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European Pharmaceutical Manufacturer November/December 2013
Volume 13 | Issue 08
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Here it is, the final 2013 issue — this year almost at a close and 2014 just around the corner. The last 12 months seem to have flown by, but rather a lot has changed during this time, with EPM receiving its BPA audit as well as launching a much improved and now thriving new website and new-look e-newsletter to boot. And I look forward to revealing all the developments 2014 will surely bring. This issue features two named customer stories, both in the Manufacturing Products and Equipment section. The first can be found on page 15 and details Molecular Profiles’s endorsement of CI Precision’s tablet and capsule weight sorter, installed at the CDMO’s site in Nottingham, UK, back in October 2012. Supporting the CDMO’s current systems for tablet and capsules for just over a year now, the verdict from Steve Kemp, VP at Molecular Profiles, is that “CI Precision’s SP140 is not only intuitive to work with, but the speed of delivery is exactly what we required.” The second forms part of the Packaging Showcase on page 17 and concerns pharmaceutical manufacturer IBSA Farmaceutici Italia’s purchase of Bosch Packaging Technology’s nested syringe filling line for its new production site in Lodi, near Milan. IBSA produces small-volume, aseptically filled and sterilised pharmaceuticals and invested in Bosch’s FXS line to “improve processes”. 15 According to Roberto Maglio, Engineering and Maintenance Manager at IBSA, this has been 17 accomplished thanks to the “flexibility and expertise” of Bosch designers and technicians. Maglio summarised that: “Together, [IBSA and Bosch have] managed to achieve a truly reliable aseptic process.” EPM’s ‘In the Spotlight’ feature on page 32 is based on an interview with Mark Dean-Netscher, Chief Operations Officer at CDMO Penn Pharma, on the company’s new, £14 million high potency manufacturing facility at its site in Tredegar, Wales, UK. The official opening took place on 26 September but the facility produced its first batch of tablets back in February. Mark discussed the facility’s success so far, with “multiple global projects”, the high containment equipment decided on for the facility and the company’s future growth strategy in terms of the high potency market. 33 Finally, this issue’s Regulatory Affairs instalment on page 34 is titled ‘What Is a Well-Established Use Application and When Can it be Used?’. Dr. Biffignandi highlights the objectives that should be met by the applicant to “justify the eligibility of the drug substance to be of well-established use (WEU).” However, he goes on to cite the recent change in attitude of competent authorities concerning WEU guidelines and questions whether their revision should be considered. So that is all from myself (and the rest of the EPM team) for this year. I hope you all enjoy a fun and, most importantly, relaxing Christmas break and wish you all a very successful 2014.
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eab members
from the editor
Henrik Broholm, Senior Specialist, H. Lundbeck A/S Henrik has been working in the pharmaceutical industry for the last 15 years, mainly in connection with finished goods packaging (blisters, ampoules and containers). At H. Lundbeck, he has gained valuable experience of working at both vendor and customer sites, further extending his pharmaceutical packaging expertise. Henrik is for the most part involved with user requirement specifications, machinery and process qualification and validation, the introduction of new products on packaging lines and incorporating new features as required by authorities, e.g., 2D matrix coding with track and trace and child resistant blisters and packs. James Cartwright, Global Granulation Leader, Particle Generation, Control & Engineering, GlaxoSmithKline James began working within the pharmaceutical industry in 1996. During this time, he has been instrumental in developing and launching three products for various clinical indications spanning acute Otitis Media, Lymphatic Filiarisis and Type II Diabetes Mellitus. James studied Chemistry and Chemical Engineering and is a Fellow of the Royal Society of Chemistry. Dr. Dimitris Dogramatzis, RPh, PhD Dimitris is a registered pharmacist and pharmacologist, whose industry career encompasses medical affairs, marketing, country and regional management positions. Dimitris has served as Regional VP — Northern Europe for SERONO and authored two textbooks entitled ‘Pharmaceutical Marketing: A Practical Guide’ (2001) and ‘Healthcare Biotechnology — A Practical Guide’ (2010). Dr. Dave Doughty, Independent Consultant Dave is an enthusiastic pharmaceutical development director with a successful, 36-year track record in a global pharmaceutical company. Key areas of expertise include: directing product development projects, including oral and transdermal dosage form, from early development to commercialisation; directing continuous manufacturing projects to QbD standards, including granulation and coating of tablets; establishing teams to deliver stakeholder agreed objectives; applying knowledge of dosage form design, processing, process analytics and manufacturing operations to help shape manufacturing strategies; co-authoring product and process patents; and presenting to audiences at all levels. John Gamble, Senior Research Scientist, Bristol-Myers Squibb After graduating from the University of Salford in 1998 with a degree in Chemistry with Industrial Experience, John began his career in quality control analysis of parental vaccines, later moving on to physical analysis of inhaled drugs, before arriving at his current position as Senior Research Scientist within the Powder Properties Optimisation group at Bristol-Myers Squibb. John has a keen interest in understanding the interrelationships between the physical properties of drugs and excipients and their subsequent behaviour during formulation and manufacturing. Aidan Mc Nabola, Engineering Director, UCB Group, SCHWARZ PHARMA Ltd Aidan is Engineering Director at Schwarz Pharma Ltd, based in Shannon Co. Clare, Ireland, and is responsible for site infrastructure, engineering systems — including capital projects — utilities, IT and automation on site. Aidan holds a B. Eng Degree in Mechanical Engineering and has more than 23 years experience in primary and secondary manufacturing in the pharmachem and medical device industries. Grégory Poujol, Manufacturing Maintenance Manager, Sanofi Grégory is an ‘Arts et Métiers’ engineer. He started working in one of Sanofi’s injectable plants in 2003, before moving to a solid form plant as a Project Manager in 2004 to install new process equipment. In 2009, Grégory moved to one of the group’s solid form plants in Spain to lead new equipment installation projects as well as take charge of process maintenance and improvements. He returned to France in 2013 and continues with projects at one of Sanofi’s API production plants. Grégory has experience of the most well-known providers of solid form equipment. Kostas Saranteas, Senior Director, Process Chemistry and Engineering, Sunovion Pharmaceuticals Inc. Kostas is Senior Director of the Process Chemistry and Engineering Dept. at Sunovion’s R&D Division. He holds BS/MS/PhD degrees in Chemical Engineering and an MS degree in Environmental Engineering. For 15 years, Kostas worked at Polaroid Corp., specialising in batch process equipment modelling, process optimisation and scale-up. For 11 years, Kostas has been employed at Sunovion. He leads cross-functional teams, championing accelerated process development for drug substance and drug product synthesis from laboratory-scale to full-scale manufacturing.
MANUFACTURING PRODUCTS & EQUIPMENT Tablet Tooling Expert Provides Design Support from R&D to Production As an industry-leading tooling manufacturer with a strong international presence, Natoli Engineering Company provides punches and dies to customers all over the world. The company understands the intimate relationship between powder and tooling and that tablet design is crucial to the quality of the tablet, efficiency of the process and customer acceptance of the product. Natoli has found that communication is the key to proper tablet design and new product success. The company’s design engineers can work with the customer’s teams throughout the product development process — from marketing and R&D through production — to ensure product and production concerns are carefully evaluated. Whether the tablet shape is simple or complex, Natoli can help design a tablet that will successfully avoid common issues such as capping, lamination, sticking and picking.
Choosing the right steel for tooling can impact tabletting success as well. Consider if the product is corrosive or abrasive and its compressibility and temperature sensitivity — proper tool material selection can eliminate issues from powders with these characteristics. Natoli’s tablet and tool design experts have experience dealing with these complex situations and will help the customer choose the right steel for their application. Natoli manufactures punches and dies only from steel that has been triple checked for quality by the mill, an independent laboratory and Natoli
Metallurgy. The customer can rest assured that their tooling investment is being made from the best materials when working with Natoli. Natoli Engineering Company, Inc. +1 636 926 8900 info@natoli.com www.natoli.com
Chromium Nitride Tablet Tooling Coatings Provide Outstanding Anti-Stick Performance Formulation sticking to the punch tip face is a renowned issue in tablet manufacturing and one that I Holland has worked hard towards solving. One way of combating tablet sticking is with the use of coatings. The ongoing development of the PharmaCote range has been a key part of I Holland’s continuous improvement programme. As part of this, two new coating products have been released, PharmaCote CX and CX+ (Chromium Nitride Extra). An enhanced chromium nitride, it has been developed to improve the performance of substrate material for punches and dies. The coating offers a very smooth finish and outstanding antistick performance. PharmaCote CX features a number of benefits over its
competitors, the main one being prolonged tooling life, attributable to a multi-layered application. The coatings have been tested, with excellent results, to provide exceptional tooling protection. The PharmaCote range encompasses many treatments and coatings that are designed to improve surface hardness, wear and corrosion resistance as well as enhance anti-stick properties. PharmaCote CX has been developed with this in mind and is I Holland’s most enhanced coating yet. As well as its more obvious benefits, it is also extremely easy to clean and maintain using an ultrasonic bath and light automated polishing. The latest coating products include
PharmaCote CX+, a more advanced product that has an additional surface modification that offers enhanced antistick properties, helps to further reduce the effect of formulation sticking to the punch tip face. For more information, visit www.tablettingscience.com. I Holland Ltd +44 115 972 6153 info@iholland.co.uk www.iholland.co.uk
Malaysian Insulins Plant Invests in Hygienic Clamp-On Impellers Chemineer has commenced manufacture of specially designed impellers for a major new fermentation plant in Malaysia, at what will reportedly become the largest integrated insulins production plant in Asia. The new biopharma facility has chosen mixing specialist Chemineer to provide high sanitary ASME/BPE clamp-on impellers as an integral part of the manufacturing process. Chemineer’s bespoke clamp-on design allows the impeller to be moved up and down the shaft without the need for a EPM 5
keyway that could compromise allimportant hygiene. The BT6 and MP4 impellers, part of a comprehensive range at Chemineer, are proven in CIP biotech applications. In addition to impellers, Chemineer is also supplying laboratory-scale agitators for optimisation work. Chemineer +44 1332 363 175 chemineersalesuk@nov.com www.chemineer.com
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Capsule Filling Machine Guarantees Absolute Protection of Both Personnel and Products
WFI with Storage and Distribution System Saves Up to 35% Space
The Bosch GKF HiProTect capsule filling machine completely isolates researchers and manufacturers from active substances during operation, maintenance and cleaning. The technology allows a variety of sizes and product types to be produced. Bosch’s exceptional cleaning technology provides excellent confidence in cleaning the equipment from product to product and preventing crosscontamination. Bosch Packaging Technology’s GKF HiProTect is suited for a wide range of filling operations, such as powder, tablets, pellets and combination filling. Its modular design concept makes it adaptable to exact customer applications by adding additional stations. The GKF HiProTect can be customised according to individual demands. For instance, it can be equipped with a statistical in-process weight control. The weight of both empty and filled capsules is determined in different stages of checkweighing. The weighing station provides automatic feedback to the powder dosing station. This process allows for self-regulating adjustments of filling levels. The optional 100% capsule control unit ensures real-time quality
Telstar has developed an integrated water systems solution for the biopharmaceutical industry. Based on the results of an extensive market assessment, Telstar has extended its range of integrated pharmaceutical water systems with a new, high performance solution. The new system combines a water-forinjection (WFI) distillation system and a storage and distribution system installed on the same skid and with a single control system. The compact unit is easy to control and operate and provides savings in cost and space. In fact, this compact combination provides a space saving of up to 35%. The new WFI production and storage and distribution skid operates to cGMP standards for pharmaceutical water and is marketed under the Telstar Puretech brand. The Telstar Puretech production, storage and distribution solution minimises space requirements by integrating all of the process technologies, instruments and controls within a single unit. The systems are designed and engineered to give reliable operation and continuous monitoring, while maintaining optimal energy efficiency, thereby lowering operating costs without compromising quality. Specialising in the development of critical installations for the biopharmaceutical industry and also in the management and execution of
checks that result in a constantly controlled process and provide high product quality. Frequent product or batch changes require thorough cleaning processes. The Bosch GKF HiProTect capsule filling machine has an integrated system that maintains the level of operator protection during cleaning. Several spray nozzles clean the entire machine and the programmable washing system stores and recalls cleaning protocols. This ensures a reproducible WIP process that can be fully validated. Bosch Packaging Technology +49 711 811 57 750 udo.comanns@bosch.com www.boschpackaging.com
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projects associated with water installations, Telstar offers complete solutions for GMP water and pure steam, spanning generation, storage and distribution systems. Both installations and equipment, developed with proprietary technologies, are designed to obtain maximum energy efficiency and reduce operational costs. The systems are designed, developed and installed as turnkey projects, including full validation packages. Telstar, S.A. +34 93 736 16 00 marketing@telstar.eu www.telstar.eu
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Centrifugal Compressor Increases Efficiency Up to 6%
Vacuum Dryer Developments Enable Multi-Purpose Processing
Ingersoll Rand is introducing the new Centac C800 centrifugal air compressor for assembly, automotive food and beverage, oil and gas, petrochemical, pharmaceutical, processing and other industrial manufacturing applications. The Centac C800 is built on the latest generation, integrated and simplified centrifugal compressor platform and is an extension of the Centac C1000 product line. Certified as ISO 8573-1 Class 0, the C800 provides 100% clean, oil-free air and is designed to minimise downtime, increase efficiency and lower total cost of ownership. The single largest contributor to lifecycle cost is loss of production. The Centac C800 is designed with features to maximise asset availability, including tapered polygon attachments to create a precision fit and evenly distribute torque and a simplified oil piping system with an integrated oil filter to keep the system running at ideal conditions. The compressor’s integrated gears, flex pad hydrodynamic bearings and components work to reduce vibration and error-proof alignment, minimising downtime and lowering operational costs. The optimised components and systems in the Centac C800 reduce energy use by up to 6% at full load. The backward-leaning impellers are designed with software and computational fluid dynamics that maximise peak efficiency and provide greater turndown. Furthermore, inlet guide vanes (IGVs) are standard on the new C800, delivering additional energy savings at partial load. Maintenance is easier on the C800 air compressor with a one-piece removable inducer, in-place rodable coolers, bull gear inspection ports and open cooler casing, which offer increased access to critical components. The fully configured compressor package also affords
Now developed to be more than just a dryer, the Vrieco Nauta vacuum dryer is capable of performing a wide range of different processes, including filtration, high-temperature and vacuum sterilisation, steam stripping, chemical and crystallisation reactions and vacuum drying. This additional flexibility across a broad range of products can be further enhanced to include mechanical dewatering prior to drying, with the installation of a filter directly on top of the dryer or even inside the vessel. Developments of this well-respected piece of equipment offer maximum flexibility with minimum operator intervention to meet a competitive processing industry demand. Using smart process engineering methods, the original multi-purpose sequences have been rearranged to deliver a 50% reduction in processing times, which also delivers potential energy savings too. Process time is reduced not only by mechanical watering prior to drying but then by heating the extracted water, which is then recirculated back to the dryer, reducing the process heating time. Alternatively, the heated water is available to other processes. Crystallisation can also be carried out in the vacuum dryer where the reactants can be first dissolved and reacted. The efficient mixing within the dryer accelerates dissolution and temperature control. Cooling of the liquid then initiates the crystallisation process. The crystals formed can be dried under vacuum.
