EPM Jan/Feb 2014 by EPM Magazine

Front cover image provided courtesy of I Holland Ltd.

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

in this issue

production art samantha hamlyn production peter bartley

advertising robert anderton

INTERPHEX 2014 PREVIEW

pages 5–11

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

MANUFACTURING PRODUCTS & EQUIPMENT

pages 12–27

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REGULARS: 12–20 26–27

Latest News Roundup Industry News

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

SHOWCASE: 32

Chromatography & Spectroscopy

INGREDIENTS & CONTRACT SERVICES

pages 34–41

REGULARS: Latest News Roundup Events Regulatory Affairs

34–38 41 41

SHOWCASE: 40

Analysis & Testing

Volume 14 Issue 1 © February 2014. While every attempt has been made to ensure that the information contained within European Pharmaceutical Manufacturer is accurate, the publisher accepts no liability for information published in error, or for views expressed. All rights for European Pharmaceutical Manufacturer are reserved and reproduction in part or whole without written permission is strictly prohibited.

ARTICLE: 39

What Pharma Companies are Doing to Avoid Another Cliffhanger By Haydn Evans, Vice President of Intellectual Property Service Solutions at CPA Global

BPA Worldwide Membership

page 42

CLASSIFIEDS EPM 3

ISSN No - 2052-4811

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A somewhat belated Happy New Year and welcome to our first 2014 issue. One half expects the first issue of the year to be, dare I say it, a little dull, as most people take a bit of time to get back into ‘work mode’ before the news starts to flood in again; quite the contrary you will be pleased to find with our January/February issue. Beginning on the opposite page is EPM’s first ever preview on INTERPHEX — a hugely successful US biopharmaceutical and pharmaceutical manufacturing event that takes place in New York on 18–20 March — featuring a number of exhibitor news items in hall and stand number order. So if you are attending the show, this could prove pretty useful. Additional exhibitor news is posted daily on our website — www.epmmagazine.com. EPM’s ‘In the Spotlight’ feature on page 24 — forming part of the Containment & Operator Protection showcase — is based on a meeting I had with Steve McAleavy, Managing Director of Ezi-Dock Systems, and details his and business partner Mike Brimson’s journey in bringing to market a highly effective powder and liquid containment transfer system. Steve describes how a fortuitous conversation with a pharmaceutical production manager led to the realisation that there was a huge and as then unmet market demand for a simple to operate, leak-free transfer device and to the subsequent development of the 6 Ezi-Flow CSV, today implemented in a number of countries around the world. This issue also features the article ‘What 24 Pharma Companies are Doing to Avoid Another Cliffhanger’ on page 39, written by Haydn Evans, Vice President of Intellectual Property Service Solutions at CPA Global. Haydn provides an overview of the patent cliff, the impact it has had and that he predicts it will continue to have over the coming years. He discusses and evaluates big pharma’s efforts in adapting to recover their losses through R&D investment, patent filings (mature brand extensions as well as new products), technology collaborations, smaller producer acquisitions, diversification into alternative therapies and medical instruments and expansion into emerging markets. 38 Lastly, the Regulatory Affairs instalment on page 41 is titled ‘The Biopharmaceutical Classification System — Is it Accepted?’ and has been written by Dr. Biffignandi’s colleague and ELC Group’s regulatory affairs expert in India Chetan Javia. Chetan outlines the key objectives of the Biopharmaceutical Classification System (BCS), a regulatory mechanism used to ‘classify’ a drug substance according to its solubility and permeability. He also lists those products that are eligible for the BCS Biowaver — clinical bioequivalence studies exemption — and advises on the likelihood of its acceptance by regulatory agencies. And that is all from me, hopefully leaving you with plenty of thoughtprovoking material until the next March/April issue.

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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, Independent Consultant Dave is an enthusiastic pharmaceutical development director with a successful, 36-year track record in a global pharmaceutical company. Key areas of expertise include: directing product development projects, including oral and transdermal dosage form, from early development to commercialisation; directing continuous manufacturing projects to QbD standards, including granulation and coating of tablets; establishing teams to deliver stakeholder agreed objectives; applying knowledge of dosage form design, processing, process analytics and manufacturing operations to help shape manufacturing strategies; co-authoring product and process patents; and presenting to audiences at all levels. 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 2014 INTERPHEX is a leading, single source event for complete biopharmaceutical and pharmaceutical manufacturing solutions to confidently process all dosage forms for life-enhancing drugs. Find out more about featured products, the PDA

(Parenteral Drug Association) education programme and networking events at www.interphex.com, and join one of the industry’s largest gatherings on 18–20 March 2014 at the Javits Center in New York City, US.

Patheon SVP Delivers Presentation on Improving Quality Performance Patheon’s Harry Gill, Senior Vice President, Quality and Continuous Improvement, will be presenting ‘Transforming Quality Performance Using Common Operational Excellence Tools’ at INTERPHEX, 19 March, 3:15 pm, stage 2.

During the presentation, Gill will discuss how the company’s Patheon Advantage II programme has been one of the main drivers of its efficiency improvement efforts. Patheon has utilised these same philosophies to create improvements, in particular right

first time, which is a key performance indicator for both Patheon and its clients. Patheon will also be showcasing its latest softgel technologies on the company booth. Booth 1438

Patheon Pharmaceutical Services, Inc. +1 919 226 3200 doingbusiness@patheon.com www.patheon.com

Bespoke Contract Services Help Customers Develop Medicines for Benefit of Patients Cobra Biologics is a leading, international CMO providing a comprehensive biologics and pharmaceuticals service offering. With multi-functional and experienced project teams, the company nurtures its customers’ products from pre-clinical through to clinical supply and commercial manufacture. Cobra has three GMP approved facilities for mammalian protein, microbial and virus production and a specialised fill

and finish facility, each with expertise tailored to serving customers across the world. The company offers its customers a broad range of integrated and standalone contract manufacturing services stretching from cell line development to the fill and finish of drug products, taking pride in manufacturing excellence, delivering what is promised and helping customers to develop medicines for the benefit of patients. Cobra supplies manufacturing solutions

to the pharmaceutical industry covering antibodies, recombinant proteins, viruses, phage, DNA, whole cell vaccines and therapeutics as well as biologics and small molecule API lyophilisation and fill and finish into injectable vials or pre-filled syringes. Visit the company’s brand new website for more information or to arrange a meeting with a member of the team at this year’s INTERPHEX. Booth 1463

Cobra Biologics +44 1782 714181 peter.coleman@cobrabio.com www.cobrabio.com

Comprehensive Powder Handling Solutions Cater for Majority of Customers’ Needs Dec Group provides high quality solutions for the pharmaceutical, chemical and food industries. This includes a wide range of patented products that enhance safety, hygiene, containment, reliability and productivity. The Dec product range covers every facet of powder handling, including transferring, filling, emptying, dosing, mixing, sampling, micronising, milling and containment. According to the company, the options

are infinite to suit the requirements of a diverse customer base — turnkey, custom built and modified as required. All systems are modular to ensure simple integration into existing processes. More than 200 companies worldwide have already successfully integrated Dec systems into their production sites. With global coverage through subsidiaries and agents in over 35 countries, the Dec Group’s reputation as

a powder handling and containment specialist is well established. Visitors are invited to discover the Dec Group booth at this year’s INTERPHEX. Booth 1532 Dec USA Inc. +1 732 202 7536 info@dec-group.us www.dec-group.net

Particle Coating Method Guarantees Precise and Uniform Results with Minimal Losses With the development of the new Bohle Uni Cone BUC, customers now have a precise method for coating particles as a utility model. “We have shown that our new method works much more accurately and evenly than the conventional Wurster process,” said Managing Director Lorenz Bohle. The Wurster process is used in the pharmaceutical industry when coating small particles, so-called pellets. Most coating systems used today are still based on this method, which was developed in 1959. For L.B. Bohle, the biggest weaknesses of the Wurster process are the calculation of scale-up parameters

and the location of the spray nozzles inside the product bowl. The scale-up parameters must be verified in multiple and lengthy tests for each product, resulting in a loss of production time and large fluctuations in coating uniformity. L.B. Bohle developed two major changes that solve both problems of the Wurster process. A sloping floor and a conical tip in the centre provide a uniform movement of product. Simultaneously, the coating substance is delivered from nozzles located tangentially to the product vortex and accessible from outside the product bowl during the process.

“Therefore, we reach the best possible coating uniformity. With this process, customers can use active substances with the highest precision,” explained Bohle. “Even in a very complex process, the losses are under 1%.” In addition, the tangential nozzles have enhanced quality advantages in handling. If a nozzle is blocked, it can be cleaned with an aqueous solution during the current process. “Because of the tremendous benefits, we can secure a patent protection for the process and protect the Bohle Uni Cone BUC as a European brand,” concluded Bohle. Booth 1842

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

INTERPHEX 2014 PREVIEW Modular Approach Enables Filling of Three Container Types On Single Machine Optima Pharma will present its very latest technologies for aseptic filling at this year’s INTERPHEX. The focus is on flexibility more than ever when it comes to the processing of nested syringes, vials and carpules. Optima Pharma offers modular machine solutions that can process all three container types on one unit. Disposable systems for the various kinds of dosing pumps can be integrated as required and further increase the flexibility of the units. With new types of medications — which are mainly high-priced biopharmaceutical products and often processed in small

batches — integrated inprocess monitoring results in the highest possible degree of precision of filling and maximum batch yield. Batch-to-batch turnaround and idle times of machines employing isolator barriers can be minimised through the use of catalytic ventilation to reduce the time required for decontamination cycles by 50%. This creates units that combine outstanding efficiency and flexibility with one another.

Optima Pharma will highlight example systems and units and many other projects in virtual reality in a 3D box. These include, for example, units that produce saleable product right from the start of the batch without rejects, freezedrying units, automated loading and unloading systems, systems for diagnostics and much more. Booth 2227 OPTIMA packaging group GmbH +49 791 506 1410 sabine.gauger@optima-ger.com www.optima-ger.com

Dual Isolator Facilitates Both Aseptic and High Potency Manufacturing Aseptic filling of sterile drugs remains one of the most challenging processes in biopharmaceutical manufacturing. The increased potency of sterile products requires evaluating the manufacturing process from two different angles: the high containment requirements for operator and environment safety and the aseptic process regulations for protection of integrity for the finished sterile product. Powder Systems Ltd (PSL) has developed an alternative technology, the dual isolator, to the heavy and complex existing solutions (consisting mainly of integrating an aseptic isolator inside a containment isolator). A dual isolator is a

polyvalent containment solution enabling the manufacture of sterile products under aseptic conditions and potent products under high containment operations. The typical operations that can be carried out within the dual isolator are sterile powder handling, sterile liquid handling, manual filling, microsphere handling and vials crimping. Design features of the dual isolator include lift-up windows with an inflatable seal for easy access and maintenance, glove-port design for aseptic production, no dead legs, automatic leak rate and temperature monitoring. The dual isolator is mobile and has flexible RTP

connections, reduced footprint and remote I/O (integrated into isolator main fabrication). The use of airlock systems to sterilise materials prior to entering the isolator is also available. All these features make the dual isolator a truly versatile and polyvalent technology, ideal for multi-product manufacturers or CMOs. Booth 2232 Powder Systems Ltd +44 151 448 7700 info@powdersystems.com

B&W Tek Announces Interactive Demos of Handheld Raman Spectrometer on Booth The NanoRam — a handheld Raman instrument for non-destructive identification and verification of materials such as APIs, excipients, intermediates and finished products — is to be highlighted by B&W Tek at this year’s INTERPHEX. Compact and agile, the NanoRam can be used by nontechnical users to rapidly identify samples in the laboratory, warehouse, loading dock or field, helping to eliminate quarantine areas and expedite materials through the manufacturing lifecycle. Utilising Raman technology, non-contact analysis can be performed through transparent containers while

maintaining the volume and integrity of the sample. The NanoRam is fully compliant with all governing regulations, including 21 CFR Part 11 and Part 1040.10, and can play an integral role in cGMP compliant facilities. B&W Tek offers a wide variety of services, including assistance with method and/or new library development and support with IQ/OQ/PQ validation. The NanoRam handheld Raman spectrometer facilitates fast and convenient transitions between sampling accessories for raw material identification through a variety of packaging. These accessories allow the

user to measure through plastic and glass containers, take in situ measurements of liquids and powders and measure in hard to reach areas. The NanoRam also comes standard with proprietary software that allows for identification and verification, library and method development, data storage/transfer, exporting data and generating reports. Booth 2272

Lab Spiral Jet Mill in Isolator Provides Containment Below 0.1 µg/m3 F.P.S. Food and Pharma Systems is a leading company in the pharmaceutical and fine chemical fields, developing, manufacturing and installing worldwide its own range of fine size reduction machines and containment solutions for sterile and highly toxic APIs. At INTERPHEX, F.P.S will present an isolator system with a laboratory PilotMill-2 jet mill unit. The system is designed for development activities in pharmaceutical laboratories, accommodating from 2–3 g up to 2–3 kg batch sizes of HPAPIs. Containment level is guaranteed to be less than 0.1 µg/m3 (8-hour TWA). Also on show will be a selection of the spiral jet mills available from F.P.S.: • PilotMill-Zero for 10–200 mg batch sizes

• LaboMill for 0.2–100 g batch sizes • PilotMill-5 for 100 g–100 kg batch sizes • ProMill-12 for 5 kg–2,500 kg batch sizes. F.P.S. micronisation technology is the result of a study that has brought about the development of a wide range of fluid jet mills. They work with high-pressure process gas that causes the particle collision and consequent particle dimension reduction inside a micronisation chamber. F.P.S. jet mills guarantee a constant temperature process, no moving parts and easy cleaning and assembling. Booth 2439 F.P.S. Food and Pharma Systems Srl +39 031 543429 sales@foodpharmasystems.com www.foodpharmasystems.com EPM 6

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

INTERPHEX 2014 PREVIEW PP Multi-Chamber Bags Increase Parenteral Safety The multi-chamber bags developed by Technoflex are made of a polypropylene-based film with a high oxygen barrier. This particular property protects amino acids against oxidation, the main factor in their degradation. The bags are compartmentalised into two or three chambers containing macronutrients in the form of binary mixtures (glucose and amino acids) or ternary mixtures (lipids, amino acids and glucose). These standard mixtures are suitable for the majority of patients. To prevent the inevitable

interactions between some of these macronutrients, peelable welds (removable thermo-welds) are put in place to separate them from each other. In order to reconstitute the mixture, the welds are simply squeezed by hand to break them. Multi-chamber bags offer many advantages. They enhance patient safety as they reduce handling and thus the risks of contamination of the nutritional mixture. They bring down the waiting time linked to the opening hours of manufacturing units (the solutions are prepared in

hospital pharmacies). The drugs can therefore be dispensed by healthcare staff as soon as they are prescribed. The bags also come in more extensive ranges with simplified storage conditions. All these advantages have allowed the widespread use of these ready-to-use parenteral nutrition bags in hospitals but also in healthcare at home. Booth 2457 Technoflex SA +1 949 715 1341 www.technoflex.net

Bausch+Ströbel Processes Single-Use Syringes in Nests on Booth

South German special machines manufacturer Bausch+Ströbel has been a market leader for years in the field of syringe processing and has reportedly set standards in the processing of single-use syringes in nests. The company will demonstrate the SFM 5110 at INTERPHEX. When pharmaceutical products are filled and packaged in large quantities, the containers are usually prepared for aseptic processing using rinsing machines and a sterilising tunnel. However, for smaller batches, e.g., for formulation and development laboratories, this procedure is generally uneconomic. For this reason, glass manufacturers have been providing pre-sterilised containers in nests inside tubs for quite some time now. The SFM5110 has been specifically designed for this branch of the pharmaceutical industry. This machine processes not only syringes in nests but also the vials and cartridges that have recently complemented the glass manufacturers’ range. All the systems from the major glass manufacturers on the market can be processed. The machine runs at two containers per machine cycle and reaches an output of up to 5,100 containers per hour. The nests containing syringes, vials or cartridges are loaded into the work area manually by the operator. All the subsequent work processes are then fully automatic; dosing the product and closing the various types of container with plunger stoppers, lyo stoppers or other closures depending on the application. The containers are positioned precisely in the work area by the integrated centring device. The machine can be equipped with two dosing systems. In this way, the product can be dispensed either by valveless rotary piston pumps or alternatively with peristaltic pumps. Booth 2505B Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG +49 7904 701816 tanja.bullinger@bausch-stroebel.de www.bausch-stroebel.de EPM 7

INTERPHEX 2014 PREVIEW IMA Highlights Latest Processing and Packaging Machinery Developments The IMA booth at INTERPHEX will offer visitors the chance to discover what is new in the IMA world for the pharmaceutical industry, demonstrating the high precision technology of its automatic machines. The company will display a selection of the latest processing and packaging solutions for the pharmaceutical industry from its vast range of machines and complete lines. New, cutting-edge technological advances will be on show, together with proven quality IMA solutions for the processing and packaging of

pharmaceutical products. IMA staff will be on hand to highlight the key features of the company’s new solutions as well as discuss its range of machines and complete lines. IMA Pharma is a world leader in the design and manufacture of automatic machines for the processing and packaging of pharmaceutical products thanks to a high technological profile and the ability to offer tailor-made solutions to satisfy the most sophisticated requests of the market. IMA Pharma includes three highly specialised divisions: IMA Active (Solid Dose Solutions), IMA Life (aseptic

processing and freeze drying solutions) and IMA Safe (packaging solutions). Booth 2553

Mouvex Presents Product Recovery Capabilities of Eccentric Disc Pumps At this year’s INTERPHEX, Mouvex, part of Pump Solutions Group, will feature its hygienic SLS Series eccentric disc pumps, which have been specifically engineered for use in a wide array of pumping applications that require extremely hygienic operations and full containment, including those found within the pharmaceutical industry.

