EPM 12_5 Progress_Layout 1 24/07/2012 09:46 Page 1
www.epmmagazine.com
epm
IN THIS ISSUE: Tablet Compression Chromatography Coatings, Films & Capsules
European Pharmaceutical Manufacturer July/August 2012
Volume 12 | Issue 05
Front cover: Elizabeth is your global partner for precision compression tooling. With modern manufacturing and customer service centres in America, Europe and Asia: Elizabeth assures complete customer satisfaction anywhere in the world.
www.epmmagazine.com
epm head office Controlled Media, Unit 2, Chowley Court, Chowley Oak Lane, Tattenhall, Cheshire, CH3 9GA.
Tel. +44 (0)1829 770037 Fax. +44 (0)1829 770047 Web: www.epmmagazine.com
editorial editor elizabeth valero, ellie@rapidnews.com
in this issue
publishers mark blezard, michael taylor
production art samantha hamlyn production peter partley
advertising robert anderton tel: +44 (0) 1829 770037,
MANUFACTURING PRODUCTS & EQUIPMENT
pages 5–20
Equipment, IT solutions and supplies for all aspects of pilot- and full-scale pharmaceuticals manufacturing through to their packaging and anti-counterfeiting.
fax: +44 (0) 1829 770047, rob@rapidnews.com
subscriptions
REGULARS:
subscriptions tracey nicholls,
5–15 19–20
Latest News Roundup Corporate News & Events
tracey@rapidnews.com
SHOWCASES:
qualifying readers
16 17–18
Pumps Tablet Compression
Europe - Free, ROW - £115
outside qualifying criteria
LABORATORY PRODUCTS & EQUIPMENT
pages 21–26
UK - £80, ROW - £115
please subscribe online at
Equipment, IT solutions and supplies for preparation, analysis and storage of samples through to formulation and lab-scale manufacture of pre-clinical/early clinical phase pharmaceuticals.
www.epmmagazine.com
REGULARS: 21 26
Latest News Roundup Corporate News & Events
Address changes should be made on the original carrier sheet (address label) that came with this issue and then faxed to the publisher at +44 (0)1829 770047. European Pharmaceutical Manufacturer is published by Controlled Media Limited.
SHOWCASES: 24 25
Chromatography Luminescence, UV & Image Analysis
INGREDIENTS & CONTRACT SERVICES
pages 27–34
APIs, excipients and intermediates supply and drug development and manufacturing services — from clinical research and formulation through to commercial manufacturing, packaging and logistics.
REGULARS: Latest News Roundup Events
27–31 34
SHOWCASES: 32 33
Coatings, Films & Capsules Logistics & Distribution
page 35
CLASSIFIEDS EPM 3
European Pharmaceutical Manufacturer is distributed in electronic and print formats to a combined readership of 25,000 pharmaceutical manufacturing professionals. Send address changes to European Pharmaceutical Manufacturer, Unit 2, Chowley Court, Chowley Oak Lane, Tattenhall, Cheshire, CH3 9GA, UK. © August 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.
“
Rain, rain and yet more rain! Apologies, but as a Brit, I feel almost compelled to complain about our abysmal weather and so far disappointing summer. Anyway, rant over, so let us move on to the content of the July/August issue. Since my last ‘From the Editor’, the EPM team has attended ACHEMA 2012, returning with plenty of news on new developments and product unveilings — a number of which can be found highlighted in the product and equipment sections. Containment is a dominant theme in this issue’s Manufacturing section, which features two case studies 6 that focus on this increasingly important topic. The first, on page 6, has been supplied by Powder Systems and summarises its support of Helsinn Advanced Synthesis through the provision of several high containment solutions for the company’s new cytotoxic facility, which will begin producing anticancer molecules as of January 2013. Powder Systems has so far been commissioned to supply a clinical trial isolator, two 26 charging gloveboxes with slurry vessels and two FilterBoxes (pressure filter dryers). The second, on page 8, details Haupt Pharma Münster’s decision to install a Gebr. Lödige coater at its manufacturing facility for tablets containing sex hormones. The coater was selected on account of its partially perforated, cylindrical drum section, as this allows for non-exposure of the actual coating drum to the outside. The Laboratory section features a Q&A on pages 22-23, with Trish Meek, Director of Product Strategy for Life Sciences in Thermo Fisher Scientific’s Informatics division. Meek outlines the key 32 benefits of the business’s recently launched CONNECTS for The Paperless Lab, explaining how going paperless can result in a far more streamlined workflow that is significantly less prone to human error; the efficiency gains of which are not only realised by the laboratory researchers themselves, but also by staff at manufacturing and enterprise levels. In his Regulatory Affairs column on page 34, Dr. Biffignandi refers to “a new era in regulatory informatics” following the recent XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) compliance deadline. He forecasts that the IDMP (Identification of Medicinal Products) ISO standards, an ongoing project for many years now, will prove a useful model for manufacturers to follow in their international evolvement of the European XEVMPD. Also of special interest in the Ingredients section, and appearing in the Coatings, Films and Capsules Showcase on page 32, is a case study on GSK’s successful use of Capsugel’s liquid-filled hard capsules for an established brand in the urological market. According to GSK, Capsugel’s technology has proved to be leak-free and has reduced product lead times by an impressive 12 weeks. That just about sums up the highlights of this issue. Please continue to help us to help you by emailing me with any comments on or suggestions for EPM’s content — ellie@rapidnews.com. EPM 4
eab members
from the editor
Henrik Broholm, Senior Specialist, H. Lundbeck A/S Henrik has been working in the pharmaceutical industry for the last 15 years, mainly in connection with finished goods packaging (blisters, ampoules and containers). At H. Lundbeck, he has gained valuable experience of working at both vendor and customer sites, further extending his pharmaceutical packaging expertise. Henrik is for the most part involved with user requirement specifications, machinery and process qualification and validation, the introduction of new products on packaging lines, and incorporating new features as required by authorities, e.g., 2D matrix coding with track and trace and child resistant blisters and packs. James Cartwright, Global Granulation Leader, Particle Generation, Control & Engineering, GlaxoSmithKline James began working within the pharmaceutical industry in 1996. During this time, he has been instrumental in developing and launching three products for various clinical indications spanning acute Otitis Media, Lymphatic Filiarisis and Type II Diabetes Mellitus. James studied Chemistry and Chemical Engineering and is a Fellow of the Royal Society of Chemistry. Dr. Dimitris Dogramatzis, RPh, PhD Dimitris is a registered pharmacist and pharmacologist, whose industry career encompasses medical affairs, marketing, country and regional management positions. Dimitris has served as Regional VP — Northern Europe for SERONO and authored two textbooks entitled ‘Pharmaceutical Marketing: A Practical Guide’ (2001) and ‘Healthcare Biotechnology — A Practical Guide’ (2010). Dr. Dave Doughty, Director of 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. 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
Single-Use Bioreactor Reduces Risks and Times in Scaling from Benchtop Pilot to Production Xcellerex has introduced its XDR-10 single-use bioreactor for benchtop use. The XDR-10 allows smooth scale-up to full production and is ideal for GMP clinical and commercial manufacture of biotherapeutics, vaccines and other biologics. According to the company, the new system is the industry’s first and only bag-type single-use bioreactor, flexible enough to handle volumes from 4 to 10 l. It is available in single-, twin-, triplet- and quad-vessel configurations. The new bioreactor joins Xcellerex’s existing line of fully-integrated, fullycharacterised systems available with working volumes of 50, 200, 500, 1,000 and 2,000 l — and features the same fluid contact materials, fluid dynamics and control strategies. It also integrates with Xcellerex’s exceptional FlexFactory biomanufacturing platform. The XDR-10’s reliable, predictable results greatly reduce risks and times in scaling from benchtop pilot to production. Features and benefits include: • superior sparging flexibility for reportedly unmatched adaptability to the broadest range of cell lines; • a low shear, high input-power impeller provides gentle, efficient mixing for sensitive cells or media; • optimised impeller position maximises volume range and turndown ratio; • industrial-grade automation ensures
process performance and consistent data management; • and perfect for process development, small-scale production, seed train culture or process troubleshooting. The XDR-10 was designed with extensive customer input to execute the most critical biopharmaceutical tasks in a benchtop form factor. It can function as a production vessel in its own right or become a scale-down tool or satellite platform (with multiple-vessel configurations available) for larger projects to be continued in larger bioreactors. The XDR-10 handles the industry’s toughest challenges in process development — to perform as a smallscale production vessel and work as an ideal vehicle for seed-train culture. In any application, the XDR-10’s power and flexibility minimise the number of required runs to save time, work and costs. As are all XDR single-use bioreactors, the XDR-10 is an integral component of the Xcellerex FlexFactory modular biomanufacturing platform that leverages single-use technology and advanced process automation. The flexible platform enables biomanufacturers to
accelerate their deployment of new manufacturing capacity while lowering risk, decreasing time-to-market and reducing capital costs. The approach enables the deployment of new production facilities in nine to 18 months (versus three to five years for current technology) at a total cost of less than 50% of conventional plants. Xcellerex, Inc. +1 508 683 2200 webinquiry@xcellerex.com http://xcellerex.com/platform-xdr-10single-use-bioreactor.htm
Weigh Modules Simplify Installation and Engineering A common dilemma exists for machine and instrument manufacturers — many of their customers are on a budget, yet require customised solutions. Most manufacturers solve this problem by designing standardised modules used to build customised solutions. Mettler Toledo supports the manufacturer’s strategy of modularisation, providing both standardisation and flexibility. The product family offers capacities ranging from 120 to 6,200 g and resolutions between 0.1 mg and 0.01 g. The most highly performing model has a repeatable readability of 1 mg over the entire weighing range of 1,200 g. This allows weighing of small and large items and enables permanent installation of adapters on top of the weighing platform. Mettler Toledo weigh modules’ slim
and compact design facilitates installation in tight spaces. A patented snap closure locks the weighing platform to the module. This allows fast replacement when changing formats or fast removal for cleaning. The weigh module is available with or without builtin calibration weight. With this calibration device, accuracy can be checked and
EPM 5
adjusted automatically or on demand without the need for removal of customised adapters. It is easy to set up communication between WMS weigh modules and industrial computers or PLC systems. Thanks to programme function blocks for PLC or automatic parameter recognition, it takes little effort to set up communication via standardised interfaces such as RS232/422, Profibus DP, Profinet, DeviceNet, EtherNet/IP and CC-Link. Readers can watch a short video about weigh module installation at www.mt.com/ind-eoi. Mettler Toledo +41 44 944 25 68 eugen.schibli@mt.com www.mt.com/wmc
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP CASE STUDY Helsinn Advanced Synthesis SA (HAS), located in Biasca, Switzerland, is the chemical manufacturing business unit of the Helsinn Group. To meet the demand for anticancer molecules, HAS is in the process of building a cytotoxic facility. The facility will be dedicated to cytotoxic compounds that require safe product handling in a contained area for operator, environment and product protection. Powder
FILTRATION AND DRYING SPECIALIST SUPPORTS HELSINN ADVANCED SYNTHESIS’ EXPANSION INTO CYTOTOXIC MARKET WITH HIGH CONTAINMENT FILTER DRYER
Systems Ltd (PSL) worked closely with Helsinn to develop suitable solutions for its cytotoxic facility and is providing a suite of high containment systems, including contained Agitated Nutsche Filter Dryers (ANFDs). Helsinn’s cytotoxic facility comprises a smallscale GMP area for the production of reduced quantities of cytotoxic APIs for clinical and registration purposes that will be available in June. PSL will install a clinical trial isolator in this smallscale GMP area. Numerous operations will be processed inside the high containment isolator, including small-scale reactor charging, reaction with glass reactor of 20 l or hydrogenation, filtration, drying, dispensing and packing with an OEL of less than 50 ng/m3 in eight hours TWA. The cytotoxic plant is due to open two further production areas in January 2013. PSL will provide two charging gloveboxes with slurry vessels and two FilterBoxes (Hastelloy pressure filter dryers with high containment). According to PSL, the FilterBox is the optimum contained filtration and drying solution for handling cytotoxic compounds, allowing the following operations to be performed in one unit within a completely contained environment: filtration and drying; contained sampling;
discharging, dispensing and packing; safe and contained base opening and washing; and filter mesh inspection and changing. The FilterBox consists of PSL’s laboratory to production filter dryer (0.002 to 0.3 m2) surrounded by a high containment glovebox isolator for an exceptional containment solution. The two FilterBoxes to be installed in Biasca will have a filtration area of 0.125 and 0.3 m2. PSL’s filter dryers are specifically designed for handling potent and cytotoxic products and comprise numerous design features for high performance, including PSL’s minimum volume clamp base design, PSL’s tapered filter plate for optimum seal, full heating jacket to maximise heat transfer, onepiece agitator equipped with omega wave bellows and more. Even with the efficient CIP and reflux cleaning systems incorporated into PSL’s filter dryer, HAS required higher containment with an OEL test result of <50 ng/m3 during the sampling period for its cytotoxic facility 3b category. Due to the characteristics of the products, it was crucial that staff could open the vessel base completely and manually clean some critical areas in a contained manner. With the FilterBox, the cleaning procedure can be performed safely and thoroughly as the complete vessel base, filtration media and discharge plug can be accessed in a completely contained environment. Powder Systems Ltd +44 151 448 7700 sales@powdersystems.com www.powdersystems.com
Packaging Provider Acquires Folder Gluer with In-Line Braille Unit According to Falconer Print & Packaging, it is the first company in the UK to install a Diana X folder gluer with an in-line Braille unit. This investment fits the company’s ethos of providing high quality packaging in as cost-effective a manner as possible to meet the demands of its pharmaceutical customers. Falconer’s Diana X incorporates a Leary Braille scanner that checks the accuracy of every carton going through it, which is highly advantageous when running at optimum speeds. A screen readout of the Braille enables operators to perform a visual check to confirm the Braille and any rejected cartons are ejected from the finishing line without interrupting production. The glue line detection and barcode reader further reduces the possibility of rogue carton contamination and machine downtime. MD Hadyn Bradbury commented: “We pride ourselves on being able to provide the very high print quality associated with cosmetic, giftware and healthcare
packaging production, but the Diana X is a state-of-the-art in-line solution for our pharmaceutical customers.” In future, all of the company’s primary customer market sectors — in addition to the pharmaceutical market — could be required to comply with European legislation to meet the needs of the partially sighted. The Diana X puts Falconer in prime position to be proactive in responding to these needs. The machine setup is precise too — the Braille unit is situated immediately after the alignment station to ensure exact positioning. It uses the malefemale method with an etched plate to create the Braille dots. The flexibility of the system enables it to emboss on any panel and on any size of carton with multiple lines of information. Falconer advises that the German machine was chosen for its robust build quality and value for money, with the length of the machine also offering more options in terms of carton design. Plant visits can be arranged by
appointment. A number of customers have already been to see the setup and Commercial Director John Sherwood is happy to organise an appointment for anyone interested in a future visit or audit.
Falconer Print & Packaging Ltd +44 1422 373377 john@falconerprint.co.uk www.falconerprint.co.uk/dianax
Pharma Company Invests in Mobile Reactors for R&D Facility Pfaudler has installed two 250 l mobile reactors for an R&D facility at a leading pharmaceutical plant in the UK. The glass-lined carbon steel reactors, which have been designed for enhanced performance, with optimum heat exchange area ratio to process volume, are being utilised for multi-purpose duties, including solvents, acids and alkalis.