efficient installation — no special foundation or grouting required. The single inlet and outlet connections for cooling water also reduce installation time and cost. These features were specifically designed to optimise and enable system efficiency and reliability. The web-enabled Xe-Series controller enhances productivity and enables plant and operations managers to remotely access and adjust the system from virtually anywhere. It presents real-time monitoring and trending of critical components, making it easy to predict maintenance needs and correct operating parameters from web-enabled smartphones, tablets and personal computers. “Lost production caused by unscheduled downtime is the largest contributor to a compressor’s lifecycle cost,” said Alberto Crippa, Product Manager Process Compressed Air System, Europe, Middle East and Africa, Ingersoll Rand. “Ingersoll Rand manufactured the C800 with fewer parts, integrated components — and easily accessible critical components — to increase the compressor’s reliability and efficiency.” Ingersoll Rand +32 2 746 1190 celine.basset@irco.com www.ingersollrandproducts.com/C800
Skid-Mounted Agitated Reactors Allow Operators to Achieve Safe and Precise Mixing Charles Ross offers a wide range of custom-designed agitated reactors for chemical processes and sanitary applications. This selection includes new designs of skidmounted, highpressure reactors, specially developed to meet the exact needs of end-users. Pictured are 136 l dished-bottom reactors, each equipped with a topentering impeller agitator, dip tube, multiple feed ports, removable thermowell and flush bottom ball valve. Designed for 100 psig internal pressure at 93˚C, the reactor vessels are built to ASME Code Section VIII, Div. 1 and registered with the National Board of Boiler and Pressure Vessel Inspectors. A dry-running single mechanical seal allows the agitator to be operated at the in-tank pressures. The vessel sides and bottom include a 50-psig baffled jacket for heating/cooling to the optimal reaction temperature.
Powered by an explosion-proof motor to run up to 500 rpm, the variable speed agitator delivers precise mixing at all stages of the reaction. An intrinsically safe, local control panel installed on the skid enables operators to control mixer speed, read power load and start/stop the reactor. The mixer can also be controlled from a remote PLC control panel. Charles Ross & Son Company +1 631 234 0500 sales@mixers.com www.mixers.com EPM 7
Chemical reactions, including those where solids react with gases or liquids, can be handled very effectively with the high efficiency of the mixer ensuring a homogenous result in product conversion, while the reaction energy is efficiently removed or supplied by the efficient heat transfer within the dryer unit. Hosokawa Micron Ltd +44 1928 755100 info@hmluk.hosokawa.com www.hosokawa.co.uk
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Filter Ensures Efficient Recovery of Costly Products During Milling The latest addition to the ProFi product line is a standalone filter system especially developed for product recovery in milling processes. The newly developed and patent-pending ProFi – Clean filter is easily installed by a clamp connector as a module on the milling chambers or inlets/outlets housings of all Frewitt mills (OscilloWitt, HammerWitt, ConiWitt and TurboWitt). Sieve mills in existing systems can be retrofitted in a few simple steps. Numerous advantages set this filter system apart from others, including: • Low-pressure filling — Exhaust air at atmospheric pressure escapes from the milling chamber via the filter, which traps any product. To prevent product build-up on the filter, the exhaust air filter is cleaned by a time-controlled pressure surge. The advantage of this
method is that continuous, uninterrupted product filling is possible. The product is fed back into the process by means of the exceptionally efficient pressure surge cleaning. • Dust-free atmosphere — Particles >5 µm can be filtered out, thus fulfilling the requirements for class M filters (BGIA) of DIN standard EN 1822 (H12). The high filtration efficiency results in a dust-free atmosphere corresponding to OEB level 3. The exhaust air escapes in a controlled manner via the filter, thus protecting the operator and the environment from contamination. Various options enable a broad range of applications. For instance, stainless steel cartridges can be used for processes that demand higher mechanical stability, a Venturi system ensures reduced power
consumption and H13 class HEPA filters can be used when high quality is expected. • Compact and standalone — The filter system consists of the housing, the filter cartridge and the compressed air and control unit that is attached to the filter housing. This design allows the user to mount the unit on any new or existing Frewitt sieve mill. At this point, it should be mentioned that the HammerWitt is equipped with a connection for an ISO 2852-compliant DN 32 clamp as a standard feature. Frewitt took a bold step in a new direction that really paid off. The company applied its expert sieve technology know-how to the development of a filter system that fulfills a critical need, namely the efficient recovery of costly products.
Frewitt SA +41 26 460 74 00 www.frewitt.com
Pressure Sensor Offers High Accuracy for Critical Dosing and Dispensing The flowplus16 pressure sensor from Intertronics offers high accuracy monitoring in a design suited to critical dosing and dispensing applications. Accurate in-line pressure sensing can deliver important quality assurance in a whole range of automatic processes, e.g., in medical, pharmaceutical and semi-conductor manufacturing as well as the wider areas of process control. The flowplus16 is compact and is easily installed into the fluid path by means of standard luer lock fittings. It measures the pressure of the liquid
being dispensed or dosed and provides precise monitoring of material flow. This information is useful in many analytical and laboratory situations but also has real value in production environments where, e.g., it can detect irregularities caused by air bubbles in adhesives that would disrupt tight tolerance dispensing on medical devices or visual displays or identify a blockage building up in filled fluids, so enabling corrective action to be taken. The flowplus16 is one of the smallest piezo-resistive pressure sensors
available and is maintenance free, featuring an inert fluoropolymer internal coating that provides a smooth and consistent fluid pathway with no internal dead space. The compact unit incorporates an integrated micro-chip, which converts the pressure sensing to a standardised 0-10V digital output signal. Any detected pressure fluctuations enable problems to be identified at an early stage, e.g., clogging, microbubbles or variable pressure feed. Constant readout via a standard connector provides verification of correct dosing or dispensing and may be simply integrated into existing PLC control systems, providing temperature compensated readings, without complicated calibration, in a userfriendly package. Managing Director of Intertronics Peter Swanson explained: “When you absolutely have to know your process is
right every time, the flowplus16 provides assurance, process reliability and reduced downtime. It is suitable for use with a wide range of materials such as enzymes, drugs and medicines, critical ingredients, inks and adhesives.” flowplus16 can operate with flows of up to 100 ml/min at pressures of 0–16 bar and between 15 to 45°C. Intertronics +44 1865 842842 info@intertronics.co.uk www.intertronics.co.uk
Dr. Reddy’s Laboratories Deploys Manufacturing IT Business Platform Across Indian Site Pharmaceutical major Dr. Reddy’s Laboratories Ltd has successfully rolled out Werum’s PAS-X manufacturing IT business platform at its Indian greenfield site in Visakhapatnam. Dr. Reddy’s deployed PAS-X for the first time as full-blown MES covering all operations from material receipt to production. Dr. Reddy’s required an MES Go-Live within a minimum of time. The system had to reliably document the batch production processes to meet all regulatory requirements. In order to ensure the approval of the greenfield plant by all regulators, particularly the FDA, the pharmaceutical company was especially interested in a fully tried and tested MES. “Based on the good experiences with PAS-X V3 at our Hyderabad plant, we EPM 8
took this system as template and rolled it out at our site in Visakhapatnam,” said Sanjay Mantri, Director at Dr. Reddy’s Laboratories. “This way, the PAS-X MES was set up within five months only and we were able to quickly start producing the first trial batches. PAS-X helps us to ensure full compliance and the highest quality right from the beginning.” The MES project was implemented by Werum’s Asia Support Center in close cooperation with Dr. Reddy’s Centre of Excellence. The pharmaceutical manufacturer plans to install Werum’s PAS-X at three further facilities in India. Werum Software & Systems AG +49 4131 8900 689 dirk.ebbecke@werum.com www.werum.com
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Lockable Settle Plates for Safe and Efficient Monitoring of Viable Air and Personnel Merck Millipore, the Life Science division of Merck, has launched lockable ICRplus Settle Plates for viable air monitoring and personnel monitoring in cleanrooms and isolators. The new plates are based on the original Merck Millipore ICR settle plate technology and provide semi-quantitative determination of microbial contamination. ICRplus settle plates feature a new, twoway closure system: the ‘CLOSED’ position allows safe transportation and aerobic incubation while the ‘VENT’ position expands incubation for the detection of anaerobic and microaerophilic microorganisms. ICRplus Settle Plates are filled with Casein Soybean Digest Agar (TSA), which is recommended by the FDA Guidance for Industry (2004): Sterile Drug Products Produced by Aseptic Processing — cGMP. The plates are offered in formulations with neutralisers for the inactivation of disinfectant. Additionally, the plates can be utilised for the detection of fastidious bacteria when used in combination with chocolate agar and lecithin, Tween 80 and histidine (LTH). “Efficient and reliable environmental monitoring of isolators and cleanrooms is essential to support product quality and customer safety,” said Yvonne
Hochheimer, Product Manager at Merck Millipore. “With our unique two-way closure system of the ICRplus settle plates, customers can be assured of safer transport and reliable detection of aerobic and anaerobic microorganisms. The plates also offer the ultimate in convenience with room temperature storage at the site of use and a long shelflife. This translates into decreased storage costs and less incoming goods controls and QC testing.” ICRplus settle plates are produced under aseptic conditions, gamma-irradiated and triple-bagged, making them optimal for personnel monitoring, passive air sampling and active air sampling with sieve-like samplers (e.g., MAS air samplers) in isolators and cleanrooms. Furthermore, the new products enable inactivation of residual vaporous hydrogen peroxide (VHP) during active air sampling. Each ICRplus settle plate contains a data matrix barcode, which allows secure identification of plates and supports the paperless laboratory. The 90 mm plates have a high
RF Galvanic Isolator Reduces Cost of Installing Wireless Equipment in Hazardous Environments Extronics has launched iSOLATE500, claimed to be the world’s first radio frequency galvanic isolator for hazardous areas. According to the company, this solution revolutionises the way that wireless networks can be installed in hazardous environments and will deliver significant cost savings to users in a wide range of industries, including oil, gas, pharmaceutical, chemical and food processing. According to John Hartley, Managing Director of Extronics: “Resulting from four years of extensive research and development, iSOLATE500 enables the rapid deployment of more effective wireless networks within hazardous process environments. Enabling the use of standard, off-the-shelf hardware, it also makes networks easier to install and support, providing an effective barrier to prevent sparking and eliminate any danger of explosions.” iSOLATE500 is fully ATEX and IECEx accredited and allows standard wireless equipment to be deployed without requiring costly assessment by notified bodies. It blocks all known faults, including AC/DC and hazardous transients, making any RF output intrinsically safe. This enables installers and system integrators to utilise any standard access point or antenna, including directional and omni-directional, to deliver higher performing wireless networks in any hazardous area. iSOLATE500 also allows antennas to be easily changed as required without powering down the whole network.