Mouvex SLS Series pumps have been designed to provide exceptionally high rates of product recovery in pharmaceutical applications through a measurable reduction in wasted raw materials or finished products at the end of production runs. The desire to optimise product recovery will continue to grow in importance in coming years for pharmaceutical manufacturers as they look to streamline their costs of doing business. Specifically, Mouvex will be highlighting its new SLS4 and SLS8 models at this year’s show. Other productrecovery benefits in the operation of the SLS4 and SLS8 models include the ability to handle differential pressures up to 10 bar (145 psi) in the SLS4 and 6 bar (87

psi) in the SLS8 and high-quality machined parts for optimum surface finish. Designed without mechanical seals, packing or magnetic drive, the SLS Series features a seal-less design with double stainless-steel bellows to ensure product containment and safety. The SLS Series provides very high suction and discharge pressures, which allow it to self-prime and fully strip lines, which leads to maximised product recovery. SLS Series pumps are also designed for CIP cleaning, SIP sterilisation and include versions with both 3A and EHEDG certifications. Booth 2633 Mouvex +33 3 86 49 86 81 jovani@mouvex.com www.mouvex.com

IMA S.p.A +39 051 6514111 www.ima-pharma.com

Tablet Hardness Tester Measures Five Parameters for Increased Efficiency

SOTAX offers test equipment and specialises in complete tablet testing solutions for research laboratories, IPC, QC and manufacturing plants of pharmaceutical companies all over the world. Whether the focus is on reducing costs or increasing capacities (or both), efficient physical testing processes save time and money, providing the customer with an increasingly important competitive edge in today’s challenging environment. A perfect example of an efficiency tool for the tablet analysis process is the SmartTest 50. The SmartTest 50 reportedly sets new standards in fast and efficient semi-automatic testing of up to five physical parameters. Weight, thickness, width, diameter/length and hardness of virtually all tablet shapes can be tested in full compliance with current Pharmacopeia requirements. Proven Dr. Schleuniger Pharmatron hardness measuring technology guarantees accurate and highly reliable test data that can be evaluated immediately. An integrated colour touchscreen with simple icon-based navigation makes operating the SmartTest 50 very intuitive, consequently reducing operator training time to an absolute minimum. Perfectly suited for both laboratory and production environments, the SmartTest 50 has been designed to optimise efficiency of the quality control process without limiting the range of possible applications. Visit SOTAX at INTERPHEX to see this and many other examples of workflow optimisation via automation. With more than 40 years of experience and more than 20,000 testers on the market, SOTAX instruments, alongside Dr. Schleuniger Pharmatron hardness measuring technology, are a safe investment. Booth 2674 SOTAX Corporation +1 508 417 1112 sotaxusa@sotax.com www.sotax.com

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INTERPHEX 2014 PREVIEW Punch Tip Coating with Exceptional Anti-Stick Properties Launches I Holland, a leading specialist manufacturer of tablet tooling for the pharmaceutical and nutraceutical industries, will once again be attending INTERPHEX and will showcase a number of products, including the new PharmaCote CT coating, which will be launched exclusively at the show. This exclusive, patent pending coating generates an outstanding anti-stick tip face for tablet production. Samples will be available to view at the I Holland booth. Clare Taylor, I Holland’s Marketing Manager, said: “This is our fifth time at the show and we are really looking

forward to introducing industry leaders to our newest product from the PharmaCote range. PharmaCote CT is widely anticipated to be our most effective anti-stick coating to date. It also showed great corrosion resistance in intensive salt spray tests, offering an impressive eight hours corrosion resistance, as well as very good wear resistance. It is also extremely easy to clean and maintain using an ultrasonic bath. “INTERPHEX is the perfect opportunity to introduce our product portfolio to a worldwide audience. We will not only present our extensive range of punches

and dies, including multi-tips, coatings and designer shapes, at America’s main trade fair for pharmaceutical and biopharmaceutical industries, but we will also show our latest addition to the PharmaCare range, the MF40 automated punch and die polishing machine.’’ The MF40 was developed to be used as part of the recommended PharmaCare 7-Step Process, a

professional punch and die maintenance and storage programme designed to prevent costly tablet press downtime and tablet compression problems associated with capping, tablet weight and thickness variation to name but a few. To find out more about I Holland’s product portfolio and talk to the team of experts, visit the company’s booth at INTERPHEX. Booth 2970 I Holland Ltd +44 115 972 6153 info@iholland.co.uk www.iholland.co.uk

Medipak Systems Demonstrates Host of Packaging and Inspection Solutions Körber Medipak Systems North America will present the latest packaging and inspection solutions for the pharmaceutical industry from companies Seidenader Maschinenbau, Dividella, Rondo-Pak and Mediseal at this year’s INTERPHEX. On display will be the new inspection machine Seidenader CS, which makes automated inspection affordable for smaller production lines. It is designed for inspection of liquid and lyophilised parenterals at speeds of up to 24,000 containers per hour. Customers benefit from the same features and inspection stations as with the larger Seidenader MS or VI series. The small platform of the CS series accommodates up to seven camera

stations for the inspection of ampoules, cartridges and vials up to 100 ml in size, enabling the detection of particles in the product and cosmetic defects of the container. Interchangeable infeed and outfeed modules offer outstanding flexibility and allows for the running of stable and unstable products. Also to be highlighted is Seidenader’s three-stage technology approach to serialisation — consisting of serialisation, aggregation and data management — which is particularly effective as it can be flexibly adapted and expanded to future requirements. Dividella will demonstrate its AmeriStar and WorldStar winning syringe package, along with vial and autoinjector packages used by the leading

biopharmaceutical companies, as well as videos of its NeoTOP packaging lines. Rondo-Pak will focus on the importance of safetyorientated packaging design and applications, presenting its solutions for tamper evident and child resistant packaging. Finally, Mediseal’s containment solutions combine high safety standards and equipment efficiency for the safe packaging of solid, high-potency drugs, which is of increasing importance for pharmaceutical companies as the legal regulations increasing steadily. Booth 3007

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Körber Medipak Systems NA Inc. +1 727 532 6509 info@kmedipak.com www.kmedipak.com

INTERPHEX 2014 PREVIEW Packaging Sorbency Know-How 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 Calculations through Operations program assists with the transition from product formulation to packaging operations, providing the most effective solution for ensuring stability throughout the entire shelflife of the product. The company’s seasoned team of packaging professionals, chemists, biochemists and systems engineers provide skilled resources to understand and solve virtually any product stability issue. Multisorb scientists use SimulSorb and SimulOx pseudo-empirical modelling programs to help predict physical and chemical stability outcomes for healthcare products in their associated packaging. These programs assist with ensuring that an optimised sorbent solution (desiccant, moisture regulator, oxygen absorber, volatile absorber) is provided and help to improve manufacturers’ speed to market with new products. The sorbent formulation is then provided in a platform that is best suited for the product— packets, canisters, self-adhesive backed, solid forms, film or PolySorb sorbent

Qualicaps Showcases Latest Capsule Machinery

components with desiccant integrated into a thermoplastic functional part. The customised sorbent in packet or canister formats can be inserted into 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 booth. Booth 3041

Once again, Qualicaps will attend INTERPHEX, presenting its capsule checkweighing, filling and sealing equipment. On-site demonstrations of the CWI-90 capsule checkweighing machine will take place. The CWI-90 weight checks by way of an electromagnetic force compensation balance, which makes high measuring accuracy possible. This machine has an output range of 90,000 capsules per hour. The F-40 capsule filling machine and the S-100 capsule band-sealing machine will also be on display. The capsule filling machine features a compact size with easy conversion, highly accurate filling and the ability to handle a variety of dosage forms. The capsule band-sealing machine features precision sealing through conveyor belt seating, a durable double-seal and output range of 100,000 capsules per hour. Contact Qualicaps to set up an appointment for a machine demonstration during INTERPHEX. Booth 3516

Multisorb Technologies +1 716 824 8900 info@multisorb.com www.multisorb.com

Qualicaps Inc. +1 336 449 3900 info@qualicaps.com www.qualicaps.com

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INTERPHEX 2014 PREVIEW Natoli Shares Tabletting Expertise on Booth and Stage

Tablet compression tooling, presses, accessories and services provider Natoli Engineering Company will be exhibiting at INTERPHEX. Visitors are invited to check out Natoli’s display of high-quality tablet tooling, die segments, parts and more. Some of the company’s most popular products will also be on display with hands-on demonstrations available. Natoli’s tooling experts will be only too happy to help visitors find solutions to their most complex tabletting challenges. With more than 40 years of experience in the tablet compression tooling industry, Natoli understands what it takes to produce high-quality tablets efficiently. Natoli will present the Innovation Stage session ‘Back to Basics: Tablet Design and Common Tooling Options’, which will focus on how to correct tabletting issues. Representatives from Natoli Scientific and the Natoli Institute for Industrial

Pharmacy Development and Research at Long Island University will also be on hand to engage in discussion regarding the resources the institute will provide to the industry, including preformulation studies, sticking and picking evaluations and new formulation technologies. One of the few industrial pharmacy programmes in North America, the Institute will be dedicated to advancing knowledge in the field of pharmaceutical solid oral dosage engineering operations and instrumentation. Stop by Natoli’s booth so staff can demonstrate what the company slogan “You Demand. We Deliver.” really means. Booth 3711 Natoli Engineering Company, Inc. +1 636 926 8900 info@natoli.com www.natoli.com

Universal Sterile Connectors Simplify Single-Use Systems Integration

Colder Products Company (CPC) is a leader in the design and manufacture of single-use connection technology and connectors for the life science markets. CPC offers a wide variety of bioprocessing solutions, including sterile connect, sterile disconnect, SIP connect and quick connect. The company’s designs provide flexibility for biopharmaceutical manufacturers to easily combine multiple components, single-use or hybrid systems, including process containers, tubing manifolds, transfer lines, bioreactors and other bioprocess equipment. The AseptiQuik family offers quick and easy sterile connections for small (1/8”) through large (1”) flow applications. The new AseptiQuik G connectors’ easy-touse, genderless design simplifies system integration and minimises the risk of operator error. The connectors’ robust construction enhances user confidence and provides reliable performance without the need for clamps, fixtures or tube welders. Biopharmaceutical manufacturers benefit from the AseptiQuik G’s full range of interchangeable genderless

terminations from 1/4 to 3/4”. Easy-to-use single-use connectors from CPC maintain flow path sterility and integrity while enabling biopharmaceutical manufacturers to improve production yields, decrease time to market and reduce costs. CPC is ISO 13485 certified and its products for bioprocessing applications are manufactured in an ISO Class 7 certified cleanroom. Founded in St. Paul, Minnesota, US, in 1978, CPC offers more than 10,000 standard and custom products, with offices in nine countries and distributor representation in North America, Europe, Asia, South America and Australia. CPC is a Dover company. Booth 3735 Colder Products Company +1 651 645 0091 info@colder.com www.colder.com/bio EPM 11

MANUFACTURING PRODUCTS & EQUIPMENT Stainless Steel Bottles for Powders and Liquids Available from Stock The new range of GMP PharmaBottles from Sampling Systems is ideal for production and laboratory work. The range is made to the highest standards from 316L stainless steel and is available in a wide range of sizes from 1 to 20 l. The containers are crevice-free and the surface finish is better than 0.2 µm Ra. Stainless PharmaBottles are fitted with standard 4” ferrules. This not only allows the containers to be clamped to existing

pieces of processing equipment but gives excellent access for cleaning and inspection. Each container is supplied with a lid, clamp and silicone gasket. Stainless PharmaBottles are ideal for use with both powders and liquids and they are available from stock. Sampling Systems Ltd +44 1675 466 992 info@sampling.com www.sampling.com

Discharger Dust Hood Contains Bag Spout Leaks and Spills A new dust hood for Flexicon bulk bag dischargers contains spillage and dust that can escape through seams in the bag and folds in the spout. The six-sided enclosure sits against the rim of a hopper or flange of downstream equipment and is equipped with an exhaust port for dust collection and a hinged door with inspection window. The top of the enclosure contains a circular opening that allows passage of the bag spout to the equipment connection point. The flat bottom of the enclosure supports a tele-tube telescoping tube that pneumatically raises a Spout-Lock clamp ring connecting the clean side of the spout to the clean side of the equipment. Allowing the telescoping tube to descend under its own weight maintains constant downward tension on the spout as the bag empties and elongates, while Flow-Flexer bag activators raise and lower opposite bottom edges of the bag at timed intervals to loosen compacted materials, promoting complete discharge.

The enclosure contains incidental leakage of fine powders from seams in the bag as well as material released from bag spout folds during connection and disconnection activities. Associated dust is vented through the sidewallmounted port to an optional Bag-Vac dust collector or plant bag house, preventing contamination of the environment. For applications requiring retying of partially empty bags, an optional PowerCincher pneumatically actuated flow control valve cinches the spout concentrically on a horizontal axis for easy tie offs and vertically in a tight zigzag pattern to prevent leakage of powders. Constructed of stainless steel finished to food, pharmaceutical and industrial standards, the dust hood is offered on all Flexicon dischargers, including models requiring forklift loading of bulk bags, models that load bags using an electric hoist and trolley, half-frame dischargers that require a forklift or plant

hoist and split-frame dischargers for forklift loading of bags in low headroom areas. All can be integrated with the company’s mechanical, pneumatic and tubular cable/disc conveyor systems and are available with controls for automated weigh batching directly from bulk bags. Flexicon Europe Ltd +44 1227 374710 sales@flexicon.co.uk www.flexicon.co.uk

MES Content Packages Accelerate Master Batch Record Creation In order for pharmaceutical and biotech customers to implement PAS-X MES projects even faster and more easily, Werum Software & Systems has expanded its PAS-X content packages, offering further PAS-X MBR Design Elements content packages based on the best practice of the industry and directed by the PAS-X user community PFU. They accelerate the creation of master batch records (MBRs) and help to assure higher quality MBR design in the configured system. The MBR Design Elements are templates for the fast and simple creation of MBRs for specific processes in pharmaceuticals and biopharmaceuticals production such as granulation, IPC testing or reconciliation. They focus on the most

efficient use of PAS-X functionality and are designed to operate together. The MBR Design Elements are part of specific libraries available for all major manufacturing types, such as solids, liquids and packaging. In addition, Universal Elements are also on offer, covering general processes that are not related to specific manufacturing types. The PAS-X MBR Design Elements content packages provide a comprehensive framework for harmonising and standardising processes within or between different plants and drive efficiency in global organisations. Customers can expand and modify these elements to meet their own specific process and equipment requirements.

