EPM Jan/Feb 2012

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IN THIS ISSUE: The Future of Tabletting

Containment

European Pharmaceutical Manufacturer

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January/February 2012

APIs

Volume 12 | Issue 01

Anti-Counterfeiting & Security

Front cover: Natoli’s Laser Vision System (LVS) inspection device automatically collects critical punch inspection measurements. Schedule a free webinar at natoli.com/LVS.html.

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A Happy — yet somewhat belated — New Year to you all and welcome to the first 2012 issue, which as usual is packed with a number of features that I hope you will find both informative and useful.

For the first time, we have included a Supplier Roundtable, entitled ‘The Future of Tabletting’, where the senior execs of tabletting equipment manufacturers have been consulted on how current industry trends — namely the expiry of blockbuster drug patents and increased generic and developing market competition — are placing new demands on their businesses and how efforts are being made to accommodate 12 these. You can find out what representatives of I Holland, IMA Kilian, GEA Pharma Systems, Fette Compacting, The Elizabeth Companies and Natoli Engineering Company had to say on page 14.

Also, in line with our Anti-Counterfeiting & Security Showcase, Paulo’s Regulatory Affairs Column on page 29 — entitled ‘Implementing Controls Against Falsified Medicines’ — highlights the ‘uncertainties’ surrounding the ‘precise implementation’ of Directive 2011/62/EU, aspects of which are subject to evaluation after a two-stage public consultation conducted in November and December 2011.

Finally, on page 31, Frances DeGrazio, Vice President, Marketing and Strategic Business Development at West Pharmaceutical Services, Inc., offers ‘Three Tips on 32 Packaging Selection for Parenteral Pharmaceutical Drug Manufacturers’, outlining the key factors to be considered in choosing packaging materials and the advantages that may be gained from involving a packaging specialist from the outset.

As always, I look forward to receiving your comments on the content of this issue and would be interested to learn of any ‘burning topics’ that you feel should be addressed in future 2012 issues.

ACHEMA Amixon Bachem Bibby Scientific Biopharma Dynamics Dales Pharmaceuticals Driam

Page 6 8 31 23 9 30 9

Elizabeth Carbide GEA Courtoy Honeywell Hosokawa Korsch Lyofal Müller

35 36 13 7 2 28 13

Natoli Optima Process Components Russell Finex Sartorius SVIAC

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James Cartwright, Global Granulation Leader, Particle Generation, Control & Engineering, GlaxoSmithKline James began working within the pharmaceutical industry in 1996.

During this time, he has been instrumental in developing and launching three products for various clinical indications spanning acute Otitis Media, Lymphatic Filiarisis and Type II Diabetes Mellitus.

James studied Chemistry and Chemical Engineering and is a Fellow of the Royal Society of Chemistry.

Dr. Dimitris Dogramatzis, RPh, PhD Dimitris is a registered pharmacist and pharmacologist, whose industry career encompasses medical affairs, marketing, country and regional management positions.

Dimitris has served as Regional VP — Northern Europe for SERONO and authored two textbooks entitled ‘Pharmaceutical Marketing: A Practical Guide’ (2001) and ‘Healthcare Biotechnology — A Practical Guide’ (2010).

Dr. Dave Doughty, Director of Process Understanding & Control, GlaxoSmithKline In his 30 plus years in the pharmaceutical industry, Dave has a superb track record in leading teams to develop and commercialise products. This is underpinned by his expert knowledge of the science and mechanistic principles of dosage form design and processing, including PAT, manufacturing operations and GMP. Dave has co-authored product and process patents. Product innovations include oral and transdermal dosage forms.

Process innovations include compression and coating of tablets and continuous manufacturing methods and associated PAT. Continuous processes include feeding, mixing, granulation, drying, coating and a novel method of manufacturing low-dose, high-potency drugs.

John Gamble, Senior Research Scientist, Bristol-Myers Squibb After graduating from the University of Salford in 1998 with a degree in Chemistry with Industrial Experience, John began his career in quality control analysis of parental vaccines, later moving on to physical analysis of inhaled drugs, before arriving at his current position as Senior Research Scientist within the Powder Properties Optimisation group at Bristol-Myers Squibb.

John has a keen interest in understanding the interrelationships between the physical properties of drugs and excipients and their subsequent behaviour during formulation and manufacturing.

Aidan Mc Nabola, Engineering Director, UCB Group, SCHWARZ PHARMA Ltd Aidan is Engineering Director at Schwarz Pharma Ltd, based in Shannon Co. Clare, Ireland, and is responsible for site infrastructure, engineering systems — including capital projects — utilities, IT and automation on site.

Aidan holds a B. Eng Degree in Mechanical Engineering and has more than 23 years experience in primary and secondary manufacturing in the pharmachem and medical device industries.

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ADVERTISERS’ INDEX Company

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.

1 10 11 12 11 12

Grégory Poujol, Manufacturing Maintenance Manager, Sanofi Grégory is an ‘Arts et Métiers’ engineer, working for the wellknown French pharmaceutical company Sanofi.

Grégory started working in one of the group’s injectable plants in 2003, before moving to a solid form plant as a Project Manager in 2004 to install new process equipment. He later moved to Spain and continues to lead new equipment installation projects at one of the group’s Spanish solid form plants and since 2009 has been in charge of process maintenance and improvements.

Grégory has experience of the most well-known providers of solid form equipment.

Kostas Saranteas, Senior Director, Process Chemistry and Engineering, Sunovion Pharmaceuticals Inc. Kostas is Senior Director of the Process Chemistry and Engineering Dept. at Sunovion’s R&D Division. He holds BS/MS/PhD degrees in Chemical Engineering and an MS degree in Environmental Engineering.

For 15 years, Kostas worked at Polaroid Corp., specialising in batch process equipment modelling, process optimisation and scale-up.

For 11 years, Kostas has been employed at Sunovion. He leads cross-functional teams, championing accelerated process development for drug substance and drug product synthesis from laboratory-scale to full-scale manufacturing.

MANUFACTURING PRODUCTS & EQUIPMENT

soundbyte

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EPM is a simple and reliable source that keeps me updated on the latest innovations from the main providers of pharma production equipment. In

particular, the Showcases are useful for getting a good overview of what these providers have to offer and ensuring that none are missed off the list when it comes to obtaining quotations and tenders.

Grégory Poujol, Manufacturing Maintenance Manager, Sanofi

Vacuum Drying at Low Energy Input with Gentle Mixing Operation Semi-finished and finished end-user pharmaceutical and chemical products are mostly produced through synthesis.

For reasons associated with thermodynamic characteristics, syntheses are usually carried out in the liquid phase. Solids originating from precipitation or evaporation first have to be dried mechanically and then thermally.

For the thermal process, suitable horizontal or vertical evaporative dryers are used. The energy required for drying is mainly provided through contact heat transfer, based on the following equation: Q = k * A * delta T. Q is the required quantity of heat in kJ, k is the heat transfer coefficient in W/m2K, A is the heat transfer area in m2 and delta T is the driving temperature gradient between the material being mixed and the thermal transfer medium.

Since evaporation of volatile fluids enforces a fluidised bed, the heat transfer is initially rapid and slows down

with increasing drying success. High temperature gradients can be avoided by mechanically influencing the material to be dried. In many cases, secondary drying with inert carrier gases is used.

This process is comparable with adsorption processes. amixon VMT and AMT type vacuum mixer-dryers have been tried and tested for this type of drying process. Very short drying times can be realised due to the nature of the mixing process as a result of mixing tool action. The vacuum mixer-dryer can be used for almost any type of suspensions or liquid components to be evaporated. Drying processes can be analysed using test equipment at amixon’s laboratory in Paderborn, where all relevant parameters are recorded in real-time. amixon GmbH +49 5251 688888 0 info@amixon.de www.amixon.com

Videoconferencing for Custom Pharma Leak Detection Systems Pharmaceutical processors and packagers seeking best match leak test solutions can now rely on Uson’s no-cost videoconferencing consultations to facilitate discussions and visual inspection of leak-proof vials, ampoules, packaging and other drug storage and delivery components for which the appropriate leak detection equipment, fixturing and all other leak test specifications are required. Uson’s videoconferencing capability is especially designed for companies that either do not want the delay in time-to-market that shipping parts to outside facilities involves or in cases where release of a proprietary pharmaceutical product

design is against company policy and non-disclosure requirements.

Joe Pustka, who helped pioneer the videoconferencing capability, explained that details of part geometry, sealing locations, elasticity and other part characteristics are greatly facilitated by shared and simultaneous viewing of the parts for which a leak detection solution is sought. Pustka said: “Uson goes to great lengths to ensure that QC engineers, responsible process engineers and the entire customer team impacted by the specifications of the leak detection equipment have a detailed understanding of various equipment and fixture options and how these will affect cycle times,

gauge R&R and measurement accuracy.

These video consultations not only allow us to have the feel of face-to-face meetings and eyeball-to-eyeball discussions, but also speed up design of best-match leak detection solutions.”

Pustka continued: “Uson would never say, for example, that a test sensor delivers the same accuracy in a test lab as it does in one or another production line — that is simply misleading. Many factors interact with the test sensors in real plant conditions. Often the geometry of a part dictates how we approach developing an application match and being able to explain and discuss the pros and cons of various approaches while we are all looking at the same part is unbeatable. Yes, anyone is welcome to come to our leak test applications laboratories for in-person consultations at any time. However, most are too busy to hop on planes and take time away from their many other duties. Now, we can have one video call or as many as required to ensure everyone is talking about the same part, the same leak detector, the same fixture designs, etc.”

Uson +1 281 671 2212 joe.pustka@uson.com www.uson.com

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MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Record Sales of De-Blistering and Leak Testing Equipment

Sepha has reported record sales of its recently extended range of nondestructive leak testing equipment for the world’s pharmaceutical packaging industry. With demand up across all major markets, the company says the increase will fund future R&D and enable it to bring forward future innovations aimed at reducing costs and driving quality for pharmaceutical manufacturers and contract packers.

“When the recession hit the global pharmaceuticals market, we responded to the challenges our customers were facing,” explained Head of Sales & Marketing Paul Kelly.

Sepha has introduced three new machines over the past two years and made further refinements to existing products.

Visionscan uses hi-resolution imaging technology to test for leaks in the packaging of pharmaceuticals, which, according to the company, has given it the ability to offer customers a lower cost entry-point into nondestructive leak testing that is more reliable than older methods of testing on the market. “At a time when the industry is looking to drive up quality and reduce production costs, Visionscan does both,” said Kelly. “It is a tool-less leak testing device. The flexibility we have designed into this machine is ideal for contract packers operating in the growing non-branded drug or generics market where there is a need to switch production quickly from one drug to another.”

Mediscan was launched alongside Visionscan, but for testing leaks in single non-porous pouches, medical device packaging and sachets.

The third new machine, EZ Blister II is a compact blister-packing machine for clinical trial laboratories and R&D facilities. This has proved very popular with customers who need a low-volume packaging solution.

Sepha is now about to embark on a customer roadshow across Europe, Asia and the US, which will see the company bring its new leak testing machines directly to the doors of customers.

High-Performance Addition to Vibrating Screen Range Russell Finex has extended its range of Russell Compact Sieves with a highperformance, low-profile vibrating screen for safety screening of liquids and powders.

First invented over two decades ago, the Russell Compact Sieve has been installed within a wide range of industries all over the world. Renowned for its compact and easy-clean design, according to the company, this unit has evolved to become the most successful vibrating screen throughout the world and its most recent refinements make it the most versatile screener on the market.

Mounted on a reportedly unique rubber suspension system, the Russell Compact Sieve offers considerable benefits over conventional spring mounted systems. As well as quieter operation (typically less than 70 dBA), the screener is able to transmit significantly more vibration to the mesh screen surface. Combining this with its straight-through design allows for much higher flow rates and improved product

separation. In some cases, a 22” unit can handle flow rates similar to a traditional 48” spring mounted unit.

In all manufacturing processes, minimising downtime and maximising productivity is key to achieving optimum profitability. This is why the Russell Compact Sieve has been specifically designed to enable rapid assembly and disassembly without the need for tools. This is achieved by minimising the number of product contact parts and by incorporating quick release toggle clamps instead of conventional band-clamp systems. This means one operator can dismantle the screener, replace the mesh screen and reassemble within a matter of minutes.

The Russell Compact Sieve is now available in five different sizes, ranging from a 10” laboratory unit up to a 60” production scale unit. Therefore, whether the customer is processing small batches, running a pilot- or full-

scale production plant, they can be sure that the right screener will be selected to match production requirements.

Another enhancement is that all sizes are now available in full stainless steel.

This provides increased durability within corrosive environments, as well as the option for brush or mirror polished finishes for food and pharmaceutical applications.

Russell Finex Ltd +44 20 8818 2058 christine.dyos@russellfinex.com www.russellfinex.com

High-Speed Laser Cutting Machine Provides Exceptional Cut Quality for Pharma Labels Pharmaceutical manufacturers seeking exceptional laser cutting machine technology to use both with flexo overruns and in-line or off-line with digital presses can now get the same superior software engineering and integration that is included in higher priced Spartanics Finecut Laser Cutting Machines at highly competitive prices.

According to the company, unlike similarly-priced laser cutters sold in the world market, Spartanics L-350 High Speed Laser Cutting Machine’s single laser head design enables highest quality cuts with a 210 µm spot size in a 350 mm cutting field at speeds as fast as 80 m/min. Like every Spartanics laser cutting machine model, the L-350 automates optimisation of web speed, eliminates quality issues in many applications that require stitching cuts from two laser sources, enables job

changeovers on-the-fly and is reportedly widely recognised as the most operator-friendly technology due to its intuitive operator interface and behind-the-scenes sophisticated control engineering software.

Spartanics L-350 High Speed Laser Cutting Machine includes UV coating stations, lamination, slitting and sheeting options.

Superior cut quality is achieved with polyester, polycarbonate, polypropylene, metalised and paper among a wide range of other materials. Like other Spartanics Laser Cutting Machines, only sealed CO2 supplies are used to power lasers, both to minimise costs for CO2

Sepha Ltd +44 28 90484848 paul.kelly@sepha.com www.sepha.com

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and to avoid the inherent quality issues of open CO2 delivery systems.

Spartanics +1 847 394 5700 sales@spartanics.com www.spartanics.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Continuous Tablet Coating System for High-Quality Coating eliminate these aforementioned disadvantages and to combine the advantages of continuous and batch coating machines into one machine to permit high-quality coating in a continuous process.

DRIAM’s system employs a cycling process that divides the coating pan into individual chambers or compartments where tablets are held for a specified length of time before being transferred to the next stage as a mini batch. This continuous tablet coating platform is ideal for manufacturers wishing to improve process efficiency in challenging economic times.

It is the aim of many pharmaceutical manufacturers to be able to apply high-quality coatings to tablets in a continuous process. The continuous coater DRIACONTI-T pharma, developed by the German coating technology specialist DRIAM, comes close to these expectations. Based on the experiences accumulated with continuous as well as batch coating machines, a reportedly new generation of machine has been developed.

Conventional continuous coating systems are challenged by the fact that only very short and limited processes can be accomplished. Due to this fact, only thin, low-quality layers of coating can be applied. In addition, the flow control of the tablets in the pan is not sufficient and the uniformity of the tablets is poor. The goal for the development of the continuous coater DRIACONTI-T pharma was to

DRIAM Anlagenbau GmbH +49 7541 97030 info@driam.com www.driam.com

First Combined ERP/MES System at Novo Nordisk’s Denmark Site In the framework of the global PS@ SAP programme Accenture, Werum Software & Systems and NNE Pharmaplan have rolled out the first combined ERP/MES system at Novo Nordisk’s site in Denmark.

The main objective of the programme is to implement a globally standardised ERP/MES solution on the basis of SAP and Werum’s PAS-X. The programme is intended to be rolled out later to most of Novo Nordisk’s worldwide manufacturing sites.

Novo Nordisk decided on Werum’s PAS-X because it provides essential functionalities out-of-the-box.

Another factor that convinced Novo Nordisk to choose Werum’s manufacturing execution system is the fact that PAS-X has a proven record of successful installations throughout the industry.

The programme started with the development of a standalone PAS-X pilot system in Denmark during 2008 and with some other implementations throughout the organisation. Since then, Novo Nordisk, Werum and NNE Pharmaplan have been cooperating closely and have designed and implemented a MES PAS-X Core system.

Werum Software & Systems AG +49 4131 8900 689 dirk.ebbecke@werum.com www.werum.com / www.pas-x.com

Continuous Tabletting Becomes Reality In its strive to improve operational efficiency and reduce its cost per tablet, the pharmaceutical industry is engaged in a strategic shift from batch-based manufacturing to continuous manufacturing. Such methods have been extensively proven in other process industries, although not to the same regulatory requirements.

It is now feasible to manufacture solid dosage pharmaceuticals continuously, from dispensing through to granulation, tabletting and coating, to continuously supply high-speed packing lines.

However, initial thinking of small product dedicated lines have been expanded to multi-product processing and semi-continuous, high-efficiency manufacturing.

Process control, driven by QbD principals, ensures control of critical parameters. PAT advances of the last five years have enabled such control of defined product critical control attributes.

Key benefits of continuous tablet manufacturing include: reduction in capital investment; substantially lower operational and utility costs; smaller GMP areas and facilities; reduction in inventory; substantial reduction in R&D costs and risks; and reduction in sampling and analysis costs.