The ability to use standard, high-performance antennas to concentrate the signal where it is needed the most will also help to reduce the cost of installing wireless networks in hazardous environments. In fact, early deployments have shown that fewer access points are required when iSOLATE500 is used as part of high-performance wireless networks. iSOLATE500 has an operating temperature range of -60 to +80˚C and is available in three different versions to meet a wide variety of applications. The 5 and 2.4 GHz models are designed for use with wireless voice and data networks, CCTV, IP telephony, video conferencing and Bluetooth applications. The 900 MHz version can be used for RFID tracking and GSM. Extronics +44 845 277 5000 ross.tye@extronics.com www.extronics.com
High-Precision Powder Mixer Delivers Optimum Mixing Results with Better SelfDischarging According to amixon, the real innovation of its AM-type mixer does not lie in the conical floor but in the mixing tool; amixon engineers have succeeded in developing a patented helical ribbon shape of mixer tool that also allows even mixing in the cone. This is because the helical ribbon implements three-dimensional movement of the items to be mixed; upwards spiral movement at the periphery and downwards flow in the centre. At the same time, superb self-emptying behaviour of flowing materials is achieved by means of the coneshaped floor and the discharge area without dead spaces. The residue emptying rate is mostly 99.998% and better. The EHEDG- and FDA-conformed equipment achieves a very high mixing quality and can be used for dry and wet goods as well as suspensions, pastes and doughy materials. amixon GmbH +49 5251 688888 0 info@amixon.de www.amixon.com
Cone mixer equipped with SinConvex spiral stripe tool and EasyAccess door for inspection and cleaning of the mixer. EPM 9
filling volume of 30 ml, which allows prolonged incubation. With the new ICRplus settle plates, Merck Millipore claims to stand out as the first supplier of a complete portfolio of lockable, ready-to-use settle and contact plates (ICRplus contact plates) for environmental monitoring in the pharmaceutical industry. Merck Millipore +1 978 715 1567 karen.hall@emdmillipore.com www.merckmillipore.com
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP PAT Software Customers to Benefit from Analytics Performance Boost Optimal has announced an enhanced working relationship with CAMO Software, which has resulted in further integration of the suppliers’ software products, offering faster drug development within a process analytical technology (PAT) framework. The respective software products are designed to deliver a simplified route to increasing production efficiency and accuracy in complex, data heavy process applications — as typified in commercial pharmaceutical manufacturing. SynTQ from Optimal and The Unscrambler X from CAMO Software have both been developed
independently but very much in the same vein. Having worked together on several projects, the products can now be fully integrated into an R&D or production environment. The result for end-users is a powerful model development, data management and production management solution that easily transfers from the laboratory to the production floor. As manufacturing processes have evolved with the introduction of smart sensors, new testing procedures and data analysis techniques, there has been a huge increase in the amount of data being generated throughout the production cycle. In turn, the
requirement to manage this data in a more efficient way has led to the adoption of increasingly powerful software products. The design, development and test process is also becoming far more integrated into manufacturing so it is essential that the software packages become more integrated in order to simplify use for the operator and reveal previously hidden
information. This is the core benefit of the closer CAMO and Optimal cooperation, as both multivariate analysis and PAT data management software tools are vital components of a successful and compliant PAT implementation. Moving away from a batch orientated production regime that has to be halted for quality checks to be made and towards a more continuous in-process solution requires powerful software, especially when regulatory compliance demands strict quality standards, data storage tracking and traceability. A key mechanism in achieving this transition is the implementation of PAT. Part of a PAT process necessitates definition of the product’s critical quality attributes (CQAs). By measuring and controlling the process to optimise these CQAs, the manufacturer can produce a finished product of consistent and enhanced quality, while also reducing costs and waste. In order to measure these CQAs in real-time, two software components are required — a PAT Data Manager such as synTQ from Optimal and a multivariate data analysis package such as The Unscrambler X from CAMO. synTQ is used to configure, run in real-time and coordinate all the spectral instruments demanded by the process. It also stores all the gathered data for regulatory purposes and passes the data on to The Unscrambler X for multivariate model building. When the models are built, users can then run them in real time within the synTQ environment combined with CAMO’s Process Pulse software or analytical engines. Users can then improve their process understanding by carrying out experiments where input parameters are varied and the resulting changes in CQAs are predicted in real time. Armed with process understanding and using the facilities in both packages, users can then develop and run control models using synTQ, ultimately enabling closed loop feedback and feedforward control. By introducing a PAT data management system such as synTQ and combining it with multivariate software from CAMO, manufacturers are able to reduce the overall cost of production, improve the quality of the final product and customer confidence in that product. All of this can be achieved while also meeting FDA and other regulatory guidelines. Optimal Industrial Automation Ltd +44 1454 333 222 mgadsby@optimal-ltd.co.uk www.optimal-ltd.co.uk
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MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Conveying and Weighing Systems Testing Service Ensures Satisfied Customers Very few people would buy a new car without a test drive or a house without at least one visit and evaluation, so why would a manufacturer make a significant investment in new capital machinery without having the chance to test it? Spiroflow is one of the few suppliers of conveying and weighing equipment to offer a full testing process prior to purchase. Spiroflow believes that customers should have complete confidence in the efficiency of their new systems, regardless of the level of investment.
The manufacturer of conveying and weighing systems actively encourages customers, old and new, to use the fully equipped test centre at its Lancashire, UK, site before purchasing any of its flexible screw conveyors, aero mechanical conveyors, tubular cable and chain drag conveyors, vacuum conveyors, bulk bag dischargers, bulk bag fillers or ingredients handling and weighing systems. Whether the equipment is required for efficiently conveying food ingredients such as flour, cereals and coffee
Bag discharger.
granules or accurately controlling the flow of materials for the chemical and water treatment sectors, high quality testing facilities like those at Spiroflow can reassure customers that the systems they are planning to invest in will provide optimum performance and offer value for money. According to Spiroflow, carrying out thorough throughput and degradation trials using its conveying, bulk bag filling and discharging technology — replicating the client’s working conditions, including temperature and humidity — can iron out any flaws and ensure each system will meet requirements. Spiroflow works closely with the customer on the testing, sharing the results for analysis and, if necessary, conducting follow-up tests. Offering this outstanding level of customer service is part and parcel of the Spiroflow experience and is one of the reasons why companies in the food, chemicals and process industries return again and again to Spiroflow for their filling, discharging and conveying needs. Spiroflow’s After Sales Manager Jeanette Carter explained: “We offer a comprehensive testing and installation facility because we want to make sure the client is buying the right equipment for the product. Once we have a guideline from the customer, a dedicated test engineer will set up the trial in accordance with those requirements. He will also make additional recommendations if he believes it will improve the process.
Continuous Process Technology Supports AstraZeneca’s Further Investments in R&D AstraZeneca is a leader in the development of continuous processing of tablets. To further strengthen its clinical trial manufacturing capability in Mölndal, Sweden, AstraZeneca has recently invested in a continuous wet granulation unit, ConsiGma 25, from GEA Pharma Systems. The wet granulation unit will be used for the development of novel drugs and also to produce materials for clinical trials. AstraZeneca develops formulations and manufactures materials for global clinical trials in its R&D facility in Mölndal. Larger scale production is transferred to AstraZeneca’s commercial production facilities. According to GEA Pharma Systems, it is at the forefront in providing the pharmaceutical industry with new technologies based on the most innovative way of granulating, drying and making tablets using potent APIs. The concept of converting traditional batch production into continuous processing has been developed further over the last decade and is now rapidly gaining interest. “There has been a long-standing relationship between AstraZeneca and GEA Pharma Systems for batch granulation technology, and the continuation — with its third purchase of continuous granulation technology — strengthens this relationship further,” said Michael Van den Bossche, Sales Manager of GEA Pharma Systems. The ConsiGma can produce granules continuously, there is no waste during startup and shutdown and the batch size
is determined simply by how long the machine is run. It also provides benefits in the development of new products as process parameters can be changed easily during experiments, resulting in shorter development time with less material used. Critical quality attributes are measured throughout the process. ConsiGma was developed in compliance with the FDA’s QbD initiative. It satisfies the industry’s need for reduced risk and higher quality while avoiding lengthy and costly validation and scale-up to bring products to market much faster. This flexibility enables the production of products to meet demand, keep expensive cleanroom space to a minimum and reduce inventory costs. Integrated advanced process control and PAT tools allow monitoring during production, therefore quality can be designed into products from the start. GEA Pharma Systems +32 3 350 12 80 michael.vandenbossche@gea.com www.geapharmasystems.com EPM 11
Conveyor. “For example, if we set up a system with a spiral conveyor and the product is smearing or sticking to the tube wall, we can change the profile of the spiral to achieve the result the customer is looking for and the throughput requirement that they are aiming for as well. We can monitor changes to bulk density during conveying or assess the effect of conveying at very steep angles. Obviously we are also careful to ensure safe working practice and satisfy COSHH and ATEX regulations.” Spiroflow Ltd +44 1200 422525 ben.ayrton@spiroflow.com www.spiroflow.com
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP Handheld Particle Counter Makes Regular Environment Monitoring Affordable Manufacturers across many sectors use ISO classified cleanroom environments to conduct critical processes that demand protection from harmful contamination. The only way companies can ensure they are consistently meeting ISO classification parameters is to regularly monitor the environment. However, despite the critical process and expensive investment in a cleanroom, many companies rely solely on their annual or bi-annual validation visit from contractors to check that the cleanroom is meeting its specified ISO classification parameters. Every day, contamination risks are generated from production staff, processes and products that may not be present during the annual validation visit. Filter blockages, a too low airflow rate, poor operator practice and product/packaging have the potential to increase product failure rates and expensive recalls. This could negatively
impact on and cause long-term damage to an organisation’s PR. For pharmaceutical, medical or food markets, contamination issues could even be fatal. Regular environmental monitoring promotes cleanroom class confidence to satisfy internal or external audits. It also allows organisations to detect and address contamination sources quickly, before they cause issues. The good news is that particle counters are no longer too expensive, too large or too inaccessible for organisations to invest in. Cleanroomshop.com has recently launched a new range of particle counters that offer great value. The online cleanroom supplies specialist confidently claims that the three-channel particle counter is the best value in the market, owing to its low price, accuracy, functionality and ease of use. ISO 14644-1 specifies maximum limits for a range of particle sizes, which is why this particle counter monitors three
channels simultaneously: channel 1 — choice of 0.3 and 0.5 µm; channel 2 — choice of 0.5, 1.0, 2.0 and 2.5 µm; and channel 3 — 5.0 µm. For users monitoring ISO Class 7 or 8 cleanroom environments, the most popular channel combination is 0.5, 1.0 and 5.0 µm. This particle counter is easy to use, with a colour display, and saves up to 8,000 data set records, which is higher than average for a handheld unit. When ISO mode is selected, this threechannel particle counter automatically calculates average, standard deviation and UCL, speeding up the process and improving accuracy by reducing manual calculations. ISO 21501-4 calibration with ongoing calibration service is offered and a carrying case is included to protect the investment. To offer a higher level of environmental monitoring, Cleanroomshop.com also offers a six-channel particle counter that calculates minimum sampling locations
and minimum sampling time as well as simultaneously monitors six channels. Connect 2 Cleanrooms & Cleanroomshop.com +44 1524 813022 info@cleanroomshop.com www.cleanroomshop.com
Mixer Provides Rapid One-Step Dispersal/Degassing in Production Size Material Quantities The Thinky ARE-500 mixer from Intertronics is a high-performance, industrial, non-contact planetary mixer that is suitable for all engineering compounds — liquids, pastes and powders. It mixes, disperses and degasses materials in seconds to minutes, in a sealed or lidless container such as a jar, beaker, syringe tube or cartridge, using a non-contact mixing principle that makes it possible to formulate compounds from very small amounts such as 0.5 ml to large production scales up to a full 1.1 kg, while mixing and removing bubbles simultaneously. The Thinky ARE-500 conditioning mixer can be used for the mixing and/or bubble removal of epoxies, silicones, conductive pastes, medicines, laboratory or production chemicals and many other fragile or complex materials. Typical mixing times are in the order of a few seconds to a few minutes, depending on material viscosities and complexities — a viscous epoxy resin and hardener can be homogenously mixed with aluminium powder filler in a few minutes, for example.
