EPM September 2013 by EPM Magazine

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IN THIS ISSUE: CPhI Worldwide 2013 Preview Containment Raw Materials Inspection Weighing Formulation

European Pharmaceutical Manufacturer September 2013

Volume 13 | Issue 06

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It all seems to be about CPhI Worldwide now as the build up to this allimportant meeting venue for pharma and biopharma professionals gains momentum and our diaries over 22–24 October begin to look somewhat chaotic. As is now custom, the September issue features our fourth CPhI Worldwide 2013 Preview, a collection of the latest announcements from exhibitors at CPhI Worldwide and co-located events ICSE, P-MEC Europe and Innopack. For your convenience, these are all in highlighted hall and stand number order. Branching out, CPhI organiser UBM recently launched ‘CPhI Pharma Evolution’ — www.pharmaevolution.com — an information exchange portal that allows pharmaceutical and biopharmaceutical professionals to share their thoughts on a variety of subjects including APIs, excipients, formulation, R&D, manufacturing, packaging and anticounterfeiting and regulatory compliance. CPhI Pharma Evolution has also released the first in a line-up of well-researched, high profile reports that employ the expert knowledge of specially selected expert panellists to examine current and future industry trends. In my latest August blog — which can be found at www.epmmagazine.com/pharma12 blogs — I spoke to CPhI’s International Marketing Manager Kevin Wetzel and Pharma 16 Evolution’s Editor-in-Chief Agnes Shanley about CPhI having responded to significant demand for such a service and the positive feedback received thus far. Returning to this issue, the Manufacturing Products & Equipment section includes two customer stories. The first, on page 16, concerns pharma manufacturer STADA Arzneimittel’s switch from using laser to vision technology in its distribution centre, resulting in a significantly reduced number of incorrect barcode readings and ultimately ensuring that “cartons safely reach their destination”. The second can be found on page 22, and pharma contract manufacturer Sanico’s investment in four metal detectors to increase tablet inspection to 100% and “offer the reassurance of contaminant inspection across [the company’s] entire tablet range.” In this issue’s Regulatory Affairs column on page 41, Dr. Biffignandi reports on the EMA’s pre-authorisation 22 procedural advice update, released in August. The update addresses “common mistakes” made by users of the centralised procedure “during the validation of initial marketing authorisation applications”. A lengthy document, Biffignandi focuses on active substance master file (ASMF) application criteria and typical pre-submission issues. And that is all from me until the next, post-CPhI Worldwide issue. In the meantime, you can keep abreast of the event’s news by visiting our dedicated webpage: www.epmmagazine.com/cphi-ww.

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eab members

from the editor

Henrik Broholm, Senior Specialist, H. Lundbeck A/S Henrik has been working in the pharmaceutical industry for the last 15 years, mainly in connection with finished goods packaging (blisters, ampoules and containers). At H. Lundbeck, he has gained valuable experience of working at both vendor and customer sites, further extending his pharmaceutical packaging expertise. Henrik is for the most part involved with user requirement specifications, machinery and process qualification and validation, the introduction of new products on packaging lines and incorporating new features as required by authorities, e.g., 2D matrix coding with track and trace and child resistant blisters and packs. James Cartwright, Global Granulation Leader, Particle Generation, Control & Engineering, GlaxoSmithKline James began working within the pharmaceutical industry in 1996. During this time, he has been instrumental in developing and launching three products for various clinical indications spanning acute Otitis Media, Lymphatic Filiarisis and Type II Diabetes Mellitus. James studied Chemistry and Chemical Engineering and is a Fellow of the Royal Society of Chemistry. Dr. Dimitris Dogramatzis, RPh, PhD Dimitris is a registered pharmacist and pharmacologist, whose industry career encompasses medical affairs, marketing, country and regional management positions. Dimitris has served as Regional VP — Northern Europe for SERONO and authored two textbooks entitled ‘Pharmaceutical Marketing: A Practical Guide’ (2001) and ‘Healthcare Biotechnology — A Practical Guide’ (2010). Dr. Dave Doughty, Director of Pharmaceutics, GlaxoSmithKline In his 30 plus years in the pharmaceutical industry, Dave has a superb track record in leading teams to develop and commercialise products. This is underpinned by his expert knowledge of the science and mechanistic principles of dosage form design and processing, including PAT, manufacturing operations and GMP. Dave has co-authored product and process patents. Product innovations include oral and transdermal dosage forms. Process innovations include compression and coating of tablets and continuous manufacturing methods and associated PAT. Continuous processes include feeding, mixing, granulation, drying, coating and a novel method of manufacturing low-dose, high-potency drugs. John Gamble, Senior Research Scientist, Bristol-Myers Squibb After graduating from the University of Salford in 1998 with a degree in Chemistry with Industrial Experience, John began his career in quality control analysis of parental vaccines, later moving on to physical analysis of inhaled drugs, before arriving at his current position as Senior Research Scientist within the Powder Properties Optimisation group at Bristol-Myers Squibb. John has a keen interest in understanding the interrelationships between the physical properties of drugs and excipients and their subsequent behaviour during formulation and manufacturing. Aidan Mc Nabola, Engineering Director, UCB Group, SCHWARZ PHARMA Ltd Aidan is Engineering Director at Schwarz Pharma Ltd, based in Shannon Co. Clare, Ireland, and is responsible for site infrastructure, engineering systems — including capital projects — utilities, IT and automation on site. Aidan holds a B. Eng Degree in Mechanical Engineering and has more than 23 years experience in primary and secondary manufacturing in the pharmachem and medical device industries. Grégory Poujol, Manufacturing Maintenance Manager, Sanofi Grégory is an ‘Arts et Métiers’ engineer. He started working in one of Sanofi’s injectable plants in 2003, before moving to a solid form plant as a Project Manager in 2004 to install new process equipment. In 2009, Grégory moved to one of the group’s solid form plants in Spain to lead new equipment installation projects as well as take charge of process maintenance and improvements. He returned to France in 2013 and continues with projects at one of Sanofi’s API production plants. Grégory has experience of the most well-known providers of solid form equipment. Kostas Saranteas, Senior Director, Process Chemistry and Engineering, Sunovion Pharmaceuticals Inc. Kostas is Senior Director of the Process Chemistry and Engineering Dept. at Sunovion’s R&D Division. He holds BS/MS/PhD degrees in Chemical Engineering and an MS degree in Environmental Engineering. For 15 years, Kostas worked at Polaroid Corp., specialising in batch process equipment modelling, process optimisation and scale-up. For 11 years, Kostas has been employed at Sunovion. He leads cross-functional teams, championing accelerated process development for drug substance and drug product synthesis from laboratory-scale to full-scale manufacturing.

Preview CPhI Worldwide — taking place at Messe Frankfurt, Germany, on 22–24 October 2013 — is a leading worldwide pharmaceutical networking event. Along with co-located shows ICSE, P-MEC Europe and InnoPack, it focuses on technology, equipment and machinery, ingredients, contract services and packaging, allowing the pharma

industry to meet, network and do business in a single place for three days. Exclusive to EPM magazine readers, the organiser of CPhI Worldwide, co-located events and pre-connect conference is offering a 20% discount on all paid packages. Enter code MP1236 when registering to benefit from this offer, www.cphi.com/register.

Oral Drug Delivery Partner Delivers Patient-Optimised Products Aptalis Pharmaceutical Technologies is known for overcoming even the most demanding oral drug delivery challenges. The company’s comprehensive portfolio of oral drug delivery technologies for bioavailability enhancement, custom release profiles and taste masking for orally disintegrating tablets (ODTs) and other dosage forms are employed in a customised approach to meet partners’ requirements. As an experienced oral drug delivery partner to the global pharmaceutical

industry, Aptalis is focused on delivering high-value products with robust, defensible proprietary positions for its partners that grow the commercial value of their portfolio. The company is committed to its partners’ success, providing flexible and tailored co-development and product outlicensing agreements for value-added Rx and OTC products across multiple therapeutic categories. Aptalis provides integrated R&D and manufacturing facilities in the US and Europe, where its teams of experts

Product Line Extension with User-Friendly Solid Dosage Forms HERMES PHARMA is an expert in developing and manufacturing user-friendly solid oral dosage forms such as effervescent and chewable tablets, lozenges, instant drinks and orally disintegrating granules. These dosage forms are rapidly gaining acceptance with consumers and healthcare providers as they are easier and more convenient for patients to take, therefore boosting treatment compliance and effectiveness. Good-tasting medicines that, for example, can be dissolved in water, chewed or sucked are much easier to swallow than conventional tablets or capsules. They provide tangible benefits, especially for older patients who often suffer from dysphagia. However, difficulties in swallowing occur in all age groups, especially with patients on long-term medication and children who commonly have a high sensitivity to bitter-tasting substances and experience difficulty in ingesting adult-sized tablets. As a division of Hermes Arzneimittel, a leading German provider of branded high-quality medicines, HERMES PHARMA offers customised solutions at every point along the pharmaceutical value chain, from the development of new, user-friendly products, to manufacturing and regulatory support.

User-friendly dosage alternatives. User-friendly dosage forms are a great opportunity to expand existing product lines, prolong product lifecycles and revitalise brands. Such line extensions can lead to increased customer loyalty, greater brand value and stronger differentiation from competition. For more information about the benefits to be had from licensing-in userfriendly solid oral dosage forms and how HERMES PHARMA can support partnering business needs, visit the company’s stand. Stand 31E28 Hermes Arzneimittel GmbH Division HERMES PHARMA +49 89 79 102 261 www.hermes-pharma.com

apply a rich array of development, manufacturing and regulatory skills to successfully deliver patientoptimised medicines to its partners in various regions around the world. CPhI Worldwide attendees are invited to meet with licensing representatives to learn how a partnership with Aptalis can advance their products towards commercial success. Stand 31D62

Aptalis Pharmaceutical Technologies www.aptalispharmatech.com

Packaging Sorbency Expert Helps Healthcare Customers Ensure Product Stability Multisorb Technologies provides sorbent solutions for managing moisture, oxygen, odour, hydrocarbons and other volatiles in healthcare product packaging. As a long-time supplier to the healthcare industry, Multisorb’s products are extensively used to ensure the stability of pharmaceutical, in-vitro diagnostic, medical device, dietary supplement and drug delivery products. Multisorb’s seasoned team of packaging professionals, chemists, biochemists and systems engineers provide skilled resources to understand and solve virtually any product stability issue. Using Multisorb’s Calculations through Operations program, they can assist from sorbent determination through packaging operations, reportedly providing the most effective solution for ensuring stability throughout the entire shelf life of a product. Multisorb formulates the customer’s optimised sorbent product using SimulSorb and SimulOx pseudoempirical modelling programs, which help predict physical and chemical stability outcomes for healthcare products in its packaging. This allows for the effective selection of sorbent requirements and helps improve speed to market with new products. The customised sorbent in packet or canister formats can be inserted into

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drug product packaging using its corresponding APA-series dispenser. The dispensers are custom manufactured and work exclusively with Multisorb’s sorbents, promoting accurate, precise dispensing and increased reliability. Find out how Multisorb’s solutions for managing pharmaceutical stability can help by visiting the company’s stand. Stand 41A83 Multisorb Technologies +1 716 824 8900 info@multisorb.com www.multisorb.com

CPhl Worldwide 2013 Topical Formulations CDMO Builds on 16-Year History Encube Ethicals, a pharmaceutical CDMO focussing on dermatology and semisolid manufacturing from its facility located in Goa, India, has been proudly associated with CPhi Worldwide/ICSE for the past three years. Encube claims to be the largest single site contract manufacturing company in Asia Pacific dedicated to topical dermatology products. The company has entered its 16th year of operations with customer satisfaction and fulfillment of quality requirements at the top of its list of priorities. With a number of large, global

pharmaceutical and cosmetic customers, Encube’s facility is approved by USFDA, EU GMP and many other regulatory agencies. The company provides a full, integrated support service that encompasses: • manufacturing and development of topical semisolid formulations • capabilities for handling rapid tech transfer and flawless execution • managing multiple product categories, including steroids, highly potent APIs and many others. Encube is actively looking for partners to fast track dermatology product

development, dossier out licensing, advanced manufacturing technologies as well as customers who need better products more competitively. The company welcomes all fellow exhibitors and visitors to its stand to discuss any potential opportunities and concepts. Stand 41F09

Encube Ethicals +91 22 2920 4335 pratik.k@encubeethicals.com www.encubeethicals.com

Ready-to-Use Steam-Sterilised Solution for Prefillable Glass Syringes From concept to commercialisation, pharmaceutical companies want safe and effective preparation, administration and delivery for patients. Working closely with a packaging manufacturer like West Pharmaceutical Services may help pharmaceutical manufacturers gain a thorough understanding of the containment and delivery needs of their drug products. Westar RU (ready-to-use) plungers can mitigate risk for chemical and physical deterioration of the component through an optimised autoclave steam sterilisation cycle that, when compared with high-dose gamma irradiation, may:

• minimise impact on the elastomer physical characteristics and on chemical oxidation and degradation during the plungers’ shelf-life • decrease the number and lower the level of extractables, with less potential for interaction between the plunger and the drug product • improve prefilled syringe functionality owing to lower and more consistent break loose forces. Plungers in primary configurations are available for rapid order fulfillment. West and its partner, Daikyo Seiko, Ltd., offer primary configurations in market-proven elastomer formulations. Westar RU steam sterilised plungers

are available with or without FluroTec film, fit standard prefillable syringes and comply with USP, JP and Ph. Eur. Pharmacopeia requirements. The Westar RU steam sterilisation process is fully validated and backed by the technical and regulatory expertise and support that West is known for. West helps its customers select the best packaging components for their drug products. Stand 41F63 West Pharmaceutical Services, Inc. +1 800 345 9800 (North America)/+49 2403 7960 (Europe) www.westpharma.com

Process Technology Expert Presents Lab Scale-Up Devices At CPhI Worldwide, Bosch Packaging Technology will present a selection of laboratory devices for solid dosage forms from its product brands Hüttlin and Manesty. The two process technology specialists have been part of the Bosch Packaging Technology portfolio since 2011. Hüttlin GmbH, based in Schopfheim, Germany, is a process engineering expert for the pharmaceutical industry

and will highlight its high-shear mixer granulator Hüttlin Mycromix. Manesty operates under the name of Bosch Packaging Technology Ltd, with headquarters in Knowsley, UK, and offers customised and highly flexible tablet presses and coaters. Together, Hüttlin and Manesty showcase one of their joint developments, the laboratory device Solidlab 2. Flexibility, ease of use and cost effectiveness are particularly important when developing products in the laboratory. This is why Hüttlin and Manesty have joined their knowhow and developed the laboratory device Solidlab 2. The compact and modular machine combines several process steps in a small space: drying, granulating and coating in the fluid bed as well as tablet coating in the coater. The modules can be used individually and contain the entire periphery such as inlet and exhaust air handling, sensor technology and control system. Hüttlin Mycromix is the smallest high-shear mixer granulator in the laboratory equipment range. It handles batches from 0.05 to 4 kg. The bottom drive unit Hüttlin Gentlewing ensures highly homogenous mixing qualities for granulates. All processes can be easily transferred to production equipment via scale-up. Stand 41H30 Robert Bosch GmbH Packaging Technology +49 711 811 0 www.boschpackaging.com EPM 6

CPhl Worldwide 2013 One Supplier for Both Empty Hard Capsule and Barrier Packaging Film Products

With the global pharmaceutical and nutraceutical industries witnessing decent year-on-year growth figures, the demand for a wide range of hard capsules and barrier packaging films remains strong. At CPhI Worldwide, ACG Worldwide will be displaying the following ranges of empty hard gelatin and cellulose capsules: • Ezeefit — hard gelatin capsules available in 14 different sizes (from size 000 to size 5) and various colours • Flofit — hard gelatin capsules for filling and sealing liquids or pastes • Marinecaps — fish gelatin capsules • Pearlz — hard gelatin capsules with a pearl-finish • Naturecaps — high-performance HPMC capsules • Clinicaps — double blind clinical trial capsules

Spray Drying Opens Doors for Pharma Industry

• Brandshield 4C — four-colour circular printed capsules. In addition to an extensive array of high-barrier packaging films, including PVC, PVdC, PE, duplex, triplex, ACLAR laminates, PE suppository and unit dose, ACG Worldwide will also be showcasing the following: • Alukbliss — a packaging film that has the barrier of PVC but is identical to cold form blister (CFB) foils in appearance, giving blisters a distinct look costeffectively • Brandshield — a differential grated embedded image film that offers an overt a robust anti-counterfeiting solution. Stand 41J21 ACG Worldwide int.response@acg-world.com www.acg-world.com

GEA Process Engineering will be exhibiting at ICSE/P-MEC to promote its GEA Niro pharmaceutical spray drying technology portfolio. By providing a high level of control over particle size and molecular characteristics, spray drying allows the commercialisation of previously unattainable delivery methods and the development of new pharmaceutical formulations that would be difficult to achieve with alternative technologies. Improved solubility, controlled release, taste masking and advanced powders with increased bioavailability are all achievable using spray drying. GEA Process Engineering’s Pharmaceutical Spray Drying facility in Copenhagen, Denmark, is one of the world’s most acknowledged GMP spray drying facilities and certified for the production of clinical trial materials. It is fully equipped with GEA Niro spray drying equipment for product and process evaluation and optimisation and available for contract manufacturing. GEA Process Engineering also offers single droplet drying. The GEA Niro DRYING KINETICS ANALYZER allows scientists to watch the changing structure of a single particle as it dries and thereby make tests using only a few droplets rather than the several kilos that are required with traditional test equipment. The demand for high containment technology has increased significantly in the pharmaceutical industry. The new GEA Niro high containment spray dryers