Main technologies that are making continuous processing a reality for the future include Gerteis Roller Compaction technology, which has advanced density control for consistency, and GEA ConsiGma EPM 8

technology, which provides almost instant control to adjust granule properties, enabling stable and optimum granule characteristics. GEA Courtoy tablet presses allow online monitoring of content uniformity, hardness and density, which can be used to feedback and control the process parameters. The O’Hara Fastcoat Continuous Tablet Coater significantly shortens production cycle times and provides exceptional coating uniformity.

S3 Process Ltd +44 845 50 53 53 0 info@s3process.co.uk www.s3process.co.uk

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Fully Crevice-Free Self-Cleaning Filter for Sanitary Applications The Russell Hygiene Filter is a specifically designed, self-cleaning liquid filter that meets the demands of the food and pharmaceutical industries where product quality cannot be compromised.

Utilising the latest manufacturing techniques and applying key industry standards reportedly makes it the highest specification filter on the market.

This filter has been designed in accordance with the hygienic machinery standard BS EN ISO 14159:2008 and food contact regulation EU1935/2004 to provide a high-clean, fully crevice free filter for uncompromised cleaning

between batches. Every component has been carefully designed to eliminate all crevices and bug traps to allow for sanitary standard cleaning. In addition, all product contact parts are polished to less than 0.6 Ra as standard (0.1 Ra is available if required), providing an exceptional finish.

The Russell Hygiene Filter requires no tools for cleaning or maintenance and dismantles completely, enabling one operator to disassemble the filter quickly.

This increases productivity of operators and the production process. The filter is also fully enclosed, preventing airborne contamination and safeguarding the health and safety of operators.

According to the company, in addition to its sanitary design, the Russell Hygiene Filter also incorporates the unique self-cleaning design of the Russell Eco Filter. This enables continuous removal of oversize contamination as fine as 10 micron, achieved by continuously cleaning the apertures of the filter element. By successfully removing oversize product, it saves money and ensures minimal loss of good product. Also, unlike traditional bag or cartridge filters, it uses a reusable, reduced crevice filter element that eliminates the cost and environmental implications associated with replacement filter media.

Russell Finex Ltd +44 20 8818 2058 christine.dyos@russellfinex.com www.russellfinex.com

Flexible Platform Enables Manufacture of All Tablet Formats on One Press

The KORSCH MultiFunction Platform design reportedly offers the first flexible platform that permits the production of all tablet formats on a single tablet press.

The XL 400FT MFP features a modified carrier plate and head piece that enable the installation of a wide range of compression roller modules, feeder modules and cam track modules, which enable a plug and produce approach for maximum versatility.

The flexible and modular design allows the press to be adapted to any production requirement with a simple set of change parts. According to the company, the result is unlimited flexibility, unprecedented utilisation and a single press for every application.

Key features include:

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• common machine platform; • flexible press configurations — singlelayer, bi-layer, tri-layer and core-coating; • fast change singlelayer execution; • exchangeable turret design; • plug and produce conversion kits, retrofitted at any time; • control system with auto set-up for each press configuration; • automatic layer weight control and layer sampling; • through-the-wall technology; • and exceptionally low noise level — < 75 dB(A).

KORSCH AG +49 30 43576 145 loitsch@korsch.de www.korsch.de

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Erosion Reduced with Abrasion Resistant Glass After extensive laboratory tests and field experiments, Pfaudler has unveiled a new Abrasion Resistant Glass (ARG) that — for reactors, agitators and outlet valves — can provide a massive 20% reduction in erosion when compared with conventional chemical glass qualities.

Pfaudler’s ARG is particularly suitable for poly aluminium chloride and titanium oxide production processes, as well as applications where the dissolution of ores in concentrated acids is especially high.

Although these processes are highly corrosive, Pfaudler’s new white-glasstype, with improved abrasion resistance, can achieve a significantly sustained

lifecycle improvement for component parts, without any compromise to chemical corrosion resistance.

The advanced mechanical properties of this new glass type consolidate Pfaudler’s vast experience in finding solutions to reduce abrasion for modern agitating systems, where it has a proven track record of prolonging the lifetime of glass lined apparatus — in many cases by as much as several years — compared with traditional solutions.

Pfaudler +44 1333 423020 sales@pfaudlerbalfour.co.uk www.pfaudler.de

Dependable and Easy-to-Use Rotary Tablet Presses

SVIAC is responsible for manufacturing a wide range of high-tech, versatile, dependable, economical and easy to operate rotary presses that are used around the world by some of the largest laboratories.

These machines are built in accordance with GMP standards and offer the following benefits and capabilities: • acceptance of Euro Norm or IPT tooling; • ability to accommodate 6–51 stations, capable of producing 25,200–214,200 tablets per hour; • specific R&D units, from six stations, with software for Galenic research, under Excel equivalent; • production of one, two and three layer tablets on mass production; • production of dry core tablets; • regulation of weight by strain gauge; • printing of detailed reports of production; • validation files (IQ/OQ); • fast tooling changeover; • and easy maintenance.

SVIAC +33 1 55 59 91 11 nicolas@sviac.fr www.sviac.com

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MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Vacuum Equipment Supplier Wins Significant Order from Perrigo AP

Edwards has won an order worth over £160,000 to supply dry pump systems to Perrigo API in India. The EDP400 dry vacuum pumps, which are used in the manufacturing process of fine chemicals for the pharmaceutical industries, will provide a reliable and robust system with high-performance that will enable Perrigo to optimise its process and reduce operational costs and its carbon footprint.

Perrigo API is installing the dry pumps as part of a new APIs manufacturing project at Maharashtra, India. Edwards has many successful installations in chemical and pharmaceutical plants in the area and, after a thorough review of equipment, Perrigo API recognised the benefits of dry pump technology and chose Edwards’ system for its proven high-class performance and reliability.

Capsule Filters Available in Variety of Sizes and Connections

The EDP400 pump system is based on Edwards’ oil-free, non-contacting reverse claw mechanism. It provides consistent vacuum at high efficiencies, with pumping speeds of 400 m3h-1. The dry pump completely eliminates all problems of process contamination and creation of polluted effluent, which are experienced with traditional wet vacuum pump technologies. The non-contacting mechanism in the Edwards pump provides long life and high reliability, with a minimum pump life expectancy of 25 years. As a result, it requires less maintenance and provides a low cost of ownership.

“I’m delighted to win this order, which means Perrigo API can now benefit from the operational and environmental benefits of using dry pumps,” said Vikrant Sanglikar, Country Head‚ South Asia, Edwards. “We work closely with our customers to advise on reliable and efficient systems that offer the best solution and vacuum performance for their process and this win cements our position in the industry and region as an expert supplier.”

Edwards’ equipment is also backed up by a knowledgeable service team that offers technical support to its customers, including field and onsite services and technical training.

Edwards +44 1293 603451 miles.firth@edwardsvacuum.com www.edwardsvacuum.com

Meissner’s CS/CL capsule filters are available in a variety of sizes and connections for maximum flexibility in processing applications. The capsules can be used independently or integrated into single-use biocontainer and tubing assemblies for greater application.

Meissner’s CS/CL capsule filters can be selected with membrane media in: PVDF, PES, PTFE or PP; microfibre media of glass fibre and PP; and PP depth filter media. Connection options include sanitary flange (3/4 –1”), hosebarb (3/8 –1/2”) and male and female NPT fittings. A variety of vent and drain port options are available, including sanitary valves or luer ports with caps. Additionally, capsule filters

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can be specified with effective filtration areas from .09 m2 through to .19 m2. A catalogue detailing all specifications and options is available at www.meissner.com/products/smallflow/c apsules.asp for immediate download.

Meissner manufactures advanced microfiltration products, including capsule filters for filtration of small fluid volumes through to ultra-high fluid volumes and One-Touch single-use systems used in the sterilisation of drugs, reagents and other critical pharmaceutical and biomanufacturing applications.

Meissner Filtration Products, Inc. +1 805 388 9911 leads@meissner.com www.meissner.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP ATEX-Compliant LED Lighting Range Targets Explosive Environments Managers of hazardous industrial plants know only too well the huge time losses and cost implications that result from shutting down operations in order to replace faulty lighting. A new range of high-powered LED lights offer a much needed solution.

Offering more than seven years of 24hour continuous usage, NeoBulb’s Escort ATEX range has up to ten times the lifespan of existing commercial ATEX lighting solutions. Crucially for hazardous industries, the range will considerably reduce manufacturing downtime and resultant operational losses.

AODD Pumps Provide Exceptional Sterile Performance

Designed specifically for industries that have to deal with explosives, extreme temperatures and ignitable particles, the NeoBulb Escort ATEX range offers a 70% energy saving compared with existing solutions. This provides energy-intensive industries with a simple and cost-effective mechanism for achieving challenging energy reduction targets.

“The NeoBulb Escort ATEX range has considerable potential in a range of industries, from factories using dangerous explosives to pharmaceutical facilities with harmful materials,” explained Simon Leggett, MD of OCG Lighting, which has exclusive distributor rights for the range in the UK. NeoBulb Escort ATEX lighting fixtures bring all of the benefits of high-quality LED lighting — long, maintenance-free life, excellent efficiency and incredible durability — to heavy industry applications.

The high-power LEDs are ATEX compliant, meaning they are suitable for ignitable, corrosive, wet, dusty and extremely hot or cold environments.

OCG Lighting +44 844 2571 222 sales@ocgplc.com www.ocgplc.com

Almatec has announced that its line of BIOCOR Series of air-operated doublediaphragm (AODD) pumps feature a wide array of design features that help make them ideal for use in pharmaceutical applications that require the highest level of sterile operation.

Available in three sizes — B20, B32 and B40 — with maximum capacities of 15, 34 and 70 gpm at a maximum discharge pressure of 100 psi, BIOCOR Series pumps are EHEDG certified and conform to ATEX regulations that are laid out in the 94/9/EG directive. Helping the BIOCOR pumps meet these strict sanitary requirements is a design that features no horizontal areas where product can get trapped. Additionally, the sizes B20 and B32 are equipped with four ball-lifting magnets that are attached to the pump housing at the location of the four ball valves. This method of construction and operation ensures that the pump is drained completely without having to be dismounted, which enables CIP and SIP capability while eliminating the need for mechanical ball-lifters that would be located in the wetted area.

BIOCOR pumps also feature step-less flow control via air pressure and volume without complex mechanical control units, which prevents overpressure while ensuring maximised output and efficiency. The material for the wetted housing parts is electro-polished 316L (Basel Standard II, ferrite content < 1%) stainless steel with a centre block of PE conductive, while the diaphragms, ball

EPM 12

valves and O-rings are made of PTFE or EPDM. Finally, BIOCOR Series pumps are also equipped with the patented PERSWING P air control system. This metal-free, pneumatically pilot-operated control system ensures accurate reversal of the main piston and is characterised by low noise level. It does not require maintenance, operates without any lubrication and is made up of no more than four different parts.

Almatec +49 2842 961 0 frericks@almatec.de www.almatec.de

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP White Paper Addresses Issues in ‘Refining inhaled product testing’

Dr. Reddy’s Laboratories Completes First Implementation Phase of MES at Hyderabad site

Copley Scientific has published a new, freely available white paper that discusses ‘Refining inhaled product testing’.

This timely review — downloadable at www.bit.ly/copleywp — comes as the pharmaceutical industry maintains its drive towards greater efficiency, from faster time-to-market through to better manufacturing practice. It is against this backdrop that analytical tools are currently facing considerable scrutiny as to whether they provide relevant information and enable maximum productivity.

Inhaled product development is uniquely challenging, but there is a desire to move towards a more knowledge-driven approach. Focusing on the core technique of cascade impaction, Copley Scientific Sales Director Mark Copley looks at how testing is being refined to support the aspiration of more efficient practice and the generation of better product understanding. A key goal is to achieve better in vitro-in vivo relationships, as well as reducing the burden of QC testing.

‘Refining inhaled product testing’

The pharmaceutical major Dr. Reddy’s Laboratories Ltd is reportedly the first Indian company to improve its manufacturing processes by installing an electronic PAS-X Manufacturing Execution System (MES). Dr. Reddy’s opted for Werum’s MES PAS-X to help enhance the quality and compliance and to optimise the efficiency and productivity of its pharmaceutical shop floor processes.

Implementing PAS-X forms part of Dr. Reddy’s expansion strategy. The first step, now successfully completed, involved installing PAS-X at one of the company’s FDA and MHRA approved production facilities at Bachupally in Hyderabad.

In its first step, the PAS-X handles and controls the Warehouse Management System, such as receiving, sampling and

reviews current testing regimes and discusses ideas surrounding Abbreviated Impactor Measurement/Efficient Data Analysis and the progress that has been made, summarising experimental work to date.

Changes to nebuliser testing are given as an example of how some areas are already being revised, with more representative breath profiles and cooling for more accurate APSD measurement.

Copley Scientific Ltd +44 115 961 6229 m.copley@copleyscientific.co.uk www.copleyscientific.com

Dr. Reddy's site in Hyderabad, India

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storing of materials. It also carries out weighing and dispensing and equipment management operations.

Using mobile terminals, PAS-X coordinates the barcode-controlled process for material tracking and tracing of containers as they travel from the warehouse to the dispensing area. An automated interface allows PAS-X to communicate directly with Dr. Reddy’s ERP (SAP).

The project is being carried out by a team of experienced experts at Werum’s Asia Support Centre with Dr. Reddy’s Internal Core Team.

Werum Software & Systems AG +49 4131 8900 689 dirk.ebbecke@werum.com www.werum.com

MANUFACTURING PRODUCTS & EQUIPMENT ROUND TA B

LE The tabletting industry is currently undergoing a seismic shift. The main contributing factors are the number of expiring blockbuster patents and subsequent growth of generic drug producers and contract manufacturers. Another key driver is of course the emergence of and competition from developing markets, with the majority of pharmaceutical companies also relocating their facilities in order to capitalise on these.

So the pressure is on, now more than ever, for tabletting equipment manufacturers to supply their customers — both pharmaceutical companies and their generic competitors — with minimal investment equipment that increases productivity and reduces costs.

EPM has consulted a number of tabletting equipment manufacturers on how the aforementioned issues and demands can be best addressed both now and in the future.

THE FUTURE OF TABLETTING

Steve Deakin, Director, I Holland Ltd

Jens Torkel, Managing Director, IMA Kilian GmbH & Co. KG

I believe that expiring patents are certainly driving many changes in the tabletting industry and have been doing so throughout the last decade. In response to future patent loss, many ethical tablet manufacturers have increased productivity of their blockbusters in order to counter the generic competition. The key to this process must be to improve tabletting capacity, while keeping a firm grip on costs and capital investment. As a supplier, we are always moving to meet the ever increasing emphasis on speed of response and value for money that these changes require. I think that providing solutions that allow tablet manufacturers to make these improvements, while maintaining high-quality assurance standards, can only be met by continuous improvement in our own manufacturing practices, R&D and academic studies.

We are seeing the expanding globalisation of tablet production and the opening up of developing pharmaceutical markets in South America, Africa and Asia. This drives the relocation of products to alternative sites, which clearly makes commercial sense, but it can present challenges in tablet production. Even small changes in environmental conditions and raw material supply have been shown to lead to issues such as sticking and a reduction in yield. When this is coupled with the additional consideration of training new operatives, it can amount to a serious challenge. I have found that a swift application of the knowledge and support of key suppliers, preferably those with established worldwide experience and infrastructure, helps to ease this process.

Several advances in tablet compression have made a positive impact on productivity within the tabletting industry. The use of multi-tip punches in tablet compression is becoming more widespread as this can allow a significant increase in the number of tablets produced per hour without the large capital expenditure usually associated with increasing capacity. The introduction of multi-tipped punches can be a technically involved process, although training and support should be available from a responsible tooling supplier, but the rewards I have seen in our customers’ productivity are well worth the effort.

The development of more direct compression suitable excipients and advances in press technology have led to more tablets being produced by the potentially highly productive direct compression method. However, there are tooling design considerations for optimising this form of compression and a competent punch and die manufacturer should be able to assist with this.

I have always believed that planned tooling maintenance is vital to increase tooling life. This — together with the advances we are making in punch and die coating, including research into their scientific application — is definitely improving tooling efficiency, particularly when dealing with challenging formulations. The use of segmented die tables is also becoming more commonly adopted, speeding up press changeover. All of these solutions are helping to reduce downtime and maximise productivity.

Of course maximum attention to costs containment is now also a priority for equipment manufacturers and one of the key drivers for innovation as well as the internal organisation of the manufacturing process. However, capital assets expenditure is only a portion, and certainly not the largest portion, of overall production costs for pharmaceutical companies; equipment productivity and effectiveness and reductions in waste, time-to-market and cost of inventory assets must also be considered. As a global partner and not merely a supplier, IMA has a wider approach to the problem, considering the overall profitability of the process that the tabletting equipment is serving.

Take, for example, our new CWC (Continuous Weight Control) system, which allows one tablet to be checked each turret revolution, with all stations being checked in sequence; the more frequent weight checking guarantees extremely precise feedback on machine working parameters, ensuring high-quality production with the most difficult products.

The HMI is also a crucial factor when talking of machine efficiency and the new ‘Trending’ and ‘Human RQ’ options enable easy and quick machine setup. When considering the profitability of the whole pharmaceutical manufacturing process, the reduction in waste and the improvement of product quality achievable with these features have a far greater impact than the initial capital investment for purchasing the equipment.

Or consider, for instance, minimisation of downtimes for machine cleaning and maintenance, which our customers have always considered to be key factors when deciding on a new machine, although they become even more crucial when looking to achieve inventory reduction and just-in-time manufacturing. This is why our customers appreciate the well-known separation of the compression area from the lower machine compartment, which is the hallmark of the Synthesis series; besides minimising the area to clean (and thus cleaning times), the absence of powder in the mechanical area means less maintenance interventions and longer machine life.