Suitable for low-level, general purpose mixing, baffling, baffle temperature control and sampling, these small-scale Pfaudler reactors are ideal for customised head layouts and also maximise the quantity of nozzles at normal bore sizes, appropriate to the vessel diameter. Gasket and top-head fouling is avoided, with rated volume within the jacket area and below the
gasket. The reactors also benefit from low-level baffling, mixing, temperature measurement and sampling. For scale-up capabilities, from laboratory to industrial-sized plant, Pfaudler has also proportionally optimised the agitators and incorporated flanged beavertail baffles, top-head nozzles, charge holes and outlets accordingly. Pfaudler’s easy access
EPM 6
charge port allows improved visibility of processes, whilst maximised nozzle diameters are included for instrumentation to show parameters such as levels and pH. Pfaudler-Balfour Ltd +44 1333 423020 sales@pfaudlerbalfour.co.uk www.pfaudler.de
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP CASE STUDY The pharmaceutical industry often has to deal with highly potent substances such as sex hormones, which require special equipment and machines in order to avoid contamination of employees, the environment and the product. This is the case at Haupt Pharma Münster GmbH, where products containing sex hormones are developed and produced in the form of film- and sugar-coated tablets. For the newly constructed production department, which consistently observes the closed- and high-containment principle, Lödige has developed a coating solution to mesh seamlessly with this concept. The key requirements to be met by the new system were firstly, safe processing of substances with OEB Level 4, and secondly, as a prerequisite US market production, the coating system had to conform to the regulation 21 CFR Part 11 issued by the FDA. The decision was taken in favour of Lödige’s Type LHC 190 coater with a partially perforated
HAUPT PHARMA MÜNSTER REPORTS ON SUCCESSFUL INSTALLATION OF COATING SYSTEM FOR PRODUCTION OF HORMONE PREPARATIONS
drum. Besides its compact design, the main feature of this coater type is the horizontal coating drum, which has four exchangeable perforations. Only about 25% of the cylindrical drum section is perforated; the coating drum itself is closed to the outside. This was a major prerequisite for use within the high-containment system. Several modifications of the coater were made to enable perfect integration. For example, Lödige designed the seals especially for the highcontainment OEB Level 4. The coater is loaded with tablets for coating from barrels through a containment flap and feeder. After feeding, the dust is removed from the inside front part of the coater by a special, compressed air blower and the particles are suctioned off. This pneumatic dedusting is repeated prior to emptying the coater to avoid carrying out product dust upon discharge. During the coating process, as during feeding and discharge, there is a vacuum in the coating drum to prevent the emission of product dust and therefore contamination of the operating personnel or surroundings. A filter bypass for the exhaust air filter was dispensed with for containment reasons. Emission of product dust is therefore impossible. Following the successful commissioning of the modified LHC 190 coater, it has fulfilled all expectations and shown that the highest OEB
Level 4 is constantly upheld. A second system of the same type has been ordered to accommodate an extension of production at the site. Gebr. Lödige Maschinenbau GmbH +49 5251 309 0 info@loedige.de www.loedige.de
Extractables Test Results for Silicone and TPE Tubing Help End Users Select Products
Latest Version of Integrated Production Control System Optimises Plant Operations
AdvantaPure now offers one of the most comprehensive portfolios of extractables testing for silicone and TPE (thermoplastic elastomer) tubing in the pharmaceutical and clean application industries. The company conducted the tests to address customer needs and to assure potential end users that its products meet or exceed stringent requirements. AdvantaPure’s tubing is used primarily for fluid flow and is available as single-use moulded manifold assemblies, bulk coil lengths and assembled with sanitary fittings. Although there are no regulations naming tests that must be carried out, AdvantaPure chose to conduct analytical extractables testing in order to help end users evaluate their products with as much information as possible. Extractables — substances that can be drawn out of a product under extreme conditions — must be known long before a section of tubing can be used in a pharmaceutical or biopharmaceutical manufacturing process. Testing is costly, but necessary to demonstrate a supplier’s commitment to its customers and the purity of its products. “We’re covering a lot of bases with our tests,” noted John Stover, AdvantaPure’s Director of New Business Development and Product Technical Director. “Customers who view our test portfolios are impressed with the level we’ve gone to and that substantiates our credibility and reliability as a supplier. Our testing was done with forethought and a
A shift towards larger and more efficient industrial plants that make use of highly functional systems and devices has meant that processes are growing more complex. To meet the resulting new demands, Yokogawa has announced the latest version of its integrated production control system CENTUM VP — the cornerstone of the company’s VigilantPlant business concept for operational excellence, which is used throughout the world for process control and monitoring in the pharmaceutical industry. To give plant control managers better access to essential information, Release 5.02 offers new functions that improve the operability of the control and monitoring displays. In addition, the PROFIBUS communication function has been enhanced to ensure plant operations are optimised by making full and effective use of digital information exchanged between intelligent field devices and the CENTUM VP system. The latest software release provides operators with even quicker and easier access to information on the status of plant operations, made possible by the Yokogawa design team enabling the creation of hierarchies through an instrument tag name function. Additional changes that improve operational and maintenance efficiency include more memory for the storage of historical data, improved graphic display operability, enhanced control logic correlation and standardised printing formats. Thanks to these new functions, Yokogawa’s CENTUM VP integrated production control system addresses the
chemistry approach that relates to the end users’ conditions.” AdvantaPure tests its tubing and reinforced hose manufactured from Class VI, platinum-cured silicone, its platinum-cured liquid injection moulded silicone and its AdvantaFlex biopharmaceutical-grade TPE tubing. Products are tested after autoclave sterilisation and gamma irradiation. Testing includes some of the fluids that AdvantaPure’s customers use in their manufacturing processes to better approximate actual conditions. Tests are conducted by outside laboratories and include those for endotoxins, particulate, pH and polarity. Test results are available by request through the company’s website or via phone. Customers may order a summary or a comprehensive report that shows chemical, analytical bracketing of various test parameters. Both are complimentary and available on CDROM or as PDF files. AdvantaPure +1 215 526 2151 sales@advantapure.com www.advantapure.com/validationrequest.htm
EPM 8
requirements of the VGB R 170C operational guideline. This means that the growing power plant markets in Europe can take full advantage of this sophisticated plant control system. Ever mindful of the need to conform with industry standards, this new update includes the ALP121 module, which complies with the PROFIBUS communication standard that has been widely adopted by the chemical and other industries, primarily in Europe. As specified in PROFIBUS User Organisation guidelines, the ALP121 module supports the use of redundant communication paths with subsystems, improving overall system reliability. The installation of additional devices and online parameter changes are also enabled, which makes it easier to maintain devices and operate a plant. With CENTUM VP as its core platform, Yokogawa continues to develop a variety of production control systems. As called for in the Evolution 2015 mid-term business plan, Yokogawa is strengthening its offering of comprehensive solutions to target markets. Yokogawa UK Ltd +44 1628 535640 louise.mungrue@uk.yokogawa.com www.yokogawa.com/uk
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Labeller Performs Multiple Labelling and Outserting Tasks NJM Packaging has introduced a highspeed, in-line pressure sensitive labeller that is ideal for solid dose pharmaceuticals. Model 426 AUTOCOLT labels square, rectangular and round bottles at speeds up to 300 containers per minute, applying wraparound or three panel labels and optional sideand/or top-serts. It provides accurate, high-speed labelling and the ability to handle multiple labelling and outserting tasks. Using the new servo Oscillating Pressure Station (OPS), the 426 AUTOCOLT applies three panel labels and a side-sert at higher speeds than traditional in-line pressure sensitive
labellers, which allows it to compete with rotary labellers. Compared with complex rotary labellers, the in-line 426 AUTOCOLT offers faster changeovers with fewer change parts, along with a much smaller footprint and lower capital cost. NJM can equip the 426 AUTOCOLT with a wide variety of options, including glue sidesert and/or top-sert
applicators, continuous thermal transfer printing from Videojet Technologies and OCV/OCR vision inspection from Optel Vision. NJM outsert applicators allow customers to apply thicker outserts. Each outsert applicator can be equipped with an automated magazine feeder to increase the run time between reloading. The thermal transfer printer can print lot codes, expiration dates, barcodes and other variable and fixed data to the pre-printed pressure sensitive labels. Vision systems inspect the label web as well as labelled containers and trigger a no-feed response to the outserter to track and reject the container without dispensing and applying an outsert when faults are identified. This state-of-the-art labeller easily accommodates RFID tagging and is ready for integration with trackand-trace serialisation systems. Ethernet connectivity enables the labeller to
Process Monitoring Software Enables Easier Validation and Reporting of Wireless Data-Logger Data Cherwell Laboratories has introduced DataTrace Pro (DT Pro) integrated software for use with DataTrace wireless data-loggers for critical manufacturing and validation applications. DT Pro offers users greater insight and productivity through the simple creation of process reports to enable analysis and understanding of data whilst complying with regulatory requirements. DT Pro software is equipped with time-saving features such as shortcuts to minimise key strokes, intuitive screens and batch functions. New reporting capabilities allow for simplified and customised reporting where field calibrations, logger battery changes and data logging events are automatically incorporated into the audit trail. DT Pro also offers improved password protection and administrative security options, such as electronic signatures and data encryption to ensure 21 CFR Part 11 or GxP compliance. “The DataTrace Pro software is specifically designed to make our customers’ validation and process reporting easier,” said Andrew Barrow, Sales Manager at Cherwell Laboratories. “It offers greater efficiency by enabling easy data collection and analysis with clear presentation.” Cherwell Laboratories supplies the complete DataTrace range of fully
patented, high-precision data logging systems. Since no wiring is required, they can be used to measure temperature, humidity and pressure directly inside a process or a product during manufacturing with minimal production downtime. DataTrace wireless data loggers are rated as intrinsically safe and can operate over a wide temperature range. From chilling, freezing and room temperature to pasteurisation, EtO or steam sterilisation and depyrogenation, DataTrace data loggers provide highly accurate data with remarkable ease. For more information on DataTrace wireless data-loggers and DT Pro software, please visit the website or follow @CherwellLabs. Cherwell Laboratories +44 1869 355500 andrew.barrow@cherwell-labs.co.uk www.cherwell-labs.co.uk EPM 9
communicate with external line monitoring systems. The 426 AUTOCOLT handles containers from 2.5 to 22.8 cm in height and from 2.5 to 12.7 cm in diameter. Changing over the labeller to handle a new container size and shape and achieve a new label configuration takes less than 25 minutes, with no tools required. The standalone electrical box provides easy access for maintenance and minimises the footprint of the machine. The compact 426 AUTOCOLT accomplishes multiple labelling and outserting tasks within a space only 6.4 and 3.4 m. To help achieve high line speeds, an all-new servo free loop vacuum box system allows continuous motion thermal transfer printing to sync with the intermittent label application function. Featuring Rockwell Automation Kinetix servos and a Rockwell Automation ControlLogix PLC, all motion control for the main operations are provided by servo technology, which maximises the reliability and accuracy of the system. Wrap and panel labels are applied within a tolerance of ± 1 mm and outserts are placed within a ± 1.5 mm tolerance. NJM Packaging +1 603 448 0300 marlastallmann@njmpackaging.com www.njmpackaging.com
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Sustainable Films Range for PSA Labels to be Presented at Labelexpo
Clarifoil will be showing its range of cellulose acetate films for Pressure Sensitive Adhesive (PSA) labels at this year’s Labelexpo, in Chicago, US, on 11–13 September, Stand 1550. They are produced from sustainably sourced wood pulp and are biodegradable and home compostable according to EN13432 and ASTM 6400. At the same time, there is no compromise to aesthetics. The films have excellent transparency with low haze that will not distort print or images. The latest addition to the product range is Clareflect, a biodegradable metallised film in 50 µm, with a mirror-like finish. Also showing is Integuard, Clarifoil’s destructible film for tamper evident labels and seals. Its specifically designed formulation delivers high tensile strength and high stiffness to overcome the difficulties of matrix stripping and high-speed applications associated with other tamper evident films. Once adhesive-coated and applied, it fragments into tiny pieces upon attempt of removal. Available in ultra clear and white, it is an excellent choice for transparent security labels and, as tamper slits are not needed, there is greater flexibility in label design. According to Clarifoil, it is the only manufacturer of tamper evident cellulose diacetate films and therefore controls distribution of the product. Being a safety measure in itself, the film can be combined with other customised ingredients and additives. The result is a reportedly unique film that opens up new options for brand owners to design an anti-counterfeit packaging solution. Clarifoil supplies exceptional quality packaging materials that meet the environmental demands of the food, cosmetic and pharmaceutical industries. Clarifoil +44 1332 681835 www.clarifoil.com
Process Ball Valve Features Bolted Construction For Installation Security A high integrity ball valve that combines a forged body with a bolted construction to ensure installation security has been launched by the instrumentation products division of Parker Hannifin. Designed for use with liquid or gas, the valve is suitable for diverse process isolation applications across a broad range of industries, including chemical, petrochemical, biotechnology and pharmaceutical manufacturing. The process ball valve uses the same technology as Parker’s renowned Hi-Pro range of ball valves to maximise performance and reliability. It is available with a wide range of bore sizes, from 0.5 to 2 ", and a choice of tube connection schemes, including welded and NPT (National Pipe Thread) male and female fittings. The valve is manufactured from just three principal components — the body, end plate and insert — eliminating a potential leakage path. Parker’s valve employs a two-piece body construction, with the end plate secured by four bolts; this ensures that the body cannot be unscrewed accidentally when connecting or disconnecting threaded fittings on the valve or adjacent components. The design also simplifies installation by minimising the risk of damage being caused by over-tightening when fitting connections.
The valve is fully bidirectional and is actuated by a 90° turn for fast on/off action. The operating handle features a spring-loaded detent mechanism to provide positive positioning with tactile operator feedback and is fitted with an ergonomicallydesigned protective sleeve to facilitate operation. An integral locking nut enables a padlock to be fitted to prevent unauthorised operation. The valve mechanism utilises the floating ball principle and provides 100% bubble tight shutoff. The valve is fabricated from duplex stainless steel, with super-duplex available as an option, and is offered in NACE (corrosion) and HCT (heat code traceable) versions. As standard, the valves feature PTFE (polytetrafluoroethylene) packing and a PTFE valve seat. PEEK (polyetherketone) valve seat material is available as an option and allows operation over a temperature range of -54 to 232°C. Parker’s process ball valve is
additionally firesafe to API 607 and BS6755 Part 2, and is available in 800 and 2000 Class versions, suitable for operating pressures up to 6,000 psi (414 bar). Parker Hannifin, Instrumentation Products Division Europe +44 1271 313131 ipd@parker.com www.parker.com
In-Process Metal Detection System Secures API Integrity At ACHEMA, Lock Inspection launched the INSIGHT PH Gravity Fall metal detection system to empower pharmaceutical manufacturers seeking to achieve product integrity during the production process. This new inprocess system does not negate the need for end-of-line product inspection, which remains a Critical Control Point (CCP) for pharmaceutical manufacturers, but enables customers to develop a leaner, more efficient and profitable business by reducing product waste and manufacturing downtime earlier in the production process. The evolution of the new INSIGHT PH Gravity Fall system, which inspects raw materials in powder or granular form for contaminants at a flow rate of up to 3000 kg/hr prior to the tabletting process, anticipates a new market trend, which Lock is expecting to see increase at a furious pace. Having independent manufacturing sites handle production of APIs and the finished tablet is an increasingly popular business model, resulting from lean manufacturing strategies and the drive to increase profitability. It does however increase the risk of product contamination due to the numerous parties that handle the product throughout the process. Lock’s in-process INSIGHT PH Gravity Fall system, which can be used both to review the API leaving one site and then again when it enters the next stage of the process at the tabletting site, has been specifically developed to deliver the assurance of product integrity to the growing number of manufacturers that have adopted this fragmented supply chain model. Not only is the inspection of materials before tabletting/packing increasingly important to maintain product integrity, it
also protects expensive machinery components, such as tablet press tooling, from damage by foreign objects hidden in the ingredients. The INSIGHT PH Gravity Fall machine delivers exceptional sensitivity levels; contaminated material is automatically removed using a fully integrated sealed flap or cowbell type reject, and Lock’s innovative OPTIX detector management software and Direct Digital Signal (DDS) creates vector diagrams to help manufacturers achieve quick automated product set-ups and a high level of traceability. The fully validatable system, with four level protected security, is constructed and designed to comply with 21 CFR Parts 210 and 211, and includes a comprehensive range of communication options to enable users to extract and report inspection data in a variety of ways, including a USB portal, via wired or wireless ethernet, or directly
EPM 10
feed data into the onsite SCADA system for monitoring purposes as required by the FDA. Lock Inspection +44 161 624 0333 staylor@lockinspection.co.uk www.lockinspection.com
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Plunger Rod and Backstop Insertion Machine Monitors Rotational Torque Applied to Syringes
Grade A Black Ink for Thermal Ink Jet Guarantees Endurance of Pharma Industry Rigours
Bausch Advanced Technology Group possesses over 35 years experience in supplying machinery dedicated to the pharmaceutical industry, ranging from small batch processing to full packaging lines. The company is currently demonstrating its engineering expertise with its new plunger rod insertion machine Type 515. The syringes are manually fed into an infeed chute, which transfers them to the main transport system — an automated transport starwheel. The starwheel moves the product through four different stations, helping assemble up to 60 syringes per minute. Plunger rods are supplied from a vibratory sorting bowl and travel down a feed track to the insertion station. A pneumatically-actuated gripper assembly picks up the plunger rod from the end of the vibratory track and leverages a two-axis robotic arm to thread it into a syringe. At the second station, backstops are carefully placed on the flange of each syringe. The third and fourth stations check for plunger rod and backstop presence. The key differentiator of the machine is its ability to monitor the rotational torque applied to the syringe. When the plunger and the rod are fully assembled, the
Domino Printing Sciences has received top marks in independent tests on its latest water-based BK651 black ink for Thermal Ink Jet (TIJ) applications, which was developed specifically to withstand the rigours of the pharmaceutical market. Domino’s BK651 black ink has been awarded a grade A through to Blue Wool 4 during independent testing and evaluations on printed samples of the ink to establish its performance and light-fastness, undertaken by international packaging, paper and print industry specialist PIRA International. Samples of 2D data matrix codes printed by Domino's BK651 ink were tested against samples produced using other market leading inks to assess fading characteristics. These samples were incrementally exposed to a filtered Xenon arc light source to Blue Wool 5 in compliance with ISO 105-B02. This is considered to represent the worst case lighting that is likely to occur in a retail environment. After each exposure, the legibility of the data matrix code was assessed and a measurement of the colour difference was taken relative to unexposed print samples. The results concluded that of the samples provided to PIRA, Domino’s BK651 water-based black ink maintained a grade A through to Blue Wool 4 and softened to a grade B at Blue Wool 5. This was compared with the ink from a leading competitor, of which the samples supplied achieved consistently lower results by attaining a grade B throughout
servomotor spinning the disk detects an increase in torque and stops both the rotational and z-axis motors simultaneously. In the event that the torque limiting value is not reached, the process aborts. This potentially defective part is tagged and automatically discharged to the reject station. Bausch Advanced Technologies, Inc. +1 860 669 7380 tth@bausch-group.com www.bausch-group.com
Single-Use Systems Portfolio Features in Microfiltration Specialist’s Capabilities Brochure Meissner has released a new capabilities brochure featuring fluid handling and management solutions delivered by the One-Touch single-use systems portfolio. This eight-page brochure delivers the foundation upon which the portfolio was built — exceptional quality, operational excellence and technical expertise. The brochure gives an overview of each of the primary products within the single-use portfolio, including TepoFlex PE and FluoroFlex PVDF biocontainer assemblies. Complementary products, such as FlexStation rigid outer containers, which provide robust shipping and storage solutions for fully deployed 3D biocontainers, are also covered. BioFlex tubing assemblies, which maximise process flexibility in the deployment of both single-use and hybrid systems, are highlighted. The brochure discusses the extensive documentation available for the OneTouch single-use systems portfolio. This includes biocontainer assembly standards guides, which feature best
practice designs for the most common liquid management applications, and product qualification guides, which provide a level of documentation that is reportedly unmatched in industry and is intended to fast track process qualification and validation efforts of Meissner’s clients. The new One-Touch single-use systems capabilities brochure can be downloaded at www.meissner.com/onetouch. Print copies can be requested by selecting the Literature menu tab. Meissner Filtration Products, Inc. +1 805 388 9911 www.meissner.com EPM 11
and a significantly lower grade D for the final Blue Wool exposure. Typically, packaged medicines and healthcare products within the pharmaceutical industry have to withstand significant wear from being stored in distribution hubs for periods of anything between five and 24 months or being subjected to the stresses of global transportation. At the end of these processes, it is vital that the product codes are still readable and confirm to the top quality Grade A for light fastness. Domino Printing Sciences +44 1954 782551 craig.stobie@domino-uk.com www.domino-printing.com
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP ERP Solution Earns Certified for Microsoft Dynamics Distinction New Strategies has announced reportedly groundbreaking technology for pharmaceutical organisations. AX for Pharma, a complete ERP solution built on Microsoft Dynamics AX and tailored to vertical industry needs, has achieved Certified for Microsoft Dynamics status. This distinction means that the solution has met Microsoft Corporation’s highest standard for partner-developed software. AX for Pharma brings together industry and software development expertise to give companies the rich functionality found in Tier 1 industry ERP systems, at a fraction of the cost and implementation effort. Building on the unified foundation of Microsoft Dynamics AX and Microsoft technologies, AX for Pharma also delivers the flexibility, integration and ease of use that make Dynamics AX a world leader in business management systems. By successfully meeting all certification requirements, AX for Pharma can now carry the Certified for Microsoft Dynamics logo, showing that the solution has demonstrated development quality and compatibility with Microsoft Dynamics AX. Certification involves passing rigorous software testing for
Microsoft Dynamics performed by VeriTest (a service of Lionbridge) and other requirements. Pharmaceutical and life sciences companies face challenges that go well beyond standard ERP — complex operations, advanced project and quality management, compliance with stringent regulatory and research requirements, and much more. With AX for Pharma, New Strategies has enhanced robust, role-tailored ERP and basic manufacturing capabilities in Microsoft Dynamics AX, then added functionality that meets highly specialised requirements. A modular design gives companies the freedom to work from the start with a complete system or selected modules. Built for rapid implementation and minimal customisation, AX for Pharma enables enterprise and mid-sized companies to: • enhance Microsoft Dynamics AX with industry-specific capabilities and modules that include MES/Dispensing, Advanced Quality Management and Enterprise Asset Management applications; • achieve full compliance with international guidelines and regulations,
and drive consistent compliance by enforcing GMP guidelines, 21 CFR Part 11 and FDA regulations; • integrate advanced quality management functionality, comparable with LIMS; • integrating non-conformances management and activity-based product costing;
Wet Mill Dramatically Improves API Milling Capabilities Size reduction or milling of APIs is a key step in the drug development process. When milling an API, the developer requires a tight particle size distribution that ensures consistent drug substance and drug product quality. Traditionally, dry milling technologies, such as media mills and jet mills, have been employed, but have come under increased scrutiny due to yield losses, costs associated with containment and at times, detrimental impact on physical properties, such as the creation of amorphous material and surface defects. Wet milling offers a solution to some of these challenges; however, traditional rotor/stator technologies’ lower particle size limit is often a mean volume (mV) particle size of 30 µm. As a result, wet milling has typically been performed by piston homogenisers, high pressure valve homogenisers and media mills that are restricted by low capacities, high energy consumption and frequent maintenance requirements.
To overcome these restrictions, Quadro has developed the Quadro Ytron HV-Emulsifier. The Quadro Ytron HV is an in-line emulsifier and wet mill in one and offers more than 55 times the high shear energy of conventional rotorstator systems, with precise process scaling from laboratory formulation to pilot and production processing. In independent tests across multiple compounds having a wide range of starting particle sizes, morphologies and mechanical properties, the Quadro Ytron HV produced 60% smaller particles than other conventional wet mills. Several of the compounds tested were found to mill down to a mV of 10–15 µm, compared with 28–35 µm with traditional wet mills. Other pharmaceutical applications for the Quadro Ytron HV-Emulsifier include the development of submicron emulsions (high shear homogenising
with a droplet size = 0.2–1 µm), drug suspensions (high shear wet milling with a particle size = 1–10 µm) and topical formulations and semi-solids (droplet/particle size = 0.4–3 µm). The HV-Series features three different models ranging from 7.5 to 60 HP, with capacities ranging from 1 l/min up to 285 l/min. According to Quadro, all models utilise energy optimised tooling that operates at very high tip speeds up to 70 m/s with the lowest power consumption in the industry. The HV is designed with a sanitary, high-speed mechanical seal that eliminates potential trap areas around the rotor shaft for improved CIP/SIP results and can be customised for easy integration. Quadro Engineering Corp. +1 519 884 9660 quadrosales@idexcorp.com www.quadroytron.com
• and ensure project and quality success with GxP-compliant development, manufacturing, inventory, plant maintenance and supply chain management capabilities. New Strategies info@axforpharma.com www.axforpharma.com
Improved Product Grade Heat Transfer Fluid Demonstrates High Performance Corrosion Protection
The Dow Chemical Company launched DOWCAL 100 at ACHEMA, the newest iteration of its inhibited glycol-based line of heat transfer fluids. DOWCAL 100 is an ethylene glycolbased heat transfer fluid, ideal for use in pharmaceutical and many other ventilation and cooling systems, in addition to heat recovery applications, including applications that require corrosion protection at lower concentrations of glycol. The formulation of this version of DOWCAL has improved performance and corrosion protection and can last more than 20 years in properly maintained systems. In fact, it is suitable for use at a minimum of 20% concentration for high and low temperatures. It also has hard water stability, thus enabling its use with local water supplies. Furthermore, the products inhibitor package does not contain amine, nitrite and phosphate, which is in line with Dow’s sustainability goals for 2015. DOWCAL 100 will be available in Europe, the Middle East, India and Africa starting in August.
