIC FILLING Overcoming Challenges in Technical Transfer of Biopharma Products Catalent Pharma Solutions is a leading expert in the rapid transfer of complex pharmaceutical and biopharmaceutical products for volume aseptic filling and finishing. Recently, the company’s Brussels-based facility introduced a reportedly novel wound healing treatment that initially presented a number of challenges. The customer’s ambition was to launch during 2012, yet clearly it was important that the filling and packaging process be designed to assure the required levels of sterility and scalable production to meet anticipated demand following successful launch. Presented in vial format, the product was designed to be topically administered to assist the natural wound healing process once applied to the skin. Coupled with the handling characteristics required for current GMP processing of such a product, the API and finished product also required storage at -20°C, presenting significant challenges to effective transfer. Yet Catalent’s demonstrated capabilities in handling products that require controlled temperature processing and storage proved key in managing the transfer effectively and the company was also able to meet the customer’s requirement that equipment be dedicated to the product through

the specification of single-use components and through the selection of the most appropriate, compatible materials. Catalent also assisted with component design for efficient manufacture and specified packaging capable of withstanding storage at low temperatures. “The transfer is being completed within the challenging timelines required by the customer and this despite the client organisation being acquired by another pharmaceutical company and the project team doubling in size mid-way through the project,” said Edwin Hoppenbrouwers, Director New Product Introduction at the Brussels facility. “We dealt with a number of challenges in process and product design, but this is not untypical for such programmes and in my view such transfers can only be achieved through the effective deployment of an experienced, multi-disciplinary team. We are fortunate to have a good deal of experience in the reliable supply of many complex biopharmaceuticals,” he added. Catalent Pharma Solutions +44 7580 041073 chris.halling@catalent.com www.catalent.com

CDMO to Deliver Vial Filling Project SCM Pharma is to develop and manufacture an injectable neonatal product for BrePco BioPharma to be used in a clinical trial researching the treatment of critically ill premature babies suffering from hypotension. Ireland-based BrePco selected the CDMO to initially produce development and clinical batches for eight clinical trial sites across Canada and Europe and then scale-up to commercial production should the product get licensed. In line with SCM Pharma’s expertise in filling sterile products, this latest vial filling project involves the product needing to be presented as a terminally sterilised vial. The CDMO has already manufactured engineering batches and will commence work on a stability study with process validation batches next in the project plan. The product is based on an established and approved inotropic agent. However, the currently approved drugs were developed for adults and are not specifically licensed for use in children. The aim of the trial is to therefore develop a ready-to-use, licensed treatment for vulnerable, preterm infants. Paul Breen, co-founder and Chairman at BrePco Biopharma, said: “With a few years of research already completed on the project, we needed a drug manufacturing partner like SCM Pharma that has a proven track record both in terms of quality and its capability to manufacture products for clinical trials. “It was vital for us to have a contract manufacturing organisation that not only understood the challenges of clinical manufacturing, but could

also provide the potential to scale up to commercial production when required. “The project is progressing well and already the SCM team has shown its technical ability and commitment to meet our deadlines and deliver the project to the available budget.” BrePco, along with 12 research partners across Ireland, Europe and Canada, led by Cork University Maternity Hospital, secured €5.6 million from the European Commission's Healthcare FP7 Programme for the project last year. This was based on hypotension (low blood pressure) being a common problem amongst very premature infants and is often associated with tragic outcomes, including brain injury and death. At present, the existing licensed product is typically diluted before use depending on the dosage required, but involves a challenging administration process, as it is usually needed immediately following birth of a low weight child. Dianne Sharp, MD at SCM Pharma, said: “This project with BrePco is a very significant one given the beneficiaries of the product. With our established vial filling capability, we will be working closely with the BrePco team to fast track their project as quickly as possible to help them meet their clinical trial deadlines.”