IMA’s long-standing partnerships with the most diverse pharmaceutical companies (from small- and medium-sized to big multinationals, producing branded or generic drugs) has generated an exclusive expertise based on a deep knowledge of pharmaceutical production. This is why we believe that concepts like cost containment and minimal investment equipment should be integrated in a more holistic approach that considers the overall profitability of the drug manufacturing process.

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MANUFACTURING PRODUCTS & EQUIPMENT ROUNDTABLE

Jan Vogeleer, Managing Director, GEA Pharma Systems - Courtoy

Our most powerful asset in successfully dealing with today’s challenges is our advanced technology. We strongly focus on increasing the productivity of our tablet presses, which gives us an edge over our competitors. Two exclusive Courtoy machine features have enabled us to greatly enhance productivity. The first is the air compensator, which extends the dwell time and thereby allows our tablet presses to run at higher RPM than other machines. A second major development, which has helped us to maximise machine productivity, is the patented ECM (Exchangeable Compression Module) concept.

With the ECM, extremely fast product changeover can be achieved, contributing in turn to the overall productivity of the tablet press and tabletting line. The increasing success of our ECM-based MODUL range illustrates that a strategy of innovation is one way of effectively navigating the current shifts in the industry.

“While it is certainly true that the rise of contract-manufacturers and generic producers poses a major challenge, we also see a number of interesting opportunities in today’s pharma landscape.

We have followed the rapid growth of a number of speciality applications with great interest.

These have proved to be both technically demanding and particularly suited to GEA Pharma Systems - Courtoy’s advanced technology. One example is the highcontainment processing of highly potent drugs, where GEA Pharma Systems - Courtoy has become market-leader in recent years thanks to its unique and patented WOL (Wash-Off-Line) concept. This demonstrates once again that innovation is key; by responding very quickly to budding trends in pharmaceutical manufacturing, we have managed to secure the lead position in several increasingly important markets.

We are, of course, continually striving to cut the cost of manufacturing, so we can supply our technology at the best possible price. Being part of the GEA Group is of invaluable importance in this respect; a network of over 20,000 employees, spanning more than 50 countries worldwide, opens up many opportunities for lowcost sourcing around the globe. Access to such a wealth of resources, as well as the implementation of the ‘design for assembly’ principle, allows us to manufacture and build our machines with maximum efficiency, resulting in short delivery times and competitive prices.

Olaf J. Müller, CEO, Fette Compacting GmbH

The pressing as well as challenging question of how the global pharmaceutical market will develop in the future has over the last few years been of the highest priority for Fette Compacting.

At various locations and events all over the world, we took the opportunity to engage in profound discussions with customers and partners, always trying to evaluate how to best meet the challenges of the future.

In 2012, at our ‘Focus Pharma 2015’ symposium, leading economic and industrial experts from companies such as McKinsey and IMS Health presented new developments and likely to occur prognosis. The following roundtable discussions brought up interesting views of the developments in the pharmaceutical sector.

Interviewing our customers’ key employees, we analysed their future visions and demands on technical suppliers. The goal was to develop products that would meet the requirements of our customers and equip them with the right technology to step into the future in a competitive manner.

A consolidated view indicates that the pharmaceutical industry will in the future have to produce more, more flexibly, faster and, above all, at lower cost — in a nutshell, production will have to become more efficient.

As technology and world market leader in tabletting technology, Fette Compacting is capable and willing to influence the developments in the interests of our customers.

The FE55 as a new generation of tablet presses has been optimised to provide the highest levels of productivity, flexibility and availability and aims to set new standards for efficiency in tabletting.

The Fette Compacting TRI.EASY technology makes its début with the FE55. The idea behind it — technology can only be efficient if it is equally easy in the three dimensions of operation, service and maintenance. TRI.EASY technology focuses on users. Regardless of the quality level availed of by the operator, TRI.EASY guarantees smooth and safe operation.

In addition to new technology in tablet presses, carefully targeted investments are enabling us to expand our range of services and position ourselves as consultants on overall equipment effectiveness in the field of pharmaceutical production. Optimising the processes of our customers plays an immense role in ensuring the highest efficiency of their tablet production.

Finally, we shall be intensifying our activities in the new growth markets to further improve our local support for users.

All of these developments are also reflected in our new corporate logo and motto ‘be efficient’.

This maxim represents the promise we make to our customers — and the goal we have set ourselves.

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Ryan D. Keefer, General Manager, The Elizabeth Companies Both multi-layer and core tabletting technologies have become hot topics in the recent decade due to the advancement of many high potency formulations; there is an ever-increasing demand for these innovative oral drug delivery systems by the pharmaceutical and nutraceutical industries.

There are various factors that determine the need for the multi-layer tablet over the conventional single-layer tablet, perhaps the most prominent of which is the incompatibility of multiple drug matrixes to be contained in the tablet — in a multi-layer tablet, incompatible matrixes are separated by an inert barrier layer to prevent interaction.

Then there are the distinct commercial and financial advantages of utilising the multi-layer tablet such as: combining two or more different drugs in one solid dosage form; a unique tablet appearance for the marketing of new products to consumers; a marketing advantage over competitors by putting a new spin on an ordinary product; and ability to extend product patents by introducing established products in new forms.

Accompanying the recent innovations in multilayer tabletting, the manufacturing capabilities of new product concepts allow for creative solutions in formulation development. Tablets unheard of a few years ago, such as the Poly Pill, are being introduced. These enable modified-release formulations and multiple active ingredients to be kept separate from the ordinary single-layer tablet, allowing a single dose or pill as opposed to multiple doses to be administered — ideal where there are concerns over elderly patients remembering to take prescribed amounts of tablets throughout the day.

In addition, advancements in core tabletting technology and the more recent multi-layer core tablet technology are receiving increasing levels of interest. As many new high potency formulations that must be released in the lower stomach are being developed, a dependable, accurate delayed release delivery mechanism is being sought. New product possibilities with time-release, time-delayed and extended timerelease drug delivery systems are being added to the physician’s arsenal of weapons to fight various diseases and ailments. This type of flexible solid dosage form allows for a multitude of drug matrix combinations, creating a broader range of product possibilities.

To accommodate the aforementioned increasing demand for high potency drug products, advanced core tabletting methods have achieved exact core placement versus the antiquated core-placement methods of the past.

The new developments in core placement enable the core to be positioned precisely in the tablet — top, bottom, side-to-side or exact centre. This allows the tablet designer to anticipate the rate of dissolution of the core coating before activation of the active core. We, at The Elizabeth Companies, have patented a mechanical method to achieve precision core placement with the Hata Core-Tableting Press System. The Hata Core-Press is capable of single-layer, bi-layer, multi-layer and custom core tabletting with a unique multi-layer core capability.

This recent ability to provide precise core placement and flexibility of multi-layers has allowed tablet designers to expand their product development into exciting new areas with new solid dosage innovations.

MANUFACTURING PRODUCTS & EQUIPMENT ROUNDTABLE Bad Key Angle.

Dale Natoli, President, Natoli Engineering Company In 1966, Eng. Charles Swartz — employed by Smith Kline French (SKF) in Philadelphia Pennsylvania, today known as Glaxo Smith Kline (GSK) — realised the need to establish standards for tablet compression tooling used in the pharmaceutical industry. His main focus at that time was to engineer and make available tablet compression tool drawings, which could be used to source tooling from competent machine shops other than the OEM. At the time, they had unacceptable manufacturing lead times commonly exceeding six months. The other advantage of standardisation was to allow tooling to be interchanged between the most common tablet presses.

There is no question that the pharmaceutical industry, tablet press manufacturers and tooling manufacturers continue to enjoy the benefits from the hard work and initial framework of Eng. Swartz’s tablet tooling standardisation. With the support of the American Pharmaceutical Association, which acted as the organiser, publisher and distributor of the tooling standard known as the ‘IPT’ manual, an industry guideline was established. It is known today as the Tableting Specification Manual, or ‘TSM’ American standard, currently in its 7th edition. The TSM continues to be instrumental for tablet press and tooling manufacturers by providing a guideline for interchangeability of tablet compression tooling.

Shortly after releasing the 3rd edition of the TSM, an English tooling manufacturer, I Holland Ltd, realised the importance of the American standard and established a guideline for the European community known as the ‘EU’ standard, which has recently been superseded by the ‘ISO 18084’ international tablet tooling standard.

Unfortunately, the TSM, EU and ISO 18084 tooling standards did not address the type or position of the upper punch key, which is required for pressing shaped tablets such as capsules and ovals. As there is not a standard for the upper punch key position, it

Good Key Angle.

“

pharmaceutical industry, tablet press

The

manufacturers and tooling manufacturers continue to

enjoy the benefits from the hard work and initial framework of Eng. Swartz’s tablet tooling standardisation

”

allows tablet press manufactures to engineer and build presses, placing the key position in various radial locations. This eliminates the possibility of interchanging tooling between the most common tablet presses.

As an example, tablet presses made by different manufacturers, while both adhering to the standard ‘B’ tool format, may not be interchangeable. The problem arises at the ejection cycle of the tablet where it makes contact with the tablet take-off and is removed from the press. When tooling is interchanged between these presses, the tablet may not be properly orientated. With improper orientation, the tablet must rotate or spin at ejection, causing tablets to accumulate on the die table at the takeoff, resulting in damaged tablets and adversely affecting press output.

EPM 16

This situation with random keyway locations results in extra expenses, as many companies are not aware that their tooling is not interchangeable between presses. Additional operating costs are incurred due to multiple sets of the same required tooling.

In order to help rectify this problem and, in doing so, better serve the pharmaceutical industry, I believe that tabletting equipment manufacturers and also drug manufacturers themselves should be supporting the need to update ISO 18084 and make it complete with standardisation for key type and location. I would therefore like to invite readers to register their interest in supporting the cause by contacting either myself (dale@natoli.com) or ISO Secretariat Mme Elisabeth Guérin (e.guerin@unm.fr).

SHOWCASE ANTI-COUNTERFEITING & SECURITY Protection and Transparency Across Supply Chain with Sealing Solutions Range For the pharmaceutical sector, the need for transparency and reliable protection for consignments across the whole logistics chain to the customer is of vital importance. tesa has responded to this challenge in developing the tesa Security concept and SecuritySeal adhesive tapes and labels that clearly show whether a shipment has completed its previous journey in the logistics chain intact and in its original packaging.

Providing a secure seal and reliable protection, tesa’s SecuritySeal products undergo a physical and visual change when they are opened. Such changes are irreversible, meaning that any attempted tampering is clearly evident.

When the seal on the tape or label is opened, a warning appears and remains visible when closed again. tesa SecuritySeal labels can be printed with logos, serial numbers and itemspecific barcodes. As a result, the labels

can be used for track and trace purposes. If label barcodes are scanned every time goods are delivered, manufacturers and retailers can immediately see that boxes and pallet packaging have been delivered intact and logistics partners can consistently prove that shipments have been delivered in full and in the original packaging.

The label material can be supplied in different formats, colours and sizes and customised to the customers’ needs to ensure protection against limitations.

Additional benefits include: • ease of application allows the creation of a smooth packaging process for shippers; • barcode scanning features offer fast inventory control during stock-taking; • the identification of weak points in the logistics chain; • security and quality assurance at each point of transfer;

• complete delivery reinforces customer trust and satisfaction; • StretchSeal and SecuritySeal tags provide security closure for reusable containers and can be quickly attached and easily removed without leaving residue.

The tesa Security concept guarantees maximum security as a result of tailored advisory services, solutions and comprehensive guidance. tesa SecuritySeal products ensure that unauthorised access is immediately detected. However, employees, logistics partners and customers need to be aware of the security concept and need to report any irregularities immediately. For this reason, tesa offers guidance at the

customer’s location and provides relevant information to all those concerned. tesa UK Ltd +44 1908 211333 www.tesa.co.uk

Serialisation and Tracking Technology Provides Reliability and Security at Low Cost

Authentication of Moulded Parts with iPhone4 Application

Reportedly groundbreaking technology has been launched by Norwegian company Kezzler that will dramatically assist pharmaceutical companies in the face of mounting pressure to serialise and track and trace products across the supply chain.

Until now, generating and validating serial numbers and tracking products relied upon databases as companies sought to adapt these traditional systems for specialised needs.

However, databases need to keep all data on the system and therefore have built-in limitations, which at the extraordinarily high volumes of data commonplace within the pharmaceutical industry, slow down retrieval times, increase costs and are not completely secure.

Kezzler’s SSP platform has been specifically designed for Product & Supply Chain Security. SSP includes serialisation and tracking technologies, which Kezzler believes is unmatched in terms of its product breadth and capability. The company has been developing and selling its technology for a number of years to multinational corporations and industries facing similar issues managing high-volume data. A new product — Patient Adherence — now completes the suite of SSP modules.

The SSP platform is open standard and complies with all interoperability standards as well as interfaces with SAP and other enterprise planning systems.

AlpVision has taken a big step forward in providing mobility for on the fly genuine or fake verification of moulded parts with an iPhone4 mobile device. The application is suitable for many items, for example for fast-moving consumer goods containers for liquid, powder or tablets, which are present in millions of stores worldwide. Moulded parts are heavily used in toys, footwear, home appliances, circuit breakers and many other products in industrial and consumer markets.

Using AlpVision’s patented Fingerprint technology, a regular Apple iPhone4 equipped with the AlpVision ‘Genuine or Fake’ detection application is sufficient to verify the authenticity of a moulded part anywhere, anytime. This anti-counterfeiting solution does not need any additional marking of the moulded part and its use is very intuitive.

After selection of a product type, for example, a 300 ml container, and a mould cavity number that is visible on the item, an overlaid shape appears on the iPhone4 screen. Then the user has only to position the iPhone4 to match the overlaid shape with the item to be verified. If the item is genuine, a beep sounds and a message appears on the screen. A genuine or fake verification usually takes about three seconds, most of which is taken up by the time it takes to pick up the item and position the

The system is able to deliver unique and random serial numbers (Kezzlercodes) at ultra-high speed, which can be applied directly on the manufacturing lines to the packs and allow for multilevel hierarchies of cartons, master cases and single packs. Kezzlercodes are then used to identify exactly when, where and by whom a product was manufactured and by whom any individual product was first purchased.

The technology provides detailed realtime product traceability as well as ubiquitous authentication and its advanced heuristics help detect suspicious activity in the supply-chain.

Kezzler’s SSP is open-standard and technology-agnostic and does not require the acquisition or installation of specialised hardware or software, thereby reducing IT investment.

Kezzler AS +34 662 557 808 t.urquhart@kezzler.com www.kezzler.com

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iPhone over it. This performance is achieved through the iPhone4 application working in real-time at a rate of 10 detections per second; similar to reading a barcode with a laser scanner.

According to the company, this is a breakthrough in authentication processes that will allow branded product manufacturers to multiply the number of verifications made worldwide through provision of the iPhone4 application via online download.

AlpVision SA +41 21 948 6464 fred.jordan@alpvision.com www.alpvision.com

SHOWCASE Docking System Simplifies Charging and Discharging of Big Bags

CONTAINMENT

Safe and efficient filling and emptying of big bags is challenging, but Dec now offers a transfer solution that protects both operator and environment.

The UniDock System allows for efficiency, high containment levels and easy operation. It is designed for solventmoist products and is compatible with standard FIBCs. A protection sleeve excludes any contact with the product.

The pressure-tight equipment is available in standard (LPDE) or HighStress

5D Containment Screens Provide OELs Down to <1 µg/m3 According to Hosokawa Micron, it is now able to offer innovative designs of downflow booths, featuring the very latest development of 5D Rigid Containment Screens that can offer powder handling operatives unprecedented Operator Exposure Levels (OELs) as low as <1 µg/m3, dependent on application.

The new 5D Containment Screens create a physical barrier between the operator and the source of dust particles, enabling contamination levels of <1 µg/m3 to be achieved, a result more routinely achieved in a glovebox or isolator. The 5D screen option offers movement up and down, back to front, side to side, tilt and pivot, giving operators greater operational movement than other restricted movement screens.

Because operatives have more freedom of movement, they are able to carry out processing and packing tasks simply and effectively with no deviation from standard operating procedures.

The screens move easily to allow the operator maximum freedom to carry out procedures without restriction, however they can also be locked into set positions should this be required for safety reasons whilst undertaking specific tasks. When not in use, the screens can be secured against the wall of the booth.

The 5D screens are the latest addition to the range of rigid and flexible 2D, 3D

versions and complies with cGMP requirements. The system can be easily cleaned in place.

With easy handling and minimal cleaning efforts, the UniDock System combines essential advantages for the use of big bag filling and emptying tasks.

Dec Group +41 21 694 20 40 g.mikhaiel@dec-group.ch www.dec-group.net

Split Butterfly Valve Minimises Operator Exposure to Liquids and Powders

and 4D screens. The rigid screens are manufactured from glass or clear Perspex for optimum visibility and are available in any size. Customers can choose from a range of neoprene, vinyl or latex glove or gauntlet options fitted within the screens to suit individual requirements. It is also possible to retrofit the containment screens into existing downflow booths to improve operator protection levels.

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

When it comes to transferring powders and liquids, one of the biggest problems is containment of any spillage at the point of connection and disconnection. Powders offer additional challenges as they are often more abrasive to valves and seals, as well as being more difficult to contain.

Dry Link has been used for many years to solve issues with liquid spillage, but now offers a solution for powder applications.