The Dow Chemical Company +1 989 638 9132 cmyers2@dow.com www.dow.com/heattrans EPM 12
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP MES Solution Brings Improved Time to Results to Life Sciences Industry Rockwell Automation has launched its latest release of Rockwell Software PharmaSuite, version 4.0, the next generation of MES software specifically targeting regulated industries. Leveraging more than 20 years of experience in pharmaceutical manufacturing, Rockwell Software PharmaSuite enhancements reportedly set a new standard for lower risk, lower cost and time to results, while meeting the regulatory requirements found in the life sciences industry. “The enhancements to Rockwell Software PharmaSuite reinforce our commitment to the life sciences industry,” said John Genovesi, VP, Information Software and Process Business, Rockwell Automation. “The new version offers significant performance, usability and deployment advantages, enabling our customers to reduce cost of compliance and improve their manufacturing capabilities.” Rockwell Software PharmaSuite contains a comprehensive set of functions that address the most common applications, such as dispensing, quality and electronic batch recording. The software suite allows regulated manufacturers to meet their operational goals and productivity requirements in a consistent and predictable way. The software tracks material, equipment and personnel involved in the manufacturing
process and maintains a complete electronic batch record. Rockwell Software PharmaSuite is based on S88 and S95 standards, which allow for better integration with other enterprise systems involved in manufacturing operations. The software suite is built on the FactoryTalk ProductionCentre platform, proven in multiple installations across different
Mixer Offers Continuous Fine Layer Coating of Particles
For fine layer coating of individual particles, the intensive, continuous mixing action of the Hosokawa Turbulizer makes it one of the most successful units on the market. If the customer’s requirement is for efficient dispersion of a small quantity of material into a larger bulk for thin layer coating of individual particles then the Turbulizer is ideal. The high efficiency mixer is proven in coating applications for taste masking, improved flow characteristics, the protection of core particles and controlled release effect or controlled dissolving time. The fine coating of a chemical or a mineral with a 0.5 to 3% melt, where the primary particle size is in the range of a few microns, for example, is typically achieved using a powdery melt. The base product, as well as the powdery melt, are gravimetrically fed at room temperature to the product inlet. The powders are blended into a homogeneous mixture within the Hosokawa Turbulizer. The jacketed vessel heats the powdery melt up to slightly above its melting temperature; jacket temperatures up to 320°C are achieved with hot oil for this application,
Rockwell Automation Ltd +44 870 242 5004 ukmarketing@ra.rockwell.com www.rockwell.com
Next-Generation Sterilising Grade Filters Increase Product Yield and Improve Manufacturing Workflow
although steam at 16 bar(g) can also be used. Product residence time is only approximately five seconds, during which the base product is coated with the melt. Product discharge temperatures are typically 65°C for this type of application. The Hosokawa Turbulizer offers effective fine layer coating and dispersing of liquids on solids on a wide range of products, as well as heating and cooling of powdery products, continuous reacting of gasses with powders and fine agglomeration. The Turbulizer is also extremely efficient in solids-solids mixing. The flexibility in operation of this high speed paddle mixer delivers rapid, 1–40 second lump free mixing and low energy usage as only a small amount of product is actually being mixed at any one time. The unit is available in a range of sizes and is used in the food, chemical, mineral and pharmaceutical industries. Hosokawa Micron Ltd +44 1928 755100 info@hmluk.hosokawa.com www.hosokawa.co.uk
industries and scales of deployments. It leverages a service-oriented architecture for cost-effective, flexible deployment and integration with business and automation systems. Its object-oriented design makes it simple and quick to build and modify applications, and systematically deploy them across multiple sites. Janice Abel, Principal Consultant for
ARC Advisory Group, commented: “Rockwell Software PharmaSuite offers a comprehensive solution for the supply chain and manufacturing that can be used for collaboration and integration to enforce quality and compliance, reduce costs and increase efficiencies in the life sciences industries.” “From the very beginning of PharmaSuite development, we embarked on a path of relentless innovation in pursuit of time to results for every user. With every new release, we broke limitations in performance, usability and deployment time previously known in life sciences manufacturing execution systems. Release 4.0 takes this tradition even further with the introduction of Intelligent Migration and Modeling Support in recipe authoring, and extensive enhancements in performance and content extension capabilities,” said Vladimir Preysman, Chief Software Strategist, Rockwell Automation. “We are especially proud of our Intelligent Migration, which allows customers in regulated industries to adopt our technology innovations while minimising cost of validation and disruption to operations.”
Sartorius Stedim Biotech (SSB) introduced a new generation of sterilising-grade filters, Sartopore Platinum, at ACHEMA. This product family reportedly sets new standards in sterile filtration and expands the comprehensive Sartorius filter portfolio. The surface of the Sartopore Platinum polyethersulfone filter membrane has been modified using a hydrophilic and highly thermostable polymer. This surface modification gives the membrane excellent wetting properties and minimises its protein binding. Less than five litres of WFI is needed to wet a 10” Sartopore Platinum cartridge fast and reliably for subsequent integrity testing that provides dependably accurate results. The membrane’s minimised protein binding considerably increases product yield, thus augmenting the efficiency of manufacturing processes. Sartopore Platinum filter cartridges can be drysteam sterilised in the forward or the reverse direction, without altering the properties of their membrane. These sterilising-grade filters can be used in the entire pH range from 1 to 14 and thus for nearly any filtration application in biopharmaceutical manufacturing. The membrane of the Sartopore Platinum filter cartridges has been pleated using SSB’s newly developed, proprietary TwinPleat process. The alternating long and short pleats of the membrane increase the filter area of a 10" cartridge by more than 60%. At the same time, this geometry ensures that liquids flow through the entire filter area so that the filtration capacity of the cartridge is used to the fullest extent. As a result, Sartopore Platinum filter cartridges substantially boost filtration
EPM 13
performance and lower filtration costs. The new sterilising-grade filter cartridges are available in a choice of different sizes and constructions ranging from laboratory to production scale. In all sizes, identical materials of construction with consistent performance characteristics are used. Therefore, Sartopore Platinum enables linear scale-up for a large number of applications in the biopharmaceutical industry. Sartorius Stedim Biotech +49 551 308 3324 dominic.grone@sartorius.com www.sartorius.com
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Collaboration Results in Formation of Turnkey Service for Pharmaceutical Leak Testing Automation Pharmaceutical processors and packagers seeking to eliminate the risk of releasing defective pharmaceuticals not protected from humidity and other
environmental impacts to market can now rely on USON-Innovative Systems (UIS), a newly created joint venture between USON’s best-in-class leak testers and Innovative Products and Equipment’s automation systems expertise. UIS is a single source turnkey solution for semiautomated and fully automated leak testing applications. Sophisticated automation systems, such as state-of-the-art robotic part handling, are tightly
integrated with the USON leak detector best suited for a particular leak testing application challenge by the exceptional industry engineering talent comprising the UIS service. Dave Foran, President of USON, commented: “UIS marries a deep bench of mechanical and control engineering talent from Innovative Products and Equipment with USON’s unsurpassed leak testing applications engineering team. Our customers seeking to automate or semi-automate their NDT leak testing operations will be able to get a turnkey, single source custom clean assembly design that is not only tuned to their leak detection needs, but is also the most efficient production line design possible. This means lower costs, faster throughputs and faster time to market.” Dale Beaver, President of Innovative
Products and Equipment, further explained: “UIS is an extension of a collaboration that began many years ago to develop elegant designs for production lines that include best-inclass USON leak detection equipment. There is very little in terms of leak testing production lines that we haven’t encountered before. We bring a number of state-of-the-art automated assembly designs to give the customer a tried and true solution, and when they have unique needs, we have the team in place to create new solutions in rapid order.” In most cases, UIS will provide a detailed application quote within two weeks of request. USON +1 281 671 2000 joe.pustka@uson.com www.uson.com
Ultra-High Shear Mixer Produces Very Fine Emulsions and Dispersions in Short Cycle Times The Ross MegaShear ultra-high shear mixer is a patented inline rotor/stator designed for high-volume and highthroughput deagglomeration, emulsification and homogenisation requirements. Outperforming conventional high shear mixers, colloid mills and even expensive high pressure homogenisers in many applications, the MegaShear is capable of producing exceptionally fine emulsions and dispersions at a fraction of the cycle time. Just as important, it is not susceptible to common milling and homogenisation issues such as clogging, sensitivity to viscosity changes, time-consuming clean-up and intensive maintenance. The MegaShear is ideal for a wide
range of processing applications, including pharmaceutical emulsions, creams and ointments, gels, pastes, nutraceuticals and supplements, biosuspensions, active ingredient dispersions, additive formulations, medical coatings and adhesives. The MegaShear generator (US Patent No. 6,241,472) consists of high-velocity pumping vanes and precisely-machined semi-cylindrical grooves where the product splits into different streams that collide at high frequency before exiting the mix chamber. Complex flow patterns are produced by the rotor running at tip speeds over 3,352.8 m/min, subjecting the material to thousands of intense mechanical and hydraulic shearing events in a single pass.
Catalogue Showcases Latest Temperature Control Equipment Huber Kältemaschinenbau offers temperature control technology for both laboratory and process. In the new 2012/13 catalogue, a range of new products are available, the highlight of which is the new touchscreen controller Pilot ONE. Huber’s new 2012/13 temperature control catalogue features numerous, dynamic temperature control systems, chillers, classic circulators and the new Pilot ONE controller for use in research, pilot plant and production. Under the motto ‘One for all and all for one’, the newly developed Pilot ONE offers the latest touchscreen technology, giving the look and feel of current smartphones. The new controller offers maximum ease of use, USB/LAN connections and menu guidance in 11 languages. Thanks to a reportedly unique plug and play technology, the introduction of the Pilot ONE modernises the entire Huber programme through additional functionality and new features. In addition, the catalogue contains information on services such as maintenance contracts, certificates, IQ/OQ documentation and training, and rental equipment. Also, 12 new case studies are available in the catalogue. These show various cooling circulators used in conjunction with reactor
Charles Ross & Son Company +1 800 243 7677 sales@mixers.com www.mixers.com
Achieving the Highest Level of Performance in Bioreactor Process Control eBooklet
systems from De Dietrich, Radleys and Syrris, documenting the precision of the Huber range. The catalogue is available to download as a PDF or can be obtained free via the online order form on Huber’s website and by calling the company direct. Peter Huber Kältemaschinenbau GmbH +49 781 96030 info@huber-online.com www.huber-online.com
Mixer wetted parts are stainless steel type 316 polished to 150-grit finish. The mix chamber is designed for 150 psig internal pressure at 121.1°C. The MegaShear is available in laboratory (7.6 cm diameter rotor) and production (15.2 and 22.9 cm diameter rotors) sizes. A high-performance, cartridge-type double mechanical seal with barrier system is supplied as standard on all units. Options for gas seals, sanitary connections, CIP features and heating/cooling jackets are available.
Mettler Toledo has launched a new ebooklet for the pharmaceutical industry. Achieving the Highest Level of Performance in Bioreactor Process Control highlights different analytical measurement challenges during biopharmaceutical fermentation and explains the value of implementing inline process analytical equipment to enable reliable, repeatable production of high quality pharmaceutical products, batch after batch. Several critical processes are outlined in case studies, in which solutions and their implementation are detailed. In pharmaceutical operations, it is crucial that process reliability is always high and consistent. Central to this aim is timely measurement of analytical parameters. Although analysis of grab samples offers accurate results, it is time-consuming, sample contamination is possible and it does not supply continuous, real-time data. The use of in-line process analytical equipment reduces the workload of laboratory staff, measures directly in the process and supplies a constant stream of realtime measurements, allowing rapid corrective action when necessary. The FDA’s PAT initiative recognises the importance of real-time process
EPM 14
control, which is made possible only when continuous, in-line analytical measurements are available. The eBooklet is available at: www.mt.com/pro-pharma-ebook. Mettler Toledo Process Analytics +41 44 729 6273 santare.rukaite@mt.com www.mt.com/pro
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Sensor Provides Dependable Monitoring of Dissolved Ozone in Pharma Waters
Generic MBRs Simplify Recipe Maintenance and Help Streamline Manufacturing Process
Mettler Toledo Process Analytics has launched a new sensor with Intelligent Sensor Management (ISM) for the continuous, fast and reliable monitoring of dissolved ozone in pharmaceutical waters. Ozone is an effective sanitiser for pharmaceutical applications. Typical applications include monitoring dissolved ozone in APIs, Water For Injection (WFI), Pure Water (PW), High Purity Water (HPW), vaccines, etc. The new Thornton 6510i ozone sensor utilises ISM capabilities to optimise ozone measurement. Features allow the user to maximise the lifetime of the sensor and minimise downtime to perform routine maintenance. Benefits of the new ozone sensor include: • full sensor identification, including sensor type and serial number; • calibration history to facilitate maintenance planning; • Adaptive Calibration Timer (ACT) to track maintenance schedule and increase uptime of the measurement loop; • Time To Maintenance (TTM) to indicate when the membrane and electrolyte need to be replaced; • Dynamic Lifetime Indicator (DLI) to predict life of inner body and membrane; • and Sanitisation counter (SAN) to programme the limit of ozone
Werum Software & Systems has introduced Generic Master Batch Records (GMBRs) for its PAS-X manufacturing IT business platform. The new PAS-X function was initially successfully implemented for a pilot customer and now helps customers from the pharmaceutical and biotechnology industries to considerably streamline the management of their Master Batch Records (MBRs). The GMBRs from Werum reduce the number of MBRs by combining processes that always have the same workflow and only differ from each other in the values of their parameters. This especially applies to the field of packaging, where there are a large number of different MBRs due to the many product variants, for example, with regard to the number of pills, the language version of the package insert or of the packaging to be used. When using GMBRs, PAS-X retrieves the current parameters for the specific order from easy-to-maintain lists or adopts them from the integrated Enterprise Resource Planning system. The benefits of GMBRs for the customer primarily lie in the reduced
concentration and duration of sanitisation cycle. The 6510i ozone sensor with ISM can be used with Thornton M300 ISM or M800 multi-parameter transmitters. This enables the use of two or four digital sensor inputs for continuous measurement of ozone, dissolved oxygen, conductivity, pH and TOC. Mettler Toledo Ltd +44 116 235 7070 enquire.mtuk@mt.com www.mt.com
administrative effort and the easier maintenance of the MBRs, and therefore in much more efficient processes. “Companies using hundreds or even thousands of MBRs in their production processes are faced with the urgent question ‘who is to continuously maintain them all?’” said Rolf Blumenthal, Senior Director of Consulting & Product Management, Werum Software & Systems AG. “With our new PAS-X function, we have succeeded in reducing the number of MBRs to 20 for a customer with 2,000 packaging products.” Werum Software & Systems AG +49 4131 8900 689 dirk.ebbecke@werum.com www.werum.com / www.pas-x.com
Bioprocess Monitoring System Increases Yields of Biologics Stratophase has announced the launch of Ranger, its system for the biopharmaceutical industry that provides real-time, in-line bioprocess monitoring and fermentation control, to increase yields of fully functional biologics. The Ranger system can be integrated into all bioprocessing systems, running microbial or mammalian cell cultures, and enables bioprocess managers to monitor and control metabolic rate, observe batch processing trends and accurately determine the end of the process. Ranger provides bioprocess managers with new measurements that, through the integral data analysis software, give simple instructions on the provision of nutrients. The output from Ranger can be used to automate the feeding regime of the culture.
Ranger is comprised of Ranger Manager, an intelligent multi-probe management system, and Ranger Probe, a refractive index media sensor; together, these give real-time feedback on glucose metabolism. Harnessing refractive index measurements, the extent to which light waves bend when in varying density solutions, Ranger gives instantaneous insight into process kinetics by monitoring the composition and temperature of the bioprocess culture. Ranger can be used to determine both the relative batch quality, compared with previous process trends, or to identify and react to key process characteristics. Applications include automated fed batch control of additions into a bioreactor, such as optimising nutrient feed rate to an organism’s requirements
in real time. Additionally Ranger generates real-time data and feedback on end of process. Ranger probes are compatible with standard sensor housings and ports, permitting probe installation across a wide range of bioreactor volumes. The stainless steel probes are reusable and designed to withstand standard cleaning and sterilisation procedures used with existing bioprocess sensors. The Ranger control units allow from four to eight probes to be deployed in parallel and are designed for laboratory benchtop use, pilot-scale environments and full production scale. The touchscreen interface allows data capture and the real-time display to be customised to the user’s preferences.
Versatile Mill Offers Gentle Yet Effective Grinding of Difficult Products If a customer is looking to gently grind products that are traditionally problematic to grind, because they are fatty, heat sensitive, sticky or moist, the Bexmill from Hosokawa Micron is an ideal solution. This versatile cone mill is ideally suited to process materials within the food and pharmaceutical industries. There is even a through the wall version for pharmaceutical cleanrooms, which keeps all drives and control components in a separate non-hazardous area. Its compact conical chamber design is easy to clean and is gas and dust tight. Heat generation is minimal because of
the short residence time and low drive motor powers, which also helps when handling sticky materials without build up. The Bexmill produces a ground product with a steep particle size distribution curve with minimal fines. This new generation of Bexmill is easy to maintain with ultra-fast access to the inner grinding chamber provided by releasing external swingbolts, leaving the grinding rotor and inner screen fully exposed for cleaning and maintenance. No dust filtration is required with the Bexmill as there is no airflow that can carry fine dust particles out of the
grinding system, unlike with some other milling arrangements. The unit is extremely compact and mobile, and is available in five sizes from 1.5 to 15 kW, with typical throughputs ranging from 200 kg per hour to eight tonnes per hour. A wide range of grinding rotor and screens are available, hence one mill can cope with many different products just by changing internals. Hosokawa Micron Ltd +44 1928 755100 info@hmluk.hosokawa.com www.hosokawa.co.uk
EPM 15
Recorded data can be exported from the system for offline analysis using the USB interface or transmitted over a data network via Ethernet protocols. Stratophase Ltd +44 1794 511226 enquiries@stratophase.com www.stratophase.com
SHOWCASE PUMPS Pump Range Provides No-Valve Metering Capability for Chemical Applications Watson-Marlow’s Qdos 30 pump range made its global exhibition debut at ACHEMA. Developed in response to extensive industrial customer feedback for improved chemical metering, the Qdos 30 eliminates ancillary equipment, enhances productivity and reduces chemical waste through more accurate, linear and repeatable metering than typical solenoid or stepper driven diaphragm metering pumps. The Qdos 30 delivers exceptional flow performance from 0.1 to 500 ml/min at 7 bar, even when metering difficult fluids where pressure, viscosity and solids content vary. There are no seals or valves in the flow path to clog, leak or corrode. Therefore, fluids that are caustic, abrasive, viscous, shearsensitive, gaseous, are slurries or contain suspended solids can be safely and securely handled. Advanced control features include fluid level
monitoring, fluid recovery, line priming and intuitive flow calibration. Developed in response to extensive customer feedback, Qdos 30 pumps feature Watson-Marlow’s patented ReNu pumphead technology. Quick and easy pumphead removal and replacement minimises process downtime and requires no specialist tools, training or technicians. The pumphead can be configured on the left or right, making it ideal for installing in restricted environments or on skids, while its sealed design and fluid recovery eliminate wastage and ensure operator safety. Operation is intuitive via a menu-driven interface with a 3.5” TFT colour display, providing high-visibility status indication. The keypad and display are positioned for easy access, along with input and output connections. The premium model in the new range is the Qdos 30 Universal+. This
impressive pump offers features and functionality that reportedly set it apart from competitive diaphragm metering pumps. For example, the pump response to the 4-20 mA input signal is fully configurable, and a 4-20 mA output and alarm output is available. Featuring all-new hardware and software, applications for Qdos 30 include: disinfection and pH adjustment of drinking water and industrial process water; flocculation; industrial cooling water preparation; and reagent dosing in mineral processing, to name but a few. The versatile pump design and range means customers can select the pump that meets the precise application requirements. Maintenance intervals are up to an impressive six months at typical usage, reducing the impact of process downtime. In addition to the Qdos 30 Universal+ pump, four other variants are available.