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Use of PAS-X MBR Design Elements. Werum Software & Systems AG +49 4131 8900 689 dirk.ebbecke@werum.com www.werum.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP CASE STUDY Effective condensate removal has reduced tablet drying times on steam-heated ovens at Piramal Healthcare’s pharmaceutical production site in Morpeth, Northumberland, UK. Automatic pump traps (APTs) from Spirax Sarco have proved so effective at improving temperature control and solving maintenance problems on three of the company’s ovens that Piramal plans to install them on the site’s two remaining units. “The temperature control on the ovens was previously ±5˚C, but now it’s accurate to ±0.5˚C,” said Mechanical Engineer Paul Lunn. “We don’t know exactly how much we’re saving, but we know that the improved control must be saving energy because it’s reducing the drying time.” The build-up of condensate was also causing corrosion and erosion in the heating coils. Piramal typically had to replace each coil once or twice a year, putting an oven out of action for three days every time. As well as the cost of the repairs and downtime, any product in the oven when a coil sprang a leak had to be scrapped. “We haven’t had any problems with the coils since the Spirax Sarco pump traps were installed,” added Lunn. “I’d say the reduction in maintenance has been the biggest benefit for me.”

AUTOMATIC PUMP TRAPS IMPROVE PRODUCTION EFFICIENCY AT PIRAMAL HEALTHCARE

All the problems were caused by a build-up of liquid condensate in the steam coils. Back pressure made the liquid difficult to clear using conventional steam traps, but APTs from Spirax Sarco can always clear condensate effectively, even under vacuum. The APTs act like steam traps to drain the condensate normally as long as there is positive pressure in the steam coils; but if the pressure in the system drops below the condensate back pressure, the steam-driven APTs actively pump the condensate away. Lunn concluded: “We’ve worked well with Spirax Sarco before and this time the local engineer worked with us to design a solution and apply it successfully. Now we’ve seen how well the APTs are working on the first three ovens, we’re planning to fit them on the other two.” Piramal Healthcare is a leading contract pharmaceutical manufacturer. The company took over the Morpeth site in 2006, where it continues to make a range of hormone-based products, including oral contraceptives. Spirax Sarco UK +44 1242 521361 webenquiries@spiraxsarco.com www.spiraxsarco.com/uk

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MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Single-Use Quaternary Diaphragm Pumps with Injection Moulded PE Chambers Speed Up Production

Cleanroom Equipment Supplier Launches Manufacturing Product Range

Quattroflow has announced that its 1200SU-M Series single-use quaternary diaphragm pumps are now available with plastic pump chambers engineered with injection moulded polyethylene (PE). Manufactured to be a more cost-effective alternative to standard solid plastic pump chambers, these injection moulded PE pump chambers are assembled under controlled and clean conditions to accommodate a wide variety of pharmaceutical and biotech systems. Equipped with a product wetted plastic pump chamber that can be replaced as a complete unit, Quattroflow 1200SU-M Series single-use pumps have been specifically designed to meet the needs within demanding pharmaceutical and biotech applications. The simple disposal of the pump chamber saves time and money, removing the need for extensive cleaning, sterilisation and complex cleaning validation. In addition, 1200SU Series pumps reduce downtime between batches and are quick and easy to change. “The use of Quattroflow single-use pumps creates a quicker production process, as well as one that delivers the required levels of product purity and sterility with no harm to the product and no chance for costly cross-batch or cross-product contamination,” said Dr.

Relative newcomer Pharma Hygiene Products (PHP) is not just a supplier of cleanroom and laboratory products. With many years’ experience installing and maintaining pharmaceutical production machinery around the world, the company understands the exacting standards and importance of GMP compliance in drug manufacture. Also, having worked alongside A small selection of PHP’s existing range, including the pharmaceutical production new open top drums. engineers, PHP also appreciates the importance of process continuity and the costs associated with losing control over it. This is why the company has brought together a range of products specifically for pharmaceutical manufacturing. All products are manufactured from FDA-approved materials, to GMP compliant designs and appropriately certified to provide the highest levels of hygiene and reliability. As a specialist supplier, PHP’s knowledgeable team offers a fast, reliable service, bespoke advice and a constantly expanding product range. Recent additions to its range include open top drums, drum skids and discharge cones, Hygienic butterfly valves will be available by with hygienic valves and vaccine vessels Spring. following by the spring. Pharma Hygiene Products The company’s website and catalogue +44 121 661 6548 have been designed for easy sourcing of sales@pharmahygieneproducts.com products, with all information provided in www.pharmahygieneproducts.com a simple, straightforward way.

Andreas Frerix, Applications Manager Biotech/Biopharma for the Quattroflow brand. Additional features and benefits of the new injection moulded PE pump chamber include: • about one-third lower in price than standard solid plastic pump chambers • available with ¾” TC, front connections • maximum pressures up to 58 psi (4 bar) • maximum temperatures up to 50˚C • wide flow range from 1.6 to 317 gph (6 to 1200 lph) • conform to USP Class VI, FDA • gamma irradiation possible. Quattroflow +49 2842 961 0 rainer.frericks@psgdover.com www.quattroflow.com

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10 11 12 13

Sterility Indicators

Sterilisers — Dry, Heat, Electric

Sterilisers — Dry, Heat, Gas

Sterilisers — Gas (ETO)

Sterilisers — Ionising Radiation

Sterilisers — Laboratory

Sterilisers — Membrane Filtration

Sterilisers — Nitrogen Dioxide

3M: Purification Division +44 1344 858000 ccahir@mmm.com www.3m.co.uk/purification 2

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

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

11 12 13

Noxilizer Ltd +44 1246 570777 smorley@noxilizer.com www.noxilizer.com

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

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

IMA S.p.A - IMA Life division +39 051 651 4111 mktg.life@ima.it www.ima-pharma.com

Priorclave Ltd +44 2083 166620 sales@priorclave.co.uk www.priorclave.co.uk

Additional

Getinge Infection Control +44 1623 510033 info@getinge.com www.getinge.com Honeyman Group Ltd +44 1833 696425 enquiries@honeyman.co.uk www.honeyman.co.uk

Sterilisation Equipment Servicing

Sterilising Tunnels

Sterilisers — UV Radiation

Sterilisers — Autoclaves

sterilisation

Steriliants — Liquid

buyers’ guide

Cycle development and material compatibility studies. 4

Standard ranges and bespoke manufacture to meet customer needs.

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MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Multiple Lanes Gain in Productivity through Checkweighing Solution Mettler-Toledo Garvens has designed a multiple-lane checkweigher to provide food and pharmaceutical manufacturers with a high-precision weighing and sorting system to facilitate faster production times and increased output. Whereas standard applications can only be configured with two to four lanes, the Multi-lane Checkweigher has the capacity to inspect up to 1,500 packaged products per minute on up to 16 lanes for correct weight and fill levels, enabling manufacturers to boost throughput speeds. “According to the European Commission, consumer confidence in both the Eurozone and the European Union has grown in recent months, as a result of sustained economic recovery in countries such as Germany, France and the UK. In addition, renewed demand for goods has led to cost pressure and higher operating efficiency requirements as consumers feel more comfortable spending money,” said Kerstin Bernhart, Marketing Manager, Mettler-Toledo Garvens. “To meet this demand,

manufacturers need to find ways to increase production line output effectively. Checkweighing technologies, such as multi-lane applications, can help them achieve this objective through allowing higher production throughput rates and enabling greater control over products and costs.” In addition to expanding capacities, the multi-lane checkweigher feedback control function minimises product weight errors through proactive feedback per lane or a combined feedback for all lanes to keep filler heads properly adjusted. This means adverse fill level trends can be corrected before they become a problem, minimising costly overfilling or unlawful underfilling in order to comply with metrology legislation such as the European Commission Measuring Instruments Directive (MID), 30 April 2004, based on International Organisation of Legal Metrology (OIML) guidelines. Data collected by the Multi-lane Checkweigher is stored and accessed through a single, easy-to-use

touchscreen terminal, providing separate statistics for each level as well as overall statistics. With a single terminal, all lines can be controlled and monitored at any time, which reduces inspection time for operators. The eradication of multiple user interfaces allows closer lane spacing, creating an enhanced solution with a much smaller footprint than traditional multiple line machines, saving space on the factory floor and reducing installation time and costs. For manufacturers already employing checkweighing and metal detection, Multi-lane CombiChecker replaces the need for separate machines as it combines checkweighing and metal detection capabilities, offering solutions to optimise footprint. The Multi-lane Checkweigher comes with optional XS multi-lane software, which enables production lanes to work asynchronously and independently from one another. For example, manufacturers can now shut down an individual production lane through the software’s lane selective emergency run

function while remaining lanes continue to operate as normal, ensuring that maintenance can be carried out with minimum production downtime. For system integrators, a checkweigher version with pulse-controlled intermittent weighing operation is also available. Mettler-Toledo Garvens GmbH +49 5121 933 0 kerstin.bernhart@mt.com www.mt.com/pi

Small Machine Platform Makes Sophisticated Inspection Affordable High-tech inspection of liquid or lyophilised parenterals at speeds of up to 24,000 containers per hour is no longer a privilege reserved only for global manufacturers. Seidenader’s CS machine customers now benefit from the same technology features and inspection stations as larger Seidenader MS or VI series customers: • outstanding camera technology • complementary inspection technologies • smooth product handling by enhanced vacuum transport system — no side guidings in the starwheels • programmable servo drives for individual rotation profiles in every position of the inspection carousel • split infeed screw for controlled line clearance • Seidenader hyseptic standard to meet GMP requirements.

The small platform of the CS series allows up to seven camera stations for the inspection of ampoules, cartridges and vials up to 100 ml in size, for the detection of particles in the product and cosmetic defects of the container. In addition to the visual inspection by camera, high voltage leak detection (HVLD), head space gas analysis (HSA), near infrared spectroscopy (NIR) or glass stress verification (GSI) can be integrated into the machine to detect invisible defects. To meet various customer requirements, Seidenader has developed a new machine concept that offers flexibility by interchangeable infeed as well as outfeed systems. This concept allows the CS to run stable as well as unstable products, either inline from an upstream machine or manually loaded. This new concept will be

adapted to all Seidenader machine platforms. The CS is equipped with an enhanced software design and a new integrated electrical cabinet. The clearly laid out HMI offers the operator an intuitive graphic user interface and scores with advanced recipe manager, smart camera trigger technology and OEE reporting for easy analysis of line efficiency. The separated cabinet at the back of the machine allows for quick access to electrical components as well as accessibility from all sides for easy cleaning. Sealed optical elements, column concept, trimmed edges and hidden cables — the Seidenader

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hyseptic standard — also contribute towards GMP compliance. Seidenader Maschinenbau GmbH +49 8121 802 486 heidrun.sing@seidenader.de www.seidenader.de

SHOWCASE CONTAINMENT & OPERATOR PROTECTION

Two-Tone Flooring Solution Further Prevents Cross-Contamination Dycem flooring has been developed to create a two-tone system, utilising its range of colours and flexibility to create a more complete contamination control solution. Dycem’s two-tone solution creates a highly visual separation between clean and dirty areas, whilst eliminating the need for a physical barrier. The visual barrier created by Dycem helps to lessen health and safety risks associated with physical

barriers, such as step-over benches, which can create obstacles for personnel in the event of fires or facility evacuations. Dycem’s highly trained service technicians are able to bespoke install Dycem, wall to wall, to encompass an entire area of virtually any shape, offering a more complete contamination control solution for areas that have previously been interrupted by physical barrier systems.

The flooring is hot weld sealed to maintain the strength of the seal and ensure that no moisture is able to permeate underneath. Dycem can be easily integrated into cleaning, quality and audit SOPs, whilst capturing up to 99.9% of contamination from entering core critical areas, such as primary packaging areas, tabletting areas, product transfer rooms, dispensing booths, gowning areas and airlocks.

Dycem Ltd +44 117 9559921 info@dycem.com www.dycem-cc.com

Isolators Deliver Contamination-Free Handling of HPAPIs

Disposable Coverall Offers Barrier to Broad Range of Chemicals

Dec Group multipurpose isolators are designed for use in pharmaceutical manufacturing areas for the contamination-free handling of HPAPIs. The containment systems are developed with Dec’s ergonomic package to offer ease of use and an ultra-safe working environment where there is little chance of API egress. Dec’s own designed seal system, governed by PLC, with glove in-rush guarantees safety of the product from the surrounding area. These systems incorporate Dec’s enhanced safety system developed from the company’s experience of installations operating around the globe. A typical isolator in this category consists of three chambers, which are used for weighing and filling operations of potent active ingredients, final and intermediate products, verification of product quality and sampling in a completely closed working area. Dec Group multi-purpose isolators provide a safe barrier between the operator and the active drug substance to protect both operator and product. The systems can be designed for multi-

DuPont is introducing a Tychem coverall for workers seeking safe and comfortable protection in more demanding applications. Tychem 4000 S, made from DuPont Tyvek laminated with a chemical barrier film, presents wearers with an optimum barrier against a range of chemical environments and hazards while also being supple and lightweight. For workers exposed to harmful chemicals, the requirement to wear chemical protective clothing goes without saying. In such situations, many Type 3 protective coveralls are considered to be restrictive and uncomfortable. We believe that uncomfortable personal protective equipment (PPE) can influence noncompliance of safety procedures in the workplace, and that by developing proper and comfortable PPE, we can help to improve compliance and thus reduce the risk of injury,” explained Chloe Caux-Wetherell, New Product Leader EMEA at DuPont Protection Technologies. Tychem 4000 S garments utilise a chemical barrier film laminated to Tyvek fabric to achieve a barrier to permeation by a broad range of inorganic and also organic chemicals, including phenol, ethanol and methanol. As well as providing high chemical protection, the suppleness and flexibility of the fabric results in a lightweight, comfortable garment that is easy to wear. The new

product use for OEB5 category potent compounds. The isolators are controlled by a Dec designed PLC system incorporating Dec’s Enhanced Safety System (ESS) and are developed using Dec’s own Ergonomic Design Development (EDD) tool that has proven to be successful on recent additions to the DEC family of products. Dec’s isolators, whether standard or customised complex systems, enable ergonomic and flexible working in a safe environment. Dec Group +41 21 694 20 40 info@dec-group.ch www.dec-group.net

Spray Nozzle Supplier Diversifies with Safety Showers and Eye Baths Wherever hazardous materials are being handled, used or processed, the deployment of safety showers is often required by law. Compliance with safety standards and regulations is an increasing necessity for any business, as failure to provide adequate showers can expose any company to potential litigation. To meet the increasing demand, spray nozzle company Bete Ltd has announced a significant expansion and diversification of its product range. Bete will now be representing FSP Tech, a German manufacturer of industrial safety showers and eye wash units, as its exclusive UK distributor. The new range of products fits very well with Bete’s existing customer base,

explained Bete’s Marketing Director Ivan Zytynksi: “We are already well known as a quality supplier of nozzles and spray technology for a wide range of industrial, food processing and chemical production applications. Many of the customers that trust our expertise in specifying spray nozzles will also require safety showers so it’s a logical extension of our offering.” Whilst the markets for spray nozzles and safety showers do overlap considerably, there are differences between the way people search for such products. Further to this, the Bete brand is specifically associated with spray nozzles only. Therefore, to avoid possible confusion, Bete has made the decision to market its safety product

through the new trading name: The Safety Shower People. To this end, a new website — www.safetyshowerpeople.co.uk — has been launched, which gives detailed information on all safety shower products, tips on satisfying safety standards and information on safety shower best practice. The aim of the site is to provide prospective customers with clear and concise information to guide them in choosing the correct products for their specific needs. The Safety Shower People +44 1273 400092 info@safetyshowerpeople.co.uk www.safetyshowerpeople.co.uk

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garment also benefits from several smart design features, such as a double-zip and double-cuff systems, which enhance user-acceptance and overall protection. Tychem 4000 S will be commercially available through authorised distributors from May 2014. To find out more information about the new garment, including further details on its barrier performance, visit the company’s online garment selection tool www.safespec.dupont.co.uk or website http://chemicalprotection.dupont.co.uk. DuPont International Operations Sàrl www.dpp-europe.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP

IN THE SPOTLIGHT A BRIEF HISTORY OF BRINGING TO MARKET A HUGELY SUCCESSFUL CONTAINMENT TRANSFER SYSTEM

Ezi-Dock’s MD Steve McAleavy.