The ARE-500 stores five different sets of mixing and degassing conditions (time and speed per mode) in a single batch cycle, which consolidates otherwise time-consuming formulation into a single step, completing in seconds to minutes what might otherwise take a great deal longer. Precise control of the mixing/dispersion process makes it possible not only to deliver improved and consistent formulation quality but also to eliminate human errors and the need to rely on special operator skills. Shear forces are minimal so as not to damage delicate materials, whilst cooled or heated materials can be processed using special adapters. Standard containers range from 650 ml jars right down to small syringes. The ability to mix in the user’s own container eliminates the need to clean between batches, saving significant time and lowering costs, while improving yield rate. Thinky mixing and degassing has been found valuable for high viscosities, for materials with highly different densities and for mixing dry particles into liquids. The simultaneous process of
dispersion and degassing in one batch gives major time savings. It can remove voids and re-disperse filled materials in pre-packed syringes prior to use. The noninvasive processing eliminates any risk of cross contamination between batches. The ability to process quantities as small as 0.5 ml saves wastage of valuable materials, while re-mixing of separated materials can prolong shelf life and save stock costs. The ARE-500 has a high-durability drive system suitable for production and enabling up to 500 ml or 1.1 kg of material to be simultaneously mixed and deaerated. Material possibilities include adhesives, sealants, moulding compounds, lubricants, slurries,
coatings, inks, paints, abrasives, bio chemicals, cements, medical compounds, cosmetics/personal care materials, detergents, conductive pastes, dental materials, foods, construction materials or any other materials that are hard to mix or hard to degas. Intertronics +44 1865 842842 info@intertronics.co.uk www.intertronics.co.uk
Video Shows Controlled Filling of Various Capacities on Same Device
Redesigned Electromagnetic Flow Meters Promise Greater Accuracy and Convenience
Typically, precision load cells work at their highest accuracy only in a very specific capacity range. A new video from Mettler Toledo shows how a new weigh module reproducibly provides 1 mg readability over a full 0–1,200 g capacity range. That allows for gravimetrical-controlled filling of a large variety of capacities on the same filling device. The video explains how businesses can improve efficiency and quality by incorporating WMS weigh modules from Mettler Toledo into their filling machines. The weigh module is often used in machines that fill both very large and very small vials. The WMS can be configured for any environment and comes with easy-to-use software for fast startup. In addition, it is IP54 rated for protection against dirt or other particles in the industrial environments in which it often operates. The video also shows how the WMS
GEA Diessel has redesigned its range of IZMAG stainless steel electromagnetic flow meters to make them even more accurate and flexible for applications throughout the food, beverage, pharmaceutical and biotech industries. The new IZMAG2 features a redesigned measuring tube that eliminates the need for inlet or outlet pipe sections. This simultaneously saves space and improves the IZMAG2’s already impressive measurement accuracy by +/-0.2%. Vacuum resistance is achieved by mechanically anchoring the synthetic material to a stainless steel lattice. This makes the IZMAG2 impervious to water vapour and resistant to cleaning temperatures of up to 80˚C. These developments represent an evolution of the original IZMAG flow meters, which themselves — when launched in 2010 — included outstanding features such as a visual display, 360°
weigh modules offer 100% in-process control by weighing all filled vials, which is often required in the pharmaceutical industry today. Watch the video to see how the WMS weigh modules can help businesses achieve quality and efficiency targets at www.mt.com/ind-filling-ofpharmaceuticals. Mettler-Toledo (Schweiz) GmbH Industrial Weighing +41 44 944 25 68 eugen.schibli@mt.com www.mt.com
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positioning and Bluetooth compatibility for simple data gathering. In common with all electromagnetic flow meters, the IZMAG has no moving parts, offers bi-directional metering for all conductive liquids and is suitable for use at high temperatures or under vacuum conditions. The latest IZMAG electromagnetic flow meters now feature a quick response (QR) code on the type plate of each instrument, a quick, simple way for customers to access information and to contact GEA Diessel instantly from the location where each instrument is installed, thereby receiving the fastest, most effective service from the company’s after sales team. GEA Diessel GmbH +49 5121 7420 hermann.hartmann@gea.com www.gea.com
MANUFACTURING PRODUCTS & EQUIPMENT ROUNDUP CASE STUDY CI Precision has been endorsed by CDMO Molecular Profiles, which recently integrated CI Precision’s SADE SP140 tablet and capsule weight sorter into its current systems. The pharmaceutical development services specialist, in Nottingham, UK, dedicated to advanced characterisation, pre-clinical and clinical development, clinical manufacturing and analytical support to pharmaceutical companies globally, required a new system to provide the precision measurement of capsule and tablet manufacture. With its ability to sort both tablets and capsules of a wide range of shapes and sizes and without the need for change parts, plus its consistent high accuracy, the SADE SP140 is the ideal weight sorter for both R&D and production facilities. The unit’s real-time display of statistics and detailed reporting means operational staff are always well-informed of project progress. Installed by CI Precision in October 2012 to support Molecular Profiles’s current systems for the manufacture of capsules and tablets, the SADE SP140 was chosen on account of its costeffectiveness, versatility and quick delivery. “We manufacture a range of dosage forms
MOLECULAR PROFILES COMMENDS CI PRECISION AFTER WEIGHT SORTER INSTALLATION
from liquids to tablets, so the equipment we employ must be fit for our purpose and integrate well with our technology,” explained Steve Kemp, VP at Molecular Profiles. “CI Precision’s SP140 is not only intuitive to work with, but the speed of delivery is exactly what we required. With plans for expansion underway in our pipeline, the SP140 has suited itself to our systems to such a degree that we will certainly consider CI Precision’s solutions as part of this growth plan, particularly after the excellent aftersales support we have received.” “We’re delighted to have started a productive working relationship with Molecular Profiles,” added Will Eaden, Sales and Marketing Director at CI Precision. “Molecular Profiles is a company at the cutting edge of research and formulation
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development, so it is a privilege to call ourselves a supplier and we look forward to delivering more of our services and high quality support.” CI Precision +44 1722 424 100 sales@ciprecision.com www.ciprecision.com
Ajax Equipment Ltd +44 1204 386723 sales@ajax.co.uk www.ajax.co.uk amixon GmbH +49 5251 68 88 88 0 info@amixon.com www.amixon.com Charles Ross & Son Company +1 631 234 0500 cross@mixers.com www.mixers.com
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Pharmatech +1 675 46 76 36 sales@pharmatech.co.uk www.pharmatech.co.uk
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Diosna Dierks & SĂśhne GmbH +49 541 33 104 810 dietzmann@diosna.de www.diosna.com
Natoli Engineering Company, Inc. +1 636 926 8900 sales@natoli.com www.natoli.com
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Chemineer UK Ltd +44 1332 363 175 tr-gbr-chemineersales@nov.com www.chemineer.com
Hosokawa Micron Ltd +44 1928 755100 info@hmluk.hosokawa.com www.hosokawa.co.uk
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Devices for complete discharge and automatic wet cleaning available. Static, multi-shaft and ultrahigh shear mixers and paddle, vertical cone screw and cylindrical blenders.
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Ribbon Gravity Column Homogenising Pneumatic Portable Hoppers
mixing & blending
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Aerators Ball Mills Conical Continuous Cooker Dispersion Fluid Bed High Shear Homogenising Hydraulic Mill In-Line Jacketed Kneading Low Shear Paddle Planetary Pneumatic Portable Roll Mills Roller Sanitary Screw Self-Cleaning Tumble Ultrasonic Vacuum Vibratory
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SHOWCASE PACKAGING
Latest Security Feature Prevents Application of Faulty Labels Newman Labelling Systems has designed the Faulty Label Removal (FLR) system for use with its full range of pharmaceutical standard labelling systems. The traditional method of tracking faulty labels, applying them to a container and then rejecting the container, whilst being effective, has been seen as wasteful. The FLR System has been introduced in response to the growing demand within the international pharmaceutical industry for a labelling system to have a reliable and efficient system for removing faulty labels prior to application to a container. The FLR System will remove a faulty label as designated by the labelling system PLC control and, should the system not receive good signals from the scanning devices in use (including barcode reader, missing overprint detector, OCV camera and 2D matrix code reader), the faulty label is securely removed from the label web prior to
application onto the container. These faulty labels are then transferred to a paper roll for batch reconciliation and inspection. Newman Labelling Systems Managing Director John Clayton is keen to point out that his FLR system operates differently and, he claims, more effectively than other systems already on the market: “Newman isn’t the first to introduce a system to remove faulty labels, but we have spent longer in R&D and designed a system that we believe is superior. The problem with systems currently in the market is that many have to slow the labelling machine down to remove the faulty label prior to application and some systems accumulate faulty labels on top of each other on a sleeve, making physical reconciliation impossible. Both of these are major drawbacks for obvious reasons. “The Newman engineering team has now fully developed (patent pending) a
compact new system that overcomes the deficiencies of the existing systems, whilst fully satisfying the highest level of GMP Standards demanded by the industry.” The Newman FLR is available now as an optional extra on Newman Labelling systems. It can handle both paper and clear labels and can be validated at production speeds up to 550 C.P.M., with a full physical label reconciliation capability. Newman Labelling Systems is a leading manufacturer of labelling systems, with models designed specifically for the pharmaceutical industry. It has a customer base that includes the world’s top ten
pharmaceutical companies. All purposebuilt systems are fully compliant with FDA cGMP requirements and can be supplied with validation completed up to PQ. Newman Labelling Systems Ltd +44 20 8440 0044 sales@newman.co.uk www.newman.co.uk
CASE STUDY Bosch Packaging Technology has delivered its first FXS 3100 nested syringe filling line to Italy. IBSA Farmaceutici Italia purchased the line to improve its aseptic prefilled syringe operations in Lodi. IBSA Farmaceutici Italia, a subsidiary of the Swiss Institute Biochimique S.A., specialises in small-volume production of aseptically filled and sterilised pharmaceuticals. This includes 16 million pre-filled syringes per year containing sodium hyaluronate for intra-articular and intradermal use and 2.2 million syringes for physiological solutions used as solvent for freezedried powders. IBSA recently added a new production building to its site in Lodi, close to Milan. To improve processes for its aseptically pre-filled syringes, the company decided to equip the plant with a Bosch FXS line. “Bosch designers and technicians showed the best attitude towards the project and were very fast in accepting our specifications,” commented Roberto Maglio, Engineering and Maintenance Manager at IBSA. On the new line, IBSA will mainly produce diclofenac, an anti-inflammatory API used for muscular and rheumatic treatment. In a further step, the company also plans to fill hyaluronic acid for intra articular and intradermal use.
NESTED SYRINGE FILLING LINE GREATLY IMPROVES OPERATIONS AT IBSA FARMACEUTICI ITALIA
Special emphasis on contamination issues The new nested syringe filler for presterilised syringes produces at medium to high rates. IBSA achieves an output of 12,000 syringes per hour with watery products and 6,000 syringes per hour with
viscous products. “Viscous products are filled and stoppered under vacuum, hence the lower output rate,” Maglio explained. The line is based on the FXS 3100 nested syringe filler from Bosch Packaging Technology. Combined with an ABO 5000 bag opener and an ATO 5000 tub opener, as well as open restricted access barrier system (RABS) technology, the line was configured to the special requirements of IBSA Farmaceutici Italia. “Bosch was always open to new suggestions and quickly implemented our modifications,” said Maglio. Paola Emaldi, responsible for quality assurance at IBSA’s Lodi site, added: “The project was not only about the filling of our syringes; the complete process needed to be taken into account. We had to pay particularly high attention to microbiological contamination issues.” During the process, the empty sterile syringes contained in tubs are moved from the non-sterile area to the cleanroom area and sterility of those syringes must be ensured. Microbiological controls are executed by high-precision instruments being able to detect microbial contamination in real time, proving that no contamination occurred. A truly reliable aspetic process During the testing and implementation phase, both companies benefitted from each other’s knowledge and working conditions. “IBSA could draw on Bosch’s expertise and flexibility for the line configuration,” Maglio explained, “Together, we managed to achieve a truly reliable aseptic process.” The first series of factory acceptance tests (FATs) were performed at Bosch’s location in Crailsheim, Germany, before the line was shipped to Lodi, where more tests and adaptations were carried out. Both companies profited from testing at the actual place of production, including cleanrooms grade A, B and C. The specific application at IBSA’s plant in Italy required some changes to the line configuration.