Watson-Marlow Pumps Group +44 1326 370 370 heatherbeale@watson-marlow.co.uk www.watson-marlow.co.uk
Dry Vacuum Pump Range Offers High Reliability and Low Cost Ownership Edwards’ CXS pump range delivers exceptional vacuum performance in harsh chemical, petrochemical and pharmaceutical processes. The easy-touse pumps feature cutting-edge tapered screw technology, offer excellent reliability, are simple to install and
environmentally friendly, and boast improved liquids and solids handling. CXS pumps enable users to minimise their environmental impact. They provide all the advantages of dry pumps, with low energy usage and utility costs, deep and flexible vacuum down to 10–3 mbar, no contamination of the process stream or cooling water and no effluent generation. They are robust and reliable, even in harsh pumping environments, and have excellent liquid and solids handling capability, with the ability to pump up to one litre of liquid per minute continuously and up to 25 l slugs without stopping. The pumps are independently certified for use in hazardous environments to ensure safe pumping of flammable gases. The advanced screw technology gives
smooth, gradual compression along the length of the rotor, which results in improved thermal control and optimised pumping at all inlet pressures. The CXS pump design incorporates reportedly novel compression and motor technologies that contribute to its excellent performance. It uses flooded air-gap potted motors, which are up to 15% more efficient than standard motors, and integral drive and control systems, helping to lower the cost of ownership. The energy-efficient CXS pumps are available as standalone pumps, or complete systems, including mechanical boosters for higher pumping capacities and with accessories such as valves, flame arresters, condensers, knock-out pots and filters. There are two models — CXS160 and CXS250 — which give
nominal capacities of 160 m3h-1 and 250 m3h-1 respectively. All of the combinations are simple to install and easy to use. They have an integral controller, PID pressure control and safety systems for plug-and-play operation, and can be linked to any external control system via a variety of modern communication interfaces such as Ethernet and Profibus DP. They provide fast pump down and excellent control that result in optimum performance in a variety of applications, such as distillation, drying, evaporation, reactor service, house vacuum, solvent recovery, crystallisation and filtration. Edwards +44 1293 603451 miles.firth@edwardsvacuum.com www.edwardsvacuum.com/nxds
IBC Emptying Pumps Range Now Available with Longer Tubes The polypropylene version of the established Finish Thompson EF series drum emptying pumps now has the option of a longer tube length designed specifically to work with larger IBCs and carboys that typically hold volumes of up to 1,250 l. Available from pumping specialist Michael Smith Engineers, these longer tube sets measure 137 cm and can be coupled to any of the EF series air and electric motors. Drum or barrel emptying pumps are acknowledged as being the ideal alternative to hand pumps for the safe and efficient transfer of acids, chemicals and corrosives from tanks, drums and
carboys, and Michael Smith Engineers claims that the EF Series is the highest quality powered drum pump in its class and the most competitively priced. EF Series sealless pumps are designed for light to medium duty and are capable of delivering flow rates up to 64 l/min at discharge pressures up to 6.1 m. In addition to the longer 137 cm tube, EF pumps can also be supplied in tube lengths to suit most popular drum and tanks sizes, for example, 40, 70, 100 and 120 cm. The EF 137 cm tubes are available in standard polypropylene construction, with a polypropylene outer tube, 316
stainless steel build, as well as a pure PVDF/polypropylene construction. Other features of the EF Series include dual speed, adjustable, continuous duty electric or air motors that have CSA or CE certifications. The motors are also interchangeable with any tube selection.
stainless steel shaft, PTFE vapour seal and FKM O-rings. In addition to the polypropylene tube set, the EF series is also available in a
EPM 16
Michael Smith Engineers Ltd +44 800 316 7891 info@michael-smith-engineers.co.uk www.michael-smithengineers.co.uk/products/drum-andbarrel-pump/ef-series.htm
SHOWCASE TABLET COMPRESSION Single Rotary Press Allows for Exceptionally Fast Product Changeover Fette Compacting presented the second machine in the new FE Series at ACHEMA. The FE35 is a single rotary press that can be fitted with up to 51 punch stations, enabling the production of approximately 370,000 tablets per hour. However, it is the rapid product changeover that makes this new machine so efficient. For example, Fette Compacting estimates that the turret can be removed within a mere 15 minutes. According to the company, what makes the aforementioned possible is an all-new design, as well as a number of technical innovations. In addition, many features introduced with the FE55 last year have been successfully implemented on the FE35. With the newly-developed Fill-O-Matic, customers can increase the product output or the production capacity with a wide array of products up to 100%. The die table segments in the FE35 are another new development. Despite a larger pitch circle diameter of 325 mm, these segments have the same weight as segments with a smaller pitch diameter. Fette Compacting also claims that the FE35 is the only machine in its
class offering upper and lower automatically adjustable compression rollers, as well as pressure measurement cells with integrated measuring amplifiers and drive units with a new position measurement system — all contributing towards much shorter refitting times. Likewise, Fette Compacting has consistently implemented its new TRI.EASY concept in the FE35. The idea behind this concept is that technology can only be efficient when it is equally easy in all three aspects of operation, refitting and maintenance. With the FE35, the implementation of this principle is the foundation for quick product changeovers. It starts with the layout of the machine, which allows for quick and easy access to all modules. When changing the turret, all operational steps are fully automated or can be executed tool free. Furthermore, all supply lines are connected to the machine via a single plug. Another highlight is the new exhaust unit, which can be connected above, under or to the side of the press. The
Tablet Press Customers Benefit from Bi-Layer Boost
production. The bi-layer kit consists of a limited number of components and is very fast and easy to install. The first bi-layer capable PERFORMA P presses were sold earlier this year. The PERFORMA P in bi-layer configuration is available at GEA Pharma Systems - Courtoy for demonstrations and trials. By adding this new asset to the many benefits of its advanced compression technology, GEA Pharma Systems Courtoy has further enhanced the flexibility of its machine range. GEA Pharma Systems - Courtoy +32 2 363 83 26 veerle.chiau@gea.com www.gea.com
Fette Compacting +49 4151 12498 tablet@fette-compacting.com www.fette-compacting.com
Automated Punch and Die Polishing Machine Receives High Level of Interest from Show Visitors
To make the most of this large output capacity, GEA Pharma Systems Courtoy has developed a bi-layer kit for installation on the PERFORMA P, making the machine capable of both single- and bi-layer GEA Pharma Systems Courtoy’s MODUL P tablet press, available for both single-layer and bi-layer tablet production, has been successful for some years. According to the company, featuring highly innovative process capabilities — such as full dwell time control and equal porosity tabletting — it has proven its quality, versatility and reliability in R&D and small-scale production environments. The PERFORMA P is identical to the MODUL P, except that the Exchangeable Compression Module (ECM) has been replaced by a removable turret featuring the exceptional Exchangeable Die Disc (EDD). The PERFORMA P turret has a larger pitch diameter and more compression stations than that of the MODUL P with ECM. This increased number of punch positions results in an instant increase in machine output.
removal or installation of the unit itself takes only seconds. As with the FE55, operators can align the table on which the filling unit is located via a lever that is accurate down to 30 µm. Also, the FE35 features the completely new HMI developed by Fette Compacting. Peripheral devices can be connected via a standardised plug and play interface in which all the cables and the dust extraction unit are integrated. The mechanical design of the FE35 is also new. The optimised structural frame allows for low-vibration operation and reduces noise output. The direct torque drive features an enormous reserve capacity, easy maintenance and low heat generation. Customers may choose between an integrated and an external switch cabinet. As with the FE55, the housing of the FE35 is made of an FDA-approved high-performance plastic. Following the introduction of the FE35 prototype at ACHEMA, Fette Compacting plans to ship the first units in spring 2013.
I Holland staff were delighted by the response from ACHEMA visitors who viewed the company’s new MF40 automated punch and die polishing machine. This brand new design updates the highly successful, current range of MF polishers. The stainless steel construction (frame and cabinet) is both highly durable and easy to clean. A 40 l media drum and increased capacity holders allow for up to 17 B or 12 D punches per holder, giving a maximum of 51 B or 36 D punches per polishing cycle. The CE marked MF40 uses single-phase power and fits in the same compact 940 x 750 mm footprint as the MF35. Automated polishing is an integral part of I Holland’s PharmaCare 7-Step Process, designed to maximise troublefree tablet production by assisting customers in maintaining tablet tooling in a productive condition for as long as possible. Some sticking issues can be simply solved by regular use of an MF polishing machine. It is straightforward to use via easily accessible touchscreen software, available in several languages, and will give consistent, repeatable polishing every time.
EPM 17
Contact I Holland for further details on automated polishing and the wider PharmaCare 7-Step range. I Holland Ltd +44 115 972 6153 Info@iholland.co.uk www.iholland.co.uk
SHOWCASE TABLET COMPRESSION Continuous Solid Dose Technology Specialist Wins Large Order from Major US Pharma Company
Latest Edition of Catalogue Acts as Complete Guide for Tablet Compression Accessories cleaning and lubrication accessories, polishing equipment, inspection tools, analysis equipment and more. The catalogue is available in three convenient formats: an interactive online version with clickable products linked directly to a quote request feature; a downloadable PDF version; and the traditional printed version, which is shipped free of charge.
Featuring more than 1,500 items, Natoli Engineering’s 162-page, full-colour Tablet Compression Accessories Catalog is a complete accessory guide for tablet compression. According to the company, a refined product selection showcases new analysis equipment, exclusive die segment storage cabinets, customisable tablet totes and innovative digital mini microscope inspection devices. The catalogue also features two new sections: Tablet Press Parts and Encapsulator Parts. Other sections feature compression room products,
Natoli Engineering Company, Inc. +1 636 926 8900 info@natoli.com www.natoli.com
Wide-Range of Compression Tooling Products Available from Reputable Tablet Press Manufacturer
GEA Pharma Systems has announced an agreement with a US pharmaceutical company to supply a complete continuous processing line for the production of solid dose drugs. The order is one of the more significant for ConsiGma oral solid dosage continuous processing equipment and represents the first phase of a potentially long-term commitment for this customer. Delivery is scheduled for early 2013. The order is to deliver a continuous solid dosage production platform, including continuous blending, wet granulation and drying, dry granulation and direct compression. In addition to the Courtoy MODUL tablet press and a tablet relaxation module, the system will also include the first commercial continuous GEA coater. The entire line will be equipped with a range of PAT instruments (partly based on the GEA’s patented Lighthouse Probe technology) for on-line measurement of particle size distribution, humidity, blend/content uniformity and coating quality. This data will be captured in an overall control and information system that allows for real-time-release of the finished tablets. Jan Vugts, MD of GEA Pharma Systems in Wommelgem, Belgium, said: “We were all delighted to receive the order. GEA has many years experience with continuous processing in other industries and GPS is a market leader in batch granulation, drying and compression technologies for the pharma industry. I believe this experience and the expertise of the team in our global competence centre near Antwerp, Belgium, have greatly contributed to the confidence this customer has shown in GPS.” GEA Pharma Systems +32 3 350 12 88 kris.schoeters@gea.com www.geapharmasystems.com
The powder compression field demands a very high level of engineering and mechanism. However, requirements differ depending on each, individual customer’s products, machines and business area. According to Elizabeth Europe, it has the widest range of compression tooling products available on the market and boasts: • an exceptionally cost-effective tooling range; • a wide TSM norm tooling range; • a wide ISO norm tooling range;
To help the customer in making their choice and support them in their development, Elizabeth Europe has a highly skilled technical department. Also, Elizabeth Europe is the only compression tooling specialist able to provide spare parts for the Hata and Eliza-Press tablet press ranges, as well as the presses themselves.
• a wide multi-tip tooling range; • and a wide industrial and specialty tooling range.
Single Punch Tablet Press Guarantees Full Operator Protection The KORSCH XP 1 WipCon covers all aspects of operator safety and current R&D requirements, and provides exceptional flexibility for feasibility, development and material characterisation. According to KORSCH, it also complies with the highest levels of GMP, as the need for full operator protection equipment is eliminated and the ability to conduct product development activities with minimum product quantities, at extremely slow speeds and by manual operation is made possible. Flexibility was a key milestone and it is possible to use the XP 1 WipCon in containment mode with under pressure or uncontained mode with the isolator open but using an additional covering in front of moving parts. Operator protection and decontamination of the product contact area is guaranteed by way of the reportedly unique design that separates the compression zone from other mechanical parts. Key features of the XP 1 WipCon are: • reportedly unique isolator design concept; • ergonomic glove port configuration; • minimum space requirements, fully portable;
• complete separation of product contact area from mechanical area; • high containment range for development and material characterisation OEB 5 (1 µg/m3 > OEL > 0.1 µg/m3) with RTP transfer system; • manual WIP system with spray gun and dust extraction for efficient decontamination, negative pressure control system with safe-change HEPA filters (push through); • integration of manual analytical procedures due to weight/hardness/thickness measurement being made possible in isolator; • versatile design permits contained and conventional handling on one machine; • full GMP compliance (documentation according to GAMP4 with risk analysis available); • and split valve connections for material inlet and tablet outlet. KORSCH AG +49 30 43576 0 berlin@korsch.de www.korsch.com
EPM 18
Elizabeth-Europe +33 2 54 90 21 20 service@epmo.com www.epmo.com
Corporate News & Events
Pneumatics and Automation Control Expert Announces Distributor Partnership SMC Pneumatics has expanded its list of distributor partnerships with the signing of an agreement with BioPharma Dynamics. The deal sees SMC team up with one of the country’s leading suppliers of process solutions in the UK healthcare market. Operating out of premises in Manchester and Didcot and offering nationwide coverage, BioPharma Dynamics prides itself on offering an extensive range of solutions for pharmaceutical processing — from sensors and monitoring to controlling and pumping — supplying companies from small-scale laboratory production to full-scale manufacturing. The company works with its customers to find cost-effective solutions from the most innovative manufacturers in the marketplace. This new partnership is proof of SMC’s commitment to supporting the life science market, said the company’s UK Industry Sales Manager John Turner. “The life sciences industry is one of several where we have a specific, longterm focus in order to understand the
needs of our customers. As well as having a sector specialist, we take on board our customers’ views on existing products, so we can develop our ranges to give users what we know they need — not just what we think they need. By working with BioPharma Dynamics, we hope to reach new customers who might not be aware of SMC and how we can help them, and that in turn will help increase our understanding of this important sector.” Joe Brennan, GM of BioPharma Dynamics, said synergies between the two companies would produce significant benefits for users. “BioPharma Dynamics and SMC are both very forward-thinking companies. We pride ourselves on offering a wide range of innovative solutions for the biotechnology, healthcare and pharmaceutical markets, and SMC’s constant work on product development and innovation means they can offer a significant enhancement to our range — and that will also help keep us as a distributor right up-to-date with the very latest technologies available.”
without visible damage. “No further tools are required in this case to check for manipulation,” explained Meino Adam, Head of Packaging Development for Health Care at the Edelmann Group. “Through the CElock system, which has been registered for a patent, we already have folding carton designs in our portfolio that work accordingly.” In terms of packaging technology, the CElock system is special as tabs are torn along a perforated line upon opening. This means that the original act of opening remains visible. The system was recently used again in the packaging solution realised by Edelmann for the blood-pressure reducer Sevikar, a product from the Japanese pharmaceuticals producer Daiichi Sankyo. Carl Edelmann GmbH +49 7321 340407 pressestelle@edelmann.de www.edelmann.de
SMC Pneumatics (UK) Ltd +44 0845 121 5122 sales@smcpneumatics.co.uk www.smc.eu
BioPharma Dynamics +44 1235 750690 info@biopharmadynamics.com www.biopharmadynamics.info
PHARM Connect Congress 2013 Opens for Registration
Packaging Solutions Provider Assists in Development of European Standard for Tamper-Evident Closures A European group of experts is currently working on a CEN standard for tamper-evident closures on medicine packaging. The Edelmann Group is represented and has taken on a leading role. The backdrop to these endeavours are the so-called guidelines against counterfeiting for pharmaceuticals packaging approved by the EU in 2011. Besides the inclusion of security features, they also call for measures to safeguard originality — they should allow dispensing chemists to see whether packaging has already been opened and possibly had its contents exchanged. Because the guidelines do not specify the corresponding features, German pharmaceutical companies and associations, as well as packaging companies, have taken the initiative to specify the technicalities. The basis is a DIN (German Institute for Standardisation) draft that was previously created by a German working group. The European working group will publish an initial draft this year. The Edelmann Group is represented in both working groups, contributing its expertise in the area of pharmaceuticals packaging. Edelmann sees advantages in terms of manipulation prevention, in particular among folding cartons with constructive tamper-evident closures. Due to their construction, they can only be sealed once and then cannot be opened again
Joe Brennan, GM of BioPharma Dynamics, with Nick Pittwood, SMC’s Head of Sales for the UK, in front of SMC’s state-of-the-art cleanroom for assembly and packaging of dust and contaminant-free components, at SMC’s UK headquarters.
The annual PHARM Connect Congress is one of the largest pharmaceutical and biotechnology manufacturing events in Central Eastern Europe and the CIS market in 2013. The event is bringing together around 500 senior decision-makers from Europe’s leading pharmaceutical and biotechnology companies, giving them the opportunity to share their knowledge and discuss their key priorities. PHARM Connect is supported by numerous leading local and regional media partners and associations, an exposure that ensures the regional focus of the congress. Furthermore, the Programme Advisory Committee assures the highest relevance of the conference programme, which will include the most up-to-date market insights into R&D, production, packaging, logistics, supply chain and quality management-related topics. Moreover, it is the perfect setting for local and international solution-providers to present their products and services directly to key decision-makers. Each solution-provider is selected based on requirements and interests stated by attending professionals prior to the event.
EPM 19
Several weeks in advance of the congress, the TEG (The Events Group) Meeting Scheduler is made available to every solution-provider and delegate attending. On the site, they are able to select key presentations and preschedule one-to-one meetings, giving them the opportunity to create their own itinerary prior to the congress taking place. Furthermore, additional networking activities such as seated buffet luncheons, a cocktail reception and specially organised plant visits to leading pharmaceutical production plants provide an excellent opportunity for all participants to network in a more relaxed environment. The Events Group +36 1 219 57 25 info@tegevents.eu www.pharmconnect.eu
Corporate News & Events
Collaboration to Offer Single-Use Aseptic Filling Product Line Bosch Packaging Technology and Sartorius Stedim Biotech (SSB) announced a long-term global partnership agreement at ACHEMA. SSB is a leading international supplier of equipment and services for the development, quality assurance and production processes of the pharmaceutical and biopharmaceutical industry. The agreement covers the mutual design and development of single-use filling solutions to be used on aseptic filling equipment from Bosch for final filland-finish operations of liquid pharmaceuticals. SSB will provide Bosch with pre-configured single-use filling transfer sets, consisting of bags, filters, tubing and connectors. Bosch will combine these sets with its aseptic filling and barrier isolation technology to form new systems for aseptic filling and exclusively market, distribute and service
these new filling systems under the Bosch brand. With the new product line PreVAS (PreValidated, Pre-Assembled, PreSterilized), Bosch will supply its customers with highly cost-effective plug and play tools that provide additional flexibility for aseptic filling operations, backed by comprehensive validation packages. Joachim Brenner, responsible worldwide for the Bosch Pharma Liquid portfolio and GM at the Crailsheim plant, stated: “By integrating SSB’s single-use technologies into our aseptic filling systems, we are expanding our product and service portfolio in the area of filland-finish unit operations by an important component. With our joint expertise, we intend to develop configurable and customised single-use filling solutions and to provide strong validation and technical support.”