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provide high personal protection during operation, discharge and cleaning, and they allow pharmaceutical companies to exploit the benefits of spray drying highly potent products. GEA Process Engineering will bring a GEA Niro MOBILE MINOR spray dryer to P-MEC. The MOBILE MINOR is a laboratory spray dryer used by many of the leading companies working with pharmaceuticals and pharma-grade products worldwide. It is the ideal choice for performing test work and samples, and for establishing the process data required for commercial production. Company representatives will be available to discuss how working with GEA helps clients exploit the full potential of pharmaceutical spray drying. Stand 41J72 GEA Process Engineering A/S +45 3954 5454 gea-niro.pharma@gea.com www.geap.com

CPhl Worldwide 2013 Microniser Range Greatly Enhances API Solubility and Performance The NETZSCH DELTAVITA has been specially designed to efficiently increase solubility of APIs, thereby enhancing their efficacy, and is completely scalable and reproducible. The versatile DELTAVITA is constructed of stainless steel or ceramic materials with surface finishes to Ra = 0.4 µm for all product contact components. This machine is designed for easy cleaning and sterilisation. Adhering to strict guidelines, the DELTAVITA is built in accordance with cGMP, GAMP, GAMP5, ASME, BPE, UL or CE and FDA guidelines. With this machine, users can achieve consistent particle size distributions below 100 µm to increase surface area, solubility and bioavailability. Nanometer particles provide many advantages. Gene and vaccine delivery becomes more targeted and now NETZSCH can develop particles that cross the brain blood barrier. Nanoparticles can enhance the properties of time release molecules and nanoreceptors can be added to drug surfaces to release drugs exactly where needed. Improved imaging techniques such as MRI benefit from nano iron oxide. The DELTAVITA 15-300 is designed with growth and flexibility in mind, with

Simple Yet Powerful Capsule Filler for R&D and Clinical Trials

several available and interchangable chamber sizes in stainless steel and ceramic construction. The Laboratory Series sizes range from 15 to 300 ml chamber volume. The Pilot Series is the DELTAVITA 600. In the Production Series, NETZSCH offers models from 2,000 to 60,000 ml. DELTAVITA systems are available in portable and permanently mounted through wall installations. Each machine is designed specifically for the customer’s process requirements. Stand 41K27 NETZSCH-Feinmahltechnik GmbH +49 9287 797 0 info.nft@netzsch.com www.netzsch.com/deltavita

Thanks to its 47 years of experience, MG2 can handle any type of capsule dosing application; MG2’s capsule fillers satisfy all requirements with the maximum flexibility, from small batches for testing to 24-hour production cycles. MG2 has created a range of products called Think Smart Project, which is especially aimed at those customers looking for excellence in terms of quality, reliability and service but with a low budget; small and medium pharmaceutical producers, laboratories and pharmacies, as well as customers in the nutraceuticals and health food sectors, not to forget those producers in emerging countries, are increasingly fitting this profile. The LABBY capsule filler, which will be on show at P-MEC, belongs to this special range. A plug and play machine, the LABBY is modular and compact but fully automatic, ideal for R&D laboratories, clinical trials and small batch outputs. Configured for production speeds up to 3,000 capsules per hour, it is based on the same functioning principles as MG2 highspeed machines, thereby facilitating scale-up. The LABBY can work either in continuous or intermittent motion (depending on the type of dosing unit installed); it can be equipped with one of the following dosing units: powder (by dosator), pellet, tablet, microtablet, liquid, low dosages of powder to be inhaled without compactation (dosator type) and Microdose.

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Stand 41K96 MG2 S.r.l. +39 051 4694111 info@mg2.it www.mg2.it

CPhl Worldwide 2013 Contract Analytical Services Specialist Highlights Microbiology Services for Medical Devices Wickham Laboratories, based in Gosport, Hampshire, UK, is a specialist contract microbiology laboratory that

serves the pharmaceutical, medical device and allied healthcare industries. This year will be the company’s second time exhibiting at CPhl Worldwide. Visitors who are interested in obtaining some details about the business or would like to have an informal chat, will be able to find Wickham Laboratories within the Analytical and Lab Services zone.

The company’s main objectives are to meet existing and potential clients and to learn about outsourcing solutions in the pharmaceutical sector. The event also provides a great opportunity for networking with colleagues in the same industry. On this occasion, Wickham Laboratories intends to promote its microbiology services for medical devices. The company has an exemplary track record for testing medical devices with antimicrobial properties and validation of a wide range of products. In 2012, Wickham Laboratories moved into a new facility at Hoeford Point. The

layout of the new premises has allowed for more streamlined processing of samples and the range of equipment has been significantly increased. This enables Wickham Laboratories to take on board new challenges and enquiries. The Wickham Laboratories teams looks forward to speaking to all those interested in their work and activities and possible partnerships. Stand 42B47 Wickham Laboratories Ltd +44 1329 226600 mail@wickhamlabs.co.uk www.wickhamlabs.co.uk

APIs and Formulated Products CDMO Addresses Industry Challenges at Speaker’s Corner

Aesica’s Cramlington site. Aesica is a leading, global full-service provider, establishing long-term strategic partnerships with its clients, responding quickly and effectively to market demand and developing tailored solutions for specific requirements. As a fast growing CDMO, Aesica currently employs 1,300 skilled personnel with development and manufacturing sites located in Cramlington, Newcastle, Nottingham and Queenborough in the UK, Zwickau and Monheim in Germany and Pianezza in Italy. One of Aesica’s key values is its awareness that customers want more than a supplier, which is why the company works in partnership to provide a flexible, efficient and reliable service. Aesica provides services that stem the entire product lifecycle, from the manufacture of APIs, formulation and development for clinical trials to largescale commercial manufacturing. The company offers global supply and delivery combined with regional expertise and understanding. Aesica will be running a drinks reception on Tuesday 22 and Wednesday 23 October 2013, from 4–5:30 pm, at its stand, where visitors can learn more about the company’s services, including particular areas of specialism such as continuous tablet processing, inhalation and potent drug capabilities. This year, Aesica will be providing key insights into its offering and how specific industry challenges are overcome at CPhI’s Speaker’s Corner. Join Aesica on Wednesday 23 October at 10 am for an informative session on ‘Trends in Abuse Resistant Formulations and Continuous Tablet Processing’. Stand 42D09 Aesica Pharmaceuticals Ltd +44 191 218 1960 weshouldtalk@aesica-pharma.com www.aesica-pharma.co.uk EPM 10

CPhl Worldwide 2013 Aerosol Contract Manufacturer Celebrates 60 Years in Business ASM Aerosol-Service has reached an important milestone this year — six decades of experience as a contract manufacturer of sophisticated fluid and semi-fluid aerosol products. ASM Aerosol-Service AG was founded on 3 June 1953 and was reportedly Switzerland’s first independent contract manufacturer of aerosol products. Today, ASM can look back on six decades of experience in the manufacture of sophisticated fluid and semi-fluid products for customers in the pharmaceutical, cosmetics and technical sectors. ASM is proud of its long tradition of being a well-established and internationally oriented contract manufacturer.

As ASM Chief Executive Officer Tayaout Perret put it: “As a contract manufacturer, we systematically focus on the needs of our demanding international clientele. Thanks to our outstanding performance in the fields of development, production and customer service, we have made Switzerland a force to be reckoned with on the global playing field.” ASM has a successful market track record and today offers a wide ranging portfolio comprising the following: • proactive product development and project management • formulation development • formulation production

• filling • full service. ASM also holds a number of prestigious certifications, including ISO 9001:2008, ISO 13485:2003, ISO 22716:2007 and GMP. Needless to say, the company manufactures its products under controlled cleanroom conditions, and its quality system is FDA (cGMP) compliant. Stand 42J34

Tayaout Perret, ASM CEO.

CDMO with 50 years’ Expertise in Pharma and Cosmetics

Laboratoires CHEMINEAU is a European CDMO for semi-solids, aerosols (including bag on valve (BOV)) and liquids, based in Vouvray, the Loire Valley, France. As a certified ISO 9001 and ISO 13485 manufacturer, CHEMINEAU offers a complete outsourcing solution for topical and ear, nose and throat (ENT) products thanks to its strong, 50 years’ expertise in the pharmaceutical and cosmetic sectors. In June 2013, CHEMINEAU joined the ANJAC Health & Beauty pole (alongside Shadeline, Sicaf and Eurowipes) and created a multi-business platform specialising in the fields of health, hygiene and beauty. Stand 42G50 Laboratoires CHEMINEAU +33 2 47 52 70 30 e.david@chemineau.com www.chemineau.com EPM 11

ASM Aerosol-Service AG +41 61 855 67 67 info@aerosol-service.com www.aerosol-service.com

CPhl Worldwide 2013 Comprehensive Partnering Services to Advance Human Health Almac provides a range of integrated services from research through pharmaceutical and clinical development to commercialisation of product. Almac is a financially stable, privately owned organisation with over 3,300 employees located in the UK and US. Over 95% of work is repeat business, testament itself to the quality, efficiency and high level of customer satisfaction achieved. Almac has completed its GMP manufacturing facility expansion and highly potent APIs (Phase 1 to commercial) can now be manufactured in batches up to 150 kg.

The company is now in able to offer all the services required to manufacture 14C-labelled antibody drug conjugates, making a real impact on first in human study programmes. In addition, Almac recently invested $10 million in a new non-GMP pharmaceutical development facility, enhancing speed and flexibility by providing streamlined progression between development and GMP phases of projects. A further $10 million investment was made in a 9,290 m2 facility in Audubon, Pennsylvania, US, which offers quality,

flexible US commercial packaging solutions for solid oral and sterile biopharmaceutical drug products. Almac’s clinical service offering has been further expanded by the introduction of contained drug handling capabilities both in Europe and the US, thus enabling the company to now dispense and bottle solid dosage products.

Stand 42L08 Almac Group Ltd +44 28 3833 2200 info@almacgroup.com www.almacgroup.com

API Producer Presents Recent Additions to Commercial Product List CPhI Worldwide is an excellent convention for meeting pharmaceutical industry professionals from all over the world in one location and the Rhodes Technologies team is looking forward to meeting friends and colleagues there. In 2013, Rhodes added naloxone and methylphenidate to its commercial API product list and will be presenting these products to its customers at CPhI. In 2014, Rhodes’s product list will grow again owing to the addition of several new products and the company will use this opportunity to evaluate commercial prospects for these products. Rhodes staff will meet with existing, new and prospective customers to discuss how the company can help them with their API needs. They will also meet with Rhodes’s raw materials

and intermediates suppliers and prospective suppliers to discuss the company’s current and future requirements. Rhodes is an API manufacturer, with a cGMP facility located in the US, in the state of Rhode Island. This facility has been registered by the US Drug Enforcement Agency (DEA) for the R&D and manufacturing of controlled substances including opioids and cannabinoids. Rhodes imports narcotic raw materials for its manufacturing needs and supplies its APIs to multiple customers both in the US and abroad, which manufacture a large variety of drug products. Rhodes is affiliated with a large international group of privately held companies.

Stand 51B57US

Reactor bay.

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Rhodes Technologies +1 401 262 9090 valeri.melekhov@pharma.com www.rhodestec.com

CPhl Worldwide 2013 Global Excipients and Actives Supplier Highlights Compression Modelling Service Roquette is a long-established supplier of actives and excipients for the pharmaceutical and cosmetic industries. The company’s slogan — ‘Simply formulate your wishes’ — points to the many services and strength of support offered to its customers. Roquette Pharma’s wide range of excipients and actives has exceptional potential for meeting the customers’ needs, notably in the areas of: • injectables, tablets obtained by direct compression or wet granulation • film forming and film coating • syrups, suspensions, granules and sachets • orodispersible tablets • OTC products and nutraceuticals • toothpastes and mouthwashes. Roquette also offers on-site assistance for coating. Customers can obtain more process insights at www.readilycoat.com.

Today, the direct scale-up of formulations is a new way to reduce drug development time and cost. To further strengthen this drive, Roquette provides a new compression modelling service. More information on this service can be found at www.roquettepharma.com/focus-oninnovation/roquettes-services. Roquette’s Pharma Application Development Centres are also offering the new support model ‘Boost your NutraPharma project’. Manufacturers of nutraceutical and pharmaceutical products wanting to get new products onto the market more quickly and reliably can access a laboratory with modern equipment and experienced application experts. More information on this service can be found at www.roquettepharma.com/2013/product-developmentboost-your-nutrapharma-project.

Roquette’s experts and commercial team look forward to welcoming visitors to the company’s stand and will be ready to answer any questions on the aforementioned services. Stand 61A70

Roquette Pharma +33 3 21 63 36 00 pharma.business.unit@roquette.com www.roquettepharma.com

Perfect Platform Excipient for Oral Applications BENEO-Palatinit’s excipient galenIQ (Isomalt Ph Eur, BP, USP-NF, approved also in Japan and China (Import Drug License)) is a range of multifunctional fillers and binders. galenIQ includes grades for powder blends and compression applications as well as special grades for processing technologies such as wet granulation, roller compaction and fluid bed agglomeration. Its broad range of different particle modifications and

solubilities provides the best solution for various direct oral applications such as tablets, capsule and sachet fillings. All grades exhibit the multifunctional characteristics such as excellent compactibility, flowability and very low hygroscopicity. galenIQ has a specific morphology that prevents segregation and thus ensures content uniformity, which makes it suitable for very high dose as well as low dose applications.

Also, it is extremely stable physically and chemically. Derived from sugar beet, it has a sweet sugar-like taste. This sweet, well balanced taste is a decisive advantage for the formulation of direct oral applications, even in combination with active ingredients that have unpleasant taste profiles. galenIQ grades have excellent compactibility, making them suitable for tablets, showing a smooth surface that can easily be film- or pan-coated.

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BENEO-Palatinit, part of the Südzucker Group, is a member of the International Pharmaceutical Excipients Council (IPEC) and produces galenIQ under GMP conditions for pharmaceutical excipients. Stand 61C09 BENEO-Palatinit GmbH +49 621 421 150 galeniq@beneo.com www.galeniq.com

CPhl Worldwide 2013 Ingredients Partner Underlines Commitment to Both Food and Pharma At CPhI Worldwide, contract manufacturer SternMaid will be showing a wide range of processing options. For tablet premixes, instantised granulates or other dosage forms, SternMaid, a specialist in powdered products, will present its technical capabilities and also its comprehensive service portfolio. For manufacturers of pharmaceutical excipients and food supplements in particular, SternMaid offers outstanding production conditions. With state-of-theart processing technology, such as its fluid bed unit, the company is able to ensure optimum adjustment and standardisation of product attributes. Gentle drying, coating, agglomeration

or granulation results in products with optimal distribution of the active constituents, excellent tabletting properties, good flowability, precisely defined solubility or very uniform particle size depending on customer requirements. Highly complex processes are possible too; enzyme solutions or vitamins can be applied to carriers and sensitive substances can be encapsulated in a protective layer of fat. The company’s modern countercurrent container blending line is GMPcertified, and GMP certification of the new fluid bed processor is already in the pipeline.