Ezi-Dock Systems in Kirby in Ashfield, Nottingham, UK, specialises in the provision of liquid- and dust-free powder transfer and handling solutions. Editor Elizabeth Valero visited Ezi-Dock’s Managing Director Steve McAleavy to learn about the company’s origins and the reasons behind its Ezi-Flow CSV high containment transfer system having taken the pharma industry by storm. The journey begins Steve and long-term business partner Mike Brimson launched Ezi-Dock Systems in 2003, after having spent many years working in the field of specialist injection moulding to produce components and flexible packaging products for medical and pharmaceutical markets. Being entirely their own business, Ezi-Dock allowed Steve and Mike to develop and market their first patented product concept — a two-part docking ring that attached to FIBCs (flexible intermediate bulk containers) and large sacks, providing totally dust-free transfer of product. As Steve retrospectively admitted: “The aim was to have one of these docking systems on every big bag sold in the world, but it never quite worked out like that. That said, it’s a good, stable product that continues to do pretty well, with around 10,000 sales per month.” In fact, the product proved useful in an application not initially anticipated by Steve or Mike. “It worked very effectively on 14 and 16" chutes discharging from a big bag, but we discovered it worked just as well on chargebags,” explained Steve. The decision was made to invest in injection mould tooling for additional 2, 4 and 6” versions of the docking ring and

sell these as chargebag assemblies. At the time, Ezi-Dock did not have a facility to make the bags so bought them in and paired them with the docking rings in very small numbers. A class 10,000 ISO 7 cleanroom was quickly built so EziDock Systems could increase production volume and really begin to target Steve and Mike’s desired market of pharmaceuticals.

Introducing the Ezi-Flow CSV high containment transfer system Around this time, an opportune meeting at a UK pharmaceutical plant revealed the production manager’s need for an alternative contained transfer method to the one currently implemented in his production path, which he said had been failing miserably. He had been unable to find a suitable alternative. Eager to provide a solution, Steve and Mike took just three months to develop the Ezi-Flow CSV system. In Steve’s words: “It took off like a rocket,” and three years on, they have introduced the Mark 3 version. The Ezi-Flow CSV is based on a twopart passive and active, similar in concept to most split butterfly valves but claimed to be offering significant advantages in cost and performance. Both parts are interlocked to ensure operator and product safety, although the system is remarkably easy to use and so costeffective that take up of the design was immediate. Launched last year, the third and latest version has seen significant functional improvements to the operation, such as removal of buttons on the front Business partners Mike Brimson and Steve McAleavy.

to be replaced with a toggle on the back. This feature has not only achieved a liquid-tight seal but users wearing bulky PPE have found it a lot easier to operate. Making it even simpler to use, the Mark 3 design numbers the one to three operational stages. “We weren’t sure whether some people might find that condescending, but everyone has said it’s great,” said Steve. “And it really is as easy as 1, 2, 3 — step 1/Load and secure the chargebag to the Ezi-Flow system, step 2/Open the Ezi-Flow system and step 3/Engage the two side toggles to achieve a contained seal.” The Ezi-Flow CSV is of course aimed at those new adopters of single-use technologies. As Steve pointed out: “In most cases it doesn’t make sense to reuse because it costs more to clean the equipment, handle the waste, revalidate, etc., than it does to use once and dispose.” At the start of the project, Steve and Mike aimed to achieve a 1–10 µg OEL (operator exposure limit), but they actually managed to achieve less than 1 µg, which is as good as, if not better, than many split butterfly valves, according to Steve. “That’s how we started to make real inroads into the pharma market,” he said. “We’re supplying 10 of the top 12 pharma companies and the customer list grows daily. “We’ve got a number of sales agents in Ireland, Switzerland, Germany, America and the Far East, but we are picking up business by word of mouth as well, for example, one organisation we’ve spread through like wildfire just because one engineer spoke to another engineer and so on.” So what next? Steve admits that he and Mike always have a wish list of further improvements for their products — some their own and others customer driven. Top of the list is to produce an aseptic version of the Ezi-

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Flow CSV, because it is not possible to steam sterilise the Mark 3. “Some customers gamma irradiate it, but we are looking — in the not too distant future — to produce it in a material suitable for steam sterilisation,” Steve affirmed. Ezi-Dock Systems Ltd +44 870 041 0326 steve@ezidock.com www.ezidock.com

SHOWCASE TABLETTING

Materials Science Paves Way to Right First Time Tooling Steel Selection Wear and degradation of tooling is inevitable in tablet manufacture and will lead to other tablet-making problems, such as adherence of the granules because of the pitted and worn surfaces of the punches and also capping or lamination of the tablets. To overcome this problem, I Holland has studied materials science and uses a continuous component testing programme and the MCP (Metal Conditioning Project). This project has led to advancement in I Holland’s understanding of steel metallurgy, allowing the company to further improve the properties of the I Holland PharmaGrade steel types for tablet tooling. The correct choice of material will help to reduce the risk of damage to the punches and dies from the effects of abrasion, corrosion and impregnation of hard granules. There are thousands of steel types available, yet only a few meet the complex design and functional requirements necessary for tablet tooling. The right steel is key to the successful performance of tablet compression

tooling. I Holland’s PharmaGrade range of steels have been tested to achieve the following necessary characteristics: • Strength: ability to withstand an applied stress without failure. • Fatigue resistance: aggressive and localised structural damage that occurs when a material is subject to cyclic loading. • Toughness: resistance to chipping, cracking and punch tip breakage. • Abrasive wear resistance: resistance to abrasive wear of punch tips and die bores. • Adhesive wear resistance: resistance to adhesive wear, galling and welding. • Hardness: resistance to impregnation from hard, sharp granules. • Compressive strength: resistance to die bore ringing and plastic deformation of punch tip edges. • Corrosion resistance: resistance to oxidising, staining and discolouration. Chemical composition of the steel is only one part of the overall equation, material selection must also be considered together with good tablet

design for strong punch cups and punch tip edges. After years of extensive research and development, I Holland has a number of steel types in the PharmaGrade range to suit a variety of applications, including the standard HPG-S steel to the HPG-TC — a PharmaGrade Tungsten Carbide. Together

stack securely while nested or rest flat on the bottom of the box. A side identification tag location was also built in for easy identification of segments. The Natoli die segment storage box was designed to be used with Natoli tool storage boxes to optimise shelf space and eliminate the need for additional shelves or storage units. Contact Natoli to find out more about how to securely store and transport die segments in this new die segment storage box.

components results in less floor space and simplified equipment maintenance compared with other tablet press systems.

Using Pmax segment turrets with FS12 punches, customers are able to increase the output quantity of the tabletting process by up to 40% in the same production time. The Pmax segment turret is available with 45, 66 and 110 stations for the i-Generation and with 51 and 87 stations for the FE-Generation. Up to 1.3 million tablets and more per hour can be pressed in the Fette Compacting 3090i double-sided rotary press. Pmax technology is crucial for this capacity. The segment turret with FS12 punches is equipped with 110 stations. This is possible because the punches, with a shaft diameter of 12 mm, are much smaller than conventional ones and therefore require a smaller distance between the die holes. The maximum compression force is reduced in comparison with other standard punches. The compression force of 25 kN is sufficient for most products in the pharmaceutical sector. Production efficiency can be significantly optimised with Pmax technology without additional investment.

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

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

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

Rotary Tablet Press Users Benefit from Ergonomic Design and High Yields When Bosch Packaging Technology added Manesty tablet presses to its portfolio in 2011, the company significantly enhanced its competences in process technology. The Manesty Xpress range of tablet presses fulfill the pharmaceutical industry’s needs for flexibility and safety as well as low investment and operation costs. The Manesty Xpress product range from Bosch Packaging Technology consists of both single and double-sided rotary tablet presses as well as a WIP option, allowing for flexible tablet production of small, medium and large batch sizes. The double-sided Manesty Xpress 700 tablet press, for instance, manufactures up to one million tablets per hour and can be converted from single layer to double layer production within a very short time period. It features precise independent monitoring

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

Segment Turret Increases Production Up to 40%

Die Segment Storage Box Ensures Secure Transportation Natoli Engineering Company has introduced a secure and efficient way to store and transport die segments. The die segment storage box features rugged construction with foam inserts and outside clips to keep die segments secure. With foam inserts available in several sizes to accommodate different sized segments, these storage boxes are made of FDA-compliant materials and can be used with preexisting shelves. Boxes can be nested horizontally or stored vertically in bookshelf style to maximise space. This cost-effective storage solution has been designed to

with the range of PharmaCote treatments and coatings, all tablet manufacturing problems can be dealt with.

of each layer, special air jets to prevent cross contamination between layers and a clear demarcation line between the individual layers. Manesty Xpress tablet presses feature an ergonomic design, short product changeover times, high product yield and OEE. The stepped cabinet design of the tablet presses offers complete separation of production and mechanical zones to not only help avoid product contamination but also protect maintenance staff. Fast and simple opening of both upper and lower pressure rolls ensures easy access to the compression zone and significantly reduces tool changing times. A newly developed combination of removable turret and exchangeable die plate offers fast changeover and easier cleaning. The compact footprint with integrated electrical and pneumatic control

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Industry News

Industry Veteran Joins Noxilizer’s Leadership Team to Build European Operations Noxilizer, Inc. — the company advancing a room temperature, nitrogen dioxide (NO2)-based sterilisation process for life science manufacturers — has appointed Stephen Morley as Vice President, European Sales and Service, Noxilizer Ltd, the newly established entity for Noxilizer’s European sales and service operations. Noxilizer’s entrance into Europe, the next step in their global expansion strategy, is intended to accelerate the global acceptance of NO2 sterilisation as a powerful, efficient and cost-saving alternative to traditional sterilisation methods. This announcement follows Noxilizer’s Spring 2013 asset acquisition of SAIAN Corporation and the creation of Noxilizer Japan KK, establishing Noxilizer as a global player in the life science sterilisation market. “Well-regarded in the industry, Steve has a demonstrated track record of building strategic partnerships and

developing business opportunities that have resulted in strong revenue growth,” noted Lawrence Bruder, Noxilizer CEO. “We are confident his leadership will be an asset as we establish our European presence and grow the sterilisation business.” Morley joins Noxilizer with 30 years of successful operational and strategic business development experience. He led a distinguished career with Getinge Group, where he held positions of progressive leadership, most recently serving as Portfolio Manager with Getinge Infection Control AB. Among his notable achievements, Morley established operations for Getinge in Japan, led the integration of acquired companies and helped establish centralised marketing and business development activities for the organisation. Morley holds an honours degree in Physics and Chemistry from Nottingham University.

“This is an exciting opportunity. I am pleased to join an organisation whose leadership is committed to delivering a new sterilisation solution to customers,” said Morley. “I also look forward to introducing the European market to the exceptional technological advantages of NO2 sterilisation.” NO2 sterilisation eliminates preconditioning, maintains material properties in heat-sensitive products and does not require long aeration. It is gaining recognition as an ideal sterilisation alternative for pressure and temperature sensitive products. In addition to the technological advantages of NO2, customers are recognising the potential manufacturing efficiencies and resulting cost savings. Morley will conduct business from the UK-based, Noxilizer Ltd office. Noxilizer’s headquarters will remain in Baltimore, Maryland, US.

Noxilizer Ltd +44 1246 570777 smorley@noxilizer.com www.noxilizer.com

Cleanroomshop.com Extends Range with Essentra Polyester Wipes As a specialist supplier of cleanroom wipes and cleaning agents, Cleanroomshop.com understands that for many organisations the task of selecting the correct wipe can be daunting owing to the wide range of options on the market. Working with Essentra Porous Technologies, a division of Essentra plc, Cleanroomshop.com now offers a range of polyester wipes that are of optimal strength and durability with low particle and fibre generation. Combined with the attributes of high absorbency, purity and cleanliness, the new polyester range is instrumental for

mission critical environments. The range includes: • A 100% polyester interlocked wipe and 100% polyester purity wipe with knit construction for exceptional absorbency and cleanliness. (Product codes WPNS1 and WPNS2). • A 100% continuous filament polyester pinsonic, two-ply wipe that delivers ultra-low particle generation — ideal for critical cleanroom environments. (Product code WMNS1). • A more general-purpose cellulose/polyester blend wipe that can be used for cleaning and

ChargePoint Technology Appoints Containment Expert to Grow European Business Malcolm Cunningham, a specialist in containment and powder transfer with over 25 years’ experience in this field, joins ChargePoint Technology as its new Business Development Manager to increase the business in northern and southern Europe. Prior to joining ChargePoint Technology, Cunningham worked for companies within the pharmaceutical and other process industries, successfully increasing their market penetration and turnover. He commented: “There are many opportunities in the market related to containment, especially when working with contract manufacturers of APIs and other ingredients. I made the decision to join ChargePoint Technology as I wanted to be part of a young and dynamic company with entrepreneurial spirit, supporting their exciting growth plans.”

Chris Eccles, Managing Director of ChargePoint Technology, said: “We have been able to attract a number of people of Malcolm’s calibre to develop and grow the sales of our aseptic and high containment product ranges. This year is extremely exciting for us and we will continue to grow our business by delivering world-class solutions and total customer support, no matter what.” ChargePoint Technology Ltd +44 151 728 4500 adriana.garcia@thechargepoint.com www.thechargepoint.com

maintenance both inside and outside of a cleanroom environment. Economical, the wipe is made up of 55% cellulose and 45% polyester fibres that are hydroentangled to create maximum strength and durability. (Product codes WCRE1 and WCRE2). “We are excited to be partnering with Connect 2 Cleanrooms, and while we are changing our face to the customer with new products, marketing and innovations, our commitment to partnerships will continue to be our primary focus,” said Ninette van Lingen, Senior Sales Director, Americas, Essentra plc.

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

OPTIMA pharma Announces Highly Qualified CEO Stephan Reuter is the new CEO of OPTIMA pharma GmbH in Mornshausen, Germany, a worldwideknown manufacturer of high quality freeze-drying systems for the pharmaceutical and biotech industries. Reuter joined Optima Pharma from an executive position at B. Braun Melsungen AG. As a qualified engineer, he brings to this new position two decades of professional and management experience in pharmaceuticals. His previous fields of responsibility included the development of project management processes, management of complex international product developments and investment projects, the structuring and managing of project management departments and the execution of major projects worldwide. As head of project management and engineering, Reuter spent many years in a pharmaceuticals-oriented engineering

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and management consulting business and, prior to this, in leading international plant engineering companies. With his extensive knowledge of pharmaceuticals technology and many years of experience in management and project management, he is ideally qualified for successful management of the Mornshausen plant. OPTIMA packaging group GmbH +49 791 506 1410 sabine.gauger@optima-ger.com www.optima-ger.com

Industry News

Schubert and IPS Combine Pharma Packaging Competencies Gerhard Schubert and IPS International Packaging Systems are combining their expertise in pharmaceutical packaging. They jointly launched the Schubert Pharma competency team on 1 January 2014. Customers in the pharmaceutical industry will benefit from crossdisciplinary consulting. “Together we are able to respond even more efficiently to the specific market requirements of the demanding pharmaceutical sector,” explained Olaf Horrenberger, CEO of IPS. The company is aiming to double revenues from the pharmaceutical sector over the next three years.