Dry Link is based on a split butterfly valve design that addresses many of the reported problems with other valve types such as dead volume, weight and ease of operation. The valve design consists of two halves of a body. A single flowcontrol handle opens both halves simultaneously; the patented triple sealing design then ensures clean, secure and safe product transfer. Built-in safety interlocks prevent accidental separation.

The smooth bore has no voids, dead

spaces, crevices or fillers to trap material, meaning efficient cleaning can be done using CIP/SIP methods. The valve surface finish, end connections and seal materials can be specified to the customer’s application requirements, available in Stainless Steel, Hastelloy and Alloy 20.

BioPharma Dynamics +44 1235 750690 info@biopharmadynamics.com www.biopharmadynamics.info

Gland Seal Solution for Cleanrooms The MUCON Iris Diaphragm Valve (IDV) has proved itself to be one of the most versatile flow control valves for dry bulk solids. When fitted with an elastometric diaphragm, the valve is capable of closing around lumps of products or even foreign bodies trapped during closure, whilst still providing an effective seal to smaller particles and dust. It is this reportedly unique feature that has enabled the MUCON IDV to be used for a variety of unusual valving applications.

One of these applications is sealing around service tubes between cleanrooms.

The problem — The transfer of material from one ‘condition’ to another, for example, between light and dark rooms or rooms with a pressure differential. Should cleanrooms operate at a slight over pressure, with one being at a higher pressure than the other, problems or pressure loss can occur on a regular basis.

The need — Operators require an effective, hygienic and reliable way of sealing around the tubes passing ‘through the wall’, separating one condition from another, such as temporary sealing of service pipework or

High Containment Filtration and Drying Technology

tubing, for example, CIP and gas pipes.

The solution — The MUCON high hygiene K-Series Iris Diaphragm Valve, with quick-disconnect flanges, brings the tubes together and closes tightly around them. The material flows freely without pressure leakage or damage to the tubes.

The one piece moulded diaphragm also acts as the valve gasket. In addition, both the diaphragm and the valve itself can be removed easily without tools.

Process Components Ltd +44 1615 412000 sales@pro-components.com www.pro-components.com

The new GFD (glass filter dryer) FilterBox is a high containment laboratory filtration and drying technology that offers a small-scale solution to PSL’s larger FilterBox products.

According to PSL, the FilterBox is a revolutionary technology that consists of a small- to large-scale agitated nutsche filter dryer (ANFD) or GFD completely integrated within a PSL isolator, providing high containment for highly potent APIs and other highly active or cytotoxic compounds. It achieves containment to nanogramme levels, protecting both the product and operator during operations that include charging, sampling, filtration, drying and discharging, as well as base opening and washing, filter mesh inspection and swapping. Cleaning can be performed safely and thoroughly as the complete vessel base, filtration media and discharge plug can be accessed in a contained environment.

The FilterBox provides a more compact design than traditional, separate ANFD and containment products, reducing floor space requirement and impact on

EPM 18

plant design. The FilterBox solution is easily scalable for laboratory to industrial production, including 0.002 m2 to 0.3 m2 ANFDs. The GFD Filterbox is part of the FilterBox family and can comprise 0.002 m2 to 0.05 m2 GFDs. The GFD itself works on a vacuum and has a heated jacket for drying and a removable filtration basket for collection of the product.

Powder Systems Ltd +44 151 448 7700 sales@powdersystems.com www.powdersystems.com

buyers’ guide

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Ovens — Vacuum

Ovens — Sterilising

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Bolz-Summix, UK & Ireland +44 161 4855494 adriancameron@acprocess.co.uk www.acprocess.co.uk

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Safety drying ovens and tempering ovens.

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Caleva Process Solutions, UK +44 1258 471122 steve@caleva.co.uk www.caleva.com

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°Celsius, The Netherlands +31 416 382292 info@celsius.nl www.celsius.nl

Caleva dryer for very small quantities in R&D only.

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Diosna Dierks & Söhne GmbH, Germany +49 541 331040 info@diosna.de www.diosna.com

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GEA Pharma Systems - Collette +32 3 3501211 wim.vandergoten@geagroup.com www.gea-ps.com

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Glatt GmbH, Germany +49 7621 664 0 info@glatt.com www.glatt.com

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Heinkel UK & Ireland, UK +44 161 485 5494 adrian.cameron@acprocess.co.uk www.acprocess.co.uk

Filter centrifuge, lab, pilot and production dryers.

New and refurb dryers.

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Hosokawa Micron BV, The Netherlands +31 314 373333 info@hmbv.hosokawa.com www.hosokawamicron.nl

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Hüttlin GmbH, Germany +49 7622 6884 0 info.packaging-scm@bosch.com www.huettlin.com

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Lödige Maschinenbau GmbH, Germany +49 5251 309 0 lemperle@loedige.de www.loedige.de

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Martin Christ Freeze Dryers, Germany +49 5522 500 0 info@martinchrist.de www.martinchrist.de

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Vacuum dryers, continuous granulation dryers and vacuum mixer dryers.

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Neuhaus Neotec GmbH, Germany +49 4221 859 0 info@neuhaus-neotec.de www.neuhaus-neotec.de

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O’Hara Technologies Inc., US +1 905 7073286 david.decker@oharatech.com www.oharatech.com

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

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Usifroid, France +33 1 3013 1870 info@usifroid.com www.usifroid.com Vector Corporation, US +1 3193778263 mike.bailey@vectorcorporation.com www.vectorcorporation.com

Ovens — Microwave

Vacuum mixer dryer. l

Binder GmbH, Germany +49 7462120050 www.binder-world.com info@binder-world.com

IMA S.p.A. - IMA Active +39 051 6514111 tenorec@ima.it www.ima.it

Ovens — Drying

OTHER

Dryers — Vertical

Dryers — Spray

Dryers — Spiral

Dryers — Shelf, Truck, Vacuum

Dryers — Shovel

Dryers — Rotary

Dryers — Pan

Dryers — Ribbon

Dryers — Paddle

Dryers — Microvawe

Dryers — Liquid

Dryers — Gas Assisted

Dryers — Freeze/Lyophilisers

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Dryers — Fluid Bed

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Dryers — Flash

Dryers — Conical

amixon GmbH +49 5251 688888 0 mboening@amixon.de www.amixon.com

Dryers — Continuous

Dryers — Air

drying & moisture control

DRYING & MOISTURE CONTROL EQUIPMENT

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Agitated Nutsche Filter Dryers and Glass Filter Dryers for lab.

Corporate News

Global Partnership to Offer Flexible Biopharma Production Platforms Sartorius Stedim Biotech (SSB) and GCon have entered a global collaboration to offer highly advanced and flexible production platforms for the biopharmaceutical manufacturing industry. The new product line will leverage G-Con Manufacturing’s modular, mobile cleanroom pods and SSB’s single-use and reusable product portfolio to create a totally integrated production process platform.

SSB has incorporated its products into unit operations for media/buffer preparation, seed fermentation, cell cultivation and harvesting, ultradiafiltration, membrane chromatography and viral clearance for biopharmaceutical development and manufacturing. Combining SSB’s technology with G-Con’s modular, scalable and flexible pod platform will reportedly provide the biopharmaceutical manufacturing industry with an unparalleled set of costeffective, plug-and-play tools for nextgeneration manufacturing facilities.

Maik Jornitz, SSB’s SVP of Marketing for Bioprocess Solutions (pictured) commented: “The combined product portfolio will fundamentally change the way biopharmaceutical manufacturing processes will be designed and configured. Our Integrated Solutions unit will implement G-Con’s platform of modular cleanroom systems into its designs. In addition, our teams will benefit from G-Con’s engineering and design expertise. Our vision is to create standardised unit operations,

Expansion of Cleanroom Wipe Products Facility in China

implemented into the selfcontained GCon modules.

These modules can be used as individual process units or joined to an entire process.”

Barry Holtz, President of G-Con Manufacturing, stated: “Our common goal is to combine our complementary expertise to develop revolutionary solutions for the next generation of flexible, single-use manufacturing concepts. We couldn’t be more excited about having an agreement with a leader in single-use products like Sartorius Stedim Biotech.

Effective immediately, G-Con’s modular containment units are available through SSB’s Integrated Solutions unit and will be rolled out globally in early 2012.

Jornitz concluded: “We did not want to delay the availability of the G-Con units and therefore decided to have our Integrated Solutions unit utilise the containment systems and G-Con’s engineering capabilities now. The global launch through our sales organisations will follow.”

Sartorius Stedim Biotech +33 442 845600 info@sartorius-stedim.com www.sartorius-stedim.com

The CPIER’s education programme has a faculty of approximately 80 lecturers and 170 master’s degree students who work at manager-level positions in the biopharmaceutical industry. Merck Millipore — the only filtration and separation company invited to participate in the master’s course — teaches a module on quality and production processes, focusing on sterilising filtration, aseptic processing and critical filter validation.

In 2011, Merck Millipore opened a state-of-the-art Biopharmaceutical Technical and Training Center in Shanghai, China, reinforcing its commitment to support the production of safe, quality drugs in the region.

CPIER will utilise the centre for GMP and aseptic process manufacturing training.

Merck Millipore +1 781 533 5197 janice.paquette@merckgroup.com www.merckmillipore.com

Cornelius Choi, General Manager for Contec China. “From increasing our manufacturing to additional R&D capabilities, our new space allows us to meet the needs of the growing Asian cleanroom market.”

“As we grow as a company, our facilities need to change to meet the needs of our pharmaceutical customers,” said Jack McBride, CEO at Contec, Inc. “We are proud to continue serving our customers in Asia and Europe. Our hope is that our new facility will further help us meet their needs and exceed their expectations.”

Contec, Inc. +44 845 652 2582 wipers@contecinc.com www.contecinc.com

Corporate Identity Re-Design for Packaging Specialist

Collaboration to Advance Training of Pharma Manufacturing and Regulatory Professionals in China Merck Millipore, the Life Science division of Merck, has been invited to serve on the faculty of the Center for Pharmaceutical Information and Engineering Research (CPIER) at Peking University in China. The groundbreaking programme, established in 2006 with the help of the U.S. Food and Drug Administration, relies on faculty from industry partners to prepare master’s degree candidates in its international pharmaceutical engineering programme.

Through the programme, these future leaders gain a deeper understanding of pharmaceutical R&D, manufacturing and regulatory agencies in China.

“It’s a privilege for Merck Millipore to collaborate with top pharmaceutical companies and regulators in delivering a curriculum to advance industry best practices in China,” said Jean-Paul Mangeolle, Head of Merck Millipore’s Process Solutions business. “Our expertise will help ensure that education focuses on the quality and safety of products — made and consumed locally — in the years to come.”

Contec is always looking for new ways to meet its pharmaceutical customers’ needs and demands. To serve its growing customer base in the Asia-Pacific and European market, Contec’s facility in China has expanded its offices and manufacturing facilities in Suzhou Industrial Park in Suzhou, China.

Contec has been manufacturing in China for the last five years and made the decision to expand its operations.

After months of planning, the company is now operating on a full-scale basis at the new facility.

“The new facility has approximately 70,500 square feet of manufacturing space, with room for future expansion,” said Don Batts, Project Manager. “It includes state-of-the-art ISO Class 4 and ISO Class 6 cleanrooms, laundry and saturation, allowing Contec to continue making the quality cleanroom wipe products people are used to seeing.”

Having manufacturing, quality and R&D capability in both the US and China allows Contec more flexibility and gives its international customers more options than ever before.

“We took many things into account with the design of this new facility,” said

Following rapid growth in the past years, Optima has accentuated the unity of the company with a new corporate design.

The Optima Group will roll out its new image worldwide.

“We want to present ourselves with the single brand Optima in the future,” explained the company President Hans Bühler.

“We are one company, have one spirit and speak one language. That should be made visible.”

The most obvious change is the new company logo, which focuses on the essentials; it is easily legible and succinct. The wordmark appears in bright blue and stands as the corporate brand for all Optima worldwide.

“We’ve begun with the primary communication methods, converting the homepage, letterhead and business cards to the new format. The remaining conversions will take place later in the year, with our machine labelling and at trade shows; Optima worldwide will change to the new design,” explained

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Marketing Director Sabine Gauger. “We want to further strengthen the Optima brand worldwide.”

Corporate design incorporates specific style characteristics that allow a company to present itself in a visually standardised way. In this way, the presence appears to be cast from a single source. At the same time, employees save time when the layouts are defined and made available for use.

The brand recognition in advertisements and at trade shows will increase.

OPTIMA packaging group GmbH +49 791 506 1410 sabine.gauger@optima-ger.com www.optima-ger.com

LABORATORY PRODUCTS & EQUIPMENT

soundbyte

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In the R&D environment, the need for new and novel solutions to manufacturing and analysis issues is simply a way of life.

I have found EPM invaluable for keeping abreast of new and developing technologies, particularly the growing range of technologies for enabling Quality by Design.

John Gamble, Senior Research Scientist, Bristol-Myer Squibb

Spectroscopic Imaging System Targets Pharma R&D Market Advantest Corporation has developed a desktop spectroscopic and imaging system for the pharmaceutical R&D market, the TAS7500, which utilises terahertz waves to perform nondestructive sample analysis.

The TAS7500 relies on a proprietary method developed by Advantest to achieve rapid, non-destructive imaging and analysis of pharmaceutical samples in the liquid or solid state. Crystalline qualities, the characteristics of constituents and even the thickness, density and internal structure of pill coating — formerly impossible to analyse non-destructively — may be analysed and visually rendered in two or three dimensions. The system offers lower costs and higher efficiency at all stages of drug development from laboratory research to process scale-up.

According to Advantest, the TAS7500 is poised to contribute to the new approach to pharmaceutical R&D, which is based on intelligent risk management

and incorporates the ICH2 guidelines that are being adopted by an increasing number of firms.

The terahertz technology powering the TAS7500 is capable of acquiring fingerprint spectra based on molecular interactions in the terahertz frequency range, making the system ideally suited to rapid evaluation of the crystalline properties of drugs, which has grown progressively more complex in recent years. Three different measurement modes — transmission, reflection and attenuated total reflectance — are available by one-touch module exchange, enabling the system to analyse the physical and spectral characteristics of drugs in any form from liquid to solids, pills and tablets. The design of the TAS7500 emphasises ease of operation and allows for rapid set-up.

The TAS7500 houses Advantest’s

proprietary terahertz wave, highperformance optical sampling technology, facilitating high measurement throughput, in a compact tabletop unit that can easily be installed wherever it is needed.

Advantest Europe GmbH +49 89 993 12 131 products@eu.advantest.com www.advantest.com

Light Scattering Supports Formulation Development for Novozymes’ Recombinant Albumins Scientists from Malvern Instruments and from biological ingredients and technology developer Novozymes Biopharma have successfully completed the first phase of extensive collaborative studies. These have involved the application of Malvern’s light scattering technologies in evaluating the formulation stability of two of Novozymes’ leading recombinant albumin products — Albucult and Recombumin — which are used in the manufacture of human therapeutics.

The teams applied the resolving and detection capabilities of size exclusion chromatography light scattering (SECLS) and dynamic light scattering (DLS) offered by Malvern’s Zetasizer Nano system to monitor the stability of these Novozymes products. These results have now been published as a series of application notes that are freely available on the Malvern Instruments website: www.malvern.com/labeng/industry/protei n/novozymes.htm.

Mark Perkins, Customer Solution Specialist, Novozymes, explained: “When developing an API, it is important to design a formulation that offers longterm stability over a range of storage conditions. Liquid formulations allow

”

easy and economical product handling during manufacture and convenience for the end-user, but some proteins prove difficult to formulate in this way. Recombumin and Albucult have been designed to aid in the development of liquid formulations of unstable APIs and a detailed understanding and confirmation of their stability under a variety of conditions is essential. The Malvern systems have proved highly effective in this application, allowing us to further demonstrate the stability and purity of our products and how this may be translated into improving liquid biopharmaceutical formulations.”

Malcolm Connah, Product Marketing Manager, Malvern Instruments, said: “Malvern is delighted to be working with

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a company so active in this important area of biopharmaceutical development.

We look forward to seeing Recombumin and Albucult helping in the delivery of drugs and vaccines that are challenging to formulate.”

Malvern Instruments Ltd +44 1684 892456 salesinfo@malvern.com www.malvern.com

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Semi-Automated Diluter/Dispenser Simplifies Compliance to FDA GXP Regulations HAMILTON Bonaduz has announced the newest feature of the semi-automated diluter/dispenser MICROLAB 600 — a comprehensive compliance package for the laboratory in regulated environments such as pharmaceutical and forensics.

The MICROLAB 600 now provides a variety of security protections and simplifies adherence to CFR 21 Part 11 and FDA GLP/GMP regulations.

Highlights include the ability to administer user accounts and passwords, log methods with electronic signature capability and print documentation.

The new MICROLAB 600 software, which is field-upgradable free of charge and included in all new instruments, is now available in ten languages, adding convenience for HAMILTON’s customers worldwide. For laboratories

that require report printing directly from the instrument, the software update integrates with a new printer accessory kit. It is also compatible with LyncStore, a PC-based log file management system that allows users to sort, save and print files from any computer.

“Our new MICROLAB 600 instrument has seen success in a wide range of industries and geographical areas and we have collected a good deal of feedback from customers,” said Dr. Clara Caminada, Head of Marketing Laboratory at Hamilton Bonaduz, Switzerland.

The MICROLAB 600 semiautomated laboratory diluters and dispensers streamline sample preparation. Based on HAMILTON’s reportedly leading syringe technology, the MICROLAB 600 instrument has been designed to offer ease of use, precision and cost effectiveness.