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Both the machine shape and the dimensions of critical machine parts were adapted and now ensure a smooth air pathway and material movement to and from the classified areas without contamination. The final tests had to wait until the line had been installed and the environmental conditions completed. The results confirmed that all improvements had been successfully implemented. “Everyone involved was continuously seeking to improve processes and to find the best solutions for IBSA,” Maglio emphasised, adding that this attitude “really came out naturally.” Bosch Packaging Technology — Business Unit Pharma +49 7951 402 517 klaus.ullherr@bosch.com www.boschpackaging.com
SHOWCASE PACKAGING
Non-Destructive Multi-Bottle Leak and Seal Tester Draws Pack Expo Crowds Belfast-based pharmaceutical packaging integrity expert Sepha launched BottleScan — claimed to be the world’s first tool-less, nondestructive, multi-bottle integrity tester for induction-sealed pharmaceutical bottles — at Pack Expo, in Las Vegas, on 23 September 2013. BottleScan, which has been designed, developed and manufactured at Sepha’s UK headquarters, uses force decay technology to detect weak seals and defects down to 15 µm. It has a toolless design and can test up to four bottles simultaneously in a quick test
cycle of approximately 60 seconds. The system produces objective ‘Pass/Fail’ results, enabling good bottles to be returned to the production line. BottleScan has the ability to run in compliance with 21 CFR Part 11, offering pharmaceutical manufacturers and packagers a more technologically advanced, accurate and efficient solution for testing the integrity of induction-sealed bottles. Commenting on the launch, Paul Kelly, Sepha’s Head of Sales & Marketing, said: “BottleScan is the latest addition to Sepha’s integrity testing product range and has been developed in
response to increasing market demand for a more advanced, technology-based integrity test for induction-sealed bottles. Its tool-less design and configurable methods make it ideal for pharmaceutical lines running multiple products. Operator error is also eliminated as the quick, repeatable test provides objective data that is securely stored and can be built into cGMP and used as part of robust QA testing.” Sepha Ltd +44 28 9048 4848 sarah.lamont@sepha.com www.sepha.com
Next Generation BFS Aseptic Machines Deliver Increased Production Efficiency rommelag, a leading provider of developer of blow-fill-seal (BFS) technology, has successfully introduced the bottelpack 324 aseptic machine for manufacturing IV solutions (LVP) as well as the bottelpack 324M for manufacturing of injectables (SVP). This new generation of BFS aseptic machines is servo-driven without the
use of hydraulics and provides numerous advantages during operation and maintenance, in addition to higher equipment availability and increased production efficiency. BFS aseptic machines are designed to produce single ampoules, ampoules in blocks or single bottles ranging
from 0.1 to over 2000 ml using a variety of plastic materials such as low-density and high-density polyethylene (LDPE and HDPE) and polypropylene (PP). rommelag ag +41 62 834 55 55 mail@rommelag.ch www.rommelag.com
Print Design Technologies Deliver Reliable Anti-Counterfeiting Solutions
Autoinjectors Improve Patient Experience with Multi-Functional Labels
From nine manufacturing sites across Europe, Essentra Packaging — Healthcare delivers a range of security solutions to verify authenticity and demonstrate tamper evidence to a diversified bluechip healthcare customer base. With the EU Directive on Falsified Medicines set to come into force in 2016, there are significant demands on the healthcare industry to comply. Whilst much of the focus is on serialisation of packs, tamper evidence is also a key component of the directive and so there are greater opportunities for packaging and the use of foils, labels, tapes and overwraps together with creative carton or pack design. New technology enables the introduction of additional overt and covert security measures to ensure product integrity and work against counterfeiting and falsification. Essentra’s Design Studio provides design capability for customers, adding value and delivering customised design concepts and artwork creation for packaging, building in security as part of the overall design. Security solutions range from overt features such as holograms, which can
Pen injectors and autoinjectors from SHL Medical improve patients’ personal flexibility. The product design plays an important role in these developments. On the one hand, it increases ease of use, and on the other hand, an attractive design lowers the hurdle for patients to use the injection systems in public. The speciality labels by Schreiner MediPharm address exactly these needs. They provide SHL’s autoinjectors with a unique look and additionally integrated functionalities that enhance convenience and safety. For SHL Medical’s DAI and Molly devices, Schreiner MediPharm developed customised sample labels for demonstration of the autoinjectors to pharmaceutical manufacturers. “The development and manufacturing of autoinjectors up to serial production is a complex process. The multi-functional marking solution by Schreiner MediPharm underscores our aim to continually innovate at all levels and provide the best solutions for our partners,” said David Markham, Project Manager from SHL. The Swedish specialist for drug delivery devices offers its customers integrated solutions across the entire process chain from design and development through the manufacturing process, including final assembly, labelling and packaging. “The specialty labels make customised
provide on-shelf pack authentication to consumers, through to covert and forensic technologies, which only trained investigators can identify. Design and security print play a key part in any secure solution through using different print techniques such as gravure, UV flexo, litho, screen and digital printing capability. Overt techniques such as Numismatics, which create reliefs to designs so they can appear to be raised or inverted, can be added alongside covert techniques such as Microtext, which can provide a highly secure and cost-effective means of protecting a brand. The Essentra Packaging portfolio of security products ensures there is a tamper evidence and authentication solution relevant to each brand. Essentra Packaging +44 1274 622222 www.essentrapackaging.com
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branding possible and thus emphasise the manufacturers’ brand presentation. Thanks to integrated features, the label adds further value,” explained Michael Crumbiegel, Product Manager from Schreiner MediPharm. The anti-slip varnish improves grip and avoids slipping during the injection. A detachable label part is integrated for documentation of the medication. For brand protection, the label is equipped with a hologram. Furthermore, the printed QR code allows the end user to directly access the manufacturer’s website to receive further information such as a demonstration video for the correct use of the autoinjector. Schreiner MediPharm Schreiner Group GmbH & Co. KG +49 89 31584 5400 info@schreiner-medipharm.com www.schreiner-medipharm.com
SHOWCASE PACKAGING
Vial Range Offers Significantly Minimised Delamination Risk SCHOTT has launched SCHOTT Vials DC — a pharmaceutical vial that, reportedly for the first time ever, allows for the risk of delamination to be determined based on threshold values. SCHOTT monitors these values over the course of the manufacturing process and is thus able to minimise the risk of delamination. The company succeeded in optimising its manufacturing process to ensure that SCHOTT Vials DC have a more homogeneous surface, hence offering high chemical stability. Furthermore, SCHOTT claims it is the first manufacturer to develop a patented test method that even allows for this lower tendency to delamination to be documented — known as SCHOTT Delamination Quicktest. SCHOTT Vials DC will be available as 2R to 10R ISO vials at the beginning of 2014. The problem of delamination, in other words the peeling off of flakes from the inner glass surface of a pharmaceutical vial as a result of interaction with the formulation and/or medication, has become increasingly important to the pharmaceutical industry in recent years.
Numerous recalls clearly confirm this, and the US drug authority in turn is explicitly requiring that pharmaceutical companies manage their risks more closely. SCHOTT Vials DC therefore represent an interesting solution for pharmaceutical companies interested in lowering the risk of delamination by selecting an improved packaging product. These vials are an interesting alternative not only for new products but also for products that are already well established in the marketplace. According to Dr. Bernhard Hladik, Head of Product Management, the mechanism behind delamination has been researched quite thoroughly and is well understood. “When the bottom of the vial is formed, volatile components like boron and sodium evaporate,” he said. “They then go on to form inhomogeneous spots on the glass surface near the bottom of the vial that show a higher tendency to delaminate. With our new SCHOTT Vials DC, we have developed the production process even further to ensure that the glass
surface is more homogeneous and thus less susceptible to delamination.” To confirm this effect, SCHOTT conducted storage studies with systems that showed a high tendency to experience delamination while using standard Type I vials. The result was that SCHOTT Vials DC remained stable even after six weeks of storage involving a 15% potassium chloride solution and a 10% sodium thiosulfate solution at a temperature of 60°C, while conventionally manufactured vials showed clear initial signs of delamination. According to SCHOTT, it is also the first manufacturer capable of determining the risk of delamination
based on threshold values and then monitoring these values over the course of manufacturing. To achieve this, the company developed a Quicktest and had it patented. Hladik described the way in which the SCHOTT Delamination Quicktest works: “A certain number of vials are removed from every batch. The random samples are then subjected to stress for four hours inside an autoclave in order to tease out the delamination critical zone. In a second step, the vials are filled with high purity water (water for injection (WFI)) and sodium is extracted inside an autoclave. The volume of sodium extracted correlates with the probability that the vials will experience delamination at a later point in time.” By monitoring these values and adhering to certain threshold values, SCHOTT is now able to control the risk of delamination. SCHOTT AG +49 6131 66 2411 info.cpr@schott.com www.schott.com
Peer-Reviewed Study Proves Effectiveness of Container Closure Systems for Radiopharmaceuticals West has announced the first peerreviewed data demonstrating the benefits of Daikyo Crystal Zenith vials for the synthesis of radiopharmaceutical products. The study, conducted by researchers from Massachusetts General Hospital’s Division of Nuclear Medicine and Molecular Imaging, compared the effectiveness of container closure systems made from the Daikyo Crystal Zenith cyclic olefin polymer with glass for peptide-labelled radiopharmaceuticals. The study results appear in the October 2013 issue of Applied Radiation and Isotopes. Peptide-based radiopharmaceuticals are used for the diagnosis and treatment of cancer and other therapeutic applications. Glass vials have traditionally been used as the container to enable the necessary chemical reaction that attaches radioisotopes to peptides. However, many peptides can easily be adsorbed by the walls of container closure systems, which means that costly
radiopharmaceutical product is not fully recoverable after the reaction has occurred. The study, ‘A container closure system that allows for greater recovery of radiolabelled peptide compared to the standard borosilicate glass system’, examined how much product adhered to Crystal Zenith vials compared with glass vials during the synthesis of peptide-labelled radiopharmaceuticals. Key findings from the study include the following: • container closure systems made of Crystal Zenith had less product adherence to vials compared with single-use glass vials • crystal Zenith vials retained approximately 10% less of the radiopharmaceutical compared with glass vials • improved recovery of
radiopharmaceuticals in Crystal Zenith vials was due in part to a lower adherence of the peptide. “Over the past several years, we have seen tremendous interest in Crystal Zenith vials and syringes for drug packaging due to its ability to overcome issues of breakage, delamination and particulates associated with glass container closure systems,” said Vinod Vilivalam, Ph.D., Senior Director, Global Technical Marketing Daikyo-West Products, West. “This study is an important addition to the growing body of evidence showing Crystal Zenith container closure systems are an effective alternative to glass, especially in emerging areas of cell therapy and radiopharmaceuticals.” The Daikyo Crystal Zenith polymer, with its glass-like transparency and superior packaging attributes, make it the ideal choice for packaging sensitive biologics and other drugs, including oncology drug products, products that react with glass and freezedried or protein-based products.
West Pharmaceutical Services, Inc. +1 610 594 2900 west.pharmaceutical.services@ westpharma.com www.westpharma.com
Fully Automatic Filling and Closing Machine Makes Light Work of Single Dose Syringes The PLC-controlled syringe filling and closing machine SFM 5072 has been developed for industrial high-capacity use for the processing of single dose syringes in so-called nests. The syringe barrels are supplied in these nests inside tubs and are sterile and ready to fill. All the subsequent transport and work steps are carried out fully automatically and the machine achieves an output of up to 60,000 syringes per hour.
The nest transport in the work area is carried out by two coordinate tables controlled by servomotors that are in use alternately, thus preventing loss of production time between one nest and the next. The dosing unit comprises 16 valveless rotary piston pumps. Alternatively, other dosing systems such as time/pressure filling are available.
Simple size changeover without tools is possible by exchanging complete size part sets and selecting the new size at the operating panel. Bausch + Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG +49 7904 701816 tanja.bullinger@bausch-stroebel.de www.bausch-stroebel.de
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Industry News & Events
Romaco Completes Takeover of Kilian Tableting and Appoints Management Team The integration of Kilian Tableting GmbH in the Romaco Group finally became official on 13 November 2013 after the antitrust authorities gave their approval. The firm, residing in Cologne, Germany, will in future operate under the name Kilian Tableting GmbH as a subsidiary of the Romaco Group. As part of the transaction, the day-to-day running of Kilian was transferred to a new management team. Jörg Pieper was named as CEO with responsibility for Operations, Administration and Finance. He joined the Romaco Group two years ago and is Head of the Customer Service department. Gerd Hueffmann has been appointed new Managing Director with
responsibility for New Equipment and Customer Service Sales. Prior to arriving at Kilian in September 2013, he gained extensive experience in international sales activities at Fette Compacting and Korsch AG, amongst others. Jens Carstens will act as Managing Director responsible for R&D. His long career at Kilian meanwhile began twenty years ago and in his most recent position he was department Head of R&D. The troika at the helm of Kilian Tableting will be actively supported by three other top-level executives. Marcus Behrens as Sales Director, Stefan Zabka as Production Manager and Guido Bourtscheidt as Finance Manager will round off the new leadership at Kilian Tableting.