MES Specialist and Pharma Equipment Provider Develop Industry-Specific Recipe Libraries for Granulation and Coating At ACHEMA, Werum Software & Systems and Glatt presented a new, jointly developed approach for setting up pharmaceutical production processes more easily. In future, Werum’s Manufacturing IT Business Platform PAS-X will include predefined recipe libraries for granulation and coating processes. The libraries are collections of industryspecific base elements, enabling users to quickly build and easily maintain Master Batch Records (MBRs). The supplied MBR templates are tailored for the actually interfaced Glatt equipment and provide preconfigured standard processes as they generally occur in the manufacturing of pharmaceuticals. The machinery user does not need to determine the equipment-specific parameters and enter them. The appropriate parameter values are already predefined in the provided MBR templates. “The construction kid for MBR creation is similar to Word or Excel templates defined for typical documents,” said Christian Wölbeling, Senior Director Marketing & Sales, Werum Software & Systems. “Werum and Glatt customers no longer need to start from scratch when setting up production processes and this is a substantial advantage. From now on, customers can build their modelling on the base elements supplied by PAS-X. Using our MBR templates, electronic MBRs can now be created within a rather short time.” Another big advantage is that the libraries are continuously updated, so for example, if there is a change in equipment, users may easily adjust the parameters by means of up-to-date libraries provided by Glatt. “It is our goal to offer expandable
standard solutions to our customers from the pharmaceutical industry and thus make the automation of their production processes easier to handle,” explained Thomas Hofmaier, Head of Business Unit Process Technologies Pharma, Glatt. “In future, customers who purchase a machine from Glatt will also be provided with templates for granulation or coating.” The new templates are a result of the long-term successful collaboration between Glatt and Werum and their broad experience in the field of pharmaceutical and biotechnology manufacturing. On 18 June, the companies confirmed their intensified collaboration by signing an extended cooperation agreement. Werum Software & Systems AG +49 4131 8900 689 dirk.ebbecke@werum.com www.werum.com Glatt Group +49 7621 664 375 achim.glockner@glatt.com www.glatt.com
Jean Marc Cappia, VP Fluid Management Technologies, SSB, added: “The partnership with Bosch promotes the implementation of single-use technologies into critical applications such as final filling operations and strengthens the confidence in singleuse technology. “Our customers from the pharmaceutical and biopharmaceutical industry are facing rising cost pressure and time constraints. By integrating single-use technology into filland-finish unit operations, they can handle smaller batches and product
changeovers in a safe, economic and flexible way.” Bosch Packaging Technology +49 7951 402 517 www.boschpackaging.com
Tabletting Course Attendees Benefit from Hands-On Experience Specialist pharmaceutical training company PharmaTraining has reported first-year success for its new tabletting course: Hands-on Tablet Development (including the principles of pre-formulation, formulation and process development), as attendees benefit from the blend of theory and practical hands-on experience. The course, which started in September 2011, was developed by PharmaTraining following increased interest from individuals and companies wanting to gain a basic level of understanding of the entire tabletting process. Currently a unique proposition in the UK and across Europe, course attendees are benefiting from the ability to get actual hands-on practical experience of tabletting supplemented with lecture-based theory through conjoining practical sessions. This is a combination that is proving hugely successful with clients. Available three times a year, the threeday, full time course is held at PharmaTraining’s head office in Beckenham, London. Each day is structured to lead with lectures on aspects of tablet development, including pre-formulation, formulation and process development, complemented with related experimental work where attendees can put their learning to the test. Designed to offer a small and intimate study environment, each course runs to a maximum capacity of 10, where members have the freedom to experiment, but also have support from the on-hand technical team. Hands-on Tablet Development is an introductory overview to teach the multifunctional aspects of tabletting. A
EPM 20
perfect introduction for new starters, as well as to train experienced personnel who may require a broader overview, or alternatively, to meet the needs of companies that regularly rotate staff into different roles that may require knowledge of tabletting. The course is run using benchtop equipment, including blenders, The Gamlen Tablet Press and analysis apparatus to teach attendees the processes of compression, ejection and breakage in accordance with the Quality by Design (QbD) initiative. The Hands-on Tablet Development course is structured as follows: Day One — Overview of how tablets are produced in accordance with QbD, material properties and their impact on processing and the role of excipients; Day Two — Formulating good products; Day Three — Process development and validation. Places are available for the next course on 26–28 September. Alternatively tailored and/or bespoke training courses, held in-house, can also be provided. PharmaTraining Ltd +44 7802 895 193 michael@pharmdservices.com www.pharma-training-courses.com
LABORATORY PRODUCTS & EQUIPMENT
Benchtop Equipment Specialist Launches High Capacity Shaking Incubator for Cell Culture Applications Stuart unveiled a new addition to the company’s SI Series of incubators at ACHEMA. The SI600, with built-in orbital shaker, has a capacity of 115 l — more than double that of the existing SI500 — and can accommodate up to six 2 l Erlenmeyer flasks. Both of these benchtop systems are equipped with Biocote antimicrobial protection and are ideal for use in cell culture, especially suspension culture applications, with the larger SI600 supporting growing demands for larger scale production. The SI600 incubator is designed for reliable, convenient operation. Like the SI500, it includes a reportedly unique retractable platform for effortless loading and unloading. Under normal use, the platform is locked in place, but can be drawn forward from the chamber to give easy access to samples at the back. Accurate maintenance of a stable and uniform temperature is essential for reliable results over extended periods. Microprocessor control delivers long-
term temperature stability, with forced air circulation ensuring uniformity throughout the incubator. Separate control of temperature and shaker speed guards against accidental temperature adjustment, while USB enabled communication allows long-term tracking of the incubator temperature. A wide range of stainless steel accessory racks is available with angle-adjustable holders for 1.5, 15 and 50 ml sample tubes. These racks magnetically couple to the orbiting platform so require no tools to fix into place. Additionally, the flexible sample platform can accommodate a variety of flasks without the need to add tulip clamps or use tools to secure. “With life scientists under pressure to scale up production of cell growth, the
ability to use larger flasks in the new SI600 enables researchers to increase their chances of success by being able to produce more cells,” said Rob Skehens, Marketing Director of Bibby Scientific. Bibby Scientific Ltd +44 1785 812121 info@bibby-scientific.com www.stuart-equipment.com
Heating Block Enables Accelerated Development of Crystallisation Methods Asynt has supplied the Wilson Structural Chemistry Research Group at the University of Bath, UK, with a custom DrySyn heating block system. The adapted DrySyn system, designed by Asynt in conjunction with the University of Bath, is being used to help simplify and accelerate development of crystallisation methodology to selectively control polymorph formation, and to generate multi-component crystals with favourable target physical properties, such as optical effects, solubility and porosity. Control of the solid form of crystalline materials is desirable in many industrial sectors, including the pharmaceutical and agrichemical industries where the production of different polymorphs, cocrystals or salts are known to affect significantly the physical properties of target active ingredients. There are many factors known to affect crystal formation, including choice of solvent or solvents, temperature of crystallisation and the presence of additives or additional components in the crystallisation process. Dr. Lynne Thomas, a research fellow at the University of Bath, commented: “Temperature fluctuations in particular are known both to induce crystallisation
and potentially can act as a switch controlling which stable crystalline form is obtained. Careful temperature control of samples crystallising is therefore of critical importance in this field, as is a heavily parallel approach to allow systematic investigation of the effect of crystallisation conditions on solid form. The number of potential temperature and solvent combinations thus makes screening conditions through a parallel approach to temperature controlled crystallisation much more efficient, and in many cases essential.” Dr. Thomas added: “In collaboration with Asynt, we have designed and installed custom heating blocks in our crystallisation laboratory to optimise the temperature controlled space on each DrySyn heating block. The adapted
EPM 21
DrySyn heating block, which enables precise control of 19 crystallisations in parallel, has proven its ability to increase the flexibility and speed of low to medium throughput crystallisation experiments.” Asynt Ltd +44 1638 781709 sales@asynt.com www.asynt.com
Q&A
In March 2012, Thermo Fisher Scientific introduced CONNECTS for the Paperless Lab. According to Trish Meek, taking the paperless route not only benefits laboratory researchers, but also those life sciences staff at manufacturing and enterprise levels, by significantly reducing THERMO FISHER human error, increasing efficiency and facilitating integration, and ultimately fostering more robust collaboration both inside and SCIENTIFIC outside the organisation. Trish Meek, Director of Trish Meek spoke with EPM about how the paperless laboratory Product Strategy for Life concept could prove to be a game changer for the pharmaceutical and Sciences, Informatics other life sciences industries, and reports on the impact of achieving a Division truly paperless lab.
What are the disadvantages of the traditional, paper-based laboratory environment? We could start by asking ‘what are the benefits of using paper?’, which are obvious — paper is generally easy to use, it’s often convenient, frequently portable and much of the time legally defensible. Also, paper requires no user training, so for the most part, new users can be trained on a process and quickly accomplish the task. Those are the positive aspects of paper. However, as you’d expect, the downside to paper is greater than the upside. Using paper-based methods for sensitive and complicated laboratory workflow creates a number of security, expense and productivity challenges. First of all, paper reports or workflow documents introduce significant security risks into what should be a completely secure process. Paper processes also always introduce a human factor and any human activity is inherently prone to errors to some degree. Organisations have to keep strict controls around their paper processes because they must control document access, version control and cataloguing the information to ensure that it can be located when required. Paper-based processes are costly, both in terms of the physical purchase of paper and in terms of the human capital that is expended to manually handle the process — human capital that is probably highly skilled and trained for scientific research and laboratory processes, not managing paper reporting. So there’s a productivity factor in the cost equation to using paper.
Finally, in the current economic climate where every minute of research and scientific progress must be measured by a success factor, paper processes represent the antithesis of collaborative efforts. Today’s pharmaceutical company works in collaboration with academia, CROs and partner biotechnology companies. Their data is spread across these organisations. Paper isn’t searchable and in this era of distributed R&D and outsourced testing, paper-based processes represent barriers to collaboration and a time drain on sharing valuable scientific information. How does the paperless lab concept overcome the aforementioned issues? More and more laboratories are realising that all the investment they’ve made in setting up a state-of-the-art laboratory is not being fully optimised and they’re looking for ways to optimise that investment. The typical lab has expensive instrumentation and other laboratory equipment, all of which are generating data of some kind. Each of these instruments, if siloed, requires that a human has some interaction with that data to collate it with data from other instruments and compile reports. A fully integrated laboratory will connect instrumentation to a central data system, such as a LIMS, so that data storage and reporting is automated. You can imagine how this situation becomes more complicated when there are multiple labs across different geographies working together across an organisation. Also, in many cases, lab data
EPM 22
is required by management at some point to satisfy decision making that is reliant on key business metrics. In a manufacturing environment, this will require that the lab is fully connected with other existing enterprise systems, such as ERP, MES, PIMS, etc. So what’s occurring with the paperless lab concept now is that many companies are looking for ways to optimise the ROI for their lab investments. The key to this is integration of the lab itself, as well as connectivity of the lab with the rest of the organisation. In what ways does going paperless make a laboratory more efficient? Efficiencies in the lab come from streamlining workflow and automating processes. When the lab is fully integrated, that is that the instruments and other information systems are integrated with the LIMS, then all data collection and analysis is automated, freeing up the lab’s scientists to focus on science and more value added revenue-generating activities. The reduction in time spent performing manual paper-drive tasks can produce an enormous improvement in productivity and also cost savings. For example, a modest reduction, say 20% in man-hours spent on paper-based efforts, can produce hundreds of thousands of dollars in annual savings. It’s worth thinking about how much more revenue could be generated by those man-hours if they were spent on novel research instead of paperbased data collation and reporting processes or if a problem with production was discovered and the
LABORATORY PRODUCTS & EQUIPMENT Q&A organisation was able to react even one hour earlier in the process. This is the value many companies are seeing when they fully integrate their labs and connect the labs with the rest of the organisation. How does a laboratory begin to take steps towards implementing the paperless concept? We’re advisors to our customers and the first thing we look at is the landscape of the lab. How is the lab set up?, what instruments are in place or are planned for the future?, what is the required workflow? It’s important to ask these seemingly basic questions because often the existing workflow isn’t the one that the lab actually wants — but it’s the one that’s in place. So part of implementing a paperless lab is to find a consulting ally that can honestly assess the situation in the lab and lay out a plan that will be flexible enough to grow with the lab and the business in the near future. Once this assessment is complete and an optimum workflow has been identified, the work can begin to make recommendations for integrating all those disparate instruments and connecting the lab’s output with key business metrics for management to use. What tools are available to help companies achieve paperless status and ensure a smooth transition? The paperless lab concept has been talked about off and on for a number of years and each time it resurfaces the technologies that support this movement are a little bit closer to fully achieving the goal. This time around we’re closer still and a number of new technologies are now available that can fully integrate even the most heterogenous of labs. This is an important distinction to make because most labs will have a fairly broad spectrum of vendors installed, something that in the past has been the perceived and
sometimes practical obstacle for fully integrating the lab. The problem, up until now, has been the cost to integrate different software systems and equipment from each of these independent instrument vendors, but newer technologies based on open standards have led to big opportunities for life sciences labs today. At Thermo Fisher, we’ve spent time developing Integration Manager and Data Manager, which transform data from any instrument and deliver it to any source. While importing the final result is crucial, this solution takes it further by enabling scientists to see their real analytical data, chromatograms, mass spectra and results from other instrumentation regardless of the instrument supplier. This type of automated data acquisition and point-to-point data distribution across the enterprise is what is enabling today’s paperless lab. Are a significant number of pharmaceutical companies beginning to move in the paperless direction? We have had a tremendous response to CONNECTS. It is important to understand that life sciences industries are telling us that they want to get to a paperless lab. With CONNECTS, we are in a strong position to help our customers tackle this problem. We ensure that they understand that this is a process that starts with an evaluation of their organisation’s existing processes and how they are using their current software and hardware. We look at what works today and where paper-based, manual processes create bottlenecks that integration could address. Is it possible to cite a pharmaceutical laboratory goes paperless success story? We are working with several customers at the moment to implement paperless lab projects. As I said before,
EPM 23
Trish Meek, Director of Product Strategy for Life Sciences, Informatics Division this is a customer-driven initiative; once they complete, we will be able to discuss those projects in more detail. The reality is that this is simply leveraging the expertise and integration technology that we have developed over the past 25 years. All of the work we have done in past implementations has been to drive to a more automated, integrated environment. Customers have just reached the point where they see the value in going completely paperless.
Thermo Fisher Scientific, Inc., Informatics +44 161 9423000 marketing.informatics@thermofisher.com www.thermoscientific.com/paperlesslab
SHOWCASE CHROMATOGRAPHY LC-MS/MS Delivers Increased Productivity and Sensitivity Performance According to Shimadzu UK, it has launched the world’s fastest LC-MS/MS — the LCMS-8040 — which offers increased levels of productivity as it enables laboratories to run more scans and collect more data from fewer sample injections. An expansion of Shimadzu’s ultrafast mass spectrometry (UFMS) series, the instrument also features high sensitivity capabilities that deliver accurate measurements at low levels and high speeds so users can be confident in the results. The robust LCMS-8040 boasts a quadrupole scan speed of 15,000 u/sec at 0.1 Da step size, as well as polarity switching at 15 msec. The instrument is capable of ultrafast MRM transition monitoring, up to a maximum 555 MRMs per second. Plus, the LCMS-8040’s patented power supply technology allows the shortest loop time to give both positive and negative ion data in the shortest time. The ability to scan faster, in addition to exceptionally short pause and dwell times, of 1 and 0.8 msec respectively, means that the LCMS-8040 is able to
create more points across a peak, resulting in better quantitation to deliver more accurate measurements first time. The result is more information with less work, which leads to improved productivity, as well as an increased level of confidence in the results. For users in method development, the LCMS-8040 enables full scan data and MRM to be captured simultaneously, which allows the matrix effects to be seen more clearly. The LCMS-8040 features reengineered ion optics and collision cell technology that results in higher ion transmission and collision induced dissociation efficiency, which translates into major sensitivity performance benefits. The new instrument, which can be upgraded from Shimadzu’s LCMS-8030, is ideal for a wide variety of laboratory applications, including clinical analysis, drugs of abuse screening, ADME analysis, environmental analysis and food testing. Shimadzu is also offering customers a discount on the LCMS-8040 in return for trading in old ABSciex,
Surface Energy Analyser Provides Next Generation of Inverse Gas Chromatography Technology According to Surface Measurement Systems, the SEA continues its pioneering history with inverse gas chromatography (iGC) technology and applications, which now spans more than fifteen years. The SEA is reportedly the world’s only commercial instrument based on the iGC principle. iGC is a gasphase technique for characterising surface and bulk properties of complex solids, for example, powders, particulates, fibres, films and semi-solids. The well-proven iGC technique involves sending a series of vapour pulses through a column packed with the sample under examination. The vapour’s retention time is measured and used to determine a wide range of important surface and bulk properties of the sample — surface energy, acid/base properties, heat of sorption, glass transition temperature and solubility parameters. Surface energy is the principle characteristic measured by the SEA and it has important implications in processes involving interfacial interactions, as in wetting, blending/mixing, cohesion/adhesion, etc. Most materials are energetically anisotropic, meaning they have regions of different surface energy. Therefore, it is important to characterise the entire sample surface and not simply calculate average values, as conventional liquidbased techniques (such as the sessile drop contact angle method) do.