Laboratory Online News...

EDITOR’S PICK! Jet Mill for Highly Effective Micronisation of Limited and Costly Products The new DEC MicroJet 10 is perfect for R&D teams that need to jetmill very small quantities of material (50–1500 mgs), allowing more trials using limited or costly products that require very high yields up to 99.9%.

Based on computational fluid dynamics technology, the DEC MicroJet 10 is the first in a series of jet mills to be released.

The system fits into the existing MCOne chassis and can operate independently with just a nitrogen bottle and with the process operating at a constant temperature. The powder is fed into the system through the new Rota-Feed system, allowing nano quantities to be micronised. This, in turn — with the monoblock design and the use of smoothflow technology — ensures high velocities and increased energy is imparted to the particles entering the milling chamber.

The system’s internal design uses pressurised air or nitrogen. Particles in the milling chamber are accelerated to supersonic speed by a series of specially designed jets around the perimeter.

twitter.com/ epmmagazine.com

Intelligent Peristaltic Pumps Operated by Icon Driven Interface UniSpense PRO and OmniSpense ELITE pumps are their small footprint and angled polarised display, making them perfect for use under a fume hood or biological safety cabinet. Calibration of the new pumps is easy — a single intuitive calibration screen walks the user through the process stepwise, thus eliminating time-consuming scroll through menus and complicated instruction manuals. Additionally, the OmniSpense ELITE and UniSpense PRO can be outfitted and programmed for specific processes. Once saved, these programmes can easily recalled, ensuring a quick application turnaround.

WHEATON’s new OmniSpense ELITE and UniSpense PRO peristaltic pumps are for any laboratory or clinical setting where accurate and precise liquid dispensing is important.

WHEATON +1 856 825 1100 tracy.neri-luciano@wheaton.com www.wheaton.com

Dec Group +41 21 694 20 40 g.mikhaiel@dec-group.ch www.dec-group.net

e

HAMILTON Bonaduz AG +41 81 660 67 41 mnipius@hamilton.ch www.hamilton.ch

WHEATON has launched two new peristaltic pumps; the UniSpense PRO and OmniSpense ELITE. These peristaltic pumps have been developed to facilitate precise performance and operation, minimising researchers’ time and effort, while achieving accurate sample handling.

According to the company, the UniSpense PRO and OmniSpense ELITE are designed to be the smartest intuitive dispensing pumps on the market and are operated by an icon-driven interface that features the largest display screen available. The systems are operated via a large 5” backlit liquid crystal display with a chemical resistant keypad and options are displayed as large icons for quick operation and easy recognition in any language, any geography and any country. WHEATON’s new peristaltic pumps will simplify and accelerate laboratory throughput for dispensing or aspirating multiple aliquots or even for small filling operations.

Additional highlights of the new

The micronising effect occurs when the slower incoming particles and the faster particles collide. The centrifugal forces retain the particles longer in the milling chamber. Increased residence time results in a more controlled product and, if required, a finer product will exit with the exhaust gas from the centre of the chamber to be separated from the gas stream and collected with yields close to 100%.

To see the DEC MicroJet 10 in action, watch the video at www.epmmagazine.com.

Laser Etched 2D Tube Coding Ensures Secure Traceable Sample Storage Identifying samples via codes on the tubes can be done in a number of ways.

However, the most reliable in terms of long-term identification and tracking of samples is via a 2D coding on the bottom of the tubes. However, not all 2D coded sample storage tubes, even those using the same coding system, offer the same storage performance.

Barcodes on Micronic 2D Data Matrix and 2D TraXis coded tubes are permanently laser-etched into the tube surface, making them especially resistant to solvent attack and wear.

According to the company, uniquely manufactured from a single component, the code in Micronic laser encrypted 2D codes cannot fade or peel off, even when subjected to repeated handling and freeze-thaw cycles. Because code clarity will remain unchanged throughout the lifetime of a Micronic 2D coded tube, it reportedly offers unmatched secure sample traceability.

A new white paper available from

Micronic examines factors affecting establishing a secure traceable stored sample, including robustness of the tube coding, the purity of polymer used for tube manufacturing and having effective means of sealing tubes.

Manufactured to industry-leading strict tolerances, the precision and tube-totube consistency of Micronic sample storage tubes maximises uptime when used with automated handling systems.

Micronic Europe BV +31 320 277070 sales@micronic.com www.micronic.com

Online Chromatography Method Development Sharpshooting Thermo Fisher Scientific enables analysts to quickly and simply obtain technical advice to help resolve common problems with Liquid Chromatography (LC), Gas Chromatography (GC) and Solid Phase Extraction (SPE) protocols. The interactive ‘Troubleshoot an issue’ tool is available on the Thermo Scientific Chromatography Resource Center (CRC) and brings easy-to-access technical expertise to the user’s computer. Simply identify the issue from the list of common EPM 22

symptoms for help in finding the common causes and solutions.

Visit www.thermoscientific.com/crc to access the ‘Troubleshoot an issue’ tool, for rapid access to help with LC, GC and SPE applications from the experts at Thermo Fisher Scientific.

Thermo Fisher Scientific Inc. +1 978 905 1201 tracy.cartier@thermofisher.com www.thermoscientific.com/crc

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP FDA Purchases Imaging Particle Analysis Instrumentation System

Stability Trials LIMS Software Speeds Access to Data and Offers Major Time Savings

The U.S. Food and Drug Administration (FDA) has purchased the FlowCAM particle imaging and analysis system from laboratory instrumentation manufacturer Fluid Imaging Technologies, Yarmouth, Maine.

Proven in use for product formulation and quality assurance at global food, beverage and biopharmaceutical giants, the FlowCAM met FDA solicitation requirements for an imaging-based particle analysis (flow microscopy) instrument that offers continuous, microscopic, nondestructive viewing of samples and measures near transparent particles with particle size analysis from 2 µm and up.

The FlowCAM’s ability to automatically detect and image particles in samples of 0.5 ml volumes at greater than 85% volume efficiency, measure their size and morphology and execute pattern matching functions during image acquisition while providing a particle count and percent by type met the FDA technical requirements. Its ease of use and ability for operators to immediately view results and interact with images and data in real time in an Excel format also met the requirements.

Laboratories in the pharmaceuticals, food and drink industries regularly need to check the stability of their products and raw materials over prolonged periods of time, which is why Two Fold Software is adding a user-friendly Stability Trials software module to its Version 1.1 release of the company’s innovative Qualoupe LIMS software.

The new Stability Trials software has been specially tailored for organisations that need to run stability trials over any given period of time and different storage conditions. Using the software, the user can create protocols for parameters such as sampling regimes, detailing storage conditions, sampling frequency and time units.

When running a trial, the user can select the protocol that would then create the scheduled samples for the trial. The material being trialled would associate the methods to be performed on the samples. Trials can be associated with studies and projects. The Stability Trials software also enables the LIMS to provide prompts for sample pull schedules and the storage location.

“Qualoupe’s Stability Trials software module is much easier to use than having to rely on desktop PC tools such as Excel or using a paper-based system,” explained Clive Collier, Two Fold Software’s Managing Director. “A key benefit is that by using the Stability

Previously selected by GlaxoSmithKline, Pfizer, Amgen, Roche, Heinz, the U.S. EPA and the U.S. Army, among many other organisations, the FlowCAM replaces labour-intensive, manual microscopy with automated instrumentation that rapidly detects and images individual particles in a fluid sample. The images are saved with their corresponding size, shape, count and dozens of other measurements for further review and analysis using the company’s companion VisualSpreadsheet analysis software.

Fluid Imaging Technologies, Inc. +1 207 846 6100 faith@fluidimaging.com www.fluidimaging.com

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Trials software you cannot forget to perform the testing of samples on the allocated day. The software helps to collate the sample data of all samples tested through the trial. Seeing as some trials can continue for years, the new software offers significant time savings and quick access to the data, as well as a detailed reporting capability.”

The Stability Trial software is one of a trio of new modules now available as part of Qualoupe’s new Version 1.1 LIMS software release. The other modules provide enhanced solutions for managing consumable stock control automatically, as well as a Multi-Group capability that offers complete data management flexibility for organisations and companies that not only have multiple sites, but also include multiple laboratories within each site.

Two Fold Software Ltd +44 844 208598 info@twofold-software.com www.twofold-software.com

LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Stackable Cubic Desiccators Save Benchtop Space

Rapid Multispectral Imaging for QC Labs

For many laboratories, available work space can be an issue, for example, where a range of tasks and applications require essential equipment, yet available benchtop space may be limited. With these situations in mind, Jeiotech has developed a range of Multi-Storey Cubic Desiccators that overcome the space inefficiencies of traditional round desiccators, which occupy a large bench area whilst providing only a small circular shelf for actual sample placement.

Available from laboratory equipment specialist Medline Scientific, this range comprises four multi-shelved, stackable cubic desiccators that are made from highly transparent, non-corrosive and shatter-proof polycarbonate. The internal volumes range from 11 up to 45 l, with between two and six shelves (model dependent) and this significantly enhances the storage capacity of the desiccators.

However, less space and more compact does not mean fewer features.

For example, each unit has a full front door that uses a grease-free, airtight vacuum seal, which ensures that a

Until recently, the quality control of variable products such as seeds, powders or cosmetics would be subjective, time-consuming and expensive. To get reproducible results took hours with traditional analytical techniques and relying on human judgement introduced errors. The VideometerLab provides a solution at a stroke. The system photographs samples at twenty different wavelengths and then through the application of sophisticated statistical software, the detection and characterisation of contaminants as small as 45 µm (the size of a pollen grain) is possible. The VideometerLab can operate at wavelengths outside human vision — Near Infrared and Ultraviolet — and therefore useful information may be generated about texture, water saturation and fluorescence behaviour.

The system has been designed for fast analysis with minimum user interaction. It can automatically detect features that the user has previously defined as important.

For example, it is a simple task to identify an out-of-specification tablet in a single measurement taking six seconds or automatically detect Fusarium infection on barley grains. The analysis uses a combination of wavelength

vacuum of 1 Torr over 72 hours is held.

Also, a vacuum gauge is mounted on the top left-hand side of the door while the three-way stopcock mounted on the left-hand side of the chamber allows for the removal and replacement of the internal atmosphere as and when needed.

To further compliment the range, each unit is available in smoked acrylic to block UV light, which facilitates the safe storage of light sensitive products without the risk of discolouration.

In addition to the Multi-Storage Cubic Desiccators, Medline offers a range of traditional round-bottomed desiccators that are also made from polycarbonate, should this style be the preferred option.

Medline Scientific Ltd + 44 1865 400321 sales@medlinescientific.com www.medlinescientific.com

determination of tablets’ CU is a fast and accurate means of monitoring tablets that could be used for production and is consistent with the FDA’s PAT initiative.

For more information about this article, contact Applications Scientist Robert Mattes on the email address below.

FOSS NIRSystems, Inc. +1 301 680 9600 rmattes@foss-nirsystems.com www.foss-nirsystems.com

Petri Dish Imaging System Don Whitley Scientific has launched a new Petri dish imaging system that fits inside a workstation so that plates can be photographed during incubation without having to remove them from the workstation environment. The Whitley Petrifoto System features a Canon compact digital camera with auto focus, a wide angle zoom lens and a 12.1 megapixel high-resolution sensor, all designed to elicit good quality images from even the most amateur of photographers.

The robust unit is small enough to pass through a workstation airlock, so can be moved in and out of a workstation when required. The lighting system — a 3D light box fitted with multiple daylight colour temperature LEDs for realistic colour rendition — has underside and side lighting, which can be controlled independently. This means

AnalytikLtd +44 870 991 4044 tom.greenwell@analytik.co.uk www.analytik.co.uk

iPhone App for Selecting Bottles and Carboys

Article on Near Infrared Analysis of Tablets Containing Two Active Ingredients FOSS NIRSystems has announced that a new NIR article has been published on the subject: Near Infrared Analysis of Tablets Containing Two Active Ingredients.

This study evaluates Near-Infrared (NIR) analysis of tablets nominally containing 4 mg of chlorpheniramine maleate (CPM) and 10 mg of phenylephrine hydrochloride (PE-HCl) per dose. The data showed promising results that could relieve laboratory workload and bring analysis closer to real time for process monitoring. Ten tablets could be analysed in less than three minutes. The NIR assay for the

response and geometric information.

Multispectral imaging first appeared in the late 80s, but has only recently been adopted with imaging techniques becoming less expensive, more reliable and rapid. The VideometerLab provides a cost-effective alternative to comparable systems. It operates non-destructively in ten seconds or less and is delicate enough to use on extremely fragile materials.

Thermo Fisher Scientific has created a free iPhone and Android app for the selection of Thermo Scientific Nalgene bottles, carboys and vials. Based on their specific laboratory needs, users simply insert a Nalgene catalogue number or search terms and the intuitive app recommends the most appropriate container from Thermo Fisher’s extensive inventory of almost 700 choices. Results are based on the specific properties for chemical resistance, autoclavability, inertness, temperature tolerance and a host of other parameters and certifications for the customers’ individual laboratory activity.

To further refine product recommendations, users can change search criteria and view technical drawings and dimensional outputs to assess product suitability before purchase. Results can be saved for further study or sent to an email address.

Nalgene bottles have reportedly set the standard for quality and superior

performance for more than 50 years.

Each Nalgene bottle comes with a leakproof guarantee to protect valuable liquids. Sizes range from 4 to 50 l and small quantity to bulk packs, so scale-up can occur without the need to revalidate materials as projects progress from research into production. Nalgene bottles and containers are available in a wide range of certified materials for laboratory, food and pharmaceutical use.

To download the free Thermo Scientific Nalgene bottles and carboys app, go to the iTunes store or Android Market and search for Nalgene Bottles. Visit www.thermoscientific.com/nalgenecontai ners for more information or to try the Bottles and Carboys selection guide before downloading it. iPhone is a registered trademark of Apple Inc. Thermo Fisher Scientific Inc. +1 978 905 1201 tracy.cartier@thermofisher.com www.thermoscientific.com/crc

Microfluidic System Enables Nanoparticle Synthesis

it is suitable for all agar and colony types.

The Whitley Petrifoto System comes with an SD memory card and is compatible with Eye-Fi wireless memory cards to allow automatic image transmission to an external PC or MAC. Don Whitley Scientific Ltd +44 1274 595728 sales@dwscientific.co.uk www.dwscientific.co.uk

Dolomite has extended its range of system solutions to include an innovative Syringe-based Nanoparticle System, allowing users to generate polymeric, metal and semi-conductor nanoparticles from 1 to 100 nm in diameter, which benefits a wide range of applications, including biochemistry, drug delivery, biomolecular sensing and fibre-optics.

Built around Dolomite’s industry leading microfluidic pumps, connectors and chips, this easy-to-use system enables rapid and effective mixing of up to two reagents of 25 l to 10 ml. Using extra smooth pumps to deliver the reagents into the mixing region, the Syringe-based Nanoparticle System

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ensures precipitates of uniformly sized particles occur consistently throughout the sample, offering significant advantages over traditional techniques.

Operating over a wide flow range from 0.1 l/min to 10 ml/min, the system features a sample injection valve, reducing reagent consumption. An additional thermal control module ensures that constant temperatures are maintained throughout the experiment, ideal for targeted heating in biomedical applications.

The Dolomite Centre Ltd +44 1763 242491 info@dolomite-microfluidics.com www.dolomite-microfluidics.com

SHOWCASE COLD STORAGE Compact and Ecological -86˚C ULT Freezer for Secure Preservation of Samples Telstar has entered the field of ultra-lowfreezing by developing its own technology for cold storage applications.

Telstar Cold Storage technology has been applied to a new line of equipment focused on efficient and safe sample storage in the laboratory and research process. The new line of Telstar Igloo ultra-low-freezers ranges from low temperature range -45°C to ultra low temperature range -86°C. Under the green line concept, the new Telstar Igloo ultra-low-freezer offers -86°C temperature and provides an innovative and energy-efficient storage system, superior temperature performance and uniformity. It also offers the exceptionally low power consumption and low noise level (< 50 dB(A)) in a small footprint, which enables a more optimised freezer layout and the flexibility to adapt to any space.

This entry into the world of ecological and green ultra-freezing further expands Telstar’s offering of process solutions for biopharmaceutical laboratories and research centres through its own clean air, freeze-drying, containment, cell culture and, now, cold storage technologies. Telstar invests 3% of its turnover in R&D of its technologies and equipment.

Telstar Cold Storage offers ULT freezers in both -86˚C and -45˚C temperature configurations, all of which include Vacuum Insulation Panels. The freezers offer outstanding storage efficiency in

Energy-Efficient 700 L -86˚C Freezer

vials per m2 to save on valuable laboratory space.

According to the company, the combination of low power consumption, the lowest noise level and the standard use of ecological, green refrigerants makes it the most environmentally friendly ULT freezer range.

Reliable storage for valuable samples is safeguarded with the help of a highcapacity cooling system. All of this is controlled and monitored at eye-level by a complete, self-diagnostic control system. As a standard, internal materials are stainless steel; this includes inner walls, shelves and even the inner doors.

The Telstar freezer range offers both upright and chest models with capacities from 370 up to 830 l.

Telstar +34 93 736 16 00 marketing@telstar.eu www.telstar.eu

The new SANYO MDF-U76V ultra-low freezer combines improved cooling performance with reportedly outstanding energy efficiency. The advantages include greater security for precious research or clinical samples, as well as significantly lower running costs and added environmental benefits. A leading independent test institute in the Netherlands has measured the power consumption of the MDF-U76V at 13.77 kWh/24 hr. According to the company, based on current published data, this makes the MDF-U76V the most energyefficient 700 -86˚C freezer on the market.