Thomas Engineering Appoints European Director Tablet coating systems expert Thomas Engineering, the originator of AccelaCota technology, has named David Decker as the new Director of European Operations. A seasoned professional of the pharmaceutical equipment industry, Decker has the unique combination of business intellect and operational knowledge of tablet coating equipment and coating operations. “We are excited to welcome David Decker to Thomas Engineering,” said Joel Gray, President, Thomas Engineering. “As the company continues
to broaden its global client base, it is essential to expand our highly experienced executive team with people like David to continue achieving our European growth objectives.” With offices based in Antwerp, Belgium, Decker will lead Thomas’s European operations together with Matt Powers who will also continue covering the CIS countries. Thomas Engineering Inc. +1 847 358 5800 www.thomaseng.com
Pharmapack Europe Unites Drug Delivery and Pharma Packaging Innovators The 13th edition of Pharmapack Europe will be held on 12–13 February 2014, at a new venue, Paris Expo — Porte de Versailles, in France. More than 3,000 visitors and 320 exhibitors from over 70 countries will gather at this new venue to take stock of the latest innovations in packaging and delivery systems for drugs and healthcare products. The 2014 edition conference programme will have as its key thread the highly topical issue of compliance and security. For two days, the conferences led by leading experts will address the latest trends, technological advances and innovations in drug packaging and delivery systems that can improve compliance, facilitate the administration of the treatments or further enhance the safety of patients and caregivers. This year, the Technical Symposium returns with a full day dedicated to ‘Serialisation, Track & Trace. How to understand and deploy all aspects of Track & Trace in the pharmaceutical industry.’, a huge 2013–2014 issue. The presentations and roundtables will enable participants to exchange with top experts on their own issues relating to security in the pharmaceutical supply chain, implementation challenges,
effective labelling systems, data management solutions, barcoding and regulatory changes from point of manufacture throughout the distribution chain. Other not to be missed show features are an innovation gallery on the show floor, the Pharmapack Europe Awards Ceremony on Wednesday 13 February and the roundtable dedicated to ‘Responsible Innovation: Driving sustainable growth for SME: What issues are at stake for responsible-innovation in the healthcare sector?’. UBM Canon Pharmapack Europe 2014 +33 1 73 28 72 32 pharmapack-info@ubm.com www.pharmapack.fr
“The successful acquisition of Kilian will allow the Romaco Group to launch into the new fiscal year with an extended portfolio and stronger market presence,” announced Paulo Alexandre, CEO of the Romaco Group. “We will be able to offer integrated solutions for manufacturing, processing and packing pharmaceutical solids thanks to our purchase of Kilian. We intend to leverage and optimise this potential systematically in the coming years.” “The Kilian team is ready to scale new heights,” emphasised Jörg Pieper, CEO of Kilian Tableting. “The international sales network has been reorganised and expanded over the past few months. We’ve defined our development objectives and prepared our market
presence right down to the very last detail. Every one of us is highly motivated.” In future, Kilian will be directly represented in Germany, Italy and the US. New sales partnerships have been established to develop business in France and Spain. Existing customers worldwide will be notified in due time about the sales reorganisation by their respective contacts. For more information, visit the new Kilian Tableting website at www.kilian-tableting.com. Romaco Group +49 721 4804 0 susanne.silva@romaco.com www.romaco.com
Cleanzone Boasts Large International Component and Increased Number of Visitors Cleanzone’s continued growth has been confirmed not only by an increase in the number of visitors but also by high levels of visitor satisfaction. The trade fair and congress for cleanroom technology took place for the second time on 22–23 October 2013, drawing more than 800 participants from 44 countries to Hall 1 at the Messe Frankfurt Exhibition grounds. Messe Frankfurt launched Cleanzone in 2012. This specialist event is aimed at all sectors where production, assembly, packaging or work is carried out under cleanroom conditions. Not only did the number of exhibitors and visitors increase but the international share did as well. Providers from nine European countries welcomed trade fair and congress participants from around the world. The top five visitor countries were the Netherlands, Switzerland, the UK, the Russian Federation and the US. The exhibitors at the trade fair used this year’s significantly larger exhibition area to present nearly the entire range of what is on offer, from the planning, construction and operation of cleanrooms to consumables and training. Many exhibitors had unique and extremely attractive exhibits on display, offering cleanroom experts and newcomers alike the opportunity to test and get to know the technology. “We made a conscious decision to showcase a walk-in cleanroom and a model of an entire cleanroom system here at Cleanzone. Both of these exhibits drew a great deal of interest from visitors, giving rise to numerous promising talks,” reported Wolfgang Henker, Managing Director of Cleanroom Competence. Cleanroom training courses, seminars and events provider Reinraum-Akademie was once again responsible for the Cleanzone Congress, which focused on the worldwide increase in requirements
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for industry and on new solutions for the healthcare sector. The outstanding quality of the presentations by international experts underscored the scientific credentials of this new platform, covering everything from cross-industry trends to specialist areas of cleanroom technology. One of the highlights of the congress was the appearance by cardiologist Dr. C. Luis Vasquez. With his riveting presentation on the diagnostic centre in Yantaló, a rural district in the Peruvian Amazon, the founder and president of the Yantaló Peru Foundation highlighted the special challenges posed by efforts to establish clean working environments in many of the world’s rural areas. Another highlight was the presentation of the Cleanroom Award, sponsored by Reinraum-Akademie. This innovation award, which is worth €3,000, went to the Blautouch project submitted by the Portuguese company Laborial S.A., which was represented at Cleanzone by its cooperation partner Basan GmbH. Blautouch is an interactive laboratory bench with a touchscreen surface. The next Cleanzone will take place on 21–22 October 2014 at the Messe Frankfurt Exhibition grounds. Messe Frankfurt Exhibition GmbH +49 221 16 99 59 30 kerstin.maenner@messefrankfurt.com www.cleanzone.messefrankfurt.com
LABORATORY PRODUCTS & EQUIPMENT
Polyisoprene and Sensitive Neoprene Single-Use Gloves Target Life Sciences Market Ansell has launched four single-use gloves for the EMEA life sciences industry. The ultra-thin TouchNTuff 73-300 and 73-500 sensitive Neoprene gloves offer protection against both Type I and Type IV allergies and are intended for biotech, sterile pharmaceutical laboratories and medical device manufacturing. The premium, latex-feel TouchNTuff 83-300, the company’s first industrial polyisoprene glove, was developed for use in aseptic or clean environments. It also exists in a sterile version, the TouchNTuff 83-500. As workers in life sciences wear gloves all day, the composition of their gloves can actively contribute to the onset of allergies. “Our concern for protecting workers from the onset of dermatitis and occupational allergies is not limited to healthcare professionals,” said Peter Dobbelsteijn, Senior Vice President and Regional Director for the Ansell EMEA region. “Ansell is proud to present its best disposable protection yet for
workers in aseptic and clean environments within life sciences.” The new TouchNTuff 73-300 (and sterile 73-500) glove is a thin, single-use glove offering outstanding protection against both Type I and Type IV allergies. Latex-, accelerator- and powder-free, it offers excellent splash resistance to a broad range of chemicals including acids, bases, alcohol and disinfectant components. The thinnest Neoprene glove on the industrial market at 0.13 mm, TouchNTuff 73-300/500 is as resistant to punctures as a surgical glove (AQL of 1.00 in needle prick test). Thanks to expertise gained in formulating Ansell Medical SENSOPRENE, it was possible to make Neoprene gloves 30% thinner. This results in improved sensitivity, fit and softness in single or double gloving. Ansell’s first industrial polyisoprene glove, the TouchNTuff 83-300/500, has a 100% synthetic formulation safe for latex-sensitive (Type I) manufacturing and laboratory professionals. The premium, latex-like TouchNTuff 83-300 is a non-sterile version of the TouchNTuff 83500 sterile polyisoprene single-use glove launched earlier this year. Remarkably thin at only 0.21 mm, they are more flexible than Neoprene. Their exceptional tactility, comfort and puncture resistance combined with a low particulate count
makes them suitable for use in an ISO Class 5 environment or higher. The TouchNTuff 83-300/500 offers good splash resistance for a variety of applications in biotech, pharmaceuticals, medical device manufacturing and laboratory analysis. Usable alone or in double-donning, they are available in separate polybags for right and left hands. Both the TouchNTuff 73-300/500 and the 83-300/500 deliver a secure, ergonomic fit designed to reduce hand fatigue and increase adherence to safety protocols. An inner coating of synthetic polyurethane facilitates both dry and wet donning. The gloves successfully passed both skin irritation and sensitisation biocompatibility tests. Ideal for clean environments, their particle count is below 2,500 per cm2. They are packed in a controlled environment, in cleanroomcompatible packaging material printed with IPA resistance ink. The Ansell SureFit Technology used in surgical gloves keeps the long beaded cuffs from rolling down, limiting accidental exposure. Ansell Ltd +1 732 345 2128 frank.mantero@ansell.com www.ansell.eu
Benchtop NMR Spectrometers Now Feature Fluorine Capability Magritek has added fluorine measurement capability to its Spinsolve benchtop NMR spectrometers to meet application needs in the pharmaceutical industry. The Magritek Spinsolve NMR spectrometer — a cryogen-free benchtop NMR system — has been designed to provide an upgradable platform for versatile NMR spectroscopy applications. The latest upgrade enables users to perform both fluorine and proton measurements on the same sample without the need for complicated retuning of the probe as may be required in alternative commercial systems. Fluorine measurements are most useful to users of NMR. The 19F nucleus is one of the most important nuclei for NMR spectroscopy, owing to its 100% natural abundance and that its NMR sensitivity is
extremely high. Organofluorine compounds are in common use in the pharmaceutical industry with fluorine often used as a molecular tag so its quantitative detection is vital in the quality control of manufacturing processes. The Spinsolve NMR spectrometer can now perform both proton and fluorine experiments without any hardware adjustments, making it faster and more cost-effective than other spectrometers with single measurements being made in as short a time as 10 seconds. Users of the new Spinsolve for Education system may upgrade this 1D proton system to have the 19F imaging as well as 2D proton imaging at a very reasonable cost, an upgrade that may be carried out on site in a matter of minutes.
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Magritek’s latest applications paper shows examples of both proton and fluorine NMR on the same sample. Examples include 2, 2, 2-trifluoroethanol and 5-bromo-1, 2, 3-trifluorobenzene. Magritek +64 4920 7671 andrew.coy@magritek.com www.magritek.com
LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Analytical Balance Line Ensures Compliance and Process Security deionisation of charged samples and containers. For the highest process security, users can elect to block the release of the weighing result. By fixing SmartSample RFID tags to titration beakers, sample information entered at the balance can be securely transferred to Mettler Toledo’s titration autosampler. RFID tagged pipettes can also be scanned at the balance via EasyScan to check calibration and test dates, guaranteeing that pipettes are valid for use. Test dates on the tag can be updated when the pipette check is carried out using the built-in balance application. The new RFID capabilities not only eliminate transcription error but also offer users a higher level of process security. The new balances are fully compatible with Mettler Toledo’s LabX laboratory software, which guarantees process security and manages measurement uncertainty. Full traceability is assured thanks to flexible SOP user guidance on the balance touchscreen, automatic calculations and comprehensive data
Mettler Toledo has released a new line of Excellence analytical balances, focused on providing users with a high level of process security whilst making weighing workflows error-free, ergonomic and efficient. The new balances ensure worry-free weighing for users, with advanced intelligent features that secure reliable weighing results and also support QA demands for error-free processes and full traceability. The green StatusLight indicator gives users full visibility that all balance tests are up to date and guarantees that it is safe to start weighing, thereby ensuring results are accurate and reliable. The new StaticDetect sensor technology provides reassurance that weighing results are not influenced by electrostatic charge by automatically checking samples and containers as they are placed on the balance. Further technology advancements, such as RFID read-write capabilities, integrated routine test functionality and the newly developed graphical levelling guide, simplify daily tasks and help users to comply with relevant industry regulations.