ionised to either positive or negative ion. Shimadzu’s software provides a single platform for Shimadzu LC/GC/LCMS and GCMS with intuitive and unified operation flow and new functionalities for more efficient data processing. Shimadzu UK Ltd +44 1908 552209 sales@shimadzu.co.uk www.shimadzu.co.uk
Latest Additions to Ultrapure LC-MS Reagents Range Enable Highly Stable MS Detection
At the heart of the SEA is its injection manifold system, which generates vapour pulse sizes of the greatest precision and range, accurately producing isotherms at unprecedentedly high and low sample surface coverages. This allows for the accurate determination of dispersive and polar (acid-base) component energetic heterogeneity analysis. An energetic heterogeneity profile can be used for prediction of product properties, in particular in the formulations of blends, composites and coatings. Surface Measurement Systems Ltd +44 208 795 9400 mobrien@smsuk.co.uk www.thesorptionsolution.com
Waters and Thermo Scientific Triple Quadrupole models. Shimadzu offers prepackaged methods to enable rapid installation of the LCMS-8040. Once a user has developed new methods, individual components can easily be reused, helping to reduce rework and boost productivity. A single injection delivers full scan, MRM and pos/neg data, as well as many triggered scans. This allows quantification and confirmation in a single scan of any compound that is
Thermo Fisher Scientific has introduced three new ultrapure Fisher Chemical Optima LC-MS grade reagents that modify the mobile phase to minimise background noise and enhance MS detection. Designed for use with the existing ultrapure Optima LC-MS solvent range, the new reagents, comprising ammonium formate, ammonium acetate and acetic acid, improve chromatographic peak shape and provide stable analyte signals in a MS detector. Available in a variety of convenient pack sizes, these highly pure new additives ensure accurate and reliable results in LC-MS applications. The volatile salts, ammonium acetate and ammonium formate are utilised in LC-MS applications to improve ionisation under neutral conditions in ESI-MS, while acetic acid enhances chromatography separation under acidic conditions. These new Optima LC-MS reagents have minimal metal ion content, which limits mass adduct formation, facilitating MS interpretation. In addition, the low impurity levels, confirmed by diode array detection (LC-UV), extend column life. Purity is further enhanced by a new proprietary surface treatment applied to the HDPE bottle for acetic acid, which acts as a barrier between the bottle and acid, preventing contamination by plasticisers. Acetic acid is also available in convenient, ready to use, 1 ml glass ampoules, ensuring the freshest additive for preparing aqueous and
EPM 24
organic mobile phases in seconds, while safely eliminating the need to measure corrosive acids. To ensure optimum quality, product uniformity and purity, the ultrapure Optima LC-MS solvent range is manufactured in ISO 9001:2008 certified facilities. Lot-to-lot consistency and high purity across the entire Optima range, including the three new reagents, ensure consistent high standards during LC-MS applications and reproducible results with extremely low background noise. For more information on the Optima LC-MS reagents range and other Fisher Chemical products, visit www.acros.com or contact a local Fisher Chemical distributor. Thermo Fisher Scientific +1 978 905 1201 tracy.cartier@thermofisher.com www.thermofisher.com
SHOWCASE LUMINESCENCE, UV & IMAGE ANALYSIS Plate Reader with On-Board Camera Delivers Invaluable Insight into Sample Results Wyatt Technology has announced the launch of an all-new version of its DynaPro Dynamic Light Scattering (DLS) plate reader. The DynaPro Plate Reader II is an evolution of the first system, but with the significant addition of an onboard camera capable of acquiring images of each well. The camera enables the collection of clean and easily interpretable images, as well as providing valuable insights into the optimal conditions for each sample. The new system also offers an expanded temperature range, enabling measurements from 4°C up to 85°C for greater flexibility in protein melting and aggregation analyses. The DynaPro Plate Reader II has been designed to provide exceptional levels of ease-of-use, productivity, reproducibility and flexibility for the most demanding applications in the fields of formulation,
stability, crystallography, vaccine development, compound aggregation, nanoparticle characterisation, and any field in which determination of molecular or particle size and size distributions is valuable. Finally, the DynaPro Plate Reader II continues to be compatible with hundreds of industry-standard well plates in 96, 384 or 1,536 well formats. According to Wyatt Technology, automated DLS provides a totally new level of repeatability, reproducibility and stability for classical, kinetic and thermal studies. The DynaPro Plate Reader II contains a stable, temperature-controlled enclosure that is free from dust, providing the ideal environment for performing the most exacting and reliable DLS measurements. Offering an expanded temperature range from 4°C up to 85°C, the new system allows for a more rapid and accurate response. In
addition, the system can be fully operational and efficient, even when not all of the wells of a plate are filled. The same samples can also be analysed multiple times without having to empty and refill the wells, allowing for significant time savings. Equipped with inexpensive disposable well plates, the DynaPro Plate Reader eliminates the need for cleaning costly quartz cuvettes following each sample analysis to prevent contamination. Thousands of samples and solution conditions can be measured within a single plate for a reportedly unprecedented level of comprehensive and non-invasive biophysical characterisation. Coupled with liquid handling robots, the DynaPro
Plate Reader can also perform unattended for days, saving time in the laboratory. Wyatt Technology Corporation +1 805 681 9009 info@wyatt.com www.wyatt.com
Microplate Reader Boasts Three-in-One Measurement Capability
Latest Addition to Spectrophotometer Range Offers MicroVolume Capability
Berthold Technologies has launched the second generation of its multi-label TriStar² microplate reader, which employs the new, patent pending optical concept ALL-4-ONE, reportedly for the first time enabling luminescence, fluorescence and absorbance measurements with the highest respective sensitivity. TriStar² is also capable of reading FRET, BRET and BRET². In comparison with its predecessor, the optics have been improved and superior detection limits in fluorescence have been achieved: • less than 6 amol ATP per well; • and less than 0.3 fmol fluorescein per well. The instrument is characterised by a universal detector with extremely low noise for fluorescence and luminescence measurements and it is equipped with a photo diode for absorbance readings. Furthermore, optical filters can be used for luminescence measurements, enabling BRET (e.g., functional assays for GPCR research) and multi-coloured luciferase reporter gene applications. TriStar² can be fitted with up to three reagent injectors — based on the proven and most accurate JET technology — and temperature control for the microplate compartment. Two of the injectors have their tips in reading position, enabling the measurement of extremely fast reactions. New to the instrument is the reagent compartment placed at the front where the reagents are easily accessible and where they can
Jenway has launched the highly versatile Genova Nano, a three-in-one life science, standard and micro-volume spectrophotometer. With all the same features and benefits of the Genova Plus life science instrument, Genova Nano includes a micro-volume accessory for highly accurate measurement of DNA, RNA and protein in sample volumes as low as 0.5 µl. The ability to measure very small volumes makes Genova Nano the perfect analysis tool for measuring the purity and concentration of biological samples. With such small volumes there is minimal sample loss — a significant advantage for DNA researchers and other laboratories where there is limited availability of sample. The Genova Nano is simple and quick to use, producing highly accurate and reproducible results in under 6.5 seconds. It allows nucleic acid concentrations as low as 2 ng/µl to be detected. Working with micro-volumes of 0.5 to 5 µl eliminates the need to make dilutions and use cuvettes. A small aliquot is simply placed on the stainless steel read head using a pipette. After measurement, wiping the read head surfaces with a lint-free cloth removes all traces of the sample, allowing fast changeover between samples and increased sample throughput. Like the Genova Plus, the Genova Nano has pre-programmed methods for the measurement of ssDNA, dsDNA, RNA and oligonucleotide concentrations, as well as Bradford, Lowry, Biuret, BCA and Direct UV methods for protein analysis. In addition to dedicated life science measurement modes, this versatile instrument can also be used as a standard spectrophotometer with measurement modes for photometrics, concentration, multi-wavelength,
be kept cooled by the addition of crushed ice when needed. For increased sample throughput, TriStar² can be integrated into laboratory automation systems. Special reagent mounts provide a safe fixation of small reagent vials and ensure complete consumption of the reagents through inclination of the vial. Therefore, TriStar² microplate reader offers a multitude of possibilities and a wide range of applications. Measurements of enzyme activities, phagocytosis, calcium flux, cell viability, apoptosis, immuno assays, protein and DNA concentrations and protein-protein interactions are only a few of the many uses of TriStar². The unit is operated via the proven and intuitive ICE software. Single and multiple endpoint readings are possible, as well as kinetic and scanning measurements. The data is displayed in numerical and graphical formats and may be exported into Excel or printed. Berthold Technologies GmbH & Co. KG +49 7081177 0 bernd.hutter@berthold.com www.berthold.com
EPM 25
spectrum scanning, quantitation and kinetics. A large graphical display is built into the lid of the unit and the icon-driven software with soft-key navigation is intuitive and simple to use. The large internal memory can store over 300 methods, while methods and results can also be saved to a USB memory stick. Like the rest of the 73 series, the Genova Nano has an optional printer, which fits into the top of the spectrophotometer, minimising the bench space required and enabling the production of instant results. The Genova Nano also offers the flexibility to use the full range of 73 series accessories. Bibby Scientific Ltd +44 1785 812121 info@bibby-scientific.com www.bibby-scientific.com
Corporate News & Events
Learning and Launches at easyFairs LAB INNOVATIONS 2012 There will be plenty to see when easyFairs LAB INNOVATIONS opens its doors on 7 and 8 November at Birmingham’s NEC, UK. The event will showcase the latest laboratory technology and consumables, analytical and biotech equipment from key pharmaceutical suppliers such as RivaEurope, Brookfield Viscometers, Sartorius, Broadley-James, Steritech, Bruker UK and Vaisala. There will be lots of learning and career development opportunities too, as the Royal Society of Chemistry is running a unique conference programme at the show. This will span health and safety and analytical chemistry, including the latest advances in measurement and life sciences. The conference will also include sessions designed to help laboratory
professionals with their continual professional development. For instance, RSC Careers Specialist Charlotte AshleyRoberts will cover ‘continuing your career’, while ‘achieving chartered status’ will be addressed by RSC Professional Standards Specialist Dr. Andrea McGhee. Prompted by the show’s unique role in the UK market, many exhibitors are using it as a launch-pad for products into the pharmaceutical sector. Containment Technology Services (CTS) will be launching a new laboratory enclosure unit that represents a real step change for pharmaceutical industry labs. Sean Codling, CTS’ MD, said: “As the only UK show of its kind, we felt this was the perfect opportunity for us to get this major new product in front of lab professionals. I can’t give away too
much information at this stage as it genuinely is a new development that our team is still working on, but suffice to say we think it will receive a lot of attention at the show.” Similarly, LAB INNOVATIONS will be the first show where people can see SAIREM’s repotedly groundbreaking MiniFlow200 and MiniLabotron2000 compact microwave-assisted instruments. Those focused on accelerating time to market should check out BroadleyJames, which will be sharing the latest thinking on ROI benefits of process development laboratories. easyFairs +44 20 8843 8822 richard.thompson@easyfairs.com www.easyfairs.com/labinnovations
Yole Développement Report Names Leading Supplier of Flow Chemistry Solutions Syrris has been identified as the leading global provider of flow chemistry equipment in a recent independent report conducted by market research expert Yole Développement. The company first established itself in the rapidly growing flow chemistry microreactor market with the versatile Africa flow chemistry system and has now reportedly secured the
largest market share thanks to the introduction of the Asia flow chemistry microreactor system in 2011. The Asia series includes a range of modules that can be independently configured to cover a broad variety of applications. Its user-friendly proprietary technology allows for manual or automated experiments, and the modular
Particle Sizing Specialist Sponsors Filtration Society’s 2012 Conference Whitehouse Scientific is once again a major sponsor of The Filtration Society’s annual conference and exhibition, which returns on 2–3 October to the Mercure Chester East Hotel, Christleton, Chester, UK. The main one-day event this year focuses on Filter Characterisation and will be preceded by a Filter Testing Short Course. Dr. Graham Rideal, CEO of Whitehouse Scientific, is a former chairman of The Filtration Society and currently its science correspondent. “Whitehouse Scientific is delighted to again support the annual Filtration Society conference,” he said. “One of its attractions for me is the way that it gives conferees the opportunity to raise matters related to filter testing that are of particular interest to them, thus enabling us to learn from one another.” The Filtration Society conference always attracts industry leaders and this year is no exception. On day one, short course presenters will be Mark Crooks (TSI, UK), Danny Pattyn (Porometer.com, Belgium), Dr .Christophe Peuchot (IFTS, France), Dr. Steve Tarleton (Loughborough University, UK) and Professor Richard Wakeman (Consultant, UK). Topics covered will include particle size and shape analysis, porometry and characterising and testing filter media.
investment in research into new technologies, with several innovative products currently nearing commercial readiness. Syrris Ltd +44 1763 242 555 info@syrris.com www.syrris.com
Microbiology Company Completes Move to Manchester HQ
On day two, the main Filter Characterisation event will include expert presentations on topics as diverse as air filter testing, planning laboratory-scale filtration tests and the importance of particle statistics in challenge testing. Attendees will also be able to see the latest filtration products at the trade exhibition, which features the unique Technology Burst session, in which exhibitors are given the opportunity to make 5–10 minute presentations about their products or services. Full details of the conference programme, short course and exhibition, together with registration information, are available on the Filtration Society’s website at www.filtsoc.org. Whitehouse Scientific Ltd +44 1244 332626 info@whitehousescientific.com www.whitehousescientific.com
design makes it suitable for everything from a manually operated starter system to a fully automated reaction optimisation setup with integrated analysis. The Yole report also acknowledged that continued growth in this market is expected. Syrris will be well placed to meet this expansion, thanks to a strong development pipeline and continued
After almost a year of highly detailed planning, preparation and fitting out, on 18 June microbiology company Lab M moved into its new global headquarters. At a meeting to welcome the Lab M teams to their new home in Heywood, Greater Manchester, UK, Chairman Colin Goodwille paid tribute to everyone for their roles in achieving the move with minimum disruption. “I’d especially like to thank Ian Morris, who joined Lab M as Managing Director part way through the design and fitting out process,” he said. “Ian masterminded many of the critical stages and has ensured that we have stayed firmly on track.” He went on to add: “It has been a very exciting 12 months seeing the transformation of an empty shell into our state-of-the-art manufacturing facility. This significant investment in premises and infrastructure will ensure we operate to the highest industry standards and can further extend the range of products that Lab M supplies, and the markets we serve. Our
EPM 26
customers benefit from the expertise we bring together in housing R&D, manufacturing, technical and commercial operations under one roof and we have built in the capacity for significant future expansion.” The name Lab M has been synonymous with microbiology for more than 40 years and the company is especially well-known for the development, manufacture and supply of high-quality microbiological culture media. Lab M Ltd +44 161 820 3833 info@labm.com www.labm.com
INGREDIENTS & CONTRACT SERVICES
Biopharma CDMO’s Expansion Triggers Campaign Rentschler has undergone significant expansion in the last few years and has transformed itself into a leading contract manufacturer of clinical trial material and for market supply of drug products ranging from low-dose cytokines to higher-dose antibodies and biosimilars. Rentschler is now marking this transformation with a new campaign. During the past five years, production capacities have been increased. Among other new systems, a 1,000 l multiproduct disposable facility has been commissioned that was recently recognised with the prestigious Facility of the Year Award (FOYA) in the category Equipment Innovation. More than 300 new jobs have been created. Dr. Nikolaus F. Rentschler, CEO and Owner of Rentschler Biotechnologie, commented: “We are delighted to have received the FOYA for expanding our manufacturing facilities. It rewards our competence beyond the project business as the new facilities will allow us to cost efficiently design and build dedicated production facilities for our customers to ensure the market supply of their products.” To reflect the company’s
transformation, Rentschler has launched a new website to coincide with BIO 2012. The new slogan ‘Connect. Grow. Succeed.’ conveys that by contacting (Connect) and collaborating (Grow) with Rentschler, a successful project outcome (Succeed) will be achieved. Thus, the slogan summarises the main advantages and benefits for the customer in a nutshell. Rentschler has a very successful track
record spanning more than three decades. Today, the company operates nine independent GMP suites comprising stainless steel bioreactors ranging from 30 to 2,500 l and two 1,000 l single-use systems. Rentschler Biotechnologie GmbH +49 7392 701 810 klaus.schoepe@rentschler.de http://rentschler.de
Businesses Re-Align to Form Full Service Global Packaging Company Brecon Pharmaceuticals, a leading supplier of pharmaceutical commercial packaging solutions in the UK, and Anderson Packaging, one of the fastest growing pharmaceutical clinical and commercial contract packagers in the US, are further aligning their businesses to become a global end-to-end pharmaceutical packaging company. Both part of the AmerisourceBergen Corporation, the companies will provide innovative and differentiated packaging solutions under the name AndersonBrecon. AndersonBrecon will feature 12 facilities across two continents and more than 1,500 dedicated associates who will work to provide lifesaving medications to patients in more than 100 countries around the world. Though Brecon Pharmaceuticals and Anderson Packaging have been working together since 2006, the repositioning will enable both to better respond to the evolving pharmaceutical marketplace and provide efficient and more competitive solutions to meet customers’ global needs. “Over the last four years, the Brecon
and Anderson teams have worked together to build the foundation for a truly global healthcare packaging partner, and have demonstrated we understand our customers and can provide comprehensive, seamless solutions,” said Peyton Howell, President of AmerisourceBergen Consulting Services. “Moving to a more global organisation will better position us to offer our customers a more integrated approach for the global launch of pharmaceutical products, helping to accelerate speed-to-market and product success — and achieve an unparalleled level of customer service in the industry.” Peter Belden, MD of AndersonBrecon UK, commented: “We are delighted to announce that we are realigning Brecon Pharmaceuticals and Anderson Packaging to become a single, fullservice pharmaceutical packaging company. These new developments mean that we can offer our customers in Europe and beyond a truly global reach, with enhanced capacity and global service capabilities that enable us to support every stage of the product
EPM 27
lifecycle, from R&D through to commercialisation and long-term supply.” As part of the repositioning effort, AndersonBrecon has become a component of AmerisourceBergen Consulting Services (ABCS), a business unit of AmerisourceBergen that is comprised of market leading consulting companies including Xcenda, Lash Group, TheraCom and Premier Source. ABCS partners with manufacturers to prove product value and expand market access. The organisation offers reportedly unparalleled commercialisation support by integrating outcomes research, health policy analysis, managed markets agency services, reimbursement strategy, contract field staffing and now, packaging and clinical services through AndersonBrecon. AndersonBrecon www.andersonbrecon.com AmerisourceBergen www.amerisourcebergen.com
INGREDIENTS & CONTRACT SERVICES ROUNDUP Specialist CDMO Hires Director SCM Pharma has appointed a new director to bolster its senior team’s expertise and support its ongoing expansion. Qualified Person (QP) Paul Thomas joins the UK-based company as a Non-Executive Director and brings a wealth of sterile manufacturing, technical and commercial experience gained over 25 years in the sector, working for the likes of Warner Lambert, Penn Pharma and Nycomed Amersham (now GE). On his new appointment, Thomas said: “I am delighted to be working with the directors and the wider team at SCM Pharma at such an exciting period in the company’s continued growth into new markets. “Aside from its well-respected industry reputation, I was attracted to the company due to its world-class sterile manufacturing capabilities and ability to deal with complex drug products and processes. Given the trend towards more personalised medicines and
complex molecules, I believe SCM Pharma is very well positioned given its well-established sterile manufacturing capabilities.” A trained chemist and QP, Thomas has worked across many aspects of drug development and manufacturing during his career, including analytical, production, quality and senior commercial roles across the world. Dianne Sharp, MD at SCM Pharma, said: “We are very pleased to welcome Paul to the SCM family as he is very experienced in our sector and will no doubt bring a huge amount to the table when it comes to the future strategy and direction for the business. His expertise in sterile filling, radiopharmaceuticals and his understanding of the FDA’s quality regulatory requirements will be invaluable to have at board level and complements the existing skill set we have. “Furthermore, his vast experience in
Sterile Fill-Finish Services Provider Announces Increased Manufacturing Capacity at RTP Site in North Carolina
API and Intermediate Drug Development Company Reports 24% Sales Growth
Catalent Pharma Solutions has announced the completion of the construction of its newly renovated, approx. 307 m2 aseptic fill-finish manufacturing facility, at Research Triangle Park (RTP), North Carolina, US. Catalent has a comprehensive sterile product formulation and development offering at its RTP site. The product development group conducts preformulation, formulation development, process development and manufacturing support in addition to offering full service analytical development and stability capabilities. The state-of-the-art, sterile clinical manufacturing suite will provide Class A manufacturing space containing a flexible aseptic vial filling line capable of producing Phase I and Phase II clinical trial materials. These fill finish facilities are designed to comply with global GMP requirements. This renovation provides four-fold increase of the sterile fill-finish capacity at the Catalent RTP site and adds a new complementary technology to Catalent’s existing service offerings. “It is part of Catalent’s ongoing investment to provide integrated solutions to meet biologic and biosimilar drug development companies’ growing needs,” commented Christine Dolan, VP and GM of Catalent’s Development and Analytical Solutions business. “Combined with Catalent’s GPEx technology, expert biopharmaceutical laboratory services capabilities, world leading clinical trial supply services and commercial manufacturing capabilities, we will be able to help our customers bring more products from gene to market.” Catalent Pharma Solutions, Inc. www.catalent.com
Hovione has announced that the consolidated sales for the fiscal year ended March 2012 amounted to $180 million, the sixth consecutive year of sales growth, representing a growth of 24% in relation to last year. Miguel Calado, CFO, said: “Another year of continued strong performance by the Hovione group. During the last five years, Hovione has doubled its sales and has made bold strategic steps to both strengthen its ability to serve Innovators and to consolidate its leadership in off-patent contrast agents. Looking forward, and despite the difficult economic environment, we remain confident that 2012 will be another year of solid growth.” In addition to the financial results, which reflect the quality of the team’s performance, overall 2011 represented a year of great achievements, namely: • Hovione stood behind three NDA approvals — these were all major NMEs, and in two cases the approvals were full QbD filings in which Hovione was central to the design and data generation. • All Hovione plants underwent several successful GMP inspections by one or more of the major medicines agencies — a reflection of the large flow of filings and the high standards of compliance. Guy Villax, CEO, said: “Getting
dealing with Japanese and US companies also aligns perfectly with our current commercial activities.” Award-winning SCM Pharma primarily specialises in formulation development and the sterile production of products for clinical trials along with the supply of licensed drugs in niche markets for specialty pharmaceutical companies. Alongside its clinical manufacturing HQ in Prudhoe, SCM Pharma now has dedicated formulation development laboratory space and is currently building an approx. 2,416 m2 commercial production site near its existing sites in North East England. The CDMO recently invested in new isolator contained equipment to support vial filling and ampoule filling across many projects and further strengthen its capability for aseptic processing highly potent and toxic products. SCM Pharma recently won a North East Business Award in the Science &
Technology category for the Northumberland and Tyneside region. SCM Pharma +44 1661 838 186 raman.sehgal@scmpharma.com www.scmpharma.com
Hovione Cork plant.
multiple NDA approvals every year is becoming a habit at Hovione and this reflects well both on our customers, on our team and on the CMO model. Our patient investment in capacity, new technologies and development methodologies is paying off.”