This latest -86˚C VIP upright freezer has been specifically designed by SANYO to meet the growing demand for energy savings, without in any way compromising freezer performance. In fact, cooling efficiency, insulation characteristics and door-open recovery times have all been enhanced through exclusive SANYO innovations: a capillary tube heat exchanger, next-generation VIP PLUS insulation and the Cool Safe compressor. As a result, greater temperature uniformity throughout the freezer and faster temperature pull-down contribute to exceptional sample security.

SANYO’s advanced new capillary tube heat exchanger significantly increases the overall efficiency of the freezer. By optimising the available heat exchange areas, system reliability is also increased and energy consumption is cut. In

addition to helping minimise energy use, the high-performance patented vacuum panels together with high-density foam insulation enable SANYO VIP ULT freezers to provide up to 30% more storage capacity than a conventionally insulated freezer, saving valuable lab space. These two SANYO-developed technologies allow the use of smaller, high-efficiency 750W Cool Safe compressors in the MDF-U76V, which use less energy and reduce heat output.

An optional water-cooled condenser is available for the MDF-U76V. This enables laboratories with a chilled re-circulating water system to reduce the requirement for air conditioning within the freezer facility, reuse heat energy elsewhere and achieve even greater savings.

SANYO E&E Europe BV +31 76 543 38 33 sales.nl.seee@sanyo.com www.eu.sanyo.com/biomedical

CASE STUDY Newcastle University’s Estate Support Service (ESS) sees laboratory cold storage as a key target for energy savings.

Older -80˚C freezers can consume more than 20,000 kWh and cost over £2,000 a year to run.

Near the end of the 2008/9 financial year, the University’s Pro-Vice-Chancellor and Executive Board Portfolio Holder for Sustainable Development Professor Tony Stevenson was able to allocate £180,000 to a replacement programme.

Cara Tabaku, the Assistant Energy Manager, Steven Hogg, a Purchasing Officer, and technical managers from the Medical Sciences Faculty worked

NEWCASTLE UNIVERSITY IMPROVES ENERGY EFFICIENCY BY REPLACING LAB FREEZERS

together — within very short timescales — to plan and deliver the project.

Although energy savings were the main aim, additional considerations included easing floor space constraints (by replacing chest freezers with upright models) and improving reliability.

Departments were asked to ‘bid’ for replacements via a simple online form that asked for the type, size and age of their current fridges and freezers; 1,219 units were proposed, 512 of which were over 10 years old. Based on this initial

survey, the team assessed the energy consumption, initial purchase cost, space requirements and technical suitability of replacement options, and obtained quotes from a range of suppliers. Twelve suitable, energyefficient models were selected from two preferred manufacturers: Biocold for fridges and -20˚C freezers and New Brunswick Scientific for -80˚C freezers.

Bulk purchasing reduced the cost over less efficient models.

Sample energy consumption data was gathered by metering a range of existing fridges and freezers. The metering was generally carried out by technicians, with support from ESS. The results suggested that -80˚C freezers would have the best payback, so project funding was focused on replacing 36 of these that were more than 10 years old.

In most cases, this was with a New Brunswick U725-G model, which costs £527 a year to run at the University’s then rate of 9.5p per kWh. The result

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was a reduction from an average annual consumption of 9,349 kWh to 5,548 kWh, saving of £361 per annum per unit.

Key benefits include: •Newcastle University reduced annual electricity consumption by 136,836 kWh, saving £12,999 of expenditure and over 70 tonnes of CO2 emissions; •although chest freezers are more energy-efficient than upright ones, because cold air is relatively dense and does not escape as quickly when a door is opened, they require up to twice the floor space, so replacement by very energy efficient uprights was beneficial where space was constrained (as in several Medical Sciences laboratories); • and the school has avoided losing invaluable materials through the eventual breakdown of old equipment.

Eppendorf UK Ltd +44 1223 200 440 sales@eppendorf.co.uk www.eppendorf.co.uk

Corporate News

Pharmacy Academic to be Awarded Medal for Research into New Materials A scientist at the University of Reading, whose research into novel materials could provide new ways of administering vital drugs, is to be presented with an award for his work.

Dr. Vitaliy Khutoryanskiy, Reader in Pharmaceutical Materials at Reading’s School of Chemistry, Food and Pharmacy, has won the 2012 McBain

Medal for his visionary work in the field of colloid, polymer and interface science.

The medal, a joint award of Royal Society of Chemistry (RSC) and Society of Chemical Industry (SCI), will be presented to Dr. Khutoryanskiy at a oneday symposium in January 2013, at which he will deliver a keynote lecture.

Dr. Khutoryanskiy’s research is focused on the development of new materials to help in the administration of drugs, the treatment of wounds, and technology to contain innovative treatments, such as proteins, bacteria and living cells, such as stem cells, which could all help in the fight against disease.

His research of the behaviour of watersoluble polymers in solution mixtures has resulted in a number of advances leading to the formulation of nanomaterials, soft and superabsorbent hydrogels, thin films and microcapsules.

His research team has extensively studied the ability of various pharmaceutical polymers to stick to mucosal surfaces, such as those found in the mouth, stomach or on the surface of the eye, allowing new ways to administer drugs.

This sticking property allows drugs to be retained more easily where they are needed in the body. In the eyes, for example, conventional eye drops are quickly washed away by tears and blinking, but a sticky dose allows more drugs to penetrate the eye, making treatments dramatically quicker and more effective.

Hydrogels are also very promising for wound care applications, where their

ability to absorb large amounts of biological fluids is used to develop wound dressings that can aid the healing process, provide protection for the newly formed tissue and be easily removed without causing a trauma. Dr. Khutoryanskiy’s group has recently developed hydrogels that have excellent potential in this area, which are in development with a range of industrial partners.

Dr. Khutoryanskiy’s team has also developed different approaches for the encapsulation of proteins, probiotic bacteria and living cells, potentially leading to new approaches for the development and delivery of therapeutic treatments.

higher concentrations of pure protein product. In terms of practical applications, functional assays requiring pure protein, hybridoma screening, formulations and QC, for example, will all benefit from purification solutions that streamline workflows and foster better decision-making earlier in the research or discovery process.

“Our PhyTip column technology has added significantly to the arsenal of tools available to many researchers,” said PhyNexus CEO, Douglas Gjerde. “Through our collaboration with Rainin, we see an enormous opportunity to profoundly improve and expand the

capabilities of research labs by making powerful new sample preparation tools available to all life scientists.”

University of Reading, The School of Chemistry, Food and Pharmacy +44 118 378 7391 p.castle@reading.ac.uk www.reading.ac.uk

Joint Venture to Focus on Workflow Innovations for Life Scientists Rainin Instruments, a Mettler Toledo company, has launched a joint initiative with PhyNexus, Inc., maker of specialised sample preparation technology. The companies will leverage PhyNexus’ patented PhyTip pipette tip column technology to jointly develop products to better serve the research needs of life scientists.

By combining miniaturisation with high-performance, PhyTip columns eliminate many of the sample preparation bottlenecks encountered by researchers in their daily workflows. For protein purification, the technology is a natural fit with Rainin’s high performance pipettes and its 40-year record of advancing pipetting technology in ways that improve

accuracy, precision, ergonomics and workflow.

“This business initiative with PhyNexus is an important strategic opportunity for Rainin to further develop and expand its liquid handling systems portfolio,” said Leonard Pulig, Rainin General Manager.

“PhyNexus’ stellar reputation for innovation in liquid chromatography is a strong complement to Rainin’s considerable presence in the Life Science market and global reach through our parent firm Mettler Toledo.”

Because PhyTip columns can be used with a wide range of chemistries for life science applications, combining them with Rainin’s pipetting technology will speed sample preparation, save money by requiring fewer samples and produce

High-Tech Warehouse and Improved Logistics Set to Benefit Global Reference Material Customers LGC Standards can now offer its global customer base the benefits of its significantly improved central warehousing facilities in Wesel, Germany, reportedly setting the benchmark for handling and distributing reference materials.

The warehouse has improved centralised logistics services as well as a high-tech temperature and humiditycontrolled environment for all primary reference standards, certified reference materials, standard solutions, solids and matrix materials. Products are stored and monitored for humidity and temperature (from -70˚C to room temperature) to ensure quality during storage and transport, thereby ensuring the company adheres to current

regulations regarding dual-use goods, dangerous goods, controlled substances and precursors.

LGC Standards is now well-equipped to fulfil its expansion plans into Latin America, the US, Asia, North Africa, Australia and New Zealand. The Wesel warehouse will also play a large part in supplying products to LGC Standards’ latest acquisition and its first venture on the African continent — Industrial Analytical of South Africa.

LGC Standards’ customers will continue to place their orders in one of the seven LGC Standards offices across Europe and receive their invoice in their local currency, while the reference standards will be shipped directly to the customer with all relevant paperwork

from the Wesel central warehouse.

Reference materials suppliers across the world have partnered with LGC Standards to set up consignment stocks in Wesel, giving European researchers fast and easy access to reference materials of their choice. These include the Institute for Reference Materials and Measurements in Belgium, the Reference Materials Institute for Clinical Chemistry Standards in Japan and the National Measurement Institute of Australia.

LGC Standards +49 281 9887 277 claudia.ketteler@lgcstandards.com www.lgcstandards.com

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Rainin Instruments, LLC +1 510 564 1736 terry.peckham@rainin.com www.rainin.com

INGREDIENTS & CONTRACT SERVICES

soundbyte

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In today’s pharma industry, especially in the areas of drug product development and manufacturing, there

is a noticeable trend of increasing outsourcing services on a global scale. Also, many more drug product delivery systems in the market or under development require more complex and diverse excipients and key raw materials than ever before.

EPM provides a key service to the industry by dedicating sections covering these very important areas so that practitioners such as myself can benefit.

Kostas Saranteas, Executive Director, Process Chemistry and Engineering, Sunovion Pharmaceuticals Inc.

Pharma Manufacturer Appoints Site Manager for Cramlington API Facility Aesica has announced the appointment of a new site manager to lead its Cramlington facility. David Leaver has been promoted from the position of Operations Manager at the Aesica site, which is responsible for Aesica’s APIs production.

He will lead a team of over 130 staff.

“This is an incredibly exciting time to take on a senior position within Aesica,” commented Leaver. “Our recently announced strategic partnership in the controlled drugs arena with Noramco is a taste of things to come and my mandate is to realise our growth potential in the API field.”

Leaver has been with Aesica from its inception in 2004, having joined from BASF, and has been pivotal to its growth. In 2008, he moved to the company’s site in Queenborough, Kent, to oversee the transition from Abbott to Aesica and returned to Cramlington in 2010 as Operations Manager. David brings 20 years experience in the pharma industry to his new role at the Aesica API facility.

Kevin Cook, MD of Aesica’s API division, said: “Having been part of the Cramlington site since the very beginning, David has grown with the company as it has expanded globally and adapted to the changing API landscape. There’s no-one better placed to lead our API facility.

The Cramlington site has just passed its statutory Medicines and Healthcare products Regulatory Agency (MRHA) inspection, reaffirming its compliance with the highest quality and regulatory standards.

Aesica is a leading full-service provider of development and manufacturing services for formulated products and APIs. The company develops long-term strategic partnerships with its clients to help them deliver value into the marketplace.

Aesica Pharmaceuticals Ltd +44 191 218 1960 info@aesica-pharma.com www.aesica-pharma.co.uk

Albumin Conjugation Solution to Dramatically Enhance Patients’ Lives Novozymes Biopharma, part of Novozymes A/S, has announced that it has expanded its partnership with Nottingham-based R&D company Upperton Ltd to offer customers a new albumin conjugation solution. By linking drugs to Novozymes' new Recombumin Flex recombinant human albumin (rAlbumin), using conjugation, their pharmacokinetic and pharmacodynamic properties can be dramatically enhanced. As a result, manufacturers can benefit from the ability to tailor and control the half-life of drugs to fit patients' medical needs.

“Novozymes is delighted to unveil Recombumin Flex along with our new conjugation solution in partnership with Upperton,” said Dave Mead, Business Development Director at Novozymes Biopharma. “Novozymes has enjoyed a successful relationship with Upperton over the past 10 years and its expertise and experience in the conjugation of proteins, combined with our experience of protein engineering and production, will help customers to design drugs with tailored serum half-life and fewer side-effects. This will result in improved dosing regimes for the patient and a reduction in overall costs for the healthcare provider.”

By manipulating the interaction of albumin with its receptor, the neonatal Fc receptor (FcRn), Novozymes can produce modified albumins that bind with greater or lesser affinities, meaning a flexible half-life. Increasing the serum half-life of a drug may reduce the frequency of injections a patient receives or even reduce the amount of drug delivered, thereby significantly reducing toxic side-effects and increasing patient acceptance.

Upperton has demonstrated that proteins, peptides and small molecule APIs can be covalently attached to recombinant human albumin using a range of chemistries. Additionally, once drugs have been linked to the recombinant human albumin carrier, they exhibit dramatically improved pharmacokinetic and pharmacodynamic properties.

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Combining Novozymes’ unique IP and know-how around the albumin molecules themselves with Upperton's rP-conjugateT albumin conjugation chemistry knowledge enables the companies to work closely with customers to design and implement the best chemical linking approach for their molecule. As a result, Novozymes can provide partners with a reportedly unique service from initial product concept through to in vivo testing for developing novel drugs.

Richard Johnson, founder and CEO of Upperton, commented: “By combining Novozymes’ and Upperton’s unmatched expertise in our respective fields, we have developed a solution that solves industry challenges by enabling a tunable half-life that offers control and flexibility and has the potential to improve overall treatment efficacy.”

Novozymes Biopharma +44 115 955 3355 syke@novozymes.com www.biopharma.novozymes.com / www.upperton.com

INGREDIENTS & CONTRACT SERVICES ROUNDUP Packaging Specialist Commissions Eighth Cleanroom

CDMO Appoints President to Oversee Commercial Manufacturing Operations

Riverside Medical Packaging recently commissioned and validated its eighth cleanroom. According to the company, the Carsington cleanroom is specifically designed to house the most advanced, fully automated, ninestation ultrasonic cleaning unit.

Medical devices requiring cleaning pass through two cleaning solution ultrasonic baths, are rinsed with filtered/treated water after each and then finally with deionised water. They are then speed dried with an infra-red drier before removal.

This brings the total number of Riverside cleanrooms to eight (two Class 8 and six Class 7), each being either process or product specific.

These superb manufacturing cells, BSI accreditation to ISO 13485:2003 and a creative R&D team enable the provision of a diverse, innovative, quality range of high-performance products at an economical price — regardless of quantity.

Riverside manufactures and contract packs medical devices and is also one of the largest UK producers of medical peel pouches and sachets. The most up-to-date engineering software and equipment enables the company to design and produce all its own packaging machinery and the tooling for blister packs and pouches.

David Shaw, together with his father, the late Ivor Shaw, formed the company 33 years ago. It is now responsible for delivering more than 48 million medical devices and packs per annum, anything from simple dressings to knee, hip and spine implants. The company currently employs over 100 people at its impressive Derby facility.

Patheon has announced Antonella Mancuso’s promotion to President, Global Commercial Operations and Chief Manufacturing Officer, responsible for Patheon’s global commercial manufacturing operations.

Mancuso will assume responsibility for all of Patheon’s commercial operating units in North America and Europe. In her previous role as SVP and MD European Operations, Mancuso managed the company’s commercial manufacturing operations outside of North America.

“Antonella’s demonstrated success focusing on the customer, on quality and on margins is in direct alignment with our company strategy and directly supports the needs of our customers, our employees and our shareholders. I am excited about this opportunity to unify our manufacturing services business and leverage best practices across our business,” stated Jim Mullen, Patheon’s CEO. Mancuso joined Patheon in 2001 as Production Manager of Patheon's facility in Monza, Italy, becoming Site Director in June 2002. She has held other positions with increasing responsibility, culminating with her appointment to her new position as President, Global Commercial Operations and Chief Manufacturing Officer. Prior to joining Patheon, Mancuso held progressively senior roles in production and manufacturing during her six years at Bristol-Myers Squibb in Italy. She has also worked at Select Pharma and Bioprogress.

Mancuso holds a degree in Pharmaceutical Chemistry and Technology from La Sapienza University of Rome.

Riverside Medical Packaging +44 1332 755622 sales@riversidemedical.co.uk www.riversidemedical.co.uk

Patheon Inc. +1 919 226 3313 wendy.wilson@patheon.com www.patheon.com

UK CMO Receives FDA Approval for Manufacture of Vetoryl

Dales Pharmaceuticals, based in Skipton, North Yorkshire, UK, the manufacturing business of Dechra Pharmaceuticals PLC, has been approved by the FDA to produce Vetoryl 120 mg capsules for the US market.

Dales’ MD Mike Annice said: “I would like to thank all the staff for their contribution to this achievement. The ability to produce Dechra’s leading product, Vetoryl, for the US market will result in medium-term margin improvements for Dechra and a secure supply chain for this strategically important product.

“We will also be looking to extend the FDA approval into other products and dosage forms; this will open up further opportunities to both enhance the range of products sold in the US and add to our manufacturing capabilities provided to third-party customers.”

Dales’ Quality Director Andrew Parkinson added: “This is the culmination of a project that has involved significant investment in the quality systems and infrastructure at the Skipton facility.”

The approval complements Dales’ existing licenses and the company is now able to produce pharmaceutical products for all major world markets.