When balance calibration and routine tests are up to date and the balance is level and performing correctly, the StatusLight clearly indicates with a green light that it is safe to start weighing. Warnings are shown in yellow, with errors in red. The user has the security of knowing that all acquired weighing results meet pre-defined process requirements and hence also the relevant regulations. Electrostatic charge is one of the biggest challenges in analytical weighing. Through normal handling, samples and weighing containers can easily accumulate static, leading to difficulties in dosing and errors in weighing results. With high electrostatic influences, it may not even be possible to achieve a stable reading on the balance. When a container or sample is placed on the balance, StaticDetect measures the weighing error attributable to electrostatic charge and gives a warning if the process tolerance limit is exceeded. Antistatic measures can then be employed. The new, compact point electrode accessory attaches to the side of the balance for convenient
Laboratory Spiral Jet Mill in Isolator for HPAPIs Provides Containment Below 1 µg/m3
Primary Reference Standard Range Fills QC Gap
F.P.S. Food and Pharma Systems has launched a compact isolator system for laboratory and pilot plant micronisation. The isolator has been developed to allow the installation of an F.P.S. PilotMill-2 spiral jet mill unit in a configuration that enables the processing of batch sizes up to a few kilogrammes with jet mill, twin screws flat bottom feeder and separation cyclone filter. The micronisation control manifold is installed outside the isolator for ease of use and cleaning. The touchscreen operator panel provides full system control. Cryogenic operations are also possible with a proper cooling system. Containment levels are guaranteed to be below 1 µg/m3 (8-hr TWA), with a prechamber for the isolator inlet and continuous liner for product exit. The isolator can be easily adapted for additional activities such as dispensing or QC activities. F.P.S. Food and Pharma Systems Srl +39 031 543429 sales@foodpharmasystems.com www.foodpharmasystems.com
LGC Standards has launched a new range of pharmaceutical primary reference standards. These reference materials are designed to be used in pharmaceutical QC if no official pharmacopoeia standard exists for a given purpose. The primary reference standards are of the highest possible purity, fully characterised and satisfy the requirements of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and Food and Drug Administration (FDA). “Our pharmaceutical primary standards are produced under ISO Guide 34 and are accompanied by a comprehensive certificate of analysis,” said Dr. Christian Zeine, Global Product Manager Pharmaceuticals, LGC Standards, who has played a key role in developing the new product range. “The certificate
contains comprehensive identity information, including nuclear magnetic resonance spectrum, infrared spectrum and mass spectrometry data,” he explained. Customers will also find detailed assay data on the certificate, which is obtained by qNMR whenever possible and other accredited techniques. All assays are verified by orthogonal methods such as mass balance. “Our primary standards fill a gap in the market,” Dr. Zeine stated. “Many of our customers are required to carry out analyses as part of their quality control process, for which no official standards from the pharmacopoeias exist. In these cases, and also in the forensic and clinical environment, our new primary standards will prove ideal.” LGC Standards has released more than 30 primary reference standards, including paracetamol, itraconazole and several alkylparahydroxybenzoates.
handling. LabX fulfills the highest process security requirements and, with all data stored securely in a central database, fully supports the move towards establishing a paperless laboratory. Mettler Toledo AG Laboratory & Weighing Technologies +41 44 944 22 11 simon.taylor@mt.com www.mt.com/green-light
Dr. Christian Zeine, Global Product Manager Pharmaceuticals, LGC Standards. “This range is being continually expanded and developed to meet the needs of the industry,” concluded Dr. Zeine. To receive a brochure detailing the currently available materials, send an email to askus@lgcstandards.com. LGC Standards +44 20 8943 8480 uksales@lgcstandards.com www.lgcstandards.com
Critical Flow Controller Streamlines Inhaled Product Testing Copley Scientific has launched a new instrument, the TPK-R critical flow controller model, to improve the ergonomics of test setup for dry powder inhaler (DPI) testing. The new unit frees up bench space and simplifies connection of the key pieces of equipment routinely used for DPI testing, without compromising the validity of existing test methods. Measuring the aerodynamic particle size distribution of DPIs helps to determine their in vivo behaviour and is essential during product development and for QC. Cascade impaction is the technique specified by the regulators, and the next generation impactor (NGI) is routinely the instrument of choice for this application. Testing must be carried out at a constant, controlled air flow rate to ensure that the NGI delivers precise, calibrated performance. Copley Scientific’s TPK critical flow controllers incorporate all the
functionality required to ensure the application of a stable, precisely defined flow profile, in a single integrated system. The TPK-R is a mirror image of the critical flow controller model TPK, which is already an industry standard, has been designed specifically to match with the connection requirements of the NGI. It is identical to the TPK in all respects except for the inlet, outlet and user interfaces, which have all been reversed to connect more conveniently with the right-hand outlet of the NGI. Using the TPK-R therefore allows the more efficient use of laboratory bench
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space, without compromising the validity of existing test methods. Copley Scientific Ltd +44 115 961 6229 m.copley@copleyscientific.co.uk www.copleyscientific.com
LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Fibre Optic Probe Accessories for Handheld Raman Analysers Enable True In Situ Analysis
Rigaku Raman Technologies has announced the addition of two compact and easy-to-use fibre optic probe accessories for its Xantus-2 785 and 532 µm portable Raman analysers. Designed for pharmaceutical, research, analytical and industrial applications, the new Raman Probe II and Economy Probe will enable customers to significantly improve routine laboratory Raman spectroscopy and support true in situ analysis of an even broader range of materials. “As our customers look to improve analysis capabilities and explore new applications with Raman spectroscopy, we will continue to enhance our products to provide valuable solutions to fit their needs,” said Bree Allen, General Manager at Rigaku Raman. “The addition of these two lightweight and easy-to-use probe accessories enables customers to broaden their use of lab-based Raman spectroscopy and truly improve workflow efficiency.” Using the new probes, Xantus-2 customers will be able to perform analysis on a variety of materials, including dark or turbid solutions, and fulfill applications, such as immersion analysis, that standard spectroscopic platforms cannot achieve. In addition, both probe options are lightweight and small enough to fit inside typical laboratory-scale vessels, enabling customers to easily transport them to any location and share among multiple departments. The new Raman Probe II and Economy Probe are being manufactured for Rigaku Raman by InPhotonics, a leading developer of fibre optic sampling probes and accessories for Raman spectroscopy. Rigaku Raman’s Xantus-2 is reportedly the world’s first dual wavelength Raman analyser, designed to provide customers with application specific solutions for quality data analysis. It is equipped with options of 785 and 1064 µm or 532 and 1064 µm lasers stabilised for Raman spectroscopy, providing a combination of high sensitivity and minimised fluorescence. Xantus-2 utilises integrated software combining open architecture with customisable, user-defined settings for optimised sampling parameters that result in comprehensive and actionable data analysis. Equipped with sampling accessories for solids, liquids and powders, the Xantus-2 can perform analysis directly through sample containers without altering or destroying the sample. Users are able to perform rapid quantitative and qualitative analysis and monitor reactions like oxidation and reduction directly through clear/ambercoloured glass vessels.
Plug-In Two-Port HDI Solenoid Valve Meets Demand for Smaller and Lighter Products A new, ultra-miniature, high density interface (HDI) solenoid valve for OEM, laboratory, scientific and medical device applications is the latest example of excellence in miniature engineering from Lee Products. This plug-in style valve features a two-port, normally closed design and offers similar performance characteristics to Lee’s traditional three-port HDI design but in a smaller, lighter package. The constant demands placed upon designers and machine builders to produce reliable products that are smaller and lighter are being met,
thanks in part to the Lee Company’s ability to continue to redefine miniature fluidics. For example, this new HDI solenoid valve weighs less than 2.5 g, has an overall length of 27.2 mm and a diameter of 7.1 mm. The valve is available in options that provide a flow capacity (on air) from 4.4 SLPM @ 10 psid, with a Cv = 0.013, up to 14.6 SLPM @ 10 psid, with a Cv = 0.044. They have a low internal volume of 28 µl, an operating pressure range of 10 psi differential with inlet pressures from vacuum to 45 psig and an operating temperature range from 4 up to 49˚C.
Rigaku Raman Technologies, Inc. +1 408 705 6560 sales@rigakuraman.com www.rigakuraman.com EPM 23
Lee Products Ltd +44 1753 886664 sales@leeproducts.co.uk www.leeproducts.co.uk
LABORATORY PRODUCTS & EQUIPMENT ROUNDUP Media Guarantees Maximum Safety in Microbiological QC
Single-Use Disposable Ware Meets Pharma Requirements
Sartorius Stedim Biotech (SSB) has introduced Microsart @media to complement Microsart @vance, a product line for microbiological quality control in these sectors. Microsart @media are agar media dishes for microbial limits testing according to the USP (Chapter <61>) and EP (Chapter 2.6.12). They are pre-filled with various agar media types, such as Tryptic Soy Agar or R2A Agar, sterile packaged and ready-to-use in combination with Microsart @filter units. Moreover, the Microsart @media features a patented lid that allows touch-free transfer of the filter membrane onto the media without using any tweezers. In addition, easy access to the colonies after incubation is provided because of the liftable lid. The intelligent design and ease of use eliminates almost all handling mistakes. The combination of Microsart @media and Microsart @filters introduce a brandnew agar and membrane transfer concept. Thanks to their concerted development, the matching Microsart @media active lid fits perfectly onto the Microsart @filter base. The few steps required between sampling and incubation save time and labour, while delivering more reliable results. The
The SteriWare range of high quality, singleuse disposable samplers and laboratory ware has been developed by Sampling Systems to meet the stringent demands of the pharmaceutical industry. SteriWare products are manufactured and packed in a Class 100,000 medical cleanroom. Sampling Systems has full batch traceability and is able to offer full documentation. Many items in the range are ATEX rated for use in zones 0, 1 and 2. The sampler range includes devices for sampling powders and liquids. The laboratory range includes a huge range of scoops as well as funnels, bowls, spatulas, pallet knives, etc. Sampling Systems is constantly adding new products to the SteriWare range; one of the latest additions is a 50 ml ladle. The ladle is ideal for taking surface samples from liquids and suspensions.
touch-free membrane transfer eliminates membrane manipulation and handling, thereby minimising a major source of secondary contamination. Sartorius Stedim Biotech S.A. +49 551 308 3324 dominic.grone@sartorius.com www.sartorius-stedim.com
Sampling Systems Ltd +44 1675 466 992 info@sampling.com www.sampling.com
500 L Round Chamber Autoclave Offers Increased Loading and Sterilising Performance For laboratories looking to acquire a high capacity, front loading cylindrical chamber autoclave with an exceptional pack density at a more affordable price, a new 500 l steam steriliser being launched by Priorclave is an ideal solution. The new autoclave joins the popular Q63 range, which is renowned for sterilising chambers with a taller profile than those found in most cylindrical machines, making it ideal for accepting larger items. This range also offers better loading versatility with much easier and safer chamber access owing to the lower loading height of just 725 mm. The Q63/EH500 autoclave is the largest cylindrical-chamber steam steriliser in Priorclave’s extensive product range. It retains the same build quality and conforms to the company’s stringent manufacturing standards.
Whilst offering increased loading, the combination of features such as forced air cooling to reduce cycle times and automatic timed free-steaming for improved air removal add to the overall sterilising performance of the Q63 autoclave. All operating settings are programmed easily through the Tactrol 2 microprocessor controller, which is standard across the entire Priorclave range. A feature of the Q63/EH500 is that the control system can be configured to log all temperature, pressure time and cycle data into a single, compact archive file, which can subsequently be downloaded onto a USB flash drive for transfer to computer. The operational data can then be forwarded from anywhere in the world direct to Priorclave’s UK Service Centre for technical assistance in fine-tuning
and clarification of autoclave performance if required. As standard, the new Q63/EH500 autoclave is castor mounted for ease of positioning, fitted with two nontipping shelves and comes with a choice of optional items such as stainless steel baskets, waste containers and loading trolleys, all designed to enhance the efficiency of laboratory sterilising operations. Depending on operational requirements, it can be supplied for electrical or direct steam heating. The build quality of the new autoclave uses epoxy coated panels and frame members, which are treated with an anti-bacterial agent that is highly effective against all bacteria and fungi, including MRSA, key factors in preventing cross contamination within the laboratory.