Mark Riemer, Commercial Director of SternMaid, said: “With this wide range of processing options and our comprehensive service offering, we are in an excellent position to supply not only the food industry. With our capability for processing, blending and filling APIs and excipients, we bridge the gap between individual solutions and flexible production in just the way manufacturers need.” Stand 61E47

SternMaid GmbH & Co.KG +49 40 284 039 75 nschulze@sternmaid.de www.sternmaid.de

Clinically Documented Ingredients Offer Proven Digestive Benefits

DuPont Nutrition & Health will present its clinically documented probiotics and lactitol at this year’s CPhI Worldwide. The company’s DuPont Danisco range of premium probiotics and lactitol have been shown to have beneficial effects for digestive health in multiple human clinical studies. Studies show that HOWARU Restore premium probiotics can help relieve gut stress caused by antibiotic treatment. In a recent clinical study with more than 500 people undergoing antibiotic therapy, results included a significant reduction in the number of antibioticassociated diarrhoea episodes. In addition, subjects experienced a significant reduction in diarrhoeaassociated symptoms such as fever, bloating and abdominal pain. Clinical studies have demonstrated the gentle constipation relief provided by OsmoAid lactitol. In both children and adult populations, OsmoAid has been shown to be a well-tolerated laxative with none of the harsh side effects of other anti-constipation ingredients. Now more than ever, DuPont demonstrates its capabilities in the area of market-ready concepts. With its own blending and packaging facilities — along with a network of carefully selected contract manufacturer partners — DuPont meets the needs of the pharmaceutical and dietary supplement industries. Going well beyond digestive health, the combined DuPont Nutrition & Health portfolio addresses consumer needs within immune health, oral health, bone health, cardiovascular health, weight management, children’s nutrition, sports nutrition and healthy ageing. Stand 63A04 DuPont Nutrition & Health +1 608 395 2662 kelly.czerwonka@dupont.com www.dupont.com EPM 14

MANUFACTURING PRODUCTS & EQUIPMENT Alternative to Split Butterfly Valves Wins Global Approval A number of desirable benefits over the traditional split butterfly valve offered by the Ezi-Flow CSV transfer system from UK-based Ezi-Dock are proving popular with pharma manufacturers throughout the world. Within just three years of its launch, the Ezi-Flow CSV is in its third generation and a remarkable 11 of the top 12 pharmaceutical companies worldwide are using Ezi-Flow CSV within their operations. “In our opinion, traditional contained transfer systems are far from satisfactory,” explained Ezi-Dock MD Steve McAleavy. “Split butterfly valves require lengthy, cumbersome and potentially hazardous cleaning, and newer single-use systems often deliver inadequate levels of containment at high cost and involve long lead times for systems and consumables. Our Ezi-Flow system was designed from the ground

up to avoid all these problems, offering much higher levels of containment, lower cost and troublefree supply.” Key features of the Ezi-Flow system proved popular from the outset. EziFlow offers a full-bore for faster and easier discharge and is available in both four and six inch formats. Both the passive connection and the charge bag are disposable, drastically reducing or removing the need for cleaning and revalidation. Attractively, the Ezi-Flow system is at least four to five times less expensive than equivalent split valve equipment. The cost of consumables, which use anti-static materials as standard, is around 40% less than is common in the industry, and the CSV Mk 3, which is even simpler to operate, is totally liquid tight, allowing safe and

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easy flushing or the trouble-free addition of liquids. Ezi-Dock Systems Ltd +44 870 041 0326 sales@ezidock.com www.ezidock.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP CASE STUDY The use of imagebased technology is quickly expanding in logistics. It enables processes to be configured more efficiently and products to be traced seamlessly. Pharmaceutical company STADA Arzneimittel AG, a specialist in the production of generic and OTC drugs, shows how modern image-based technology can optimise materials management. In Europe, consumers understand that their pharmacy either has medication in stock or can get it from a pharmacy wholesaler within a few hours, although the technical expense behind this is enormous. STADA Arzneimittel, located in Germany, has over 4,100 products — including Grippostad, Mobilat and Paracetamol — at its approx. 6,000 m2 distribution and service centre in Florstadt, ready for delivery. Up to 1,000,000 medication packages leave the logistics centre every day in up to 11,000 different packages. STADA uses modern image-based technology to ensure that all cartons safely reach their destination. A camera portal, implemented by Weber System Technology, reads 1D barcodes quickly and reliably with VisionPro vision software from Cognex.

VISION SOFTWARE ENSURES PERFECT CODE READING ON STADA ARZNEIMITTEL’S DISTRIBUTION PACKAGES

Cartons assigned to customer order through print and apply application STADA is working with commissioning waves for the highest degree of logistics efficiency. A varying

number of cartons, based on order volume, moves over the approximately two kilometre long conveyor belt of the distribution and service centre. Each carton is first assigned to the relevant customer order through a process coined ‘marriage’, also known as a print and apply application. This occurs after its passing through the camera portal. The barcode of the incoming carton is read and linked to the customer order in SAP, and a labelling machine attaches the job code as an additional adhesive ticket for further processing. Increased labelling efficiency with image-based technology The greatest difficulties in logistics are often experienced with the labels. A label can be attached wrongly, may be damaged, have a defective printed image or may be missing altogether. STADA had previously used a laser scanner and up to 15% of the overall carton count was unreadable, which led to additional expense in manual reprocessing and could lead to wrong products being shipped. STADA’s demand for quality and efficiency led to a switch from laser to vision technology. Using imagebased technology, the number of erroneous reads was reduced to under four percent within the shortest period of time — a significant increase in efficiency that reduced costs. All sides of cartons inspected The vision portal created by Weber System Technology contained five cameras to read the barcodes on the incoming packets. Two cameras inspect the long sides of the cartons on the same level as the conveyor belt; two additional cameras examine

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the front and back sides in the direction of movement 45 degrees from vertical; and the fifth camera looks down on the top nearly vertically. Powerful vision technology from Cognex decodes the barcodes and transmits the data to the print and apply machine. The vision system is intelligent enough to ignore non-critical changes in the look of the code and to concentrate on the critical characteristics. Cognex software algorithms are powerful enough to be able to read barcodes that are damaged, highly reflective and omni-directional in only 400 ms. The outcome The camera portal offers STADA not only increased efficiency through the significantly improved barcode reading process but also performance feedback if no reads occur. Image-based technology takes pictures of the barcode to read it, so if no reads occur, STADA can go back and review why and quickly alleviate any process errors. Cognex UK Ltd +44 1327 856040 www.cognex.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Stainless Steel Remediation Pads Feature Various Abrasive Levels for Effective Cleaning

US Capsule Filling Systems Receive Significant Interest from European Market

Corrosion of stainless steel equipment in sterile process manufacturing is a significant problem for many life science manufacturers. Corroded surfaces are difficult to clean and disinfect as the rough surface does not allow good contact with the disinfectant and provides places for bacteria to hide. To facilitate remediation, Contec’s ABRATEC abrasive pads are made using various levels of abrasive grit backed with Contec’s Quiltec fabric. The use of Quiltec two-ply, sealed edge, 100% quilted polyester instead of a foam backing produces a significantly more durable and abrasion resistant pad. This abrasion resistance and Contec’s sealed border technology allows the Quiltec backing side to remove sanding debris without contributing any additional particles to the remediation work. Designed to be used with alcohol as a solvent, the various levels of grit allow safe and easy remediation of stainless steel, including removal of disinfectant staining and minimisation of rouging owing to residues and soil. ABRATEC cloths are also available, irradiated with a dose of no less than 25 kGy, which helps maintain the integrity of sterile environments and are autoclavable at a recommended setting of 121˚C.

Riva Europe is an authorised European distributor of US ProFiller handheld and benchtop capsule filling systems, which are steadily gaining in popularity. ProFiller systems are suitable for R&D, clinical trials, hospital dispensaries, pharmacy compounding, nutritional supplements and overencapsulation. They are ideal for new or hard-to-fill formulations and natural products as lubricants and other additives are not required. Powders, granules and liquids for stability studies may be filled using the ProFiller. Fill weights meet USP/EP standards. One hundred-hole and 300hole systems can be used under a powder hood or in a glove box. The optional powder vibrator is useful for reducing weight variation and filling powders that bridge or are granular, fluid or flour-like. Accessories include overencapsulation parts for tablets, capsules and caplets. ProFiller systems are available in 100 to 300 holes, in capsule sizes 000-5, 00el2el and AAA-D. All systems are fully equipped for one capsule size and include an orienter, filler, tamper, powder spreader, powder tray with reservoir and

Feedback from the beta test site was incredibly positive: “As rust is always a concern in the pharmaceutical industry — rust removal coupled with the concern of further damage to stainless steel is a greater concern. To use aggressive cleaners or sanding aids to clean stainless steel presents risks to the metal that may lead to expensive passivation activity or eventual equipment replacement. The fineness of the grit protected the metal yet facilitated the removal of the rust. That’s pretty close to magic in my experience.” For more information or to request a sample, call customer service or visit the website. Contec, Inc. +33 2 97 43 76 90 infoeu@contecinc.com www.contecinc.com

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video CD. Handheld systems include an exclusive capsule locker and powder tray clamps to prevent powder loss. Benchtop systems have these features inbuilt. Capsule size change parts snap-in and require no adjustments. Change parts are common for all 300-hole systems, allowing for an easy upgrade from handheld to benchtop. All powder contact parts are SS316 (Inox) or food certified plastics for high GMP and easy cleaning. Validation packages are available. ProFillers include a variety of patented features that reportedly make them the fastest and easiest 100-hole to 300-hole filling systems on the market. A full line of accessories and demonstration videos are available at www.profiller.com. Riva (Europe) Ltd +44 1252 345923 sales@riva-europe.co.uk www.riva-europe.co.uk

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Bulk Tablet Counter Triples Output with 100% Accuracy Logic TPS has announced the UK launch of DATA Detection Technologies’s ICU Series tablet counting machine range. Today, the majority of pharmaceutical companies rely on slat, vibratory or rotary wheel technologies. Although these machines differ from one another in their counting method and speed, the main similarity lays in the fact that each machine counts one tablet at a time. Examining existing technology, DATA realised that the pharmaceutical solid dose packaging industry lacks a hi-tech tablet counter that can fully meet market needs. With this in mind, DATA developed the ICU tablet counter using

advanced real-time image processing technology and implemented bulk tablet counting reportedly for the first time. DATA’s image processing technology employs wide track counting of multiple objects at once, eliminating the need for separating the tablets/capsules into individual lines before counting and enabling bulk counting with three times the output per footprint. The bulk tablet counter consists of one to four modules, with a counting rate of 40–160 bpm. Each module includes a three-channel system, a wide channel (Gross) for bulk counting and two narrow channels (Fine) for

count completion, resulting in 100% accuracy. DATA’s ICU cGMP design has the counting unit positioned separately from the feeding channels, allowing constant visual monitoring of the objects throughout the counting process so there are no blind spots or problems with dust. Each module has lightweight, toolfree contact parts, enabling changeover in less than five minutes and fast and easy maintenance.

Technology Transforms Safety Eyewear for Chemical and Pharma Sectors Extensive scientific research by 3M has led to a reportedly groundbreaking development in safety eyewear and the launch of a new product range ideal for chemical and pharmaceutical workers. According to the company, its SecureFit protective eyewear is the first range to feature Pressure Diffusion Temple technology, designed by 3M to provide noticeably higher levels of personal comfort and security of fit. Incorporating flexible ribs into the temple area of the frame, 3M Pressure Diffusion Temple technology allows SecureFit eyewear to self-adjust to the size and shape of the wearer’s head, reducing slippage and movement while in use. It also enhances comfort by dispersing pressure across the temple area. Nikita Shah, Technical Engineer from the Personal Safety division of 3M, explained: “3M understands how challenging it is to fit a diverse workforce with safety eyewear that provides effective protection and comfort to all. “Our research has shown that 71% of the health and safety officers we surveyed put non-compliance down to discomfort. 3M undertook comprehensive research into face shapes and sizes throughout the world, including detailed digital modelling. The result is the development of Pressure Diffusion Temple technology that, without the need for any adjustment by the user, helps to diffuse pressure across the temple while holding the frame securely in place for a secure and comfortable fit.” Featuring a stylish, lightweight design, weighing only 18 g, SecureFit protective eyewear is available in three lens colours (clear, grey or yellow) with antifog and anti-scratch coatings. SecureFit protective eyewear meets the requirements of EN166:2001 and also absorbs 99.9% of UVA and UVB radiation thanks to its polycarbonate lens. 3M +44 870 60 800 60 ohes.marketing.uk@mmm.com www.3M.co.uk/safety

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Logic TPS Ltd +44 1252 879771 sales@logictps.com www.logictps.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Isolator’s Compact Design Allows for Greater Portability Hosokawa Micron’s Flexible Compact Isolator (FCI) glove box system is designed to meet the demand for costeffective barrier containment by offering a one-man workstation that can be moved easily around the laboratory or process room. The plug and play operation means moving location is quick and easy, simply wheel the unit to where it is required. The FCI is available in a range of canopy options, including rigid, semirigid or disposable designs that fit onto a stainless steel base unit. Customers may wish to have more than one canopy per base unit to further increase the unit’s flexibility in use. With a small 1 x 0.5 m

footprint, the FCI makes it easy to have flexible barrier containment exactly where and when it is needed. Individual modules can be linked to create a pod system with individual activities contained in separate units. Multiple linked configurations can offer cost-effective operation for companies where the handling of hazardous powders is infrequent. The FCI is ideally suited to companies involved in scientific research and biotechnology or pharmaceutical development, and it ensures a high level of product and personnel protection across a range of product applications.

A specialist in contained processing, Hosokawa Micron is able to offer a range of processing and packing equipment for use in the Hosokawa Micron FCI.

Improved Bulk Bag Filler Ensures Accurate and DustFree Filling

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

Spiroflow has announced an upgrade to one of its most popular weigh fillers for pallet handled bags — the C1. Ideal for low to medium volume use where bulk bags filled on pallets are moved by forklift truck, the new C1 facilitates accurate, dust-free filling of up to 20 bulk bags per hour. Its base is directly mounted on an approved load cell weigh platform and the required weight can be pre-set for automatic cut-off. The platform includes a vibration facility for an even, accurate fill and effective compaction, perfect for handling products that aerate and resulting in a stable load for both storage and transportation. Boasting modular construction for ease of modification, the new C1 now features automatic height adjustment for different sized bags. Its inflatable neck seal ensures a dust-free environment and minimises product waste, and removing the filled bags has been made even speedier with the addition of a roller conveyor to complement the automatic bag loop release facility. The new C1 has also retained many of the features that have helped to make it one of Spiroflow’s most popular products across multiple industry sectors, including a carbon/stainless steel filling nozzle and a dual concentric filling spout incorporating a venting system. Rob Hudson, Managing Director at Spiroflow, explained: “Many millions of bulk bags, with a capacity from 500 to 1,500 kg, are sold worldwide every year, making them one of the most convenient, cost-effective methods of packaging, storage and transport. Customers in industries ranging from food and pharmaceuticals to plastics and building products use bulk bags and hence require the best equipment to fill and discharge their often fragile or fine-particle products quickly and with the minimum of fuss. “Our technical team is constantly innovating, developing new solutions and adaptations in our test centre to meet customer demand for the next improvement or upgrade. Our C Series of weigh fillers remain extremely popular as they’re both efficient and versatile, and we’re confident that the new C1 will prove an equally successful addition to our range.” Spiroflow Ltd +44 1200 422525 ben.ayrton@spiroflow.com www.spiroflow.com EPM 20

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP CASE STUDY Pharmaceutical contract manufacturer Sanico NV has increased SANICO BOOSTS tablet inspection at its TABLET INSPECTION Turnhout facility in CAPACITY WITH Belgium to 100% with the installation of four METAL DETECTORS INSIGHT PH metal detectors from Lock Inspection Systems. The investment is part of the company’s continuous drive to improve quality standards for its global customer base. “By installing an additional four metal detectors in our tabletting operation, we now offer the reassurance of contaminant inspection across our entire tablet range,” said Wim Roelants, Production Manager at Sanico. “This is a key part of our strategy to raise the bar in terms of the quality standards offered to our customers. “Lock’s INSIGHT PH unit impressed us with its highly intuitive user interface and streamlined GMP design, which offers easy disassembly for cleaning.” The four INSIGHT PH units are in-line installations

for metal contaminant inspection during compression. As the tablets leave the press, they pass through the units in containers before moving to blister packaging. Tablet size ranges from 3–25 mm in diameter and total output is between 30,000 to 300,000 tablets per hour. “The units operate 24 hours a day, five days a week, in a controlled and monitored, clean-zone production environment to European Pharmacopeia standards, so design, efficiency and performance of the metal detector units are all key,” commented James Chrismas, Marketing Manager at Lock Inspection Systems. “Following a two-week trial of one unit, Sanico was confident that our INSIGHT PH units would meet its stringent manufacturing requirements.” Designed to meet increasingly demanding pharmaceutical standards, Lock’s standalone INSIGHT PH metal detector delivers tangible benefits to manufacturers of tablets and capsules. Highly resistant to vibration, the integrated digital search head and OPTIX detector management software guarantee detection and rejection of minute metal fragments, while maintaining high productivity and outstanding sensitivity to all metals.

Lock Inspection Systems Ltd +44 161 624 0333 sales@lockinspection.co.uk www.lockinspection.co.uk

Latest Version of MES Software Extends Agility and Versatility for Life Sciences Industry Rockwell Automation has released its Rockwell Software PharmaSuite v5.0 system for pharmaceutical and biotech production, reportedly setting new standards for manufacturing execution system (MES) performance in automation, risk management, cost reduction and regulatory compliance. The new version delivers a single MES solution with the agility to integrate and streamline production not only across multiple production areas and product lines but also from line to site level. “With improved automation-layer integration, equipment modelling and non-order workflow management, the PharmaSuite v5.0 system helps manufacturers deploy systems more rapidly with greater production flexibility,” said Martin Dittmer, PharmaSuite Product Manager, Rockwell Automation. “We’re working to set new standards in performance, usability and deployment time with every new release. Version 5.0 provides a core solution poised to dramatically compress the time from deployment to return on investment, regardless of the application.”