In total, 20 pharmaceutical experts from sales, purchasing, project management, validation and service will in future work as Schubert Pharma at IPS under one roof. As a team, they will produce sophisticated packaging solutions for the pharmaceutical industry from primary packaging through to the pallet with the finished product. The organisational and spatial centralisation of the two companies will create synergies. Schubert brings its expertise in highly flexible TLM packaging machines and its longstanding business relationships with pharmaceutical companies, while IPS offers extensive experience in project management. As a general contractor and engineering service provider, IPS has supplied individual and tailored packaging solutions for over 40 years. Gerald Schubert, Managing Director, Gerhard Schubert, and Schubert Pharma’s Olaf Horrenberger, CEO, IPS International Packaging Systems. portfolio includes

comprehensive engineering consultancy services, project management for turnkey systems and line optimisation for existing packaging lines. The company also takes over the maintenance of systems for their entire lifespan. As part of its engineering consultancy activities, supplier-independent track and trace Gerhard Schubert and IPS International Packaging Systems are solutions are combining their expertise in pharmaceutical packaging. developed and implemented to customers’ specific Gerhard Schubert GmbH requirements. Schubert Pharma also +49 7951 400 0 designs system solutions for future info@gerhard-schubert.de product lines and volume capacities. www.gerhard-schubert.com Upon request, the team evaluates the performance and process capability of IPS International Packaging Systems existing machine technologies, produces GmbH budget and target figures and supports +49 7951 494 0 companies during their approval communication@ips-packaging.com processes. www.ips-packaging.de

GEA Diessel Appoints MD to Focus on International Fermentation for Pharma and Biotech

AAIPharma and SP Scientific Enter Supply Agreement for Lyophilisers Nucleation On-Demand Technology

Hans-Peter Casel has taken over as Managing Director of the Liquid Pharma Business for GEA Diessel. The company is the GEA specialist for upstream biotech and pharmaceutical fermentation and part of GEA Pharma Systems, a strategic business unit within GEA Process Engineering. In his new role, Casel will be responsible for building the company’s high-tech brand and expanding its global customer base. Casel has spent his entire working life in the pharmaceutical and biotech sectors and brings with him over 20 years of general and project management experience. After leaving the Technical University of Dortmund, where he studied chemical and process technologies and business administration, Casel joined GEA as a Project Engineer with GEA Messo GmbH and later as a Project Manager with GEA Wiegand GmbH. This introduced him to evaporation, concentration and fermentation technology. Over the last 14 years, he has expanded his experience, becoming more deeply involved in fermentation and biotech processing, before rejoining GEA to take up this new appointment. “I was tempted by the opportunities at GEA Diessel,” he explained. “I wanted to use fully my experience and specialist knowledge of pharma and biotech fermentation and GEA Diessel provides me with the perfect opportunity to do just that.”

SP Scientific, a leading provider of wellestablished and highly regarded scientific equipment brands, and AAIPharma Services Corp., a leading provider of pharmaceutical analytical testing, product development and manufacturing services, have entered into a purchase agreement where SP will supply AAIPharma with a LyoStar 3 pilot-scale lyophiliser paired with a complementing Hull production-scale lyophiliser, both equipped with Praxair’s ControLyo nucleation on-demand technology. “By procuring both the pilot-scale and production scale lyophilisers with ControLyo technology, AAIPharma significantly enhances its lyophilisation development and optimisation capabilities while dramatically increasing our scalability and total lyophilisation capacity,” stated James Fife, Senior Director of Parenteral Operations at AAIPharma. “Cycles will be developed on site in the LyoStar 3 and easily transferred to the production-scale dryer.” ControLyo nucleation on-demand technology allows the manufacturer to control the nucleation temperature during freezing and ensure that all vials nucleate simultaneously. Numerous benefits have been demonstrated for controlled nucleation, including improved vial-to-vial homogeneity, reduced primary drying times, improved cake appearance, reduction in vial breakage and better stability for many protein-based formulations.

Casel explained that GEA Diessel has a very good name in the industry and is working hard to increase its international business. His brief is to expand the company globally by cooperating with GEA partners in China and India, thereby increasing its influence in those regions and elsewhere. “We will focus on hightechnology applications in fermentation and formulation where we can really make a difference,” he explained. “We have the experience, products and technical know-how to work with our customers to develop processes and recipes that will help them to bring the products of the future to market quickly and successfully. This is where our talent lies and where we will be most successful.” GEA Diessel GmbH +49 5121 7420 beata.cymara@gea.com www.diessel.com

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Hull production-scale lyophiliser. William Downs, President and CEO of SP Industries, commented: “ControLyo technology is the most significant advancement in freeze drying in perhaps decades. It is rapidly being adopted by the industry and those that hesitate to utilise the technology run a real risk of being left behind in a competitive marketplace. We are pleased to see AAIPharma adopt the technology and believe that as an early adopter they have created a compelling competitive advantage.” The pilot-scale lyophiliser will be fully validated and operating within AAIPharma’s cGMP facility by February 2014. The production scale lyophiliser is scheduled to come online in late 2014. SP Scientific Inc. +1 845 255 5000 shireen.scott@spscientific.com www.spscientific.com

LABORATORY PRODUCTS & EQUIPMENT

Autoclave Sealing Parts Withstand Four Months’ Aggressive In Situ Testing Autoclaves are widely used to sterilise equipment with high pressure saturated steam at temperatures of 121˚C or more. These conditions can be maintained for 15 to 20 minutes, depending upon the size of the system load and the contents. Pressurised, high temperature steam is, however, one of the most aggressive operating environments, but this is necessary to achieve the high level of operating sterility and purity within the autoclave. In between system loads, autoclaves are also subject to continuous cleaning cycles at high pressure/temperature steam conditions. Typical autoclave applications include pharmaceuticals, microbiology, medicine, veterinary and mycology sciences, together with dentistry and general laboratories. A growing application covers the pre-disposal treatment and sterilisation of waste material, including pathogenic hospital waste to neutralise potentially infectious agents. Owing to such challenging applications, it is of paramount

importance that autoclave components withstand the operating conditions. Autoclaves can contain in excess of 200 seals that need to maintain their performance in hot, pressurised saturated steam as well as be FDA and USP Class VI compliant. The DuPont Kalrez 6230 perfluoroelastomer (FFKM) seals have been developed to meet such requirements while providing excellent sealing qualities to comply with modern pharmaceutical processes. These seals are available from the UK authorised distributor Dichtomatik and reduce extractables to trace levels while providing excellent steam cycling resistance up to 260˚C. Where in situ tests have been conducted with saturated steam at 4 bar pressure and 140˚C temperature, the Kalrez 6230 seal parts performed well over a four month test duration of eight hours per day, five days per week. At the end of the test period, the seals exhibited little or no cracks and only minor compression set when compared with competitive perfluoroelastomer (FFKM and FKM) materials.

Dichtomatik Ltd +44 1332 524401 kalrez@dichtomatik.co.uk www.dichtomatik-kalrez.co.uk

dsDNA System for Sensitive Add-and-Read Quantitation Promega Corporation has announced the launch of the QuantiFluor ONE dsDNA system, a sensitive, dsDNAspecific fluorescent dye suitable for use in both research and clinical workflows. The new dye system is integrated into the new Promega Quantus fluorometer and GloMax detection instruments, but is compatible with any fluorometer capable of measuring the appropriate fluorescence excitation and emission spectra. The QuantiFluor ONE dsDNA system is supplied in add-and-read format, enabling users to simply quantitate even low concentration samples with confidence and without dilutions or additional tubes. The dye system has significantly increased sensitivity compared with absorbance-based systems and is highly specific to dsDNA, showing minimal binding to ssDNA, RNA, protein and interfering compounds. The QuantiFluor ONE dsDNA system expands the company’s range of nucleic

acid quantitation reagents and instrumentation, which includes the recently launched Quantus fluorometer for highly sensitive (up to 40,000x higher than absorbance-based methods) quantitation of dsDNA, ssDNA, and RNA. Quantus’s increased sensitivity and range leads to higher success rates in downstream applications such as PCR cloning, transfection and next-generation sequencing. Quantus is also the ideal solution when working with samples such as FFPE tissue, which contain low levels of nucleic acid, enabling users to move on to downstream detection assays knowing that DNA or RNA is present.

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Other dyes for use with Quantus include dsDNA system, ssDNA system and RNA system. Quantus is optimised for use with QuantiFluor dyes but is also compatible with other fluorescent quantitation dyes. Promega Corporation +1 608 274 4330 penny.patterson@promega.com www.promega.com/quantus

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Work Surface Wipes Offer Advanced Spillage Protection BenchGuard Advanced, the latest addition to Sirane Medical & Healthcare’s product range, offers bench protection for laboratories, hospitals, surgeries and other clinical environments where high absorbency and sterile surface protection is required. It has a highly absorbent surface and an effective liquid barrier layer to ensure that spillages are contained and protect the worktop. BenchGuard, sold by IPS Ltd, is a wellestablished and respected name in the market, and Sirane has worked alongside IPS in order to develop BenchGuard Advanced. Jonathan Mason, Sirane’s Business Development Manager, said: “BenchGuard Advanced is an absorbent, impermeable faced cellulosic fabric suitable for protection of laboratory benches and similar surfaces from spillage. It is fast wicking, lightweight and softer to the touch than BenchGuard Classic, making it more maleable, more flexible and generally more pleasant to work with. “Not only is BenchGuard Advanced a more advanced product than the original, but it is much more cost-effective and so should prove very attractive to the market.”

Easy-to-Use Preparative System for Efficient Protein Purification

BenchGuard Advanced is strong and tear resistant even when wet and its flat smooth surface can be written on with pencil or ink. Used BenchGuard Advanced can be readily disposed of and its clean composition means that it is suitable for incineration. BenchGuard Advanced is available in pre-cut sheets of various sizes and also in reel/roll format. It is also available with adhesive strips, preventing movement on the workbench. Sirane Medical & Healthcare’s range has recently been revamped, with a suite of compliant diagnostic specimen transportation solutions one of the latest additions. Sirane Medical & Healthcare +44 1952 230055 jonathan.mason@sirane.com www.sirane.com

Ready to use, straight from the box, ÄKTA start is a compact, affordable protein purification system. ÄKTA start represents a quick and reliable solution that removes the hassles of manual approaches and provides automated control of the purification procedure. ÄKTA start is designed as a standalone system that combines a front-facing flow path with a user-friendly interface. The system is controlled via an intuitive touchscreen, which displays the UV curve and other run data in real-time. ÄKTA start allows the implementation of all common purification techniques, like affinity, ion exchange, desalting and buffer exchange as well as gel filtration. The system therefore supports purification of tagged proteins, antibodies, untagged or native proteins and sample clean-up. ÄKTA start can be run using predefined quick-start protocols, the built-in templates or by creating custom protocols.

Application-focused prepacked columns are offered for common applications. ÄKTA start can be complemented with the Frac30 fraction collector for automatic protein collection and the user-friendly UNICORN start control software that provides additional evaluation tools and the possibility of controlling ÄKTA start from a computer. GE Healthcare Life Sciences +44 800 515 313 custservuk@ge.com www.gelifesciences.com/aktastart

Enhanced General Purpose Centrifuge Line Increases Capacity and Flexibility Thermo Scientific’s new, enhanced general purpose centrifuge product line offers clinical and life science researchers the ability to spin more samples in a single run while maximising critical laboratory space. The general purpose centrifuges feature increased capacity and flexibility with new rotors including the Thermo Scientific TX-1000 rotor, reportedly the only rotor on the market that employs a 4 l capacity in a traditional 3 l footprint. Additionally, the new Thermo Scientific MicroClick 30 x 2 rotor offers a 30-place capacity for microtube and nucleic acid spin columns and is ideal for molecular biology applications. These highcapacity rotors are designed to process more tubes in fewer runs, saving time while reducing energy and wear on the centrifuge.

“Clinical and life science researchers using a general purpose centrifuge are always looking to save time, space and money while increasing productivity,” said Maurizio Merli, Global Product Director, Centrifugation, for Thermo Fisher Scientific. “Our latest rotor innovations address researchers’ needs by allowing them to spin more samples in one run for increased production without surrendering space, performance or flexibility.” The Thermo Scientific general purpose centrifuge line is designed for a wide range of clinical and life science applications, from cell culture to bioproduction to proteomics, food safety, pharmaceutical, stem cell, microbiology and genomics. The general purpose centrifuge floor models conserve valuable bench space with an almost 25% smaller footprint compared with

Stability Testing Software for Fast and Accurate Determination of Drug Substance Shelflife ATG Scientific, in conjunction with Amebis Ltd, is now offering the ASAPprime software package that enables pharmaceutical scientists to rapidly and accurately perform shelflife studies of drug substance and drug product shelflife using the Accelerated Stability Assessment Program (ASAP) approach. ASAPprime uses much more advanced science and statistics compared with existing ICH methodology, allowing predictions of shelflife to be completed in just two to four weeks versus two to six months for ICH. ASAPprime provides an extremely robust and multidimensional analysis for estimating stability and the optimal combination of packaging, formulation, ingredient supplier and manufacturing process, without the need for repeated and lengthy laboratory studies. This means that better and faster decisions

Thermo Fisher Scientific Inc. +1 781 790 7324 marcia.goff@thermofisher.com www.thermoscientific.com/spinit

Cooling Circulators Now Reduced in Price

can be made in development operations, thereby eliminating unnecessary costly reformulations and process changes. ASAPprime also helps make regulatory packages more robust by providing scientific rationale for decisions. ATG Scientific Ltd +44 1865 261423 enquiries@atgscientific.co.uk www.atgscientific.co.uk

refrigerated benchtop models and a working height of 79 cm, providing true ergonomic design for removing tubes and exchanging rotors. The new rotors in the general purpose centrifuge line offer a number of features and benefits: TX-1000 rotor — • up to 40 x 50 ml conical tubes, 196 blood tubes or 24 microplates • advanced lubricant and corrosion resistant coating • dual-purpose large bucket design accepts adapters for tubes or microplates. MicroClick 30 x 2 rotor — • high 30-place volume for 1.5/2.0 ml microtube and nucleic acid spin columns • ClickSeal biocontainment lid for quick and easy sample access.

Huber has reduced the prices of its bath circulators CC-510w, CC-515w, CC-520w and CC-525w, which have been technically optimised and offer a working temperature range from -50/-55 to +200 °C, cooling capacities up to 3.3 kW and a heating capacity of 3 kW. The powerful variable speed pump guarantees an optimum circulation of 31 l/min and 0.6 bar (max. pressure side) and 24 l/min and 0.35 bar (max. suction side). The devices are suitable for internal and external temperature control tasks in laboratories and pilot plants. The Pilot ONE controller offers professional features to meet high application demands, such as a brilliant 5.7" TFT colour display, comfortable touchscreen operation, USB and Ethernet interfaces and 11 languages. In addition, the comprehensive features include process data logging direct to USB stick, storing and loading of

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temperature control programs and an integrated data recorder that records key operating parameters. Peter Huber Kältemaschinenbau GmbH +49 781 96030 info@huber-online.com www.huber-online.com

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP CASE STUDY The speed, accuracy and repeatability of a TABLETOP FILLING Flexicon PF6 tabletop MACHINE BOOSTS peristaltic filling machine from WatsonBESPOKE MEDICINE Marlow Pumps Group PROCESSING AT is helping a TEMAG PHARMA Hertfordshire-based supplier of customised medicinal products improve its process strategy. TEMAG Pharma manufactures and supplies medicinal specials, which are essentially unlicensed medicines, albeit ones that are registered and regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA). Consequently, TEMAG Pharma produces many oneoff batches. However, more recently, the company has witnessed increasing requirements for larger batches, up to 150 bottles in some instances. “These were proving extremely challenging to fill accurately using a manual pipette,” said Greg Tombs, the company’s Operations Manager. “It was also very laborious and repetitive, so we explored the idea of introducing a little automation. We sourced a few potential suppliers and staged trials with three machines. However, we immediately liked the build quality of the Flexicon PF6 tabletop filling machine. It came across as solid, professional and precise. Also, regarding the flow of liquid, we could see it was more consistent than the competitor machines, with far fewer bubbles.”

High accuracy filling The Flexicon PF6 offers high accuracy of ±0.5%, which is obtained through Flexicon’s pulse-free peristaltic filling. A wide range of volumes from 0.5 to 250 ml can be filled, while changeover between batches or different liquids takes less than 60 seconds. Importantly, there is no potential for crosscontamination or requirement for cleaning validation as the liquid touches nothing but the tubing and the filling nozzle. “We also like the fact that the system is expandable,” said Tombs. “If we desire, in the future we can easily upgrade to add bottle handling and capping and make the system fully automated.” Installed in early 2013, TEMAG Pharma has found itself using the peristaltic filling machine on at least a weekly basis. Enhanced process “The Flexicon PF6 machine has improved our large batch filling operations no end,” stated Tombs. “When I think about how we were doing it before — gauging bottle fill-levels by eye, mopping up spillages and so on — this machine has really changed our strategy. It has also produced financial savings. To fill a big batch manually would previously have engaged one of our technicians for an entire day. Now we can process the entire batch in just 60 minutes.”