Hovione +351 21 982 9362 ipina@hovione.com www.hovione.com
Drug Development Services Provider Receives Carbon Trust Standard Accreditation Covance has received Carbon Trust Standard accreditation in the UK for its commitment to measuring, managing and reducing energy consumption and carbon emissions. Covance, one of only 600 companies in Europe to hold this recognition from the non-profit Carbon Trust, achieved this recognition for its four UK sites through a rigorous, independent assessment of Covance’s organisational carbon management practices by the Trust. Covance’s facilities management practices at its sites in Alnwick, Harrogate, Leeds and Maidenhead were integral in reducing emissions and securing the Carbon Trust Standard accreditation. All Covance UK sites have rigorous energy reporting, management
strategies and policies in place that are guided by a corporate UK energy committee and designated energy champion representatives at each location. The company also employs a robust energy communication system across its UK sites and has provided comprehensive energy reporting to the UK government for the past three years. “The Carbon Trust Standard recognition affirms our strategy to reduce our carbon footprint on the environment, and with it, our overall energy consumption,” said Lucy Hind, Head of Facilities at Covance in Harrogate. “We are proud and responsible champions against climate change and will continue to manage our facilities and implement future capital
EPM 28
projects and improvements that both reduce emissions and deliver energy savings to our company.” “Covance’s commitment to carbon reduction is an important component of our global business strategy,” said Ann Towler, Covance Process Excellence. “While environmental efficiencies benefit our bottom line, it more importantly benefits our employees, our clients and the entire global community. The Carbon Trust Standard provides an important benchmark that we can improve against for years to come.” Covance Inc. +1 609 452 4807 www.covance.com
INGREDIENTS & CONTRACT SERVICES ROUNDUP Global Contract Research and Manufacturing Organisation Appoints President to Lead European Sales Growth AMRI has announced the appointment of Ian Shott as President of AMRI Europe, reporting to Thomas D’Ambra, Ph.D., Chairman, President and CEO. In this newly created role, Shott will have responsibility for AMRI’s business operations in Europe, including the company’s site in Wales, UK, and work closely with AMRI’s European-based business development team. As the founder of Excelysn, acquired by AMRI in 2010, and with more than 20 years experience working with global pharmaceutical, biotechnology and chemical companies, Shott will be instrumental in leading AMRI’s sales growth in European markets, as well as the worldwide effort to continue to expand revenue growth at the Wales manufacturing location. Shott was the founder and CEO of Excelsyn — now AMRI UK — acquired in February 2010 to expand the company’s
services platform and footprint in Europe. Shott serves as MD of Shott Consulting Ltd, where he provides consulting services to the healthcare and chemical industries, as well as leading industry boards for the British Government in Science, Technology, Innovation and Business Development. “Ian brings an intimate knowledge of the AMRI UK site, including its capabilities and leadership team, which will enable him to quickly embark on customer and business growth initiatives,” said Dr. D’Ambra, President and CEO, AMRI. “His extensive experience and skills strengthen our position in the European marketplace. Over the years, he has built a reputation as a leader and senior level statesman in the CRO/CMO business space, with key relationships in the European and North American healthcare community. His unique insights are a good fit with our
AMRI SMARTSOURCING brand and I look forward to his contributions in building strategic relationships with a broader customer base, which benefits all of our locations.” Shott’s earlier career included executive board posts at RhodiaChirex in France, Chirex in the US, Lonza in Switzerland and Astra Zeneca in the UK. He has been particularly involved in creating and/or transforming businesses by a combination of break out development, culture change, organic growth, internal re-engineering and external merger, acquisition and divestment. Shott said: “I believe AMRI has assembled a highly distinctive combination of skills, capabilities and capacities across three continents and can provide unparalleled solutions to customer needs. I am extremely excited at helping to develop business in Europe
in a rapidly changing business environment.” AMRI +1 518 512 2211 www.amriglobal.com
CMO Announces $2M Capital Expenditure Programme Encap Drug Delivery has announced a $2 million capital expenditure programme to support its growing CMO activities. Following the earlier expansion in 2008 when the company completed a $3 million investment involving an expansion of the Oakbank Park Way facility to provide two additional cleanroom suites, including a high potency facility and further expansion of its development laboratories, Encap is now providing new investment for additional high-volume manufacturing equipment. During the last 24 months, Encap has experienced a 20% increase in sales of its Pharmaceutical Development Services (PDS) and commercial manufacturing (CMO) activities and is forecasting a similar rate of growth in 2012/14. To compliment the growth plans, Encap has committed a further $2 million of capital expenditure, buying the latest product mixing and capsule filling
equipment, including a highly flexible Esco Labor (EL200) mixer and a highspeed Bosch filling machine (GKF2500L) and weight checker (KKE2500). Delivery of the new equipment will start August and will be completed by February 2013. Encap’s CEO Dr. Stephen Brown said: “Encap has seen tremendous growth in its PDS business in the last two years with the initiation of more than 30 new pharma client projects. We have also recently completed the launch of three new commercial pharmaceutical products in the EU and North America for which we have signed commercial manufacturing contracts. “Encap’s liquid fill and banding (sealing) technology is increasingly accepted as the sealing technology of choice for pharmaceutical products. We are seeing a growing interest in our commercial manufacturing capabilities and we have discussions progressing
with a number of companies on their late stage Phase III products. “Encap is investing to make sure that we have the best facilities and the most advanced manufacturing technology available to meet the needs of these new customers over the coming months and years. With the addition of this new equipment, we are now capable of outputting over six million capsules per day.”
CRO’s Leadership Team Further Strengthens with Key Appointment Encouraged by Harlan’s continued investment in key services for the pharmaceutical industry, Joanne Miller joins Harlan from the company’s global competitor MPI Research. Miller is an established professional within the Global CRO arena, bringing a scientific and commercial background spanning over 25 years. She has worked for both Syngenta’s Central Toxicology Laboratory and MPI Research, where most recently she was Director of European Sales. “Joanne’s passion for a true partnership approach to business, combined with her leadership and continuous improvement skills, will make her an excellent asset to the Harlan team and our clients” said Manuela Leone, CRS President. Harlan Laboratories Ltd +44 1332 792896 crs.uk@harlan.com www.harlan.com EPM 29
Encap Drug Delivery +44 1506 448080 ldunlop@encapdrugdelivery.com www.encapdrugdelivery.com
INGREDIENTS & CONTRACT SERVICES ROUNDUP Alternative Approach Provides Outsourcing and Insourcing of Contract Manufacturing and Research Services AMRI has launched SMARTSOURCING, an approach that further focuses its research and contract manufacturing services on the various needs of the life sciences and other industries. AMRI SMARTSOURCING is a series of strategic sourcing options for customers to reach more successful outcomes. SMARTSOURCING is based on 21 years of industry-leading experience and global locations, and combines high quality scientific performance and enhanced decision-making with the accountability of delivering results in a cost-competitive manner. Pharmaceutical companies are under pressure to deliver accelerated and increased drug discovery success with reduced budgets and resources. This can result in a loss of productivity where
compromises, such as putting price before quality, scientific expertise and even manufacturing capability, are often struck. Furthermore, following substantial downsizing in the US and Europe, many large pharmaceutical companies are losing experienced scientists with drug discovery and development expertise and relying more on their providers to fill critical knowledge gaps. As a result, CROs and CMOs need to reconsider their current service strategies to find more appropriate ways to meet the market’s changing needs. AMRI has taken this challenge and recently made significant changes to build a stronger, more agile organisation for its customers. SMARTSOURCING is a reportedly
pioneering approach for the industry that is fit for purpose in today’s world and puts the power of decision making, without compromise, in the hands of the customer. SMARTSOURCING is a means of insourcing or outsourcing, or even a hybrid model of both, which can deliver high-quality performance and scientific expertise, built on a foundation of 21 years of accomplishment delivering customer IND candidates and API manufacturing successes. It means tapping into AMRI’s people, knowhow, facilities, expertise and global project management to provide exactly what is needed across the discovery, development and manufacturing process. “Pharma companies are looking for
more supplier accountability, greater trust and consultation,” said Thomas E. D’Ambra, Ph.D., President and CEO of AMRI. “They want a better balance of risk, but also greater flexibility and tailored business models that address their unique needs. “With SMARTSOURCING, we offer customers innovative and strategic collaborative partnerships, without compromising quality or lowering expectations. We look forward to working with our customers as we continue to provide creative and flexible outsourcing solutions.” AMRI +1 518 512 2211 www.amriglobal.com
Chemistry and Manufacturing Specialist Strengthens Sales Team Onyx Scientific has bolstered its business development team with the appointment of an experienced new director. Brian Jolly joins the CMO’s UK team as Director of European Business Development and will be responsible for overseeing the company’s sales effort across Europe. PhD qualified, Brian brings a wealth of experience to the company, having spent over 25 years in a range of technical and commercial roles in specialty chemicals and the wider chemical industry. Operating from MHRA and FDA licensed sites in UK and India, Onyx Scientific supports pharmaceutical and emerging biotechnology, from medicinal chemistry and preclinical through Phase I-III, scaling-up to large scale commercial API production. Denise Bowser, Commercial Director
Head at Onyx Scientific, said: “We are delighted to have Brian on board as he has a huge amount of commercial experience that will no doubt benefit the company’s continued growth. “Although we have clients across the world, the European market remains a key one. It is therefore essential for us to have this level of expertise on the ground to service clients and potential customers.” The CMO recently launched a new website to reflect the company’s expanded service offering following its acquisition by Ipca Laboratories last year. Its team in Sunderland, UK, has dovetailed its chemistry services with the scale-up and manufacturing services offered by Ipca in India. Jolly said: “The thing that attracted me to Onyx Scientific was the company’s ambition for growth. It is a dynamic
business with a fantastic reputation for expertise and competence for reliably delivering on its commitments to customers. “It’s a fantastic new challenge for me and I am convinced this business has a solid foundation on which it can now grow and be recognised as a key player in the global contract manufacturing marketplace.” Working as a preferred partner of many of the world’s top pharmaceutical firms, Onyx Scientific’s UK-based laboratories deal with complex chemistry and deliver early stage programmes involving custom synthesis, lead optimisation, process development, solid-state chemistry and GMP API synthesis. It is then able to scale-up, internally tech transfer and provide increased efficiency for clients from its commercial sites in India.
Onyx Scientific Ltd +44 1915166516 brian.jolly@onyxipca.com www.onyxipca.com
CDMO Bolsters Supply Chain with Two Key Appointments
Partnership to Provide Integrated Solutions for Oral ControlledRelease Technologies
Penn Pharma has made two senior level appointments to its Supply Chain Team. Peter Goold has been appointed as Director of Supply Chain and Project Management, a newly created position for the global business; and Colin White has been appointed as Head of Manufacturing to run the production operation at Penn’s UK facility. Goold and White bring more than 30 combined years of pharmaceutical and outsourcing industry experience to the team. Between them, they have run global supply chain operations covering commercial packing, solid oral dose manufacturing and sterile products production in previous roles. With extensive experience in developing and implementing efficient supply chain and project management solutions, Goold will lead a review of supply chain efficiency, which will provide Penn with a robust foundation to grow existing business and encourage new leads for the new contained manufacturing operation due to open in 2013. White, who has a wealth of knowledge in commercial and potent product packing and experience in operator training and skill development, will help the company implement a new cellular manufacturing structure.
Catalent Pharma Solutions and Bend Research have entered into an agreement to provide integrated solutions for pharmaceutical companies seeking to develop and manufacture specialised, multiparticulate, oral controlled-release products. Under the agreement, Bend Research and Catalent will provide an integrated approach to bring complex controlledrelease products to market faster and more efficiently with optimal therapeutic and release profiles. The companies’ combined expertise in formulation development and Catalent's breadth of services in analytical/CMC, solid-state optimisation, clinical and commercial supply will provide pharmaceutical companies with optimal dosage forms and a more efficient path to market. Catalent and Bend Research are developing joint operations and technology-transfer protocols to make the customer experience seamless and efficient, while leveraging the strengths of both companies to develop better treatments for patients globally. “Our integrated approach is geared toward complex, multiparticulate controlledrelease products, which have traditionally presented a high scale-up risk when they are transferred to commercial manufacturing sites,” said Rod Ray, CEO of Bend Research. “This partnership with
Speaking on his appointment, Goold said: “It is fantastic to be joining Penn at such a momentous stage in the company’s growth. The growth plans in place are a great motivation to ensure additional business is secured for our new contained manufacturing operation.” The construction of the new, approx. 1,394 m2 Contained Manufacturing Operation has commenced and is designed to meet the highest international quality standards. The new facility will enable the team at Penn to further build upon its established 15 years expertise in the manufacture of highly potent drugs for the worldwide market. Chief Executive Dr. Richard Yarwood said: “We are in a period of rapid development both with new personnel and the new facility. Peter and Colin join Penn at an integral point in the company’s growth. Their strong technical backgrounds in their respective areas and vast customer service experience in outsourcing will be a great asset to the Penn brand.” Penn Pharmaceutical Services Ltd +44 1495 711 222 enquiries@pennpharm.com www.pennpharm.com
EPM 30
Catalent will provide an efficient pathway for these medicines from early development through commercialisation. We believe that Catalent’s breadth of services and demonstrated success in bringing controlled-release products to market, as well as supplying them globally, makes them an ideal complement to our development strengths.” “Catalent and Bend are aligning their scientific expertise and processes to ensure that developments are undertaken from day one based on QbD principles,” said Ian Muir, President of Catalent’s Modified Release Technologies business. “Bend’s added laboratory-scale modelling expertise will enhance and increase the efficiencies that Catalent will provide to customers to bring difficult to formulate and manufacture controlled-release compounds to market faster, with optimal product profiles. This should enable optimal and seamless scale-up within Catalent’s Controlled Release network, and particularly at our Winchester facility in Kentucky, which is widely regarded as the leading commercial facility for multiparticulate products.” Catalent Pharma Solutions, Inc. www.catalent.com Bend Research Inc. www.bendresearch.com
INGREDIENTS & CONTRACT SERVICES ROUNDUP 400 Jobseekers Attend Recruitment Day to Mark Pharma Manufacturer’s Major Site Expansion Aesica has welcomed 400 potential employees through its doors as it prepares for significant site expansion. The company recently announced it was creating up to 100 new jobs at its facility in Queenborough, UK, to support growth on site, bringing with it a much-needed boost for the local community. The positions will be filled during a phased recruitment drive, which will begin in the next couple of months. To raise awareness of the plans, Aesica invited interested jobseekers to find out more about the roles being created and hear from senior personnel about what the company has to offer. One of the jobseekers was unemployed former steel worker Mick Gisby from the Minster area of the Isle of Sheppey. He said: “I have been out of work since January, so attending this open day has really felt like a positive step. I am very optimistic based on what I’ve heard from the company. I feel like things are starting to come together for me.” Pupils from the Isle of Sheppey Academy also attended the open day for a behind the scenes look at what a career in the pharmaceutical industry entails, and to listen to Site Director Peter Casey, who began his
pharmaceutical career as a laboratory analyst. Casey said: “I have worked my way up through the ranks to the role of site director and am proof that the pharmaceutical industry offers excellent opportunities for young people. We really want to connect with those who are interested in a career in science and
this open day was the ideal platform to do that.” Aesica is looking to fill 50 of the 100 posts in the run up to the expansion with the additional 50 following when it is complete. The expansion will see a new 10,000 m2 production and warehousing facility built for the creation of solid dose
medication for the treatment of one of the world’s most common lifestyle diseases. Simon Clough, MD, Aesica Formulated Products, said: “This is an exciting time for Aesica and the local community. Not only are we growing as a business, we’re also creating up to 100 new jobs, which is a fantastic boost for the region’s economy. “As a long-standing local employer with plans to grow globally, we’re also looking to bring young apprentices on board, which we believe will not only strengthen the business, but also reaffirm our commitment to youth employment on the Isle of Sheppey and Kent.” The expansion plans follow the opening of the £3 million potent manufacturing facility last year, which has significantly extended the company’s capabilities in manufacturing and packaging medication for eight of the world’s ten most successful pharmaceutical brands. Aesica Pharmaceuticals Ltd +44 191 218 1960 info@aesica-pharma.com www.aesica-pharma.com
Partnership to Manufacture Oral Vitamin D3 Product Continues D3 Pharma has announced its continuing partnership with Encap Drug Delivery to expedite the commercial manufacturing and product licensing programme for its proprietary, high-dose oral, vitamin D3 product Plenachol, for the treatment of vitamin D deficiency and insufficiency. Plenachol is a patented, liquid-filled capsule formulation of vitamin D3, which
was developed in conjunction with Encap and is available at three dosestrengths: 20,000, 40,000 and 100,000 international units. Plenachol has a reportedly unique formulation base, which is free from animal derived excipients and peanut constituents. The utilisation of Encap’s world-class liquidfilling capsule technology secures
Plenachol as a first and best-in-class, high-dose oral vitamin D3 product. Plenachol will continue to be made available as a Specials product during the pre-license phase via Encap Drug Delivery. For more information regarding Plenachol Specials supply, contact Dr. Janice McLachlan — jmclachlan@encapdrugdelivery.com.
D3 Pharma Ltd +44 1622 630057 www.d3-pharma.com Encap Drug Delivery +44 1506 448080 www.encapdrugdelivery.com
Fine Chemical Products Supplier Opens Large-Scale Manufacturing Site in Budapest UBICHEM Group further grown its business by adding a manufacturing site. The new member of the group, UBICHEM Pharma Manufacturing, will be producing starting materials, intermediates and other fine chemical products for pharma and non-pharma applications in industrial quantities. This expansion positions the UBICHEM Group to be one of the biggest providers in the CEE region.
The newly acquired 55,000 m2 facility is located in Budapest, Hungary, and it is able to produce fine chemical products in multi-tonne quantities. The new manufacturing site also expands UBICHEM Group’s presence in the nonpharma sector. CEO József Répási commented: “This new plant represents a milestone in UBICHEM history. From now on, we are able to provide a comprehensive range
of services from process R&D through pilot-scale, cGMP API manufacture to high-volume manufacturing. By applying the rigorous quality control and strict production guidelines we have had in place at UBICHEM Pharma Services since 1996, we will now be able to ensure the high quality of intermediates and fine chemical products at our new manufacturing site. “We believe we have a competitive
edge over intermediate manufacturers based in Asia by leveraging the highly skilled talent pool of chemists and by meeting high-quality expectations and strict deadlines for our customers.” UBICHEM Group +36 1 347 5060 ext. 132 zszsoter@ubichempharma.com www.ubichempharma.com / www.ubipm.com
Process Development and Manufacturing Services Offering Decreases Time-to-Market Merck Millipore, the Life Science division of Merck, has launched its Provantage Solutions — world-class process development, manufacturing consulting and implementation services provided by Merck Millipore scientists, engineers and applications specialists. The new offering can be delivered either onsite at a drug manufacturer’s facility or at Merck Millipore’s advanced bioproduction facility in Martillac, France, or at one of its six access laboratories around the world. Provantage Solutions seamlessly complement biopharmaceutical and pharmaceutical companies’ internal capabilities and expertise, and are customised with the optimal mix of
products, services, consulting and project management. Provantage Solutions provide greater control and increased flexibility for both small and large molecule development and manufacturing processes. “Until now, the options for process development and manufacturing were limited to internal resources or conventional outsourcing,” described Christophe Couturier, VP of Services and Solutions, Merck Millipore. “While each option has pros and cons, Provantage Solutions integrates the best of each and helps accelerate the journey of a molecule to commercial phase.” Initial offerings include: Provantage Biodevelopment and Clinical
Supply Solutions • An innovative solution for biologics manufacturing that incorporates the latest technologies in upstream, downstream and single-use systems. • Includes process development and validation services. • GMP production for pre-clinical to phase II. • Technology transfer and scale-up services for phase III and commercial production. Provantage Bioprocess Consulting Solutions • A wide range of projects with defined milestones, deliverables and business outcomes, from upstream all the way to commercial tech transfer.