The PharmaSuite v5.0 system includes improved integration with production equipment — including premier integration to the Logix control platform — and automated batch processing using the PharmaSuite Recipe Designer. The system automatically collects data directly from production equipment, provides automation set points, monitors automation events and integrates process information into the electronic batch record to reduce the risk for human error that can result from manual data collection. The PharmaSuite Recipe Designer now supports a greater number of production processes. Its enhanced information-flow design enables access to both definition and run-time information across the entire recipe to give users added insight into real-time production information. The new data types within the expression editor enable users to deploy more sophisticated conditions, rules and calculations so they can more easily customise functionality to meet their needs. The PharmaSuite v5.0 system uses a

new equipment modeller to define the underlying model and optimise integration across the range of manufacturing types, including biological, secondary, active, discrete assembly, weigh and dispense, and packaging. This allows users to define the automation interface, maintain equipment descriptions and specifications and use the new equipment modeller as the foundation for GMP-compliance tracking and automation-integration scenarios. The user interface provides quick access to production information and is optimised to maintain and analyse massive amounts of equipment-related data. The PharmaSuite v5.0 system redefines assembling and supporting non-order-related workflows that traditionally require custom programming by a systems integrator. Using S88-recipe design principles, the

Tablet Tooling Manufacturer Extends Global Communications with Launch of Website With the aim of further enhancing customer communications and providing an even more efficient service, I Holland has re-launched its website. The new site, at www.tablettingscience.com, is packed with detailed advice for tablet manufacturers on I Holland’s punches and dies, with their individual benefits, as well as suggested steel and coating technology and an overview of punch and die maintenance equipment. The I Holland PharmaCare 7 Step process is also described with information on an associated audit service looking at how tooling should be cared for to achieve optimum lifetime and performance benefits. There is also

a useful and informative link to case studies and papers featuring research and information on tablet tooling. Available on the site is a new improved ‘Get a Quote’ facility for punch and die quotations with opportunities to directly contact I Holland’s global representatives in each of the 90 countries they serve. Visitors to tablettingscience.com will find a wealth of information to help make informed decisions. Other sections include detailed information about the company, a latest news section, covering industry, product and corporate developments, and full contact details for all of the distributors across the world.

The site is also available in a number of languages, including English, French, German, Spanish and Italian. “The aim of our customer-focused communications strategy is to bring us closer to our customer,” said Marketing Manager Clare Taylor. “The new website achieves this by offering detailed technical advice to customers, making information on our products and services widely available, and by allowing quick and easy contact with I Holland and its distributors.” I Holland Ltd +44 115 972 6153 info@iholland.co.uk www.iholland.co.uk

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PharmaSuite v5.0 system enables the on-site end-user or recipe author to create new work flows on their own, in just minutes, by re-using existing building blocks. By creating and managing these back-end tasks on their own, manufacturers can reduce overall production costs to help accelerate the return on investment. Rockwell Automation Ltd +44 870 242 5004 ukmarketing@ra.rockwell.com www.rockwellautomation.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Energy Efficient Freeze Drying Enhances Pharma Production SP Scientific has produced a new technical brief that summarises the energy saving features available on its Hull range of production freeze drying systems. Out of the many steps required to produce pharmaceutical products, freeze drying is perhaps the most energy intensive of the various production processes. Most of the energy consumed by a freeze dryer goes into the refrigeration system that must initially freeze the product and heat transfer shelves and then condense water vapour that sublimates and desorbs out of the product during primary and secondary drying respectively. For the last 20 years, Hull production freeze dryers have reportedly been at the forefront of pioneering ever more efficient use of the energy required to drive the lyophilisation process. This new technical brief details these energy saving technical developments and explains how they translate into energy/cost savings in pharmaceutical production. Smart Cool 4.0 technology utilises the inherent flexibility of electronic expansion valves to capture greater compressor capacity under heavy loads (such as fast cooling of product) while at the same time allowing precise shelf

Process Weighing Software Delivers Enhanced Formulation Capabilities

control within +/- 1˚C. The result is that a typical Hull freeze dryer can meet or exceed the performance of other production freeze dryers using fewer and/or smaller compressors, especially when combined with MultiFlex refrigeration. Employing highly efficient heat transfer fluid cooled condensers, SP Scientific’s proprietary MultiFlex refrigeration design enables Hull freeze dryers to meet process needs with fewer and/or smaller compressors, which results not only in significant energy savings but overall reduced operational costs owing to decreased maintenance requirements. In addition, the document describes and explains the benefits of screw compressor technology, variable frequency drives, water cooled heat exchangers and high efficiency liquid nitrogen refrigeration systems. Genevac Ltd +44 1473 240000 salesinfo@genevac.co.uk www.spscientific.com

Mettler Toledo has introduced a new process weighing software, the IND560fillplus. This new formulation solution meets the needs of basic and complex filling and blending applications, while preserving the ease of use associated with Mettler Toledo’s IND560 family of terminals. In today’s competitive business environment, even small errors can be costly. In manual operations, the chance of errors is high. Automated material blending using the IND560fillplus reduces errors and makes it easy to obtain process information. Time-consuming data collection and retrieval is now done automatically using technology that collects, stores and processes important data. This software solution can be simply added to any of the IND560 terminals with firmware revision 4.03 or higher. IND560fillplus users meet product accuracy goals thanks to programmable spill values and jog functions. To reduce errors, operators no longer need to enter formulas manually; they can be retrieved from memory. FillPlus performs rescaling based on a percentage of the programmed target, percentage of the available amount of material in a formula or a desired total formula weight. The IND560fillplus provides users with a way to automatically combine multiple materials in a single weigh-in cycle. FillPlus enables the

storage, retrieval and rescaling of up to 25 formulas. By using the IND560 password function, operators can specify which operators have the ability to change from one formula to another or change specific formula information. In addition, the IND560fillplus lets each of the 25 formulas have its own designated auxiliary output turned on and off based on the weight or production time requirements of that particular formula. With IND560fillplus, a variety of shared data is available to users, including alibi memory, formula ID, description and units, rescale information and total formula weight for all batches or only for completed batches. This information can be stored, printed as a report or label or used to trigger actions, making processes more efficient. Mettler Toledo Inc. Industrial Weighing +1 614 841 7348 melissa.braithwaite@mt.com www.mt.com/ind560fillplus

Dust Collector Skid Packages Offer Installation Ease and Cost Savings Camfil Air Pollution Control (APC) now offers its Farr Gold Series dust collection systems in a skid package that speeds and simplifies installation. The new Gold Series skid packages incorporate highefficiency cartridge dust collectors and all related equipment onto a single platform that is easy to transport and install. The packaged units offer time and cost savings for pharmaceutical and other industrial applications, especially when needed to facilitate installation of multicomponent dust collection systems. A typical skid package might include one or more dust collectors, active and/or passive explosion protection devices, doors for bag-in/bag-out filter change-out, BIBO HEPA filters, continuous liner discharge, fans, controls and interconnecting ductwork. Pre-assembled and shipped on a single skid, components can be easily moved by forklift or crane and are equipped with removable electrical and pipe connections. Even large units can typically be shipped in a container, eliminating the time and cost to build special crating. Skid packages can be as large or small as needed to satisfy individual customer requirements; the only limitations are the size of and access to the space where the EPM 24

equipment will be installed at the enduser site. Features of the Farr Gold Series dust collector include rugged modular construction, high efficiency, ease of service, energy savings and long filter life. The collectors come with a 12-year warranty and are guaranteed to meet applicable emission standards. A wide selection of options and accessories are available to meet fire and explosion protection, containment and other special requirements. Camfil Air Pollution Control +1 870 933 8048 filterman@camfil.com www.camfilapc.com

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Booths — Downflow

Booths — Laminar

Bottles

Cabinets — Laminar

Continuous Liner

Valves — Cone

Valves — Split Butterfly

ChargePoint Technology, UK +44 151 728 4500 sales@thechargepoint.com www.thechargepoint.com Containment Service Providers Co Ltd, Ireland +353 21 4775024 info@containment.ie www.containment.ie Envair Ltd, UK +44 1706 228416 info@envair.co.uk www.envair.co.uk Esco GB Ltd, UK +44 1725 514555 info@escogb.com www.escogb.com Extract Technology Ltd, UK +44 1484 432727 info@extract-technology.com www.extract-technology.com FAMAT SA, Switzerland +41 21 695 26 23 p.switalski@famat.com www.famat.com F.P.S. Food and Pharma Systems, Italy +39 031 543429 info@foodpharmasystems.com www.foodpharmasystems.com Glatt GmbH, Germany + 49 7621 664 0 steve.picton@glatt.com www.glatt.com Hanningfield Process Systems Ltd, UK +44 1702 549777 sales@hanningfield.com www.hanningfield.com Hosokawa Micron Ltd, UK +44 1928 755100 info@hmluk.hosokawa.com www.hosokawa.co.uk Powder Systems Ltd (PSL), UK +44 151 448 7740 info@powdersystems.com www.powdersystems.com Sampling Systems, UK +44 1675 466992 jonathan.fenner@sampling.co.uk www.sampling.co.uk

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Pack-Off Systems

containment

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Vacuum Transfer Systems

Sampling Devices

Restricted Access Barrier Systems (RABS)

Isolators — Rigid

Isolators — Flexible

Bags

buyers’ guide

Additional

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13 14

10 11

13 14

10 11

13 14

Cleaning systems, flexible and semi rigid rooms, containment consultancy.

Aseptic isolators.

Integrated isolators for agitated nutsche filter dryers, reactors, granulation equipment and packaging machines.

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High containment and sterile isolators and glove boxes. 6

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SHOWCASE RAW MATERIALS INSPECTION

Fast Raw Materials ID through Unopened Non-Transparent Packaging Cobalt’s RapID instrument is reportedly the only tool for raw materials ID verification that works through nontransparent unopened containers. This speeds up testing by enabling identification directly through closed sacks, tubs, bottles, FIBCs and barrels, maintaining sterility and avoiding operator exposure. RapID is compatible with a wide range of excipients and APIs through plastics, amber glass, multi-layer paper/plastic sacks and woven fibres. Raman and NIR spectroscopies have gone some way to speeding up the process of ID, although many materials need to be opened in a sampling booth or sterile enclosure first. The resource taken to open the packaging safely is often far greater than needed for the test. RapID circumvents this requirement.

Raman spectroscopy is used for ID because of its high chemical specificity, ease of use and regulatory acceptance. RapID uses a variant called spatially offset Raman spectroscopy (SORS) to measure a Raman spectrum through the packaging in 5–20 seconds without a sampling booth, protective clothing or other contamination-prevention measures. The measurements require a single operator and can reduce hours of testing to minutes. Sterile and biopharmaceutical manufacturers benefit from maintaining sterility during the QC testing workflow. Materials such as phenol/m-cresol or polysorbates can be identified in amber bottles in around five seconds in an open warehouse.

RapID is compatible with many materials, e.g., lactose/dextrose/glucose in multi-layer paper sacks and FIBCs, MCC and HPMC in plastic sacks and acetaminophen in plastic tubs. The integrated barcode scanner allows per-container tracking and reporting. RapID is easy to use, integrates into existing quality workflows and Windows environments and is 21 CFR Part 11 compliant. For the RapidID product lineup, visit www.cobaltlight.com/products/rapid.

Cobalt Light Systems Ltd +44 1235 856 555 info@cobaltlight.com www.cobaltlight.com

B&W Tek has also expanded its wide variety of service and support offerings to include on-site assistance with method and/or new library development and with IQ/OQ/PQ validation.

B&W Tek, Inc. +1 302 368 7824 sales@bwtek.com www.nanoram.com

Enhanced Handheld Raman Spectrometer Simplifies Sampling and Detection B&W Tek has announced major enhancements to its NanoRam handheld Raman spectrometer. According to the company, the NanoRam is already a highly popular analyser for material identification and verification in cGMP compliant facilities and the only one of its kind owing to its high-brightness OLED touchscreen display and intuitive software for both technical and nontechnical users. Now, the NanoRam is enhanced with new features to make sampling and detection even easier. The next generation of NanoRams offer numerous enhancements, including an embedded 2D barcode scanner, batch scanning capabilities, IP-64 rated (dust tight and splash proof) housing, Ethernet connectivity and many other software enhancements based on user feedback

to better facilitate tracking and reporting. B&W Tek has also introduced two new sampling accessories, a 30.5 cm immersion shaft for sampling out of large drums and a tablet holder to easily measure finished products with uniformity in order to further their mission to enable fast and convenient measurements in almost any environment. “At B&W Tek, we are committed to providing our customers with the highest performance and most user-friendly products on the market,” said Dr. Jack Zhou, COO for B&W Tek. “With these new enhancements, our customers will now be able to work faster and more efficiently than ever, while still getting the high quality spectral performance B&W Tek has become known for.”

Latest Software Improves Speed and Effectiveness of Handheld Raman Analyser Pharmaceutical manufacturers and regulatory agencies can now enhance the performance of the Thermo Scientific TruScan RM analyser by downloading the newest software update. In addition to improved speed, Thermo Fisher Scientific designed the software update to enable users to more effectively develop and validate robust

methods for pharmaceutical manufacturing and counterfeit screening. This latest software version also includes feature enhancements for compliance with cGMP. The TruScan RM is one of the world’s most widely-used handheld Raman analysers for the chemical composition of pharmaceutical raw materials and finished products. “The ability to quickly and accurately analyse pharmaceutical raw materials and finished products greatly increases a pharmaceutical company’s productivity,” said Bob Brush, Business Development Manager, Portable Analytical Instruments at Thermo Fisher Scientific. “This software update also makes counterfeit drug screening easier, enabling users to more effectively analyse samples for suspect medicines, reinforcing our commitment to helping identify and

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intercept counterfeit pharmaceuticals worldwide.” The TruScan RM 2.5 software update includes the following enhancements from the previous version: • improved data collection for more robust methods • new features for GMP compliance • improved performance over previous software versions • rapid data import/export capability • optional expert mode to further analyse spectroscopic data. TruScan RM weighs less than a kilogramme, is designed to be easy to use and to offer clear pass/fail results, making Raman analysis more widely accessible. Thermo Fisher Scientific Inc. +1 978 215 1380 barbara.russo@thermofisher.com www.thermofisher.com/rmid

SHOWCASE TABLET COATING

Choice of Solid Wall and Perforated Pans Caters for All Coating Requirements IMA continuously invests in providing new solutions for coating, always with the aim of improving efficiency, taking into consideration any environmental impacts and methods of saving energy. IMA offers both solid wall and perforated pans, a valuable choice that accommodates all customers’ requirements. The mixing baffles positioned in the central section ensure perfect mixing and uniform coating material distribution, allowing the processing of a wide range of batches in the same drum, from 25 to 100% of the pan capacity. The mixing capability is always maintained when working with a minimum or a maximum quantity of product. The position and dimensions of the outlet air duct allow a uniform drying of the product, thus saving energy. The spray system has been designed to ensure easy maintenance, simple inspection operations and quick product changeover. Two spray units are available: the film system (air) and the

sugar system (airless). The spray guns are fitted on a sliding support arm and can be positioned and adjusted from the external part of the machine. Completely automatic CIP is also possible as well as a wide range of different automation levels. The consolidated range of machines with solid wall pan includes the wellknown GS HT–HP–P/RA and HP equipment for the processing of all sizes and shapes of product — film or sugar coating of tablets, pellets and microgranules and enlargement and layering of pellets and microgranules by means of an adjustable powder dosing device. The solid wall pan is the ideal starting point for a contained installation. With the GS Evolution, the entire coating process, from product loading to final discharge and cleaning, can be achieved without any need for the operator to have contact with the processing area. The solid wall range of machines includes units for R&D and small production batches.

The Perfima series of perforated pans can be fitted with automatic product loading and discharge. On a standard Perfima pan, product discharge is achieved through a discharge tube connected to the pan by a fast fixing system. The system has no dead zone and guarantees 100% product discharge to the bin. Complete isolation of all parts in contact with the product is another feature; all openings are equipped with inflatable seals and the entire coating process can be achieved without contamination from the external environment. The Perfima Lab for R&D purposes is also available, which can be used for small production batches as well. Three interchangeable drums make it possible to work with a wide range of capacities from 3 to 60 l.

IMA S.p.A IMA Active Division +39 051 6514111 mktg.soliddose@ima.it www.ima-pharma.com

directional change of pan rotation, tablets can be discharged completely and without containment. Major advantages of the BTC 400 include through the wall installation, integrated switch cabinet and simple and functional housing. All nozzles of the BTC are supplied with suspension via a pump head. The machine can be easily controlled and monitored as the multipanel visualisation with touch panel operator unit is attached to the coater. “We set standards in pharmaceutical production with our high precision coaters,” said Lorenz Bohle, the company’s founder.

L.B. Bohle Maschinen + Verfahren GmbH +49 2524 9323 150 t.borgers@lbbohle.de www.lbbohle.de

Tablet Coater’s High Spray Volume Shortens Process Times The Bohle Tablet Coater BTC stands for economic coating. The flat tablet bed, patented air system and high spray volume ensure the quality and shorten process times by up to 35%. With exceptional mixing, BTC guarantees high coating uniformity. Three basic operations are vital for successful film coating processes — spraying, drying and mixing. Each individual step must be carefully planned and optimised in coordination with the others. The BTC 400 is the economic allrounder, with a working volume of up to 650 l. Bohle coaters are known for excellent product processing and exceptionally high profitability. The flat tablet bed with

long drum geometry ensures optimal core movement. The systematic compulsory guide in the drum enables continuous product movement. There is no tablet twinning and therefore only minor losses in solids and coatings. New concepts for the processes as well as for cleaning improve the coater functionality and deliver outstanding results. The patented air system features significant process-related advantages. The danger of spray drying the suspension no longer exists. This reduces spray losses and improves coating structure. Tablets are handled more carefully thanks to the pan geometry and the patented mixing elements in two directions. Through the

Tablet Coater Range Achieves Excellent Levels of Productivity and Consistency Thomas Engineering has been a leader in the supply of tablet coating equipment and tablet press punch and die tooling since 1959. The company’s commitment to tablet manufacturing excellence is well demonstrated with its Accela-Cota technology systems. According to Thomas Engineering, Accela-Cota are the most popular tablet coating systems on the market, boasting fully perforated coating drum technology that revolutionised coating applications in years past and today continues to set the standards for tablet coating with its unrestricted air flow, thermodynamic efficiency and integration. Designed to the most exacting standards and created in accordance with GMP regulations, each Accela-Cota system offers outstanding levels of productivity,

consistency and repeatability to suit the customer’s individual requirements. Thomas Engineering offers a wide variety of coating solutions, from the sub-kilogramme, R&D Flex 05 coater, the R&D Pilot Scale Flex100 and the new Flex 200, featuring 36” and 48” drums, to the most versatile Flex 500 production scale coater with seven exchangeable drums and the high capacity, 3,500+ kg per hour Flex CTC continuous tablet coating system. Thomas Engineering has both the experience and the equipment solutions

to accommodate all tablet production requirements. For more information on the company’s fully integrated tablet coating systems and tablet press tooling services, visit the website.