“...With a few years of research already completed on the project, we needed a

drug manufacturing partner like SCM Pharma that has a proven track record both in terms of quality and its capability

SCM Pharma +44 1661 833 693 info@scmpharma.com www.scm-pharma.com

to manufacture products for clinical trials”

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Sterile Manufacturing Specialist Invests £500K in Vial Filling Equipment

Comprehensive Portfolio of Drug-Delivery Systems

SCM Pharma is set to expand its vial filling capability after placing a major new order to help deal with several clinical trials and commercial supply contract wins. The UK-based CDMO has invested over £500k in new vial filling equipment that will arrive this summer and command a dedicated suite at its facility. SCM Pharma undertakes vial filling across many projects, but the new automated filler will deliver increased capacity, efficiency and integrate with its containment isolator. The move follows increased demand for liquid and powder filling from new clients and existing clients with scale-up requirements. Neal Wesley, Technical Director at SCM Pharma, said: “The new kit will give us a true containment system for vial filling in that it will allow us to fill various types of potent materials in different sized vials while being totally safe for the product and operator. “By having a system that isn’t compromised in any way, we are able to handle more cytotoxic products such as oncology drugs, which we can safely fill at speed into vials under aseptic conditions to meet the demands of our clients.” Although the investment will be a step change in the CDMO’s current filling capabilities, it remains at a scale that will be of interest mainly to companies requiring products for

Vetter, a leading international specialist in aseptic filling, offers a broad portfolio of drugdelivery systems. The company fills syringes, cartridges and vials according to high quality and safety standards. Vetter offers extensive experience with complex compounds, including monoclonal antibodies, peptides, interferons and vaccines. Vetter fills single-chamber syringes and cartridges for liquid compounds, liquid and lyophilised vials and dual-chamber syringes and cartridges. Also available are prefilled Water for Injection (WFI) syringes. For compounds that require lyophilisation, Vetter provides extensive experience. Vetter’s innovative dualchamber injection systems are especially patient-friendly. The Vetter Lyo-Ject and V-LK both consist of two chambers — lyophilised drug resides in one chamber, liquid in the other. The drug is reconstituted by mixing both chambers. These systems prolong shelf life, promote accurate dosing and enable patients to self-administer their medications, when appropriate. Vetter supports its pharmaceutical and biotech clients from early development through worldwide market supply. Vetter Development Service provides product management from the

clinical trials and the supply of licensed drugs needed in niche markets such as orphan drugs. SCM Pharma is planning to use Interphex — New York, 1–3 May, Booth 1372 — as the platform to showcase its capability to sterile fill vials, ampoules and syringes to the US market. The CDMO recently announced a contract to develop and manufacture an injectable neonatal product for Irelandbased BrePco BioPharma to be used in a clinical trial researching the treatment of critically ill premature babies suffering from hypotension. SCM Pharma is leading specialist in the global contract drug manufacturing market with its ability to provide cGMP sterile services for C-14 radiolabelling and potent products such as cytotoxics. The contract filling specialist offers aseptic processing and sterile manufacturing services and has specific expertise in ampoule filling and syringe filling of liquids, gels and powders. In 2011, it launched its formulation development capability after acquiring new facilities to provide developmental services for liquid formulations, including emulsions and suspensions for parenteral, oral and topical administration using either proprietary or customers’ novel delivery systems. SCM Pharma +44 1661 833 693 info@scmpharma.com www.scm-pharma.com

preclinical development phase to market launch. Vetter Commercial Manufacturing offers large-scale production and packaging with three manufacturing facilities and a state-ofthe-art secondary packaging site. Vetter Solutions develops patient-friendly proprietary innovations. The Vetter portfolio includes: • aseptic filling of syringes, cartridges and vials; • dual-chamber injection systems Vetter Lyo-Ject and V-LK; • anti-counterfeiting syringe closure systems V-OVS; • lyophilisation expertise; • and prefilled Water for Injection (WFI) syringes. Vetter Pharma International GmbH +49 751 3700 0 info@vetter-pharma.com www.vetter-pharma.com