Dales Pharmaceuticals +44 1756 791311 www.dalespharma.com

Pharma Process Development Company Acquires Creapharm Parenterals CARBOGEN AMCIS has acquired Creapharm Parenterals, a subsidiary of France-based Creapharm Group.

Creapharm Parenterals (formerly MP5), is a CDMO specialising in liquid, semisolid and injectable aseptic dosage forms. As part of this acquisition, Creapharm Parenterals has changed its name to CARBOGEN AMCIS SAS. “This exciting transaction further strengthens CARBOGEN AMCIS’ service offerings, enabling us to provide our customers with a complete and reliable manufacturing solution from process development to the supply of pharmaceutical substances and formulated products,” said Mark Griffiths, CEO of CARBOGEN AMCIS. The acquisition will extend CARBOGEN AMCIS’ comprehensive range of development and manufacturing services by adding complementary formulation, lyophilisation services and sterile GMP capabilities for the fast supply of drug products, including highly-potents, for preclinical studies and clinical trials (Phases I, II and III). “This move reflects our determination to continue to position CARBOGEN AMCIS as a leading service provider for early phase development projects and niche-scale commercial products within the Dishman Group of Companies” added Jay Vyas, MD of the Dishman Group and owner of CARBOGEN AMCIS. Creapharm Parenterals brings over 10 years of expertise in the supply of Investigational Medicinal Products, with more than 300 batches and 145 clinical batches produced since 2000.

The company employs 16 highlyqualified specialists and operates a GMP manufacturing site in Riom, France. Creapharm’s plant was successfully inspected in 2009 by the French Health Agency (Agence Francaise de Sécurité Sanitaire des Produits de Santé - AFSSAPS).

Through this acquisition, CARBOGEN AMCIS has added the following services for injectable, liquid and semi-solid pharmaceutical forms: formulation of new products; optimisation of existing formulation; development and optimisation of lyophilisation cycles; parenterals production of preclinical and clinical batches (Phases I, II and III); aseptic process validation (Media Fill Testing); GMP capabilities for the development of injectables in liquid or freeze-dried forms; and aseptic filling in vials, syringes, cartridges and infusion bags.

“We believe that the combined capabilities and services of our two companies present a one-stop solution to pharmaceutical, biotechnology and virtual pharmaceutical companies looking for a single reliable partner that can provide API and drug product development for preclinical and clinical studies,” said Maxime Laugier, Development and Projects Director at Creapharm Parenterals.

CARBOGEN AMCIS AG +41 61 935 53 53 info@carbogen-amcis.com www.carbogen-amcis.com

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INGREDIENTS & CONTRACT SERVICES CDMO Adds Commercial Product to Portfolio Encap Drug Delivery, a world leading CDMO totally dedicated to liquid and semi-solid (hot melt) filled capsules, has announced the addition of a further pharmaceutical product to its portfolio of commercial products.

The privately held company, founded 23 years ago, has spent the last few years building its development services capability and has state-ofthe-art manufacturing facilities based in Livingston, UK. The company has been successfully audited by the European MHRA and USA FDA and has over 70 staff totally dedicated to the liquid fill hard capsule technology.

The company has development and commercial contracts with a large number of pharmaceutical and biotechnology clients across the major pharmaceutical markets (Europe, the US and Japan) and is now benefiting from the progression of these products through the development phase and into commercial manufacture.

CEO Dr. Stephen Brown commented that he was delighted to have secured the commercial manufacturing contract for a proprietary pharmaceutical product that is currently licensed in Europe and is transferring to Encap from the existing CDMO: “This is a large-volume, licenced pharmaceutical and the award of this contract demonstrates that in addition to its excellent development services capability, the company is able to provide a best in class commercially competitive manufacturing service.”

Encap is working closely with its client to prepare for the successful launch of this and other products in 2012.

Dr. Brown indicated that the company had now firmly established its credentials as an excellent development services and drug delivery partner (now 50% of the company’s revenues) and is now wellplaced to continue the expansion of its commercial manufacturing business.

The company currently manufactures 10 commercial products and following the expansion of the manufacturing facility in 2008, its strategy will be to add further commercial products in the coming years. This includes highly potent compounds or those that require special handling as the company now has dedicated high containment facilities within its Livingston site.

Encap Drug Delivery +44 1506 448080 rstewart@encapdrugdelivery.com www.encapdrugdelivery.com

Latest ISO Boosts Expansion for Jebel Ali-Based Logistics Company Tranzone FZCO has added a major award, the ISO 27001, to its existing ISO 9001. GM Juergen Hirsch was justifiably proud as he explained the process of achieving this latest certificate and what it augurs for the company: “There was of course a certain rigorous procedure to follow in order to attain this certificate, part of which involved information/document collection, GAP analyses, creation of SOPs, an internal audit and an external certification audit.

Added to that, we constantly crosschecked our ISO 9001 processes and documentation in order to ensure that both systems were fully interlocking and to avoid double work.”

Asked what exactly this new award means to Tranzone, he claimed: “First of all, it demonstrates our commitment to a total quality approach. While our competitors are emphasising mainly physical security and safety, we have found it equally important to have information management well-organised and tightly controlled. This is for our own protection as well as that of our clients, especially as we operate multiple clients in our facility. In this current, modern environment, safety of information is just as important as the security of the actual, physical product. Therefore, in this context, we regard the ISO 27001 as a required extension of our ISO 9001 activities.”

Hirsch was confident as he spoke of how this latest credential would help Tranzone achieve pre-set targets: “It categorically proves our unwavering commitment to quality and endorses our capabilities. Supposing a potential client has two comparable commercial offers, obviously the decision will come down on the side of the company that can offer the highest quality in all departments, something that is vital in the healthcare sector. In fact, one of our clients, GSK, has been highly supportive of our acquisition of this certificate.”

Bang on target for its own forecast of 80% warehouse occupancy, Tranzone’s expansion plans over the next few years are quite rightly bullish; multiple warehouses both inside and outside of the Jebel Ali Free Zone and its own intraregional air, sea and land freight network, including clearing capabilities at destinations. There is also the intention to do more than store goods in the facilities, but details of this are yet to be divulged.

Tranzone Logistics fzco www.tranzone.ae

REGULATORY AFFAIRS IMPLEMENTING CONTROLS AGAINST FALSIFIED MEDICINES

In my previous report on this topic, entitled ‘Counterfeit Medicines’, published in the October issue, I discussed the new European provisions concerning counterfeit medicines, laid down by Directive 2011/62/EU, published on 8 June 2011. This Directive introduces a number of new measures directly affecting pharmaceutical manufacturers that Member States will have to start applying from January 2013, including: • obligatory features on the outer packaging of medicines to demonstrate that they are authentic; • strengthened requirements for the inspection of the manufacturers of pharmaceutical ingredients; • and the obligation for manufacturers and distributors to report any suspicion of falsified medicines.

Although the Directive is seen as a positive first step towards tighter controls against fake and unauthorised medicines, many uncertainties still exist in terms of its precise implementation.

Firstly, the Directive placed the Commission under an obligation to adopt delegated acts setting out the details relating to, among other things, the proposed unique identifier. Moreover, Directive 2011/62/EU introduces new EUwide rules for the importation of active substances. According to Article 46b(2) of Directive 2001/83/EC, imported active substances must be accompanied by a written confirmation from the competent authority of the exporting third country.

Furthermore, in respect of the plant manufacturing the exported active substance, this written confirmation must also assert that the standards of GMP and control of the plant are equivalent to those in the Union. It should be noted that the requirement of a written confirmation is waived for certain third countries listed by the Commission in accordance with Article 111b of Directive 2001/83/EC. Article 111b(2) of Directive 2001/83/EC stipulates that the Commission must adopt an implementing measure to apply all of these requirements. Duly, two concept papers have been rolled out for public consultation — in November and December 2011 respectively — with a view to preparing both the impact assessment and the delegated act.

Dr. Paolo Biffignandi, MD, PhD, QPPV, FTOPRA, is a past President of The Organisation for Professionals in Regulatory Affairs (TOPRA) and has recently been appointed to the advisory board of the panEuropean pharmaceutical regulatory affairs organisation ELC GROUP. Dr. Biffignandi is a renowned physician who graduated in Medicine with a PhDs in Endocrinology and Pharmacology. He started his highly successful career in the pharmaceutical industry after a period at the University of Torino, Italy, and in 1989 he became an independent consultant in medical and regulatory affairs.

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There are several options under evaluation that should be of great interest to manufacturers. To cite just a few: — Equivalence assessment of the rules for GMP for third country API manufacturers and related inspections have been the subject of an audit checklist.

— Under policy option 1/1, the delegated act would create a broad framework, leaving it up to the manufacturer to choose the appropriate technical solution for the serialisation number and its carrier (this may be costneutral for companies that already have a system in place, but causes a certain degree of fragmentation across the EU), or as an alternative, a Regulation could be imposed and be valid for all companies in the EU. — In order to allow identification of a pack of medicinal products, a serialisation number would have to contain, as a minimum, a manufacturer product code and the pack number, and a unique identifier has also been proposed, to include the batch number, expiry date and national reimbursement number. A linear barcode may be a preferred carrier and it is used currently in Belgium, Greece and Italy. Other mechanisms have been taken into consideration, such as a 2D-barcode, difficult to read by most pharmacies in Europe, and a radio-frequency identification (RFID), a relatively expensive solution with unknown issues of interference with the quality of certain medicines.

Whatever the outcome of the public consultation, it has been estimated that by 2020 the costs for manufacturers and importers of medicinal products will reach €6.8 bn and €11 bn respectively, depending on the safety technique chosen. For manufacturers of API, these costs are predicted to be approximately €320 m. The bulk of these costs will fall upon third country manufacturers.

Taking the issue as a whole, the European Qualified Person Association has expressed concern that counterfeit medicines are being considered a GMP issue rather than a criminal activity, therefore shifting responsibility from authorities to the already overloaded quality systems of manufacturers. From the industry’s perspective, there are certainly many practical issues to resolve in order to effectively introduce these measures. We will be keeping a close eye on developments as implementation plans progress.

Dr. Paolo Biffignandi paolo@elc-group.com He is the author of more than 160 scientific articles and co-author of three books on European Regulatory Affairs.

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

INGREDIENTS & CONTRACT SERVICES ROUNDUP Packaging Specialist Boosts Clinical Trials Department with Appointment of Business Development Manager

AndersonBrecon Clinical Services has further strengthened its team with the recent appointment of Nick Evans as Business Development Manager in the European market. Evans joined the team in Hay-on-Wye in September and is jointly responsible for establishing and managing customer accounts in clinical trial packaging, distribution, storage and returns. His remit also extends to developing the department’s portfolio of customer service offerings, including the expansion of new client accounts.

Evans brings fifteen years of experience in clinical trial materials management to his new role at AndersonBrecon. He joins AndersonBrecon from pharmaceutical development services company Aptuit, where he held a number of client facing roles during the past ten years, most recently as Senior Project Manager. Prior to that, he worked as clinical supplies project manager at GlaxoSmithKline and at clinical trial services company Almedica.

Commenting on the appointment, Sue Miles, Clinical Trials and Customer Services Director at AndersonBrecon, said: “Nick’s appointment has already given the clinical trials team a significant boost, not only through his wealth of experience, which is already paying

dividends for our customers, but in his enthusiasm and drive to further support the ongoing expansion of the company.”

Evans added: “Having come into contact with AndersonBrecon on many occasions at various industry events, I was always impressed by the company’s vision and range of service offerings. I’m therefore delighted to now be a part of this company at a time that offers so many fantastic opportunities, such as the expansion into our new Distribution facility and the significant investment in technology that it has been making. The ongoing development of our crossAtlantic partnership with our US counterpart of AndersonBrecon Clinical Services also provides huge potential for offering our customers further valueadded solutions.”

AndersonBrecon +44 1497 820829 suemiles@breconpharm.com www.breconpharm.com

Logistics Specialist to Acquire Italian Company Pieffe

UPS has announced an agreement to purchase Italy-based Pieffe Group, Pieffe Depositi, Pieffe Nord. This acquisition supports UPS’ ongoing global healthcare strategy, which has seen the company make investments to better serve its growing customer base in the pharmaceutical, biotechnology and medical device industries.

The announcement follows the opening of five new dedicated facilities

within the last 14 months in North and South America, Europe and Asia. Terms of the deal were not disclosed.

Pieffe, one of Italy’s most highly respected pharmaceutical logistics companies, is a family-owned business with more than 35 years experience offering high-quality storage, distribution and cold chain solutions to some of the world’s leading pharmaceutical brands.

“Pieffe is a perfect fit for UPS,” said Jim Barber, President, UPS Europe. “The company shares UPS’ focus on highquality service and compliance, as well as our deep-rooted culture of precision and innovation. Pieffe will make a valuable addition to UPS’ European healthcare network and we look forward to welcoming their team to the UPS family.”

In addition to the expertise and experience that comes with Pieffe, this acquisition also brings two major healthcare distribution facilities to UPS’ existing global network, one in Milan and the other in Rome. They offer a combined space of nearly 70,000 m2, including 12 cold storage areas, with options for further expansion. This adds to UPS’ global healthcare distribution footprint of more than 370,000 m2.

“This is a tremendous development for our company, our employees and our customers,” said Federico Peruzzi of Pieffe. “UPS’ renowned quality standards combined with its specialised global healthcare network will enable us to sustain the growth and momentum we’ve built up over more than 35 years, while ensuring our customers continue to experience excellent levels of service.”

UPS delivers value to healthcare companies through a broad portfolio of specialised freight and small package transportation, as well as distribution services. UPS’ existing healthcare network of 30 facilities worldwide offers services such as temperature-sensitive handling capabilities, regulatory compliance, monitoring and security, kitting and labelling, as well as order management and accounts receivable.

UPS www.ups.com/healthcare

Comprehensive Bulk Drug and Intermediates Producer Database

DPLA (Drug Process Licensing Associates, LLC) is off and running again with the launch of its newest database product called PHILL. PHILL, which stands for PHarmaceutical InteLLigence, is a database of bulk drug and intermediates producer information pertinent to members of the chemical and pharmaceutical industry. It also includes regulatory information such as Drug Master Files, Veterinary Master Files, Certificates of Suitability and Drug Approvals.

After the successful filing of API patents for manufacturing processes for Sitagliptin, Tadalafil, Tiotropium bromide and Pregabalin last year, PHILL is a new, first rate directory containing worldwide producers of APIs and chemical intermediates. It is reportedly unrivalled not only in quality, but in breadth of content. “PHILL contains information not seen in any other producer directories.

We have included descriptive information on the producing companies themselves, as well as information about their production of each product,” said Ron Schwarz, MD and Founder of DPLA. Schwarz added: “Many other directories have been criticised for containing too many trading companies and for being out of date, so we have taken great pains not to repeat the mistakes of our competitors.”

DPLA is also providing a lot of content free of charge as part of PHILL.“We wanted our colleagues in the industry to have access to important information such as DMFs, VMFs and CEPs, so we have integrated this content with the producer information and are making it available to users completely free of charge,” COO Julie Foster said. “Our competitors charge more than $3,000 for this information.”

In addition to DMFs, VMFs and CEPs, the free modules of PHILL include Human and Animal Drug Approvals, Paragraph IV Certifications and FDA Warning Letters. The fee-based modules include worldwide producers, patents and worldwide drug revenue. “PHILL is an incredible comprehensive resource and the companies who use it are going to be very pleased with the results that they find,” added Schwarz.

Drug Process Licensing Associates, LLC +1 214 838 5749 rschwarz@drugprocess.com

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INGREDIENTS & CONTRACT SERVICES ROUNDUP CDMO Adds Soft Gel Capsule Capabilities Through Partnership Patheon and PROCAPS have announced an agreement to provide the pharmaceutical industry with a new world-class line of prescription pharmaceutical soft-gel product development and manufacturing services. The offering will be branded as ‘P-Gels’ soft gels and the partnership will give Patheon rights to market PROCAPS’ soft gel technology and manufacturing capabilities in North America, Europe and Asia.

“This exclusive agreement is part of our recently announced strategy to strengthen our core operations and product offerings,” said Jim Mullen, Patheon’s CEO. “By combining PROCAPS’ manufacturing capabilities and proprietary technology with our global experience, reach and customer service, we are positioned to provide our customers with royalty-free soft gel capsule solutions for their products.”

“This partnership truly provides us with a great opportunity to leverage our quality soft gel capabilities across the globe,” said Ruben Minski, PROCAPS CEO. “The addition of commercial scale soft gel capacity to our full offering of dosage forms — which includes parenteral, solid and liquid technologies — creates a more comprehensive array of options for our clients,” commented Michael Lytton, EVP, Corporate Development and Strategy & General Counsel. “Soft gel oral drug delivery offers many advantages to some of the more challenging compounds being developed by the pharmaceutical industry today and the collaboration with PROCAPS builds on Patheon’s successful SoluPath solution set for compounds with solubility challenges.”

The capabilities Patheon gains via the P-Gels offering include large-scale commercial supply of prescription soft gel capsules for the North American, European and Asian markets. PROCAPS is an established, multinational company with over 3,000 employees and a rich history of providing quality products in food supplements, as well as OTC and Rx pharmaceuticals. PROCAPS has been developing and manufacturing soft gel capsules since 1977 and currently has capacity to manufacture up to nine billion capsules per year.

The soft gel dosage form provides important advantages for drug delivery and consumer experience. It offers rapid and consistent absorption of drugs and consistent delivery of highly potent drugs that require small dosages. In many cases, soft gels can be used to improve the solubility of drugs that pose bioavailability challenges. Consumer advantages include reliable delivery, taste masking, ease of swallowing and rapid onset. Patient feedback surveys consistently rate soft gels as the preferred dosage form.