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Thomas Engineering Inc. +1 847 358 5800 sales@thomaseng.com www.thomaseng.com

Corporate News & Events

Tooling Specialist Announces Second Trouble-Free Tablet Production Seminar Experts at I Holland will share their knowledge with the industry when a seminar discussing ‘Troubleshooting in Tablet Tooling’ is held later in the year. Part of I Holland’s educational campaign in 2013, the seminar, which will take place on 6–7 November, will approach troubleshooting from a tablet manufacturer’s point of view and aims to assist in reducing downtime by recognising tooling and tabletting problems early. The seminar will include a tour of the I Holland headquarters, with a live demonstration on how to prevent most major tablet tooling problems by adopting the PharmaCare 7-Step Process. By performing planned scheduled maintenance to keep tooling

in an immaculate condition, it reduces costly tablet press downtime and compression problems. Clare Taylor, I Holland’s Marketing Manager, said: “The seminar is designed to give an in-depth technical view on troubleshooting from a tablet manufacturer’s point of view. By adopting I Holland’s recommended professional maintenance and storage programme, the PharmaCare 7-Step Process, early recognition of tooling and tabletting issues can be reduced, which makes for less press downtime. “Combining a practical element and demonstrating the PharmaCare 7-Step Process, as well as a tour of the plant, the seminar is once more gaining interest from those wishing to learn about

optimising the life of tablet tooling and we only have a few places left. “It is a great way for us to connect and share our expertise with customers and to help counter common issues that hinder and stop tablet compression. The seminar will offer a taster of the more detailed maintenance course workshop session, which is available to take with I Holland’s experts. The Troubleshooting in Tablet Tooling seminar will not only be very informative for the audience, but it is also an ideal platform in which I Holland can meet and assist end-users and gain positive and informative feedback.” To book a place on the I Holland seminar, visit www.tablettingscience.com and click on events.

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

Leak Test and Measurement Equipment Supplier Acquires Pack Inspection Company The Belfast, Northern Ireland-based pharmaceutical engineering company Sepha has been acquired by global inspection and test organisation TASI Group. The acquisition by TASI, which has headquarters in Cincinnati, US, marks the next phase in the international development of Sepha by providing resources to expand Sepha’s customer base and to fund R&D into new products. Sepha customers, which include most of the world’s top 50 pharmaceutical companies, will also benefit from TASI’s worldwide network of sales and engineering staff. TASI is a leading manufacturer of leak test and measurement equipment used to improve quality and manufacturing efficiency in the automotive, energy,

plastics, industrial, medical device and pharmaceutical markets. As part of the TASI Group, Sepha will be able to increase sales in important markets such North America, China and India. Commenting on the acquisition during a recent visit to Sepha, TASI President and CEO David Huberfield said: “We are very pleased to partner with Sepha in expanding our global life sciences markets and products. We have an expansive engineering, manufacturing and service presence on three continents and sales coverage in almost 100 countries. Sepha joins Bonfiglioli Engineering, Air Logic Power Systems [ALPS], Cincinnati Test Systems and ATC Automation, all leaders in their fields, in providing a complementary

range of integrated test systems, pack inspection and instrumentation to pharmaceutical and medical device customers.” Sepha CEO John Haran added: “Sales of our pack inspection and deblistering machines have increased rapidly in recent years. Pharma companies are now John Haran, CEO of Sepha, welcomes David Huberfield, very focused on the issues President and CEO of TASI, and John Kerby, CEO of Tasi caused by poor packaging, Leak Inspection Division to Sepha during a recent visit namely increased costs and to celebrate the acquisition of Sepha by TASI. lower quality. We will be Sepha Ltd accelerating product +44 2890 484848 development to maintain Sepha’s lead info@sepha.com in the inspection sector in response to www.sepha.com / www.tasigroup.com market demand.”

Indian Thermoforming Machinery Specialist Celebrates 50 Years Established in 1963, IMA-PG India Private is celebrating its 50-year presence in India. The company ventured into manufacturing blister packaging machines in 1978 and since then has reportedly been responsible for significant developments in the field of thermoforming and cold forming technology, with special emphasis on catering to the demands of the pharmaceutical industry. Today, IMA-PG offers complete solutions with its wide range of blister packing machines, cartoning machines, tube filling machines, counting machines and end of line solutions.

With manufacturing locations in Navi Mumbai and Indore, IMA-PG entered into a strategic alliance with IMA S.p.A. in Italy in 1995, becoming a complete subsidiary of IMA S.p.A. in 2010. With over 2,200 installations worldwide and a presence in over 70 countries, IMA-PG is known for consistant growth and providing customised, cost-effective products that fulfill customer requirements. To strengthen its position further and support the various new technology transfers from IMA, IMAPG decided to expand its

manufacturing base in Indore, central India, near to its existing unit, to approximately 5,000 m2. The new plant is ready and its inauguration is planned for 18 September 2013, to coincide with the 50-year celebrations of IMA-PG. IMA-PG, now part of the IMA Safe division of IMA S.p.A, is also handling sales and marketing of IMA Safe products made in Italy for the Indian market. IMA-PG India Private Ltd +91 22 67179000 www.imapg.com

Processing Machinery Alliance Elects Speaker and Approves Strategy Document The members of the Excellence United Alliance — Bausch + Ströbel, Fette Compacting, Glatt, Harro Höfliger and Uhlmann — have elected Thomas Weller, CEO of Harro Höfliger GmbH, to be the new speaker for the Excellence United Board for the coming year. He assumes this responsibility from Siegfried Drost,

Managing Director, Uhlmann PacSysteme GmbH & Co. KG, who has performed this function since the Alliance was founded. Additionally, the members approved a common strategy document to further intensify and expand the close cooperation in the areas of technology,

sales and service. Among other things, the strategy document includes the provision for founding common sales and service organisations in selected countries. The commitment of the owners and executive management to the additional intensification and expansion of the

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cooperation was documented at Uhlmann by the ratification of this futureoriented strategy document. Excellence United +49 7191 501 5705 frank.erbach@excellence-united.com www.excellence-united.com

LABORATORY PRODUCTS & EQUIPMENT

Analytical Instrument for Biopharma Development Measures Viscosity and Molecular Size The new Viscosizer 200 from Malvern Instruments is the latest product to reach commercialisation as a result of Malvern’s highly focused Bioscience Development Initiative. Designed primarily to help solve key analytical challenges at the preformulation stage of pharmaceutical, and particularly biopharmaceutical, development, the automated Viscosizer 200 delivers viscosity and molecular size data on UVactive samples, using volumes of less than 10 µl. Measuring viscosity early in the development of biological formulations is critical in order to reduce the number of candidate failures during subsequent stages of development. The Viscosizer 200 has been engineered to meet early development screening requirements that demand automated measurement on extremely low sample volumes, which should ideally be recoverable, as well as operation at high sample concentrations under formulation conditions. The temperature-controlled Viscosizer 200 measures viscosity from 0.9 to 120 cP and hydrodynamic radius from 0.2 to 100 nm, in samples at concentrations from 0.1 to >300 mg/ml. Its integrated carousel autosampler can be configured with a maximum of 45 vial positions. The technology at the heart of the Viscosizer 200 is UV area imaging. This is

used to monitor the time-dependent absorbance profile of UV-active samples such as proteins, peptides and other chromophorecontaining molecules as they migrate through a microcapillary. Capillary viscometry has long been used to determine viscosity from a simple measurement of time from injection to detector but is subject to injection time errors that can result in significant errors in subsequent calculations. The Viscosizer 200 has a dual-pass capillary design whereby sample is detected at two windows along the capillary. This enables precise measurement of the transit time between windows and therefore of the sample’s viscosity relative to a reference, with demonstrable improvements over singlepass capillary systems. For sizing analyses, as the sample migrates through the capillary, diffusion leads to broadening of the sample plug, a phenomenon countered by transverse diffusion; the smaller the molecule, the more rapid transverse diffusion and the less broadening of the peak. The

Viscosizer 200 calculates mass-weighted mean hydrodynamic radius from the standard deviation of the sample profile at the two windows. UV wavelength selectivity means that the Viscosizer 200 can accurately measure the size of molecules of interest, even within an excipient-laden formulation. The Viscosizer 200 supports rapid understanding of the behaviour of candidate molecules in various formulations, enabling important decisions on suitable formulations to be made as early as possible. Malvern Instruments Ltd +44 1684 892456 salesinfo@malvern.com www.malvern.com

Next Generation Pipette Provides Accuracy and Reliability for Valuable Testing Work Eppendorf has introduced the Reference 2 pipette, the successor to the highly successful Reference pipette, enhancing the range’s already high standards with a new design, reduced weight and operating forces and multi-channel versions. As the premium product in Eppendorf’s pipette portfolio, the Reference 2 provides the most accurate results as well as robust, reliable handling and optimum user safety. These levels of security make the Reference 2 ideal for use with precious liquids or in any application requiring extremely high levels of accuracy. The Reference 2 ensures complete traceability through the use of an embedded RFID chip containing all the instrument’s relevant data, including serial number and certificate of

conformity. Furthermore, a serial number printed on multiple components of the pipette prevents parts from being mixed up and indicates if one of the volume defining parts has been exchanged. Vital reproducibility is guaranteed by the channel indicator incorporated into the multi-channel version of the Reference 2. This promises a continuously identical pipette alignment during the work process. The pipette also provides highly flexible use, with the ability to remove single cones, and easy maintenance. The combination of one-button technology and spring loaded tip cone makes the Eppendorf Reference 2 exceptionally easy and quick to use. The pipette achieves quick tip ejection with active aerosol reduction and reduces the possibility of repetitive strain injury by

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eliminating the need to move the thumb sideways. Eppendorf’s new Reference 2 is an ideal instrument for liquid handling applications where quality and precision are priorities. Eppendorf UK Ltd +44 1438 735 888 sales@eppendorf.co.uk www.eppendorf.com/reference2

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Vapour Permeability Meter Sensors Accommodate Ever Expanding Range of Materials Versaperm has announced a fast and accurate solution for laboratories to measure the permeability of almost any material against virtually any gas, from water vapour to hydrocarbons and from solvents through to hydrogen, oxygen and carbon dioxide. Vapour permeability measurements are widely used in almost every industry as it is critical in most real-life applications. It substantially alters properties such as the shelf life of pharmaceuticals and foods. Permeability also controls the handleability, jam-ability and print quality of paper, the texture of pizza, the efficiency of seals, the waterproofness of products, enclosures and textiles, the effectiveness of a lorry’s airbrakes and it has even caused missiles and aircraft to crash.

A range of sensors, using a wide different physical principals, enables Versaperm’s equipment to be used across an extensive range of applications to characterise a continually expanding range of materials, compounds, containers, products and laminates. Available sensors include gas chromatography, pressure measurements, semiconductor, electrolytic, infrared, capacitive, impedance, thermal conductivity, flame ionisation, catalytic combustion, photoionisation, zirconium dioxide, paramagnetic, electrochemical, coulometric and mass spectrometer. Manufacturing processes such as heating, forming and bending can reduce permeability to 25% of its original value. This means that results usually cannot be estimated from a

material’s properties but must be measured directly after production. The Versaperm system can do this and it offers both single and multiple chamber options. Versaperm’s permeability meter is highly automated and can cope with several samples at a time. It needs very little re-calibration and requires, at most, minimal training. Sensitivities depend on sensors, gasses and materials but are usually in the parts per million range, parts per billion for some materials. Results are both accurate and highly repeatable. Versaperm also offers a consultancy service for laboratories that need to

measure permeability of complex new materials and assemblages. Versaperm Ltd +44 1628 777668 info@versaperm.com www.versaperm.com

Power Door Autoclaves Meet Big Requirements of Small Labs The perfect solution for laboratories that sterilise large bulky items or have a high throughput is a high capacity rectangular chamber autoclave but if laboratory space is limited, conventional chamber door swing can be a problem. Priorclave has therefore introduced the RSV Power Door range of autoclaves. The big advantage of its rectangular chamber design is that the chamber door lowers and rises inside the body of the actual machine, eliminating the laboratory space normally required to allow for door swing.

The RSV Power Door range is currently available in four standard chamber sizes: a mid-capacity range produced in two chamber sizes of 230 and 350 l and two higher capacity autoclave models with 450 and 700 l chambers. Push-button controls provide hands-free opening and closing of the vertical sliding pressure door. Although easy access to the chamber is gained using the push-button controls, inherent safety features prevent door opening during sterilising cycles and at high temperatures and pressures. A design advantage of Priorclave

Power Door autoclaves is a fixed gasket onto which the door closes. When raised in line with the chamber opening, the door automatically moves forward directly onto the seal to create an air-tight lock. This closure action prevents undue wear on the fixed seal, improving long-term operational performance of these Priorclave autoclaves. RSV Power Door autoclaves are part of a comprehensive range of 40 to 700 l autoclaves — including benchtop, front and top loading floor, vacuum and double-door — designed and

Media Prep Station Increases Productivity in Tablet Dissolution Testing The new Dissomate media preparation unit from Copley Scientific is an automated, compact system for preparing and gravimetrically dispensing the prewarmed, de-aerated, dosed dissolution media required for accurate tablet dissolution testing. Operating on the ‘filtering, warming and stirring under vacuum principle’ recommended by the pharmacopoeias and FDA, it can prepare eight litres of fresh dissolution media in under 15 minutes. These fast preparation times, in combination with rapid dispensing, reduce the downtime between dissolution experiments, with proven savings compared with manual preparation. Dissolution testing is vital in tablet manufacture. Accurate analysis requires well-prepared dissolution media as air bubbles and other dissolved gases are widely recognised as sources of problems. Efficiently producing warmed, degassed dissolution media ensures productive operation of a dissolution testing laboratory and the integrity of the resulting data. The Copley Scientific Dissomate combines preparation and dispensing in a single unit. It warms and degasses the medium in accordance with the procedures defined in the pharmacopoeias and then dispenses on the basis of weight. Gravimetric dispensing avoids the issues known to be associated with volumetric filling when the standard filling temperature (25˚C) differs from the temperature on

dispensing (37˚C ) and is recommended by the USP for its superior accuracy. Automatic addition of the required volume of acid, buffer or surfactant prior to mixing and dispensing eliminates any requirement for pre-preparation while the unit’s remote dispensing gun allows in-situ filling, avoiding any need to transport the dissolution vessels. The standard 8 l Dissomate supports several dissolution testers but a larger 15 l version is available on request. This can fill two complete dissolution testers from a single preparation process. Copley Scientific Ltd +44 115 961 6229 m.copley@copleyscientific.co.uk www.copleyscientific.com EPM 31

manufactured by Priorclave. The company is also able to produce autoclaves designed and built to meet specific requirements. Priorclave Ltd +44 20 8316 6620 sales@priorclave.co.uk www.priorclave.co.uk

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Programme Makes Recycling of Lab Garments Easy Kimberly-Clark Professional has launched an initiative across EMEA that enables cleanroom and laboratory operators to recycle a wide range of used protective garments. This follows a successful launch in the US earlier this year. The programme, called RightCycle, makes it easy to dispose of previously hard-to-recycle garments such as coveralls, gloves, hoods, boot covers and hairnets in a sustainable manner. The used items are simply placed in a RightCycle collection box or the operator’s own box. Full boxes are assembled onto pallets and collected by Kimberly-Clark Professional programme partner TerraCycle. Launched initially in the UK and Germany as a one-year pilot scheme, RightCycle is reportedly the first largescale recycling solution for this kind of

waste, offering companies an opportunity to reduce landfill waste streams and enhance their sustainability efforts. After the used garments are collected, they are turned into raw materials to create eco-friendly consumer products such as plastic chairs. Ruud Sleumer, Customer Marketing Manager at Kimberly-Clark Professional, commented: “Our cleanroom and laboratory customers have ambitious sustainability goals, yet often struggle with where and how to get started. Our innovative RightCycle programme offers a powerful and easy way for them to exceed their solid waste reduction goals, while helping to make their workplaces healthier, safer and more productive.” The RightCycle programme supports the ‘Planet’ pillar of the three-pronged

Kimberly-Clark Corporation Sustainability 2015 vision, which also encompasses ‘People’ and ‘Products’. The Sustainability 2015 strategy engages Kimberly-Clark businesses, brands and employees globally. Under each of the three pillars, the company is working towards meeting a range of demanding targets that will make a major difference to the sustainability of its operations and, potentially, affect millions of people’s lives for the better. Sustainability 2015 builds on the success of previous Kimberly-Clark Professional environmental improvement programmes such as the Vision 2010 initiative, under which the company implemented a number of successful projects worldwide to improve its performance in key environmental areas. It also widens the focus and scope of the company’s sustainability agenda to

integrate elements that sustain and nurture healthy working environments and communities. Sleumer said: “The disposal of solid waste by pharmaceutical and other scientific organisations poses considerable challenges for businesses and society. Landfill options are becoming more limited and waste disposal costs continue to rise. The RightCycle programme takes recycling to a new level — beyond downcycling, upcycling and other approaches — by making it easy to recycle pharmaceutical cleanroom and laboratory garments that used to be very difficult to dispose of sustainably.” Kimberly-Clark Professional +44 1273 853 884 info@kimtech.com www.kcprofessional.com

Mass Spectrometer Uses Digital Detection for Fast Gas Processes Hiden Analytical has introduced a gas analyser — the HPR-20 QIC TMS system — specifically configured for analysis of fast transient pulses and rapid compositional changes in gaseous processes. Developed for the researcher, the system is suited to studies of diverse thermally triggered and chemically triggered reactions. The multi-mode Windows MASsoft Professional software features quantitative analysis and statistical data reduction programs, peak area integration and the APSI-MS soft ionisation mode to enhance spectral purity. The system includes provision for

import of two external signals to enable simultaneous integration of parameters such as temperature and weight with the mass spectrometer data. Operating with sample pressures from nearatmospheric up to 30 bar, the benchtop mass spectrometer uses a fast digital detection system for minimised signal response times and features the Hiden triple-stage mass filter for optimum sensitivity, species identification and

corrosion resistance. Coupling to the process is via a flexible, heated capillary interface of 0.9 m length with a throughput of just 20 ml per minute. Measurement rate is up to 500 data points per second over a seven decade dynamic range, with a compositional change at the sample point recorded in less than 150 ms. Pulse profile resolution (5 to 95% peak height) is just 60 ms.