Events CPhI Worldwide Returns to Frankfurt in 2013 after Record Breaking Year CPhI Worldwide, ICSE, P-MEC Europe and InnoPack had a record breaking year with 2,200 exhibitors and 29,920 attendees at the Messe Frankfurt in October 2011. Post show surveys attest to the event’s success, with 92% of exhibitors and 94% of visitors agreeing that the event is the key meeting place for the pharmaceutical industry. Organiser UBM has announced that the event will return to Frankfurt, Germany, on 22–24 October 2013. “We experienced a phenomenal response to the 2011 events and this has influenced our decision to return to Messe Frankfurt in 2013,” commented UBM Live Pharma Portfolio Director Greg Kerwin. “Frankfurt has traditionally been one of the most popular venues in the events’ 22-year history, not only as a result of it being located in one of Europe’s largest pharmaceutical hubs, but due to its international accessibility, quality and availability of accommodation, and the high standards of service offered by the venue.” This year the events will run on 9–11 October, at the Feria de Madrid in Madrid, Spain. CPhI Worldwide for pharmaceutical ingredients, ICSE for contract and outsourced services and logistics, P-MEC Europe for pharmaceutical technology and

machinery and InnoPack for pharmaceutical packaging together reportedly provide the world’s largest networking platform for the varied sectors of the pharmaceutical market. UBM Live +31 20 40 99 577 www.ubmlive.com

Strategy Optimisation to be Focus of Pharma Outsourcing and Procurement Summit Taking place on 21–22 May at the Hotel Palace Berlin, Germany, the Pharma Outsourcing & Procurement Summit is the must attend summit this year. Bringing together over 100 senior level industry professionals, attendees will discuss, learn and network about the latest pharmaceutical outsourcing strategies. The summit will focus on the urgent need for pharma to identify and locate the best outsourcing partnerships and solutions to stay competitive in an uncertain climate. Speakers will also address heightened regulatory pressures and the need to maintain high quality standards. Key speakers this year include: • Nick Welby, Procurement Director, AstraZeneca; • Jennifer Goodfellow, Senior Director & Global Head of Clinical Outsourcing, Sanofi Pasteur; • Vasco Marcal Grilo, Vice-President Global Pharma R&D Sourcing, Johnson & Johnson; • Ulrich Rümenapp, Head Biotech Projects, Bayer; • and Murillo Xavier, Strategic Development, Hewlett-Packard.

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The programme has been put together by recognised experts and practitioners from the life science industry and will cover: • Strategic Sourcing: Suppliers Are From Mars, Customers Are From Venus — Successfully applying strategic sourcing concepts to build profitable partnerships; • Clinical Outsourcing In Emerging Markets — Selecting and managing clinical partners in emerging countries; • Vendor Capability Assessments — Successfully selecting clinical outsourcing partners; • Risk Protection Strategies And Systems — Evaluating risk management strategies for long-term outsourcing plans; • and Successfully Utilising Spare Capacity — Understanding the advantages and disadvantages of insourcing. Confirm a place online today by going to www.outsourcingevent.com/MRK2. World Trade Group +44 20 7202 7690 michaela.melcher@wtgevents.com www.wtgevents.com

EPM CLASSIFIEDS CLEANROOMS EQUIPMENT & SERVICES CONTAINMENT

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

To advertise here, please contact Rob Anderton: Tel: +44 (0)1829 770037 Email: rob@rapidnews.com

INGREDIENTS

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Müller GmbH

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

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Transflow Industrial Services Limited 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

FURNITURE

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

COATING EQUIPMENT & SERVICES

Glatt GmbH

LABORATORY & R&D PRODUCTS AND SERVICES

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

Weiler Engineering Inc

ASSET SALES & AUCTIONEERS

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

Tel: +49 (0) 40 725 56 0 Email: info@fristam.de Web: www.fristam.de Peristaltic pumps accurately transfer fluid through a sterile and fully validated tube from source to delivery. Tel: +44 (0) 1326 370370 Email: info@wmpg.co.uk

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