THREE TIPS ON PACKAGING SELECTION FOR PARENTERAL PHARMACEUTICAL DRUG MANUFACTURERS

of the drug product. Use of consistent materials from R&D through to commercialisation enables manufacturers to determine sooner if there is any interaction between the drug and its packaging, including time-dependent issues such as glass delamination and leachables, which can affect patient safety.

Enhanced regulations and regulatory guidance on current GMPs and the trend toward biopharmaceuticals have significantly impacted drug product manufacturing. Early stage guidance from experts with experience in packaging applications and manufacturing practices can help drug manufacturers identify potential hazards associated with packaging materials while a product is still in development.

By working together from an early stage, drug and packaging manufacturers can develop customised solutions that can help mitigate risk, increase efficiencies and ensure sustainability while improving products and processes. Working with a knowledgeable partner, choosing consistent components and high-quality materials and differentiating the drug product with a unique delivery or administration system can help a pharmaceutical company deliver a safe, effective product that will stand out among those of competitors in the marketplace.

1. Choose Consistent Components Pharmaceutical manufacturers should look for packaging components that are consistent from lot to lot. Such components will help avoid costly issues when the drug is commercialised, particularly when packaging is used consistently throughout the development lifecycle

2. Mitigate Risk of Recalls As many manufacturers have learned, choice of packaging material can impact the bottom line. By selecting container closure systems made from a novel material — such as a cyclic olefin polymer — companies may incur a slightly higher initial investment, but the long-term advantages can far outweigh this cost.

Offering an alternative to traditional materials, cyclic olefin polymers enable manufacturers to offer a highquality, transparent, break-resistant material that is more inert than glass, is scratch resistant and, unlike glass, does not flake, which reduces particulate contamination within a vial or syringe system. In addition, these components can be stored and shipped at low temperatures, which is a common requirement of many biologics.

3. Differentiate Yourself How a drug product is going to be delivered should be determined based on the clinical application, plus packaging can be an important factor in getting a drug product through the regulatory approval process smoothly and to the market quickly. Initially, pharmaceutical manufacturers should seek out reliable, standardised, lowrisk packaging materials and then apply a unique administration system to differentiate and optimise delivery.

Selecting a material that can be used consistently throughout the drug development process, such as a cyclic olefin polymer, can help

Patheon, Inc. +1 919 226 3313 wendy.wilson@patheon.com www.patheon.com PROCAPS S.A. +57 5 3719 801 acortesi@procapsgroup.com www.softigel.com EPM 31

mitigate risk and reduce time-tomarket. Cyclic olefin polymers can be moulded into a variety of shapes and sizes, enabling manufacturers to offer unique delivery or administration systems without the need to retest the material for interactions with the drug product.

For pharmaceutical manufacturers, an early stage partnership with an industry-leading packaging manufacturer experienced in providing high-quality, ready-to-use components and administration systems can eliminate the in-house component preparation process, which can be a cost-effective method of complying with new regulations and streamlining the fill process. By creating such a lasting partnership, drug makers not only help to establish compliance and improve quality, but are also able to rely on expert advice and counsel throughout a drug’s lifecycle.

Frances L. DeGrazio, West Pharmaceutical Services, Inc. dran.degrazio@westpharma.com

Frances L. DeGrazio is Vice President, Marketing and Strategic Business Development at West Pharmaceutical Services, Inc. DeGrazio has more than 25 years of experience in pharmaceutical packaging, with extensive experience in the area of injectable drug delivery, such as vial/closure combinations and prefillable syringe systems

SHOWCASE APIs CMO Receives GMP Certificate

practically any requirements can be met — drums, sacks, fibreboard boxes or big bags, but also individual packs.

Most importantly, the new Glatt fluid bed processor will widen SternMaid’s range of services to include coating, agglomerating, granulating and drying.

The new unit is in two parts; it consists of a smaller plant for pilot runs and a large industrial-scale plant. The smaller pilot plant is already available for testing in the technical trials department and the large plant is due to be commissioned in May 2012. This production unit will also be built to pharmaceutical standards and designed to meet the requirements of the EU GMP Guide. It will subsequently be GMP-certified.

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

After successful qualification of the counter-current container blending line and validation of the relevant cleaning process in accordance with Part II of the EU GMP Guide, SternMaid has now been awarded the official GMP certificate by the competent drug inspectorate.

This step enables the outsourcing specialist to manufacture pharmaceutical blends of active chemical ingredients and excipients with GMP certification.

Frank Hellerun, Business Development Pharmaceuticals and Food, SternMaid, said: “The certificate is an important requirement for cooperation with companies in the pharmaceutical industry. We had been working to GMP standards already, but we lacked the official audit. We passed the audit with no trouble at all and are now looking forward to new challenges.”

SternMaid processes APIs and excipients and manufactures nutrient premixes in a modern Bohle container blending unit. The unit is made entirely of stainless steel, installed in a completely independent part of the factory and meets the strictest hygiene requirements. With the aid of the production plant, the outsourcing specialist also carries out repacking orders. “We have a fairly large blender for the pharmaceutical sector,” said Hellerung. “That means customers can have large batches made up and save on analysis costs.” Many manufacturers can only produce batches of 300 kg at most on their blending equipment, whereas SternMaid can process three times this amount in one batch. As far as packaging materials are concerned,

chromatographs and freeze dryers required for the purification and isolation of complex organic compounds such as natural products or peptides. Typically, HPAIs such as cytotoxic actives are handled in batch sizes ranging from grammes to multi-kilogrammes.

Custom product development includes all the required QC support, from the first synthesis to large-scale production.

If desired, the company also conjugates the active small organic molecules to peptides or carriers. Conjugation reactions are a specialty of Bachem.

Bachem AG +41 61 935 2333 sales.ch@bachem.com www.bachem.com

Specialty Chemicals Manufacturer Expands Lab and Production Capacity for HPAPIs

Extensive Expertise in GMP Manufacture of HPAIs and Cytoxics

Bachem has acquired considerable experience in the GMP production of highly potent active ingredients (HPAIs) and cytotoxics. These compounds are produced in a dedicated facility. Its design is based on the concept of high containment to ensure an occupational exposure limit (OEL) below 0.1 g/m3/8h (class 4 according to SafeBridge Consultants Inc). Moreover, a cascade of downward pressures throughout the facility collects and filters all airborne particles.

The various suites are isolated, each with separate access points, and the products are handled in isolators.

Consequently, projects are carried out according to the strictest safety guidelines so as to protect the personnel, the environment and the product. The design of the facility also prevents any cross-contamination by other active ingredients.

The HPAI unit is also equipped with the

Evonik Industries has set up a new laboratory at its Hanau site for highly potent active pharmaceutical ingredients (HPAPIs) and expanded its cGMP capacity for HPAPIs on a kilogramme scale at Tippecanoe Laboratories, in Lafayette, Indiana, US. The new laboratory allows Evonik to develop and optimise syntheses for HPAPIs now also in Germany. At its US site, Evonik has similar laboratory installations. Given the expanded capacity, Evonik now has a reactor volume for HPAPIs of a total of 170 m3. Of this volume, approximately 135 m3 is being used for the production of HPAPIs on the metric-tonne-scale and approximately 35 m3 is being used for small batch production and manufacturing development quantities.

“For exclusive synthesis, we can now manufacture the entire spectrum of HPAPIs from the clinical phase to commercialisation” noted Dr. Klaus Stingl, Head of the Exclusive Synthesis product line of the company’s newly created Health Care business.

HPAPIs are APIs that are effective even at very low concentrations. A maximum of 0.2 mg per kilogramme body weight or 10 mg per day is needed to have a significant therapeutic effect. These active ingredients include hormones, peptides or cytostatic drugs for cancer treatment. “The demand for synthesis development and small batch production of highly potent active ingredients for the clinical phase has gone up significantly in the past few years,” explained Stingl, justifying the investment in Hanau and Tippecanoe.

According to Stingl, this is due in part to new developments in the treatment of

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tumors and endocrine diseases.

Due to their high potency, measures must be taken to protect the environment and laboratory and production employees when HPAPIs are handled. All of Evonik’s HPAPI facilities are designed so that they can handle even active ingredients for which the allowed workplace threshold limit value (TWA, eight hours) is only 0.1 mg per m3 of air.

“Currently there are very few companies worldwide that are even allowed to work with highly potent active ingredients,” said Kevin Haehl, who is responsible for the exclusive synthesis of active ingredients at Evonik’s Tippecanoe site. “Evonik is one of the most high-performance suppliers because, as one of the very few companies, we can also adhere to respectively low workplace threshold limit values. This means that we can also safely handle those active ingredients that, due to their extremely high potency in, for example, destroying cancerous tumors, could be harmful to healthy people.”

The exclusive synthesis of HPAPIs is carried out mainly at the Tippecanoe site, which Evonik acquired from the American pharmaceuticals company Eli Lilly in early 2010. The approximately 650 employees at the site have more than 20 years experience in handling, developing syntheses and producing HPAPIs. With Evonik’s establishment of a similar laboratory in Hanau, this highly specialised expertise is now also available in Europe.

Evonik Industries AG +49 6181 59 6847 juergen.krauter@evonik.com www.evonik.com

buyers’ guide

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Eskimo Express +44 1932 560222 simon@eskimoexpress.co.uk www.eskimoexpress.co.uk Geodis Calberson, UK +44 1494 446 541 nigel.watts@geodis.com www.geodis.com Hellmann Worldwide Logistics, UK +44 1753 688 500 andreas.lohmeier@gb.hellmann.net www.hellmann.net

Pharmadex Logistics Ltd, UK +44 845 678 0081 tonypage@pharmadex.uk.com www.pharmadex.uk.com UPS Europe +32 2776 9818 sbueldt@ups.com www.ups.com

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Provides dedicated support throughout cash-toorder cycle, effectively managing supply chains, customer relationships and financial processes.

Temperature-controlled courier.

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LifeConEx, LLC, US +1 954 626 4359 federico.lupp@lifeconex.com www.lifeconex-lcx.com Palletways (UK) Ltd, UK +44 1543 418000 sales@palletways.com www.palletways.com

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Transportation — Air

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Deutsche Post DHL +49 228 182 24104 www.dhl.com www.dp-dhl.com

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Stock Management

arvato services healthcare, Germany +49 5241 80 42762 andreas.olpeter@bertelsmann.de www.arvato-services-healthcare.com

Customs Documentation and Regulations Management

logistics & distribution

Consignment Picking and Packing

LOGISTICS & DISTRIBUTION SERVICES

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Emerging market support, regional HUB.

Lead Cold Chain Solutions Provider of end-to-end temperature controlled transportation solutions for life sciences industry worldwide.

Specialises in distribution of 1–6 pallets.

Door-to-door distribution service to and from mainland Europe.

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Provides specialised distribution, customer care and transportation services to maximise supply chain efficiency, meet regulatory requirements and protect products from temperature excursions.

Events Allergan Director Prof. Trevor Jones to Chair ProcureCon Pharma Meeting in Zurich The team behind ProcureCon Pharma, one of Europe’s foremost meetings for senior sourcing professionals in the biopharmaceutical sector, has announced that Professor Trevor Jones, Director at Allergan, will chair its inaugural meeting at the Renaissance Hotel in Zurich, on 28–29 February 2012.

A former Board Director of the Wellcome Foundation, Professor Jones is also Chairman of the UK stem cell biotechnology company ReNeuron, as well as a visiting professor at King’s College London. His past R&D projects read like a ‘who’s who’ of well-know drugs, including Zovirax, Malarone and Lamictal.

Professor Jones will lead a high calibre panel of speakers at the two-day meeting, with many of the top 50 pharmaceutical manufacturers represented. These include: Ashley Readshaw, Chief Procurement Officer, AstraZeneca; Claudia Knowlton-Chike, General Manager of Global Logistics, GE Healthcare; Paula Gildert, Global Head Development Strategic Sourcing, Novartis; Jean-Philippe Collin, VP Chief

New Show Mediplas Attracts Keen Interest

Procurement Officer, Sanofi-Aventis; Mark Hollison, Procurement Director, Napp Pharmaceuticals; Don Murphy, Global Head of Distribution & Logistics, Merck Sharp & Dohme; and Imtiaz Naqui, Head of Purchasing UK, Teva Pharmaceuticals.

Vidya Gunapala, ProcureCon’s Portfolio Director, explained the reasoning for reaching out to the pharmaceutical sector: “Heads of procurement in the biopharmaceutical procurement space told us that their business model is different to other verticals and that they’re walking away from generic procurement events with an incomplete picture. So, we simply listened and developed a programme just for them.”

Indeed, the ProcureCon Pharma agenda has been written with CPOs very much front of mind and the production process has been guided at every stage by an independent Advisory Board, made up of leading industry opinion formers.

ProcureCon 2012 looks set to attract 150+ biopharmaceutical procurement officers.

ProcureCon Pharma +44 207 368 9465 procurecon@wbr.co.uk www.procurecon-pharma.com

Rapid News Communications Group (RNCG) has reported that the launch of its latest show Mediplas has been very wellreceived by the medical plastics sector.

Mediplas is a uniquely focused event for the highly specialised area of manufacturing plastic parts for the medical industry. The exhibition will cover all areas of the medical plastics supply chain.

The announcement of the new show has sparked a great deal of interest amongst the medical plastics community, with strong evidence to suggest that the show, which takes place in September 2012, will be a huge success.

Many companies have already booked their exhibition stands for the debut event. Companies confirmed to date include Zwick Testing Machines, OGP, DS Brookes, Wilde Analysis, Ensinger, Greiner Bio-One, Engel, Fibracon-Insoll, Dalau and Telsonic. The quality and strength of this lineup reinforces the organiser’s expectation of a vibrant and exciting show that brings the highly specialised medical plastics industry to a live format.

As well as aiming to provide the medical plastics industry with a show floor packed with the cream of the crop

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from industry, RNCG, along with key industry partners, is working diligently towards providing visitors and exhibitors alike with a high quality and finely tuned conference programme that is set to provide something for everyone.

Colin Robinson, Event Sales Manager for Mediplas, commented: “Interest in the show launch has been high as evidenced by the initial exhibitor takeup and the additional interest shown by our industry partners in getting involved and supporting the event. Having successfully staged Interplas for the first time in September 2011, we are now well-placed to build on this success and deliver a focused and exciting event for the medical plastics industry across Europe for many years to come.”

Mediplas 2012 will take place on 25–26 September 2012, at the NEC, Birmingham, UK, Hall 3a, and will be colocated with TCT Live, MM Live UK, MEMS Live UK and Sensing Technology.

Rapid News Communications Group +44 1829 770037 sales@rapidnews.com www.rapidnews.com

EPM CLASSIFIEDS

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

CLEANROOMS EQUIPMENT & SERVICES

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

CLEANROOM ACCESSORIES

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

Web: www.wmpg.co.uk MATERIAL/POWDER HANDLING FINE GRINDING CONTAINMENT

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

CONTAMINATION CONTROL

MIXING & BLENDING EQUIPMENT AND SERVICES INGREDIENTS

Müller GmbH

Piramal Healthcare Ltd

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

Tel: +44 (0) 1670 562 400 Email: enquiriespharmasolutions@piramal.com Web: www.piramalpharmasolutions.com

DESIGN & INSTALLATION

WET GRANULATION EQUIPMENT

PACKAGING & BOTTLING EQUIPMENT AND SERVICES

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

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

INDUSTRIAL SERVICES CHEMICAL CLEANING FURNITURE

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

Transflow Industrial Services Limited The Passivation Specialists

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

COATING EQUIPMENT & SERVICES

Weiler Engineering Inc

Glatt GmbH

LABORATORY & R&D PRODUCTS AND SERVICES

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

Fritsch GmbH

L.B. Bohle GmbH

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

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

ASSET SALES & AUCTIONEERS

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

PURIFICATION & FILTRATION PRODUCTS AND SERVICES

OYSTAR Manesty Tel: +44 (0)151 547 8000 Email: sales@oystar.manesty.com Web: www.oystar.manesty.com

QUALITY & COMPLIANCE SOFTWARE

CONTRACT STERILISATION & TESTING ENVIRONMENTAL/STABILITY ROOM

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

EXCIPIENTS

TABLET PRESS SUPPLIERS

PARTICLE SIZE ANALYSIS

HPMC FILM COATING

Whitehouse Scientific Ltd GRINDING AND GRANULATION EQUIPMENT & SERVICES

DIOSNA Dierks & Söhne GmbH Tel: +49 (0) 541 331 040 Email: info@diosna.de Web: www.diosna.de

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

WEIGHING

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

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

USED PROCESS & PACKAGING EQUIPMENT MANUFACTURING ANCILLARIES

BE HERE FOR A YEAR Call Rob on 01829 770037 or email rob@rapidnews.com

PUMPS

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

SUPPLIERS OF HIGH QUALITY PROCESS & PACKAGING MACHINERY OVER 25 YEARS EXPERIENCE IN THE INDUSTRY WE BUY EQUIPMENT FROM ALL OVER EUROPE PROFESSIONAL – EFFICIENT – RELIABLE – FLEXIBLE MAXIMISING YOUR ASSETS GLOBALLY

Unit 5, Ashmount Industrial Centre, Castle Park Industrial Estate, Flint, Flintshire. CH6 5XA

T: +44 (0)1352 792860

E: enquiries@lexmachinery.co.uk

EPM 34

F: +44 (0)1352 733855

W: www.lexmachinery.co.uk