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This is vital as TEMAG Pharma takes pride in fulfilling orders against extremely short lead-times, at high quality; and judging by its growth, the company has been extremely successful. In just five years, TEMAG Pharma has grown to employ 17 people, who today help supply a host of bespoke medicinal products to pharmaceutical wholesalers, pharmacies, dispensing doctors and hospitals throughout the UK. Watson-Marlow Pumps Ltd +44 1326 370370 info@watson-marlow.co.uk www.wmpg.co.uk / www.flexicon.dk

SHOWCASE CHROMATOGRAPHY & SPECTROSCOPY

HPLC Column Withstands pH and Temperature Extremes The new Hamilton PRP-C18 HPLC column allows efficient separation processes under extremes of pH, high pressure conditions and temperatures of more than 100˚C. This simplifies the method development in reversed-phase chromatography. Reversed-phase chromatography is the most frequently utilised technique for HPLC separations. The pH of the mobile phase plays a decisive role in the efficiency of separations. However, the low resistance of conventional HPLC columns still sets a limit to this advantage because most columns cannot handle pH values above 7 and below 3 without suffering a loss in performance. Hamilton has now developed a PRP-C18 column that can be used with virtually any mobile phase at any pH. The need for pH tolerant HPLC columns becomes more obvious in drug discovery as more than 70% of all drug

compounds are amines that can only be separated at higher pH values above 7. With the Hamilton PRP-C18, neutral amines or other organic bases can be isolated under alkaline conditions in a highly efficient manner without any degradation of the column. Nine structurally-diverse, strongly basic drug compounds were resolved in less than two minutes using a mobile phase with a pH of 11.5 and a fast acetonitrile gradient at 80˚C. One reason for the prolonged efficiency is the way the column can be cleaned. Unlike traditional ODS C18 columns, the PRP-C18 can be regenerated using strong acidic and basic solutions without causing damage. Contaminants that are normally bound irreversibly to ODS columns and may negatively affect analytical results can be easily washed away with one molar sodium hydroxide or sulfuric acid. The result is sustained efficiency, stable

retention times and a high-degree of reproducibility. The PRP-C18 is also completely inert towards the other problematic conditions in reversed-phase chromatography of high pressures and temperatures. The chemical and mechanical stability of the column allows operation at up to 5,000 psi (350 bar) and more than 100˚C. Analyses at high temperatures reduces run times, cutting down on organic solvent consumption. The highly cross-linked PRP-C18 resin packing does not swell or shrink under extreme operating conditions, providing the flexibility to explore other conditions in methods developments. The trend in modern chromatography is towards smaller column inner

diameters using smaller particles, which can be used under extreme conditions in order to increase laboratory productivity. The Hamilton PRP-C18 takes advantage of this trend for polymer resins and thus combines extreme column stability with excellent separating performance. Hamilton Bonaduz AG +41 81 660 67 41 mnipius@hamilton.ch www.hamilton.ch

Carbon-13 Benchtop NMR Spectrometer Combines 1D and 2D Power Magritek reportedly offers the world’s first Carbon-13 capable benchtop nuclear magnetic resonance (NMR) spectroscopy system, the Spinsolve Carbon. For organic chemists, carbon13 (13C) NMR forms the backbone of routine molecular analysis. According to the company, users can have the power of 1D and 2D proton-carbon NMR in a benchtop instrument that can be safely used in the laboratory for the first time. The Spinsolve Carbon has been designed to meet the needs of specific groups of users. These are split into several categories: pharmaceutical and medicinal chemists, synthetic chemists, academics focused on organic chemistry education and researchers working on the structure elucidation of organic molecules. To meet the requirements of these users, Magritek has produced a comprehensive list of features designed

to deliver cost-efficient benefits to all. Spinsolve Carbon offers users 1D 1H, 19F and 13C experiments that use standard 5 mm NMR tubes. 13C experiments include spectral editing with DEPT, 2D direct HETCOR experiment and 2D indirect experiments such as HMQC and HMBC. Users of Spinsolve systems have found them to be particularly convenient and robust to use. They have low running costs as no cryogens are required and are virtually maintenance-free. In laboratories where time to getting results is imperative, ease of operation makes it perfect for students and chemists who want immediate results. Not having to send samples away for analysis is a huge bonus. 13C NMR spectroscopy delivers more detail in its spectra than use of the more basic 1H nucleus. Carbon has a large chemical shift range of approximately

250 ppm and using composite pulse decoupling there is usually a single peak per carbon atom in the molecule making carbon spectra much more informative than proton spectra. Furthermore, multinuclear and multidimensional experiments reveal additional structural information such as how carbon and proton atoms in the molecule are connected. This enables NMR to easily resolve isomers that are often confused with other analytical methods. Intuitive software aids the simplicity of Spinsolve Carbon. Simple, one-button operation with minimal user-controlled parameters coupled to an intuitive graphical interface makes the system easy to operate by anyone from students to research chemists. For reaction monitoring applications, the system may be automated and integrates closely with MNova data processing software from Mestrelab. The

traditional NMR complexities are hidden and automated, which make using a Spinsolve a quick learning experience while delivering research-grade results. Magritek +64 4 920 7671 andrew.coy@magritek.com www.magritek.com

Wyatt Technology Launches SEC-MALS Detector at Pittcon At Pittcon, 2–6 March 2014, McCormick Place, Chicago, Illanois, US, Wyatt Technology will be launching the µDAWN — claimed to be the world’s first multi-angle light scattering (MALS) detector that can be coupled to any UHPLC system in order to determine absolute molecular weights and sizes of polymers, peptides and proteins or other biopolymers directly, without resorting to column calibration or reference standards. Wyatt Technology’s µDAWN connects to the Optilab UT-rEX, reportedly the first refractive index detector for UHPLC. According to the company, refractive index detection is a critical component of any UHPLC-SEC-MALS system, so

the µDAWN plus UT-rEX equals a winning combination that transfers the many benefits of SEC-MALS analysis to the realm of UHPLC for the very first time. In order to accommodate the narrow peaks produced by UHPLC separation, Wyatt Technology’s µDAWN engineers reduced the conventional light scattering flow cell volume from 63 to fewer than 10 µl. More importantly, a remarkable improvement was achieved in minimising interdetector mixing; the band broadening between the µDAWN MALS and Optilab UT-rEX detectors was brought to under 7 µl, while the band broadening between the UHPLC’s UV detector and the µDAWN detector is a

mere 2 µl. As a consequence of the reduced cell volume and interdetector band broadening, a µDAWN/UT-rEX system can accurately analyse the molar mass and size of UHPLC peaks without loss of resolution. Reduction in the cell volume of a MALS system can create significant technical difficulties owing to the increased proximity of the laser beam to cell/sample interfaces. This closeness leads to higher levels of stray light that can compromise instrument sensitivity. Developments in the µDAWN’s detection optics and mechano-optical train not only maintain the sensitivity level but actually exceed that of Wyatt’s popular miniDAWN TREOS MALS detector.

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Further expanding the versatility of the µDAWN is the WyattQELS dynamic light scattering (DLS) module. This embedded accessory measures DLS in the µDAWN flow cell simultaneously with MALS acquisition, computing hydrodynamic radii on-the-fly. And finally, the µDAWN user experience is augmented by its colour touchscreen front panel display, which shows the chromatographic conditions, instrument diagnostics and much more. Wyatt Technology Corporation +1 805 681 9009 info@wyatt.com www.wyatt.com

Industry News

NPL and GSK to Provide Label-Free Imaging System for Intracellular Drug Measurement The National Physical Laboratory (NPL), working with major pharmaceutical company GlaxoSmithKline (GSK), has initiated a project called 3D nanoSIMS to develop a label-free molecular imaging instrument with reportedly unmatched spatial resolution, capable of measuring the intracellular drug distribution. At present, imaging techniques cannot image beyond micron resolution without adding special chemical labels to the drug molecule. Unfortunately, these labels can significantly affect the drug’s behaviour, giving too much uncertainty in the image. This project aims to provide label-free molecular imaging in 3D through enhancing imaging sensitivity by 100 times and increasing the spatial resolution to 50 nm. Currently, one of the major challenges to the pharmaceutical industry is the measurement of the intracellular drug concentration. This powerful new instrument could help identify where drugs go at the cellular level, even within specific organelles, answering longstanding questions about whether drug concentration is sufficiently high in the right places to have a therapeutic effect or if the medicine is lodging within

cellular components and causing toxicity. If anomalies were spotted earlier, it might help to explain toxicities or lack of efficacy of a medicine and reduce costly late-stage failures. The new instrument will be based at The UK’s National Centre of Excellence in Mass Spectrometry Imaging (NiCEMSI), established by NPL and the University of Nottingham. Professor Ian Gilmore from NPL said: “This project represents significant EU and UK investment in the UK’s already thriving life sciences sector and emphasises NPL’s expertise in this field. There is no technology in the world at the moment that can achieve what this project aims to do. The new instrument will provide an unprecedented understanding of how different drugs work within cells, helping to assess the efficiency of current drugs and develop better ones in the future.” Sir Colin Dollery, Adviser to the Chairman of Research and Development and on the Global Safety Board at GSK, said: “GlaxoSmithKline scientists are looking forward to the opportunities the new equipment will provide to explore in detail the sites of action of novel drug

molecules within single cells. Designing drugs that are specific for molecular targets is part of drug development, but knowing that they reach their target molecule in the right amount, at the right place and in the right cells is only just beginning to be attainable in intact cells within tissues. This ability will be a NPL’s secondary ion mass spectrometer being used to image the great opportunity.” distribution of a pharmaceutical compound in tissue. The project will receive over £4.5 million of funding from Professor Luke Hanley, Professor and the Strategic Capability Programme of Chemistry Department Head, University the National Measurement System of the of Illinois at Chicago. ION-TOF will build UK Government’s Department of the new instrument that incorporates the Business, Innovation and Skills. powerful Thermo Scientific Orbitrap The project brings together ION-TOF, a mass analyser for high-performance leading manufacturer of mass identification of substances. spectrometers for imaging, with Professors Morgan Alexander, Martyn National Physical Laboratory Davies and Clive Roberts, University of +44 20 8977 3222 Nottingham School of Pharmacy, and www.npl.co.uk

INFORS HT Announces Dedicated US Offices with Lab Savvy Staff Producer of shakers, bioreactors and bioprocess control software INFORS HT has opened new offices in the US. Until now, INFORS HT has been represented in the US by ATR (Appropriate Technical Resources Inc.). From 1 January 2014, INFORS HT took over this part of the ATR business, including its infrastructure, existing customer relations and full complement of staff. In order to guarantee a seamless continuity of service to customers, all sales and service offices as well as production teams remain unchanged, as does any current contact personnel. By increasing its presence in the US,

INFORS HT will not only expand its customer base but give its customers direct day-to-day contact with INFORS HT representatives and no longer via a third party. Marcel Brauchli, CEO of INFORS HT, pointed out: “We’re proud of our new branches and look forward to having direct contact with our customers in the US. We’re convinced that in this way, we can improve customer relations and build more successful long term partnerships.” This new direct contact will also bring about an added value to customers. They will have access to a committed team with a wealth of

experience, technical know-how and innovative thinking. The new CEO of Infors USA Inc., Simon Egli, holds a master degree in biotechnology engineering from the University of Waedenswil, Switzerland. Before joining INFORS HT at the headquarters in Switzerland, he worked in various bioprocess production and validation positions at management level. He has been with INFORS HT for three years. Infors USA Inc. +1 301 362 3710 infors.usa@infors-ht.com www.infors-ht.us

Simon Egli, CEO, Infors USA Inc.

Priorclave Appoints Scientific Equipment Dealer to Spearhead Ireland Growth Autoclave specialist Priorclave has appointed Brennan & Company as its southern Ireland agent with responsibility for sales of its complete range of laboratory autoclaves. Lee Oakley, Sales Director of Priorclave, is delighted with the new appointment since Brennan & Company is wellestablished in Ireland as a major supplier of highly specialised technological equipment to the scientific, medical and industrial markets, commenting: “I am convinced this is the right partnership, as our steam steriliser range complements their current product range and their knowledge level extremely well.” The standard Priorclave autoclave

range has evolved over many years to an extremely high standard, offering laboratories a wide choice in design style of front and top loading machines, double-ended and power-door models, cylindrical or rectangular chambers in sizes from 40 to 700 l and a choice of electrical, direct steam or for operation from an external steam source. Laboratories have come to rely on Priorclave delivering exactly what is required to reliably undertake their sterilisation task. Talking about the appointment, Gregory Brennan, Managing Director of Brennan & Company, said: “The association with Priorclave could not be a better fit for our Scientific division.

Apart from an excellent product range that is manufactured to the highest standards, we have the benefit of being able to offer our customers autoclaves that match their brief exactly since Priorclave can adapt or produce special builds. In addition, our customers can have cost-effective systems of the highest quality that are designed for their laboratories and they will not be paying for extra system facilities that are not required.” The principal strength of Brennan & Company lies in the quality of its people, highly trained specialists who thoroughly understand the detailed needs of customers, people who put efficient customer service before everything else.

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Senior members of Brennan & Company — John Wilson, Field Service Manager, Greg Brennan, Managing Director, and Michael Ensor, Product Manager. Priorclave Ltd +44 20 8316 6620 sales@priorclave.co.uk www.priorclave.co.uk

INGREDIENTS & CONTRACT SERVICES

SCM Pharma Strengthens Sterile Manufacturing Presence in US UK-based SCM Pharma has bolstered its North American profile with the appointment of a US-based Business Development Manager. Derek Richards will oversee the CDMO’s business development activities across the territory and will be responsible for growing its overall US footprint. Previously of Aptuit, Novartis and Schering Plough, Richards brings an impressive track record in sterile fill finish and formulation development to his new role. The move comes just weeks after SCM Pharma’s UK-based clinical development and manufacturing facility was approved at the first attempt by the FDA. The inspection was triggered by the company supporting British specialist healthcare company BTG in preparation for the commercial launch of Varithena (polidocanol injectable foam), after providing clinical development consultancy for the product for several years. Dianne Sharp, Managing Director at SCM Pharma, said: “The minute we knew the FDA were due to inspect our clinical headquarters in Prudhoe, we recognised the need to strengthen our US presence as the approval will no doubt trigger more demand for our small-scale clinical and contract manufacturing services in North America. “As soon as Derek came on our radar, we knew he was the ideal person for this role. His experience and expertise in the

sterile and clinical manufacturing area is a perfect fit for our business and his energy will help us realise our ambitions to expand our client-base in the US. “We already work with big pharma and charitable organisations in the US on clinical development projects and we expect our low-volume ampoule and vial filling services will be of interest to many companies looking to run trials or supply products in Europe.” SCM Pharma already works with several companies in the US and has built its reputation around the sterile filling of novel products, difficult processes and applications and dangerous substances such as potent products requiring high containment. An experienced commercial executive, Richards has worked across the pharmaceutical sector for around 20 years and will head-up the CDMO’s US sales operations from the East Coast. He said: “I first became aware of SCM Pharma from conversations at a Parenteral Drug Association meeting and began to hear more about their capabilities and expertise in the sterile filling area. I was immediately attracted to the company as it has a real entrepreneurial spirit and can do attitude culture backed up by industry leading technical expertise and strong quality systems. “My aim is to bring US pharmaceutical and biotech firms to this highly flexible UK-based contract manufacturer that

Derek Richards at SCM Pharma. over delivers on its commitments. I am very excited to be an integral part of SCM’s US growth strategy and look forward to helping the business meet its commercial objectives.” SCM Pharma’s FDA approval topped off a milestone year for the company after gaining an MHRA license for its new commercial manufacturing facility last summer, which complements its clinical manufacturing facility nearby. Independently-owned, most of its clients’ projects involve the aseptic filling and terminal sterilisation of liquids and powders into vials, ampoules and syringes. SCM Pharma Ltd +44 1661 833 693 info@scmpharma.com www.scmpharma.com

Patheon Expands Solid Dose Offerings and Capacity at UK Facility CDMO Patheon is increasing capabilities at its European sites. The latest investments are being made at the company’s Milton Park, UK, facility. This standalone early development centre will now offer automated capsule filling, instrumented tablet compression and tablet coating capabilities as well as increased manufacturing capacity. These upgrades will include DOE and QbD enabled equipment and expansion of time-saving disposable technologies to include tabletting. The Milton Park facility will now have the capability to manufacture supplies for up to Phase IIb studies with seamless transfers to Patheon’s recently upgraded Bourgoin, France, site for later stage clinical trials on compatible, scalable

equipment. Milton Park will also now offer a wider range of dose forms: capsules, oral liquids, suspensions, tablets, microtablets and multiparticulates as well as controlled-release coating technologies. This is in addition to established capabilities in high potency API handling, manual filling of up to approximately 10,000 capsules per batch and the Quick to Clinic service offering for rapid results in early stage projects. “This latest investment in Milton Park will enhance our flexible early development offerings with a wider range of dosage forms, technologies and capacity, all from one purpose-built facility,” said Jon Sutch, Ph.D., Manager of Formulation and Clinical Trials Manufacture, based at Patheon’s Milton