HPR-20 QIC TMS transient MS QIC inlet.

Hiden Analytical Ltd +44 1925 445 225 info@hiden.co.uk www.hiden.co.uk

Particle Imaging System Wins Award Malvern Instruments’ Morphologi G3-ID has won a Readers’ Choice Award 2013, voted for by the industry readership of Laboratory Equipment magazine. The Morphologi G3-ID particle characterisation system combines automated particle imaging with the chemical identification of individual particles using Raman spectroscopy and is proving ideal for solving complex particle characterisation problems where size and shape alone provide insufficient information. Paul Kippax, Product Group Manager at Malvern, said: “I’m delighted that Malvern is receiving this award for the Morphologi G3-ID and I would like to thank everyone who voted for us. It is especially pleasing to gain such direct recognition from professionals in the laboratory. The Morphologi G3-ID is going from strength to strength, with the combination of automated particle imaging and Raman spectroscopy

proving highly valuable in supporting the greater understanding of particulate systems across many different industries and applications.” The Morphologi G3-ID is designed to enable all users, from particle characterisation scientists with limited spectroscopy experience right through to experienced spectroscopists, to gain an in-depth understanding of particulate samples. Key applications are in determining component-specific particle properties of mixtures and blends, including those used in pharmaceutical products such as tablets, nasal sprays and asthma inhalers. Simple SOP operation takes the user from integrated sample dispersion for dry powders through to size, shape and chemical analysis, with automatic selection, targeting and chemical classification of thousands of individual particles. Measurements can be made

on dry powders, suspensions and membrane filters. The system automatically measures the size and shape of particles in a dispersed sample. In contrast with other chemical mapping and imaging techniques, there is no compromise on the reliability of particle size and shape data. It then automatically finds the selected particles and collects a Raman spectrum from each. Chemical identification of individual particles based upon established spectroscopic algorithms is incorporated in the Morphologi G3-ID software, allowing enumeration of defined classes of

particles and measurement of component specific characteristics in a blend. Malvern Instruments Ltd +44 1684 892456 salesinfo@malvern.com www.malvern.com

Entry-Level Parallel Synthesis Kit Offers Full Upgrade Options Asynt has designed its range of products for parallel synthesis to share standard parts (inserts) for reaction tube, vial and round-bottom flask based reactions. Consequently, investment in an entry level DrySyn parallel synthesis kit provides an easy upgrade path to the advanced capabilities of a DrySyn Snowstorm system. The DrySyn parallel synthesis kit provides a convenient, low-cost solution

for chemists wishing to conduct simple synthetic reactions with temperature control and magnetic stirring but without the complications of reflux or inerting. The kit accommodates a range of standard reaction tubes and vials of different diameters. It can also be upgraded to a parallel reaction station using standard round-bottom flasks by using the appropriate DrySyn MULTI inserts.

In this configuration, capabilities can be added such as directly driven stirring with the Asynt Vortex stirrer system. Available in a choice of configurations, an Asynt DrySyn SnowStorm system provides controlled cooling and heating for subambient parallel chemistry without the need for jacketed reaction vessels or ice baths. Operating with a suitable

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chiller/circulator, a DrySyn SnowStorm system provides accurate, stable temperature control down to -50˚C and up to +150˚C, making it a perfect tool for crystallisation studies and screening polymorphs. Asynt Ltd +44 1638 781709 sales@asynt.com www.asynt.com

SHOWCASE WEIGHING

Balance Provides Increased Weighing Reliability in Regulated Areas The new Secura laboratory balance, developed by Sartorius for applications in regulated areas such as pharmaceutical laboratories, fulfills particularly high reliability requirements. The balance monitors its ambient conditions automatically, thereby preventing handling errors. This increases the reliability of weighing procedures in pharmaceutical laboratories and helps users to achieve even better measurement results. Nine different models of the Secura balance are available, covering a range of weighing capacities from 120 to 5,100 g and a readability of 0.1 to 10 mg. The balance is also equipped with various assistance systems designed to prevent further processing of uncertain weighing results, which frequently occur through operating errors during weighing. If errors occur, the balance identifies the uncertain weighing results in the display and blocks their transmission. Secura can therefore increase process reliability and decrease error rates in the laboratory. Precise levelling of a balance is an essential component of equipment

monitoring and a prerequisite for obtaining accurate readings. The electronic LevelControl sensor ensures that Secura is perfectly level. Noncompliance is indicated visually in the display and blocks output of the reading. Clear instructions in the display guide the user through the levelling procedure simply and safely. This means that laboratory staff can easily level Secura laboratory balances located in safety work benches or safety weighing cabinets without having to open the safe work area. Even minor temperature fluctuations in the laboratory have a considerable influence on the reproducibility of weighing results. For this reason, balances have to be calibrated regularly and as soon as the ambient conditions change. Once a specified time or temperature threshold is reached, Secura’s calibration and adjustment function, isoCAL, informs the user and automatically adjusts the balance using internal weights. Every adjustment is documented and can be traced for quality assurance purposes.

Every balance used in regulated areas such as pharmaceutical laboratories has to meet the requirements specified by the FDA. Pharmaceutical laboratories therefore have to determine the minimum sample weight according to the USP on site and measurements may not fall below this limit. On request, Sartorius service staff will determine this value during first operation of the Secura balance and issue a minimum sample weight certificate. The value will then be constantly visible in the display of the balance. If a measurement falls below the specified minimum sample weight, an alert will appear in the display and Secura will block printout and transmission of the reading. The user interface of the Sartorius Secura balance has been developed in collaboration with experienced users. The weighing applications are represented as clearly understandable icons on the touchscreen of the Secura balance. This allows users to launch any of the balance’s programs with the touch of a finger, without first having to read the operating manual. Secura only displays

the information required for the particular operation. The colour-coded information and action fields make operating errors near impossible. Settings that could change data output or the metrological performance of Secura can be passwordprotected so that access to them is restricted to authorised persons only. Sartorius Group +49 551 308 3615 karin.kleist@sartorius.com www.sartorius.com

Weighing Standard Ensures USP Compliance On 3 June 2013, the USP published the revised mandatory General Chapter 41 (‘Balances’) as well as updates to the advisory General Chapter 1251 (‘Weighing on an Analytical Balance’). The revisions define modified balance test procedures for the US pharmaceutical industry and also apply to companies exporting to the US. Mettler Toledo’s global weighing standard, GWP (Good Weighing Practice), can help pharmaceutical manufacturers and suppliers meet the new requirements. For a long time, balance users and manufacturers argued that balance assessment as per the USP’s General Chapter 41 was unclear and difficult to comply with. In addition, they frequently commented that General Chapter 1251 no longer represented state-of-the-art weighing practices. The revisions to both chapters aim to help US pharmaceutical

manufacturers and suppliers ensure accuracy and eliminate costly overtesting. The revised General Chapter 41 details a relatively demanding balance assessment, outlining accuracy and repeatability tests for calibrated balances used to weigh analytes for quantitative measures. Since accuracy can only be gauged using weights that are at least 5% of an instrument’s capacity, test weight selection criteria have also been modified accordingly. General Chapter 1251 provides additional clarification on the new procedures and extends the scope to any balance used for an analytical procedure. It details that balance performance verification should be carried out using a risk-based approach. Very importantly, it is recommended to only weigh net samples that weigh sufficiently more than the minimum

weight to account for fluctuations in the balance’s performance owing to varying influences from the environment and the balance operators. This requirement is clearly applied to the sample weight itself and not to the tare vessel. Additionally and perhaps most importantly, daily testing recommendations have been dropped. This change is expected to provide significant time savings that, if accompanied by weighing accuracy, will offer monetary savings. Mettler Toledo’s GWP can help manufacturers implement the new USP regulations. Tailored to each weighing application, GWP Verification is a riskbased service that helps eliminate redundant or erroneous testing. Thanks to determining the minimum weight and measurement uncertainty for each and every balance and scale used in the

weighing process, manufacturers not only optimise SOPs, ensure consistent product quality and pass air-tight audits, they also avoid potentially costly litigation and fines resulting from a poorlyformulated, out-of-specification product. Mettler Toledo AG Laboratory & Weighing Technologies +41 44 944 22 11 marianne.portmann@mt.com www.mt.com/gwp

Analytical Balances Combine Precise Performance and Value They can be costly but analytical balances are necessary when precise calculations are vital. Adam Equipment’s PW analytical balances offer remarkable value, weighing to 0.1 mg and quickly delivering high-precision mass measurements. Loaded with intuitive features, the PW offers durable metal construction, standard internal motorised calibration and a large backlit display that shows text prompts to help the user set up the balance quickly. The intuitive keypad and informative display make operation

easy with little or no training. Highlighted tare keys stand out for accessibility, while other buttons operate setup functions, turn the balance on or off, send data to a printer, calibrate and change modes and weighing units. The RS-232 interface enables data transfer between the balance and printers or computers. This allows foolproof data recording and traceability, freeing the operator from manually transcribing data and allowing them to focus on data analysis instead.

A security slot for optional Kensington-type lock and cable help deter theft, while password control prevents unauthorised access. A large weighing chamber with sliding glass doors allows easy weighing

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of different-size samples. Other valuable features include built-in applications for density, percentage, comparison and checkweighing, along with counting. PW balances offer 16 weighing units, including a custom unit. With models from 120 to 250 g and readabilities at 0.1 mg, there is a PW analytical balance available for most applications. Adam Equipment Co Ltd +44 1908 274545 sales@adamequipment.co.uk www.adamequipment.co.uk

Corporate News

Science Showman to Speak at Lab Innovations 2013 Professor Andrea Sella, the science showman, whose theatrical chemistry demonstrations fill theatres up and down the country, will deliver a keynote address at Lab Innovations 2013, which takes place on 6–7 November 2013, at the NEC, Birmingham, UK. The Professor of Inorganic Chemistry at University College London will not only talk on the opening morning of the first day, as part of the Royal Society of Chemistry’s conference at the show, but will also take part in a highly contentious Chemistry World Panel Debate that Lab Innovations is hosting. While the topic for the debate has yet to be agreed, the need to attract more talent into science will probably not be far from the agenda given Sella’s considerable zeal at communicating science to school children and the Lab Innovations show’s own research. Conducted in May among 112 science-

based organisations within the UK, the research found that 91% think more needs to be done to excite young people about science and 23% believe a lack of skilled workforce is inhibiting their success. Sella is one of the UK’s loudest chemistry cheerleaders, dedicating more than half his working time to science communication. In the past, he has said: “Trying to get students to go into science when you are talking to them at 16 or 17 is too late. Intervention has to be much earlier.” Commenting on Andrea Sella’s involvement in the show, Jake Morrison, Lab Innovations Event Manager, said: “I think there will be some really interesting questions from the floor when Andrea Sella takes to the podium, not least because lab professionals that we have researched are clearly worried about the talent they have going into their organisations.

“Andrea draws tremendous crowds wherever he speaks. His presence in the RSC theatre at Lab Innovations will be a brilliant addition to what’s already shaping up to be a huge show. It really highlights how determined we are to make Lab Innovations a major must-see destination for all those in the laboratory community.” Lab Innovations is dedicated to laboratory equipment, technology and services. The show is supported by the Royal Society of Chemistry, Campden BRI and Gambica and its attendees are laboratory managers and scientists working within the chemical, life sciences and food and beverage industries, plus those in research institutions. In addition to Andrea Sella’s keynote and the Chemistry World Panel Debate, Lab Innovations 2013 will feature a Royal Society of Chemistry Conference, Campden BRI technical workshops,

UKAS Pavilion and packed exhibition hall with all the latest product and service innovations from over 100 supply companies. easyFairs +44 20 8843 8822 richard.thompson@easyfairs.com www.easyfairs.com/labinnovations

Cleanroom and Lab Products Supplier Receives Funding for Growth and Jobs It can be incredibly difficult for professionals working within the pharmaceutical industry to source fully certified products and equipment that match their requirements. Even acquiring simple items can represent a challenge. Based in Birmingham, UK, and drawing on its experience installing and maintaining pharmaceutical production machinery, Pharma Hygiene Products (PHP) specialises in the supply of quality cleanroom and laboratory products and equipment. Through the company’s network of manufacturers, it provides fully certified stainless steel hygiene products that meet rigorous industry standards.

After PHP successfully pitched its ambitious plans for growth, Dragon’s Den style, to a panel of experts recently, the company is now receiving support from the Government’s Regional Growth Fund (RGF). The fund represents a significant investment, will support growth and generate new jobs. Operating from new premises and exporting globally, PHP is already winning large orders from some of the leading pharmaceutical companies. Operations Director Matthew Jeyes said: “This is an exciting time for us. In addition to significantly expanding our existing product range, we will be developing and manufacturing our own

unique products designed specifically for drug manufacturers.” Marketing Director Philip Jeyes added: “As specialist suppliers to the industry offering a comprehensive range of products, our goal is to provide a single source solution, with easy ordering through a customer focused website and purchasing processes.” A well-designed comprehensive catalogue is available in digital form or a printed version can be ordered from the company’s website. Pharma Hygiene Products Ltd +44 121 661 6548 sales@pharmahygieneproducts.com www.pharmahygieneproducts.com

Calibration Microspheres Producer Sponsors Filter Media Conference Whitehouse Scientific is once again a major sponsor of The Filtration Society’s annual international conference and exhibition, returning on 5–6 November 2013 at the Mercure Chester East Hotel, Christleton, Chester, UK. This year, the one-day event focuses on filter media and will be preceded by a Media for Gas and Liquid Filtration course. Attendance at Filtration Society meetings is open to everyone — members, non-members, UK and nonUK delegates. The full conference programme, registration and exhibition details are now available at http://bit.ly/WHT306. Dr. Graham Rideal, CEO of Whitehouse Scientific and science correspondent for The Filtration Society, said: “Whitehouse Scientific is very pleased to be supporting the annual Filtration Society conference once again, in this the Society’s 49th year. The appeal for me, especially in the

Media for Gas and Liquid Filtration course, is no matter whether you are a graduate student or a leading expert in filter media and filtration, we all learn from one another.” The Filtration Society conference has once again attracted a host of industry leaders. On day one, presenters of the Media for Gas and Liquid Filtration course will be filtration expert Professor Richard Wakeman and consultant engineer Dr. Steve Tarleton. The short course will be a review of the processes involved in the manufacture, properties and applications of filter media used in liquid and air (gas) filtration. Topics covered will include: the role of media in filtration; fibres and yarns for filter media; testing filter media for gas applications; and characterising and testing filter media for liquid applications. On day two, the main Filter Media 6 conference will include expert

presentations from speakers drawn from both academia and industry. Presenters will discuss new developments in filter media, with key elements including the role of media design, recent products emerging from industrial R&D and different modern filter media technologies illustrated through successful applications case studies. The Filtration Society was formed in London in 1964. It is a charitable, nonprofit organisation established to advance and disseminate knowledge on the design and use of filtration and separation techniques in industry, commerce and other walks of life.