EPM 31
• Applies expertise, products, services and technology to help solve a client’s business problem or challenge. Provantage Solutions incorporate Merck Millipore’s blend of expertise across the development and manufacturing spectrum with an indepth understanding of individual unit operations and applications. This allows delivery of optimised solutions that take into account the entire upstream and downstream operation. Merck Millipore +1 781 533 5197 janice.paquette@merckgroup.com www.emdmillipore.com/provantage
SHOWCASE COATINGS, FILMS & CAPSULES
CASE STUDY Capsugel’s Licaps liquidfilled hard capsules have been successfully used by major healthcare company GlaxoSmithKline (GSK) for the reportedly most established brand in the German urological market GRANU FINK. After initially launching the product in a soft gelatin capsule form, GSK’s Consumer Healthcare Division decided to investigate other dosage form options to try and improve the product’s quality and reduce its production-to-market lead time. GRANU FINK’s active ingredients, pumpkin seeds extracts and pumpkin oil were challenging to encapsulate because of the large particle size and required a long maturing period when encapsulated in traditional softgels. After testing a switch to Capsugel’s Licaps technology, GSK found the product to be leak-free and has now reduced its product lead times by an amazing 12 weeks. Dr. Stephan Wurtz, Head of Production at GSK in Herrenberg, explained: “After comparing two different automated capsule sealing techniques, the Licaps capsules had intact seals during the complete period of stability testing and we could not detect any leakage. Capsule integrity is a key parameter used to predict product shelf-life and especially helps with preventing too many product returns, and this is why we ultimately chose the Licaps liquid-filled hard capsules as our dosage form.” Since Licaps capsules entered the market nearly 10 years ago, Capsugel has made multiple technological advances, including an enhanced mechanical seal with a seal zone six times greater
LIQUID-FILLED HARD CAPSULES WITH HIGH INTEGRITY SEAL PROVIDE SOLUTION FOR CHALLENGING FORMULAS
than a banded capsule. Also, while they are able to effectively mask taste and odour, Licaps capsules also offer many branding options that may improve loyalty when compared with other dosage forms. According to Capsugel’s research, consumers perceive Licaps capsules to be high-quality, modern and natural looking in a dosage form that is memorable, easy to recognise and easy to swallow. GSK also conducted its own consumer survey to test the visual and handling acceptance of the Licaps dosage form among regular users of GRANU FINK femina and 73% of consumers were positive about the new Licaps liquid-filled hard capsule format. In addition, Licaps liquid-filled hard capsules provide a solution for a variety of challenging compounds. It can improve bioavailability for poorly soluble compounds while providing effective formulation options for low-melting point compounds and safe formulation of low-dose/high potency actives. Licaps manufacturing also offers an established and robust process with the flexibility to allow for production in-house or by Capsugel. With a straightforward manufacturing transfer, including the installation of Liquid Encapsulation Microspray Sealing (LEMS) technology, Licaps capsules can even use the same line as powder-filled capsules and are sealed and dried in a matter of minutes, making manufacturing a cost-effective and environmentallyfriendly process. Dr. Wurtz added: “The Licaps system has integrated well with our Bosch capsule filling equipment and because of the expert technical assistance we had from Capsugel’s installation and formulation teams, we put in place a number of new validated production processes with five fully trained operators in a very short time. During one shift using the Licaps system, up to 350,000 Licaps capsules can be filled. We now have full in-house
Capsugel +33 3 89205846 catherine.lehmann@capsugel.com www.capsugel.com
Drug Delivery CRO Expands cGMP Capabilities with Addition of Thin Films
Assortment of Coatings for Achieving a Multitude of Functions Mantrose-Haeuser has been supplying shellac-based coatings for more than 100 years. These products are easy to use and give consistently good performance when used in current application methods, including continuous coating machines. New products need to keep pace with the high-speed processing machines used in the pharmaceuticals and nutraceuticals industries. Products need to spread over the surface of various shapes and sizes of tablets and dry much faster. The deposit rates need to be lower, but consistent to retain the shape of the pieces. Mantrose has consistently introduced new products. Coatings perform a multitude of functions, ranging from aesthetic appeal, ease of swallowing, taste and odour masking to branding and identification of the drug. Hydroxypropylmethyl cellulose coatings (Mantrocel and Mantroclear) are used for the immediate release tablets. Water impermeable coatings can be used to modify the release of the active substance. Shellac, with its low melting point and good adhesion properties, is a useful ingredient for extrusion spheronisation. Reducit is a new food grade acid from Mantrose that is useful for the stabilisation of acidic drugs. Mantrose has recently opened a new, custom designed R&D centre in the US, with a team of scientists to assist customers with their formulation requirements and in developing new excipients.
control of the manufacture of our drug and supplement lines, which gives us a number of benefits.” Keith Hutchison, SVP of R&D at Capsugel, concluded: “We are delighted that a company such as GSK was willing to embrace and test Licaps capsules so extensively with their new pharmaceutical and nutraceutical product lines. Their work leads the way for other pharma and healthcare companies seeking rapid scale-up and production of high integrity liquid-filled hard capsules.” GSK’s GRANU FINK range of products is used to strengthen the function of the bladder and help treat prostrate disorders, and now includes GRANU FINK femina, GRANU FINK Prosta and GRANU FINK Blase.
Mantrose UK Ltd is a wholly owned subsidiary of Mantrose-Haeuser Co. Inc., which is a part of the RPM Group.
Particle Sciences has added new coating capabilities for preparing polymer film-based drug products from liquid formulations under cGMPs. According to Garry Gwozdz, Director, Formulation Services: “Our purpose is to provide clients with the most efficient drug product. Increasingly, we are seeing a demand for thin filmbased products, particularly with respect to transdermal drug-eluting patch products and rapidly-dissolving strips. The acquisition of semi-automated coating equipment will allow us to screen more formulation approaches and get our clients into the clinic faster with commercially representative film-based products.” Particle Sciences focuses on advanced drug delivery solutions and is FDA registered and licensed for all schedules of controlled substances. Gwozdz added: “Particle Sciences already had cGMP hot-melt film extrusion capability and now, with the addition of coating and drying capabilities for liquidbased formulations, our clients have access to an array of viable and scalable film-manufacturing technologies.”
Mantrose UK Ltd +44 1488 648 988 orders@mantrose.co.uk www.mantroseuk.com
Particle Sciences Inc. +1 610 861 4701 info@particlesciences.com www.particlesciences.com
EPM 32
SHOWCASE LOGISTICS & DISTRIBUTION Palletised Freight Specialist Provides Kent Pharmaceuticals with Distribution Remedy Logistics firm Palletways 51 has won a major new contract with Kent Pharmaceuticals Ltd, reportedly Britain’s largest independent pharmaceutical manufacturer, which has over 100 own label products. As a member of Palletways, claiming to be Europe’s fastest growing and largest provider of express delivery services for palletised freight, Palletways 51 is responsible for distributing approximately 1,200 pharmaceutical products lines for Kent Pharmaceuticals to wholesalers. Ashley Amos, Director at Kent Pharmaceutical, said: “We chose Palletways 51 as they have an excellent reputation in the marketplace and we felt this would be a real asset for our business and enhance our service to our customers.” Commenting on the contract, Dez
Palletways 51 is one of over 100 Palletways members — all independent transport providers with local knowledge and expertise — which make up the UK distribution network and provide a range of express delivery services for small consignments of goods across the country, as well as to mainland Europe. Utilising each other’s resources, all the member companies deliver goods to market faster and more cost effectively than traditional haulage methods. Palletways, which was set up in 1994, has over 300 depots across the UK and mainland Europe and handles up to 25,000 pallets a day through ten hub facilities across Europe. Shirley, MD at Palletways 51, said: “We are proud to have been appointed and look forward to working with Kent Pharmaceuticals. We specialise in
providing the total logistics solution tailored to the needs of each customer, enabling businesses to make cost efficiencies within their supply chain.”
Palletways (UK) Ltd +44 845 678 0081 sales@palletways.com www.palletways.com
Contract Logistics Solutions Specialist Opens Distribution Centre for Life Sciences and Healthcare in Mumbai DHL Supply Chain has opened a distribution centre for the Life Sciences & Healthcare industry in Mumbai, India. This first state-of-the-art Life Sciences facility is located within a newly constructed c.5203 m2 multi-customer distribution centre and will cater to the requirements of the rapidly growing life sciences industry in one of the most important emerging life sciences and healthcare markets in the world. Vikas Anand, COO, DHL Supply Chain India, said: “The new platform in Mumbai will enable us to provide a world-class service to our customers, enabling them to expand their businesses. Life sciences and healthcare is a key industry for DHL Supply Chain in India. By setting up this world-class infrastructure, we continue to meet the industry’s increasing logistics and warehousing needs. We have the capabilities to distribute to wholesalers, pharmacists and hospitals from our new centre in Mumbai based on customer demands.”
The new DHL Supply Chain Life Sciences & Healthcare distribution centre will offer a complete portfolio of services to manufacturers of pharmaceutical products from order management to warehousing and distribution. DHL’s services are customised to the needs of the medical devices and pharmaceutical industry, including very specific solutions such as postponement services, clinical trials logistics and order-to-cash. The MultiClient Site uses green technology such as LED lighting and wind-assisted ventilation. Angelos Orfanos, President and Global Head of Life Sciences & Healthcare, DHL Customer Solutions & Innovation, said: “DHL is strongly committed to investing in markets of growing importance. Looking to 2015 and beyond, India, China and other emerging markets are expected to be the key drivers of growth in the pharmaceutical and medical device sectors. With this warehouse, we take
another step in pursuing DHL’s global industry sector strategy by opening our new platform and delivering exactly the specialised services that our clients are asking for.” DHL operates over 150 Life Sciences facilities worldwide to support its global Life Sciences & Healthcare strategy. This provides the platform to offer sector specific solutions. The pharmaceuticals market was valued at €730 billion in 2010 and is projected to grow by 5–8% until 2015. Similar growth rates apply for medical devices, with a total market size of €200 billion. The emerging markets are forecasted to contribute approx. 75% of
global pharmaceutical sales growth by 2015. According to IMS Research, India’s rank as a pharmaceutical market is expected to increase from 2010 to 2015, from 12th to 8th place; the market’s share of US pharmaceutical spend is also expected to grow from 4% to 8% over the same period. Deutsche Post DHL www.dp-dhl.com
Logistics and Transportation Company Completes European Distribution Centre in Netherlands Movianto Nederland is set to begin operations in the new, state-of-the-art warehouse especially built to meet its pharmaceuticals and healthcare clients’ needs. The strategically located warehouse also offers the reportedly largest facility for the storage of deep frozen pharmaceutical products in Europe. The European distribution centre situated at this continental vantage point in Oss offers the pharmaceutical and healthcare industry 22,000 temperature controlled pallet spaces, ensuring high-quality standards for products according to GDP guidelines
and ISO 9001:2008 certification. A particular highlight of this new facility includes an area with 50 deep frozen pallet locations (-40°C) for specialty pharmaceutical products. A dedicated area within the warehouse has a capacity for 2,220 cold pallet locations (+2°C/+8°C), as well as 350 frozen pallets (<-20°C), which can be used for storing blood plasma products, for example, and can be extended to house a further 750 pallets if required. One thousand, one hundred narcotics pallet spaces (+15°C/+25°C) and a manufacturing room for relabelling and repackaging and postponement
activities rounds off this scaleable service offering. With its own dual temperature controlled and validated transportation fleet, Movianto Nederland can provide top quality distribution within the Benelux region in close conjunction with Movianto Belgium. This applies for ambient as well as +2°C/+8°C transport. Due to this location at the heart of Europe, Movianto has included all the functionalities of a central European warehouse, with a dedicated cross docking area and bonded warehouse facility to offer clients integrated supply
EPM 33
chain solutions, including a multilingual call centre that provides operations in a total of six languages. Movianto’s transport solution manages freight and distributes the products to local warehouses throughout the whole of Europe. Movianto GmbH +49 711 900 597 912 ottilie.krug@movianto.com www.movianto.com Movianto Nederland BV +31 412 406 420 floris.vanhaselen@movianto.com
Events
REGULATORY AFFAIRS Registration Opens for Mediplas 2012 The first wave of population of the eXtended LOOKING EudraVigilance Medicinal Product Dictionary BEYOND XEVMPD (XEVMPD) may have peaked by 2 July (the deadline for compliance), but this is just the COMPLIANCE TO beginning of a new IT era in regulatory ISO IDMP informatics. Pharmacovigilance was incorporated some time ago in the work programme of the ICH (International Conference on Harmonisation), with the definition of the IT requirements lead by the M5 group. Later, it was decided to hand the ICH project over to the ISO (International Organization for Standardization) and some work had already been undertaken independently in the US by the HL7. To avoid duplication of work, the project eventually became a joint initiative between the ISO, ICH and HL7 bodies. The original project was divided into two sections: • the adverse events messages; • and the terminology needed for a smooth and accurate building of the message, the IDMP (Identification of Medicinal Products). The IDMP standards were developed in response to a worldwide demand for internationally harmonised specifications for medicinal products. The IDMP covers all medicinal products for human use and has a broad scope, including pharmacovigilance, clinical trials, regulatory (SmPC, labelling, etc.), patient health records and future developments such as ePrescriptions. Five ISO standards have been created, including one for pharmaceutical substances (prEN ISO 11238), active and inactive, with an estimated content of 30,000+ records, and a standard for pharmaceutical product identifiers (prEN ISO 11616), which will be the same for a given product from a given manufacturer, wherever it is marketed. Manufacturers will soon then be heavily engaged in this logical model for the classification of pharmaceutical products that constitutes the global evolution of the XEVMPD, which is strictly European. It is not yet known which countries will support IDMP. The US, EU, EEA and Canada, Switzerland and Japan are currently most active on IDMP. Although, in total, 85% of all countries of the world are involved in the IDMP activities.
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 panEuropean 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
Dr. Paolo Biffignandi paolo@elc-group.com
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.
Registration for Mediplas 2012 is now officially open. Visitors wishing to attend can now register online at www.mediplasuk.com. Taking place on 25–26 September, at The NEC, in Birmingham, UK, Mediplas is a new, uniquely focused event for the highly specialised area of manufacturing plastic parts for the medical industry. The exhibition will cover all areas of the medical plastics supply chain from design and prototyping, materials, cleanroom machinery, extrusion and injection moulding to process control, mould making and regulation. Plastics production for the medical industry is a rapidly expanding market, with a diverse range of applications for polymers. From single-user pipette tips to lifelong artificial implants, the medical industry relies heavily on plastics in its manufacturing processes. Biocompatible plastics and polymer compounds are increasing becoming the material of choice for medical device manufacturers as they continue to replace metal and ceramics. On the show floor, Mediplas will play host to over 50 exhibitors that will bring the most innovative and dynamic materials and technologies available on
the market. Exhibitors to date include Engel, Albis, Distupol, Krauss-Maffei, Ticona, Netstal, Greiner Bio-One, Dyne Technology, Biesterfeld Petroplas, Carville, Classic Industries, Sumitomo Demag, plus many more. A series of free-to-attend technical seminars will be staged in a dedicated seminar zone, designed to encourage technology adoption. Sessions include Medical Grade Polymers, Materials Selection, Design & Prototyping, Efficient Manufacturing, Advanced Processing and Regulation and Legislations. At Mediplas, visitors will have the opportunity to speak to suppliers faceto-face, see actual machines in action and handle products that are the result of the latest technological advances in both machinery and materials. Mediplas is held alongside TCT Live and MM, MEMS & NANO Live. Rapid News Communications Group +44 1829 770037 events@rapidnews.com www.rapidnews.com
WTG Announces Speaker Lineup for Early Drug Development Summit With its 15 years conference production and management experience, WTG is launching the Early Drug Development Summit, taking place on 3–4 December, in Berlin, Germany. The Early Drug Development Summit brings early drug developers together to discuss maximising drug investments, toxicology, safety and biomarkers. WTG has announced that Dr. Lucette Doessegger, Global Head of Translational Safety Medicine at Roche Switzerland, will be sharing her 10 years of industry experience on early drug development at the Early Drug Development Summit on Day 2, 4 December, at 09:15–10:00, in Hotel Palace Berlin, Germany. Dr. Doessegger will discuss ‘Using Translational Medicines in Early Drug Development’, which will cover: • designing risk management protocols to understand the mechanism of action and implement safety measurements; • using translational safety medicine to measure signalling before it reaches clinical trials; • and efficiently determining the impact of toxicity effects on specific populations. Additional confirmed speakers and their presentations include: • Dr. Andy Parsons, VP Preclinical Development, GSK UK — Developing Business Frameworks for the Successful Co-creation of Value; • Peter Theil, Head of Early Development PKPD, UCB Belgium —
EPM 34
Pre-IND PK/PD Characterization of Small Molecule Drugs and Biotherapeutics to Increase the Probability of Success of Drug Development; • Stefan Proniuk, VP Development, Arno Therapeutics US — Reducing Development Timelines to Bring Products to Market Faster; • Ian Wilson, Senior Principal Scientist, AstraZeneca UK — Successfully Identifying Human Drug Metabolites for Toxicity Testing; • Frederik Deroose, Director, Global Business Office Integrator, Jansenn Belgium — Successfully Using Virtual Outsourcing for Early Drug Development; • and Prof. Jürgen Borlack, Head of Toxicology, Hannover University Germany — Utilising Better Animal Models to Improve Safety Studies. The two-day conference offers prearranged one-to-one meetings between +30 pharma industry solution providers and +120 drug development experts, as well as real life case studies from leading drug development companies; Roche, GSK, AstraZeneca, UCB and more. World Trade Group (WTG) +44 207 202 7690 michaela.melcher@wtgevents.com www.eddsummit.com
EPM CLASSIFIEDS CLEANROOMS EQUIPMENT & SERVICES
GRINDING AND GRANULATION EQUIPMENT & SERVICES
CONTAINMENT
DIOSNA Dierks & Söhne GmbH
Telstar Life Sciences
Tel: +49 (0) 541 331 040 Email: info@diosna.de Web: www.diosna.de
Tel: +34 (0)937 361 600 Email: sales.pharma@telstar.eu Web: www.telstar-lifesciences.com
CONTAMINATION CONTROL Helapet are a leading supplier of cleanroom disposables for hospital, pharmaceutical, electronic and laboratory cleanrooms providing solutions for contamination control in critical environments.
Freephone: 0800 0 328 428 Email: sales@helapet.co.uk Web: www.helapet.com
Supply of our quality range of SteriClean® sprays, offering an effective mix of alcohols, biocides and neutral detergents aiding disinfection measures in controlled environments.
To advertise here, please contact Rob Anderton: Tel: +44 (0)1829 770037 Email: rob@rapidnews.com
MATERIAL/POWDER HANDLING
HOSOKAWA ALPINE Aktiengesellschaft Tel: +49 (0) 821 5906-0 Email: pharma@alpine.hosokawa.com Web: www.alpinehosokawa.com
MIXING & BLENDING EQUIPMENT AND SERVICES WET GRANULATION EQUIPMENT
Müller GmbH
Russell Finex Ltd
Tel: +49 (0) 76 23 969 0 Email: info@mueller-gmbh.com Web: www.mueller-gmbh.com
Tel: +44 (0)20 8818 2000 Email: enquiries@russellfinex.com Web: www.russellfinex.com
PACKAGING & BOTTLING EQUIPMENT AND SERVICES DESIGN & INSTALLATION
INDUSTRIAL SERVICES
Gerhard Schubert GmbH
CHEMICAL CLEANING
Transflow Industrial Services Limited The Passivation Specialists
Tel: +49 (0) 7951 400-0 Email: info@gerhard-schubert.de Web: www.gerhard-schubert.de
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
LABORATORY & R&D PRODUCTS AND SERVICES
Teknomek Industries Ltd
Fritsch GmbH
Tel: +44 (0)1603 788833 Email: sales@teknomek.co.uk Web: www.teknomek.co.uk
Tel: +49 (0) 67 8470146 Email: info@fritsch.de Web: www.fritsch.de
COATING EQUIPMENT & SERVICES
Glatt GmbH Tel: +49 (0)7621 664 0 Email: info@glatt.com Web: www.glatt.com
L.B. Bohle GmbH Tel: +49 (0)25 24 93 230 Email: info@lbbohle.de Web: www.lbbohle.de
OYSTAR Manesty Tel: +44 (0)151 547 8000 Email: sales@oystar.manesty.com Web: www.oystar.manesty.com
Weiler Engineering Inc Tel: +1 847 697 4900 Email: solutions@weilerengineering.com Web: www.weilerengineering.com
ENVIRONMENTAL/STABILITY ROOM PURIFICATION & FILTRATION PRODUCTS AND SERVICES
LTE Scientific Ltd Tel: +44 (0)1457 876221 Email: info@lte-scientific.com Web: www.lte-scientific.com
PARTICLE SIZE ANALYSIS
Whitehouse Scientific Ltd Tel: +44 (0)1244 33 2626 Email: info@whitehousescientific.co.uk Web: www.whitehousescientific.co.uk
TABLET PRESS SUPPLIERS WEIGHING
Mettler Toledo CONTRACT STERILISATION & TESTING
Tel: +44 (0)116 2345074 Email: enquire.mtuk@mt.com Web: www.mt.com/quantos
MANUFACTURING ANCILLARIES PUMPS
Fristam Pumpen F. Stamp KG
EXCIPIENTS
Tel: +49 (0) 40 725 56 0 Email: info@fristam.de Web: www.fristam.de
HPMC FILM COATING 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
BE HERE FOR A YEAR Call Rob on 01829 770037 or email rob@rapidnews.com
Web: www.wmpg.co.uk
ADVERTISERS’ INDEX Company
Page
Company
Page
Bachem
29
Müller GmbH
9
Elizabeth Carbide
1
Natoli
36
I Holland
7
SVIAC
11
MM Live 2012
2
Verderflex
23
EPM 35