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Park facility. “It positions Patheon as Europe’s strategic partner of choice for oral dose early development.” Patheon Inc. +1 919 226 3200 media@patheon.com www.patheon.com

INGREDIENTS & CONTRACT SERVICES ROUNDUP Inhalation Capsule Filling Machine Fills Market Gap

Onyx Reports Surge of Interest in Solid-State Capabilities

Hovione has announced the expansion of its inhalation drug product development services with the introduction of a high-precision MG2 FlexaLAB capsule filling machine. This investment is in response to market demand for high-precision, capsule filling services for inhaled products and is the last step in Hovione’s plan to offer development services in all quadrants of inhalation projects, from API to formulation to powder inhalers to final unit dose. This investment intends to support Phase II to Phase III clinical trials to Hovione’s business partners. Peter Villax, Vice President, said: “We give our customers an edge in inhalation capsule filling for drug delivery to the lung by providing access to a machine capable of very high precision filling of low doses down to 5 mg. We are perhaps the only independent company with expertise in every aspect of the inhaled drug development process and this acquisition strengthens our commitment to inhalation drug development.” Hovione is currently executing inhaled drug development projects for a number of pharmaceutical companies, involving API process development, particle engineering, formulation development and clinical supplies. Capable of filling up to 3,000 capsules per hour, the FlexaLAB is the first MG2 equipment fitted with the MultiNET system, which allows 100% net weight

UK-based chemistry specialist Onyx Scientific has unveiled a huge increase in demand for its solid-state chemistry services versus last year. The contract research and manufacturing organisation has reported a 45% uplift in solid formulation related revenues, which is being driven by early stage drug development projects. The company’s close alliance with Molecular Profiles, announced last year, has also led to more work as a result of increasing activity in the biotechnology and early stage clinical sector. Denise Bowser, Commercial Director at Onyx Scientific, said: “Over the past few years, we have proudly become a real specialist in solid-state chemistry, focused on providing detailed investigation to cut lead times for clients and ensure processes are scalable. “As many drugs are formulated in solid dosage form, the need to understand, control and characterise the individual forms of a substance, in particular the polymorphic form, is vital. This is why we feel we have seen such an increased demand.” In 2013, the company worked with pharmaceutical and biotech clients across the globe, assisting with integrated chemistry, process development and custom synthesis projects. With MHRA and FDA facilities in the UK and India, Onyx Scientific assists

unit verification for increased precision and suitable internal process controls for supporting inhalation development activities. Gonçalo Andrade, Business Development Manager, said: “Hovione has a proven track record in the field of inhalation product development. With our core API process development, particle engineering and manufacturing expertise, we produce pulmonary delivery-friendly particles that can then be used to fill inhalation capsules. The acquisition of the MG2 FlexaLAB unit allows Hovione to support capsule filling activities in all stages of clinical development and even low-volume commercial manufacturing of inhalation drug products. Customers can now partner with Hovione for full service inhalation drug development manufacturing, all under one roof.” Hovione +351 219 847 619 gandrade@hovione.com www.hovione.com

Denise Bowser, Commercial Director at Onyx Scientific. companies from medicinal chemistry and preclinical through Phase I-III, scaling up to large-scale commercial API production. Onyx Scientific’s UK-based laboratories deal with complex chemistry to deliver early stage programmes, enabling the company to scale up, tech transfer and increase project efficiency using its commercial manufacturing sites in India. Onyx Scientific Ltd +1 908 412 6561 www.onyxipca.com / www.twitter.com/onyxscientific1

Avantor Performance Materials Recognises VWR International in Certified Excipient Distributor Programme Global manufacturer of performance materials and chemicals Avantor Performance Materials has added several VWR International, LLC locations in North America to its Certified Excipient Distributor (CED) programme for 2014. VWR is a global solutions provider of laboratory supplies, equipment and services, with worldwide sales in excess of $4.1 billion in 2012. The company is a long-time distributor of Avantor products, including J.T.Baker and Macron Fine Chemicals brand products used in pharmaceutical production, laboratory testing and electronics manufacturing. The certified VWR sites are located in the Pacific Northwest, West Coast and Puerto Rico, as well as in the Atlanta, Boston, Chicago and Philadelphia metro areas. Launched in 2008, Avantor’s CED programme is a strategic partnership between Avantor and select chemical distributors to provide pharmaceutical

manufacturing customers with a trusted supply chain that complies with global industry best practices. All qualified sites in the programme follow rigorous quality standards and have successfully completed a comprehensive audit conducted by Avantor’s quality department to show that they adhere to the International Pharmaceutical Excipients Council’s (IPEC) GDPs. The combination of the distributor’s certified IPEC GDP compliance and Avantor’s own compliance with current cGMPs ensures that Avantor products have a documented chain of custody and meet stringent quality standards. “We are pleased to include these VWR locations in our Certified Excipient Distributor programme for 2014,” said Paul Smaltz, Executive Vice President of Pharmaceuticals for Avantor. “This certification demonstrates our mutual commitment to deliver maximum value

Avantor has added several VWR International, LLC locations in North America to its Certified Excipient Distributor programme, including facilities in Visalia, California (pictured), Tualatin, Oregon, and Manati, Puerto Rico. to pharmaceutical customers while mitigating risk and ensuring their business continuity.” “We are pleased to now have a total of seven locations receive this distinguished certification,” shared Mark McLoughlin, SVP and President of VWR’s US Lab Business. “By receiving this certification, we are decreasing complexity while enhancing supply chain security for our customers in the pharmaceutical and biotechnology industries.” Avantor Performance Materials, Inc. +1 610 573 2661 allison.hosak@avantormaterials.com avantormaterials.com

Top CMO Executive Joins Novasep as President of Synthesis Business Unit Supplier of manufacturing solutions to the life sciences industry Novasep has appointed Thierry van Nieuwenhove as President of the Synthesis business unit. Van Nieuwenhove’s arrival completes Novasep’s executive committee. With its full executive committee (COMEX) now on board, Novasep achieves another key milestone in its strategic development. Educated as a bio-engineer, Van Nieuwenhove holds a masters degree in chemistry and biochemistry from the Catholic University of Louvain, Belgium. He joins Novasep from AjinomotoOmnichem, a European synthetic

molecules CMO owned by a top Japanese firm, where he held consecutive positions as Director, then General Manager and Member of the Board. His skill set includes driving business unit growth, leading global teams, including sales and business development, R&D, supply chain and purchasing, as well as mergers and acquisitions. “We are thrilled to welcome Thierry to Novasep as President of the Synthesis Business Unit,” said Michel Spagnol, CEO of Novasep. “His broad experience in driving multicultural custom synthesis businesses will complement our COMEX

skills perfectly. Thierry possesses the dynamics to boost Novasep’s CMO business in all our key markets.” “I am very pleased to join Novasep,” said Thierry Van Nieuwenhove. “With its unique pool of specialised technologies and talents, Novasep is well positioned for growth as a top tier service provider for the life sciences industry. The group as a whole has tremendous opportunities to develop. Really innovative solutions can come out from the cross-fertilisation of its several specialised technologies and application markets that will build future Novasep expertise. I am excited to be part of it.”

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

INGREDIENTS & CONTRACT SERVICES ROUNDUP Penn Pharma Celebrates Three Accident-Free Years Pharmaceutical manufacturer Penn Pharma has reached a significant safety milestone this month, operating for three years without experiencing a reportable accident at its facility in Gwent, South Wales, UK. The new contained manufacturing facility, which opened in September last year, and the original facility have both been operating safely for a length of time that equates to 1.75 million hours worked by c.300 staff. Penn Pharma Chief Operating Officer Mark Dean-Netscher said: “With a background £18 million expansion programme and significant construction activity on site, this is a fantastic achievement on our continued journey for operational excellence at Penn. “We have superb engagement from all of our staff with a very active near miss system and safety-focussed culture in place. Our safety record ranks with the best in the pharmaceutical sector. It shows that Penn applies the same importance to the safety of our staff as we do to the safety of the medicines we supply to patients worldwide.”

BASF Receives EXCiPACT Certification as Pharma Excipient Supplier

Adding to this achievement is Penn Pharma’s retention of its accreditation to the ISO14001 standard for environmental management. This followed an intensive two-day audit by its certification body and was achieved within three days of reaching the threeyear safety milestone. Dean-Netscher concluded: “Penn Pharma is proud of its EHS performance and is committed to achieving further success in the future.” Penn Pharma delivers integrated drug development, clinical trial supply and manufacturing services to the international healthcare industry. Penn Pharma Ltd +44 1495 711 222 www.pennpharm.co.uk

BASF has received the EXCiPACT certificate for pharmaceutical excipients for the group of polyvinylpyrrolidone (Kollidon) polymers, produced in Ludwigshafen, Germany. The certificate was issued by mdc medical device certification GmbH — one of EXCiPACT’s internationally-recognised certification bodies. The certification demonstrates that BASF manufactures and distributes pharmaceutical excipients according to the EXCiPACT GMPs. “With the certificate, we confirm that our customers only get the highest quality excipients,” said Franҫois Scheffler, Vice President Global Marketing at BASF Pharma Ingredients & Services business unit. “With our Kollidon portfolio, we ensure to achieve the highest regulatory, quality and safety standards.” BASF will conduct recertification audits every three years, plus annual surveillance audits to ensure the continued safety and quality of excipients. The EXCiPACT scheme can be made available when the regulators in the EU and US require the holder of the marketing authorisation for medicines to ensure that appropriate GMP and GDP is applied to the manufacture and distribution of both APIs and excipients. The FDA and the EMA continue to require drug producers to qualify their excipient suppliers appropriately and, as a result, the suppliers must be prepared

to receive increasing numbers of audits from their customers. EXCiPACT helps to avoid additional audits in a cost-effective manner for all parties concerned because one single audit will be all it takes to prove an excipient complies with current GMP and GDP requirements. “BASF is the third company that has been certified by EXCiPACT,” said Dr. Iain Moore, Chairman of the EXCiPACT Association’s Global Steering Committee. “With the certificate, we minimise risks for customers and help ensure patient safety while reducing costs.” BASF SE +49 621 60 48978 nina.osten@basf.com www.basf.com EXCiPACT +32 2 736 53 54 info@excipact.org www.excipact.org

ADVERTORIAL

CELEBRATING 40 YEARS OF EXCELLENCE IN ANALYTICAL CHEMISTRY Butterworth Laboratories is celebrating 40 years as a fully independent, contract analytical chemistry laboratory, delivering cost effective, timely and reliable services since incorporation in 1974. Clients can trust us to provide the right outsourcing solution for Quality Control Testing, Method Development & Validation and Stability Study Storage & Testing. Quality Control Testing Outsourcing quality control (QC) testing of raw materials, active pharmaceutical ingredients (API) and finished products can often prove to be a cost-effective option for many of our clients. Whether it’s lack of in-house facilities, cost of facility and equipment maintenance, meeting high workloads and short deadlines or

simply to provide independent certification, we are able to help. Our staff are experienced in the use of pharmacopoeial monographs, internationally published standards, client supplied or in-house developed methods. The use of the classical techniques of titrimetric, gravimetric and colorimetric analysis remain a core competency requirement for all laboratory staff as we believe the discipline of performing these techniques is the foundation of a good analytical chemist. To compliment these classical techniques we have a wide range of analytical instruments, which are all maintained and qualified to GMP standards. We are regularly investing in new, state-of-the-art instrumentation to ensure the laboratory maintains its ability to provide the most up-to-date and cost effective analytical services. Method Development and Validation With our wealth of experience in QC testing we are able to bring together, both expert understanding of the technique employed and the practical working

knowledge of our analysts to ensure successful method development robust enough for quality control purposes. Following development of a method, it is vital that its performance is fully validated. Unless the client specifies otherwise, we validate methods to ICH guidelines as required by most regulatory authorities. Performing analysis in parallel with our clients on method validation enables projects to be delivered in shorter time frames, with the additional benefit of increased robustness and ruggedness. Stability Study Storage and Testing The nature of stability studies makes them ideally suited to outsourcing. We provide assistance in the design of standard real time studies, stress testing over short periods at elevated temperatures, and photostability studies, all of which need to be in compliance with ICH guidelines. Butterworth are able to handle storage of samples as well as the associated analysis or alternatively perform testing on samples that have been stored at the client’s own facilities. Customer Focus We believe that the best way to meet your needs in ever-changing environments is to understand your business, and the key to this and to delivering a successful analytical service is good communication. We value meetings with our clients to discuss their current and future requirements, and you will always be able

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to speak directly to the analyst performing your tests. Our Commitment to Quality Routine inspections by regulatory and accreditation authorities, MHRA, FDA and UKAS to, GMP, GLP and ISO 17025, highlights our commitment to meet the requirements of the highly regulated pharmaceutical and related industries. This commitment underpins our core values of quality, reliability and confidentiality in analytical chemistry outsourcing. Introductory Offer To mark our 40th anniversary, and demonstrate the quality of service we offer, new customers can take advantage of a 40% discount on their first analysis*. Contact details John Welch – Head of Business Operations Daniel Morland – Marketing and Business Development Manager Email: marketing@butterworth-labs.co.uk Butterworth Laboratories 54-56 Waldegrave Road, Teddington, Greater London, TW11 8NY, UK. Tel: +44 (0)20 8977 0750 Fax: +44 (0)20 8943 2624 www.butterworth-labs.co.uk *Terms and Conditions apply, please contact us for details.

ARTICLE What Pharma Companies are Doing to Avoid Another Cliffhanger ABOUT THE AUTHOR: Haydn Evans is Vice President of Intellectual Property Solutions at CPA Global, one of the world’s leading providers of IP management software and services. Haydn works with a range of clients in sectors such as technology, telecommunications, electronics, chemical, pharmaceuticals and biotechnology. Clients include multinational corporations and smaller technology organisations as well as law firms. Evans can be contacted at hevans@cpaglobal.com. The next two years will be another challenging period for the pharmaceutical industry. Many of the bigger pharma companies will continue to weather the storm of patent expirations on major products, whilst simultaneously attempting to restructure their businesses for a more sustainable future. An over-reliance on a small number of high-volume blockbuster products has left major pharma companies on the edge of a steadily eroding ‘patent cliff’ as patents on these drugs have expired. It has been a harrowing experience, with massive fall-out in terms of lost revenue and the domino effect on research and development (R&D), business performance and jobs. Now, though, rather than ruefully staring down into the abyss, pharma companies are looking forward with more positive intent and seeking innovative ways to breach the chasm. The patent cliff has been an ongoing concern for the pharmaceutical industry for some years. The first major wave of patent expirations hit in 2012 and the next two years will see a continued flood of expirations on blockbuster drugs such as Abilify (schizophrenia treatment), Cymbalta (antidepressant) and Nexium