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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

INGREDIENTS & CONTRACT SERVICES

Biopharma CMO to Produce Monoclonal Antibody for Late Clinical Development and Market Apeiron Biologics, a biotech company focused on immunologic and biologic therapies against cancer, and Rentschler Biotechnologie, a full service biopharmaceutical contract manufacturer, have jointly announced a partnership agreement to manufacture GMP material for various advanced clinical studies and later on for market supply of Apeiron’s lead programme APN311. APN311 is a chimeric antibody that targets the GD2 antigen, which is abundantly expressed on neuroblastoma cells. The programme is currently being evaluated in several clinical trials in patients with high-risk neuroblastoma in many European countries and other parts of the world. Neuroblastoma is the most common extracranial solid tumor seen in children. Fifty percent of all cases are diagnosed within the first year after birth. To achieve a quick approval and make this therapy available to all patients as soon as possible, Apeiron is working closely with international regulatory authorities. Decisive factors in Apeiron’s partnering selection were Rentschler’s ability to keep to the very challenging project timelines and the company’s technical and regulatory expertise in Phase III and market projects. Apeiron receives access to experienced teams, appropriate

mammalian cell culture capacity for clinical Phase I to III and commercial production, fill and finish services as well as a scientific-driven and responsive project management. The partnership agreement includes the transfer of the manufacturing process to Rentschler, GMP manufacturing and process validation in preparation of the MAA/BLA submission as well as future market supply. “We are happy to have identified Rentschler as a professional contract manufacturer and consider this collaboration as a distinct value increase for our project APN311, which is also acknowledged in discussions with existing and potential partners,” commented Hans Loibner, Chief Executive Officer of Apeiron Biologics. “This decision resolved a significant hurdle in our effort to make this therapy available as soon as possible. I am very much looking forward to a fruitful collaboration.” “We are very excited to contribute our expertise to meet the truly challenging timeline of this project, which is so very important for children suffering from this life threatening disease,” stated Frank Ternes, Chief Business Officer of

Hans Loibner, CEO, Apeiron Biologics. Rentschler. “We are confident that this cooperative atmosphere will continue to grow and mature over the course of the entire project and ensure the success of this partnership.” Rentschler Biotechnologie GmbH +49 7392 701 491 info@rentschler.de www.rentschler.de Apeiron Biologics GmbH +43 1 865 65 77 apeiron@apeiron-biologics.com www.apeiron-biologics.com

Lab Services Provider Ranks Number 1 in Global Investigator Satisfaction Survey Covance has announced that its central laboratory services once again ranked first in an independent global survey of physician investigators participating in clinical trials. Forty-seven percent of the study participants named Covance’s central laboratory services as their ‘most preferred’ central laboratory, with investigators citing Covance more than twice as often as the nearest competitor. Investigators also reported having the ‘best overall relationship’ with Covance, rating it 8.4 on a scale of 1 to 10. Survey results underscore the growing importance of the selection of a preferred central laboratory because of its direct connection to investigators’ satisfaction and their willingness to work with sponsors in the future. In addition, most physicians who want to learn about being a clinical trial investigator talk first to other doctors involved in clinical trials. The report shows a clear link between overall investigator satisfaction and sponsors’ choice of central laboratory, with 100% of respondents reporting they were satisfied when pharmaceutical sponsors select the investigators’ preferred central laboratory. When pharmaceutical sponsors select the

investigators’ least preferred central laboratory, satisfaction drops significantly. Respondents cited central laboratory preference as a key driver of satisfaction with the pharmaceutical sponsor as well, with 91% of investigators stating that they are more satisfied and willing to work with a sponsor on trials when sponsors have selected investigators’ preferred central laboratory. Ninety-eight percent of investigators indicate the central laboratory selected by the sponsor impacts their success (and that of their staff), their day-to-day activities and their willingness to work with a particular sponsor on future studies. Effective communication, a laboratory’s reputation for reliability and quality and easy-to-use collection kits are among the factors that lead to a strong relationship between investigators and a central laboratory, the report showed. Respondents ranked Covance first in all of the key performance metrics, such as customer service, reliability and timely and accurate reporting. Covance has five dedicated laboratories in the US, Switzerland, Singapore, China and Japan. In the past

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five years, Covance central laboratories have conducted more than 214 million laboratory tests for more than 4,200 clinical trial protocols in approximately 100 countries, working with more than 125,000 investigator sites. The ‘Clinical Trial Investigator Satisfaction and Central Laboratory Performance’ survey, conducted in June and July by the Life Science Strategy Group, questioned physicians actively participating in pharmaceutical industrysponsored clinical trials as investigators. Participants were prescreened to ensure a high level of involvement and/or key decision-making authority for their investigative site. All global geographies and practice settings were represented, as were more than 20 medical specialties. The mean experience level in a clinical trial setting was 12.7 years. The study, based on a survey of 258 clinical trial investigators globally, is an update of a similar study Life Science Strategy Group conducted in 2011. Covance Inc. +1 609 452 4082 melissa.thompson1@covance.com www.covance.com

INGREDIENTS & CONTRACT SERVICES ROUNDUP CPhI & CPhI Pharma Evolution Add Stellar Names to Expert Industry Panel CPhI Worldwide, organised by UBM Live, and CPhI Pharma Evolution have announced a full expert industry panel list ahead of the publication of a forward looking annual report examining future contingencies for the pharmaceutical industry. Additionally, the panel has already contributed to the first CPhI Pharma Evolution monthly report examining the current trends in ‘Formulation and Ingredients’, such as issues relating to growth of the market, development of tablets, QbD, PAT, bioavailability, outsourcing, dissolution and stability. Each panel member has been individually chosen following an exhaustive selection process involving industry peers and journalists to ensure that the panel has the appropriate expertise to independently and holistically examine global trends. In total, CPhI now has 13 world-renowned experts, covering the entire pharmaceutical supply chain from R&D through to finished products, regulatory requirements and economic implications. Featured on the panel will be Piramal’s pharmaceutical sector lead Vijay Shah — spanning the three divisions Pharma Solutions, Critical Care and Lab Diagnostics — who has over two decades of experience and has overseen many business transformations. The Indian giant Piramal is transitioning from its traditional roots in contract and generics manufacturing

towards the development of NCEs. This step change approach has marked a seismic shift from West to East, as increasingly companies like Piramal start to challenge the traditional big pharma developers of drugs and begin to sell IP protected products into Western markets. Joining Shah will be PWC’s Director of healthcare practice Sam Venugopal, who has over 15 years’ experience across biotechnology and pharmaceuticals, with expertise that spans quality systems, regulatory compliance and supply chain activities. Mark Carver, Senior Vice President, Research, Development & Innovation, at Fujifilm Diosynth, also joins the panel and will bring a wealth of experience in the development of innovative technologies, particularly in relation to scalable and validated manufacturing processes. His industry acumen and knowledge spans 20 years of work on recombinant protein products based on microbial expression in bacterial, yeast and filamentous fungal systems. Prabir Basu, formerly of the National Institute for Pharmaceutical Technology and Education (NIPTE), will direct the panel’s attention towards how the industry can look to increase innovation. As the development of new compounds come to market, it is important that development and manufacturing techniques keep pace with the changing landscape of drug targets. He has spent the last 10 years heading the NIPTE and

is a renowned expert in looking at the future challenges in drug manufacturing and R&D. Secretary-General of the Indian Pharmaceutical Alliance and an expert on the Indian and worldwide regulatory landscape, Dilip Shah will provide insights into the future landscape and implications for pharmaceutical companies of potential changes. His experience spans over 45 years and through his consultancy practice (Vision) he works with some of the world’s leading companies looking at strategic planning. Emil Ciurczak provides an extensive range of pharmaceutical acumen across spectroscopy, PAT and QbD, having introduced NIR Spectroscopy consulting and written over 200 technical papers. He has also previously been a member of the FDA’s PAT committee and is currently President of Doramaxx Consulting. The panel will be completed by William Botha, a respected trainer and mentor in manufacturing. He is fluent in FDA regulations, including GDP and GMP, and has taught an aseptic processing course for the PDA (The Pharmacists’ Defence Association) and a quality systems course for the AAMI (Association for the Advancement of Medical Instrumentation). For the remainder of 2013, members of the panel will take part in short monthly reports entitled ‘CPhI Pharma insight series’, examining topical issues across

Vijay Shah, COO at Piramal Enterprises.

the themes: R&D; Manufacturing; Packaging & Distribution; Regulatory Compliance; Contract Services & Supply Chain Management; and QA/QC. The ultimate goal of the panel’s inception is to utilise their respective areas of expertise to scrutinise how the industry will change across the coming 5–10 years in an annual report. The report will feature a mixture of primary industry surveys and collection of in-depth essays from panel members, with experts given carte blanche to prophesise how the industry will look and operate in the future from both an economic and practical perspective. CPhI Worldwide / Pharma Evolution cphi@ubm.com / www.pharmaevolution.com

Pharma Company Announces Further Expansion and 229 Jobs Following the success of one of its key client partnered products, Almac, based in Craigavon, UK, has announced a commercial manufacturing expansion. Together with the recent completion of a new non-GMP drug development facility at the Craigavon site, this dual expansion represents a total investment of £13.7 million, which includes some financial support from Invest Northern Ireland. Over the next three years, up to 229 jobs will be created across both projects. The product, a laxative drug, which is contract manufactured by Almac, has recorded robust sales growth year on year throughout the UK and Europe. With existing facilities at full capacity and further demand forecast in a number of new markets, Almac decided to focus all production in Northern Ireland with additional equipment and resources in Craigavon. The investment will deliver blending equipment and an automated packing and integrated cartoning line,

which will enable high-volume bulk commercial manufacturing scheduled to begin in November 2013. Also at the Craigavon site, Almac is experiencing growth through the creation of a new 1,245 m2 formulation development facility and analytical laboratories. This facility focuses on the development of tablet and capsule formulations for new drugs that are in the early stages of development and that have not yet reached the market. The new non-GMP facility will enable greater speed in formulation and process development by creating an environment where development work can be progressed quickly and efficiently, free of many of the constraints usually associated with drug manufacturing. Graeme McBurney, President and Managing Director of the business unit, explained: “The laxative product has been a great success in the UK and increasingly in European markets. The

marketing and promotion of the product by our contract customer has been very effective and significant growth potential in several new territories such as China has been identified. Centralising and expanding our production in Craigavon will mean more cost-effective manufacturing and optimal quality control and distribution.” “We are also delighted to see the completion of the new non-GMP facility that, alongside Almac’s existing GMP capability, will enable us to operate with improved speed and efficiency in the early stages of projects. This latest addition makes Almac a much more attractive proposition to international clients who seek streamlined, one-stop drug development solutions.” Enterprise Minister Arlene Foster said: “This investment is good news for

Craigavon and will reinforce Northern Ireland’s position in the wider life sciences sector. The 229 new jobs will deliver almost £5.5 million annually in salaries, bringing an important and positive economic boost that will benefit local people.” Almac Group Ltd +44 28 3833 2200 info@almacgroup.com www.almacgroup.com

Drug Development Company Appoints Reputable Board Member Avillion, which focuses on clinical codevelopment of therapeutics, has announced that Ted Love, M.D, has been appointed a non-executive director of the business. Vastly-experienced, Dr. Love was most recently the Executive Vice-President of Research and Development at Onyx Pharmaceuticals, overseeing the successful approval of Kyprolis. Prior to that, he was Chairman and Chief Executive Officer of Nuvelo, Inc., a biopharmaceutical company, from March 2001 to January 2009, having been

appointed President and Chief Operating Officer in January 2001. Dr. Love joined Nuvelo from Theravance, where he served as Senior Vice President of Development from 1998 until 2001, and before that he spent six years at Genetech, Inc., holding a number of senior management positions in medical affairs and product development. Lewis Cameron, Chief Executive Officer of Avillion, commented: “To have someone of Dr. Love’s calibre and experience on our board is a fantastic

coup for Avillion. We’re sure he’ll use his insight, contacts and knowledge to the best interests of the company and will complement other board members’ specialisms perfectly. It’s great to have Dr. Love on board, and we can’t wait to start working with him. Dr. Love serves as a director of several companies, including Santarus Inc., Mast Therapeutics, Amicus Therapeutics and KaloBios Inc. He also served on the 29-member California Independent Citizen’s Oversight Commission, which oversees the $3 billion allocated to stem

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cell research authorised by California Proposition 71. Dr. Love holds a B.A. in molecular biology from Haverford College and an M.D. from Yale Medical School. He completed his internal medicine and cardiovascular fellowship training at Massachusetts General Hospital and Harvard Medical School. Avillion LLP +44 207 470 2458 tasha@avillionllp.com www.avillionllp.com

INGREDIENTS & CONTRACT SERVICES ROUNDUP In-Vitro Testing Services Provider Relocates to Larger Premises SPS Pharma Services, a worldwide leader in dissolution method development, has moved to its new site in Orléans, France. The new laboratory is approximately 10 times bigger in physical size than the previous site and will allow the company to reinforce not only its position but also to widen its range of services. Previously located within the School of Pharmacy in Clermont-Ferrand, France, since its inception, SPS Pharma Services is reportedly the first and only contract laboratory focusing on the field of dissolution and release testing. The company was created in 2005, based on an initiative of the SOTAX Group Management, and claims to have established itself since as the main resource for the method development of innovative dissolution methods. Clients are global, encompassing all continents and ranging from small niche start-ups to many of the blue chip pharmaceutical companies, including the major players for generic drug development.

SPS Pharma Services also partners closely on research with various healthcare authorities such as the US FDA, USP, Chinese SFDA, NIFDC, French ANSM and Japanese NIHS as well as academia institutions (Université d’Auvergne, France, University of Connecticut, US, Trinity College of Dublin, Ireland, etc.). After eight years within the School of Pharmacy of Clermont-Ferrand, SPS Pharma Services is now able to fulfill the needs of its clients, many wanting more than method development, in line with the relevant agencies’ expectations, and a partner for the implementation of routine analysis. The existing quality system has been completely reviewed and reinforced to ensure GMP/GLP compliance. Processes were redefined according to the new facility and are managed using centralised laboratory software (Empower for chromatography, EQM for equipment management, DOC for documentation), an appropriate

technical structure setup, and the laboratory staff is now ready for clients’ audits. SPS Pharma Services has heavily invested in laboratory equipment and is now able not only to provide dissolution-focused services but also bestin-class analytical services such as New SPS Pharma Services site in Orléans, France. HPLC/UPLC method development for assay and degradation Units Asia-Pacific. Local authorities, products, automated sample preparation including President Eric Doligé, Senator, and physical testing of solid dosage were represented through the presence forms. SPS Pharma Services is now also of Bruno Rousselet, Director of ADEL in a position to partner with its clients (Agence de Développement from the development stages to Économique du Loiret), and Anthony commercial batches and stability Durand, Project Manager ADEL. studies. The new facility was inaugurated on 24 SPS Pharma Services May 2013 in the presence of Thomas +33 6 18 74 34 53 Pfammatter, CEO of SOTAX Group, and contact@sps-pharma.com Jean-Louis Raton, Head of Business www.sps-pharma.com

National Biologics Manufacturing Centre to be Located in Darlington The Centre for Process Innovation (CPI) has announced that its new National Biologics Manufacturing Centre will be located in Darlington, UK. The independent industry advisory board chose Darlington based on accessibility in the form of excellent transport links, particularly the East Coast Mainline, close proximity to existing pharmaceutical companies and relevant universities in the north of England in addition to growth opportunities within the Tees Valley Enterprise Zone. Commenting on the new centre, Minister for Universities and Science David Willetts MP said: “The new National Biologics Manufacturing Centre will significantly increase the UK’s manufacturing capability in biologics, keeping us ahead in the global race and strengthening the UK’s position as the location of choice for life sciences companies.” CPI is the process industry element of the UK government’s national manufacturing strategy, dubbed the High

Value Manufacturing Catapult. A network of seven technology and innovation centres tasked with stimulating growth within manufacturing sectors throughout the UK. Biologics or Biopharmaceuticals are medicines manufactured using biotechnology. The products have biological foundations, usually involving live organisms such as cells, bacteria, yeast and others as tools to perform specific manufacturing processes. Pharmaceuticals produced through biotechnology are delivering significant advances in healthcare. Completely new medicines are being created, notably for rare or previously untreatable diseases. The use of biotechnology is also revolutionising the research and development of new medicines, allowing better product targeting and personalised treatments for specific diseases and patient groups. The new centre, which forms part of CPI, will help companies of all sizes in the biologics market to develop, prove,

demonstrate, scale up and ultimately commercialise new biologics process technologies. Biological medicines already account for around 10–15% of the current pharmaceutical market and the sector is outperforming the market as a whole. Significantly, more than one-fifth of new medicines launched on the world market each year are now biotechnology-derived. This will likely grow with the scientific advances currently underway; and the application of biotechnology in healthcare is leading to an increasing number of innovative products. The flagship National Biologics Centre is part of the UK Governments Strategy for Life Science and will help UK companies to develop a competitive foothold in the growing global biopharmaceutical market. Dr. Chris Dowle, Director of the National Biologics Manufacturing Centre, said: “The new facility will support the development of new innovative process technologies

and manufacturing routes. We will provide both large and small companies with open access facilities to prove and scale up their process, therefore reducing risk associated with product development. We will build on the UK's competencies in biopharmaceuticals to position ourselves as world leading.” The Centre for Process Innovation (CPI) +44 1642 455 340 matthew.herbert@uk-cpi.com www.uk-cpi.com

Vegetarian Capsules Receive Vegan Certification Capsugel has been awarded Vegan certification for four capsules in its portfolio of vegetarian capsules. The capsules are Vcaps, Vcaps Plus, DRcaps and Plantcaps capsules. The term ‘vegan’ is defined as containing no animal ingredients or animal by-products (to include honey and sugar refined with bone char), using no animal ingredient or by-product in the manufacturing process and not being tested on animals by any company or independent contractor. “The Vegan certification is enthusiastically welcomed for our plantbased dosage forms. It is an expansion of the appeal of our plant-based capsules into a very targeted niche in the booming lifestyle driven market with its wide variety of health, dietary and cultural requirements,” said Pete Zambetti, Global Director of Business Development for Health and Nutrition at Capsugel. The plant-based capsules are already free of additives, preservatives, allergens,

starch and gluten as well as being nonGMO and Kosher and Halal certified and approved by the Vegetarian Society. “The demand for Vegan certification is growing. This is a group of customers for whom core values drive purchase decisions,” added Zambetti. “In addition, by having our empty vegetarian capsules certified Vegan, we can also help our supplement manufacturing customers expedite their process of applying for Vegan certification for their finished products. This can help them enhance the attractiveness of their products in this ever-growing market as well.” In the US, 35% of supplement users say that a vegetarian or non-animal source is important when choosing a supplement, up from 26% in 2006; this market segment is among the most frequent users of supplements1. In a recent study of supplement users in Europe, more than 45% said they would be more likely to purchase a supplement if they knew it

was in a vegetarian, plant-based capsule2. Of the 70 million shoppers currently seeking vegetarian products — a market growing at a rate of 9% annually — 69% agree that regular supplement intake offers benefits3. “They prefer supplements from nonanimal sources and delivering them in a vegetarian capsule boosts the intrinsic merit of the entire package,” Zambetti elaborated. Made of pullulan, Plantcaps capsules are derived from tapioca and are a watersoluble polysaccharide produced through a natural fermentation process. These capsules reportedly offer the best oxygen barrier of all plant-based products, masking pungent odours and protecting sensitive ingredients. Organic supplement manufacturers in the US using Plantcaps benefit from ‘Made with Organic Ingredients’ labelling when delivering organic ingredients. The low-moisture Vcaps capsule, claimed to be the world’s best-selling

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HPMC capsule, is great for moisturesensitive ingredients like hygroscopic fills and dry herbal products. The Vcaps Plus capsule provides the same benefit with enhancements like a high-gloss appearance, colour choices and quick dissolution — 100% in 30 minutes or less. The slow-dissolving DRcaps capsule protects ingredients for at least 30 minutes in the stomach’s pH of 1.2, fully opening at an intestinal pH of 6.8, without costly enteric coatings — ideal for probiotics and enzymes. With this certification, a company profile of Capsugel has been added to Vegan Action’s website directory at http://vegan.org/certify/companies-andwebsites/. 1/ Natural Marketing Institute Supplements/OTC/Rx Database 2011, 2/ Capsugel Global Research January 2012, 3/ Natural Marketing Institute, 2007.

Capsugel EMEA +33 3 89 20 57 25 marketing.emea@capsugel.com www.capsugel.com

SHOWCASE FORMULATION CDMO Enters Collaboration to Promote Abuse Deterrence Technology Aesica Pharmaceuticals has announced the signing of an agreement between its subsidiary Aesica Formulation Development Ltd and QRxPharma Ltd for the global promotion of QRxPharma’s proprietary Stealth Beadlets abuse deterrence technology. Aesica supplies pharmaceutical contract development and manufacturing services internationally and operates six manufacturing sites across the UK, Germany and Italy. The company provides controlled drug services across the supply chain, for which abuse or diversion may occur, and is actively building relationships for supplying controlled drug APIs and finished dose products to market. Under the non-exclusive Collaboration Agreement, Aesica will promote QRxPharma’s Stealth Beadlets technology for specific use in controlled drugs formulations. The company will enter into fee-for-service contracts with customers for the development of the new abuse deterrent formulations (ADFs) of specific drugs, whilst QRxPharma will negotiate license terms directly with the Aesica clients concerned.

QRxPharma’s proprietary Stealth Beadlets abuse deterrence technology was developed for the MOXDUO CR (controlled release) formulation for the treatment of chronic pain. This programme is ready for Phase 2 studies and has already shown that Stealth Beadlets, incorporated into the company’s delayed release technology, provide a potential once- to twice-a-day formulation. Work is underway to assure that this ADF technology fully conforms with FDA guidelines for the provision of abuse deterrence statements in product labelling. Stealth Beadlets can be incorporated into almost any potentially abused drug (e.g., opioids, amphetamines, sedatives, etc.) that are sold in solid dosage forms. They provide significant resistance against the extraction of active ingredients if crushed, solubilised or heated. Moreover, Stealth Beadlets have no effect on the active ingredient release profile and consist entirely of patient-safe, low-cost excipients that have GRAS (generally regarded as safe) status with the FDA. Patent applications for the ADF technology are currently

under review at the US patent office and, if granted, will provide for product exclusivity through to 2029. Alan Raymond, Sales and Marketing Director at Aesica Pharmaceuticals, commented: “Aesica is very pleased to have secured this contract with QRxPharma. Indeed, we are committed to providing our customers with the most advanced technologies available for best performance and, consequently, the provision of Stealth Beadlets abuse deterrence technology in formulation development is set to be a highly beneficial addition for our customers in the pharmaceutical and life science markets.” Dr. John Holaday, Managing Director and Chief Executive Officer at QRxPharma, said: “We are delighted to announce our collaboration with Aesica. Their extensive experience in formulation development and contract manufacturing, together with established client base in the controlled drugs market, creates a wonderful opportunity for our companies to

Alan Raymond, Sales and Marketing Director, Aesica. collaborate in the application of our proprietary abuse deterrence technology by third-party pharma companies.” He added: “A head-to-head comparison between Stealth Beadlets and a market-leading abuse deterrent technology showed that Stealth Beadlets were more than twice as effective in reducing the percentage of oxycodone that could be extracted from a crushed controlled release tablet.” Aesica Pharmaceuticals Ltd +44 191 218 1960 info@aesica-pharma.com www.aesica-pharma.com

Drug Product Development Capacity Doubled with Non-GMP Facility At the beginning of the year, Almac announced the expansion of its drug product Pharmaceutical Development services with the creation of a new nonGMP formulation development facility and two new analytical laboratories at its UK headquarters in Craigavon. The new facilities have doubled the company’s pharmaceutical development capacity, meeting the growing demand for its services from existing and new clients. The non-GMP formulation development facility offers clients greater flexibility and speed in formulation and process development, creating an environment where development work can be progressed quickly and then easily transferred to the GMP environment at an appropriate stage. Although the new facility will be

dedicated to non-GMP work, it mirrors all the technical capabilities of Almac’s existing GMP pharmaceutical development facility, including high levels of control over environmental conditions as well as extending current capabilities in processing potent compounds with low OELs. Whereas the existing GMP facilities can support drug product manufacturing from Phase I up to registration and commercial scale, the new non-GMP facility will primarily focus on laboratory-scale experiments, with batch sizes ranging from <1 kg to an expected maximum of 15 kg scale for most technologies. John McQuaid, VP of Technical Operations, explained: “Our priority was to ensure we had good integration

of all technologies in both the non-GMP and GMP facilities. Duplicating equipment trains means that we can conduct non-GMP work efficiently and then transfer rapidly to GMP manufacturing for clinical and registration batches. We are finding that demand for non-GMP process development work has increased as clients seek to better understand their processes in line with the principles of QbD. This type of work also creates large sample sets for analytical testing and multiple stability studies, which is why it was also important that we doubled our analytical capacity in parallel.”

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

Formulation Development and Clinical Testing Service to be Applied to Bronchodilator Therapy Quotient Clinical has entered a collaboration with Pulmatrix Inc., a biotech company based in Massachusetts, US, to support the development of PUR0200, a new bronchodilator therapy for the treatment of chronic obstructive pulmonary disease (COPD) and the first small molecule product to emerge from Pulmatrix’s inhaled iSPERSE technology platform. Quotient will employ its RapidFACT (Rapid Formulation development And Clinical Testing) service to manufacture the spray dried PUR0200 product in

real time to support the Phase 1B clinical study in COPD patients. This capability allows within-protocol adjustment of the formulation composition in response to arising safety, pharmacokinetic and pharmacodynamic data to optimise performance. The clinical study is being performed at the Quotient Clinical site in Nottingham, UK, in conjunction with Professor David Singh at the Medicines Evaluation Unit in Manchester, UK. Mark Egerton, Managing Director of Quotient Clinical, commented: “We

are delighted that Pulmatrix has chosen to utilise our RapidFACT service to support the development of PUR0200. We have proven that RapidFACT can shorten timelines and reduce costs in early development, which ultimately contributes to enhancing R&D productivity. This particular study also demonstrates our ability to manufacture and supply drug product in real time to other clinical centres of excellence that specialise in specific disease indications and endpoints.”

EPM 40

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

Events REGULATORY AFFAIRS UPDATE TO EMA PREAUTHORISATION PROCEDURAL ADVICE

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

In August 2013, the European Medicines Agency (EMA) updated its pre-authorisation procedural advice for users of the centralised procedure to outline the most common mistakes detected by the Agency during the validation of initial marketing authorisation applications and provide guidance on how to avoid them. This document is intended to help applicants complete their submissions correctly and avoid any delays in the validation process. The issues are classified in different categories: • good manufacturing practice (GMP) • good clinical practice (GCP) • paediatrics • quality • non-clinical and clinical. Although specifically addressed to users of the centralised procedure, this document and related hyperlinks constitute an exceptional source of relevant information to all applicants. This guidance document addresses a number of questions that users of the centralised procedure may have. It provides an overview of the EMA’s position on issues that are typically addressed during the course of pre-submission meetings. Among the hundreds of points of information provided, many are of interest for professionals in pharmaceutical quality — some are well-known but now clearly explained, some others are rather new. Among them, a March 2013 revision emphasised that the concept of the active substance master file (ASMF) shall only apply to a well-defined active substance and cannot be used for excipients, finished products and biological active substances. In addition, active substances, which are present in certain medicinal products such as vaccines or cell therapy medicinal products, do not fit with the concept of a ‘well-defined’ active substance, similarly to blood derived medicinal products and vaccine antigens. From 1 September 2013, ASMF holders submitting their ASMF dossiers relating to a centrally authorised product (CAP) are asked to send it to the Agency and committee members only once. According to the new ASMF submission rules, the Agency will assign a reference number on request prior to submission of the ASMF. The EMEA/ASMF/XXXXX number is an internal reference number sequentially assigned by the EMA to enable an appropriate data lifecycle management of ASMFs used in one or more centralised marketing authorisation. The EMEA ASMF reference number does not replace the responsibility of the ASMF holders to version control their ASMF (in accordance with GMP), nor does it replace their own ASMF numbering system. Up to two weeks before submitting a complete ASMF or an update to an already submitted ASMF, the ASMF holder should request the EMEA ASMF reference number. The request should be sent to: PABUS@ema.europa.eu. The EU/ASMF reference number allows for the identification by all competent authorities (national competent authorities and EMA) of ASMFs used in centralised and national (decentralised and mutual recognition) marketing authorisation applications (MAAs) or marketing application variations (MAVs), therefore enabling the ASMF Assessment Report Work Sharing (ASMF AR WS) procedure. More information on the ASMF AR WS will be made available closer to the start of the pilot phase (1 December 2013) on the dedicated ASMF WG webpage. The EMA emphasises the importance of pre-submission meetings between applicants and EMA (Co-) Rapporteur. Pre-submission meetings — which should take place approximately seven months prior to the anticipated date of submission of the application — are a vital opportunity for applicants to obtain procedural, regulatory and legal advice from the EMA. The product team is available to address any questions marketing authorisation holders (MAHs) may have regarding their pre-authorisation application. The July 2013 update of this guidance provides information to avoid the most common validation issues related to quality, GCP, GMP, paediatrics, pharmacovigilance, clinical and non-clinical validation issues and so on, making this document a practical regulatory Dr. Paolo Biffignandi vademecum for all of us. paolo@elc-group.com

Pharma Integrates Organiser Announces Latest 2013 Sponsor

Camelot Management Consultants is the latest Silver sponsor to support this year’s Pharma Integrates alongside Nextpharma, Recipharm and 3M. Additional Platinum and Gold sponsors of the widely acclaimed, annual pharmaceutical conference include Catalent Pharma Solutions, Patheon Inc., Baxter BioPharma Solutions, SAFC Global, Piramal Pharma Healthcare and CordenPharma. The latest addition to the speaker line up is Kurt Hertogs, Head Platform Innovation & Incubator Strategy at Johnson & Johnson, who is joining Paul Turner, Vice President Business Development Europe & Asia Pacific, Patheon, to discuss ‘Do big pharma need to readdress their key competencies?’. This session will discuss at all levels within big pharma whether there are competent scientists and professionals at the helm.

Joining the debate on ‘East vs West: Future Trends in Partnering Discovery and CMC Activities’ is Paul Deutsch, Senior Director Chemical Process Development, Biopharmaceutical Process Sciences, UCB Pharma. This session is to explore perceptions of future trend — whether to continue the partnering of activities in the East or the reverse and for what activities — and fellow panellists include Fabio Brischetto, Business Development Manager Manufacturing Operations, Zambon Pharma, and Andreas Weiler, Global Head of Strategic Marketing, SAFC. Life Sciences Index Pharma Integrates 2013 +44 20 8667 2117 miranda.zouheir@lsi-uk.com www.lifesciencesindex.com

One-Day Training Course for Formulators The Society of Dryers and Colourists (SDC) has announced the launch of ‘Colour Management for Formulators’, a brand new training course aimed at those working in formulation in a wide range of industry sectors. Colour Management for Formulators aims to address a number of basic areas: • How to use and manage colour better • How to better understand how colour works • How to improve product quality by measuring and standardising colour more effectively and consistently. The course offers a balance of practical expertise, demonstrations and underpinning knowledge. It has a fantastic line up of speakers from organisations including Leatherhead Food, Tintometer, Colorcon, Verivide and X-Rite as well as SDC. The course is organised and delivered by the SDC, a world leading educational charity dedicated to colour, in partnership with iFormulate Ltd. It will benefit scientists, technologists and other professionals working in R&D, manufacturing and quality functions. EPM 41

Sessions include: • What is Colour? • Colour and Human Sensory Perception • Measuring Colour in Transmission • Colour Management Case Studies focusing on: Pharmaceutical Products, Cosmetics and Challenges with Effect Pigments • Measuring Colour in Reflectance • Visual and Camera Measurement of Colour • The Future for Colour. Society of Dryers and Colourists (SDC) Colour Management for Formulators +44 1274 761784 marketing@sdc.org.uk www.sdc.org.uk

EPM CLASSIFIEDS

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CLEANROOMS EQUIPMENT & SERVICES

GRINDING AND GRANULATION EQUIPMENT & SERVICES

CONTAINMENT

DIOSNA Dierks & Söhne GmbH

Telstar Life Sciences

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

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

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

MIXING & BLENDING EQUIPMENT AND SERVICES

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

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

MATERIAL/POWDER HANDLING

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

WET GRANULATION EQUIPMENT

Müller GmbH

Russell Finex Ltd

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

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

PACKAGING & BOTTLING EQUIPMENT AND SERVICES INDUSTRIAL SERVICES

Gerhard Schubert GmbH

CHEMICAL CLEANING

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

Transflow Industrial Services Limited

DESIGN & INSTALLATION

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

LABORATORY & R&D PRODUCTS AND SERVICES

Fritsch GmbH

Weiler Engineering Inc

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

FURNITURE

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

Teknomek Industries Ltd ENVIRONMENTAL/STABILITY ROOM

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

PURIFICATION & FILTRATION PRODUCTS AND SERVICES

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

COATING EQUIPMENT & SERVICES

PARTICLE SIZE ANALYSIS

Bosch Packaging Technology

Whitehouse Scientific Ltd

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

QUALITY AND COMPLIANCE SPECIALISTS

WEIGHING

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

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

L.B. Bohle GmbH MANUFACTURING ANCILLARIES

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

TABLET PRESS SUPPLIERS

ELECTRONIC DRIVE & MOTOR REPAIRS

CONTRACT STERILISATION & TESTING

PUMPS

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

EXCIPIENTS HPMC FILM COATING

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

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

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ADVERTISERS’ INDEX Company Beneo-Palatinit Butterworth-Labs Cobalt Contec CPhI Dales Pharmaceuticals

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Diosna Encube Ethicals Ezi-Dock F.P.S. Food and Pharma Systems IMA S.p.A. Korsch L.B. Bohle Mediplas Mettler Toledo Müller Natoli EPM 42

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Netzsch PANalytical Pharma Hygiene Products Pharmatron Phillips Medisize Powder Systems Rommelag Roquette Sartorius Thomas Engineering Xcellerex

13 19 16 12 10 24 20 9 30 2 21