(stomach acid treatment). Products that earn a combined $170 billion (€125.5/£103 billion) are scheduled to go off-patent by the end of 20151. R&D investment and rethinks In an attempt to rebuild the conveyor belt of viable products, pharma companies have invested heavily in R&D. The industry has long been aware that a patent cliff was on the horizon, but it was believed that new products could be created with sufficient financial backing. However, despite investment of $1.1 trillion2, there is still a significant void in the pipelines of the major pharmaceutical producers. Furthermore, this increased investment has not correlated to an increase in new patent filings. In fact, nearly all of the major pharmaceutical players have been seeing a steady decrease in patent activity — a worrying trend, given the importance of patents to the pharma industry in terms of protecting their innovation and safeguarding their investment. It is also another sign that R&D is faltering and not currently able to meet the expectations and demands of the pharma industry. This has led to a reappraisal of R&D strategy and processes. Rather than focusing upon a small number of products distributed in enormous volumes, pharma companies are, in many cases, considering a more diverse portfolio of smaller volume, specialty drugs. Research has predicted the launch of up to 37 new molecular entities (NMEs) per year in 2014 and 2015, compared with 25 in 20103. This can be seen as recognition that the blockbuster strategy is failing but also as a positive move towards building a more sustainable drug pipeline and revenue stream. Patent filing strategies In addition to entirely new products, the pharma industry is also re-evaluating existing products and exploring ways to extend the commercial life of mature brands. There are multiple methods of achieving this, but the core aim remains consistent: to sufficiently improve a mature product such that it overcomes a consumer’s inclination to choose a less expensive generic. Improvements can manifest themselves as better formulations to mitigate side effects, combining two or more drugs and marketing them as one product or

producing modified release formulations to better serve the needs of the target market4. A successful example of the latter is angina-treatment drug Procardia XL. By improving the casing of the original Procardia, Pfizer was able to administer the medication at a constant rate and negate the requirement for taking three separate pills daily. Innovations in improving, reformulating or combining existing products can be protected by patent filings to exclude the same modifications in generic drugs. Therefore, it is reasonable to assume that as pharma companies pursue such product enhancement strategies more aggressively, this will lead to an increase in such modifying patents. Acquisition Even so, recognising that however flexible their internal R&D is, they will not have exclusivity on innovation and ideas, many cash rich pharmas are gaining access to technology through collaboration with technology partners in revenue sharing agreements, often leading to direct investment and acquisition. Indeed, acquisitions of smaller producers have become more and more commonplace in the pharmaceutical industry in recent years. Prior to the first major wave of patent expirations in 2012, M&A activity in the pharmaceutical industry hit record levels. These moves were seen as an attempt by pharma companies to fill their short-term revenue gaps but, in many cases, it also demonstrated a shift to a more open and collaborative innovation strategy. Smaller companies that are developing medicines in Phase II or Phase III trials are a prime target for the big players, although demand is greater than supply in this arena. This perhaps helps explain why the typical takeover premium of biotech firms alone in 2012 was nearly double that of the average across other industries5. Diversification — alternative therapies, medical instruments Diversification has provided the opportunity for pharma companies to mitigate some of the losses of patent expiries. Investment in biotech, medical devices and consumer goods can provide alternative revenue streams and possibly more predictable and sustainable ones. Medical instruments and consumer goods generally have a much shorter product lifecycle than pharmaceuticals, allowing for more agile

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development and faster, perhaps more predictable, innovations. New markets As well as a focus on alternative products, the pharma industry has also turned towards alternative markets. The US remains the largest global market for pharmaceutical products and is predicted to consume 31% of total production in 2016. However, this is a significant fall from 2006, when it was responsible for 41%. This shift can be attributed to developing economies, which could make up 30% of the world market for pharmaceuticals by 20166. With this in mind, emerging markets are a priority target for expansion. The rapidly expanding BRIC (Brazil, Russia, India and China) and MINT (Mexico, Indonesia, Nigeria and Turkey) economies experience issues with counterfeit medicines, and many consumers are willing to pay more for a branded product, with the perception of quality and legitimacy that these encapsulate. Novartis CEO Joseph Jimenez has long believed such a strategy could mitigate the sharp fall in sales expected when certain products go off-patent. As Jimenez told PM Live in 2011: “We are already achieving strong growth in emerging markets and continue to expand our presence in these markets7.” In many ways, the wave of patent expirations coming in 2015 may have less dramatic repercussions than 2012. Large pharma companies now have experience of these market-changing dynamics, and many of the major structural and organisational changes have already taken place; although the scale and degree of these changes may escalate. The fact remains that the requirement for alternative approaches to pharmaceutical development and production remains critical, and the search for a viable model continues. So, while those who are involved in or following this ongoing saga find themselves deeply engrossed in a classic cliff-hanger, unsure of the next twist in the tale, the opportunity is there for pharma companies to script a happier ending — an ending that will benefit the companies, their shareholders and the millions of people around the world who rely on the industry’s research, innovation and product development to find lifechanging remedies and cures. References 1IMS Institute for Healthcare Informatics: The Global Use of Medicines: Outlook Through 2016 (Online: 2012). 2EvaluatePharma: World Preview 2018 (Online: 2012). 3The Scientist: Opinion: Parachuting Off the Patent Cliff (Online: 6 December 2012). 4PharmTech: Can Pharma Defy Gravity at the Patent Cliff? (Online, 11 December 2013). 5InvestmentU: Patent Cliff Creates Huge M&A Demand in Little Pharma (Online, 20 January 2012). 6Casey Research: Is the Patent Cliff a Lethal Blow to Big Pharma? (Online, 23 May 2012). 7PM Live: Interview: Joseph Jimenez, Novartis (Online, 17 October 2011).

SHOWCASE ANALYTICAL & TESTING SERVICES

Eurofins Lancaster Laboratories and Celsis International Partner to Provide Rapid Micro Validation and Screening Services

Spinnovation Transfers Entire Operation to Support Activities Growth

Bio/pharmaceutical GMP product testing services provider Eurofins Lancaster Laboratories and rapid microbial detection systems supplier Celsis International have entered into a collaboration through which Eurofins Lancaster Laboratories will provide contract rapid microbiology validation and screening services for the Celsis rapid detection technology platform. The Celsis rapid detection system allows companies to ensure that their products meet microbial specification 60–80% faster than traditional methods. The decrease of as many as 7 to 10 days in production cycle times results in reduced inventories and working capital requirements in addition to providing earlier notification of microbial excursions when they occur. With 50 years of delivering outstanding testing services, Eurofins Lancaster Laboratories has a stellar reputation for excellence in service quality and data reliability, enjoys long-standing relationships with many Fortune 500 clients and is part of the largest network of harmonised bio/pharmaceutical GMP product testing laboratories worldwide. “We are pleased to have expanded our rapid technologies service offerings with the Celsis system in response to this

Specialist analytical services provider Spinnovation Analytical has announced the transfer of its entire operations to Pivot Park in Oss, the Netherlands. Since 2013, Spinnovation has collaborated with Pivot Park by supplying analytical services to life science companies based on the site. The new location has enabled Spinnovation to double the size of its facilities and support the growth of its business. Furthermore, this new location will facilitate the development of GMP compliant services and expand Spinnovation’s analytical capabilities. Spinnovation provides a range of analytical services for the pharmaceutical and biopharmaceutical industries. Having first opened laboratories and offices in Pivot Park in February 2013, Spinnovation has supported the park’s initiative for open access and exchange of knowledge by providing tenants at the site with access to advanced analytical technologies. Spinnovation offers NMR-based testing and profiling methods in addition to ESITOF MS, HPLC, LC-SPE and ICP-OES applications. Spinnovation Biologics also offers services for biologics upstream development, including Spedia-NMR for spent cell media analysis and SpediaPredict for troubleshooting bioprocessing issues.

industry need,” said Mark Kaiser, Director of Pharmaceutical Microbiology. “We have the Celsis system fully operational in both our US and Irish facilities, and both sites have initiated validation projects under contract. In addition to these, we anticipate that some of our current client base will move their routine microbiology testing to the Celsis method, accelerating product release.” Eurofins Lancaster Laboratories +1 717 656 2300 ext. 1368 lbamford@lancasterlabs.com www.lancasterlabspharm.com Celsis International Ltd +44 20 7152 4459 jwoolway@celsis.com www.celsis.com/pharma

Frederic Girard, CEO of Spinnovation Analytical, said: “We are very pleased with the success of our partnership with Pivot Park and we are thrilled to expand our presence here. With our larger facility, we can better cope with the growth of our services for our customers across Europe and the US, while securing access to industry leading analytical applications for park tenants. Transferring our facility will enable us to capitalise on our success in 2013, work towards GMP-compliant assays and testing capabilities and continue to develop and grow our innovative analytical services.” Spinnovation Analytical BV +31 24 240 3400 info@spinnovation-analytical.com www.spinnovation-analytical.com

Synergy Health Brings Additional Gamma Irradiation Capacity to Europe Synergy Health has announced that its newest gamma irradiation facility in Marcoule, France, will open for business in February. The site location is significant as it lies at the meeting point of three major European routes: east to Italy, west to Spain and north across the rest of the continent. It is also about 130 km from Marseille and the company’s existing facility, with fast transport links to France’s largest port. The installation consists of a commercial gamma irradiator and an experimental irradiator. Both the

commercial and experimental irradiators are in the same building and share some shielding walls. The commercial gamma irradiator has a maximum cobalt loading of 6 million Ci treatment per pallet (dimensions: 1 x 1.2 x 1.95 m; maximum weight: 1,000 kg), maximum capacity of approximately 100,000 pallets per year, conveyer system with slave pallets and an automatic high-bay (18 m) warehouse. The experimental irradiator, with a maximum capacity of 1 million Ci, is in a spider-like configuration that consists of 60 turntables, which can be positioned at

samples at accurate and constant dose rates, achieving uniform irradiation over relatively large physical dimensions. This facility allows Synergy Health’s microbiology laboratories to treat R&D samples, units for ISO11137 dose audits and maximum dose trails, perform studies on other high-performance materials and for material synthesis.

different distances and heights from the radioactive cobalt-60 source. The turntables make it possible to hold

Synergy Health plc +33 4 66 90 39 40 marcoule@synergyhealthplc.com www.synergyhealthplc.com

Contract Microbiology Lab Tests Wide Range of Products for European and International Markets Wickham Laboratories is an independent contract analytical testing microbiology laboratory based in Gosport, UK. Conducting business with clientele from around the globe, Wickham Laboratories has been serving the pharmaceutical, medical device and allied industries for over 50 years constantly, investing in people and new technology. Central to the success of Wickham Laboratories is its total commitment to providing a quality service, combining high levels of client satisfaction together with the maintenance of appropriate accreditations. The company’s facility is GLP and GMP compliant, regularly

audited by the MHRA and FDA and routinely inspected by customers. Wickham Laboratories undertakes microbiological testing for the pharmaceutical industry, carrying out analysis of a wide variety of pharmaceutical products for batch release into European and international markets. The Microbiology departments have extensive expertise in the testing of different pharmaceutical dosage forms. Using clients’ own methods or standard procedures in house, the department provides services in microbial examination of non-sterile products, efficacy of preservatives, sterility testing and bacterial endotoxin testing. Validation

and project work may be performed to a protocol and the findings detailed in a GMP report. Routine analysis is typically reported on a certificate of analysis. In addition to laboratory services, Wickham Laboratories offers support and consultancy applicable to a range of pharmaceutical manufacturing concerns. These include advice, risk assessment and monitoring for cleanrooms, water systems and microbiological issues concerning production troubleshooting. Long-standing experience in the contract microbiology testing industry means that there is rarely a problem that has not been previously encountered by the team.

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

Events

Programme and Speakers for HPAPI World Congress Revealed According to business event organiser Terrapinn, the European high potency API market revenue is expected to reach $38 billion (€28/£23 billion) by 2017 and Germany is the largest single market for high potency APIs in Europe, making it a wise decision to attend the HPAPI World Congress, Hotel Sofitel Munich Bayerpost, Munich, Germany, 26–27 February 2014, dedicated to process enhancement, technological innovation and business development and comprising an exhibition, a clinic-based conference and technical roundtables. Participate in two jam-packed days covering new insights into classification,

safety and risk reduction, handling and containment, facility design and advanced technologies, plus much more. Reasons to attend include: • gaining the latest on industry practices and approaches to standardise compound classification and mutual recognition • exploring how leading solution providers are navigating OEL establishment and classification hurdles • uncovering the most effective risk-based assessment approaches to new potent compound safety programmes • determining the most effective means of ensuring highly potent compound handling

• understanding the right level of process containment and best practice to avoid cross contamination and exposure • joining intimate roundtables to gain real practical advice and experience on overcoming the key challenges facing the industry right now • exploring a solution provider exhibition with over 25 innovative companies that will help advance production and manufacture • gaining access to the congress attendees via the Total BioPharma 1–2–1 Partnering System, which allows attendees to set up pre-qualified business

development meetings with potential clients. Download the brochure at www.terrapinn.com/conference/hpapi to see the full programme and details of how to book. Terrapinn Ltd +44 207 092 1186 megan.rumford@terrapinn.com www.terrapinn.com/conference/hpapi

AAMI Human Factors for Medical Devices Course Comes to Europe for First Time Technology and design consultancy Cambridge Design Partnership has arranged with the Association for the Advancement of Medical Instrumentation (AAMI) to bring its highly acclaimed Human Factors for Medical Devices course to Europe. The course delivers practical usability engineering techniques that can be implemented in any medical device development programme. Importantly, it gives insights into creating usability submissions for both the US and EU regulatory regimes. The AAMI course not only addresses usability engineering itself, it also looks at the growing harmonisation between global standards, streamlining device submissions. With new guidelines about to be enforced in the US, medical device companies worldwide need to be vigilant in understanding how to navigate these changing regulatory landscapes. If device development teams are not adequately trained in human factors processes and standards, safety critical

use errors may be uncovered during validation, resulting in costly and untimely programme delays. The course — which will be held on 1–3 April 2014, at Park Inn Conference Centre, Heathrow Airport, UK — is aimed at anyone involved in bringing medical devices to the market. Well-established in the US, Human Factors for Medical Devices has always been considered as essential training for integrating human factors into the product development process, with many European-based companies travelling to the US to attend. The course leaders are the highly regarded Dr. Ed Israelski who is the convener of international HF medical standards with IEC and ISO and Dr. Robert North, who is a co-author of the FDA human factors standards. In addition, this course is claimed to be the only event held in Europe where companies can talk directly with an FDA representative and benefit from their latest insight into streamlining

REGULATORY AFFAIRS Chetan Javia is ELC Group’s regulatory affairs THE BIOPHARMACEUTICAL expert in India. Javia is well-versed in every aspect of the submissions process, from the CLASSIFICATION development of a regulatory strategy to SYSTEM — IS IT providing regulatory and scientific advice on ACCEPTED? applications for Europe and ‘rest of the world’ countries. A qualified pharmacist, he has extensive experience in overseeing new and re-registration submissions in variety of international geographies, including the Middle East and Central America. The Biopharmaceutical Classification System (BCS), introduced in 1995, provides a framework for classifying the drug substance based on its aqueous solubility and intestinal permeability. It allows for the prediction of in-vivo pharmacokinetics of oral immediate-release drug products by classifying drug components based on their solubility related to dose and intestinal permeability, in combination

with the dissolution properties of the dosage form. The objectives of BCS are to: • improve the efficiency of the drug development and review process by recommending a strategy for identifying expendable clinical bioequivalence test • recommend a class of immediate release solid dosage forms for which bioequivalence may

submissions as well as common submission errors and deficiencies. “Minimising the possibility of user error through usability engineering and good design practice is a critical part of developing safe and effective new products,” explained Mike Cane, Founder, Cambridge Design Partnership. “We wanted to help make this course available to our healthcare clients and the wider medical device manufacturing community in Europe because we believe it is the best available.” Cambridge Design Partnership’s team of human factors specialists currently help clients develop successful new products by uncovering the insights and unmet needs that drive the front end of innovation as well as ensure that new products are designed to be enjoyable, inclusive, safe to use and meet regulatory requirements. Cambridge Design Partnership is working with Pure Insight, a leading provider of innovation resources and

be assessed based on in-vitro dissolution tests • recommend methods for classification accordingly to dosage form dissolution, along with solubilitypermeability characteristics of the drug product. At first, the BCS Biowaiver was only applied for secondary strengths, scaleup and post-approval changes, although recently the BCS Biowaiver principle has been extended for the approval of new generic drug products, thereby avoiding unnecessary human experiments and reducing time and cost involved in the development. The BCS Biowaiver for secondary strengths, scale-up and post-approval changes is widely accepted by almost all regulatory agencies, but the agencies’ position on granting generic approval solely on the basis of the BCS Biowaiver — i.e. without providing any in-vivo data — is variable. Regulatory submissions based only on the BCS waiver are possible only

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Mike Cane, Founder, Cambridge Design Partnership. information to development teams, to cohost the course. To find out more about the course and register online, visit www.medical-device-regulations.com. Cambridge Design Partnership LLP +44 1223 264428 info@cambridge-design.co.uk www.cambridge-design.co.uk

for Class I (high solubility and high permeability) and Class III (high solubility and low permeability) drug substances. When making such applications, discussion and consideration should be given to the similarity and differences in the excipients used in the generic formulation against the chosen reference product, the possible drug — including excipient — interaction and the effect of manufacturing process variables affecting drug bioavailability and/or solubility characteristics. The BCSbased waiver for exempting invivo study, although a risky approach, should be explored with the agency by seeking preChetan Javia submission chetan.javia@elcgroup.com scientific advice.

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