Priorclave Ltd +44 20 8316 6620 sales@priorclave.co.uk www.priorclave.co.uk
Automated Evaporation System Receives Positive Customer Commentary Genevac has reported very positive feedback from early adopters of its Rocket 4D, a fully automated system for automatic drying or concentration of very large volumes up to 100 l. Launched worldwide during the summer of 2013, Genevac has received considerable interest from laboratories drawn by the ease of use, automated productivity and performance of the Rocket 4D. A chemistry scale-up laboratory at a major pharmaceutical company, running kilo-scale preparative supercritical fluid chromatography (SFC), was drawn by the unattended automation offered by the Rocket 4D. Traditionally removing large volumes of methanol from sample fractions using a number of rotary evaporators required a dedicated operator to top-up dry ice in cold traps, feed the systems with more product and watch the systems continually. The operator commented:
“With the Rocket 4D, you simply load your sample, select a method, press start and walk away — the system will do the rest.” Compact in size, the Rocket 4D allows the user to dry or concentrate samples with complete confidence as it uses proprietary vacuum technology to suppress solvent bumping and foaming — problems associated with sample loss when using large-scale rotary evaporators. The Rocket 4D comes as standard with a single, 5 l, 316 stainless steel vessel for drying of concentrating product. This has detachable handles and is easily lifted into and out of the evaporator. Access to the dried or concentrated product in the vessel is very easy. Dried products can be scooped out, or where enhanced user protection is needed, redissolved while the vessel is still in the system. Liquid products can be easily drained via a drain port in the side of the
rotor, using a dedicated pouring stand. Users wishing to dry volumes larger than 5 l require the Autofeed option, which enables the Rocket 4D to draw in product from the user’s own external supply. The Rocket 4D controls product feed, drying and the discharge of condensed waste solvent without any external intervention. The autofeed
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system has an integrated rinse circuit that enables dried products to be automatically re-dissolved in a small volume of solvent at the end of the process. Alternatively, the same circuit can be used under manual control for solvent exchange by selecting a different solvent for re-dissolve. Cleaning the Rocket 4D between cycles is also very straightforward. The PTFE feed tubing is easily detached for cleaning or replacement and the vessel can be readily cleaned, wiped, inspected and even put in a dishwasher. The Rocket 4D also includes powerful cold traps that maximise solvent recovery, protecting the environment and improving drying of samples. Genevac Ltd +44 1473 240000 salesinfo@genevac.co.uk www.genevac.com
SHOWCASE LUMINESCENCE, UV & IMAGE ANALYSIS
Multi-Technology Microplate Reader with Monochromators Caters for Wide Range of Applications Berthold Technologies has introduced the second generation of its multimode microplate reader Mithras, the Mithras2 LB943 with monochromator and filter technology for reading technologies: • UV/VIS absorbance • fluorescence and FRET • fluorescence polarisation • time-resolved fluorescence (TRF and TR-FRET) • luminescence • BRET and BRET2 • AlphaScreen and AlphaLISA. Already implemented in the TriStar2, the patent-pending optical concept ONE-4-ALL is employed for sensitive luminescence, fluorescence and absorbance measurements — with performances as in dedicated instruments — in the Mithras2 for filterbased reading. Additionally, the instrument is equipped with two double monochromators with high blocking efficiency and high f-number (increased transmission) for filterless measurements of absorbance and fluorescence. For utmost sensitivity in luminescence,
a third specially selected and extremely noise-reduced detector is engaged in the HiSens position, which is used for Alpha and BRET readings too. Compared with its predecessor, the optics have been improved once again to achieve improved detection limits of less than 2 amol ATP per well, less than 0.2 fmol Fluorescein per well and less than 2 amol Europium per well. Mithras2 offers the possibility to use optical filters for luminescence measurements (of course, for all fluorescence and absorbance readings too), enabling the sensitive measurement of BRET (e.g., functional assays in GPCR research) and multicoloured luciferases (reporter gene assays). Each individual filter is coded with an RFID tag and can be positively identified — a significant contribution to correct measurements and to secure quality standards. Up to four reagent injectors with the proven and highly accurate JET technology complete the unit. The
injector tips are located in reading position, enabling the accurate measurement of very fast reactions. A new feature is the reagent compartment at the front, which keeps the reagents within easy reach and can be filled with ice to keep them cool. Reagent mounts hold small reagent containers safely in place and a slight inclination of the mount ensures tubings recover the last droplet. Cellular assays are taken account of by a universal bottom reading function, a temperature control unit with an incubation compartment for the microplate and gas connectors. Thus, the Mithras2 is a microplate reader offering comprehensive possibilities and a multitude of applications. The measurement of enzyme activities, phagocytosis, calcium flux, cell viability, apoptosis, immunoassays protein and nucleic acid concentrations and protein-protein interactions are only a few of the fields of application. The unit is operated with the approved
Mikrowin software. Single and multiple endpoint measurements can be performed as well as kinetic and scanning measurements. The data can be displayed numerically and graphically and may be exported to EXCEL or printed. Berthold Technologies GmbH & Co. KG +49 7081177 0 bio@berthold.com www.berthold.com/bio
Ultra-Flat Glass Bottom Plates Optimise Imaging of Growing Cells New generation Krystal glass bottom plates from Porvair Sciences are precision manufactured using a proprietary process that results in excellent light transmission and an ultraflat optical plane (+/-15 µm), making them perfect for imaging growing cells. The complete range of 24-, 96- and 384-well Krystal glass bottom microplates is available sterilised for tissue culture to optimise cell growth or non-sterile for assay development. Deep
black plates for fluorescent studies are available, together with brilliant white plates that increase sensitivity for luminescence and absorbance work. The high optical clarity base of each plate in the range offers the advantage of easy positioning and crisp images when used with confocal microscopes. Constructed to a standard SBS/ANSI microplate format, Krystal glass bottom plates are fully compatible with automated liquid handling and robotic
devices. All plates are supplied lidded. In addition to cell growth applications, Krystal glass bottomed plates can be used for light-emitting assays measured through the glass plate base. The special design of the plate virtually eliminates well-to-well light crosstalk inherent with other clear-bottomed microplate designs, enabling outstanding accuracy, sensitivity and repeatability of photometric readings.
Porvair Sciences Ltd +44 1978 666240 int.sales@porvair-sciences.com www.porvair-sciences.com
Multiphoton System Delivers Precise Deep Imaging at High Speeds According to Olympus, its new FluoView FVMPE-RS, a dedicated multiphoton microscope system, enables highprecision, ultra-fast scanning and stimulation, allowing researchers to see deep within specimens, take measurements at the highest speeds and capture images. The FVMPE-RS is designed for electrophysiology and optogenetics studies. It is also a good match for applications such as high-speed calcium and in vivo imaging, peristalsis and blood flow studies, mosaic imaging, connectomics and functional brain imaging, stem cell research and any field that requires precise colocalisation, uncaging, simultaneous imaging/stimulation, extensive real-time signal processing or multipoint mapping. The precision timing on the system allows for microsecond repeatability and control of multiple imaging and stimulation protocols as well as millisecond repeatability over days of
time-lapse imaging. Complex multiposition imaging or optogenetic stimulation protocols can be accomplished using the advanced stage control and sequence manager. The FVMPE-RS captures 438 frames per second (fps) at 512 x 32. It also captures full-frame, 512 x 512 images at 30 fps, without any reduction of the field of view. Its scanner unit combines a newly designed resonance scanner with a galvanometer scanner to provide both speed and excellent definition. The resonance scanner offers an exclusive non-linear sampling method for smooth imaging without jitter. An optional third galvanometer scanner is also available for imaging with simultaneous 3D stimulation or uncaging. The system’s multipoint mapping capability allows ultra-high-speed measurement of rapid fluctuations in groups of cells for functional imaging studies, 3D intensity measurement or mapping with high signal-to-noise performance.
In addition to speed, the FVMPERS offers outstanding performance when imaging live cells and tissues. It provides multicolour, multiphoton excitation and imaging with a choice of lasers, along with a four-axis auto-alignment capability for precise colocalisation and coalignment without pixel shift. With its multiple-laser-line performance, researchers can work with two IR laser lines simultaneously while stimulating the sample with visible light. The system delivers sharp images with clear separation of fluorescence proteins for analysis. The high-sensitivity system offers high efficiency multiphoton excitation at wavelengths of 1300 nm, with the ability to support wavelengths of up to 1600 nm. Objectives that offer working distances of 2, 4 or 8 mm deliver super-deep imaging. Light collection efficiency is further improved by the system’s optimised light path. In Deep Focus Mode, researchers
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can tune lasers precisely for deep-tissue imaging to achieve signal improvements of 20% or more over comparable systems. The FVMPE-RS is designed to be simple to use and require minimal alignment, thanks to its robust autoalignment system and easy touch-panel control. Olympus Europa SE & Co. KG +49 40 23773 5913 microscopy@olympus-europa.com www.microscopy.olympus.eu
Industry News & Events
Cleaver Scientific Scoops First Place in Lions’ Lair at Lab Innovations 2013 Cleaver Scientific won the Lions’ Lair competition on 6 November 2013, the opening day of Lab Innovations at the NEC, Birmingham, UK. The company scooped the top accolade for its Safe series, designed to make DNA electrophoresis procedures safer, more convenient and more economical. The Safe series offers a safer and more user-friendly alternative to traditional methods as it eliminates the need for ethidium bromide and the need for ultra violet light, without compromising the results of electrophoresis procedures. The Safe series comprises runSafe, a completely safe stain for DNA, and runView, a gel electrophoresis system that utilises safe blue light, and finally runDoc, a benchtop gel documentation system that sits above the gel tank and
enables multiple real-time images of the process to be taken. Commenting on the company’s win, Cleaver Scientific Sales and Marketing Manager Alan Phillips said: “Winning Lions’ Lair is a great boost for safe electrophoresis and an endorsement for product development at Cleaver Scientific; we’re thrilled.” The company saw off stiff competition from ETI, Vacuubrand, CTS Europe and Ash Scientific, which all pitched their newest technologies to an expert panel of judges, in front of a live audience at the show. The judges (or lions) included Warren Jackson, Analytical Services Manager at Premier Foods, and Jeremy Hargreaves, PhD, Incoming Materials and Lab Manager at Nestle. Commenting on the
winner, Jackson said: “This product scored well because it focuses on lab safety and it is also a costeffective product to use.” Hargreaves also had praise for the Lions’ Lair concept: “It is really important to encourage the ongoing improvement of lab products and to foster innovation.” Lions’ Lair takes place on the first day of Lab Innovations. The show also featured a full range of exhibitors. There was also a full two-day conference organised by show supporter The Royal Society of Chemistry, plus roundtable discussions, keynote presentations from Professor Andrea Sella and Lord
Professor Robert Winston and Campden BRI technical workshops. easyFairs Lab Innovations 2013 +44 20 8843 8822 richard.thompson@easyfairs.com www.easyfairs.com/labinnovations
SLS Opens High-Tech Cold Storage Facility to Accommodate Lonza Media Products Independent UK supplier of scientific equipment, chemicals and consumables Scientific Laboratory Supplies (SLS) has recently invested in temperaturecontrolled storage facilities at its main site on the Wilford Industrial Estate in Nottingham. An investment of £15,000 in the 40 m2 high-tech storage facility has been designed to accommodate the new Lonza laboratory range, which requires cell culture media products to be stored at +4˚C. Earlier this year, Lonza appointed SLS as the sole distributor for its BioWhittaker cell biology media and serum product lines in the UK. The new facility allows SLS to respond quickly to requests from laboratories
anywhere in the UK. Items are despatched overnight in special containers to maintain a stable temperature and to keep the products fresh. Industry leading brands also held within the SLS temperature controlled facilities are GE Whatman, Roche, Oxoid and 5Prime. Taking on the Lonza business has quadrupled the SLS business via these facilities. SLS Operations Director Peter Lister said: “The opening of our new cold store is a further development in the service SLS provides to the life science and bioscience laboratory sector.” SLS has been operating for 22 years and employs 143 at its headquarters in Nottingham and in sales teams across
the UK. The company is currently working closely with the Royal Society of Chemistry on the 2014 Scientific Laboratory Show and Conference (www.scientificlaboratoryshow.com) to be held at the East Midlands Conference Centre next May. Sponsorship of the biennial Scientific Laboratory event is a major commitment by SLS to the professional development of UK laboratory personnel and coincides with the launch of its new laboratory supplies catalogue.
Operations Director Peter Lister with Warehouse Manager Andy Kingston.
Scientific Laboratory Supplies Ltd +44 1482 649665 www.scientificlabs.co.uk
Sartorius Stedim Biotech and BD Diagnostics Strengthen Cooperation in Microbiological Diagnostics Sartorius Stedim Biotech (SSB), an international pharmaceutical and biotech supplier, and BD Diagnostics, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, have announced a collaboration to develop, manufacture and market various ready-to-use, prefilled media products for microbiological applications in pharmaceutical, biotech and research laboratories. “Through our agreement with BD, we have created an excellent collaboration. BD is known worldwide for its expertise in manufacturing and filling of microbial media. BD’s expertise combined with Sartorius Stedim Biotech’s know-how in polymeric technologies and applications will help us further extend our expert capabilities in the field of microbiological monitoring,” said Dominique Baly, member of the Sartorius Group Executive Committee. Based on its many years of expertise in the development of membranes, SSB
“The products we plan to develop under our agreement with Sartorius Stedim Biotech will enhance laboratory efficiencies for our pharmaceutical, biotech and research customers with these unique product offerings,” said Bob Ferguson, Vice President and General Manager, BD Diagnostics — Diagnostic Systems, Industrial Microbiology. “By combining Sartorius Stedim Biotech’s bioprocessing and filtration expertise with BD’s microbiological media capabilities, customers will benefit from improved lab productivity and standardisation of sample processing.” Bob Ferguson, Vice President and General Manager, BD Diagnostics — Diagnostic Systems, Industrial Microbiology.
Dominique Baly, member of the Sartorius Group Executive Committee.
offers high-quality, single-use filter products for concentration of microbial contaminants in the laboratory. As part of this strategic collaboration, BD will fill special SSB single-use products with BD culture media and supply these to
SSB as prepackaged products. In addition, the companies are exploring options of extending their existing business relationship by pursuing further solutions in the field of microbiological diagnostics.
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Sartorius Stedim Biotech +49 551 308 3615 karin.kleist@sartorius.com www.sartorius.com BD +1 201 847 4796 jamie_yacco@bd.com www.bd.com
INGREDIENTS & CONTRACT SERVICES
Colorcon and Evonik Industries Launch Technical Support Cooperation for Coating System Colorcon and Evonik Industries have signed a cooperation agreement for the marketing and technical support of Acryl-EZE, an aqueous enteric acrylic system. Acryl-EZE fully formulated coating systems are produced by Colorcon and contain EUDRAGIT L 100-55, an Evonik product, as the key functional ingredient. “Colorcon is a market leader in fully formulated film coating systems and Acryl-EZE is well-established in the pharmaceutical market. This new cooperation will expand our offering and bring more choices to the customers ranging from single functional excipients to fully formulated delayed release coating systems,” commented Jean-Luc Herbeaux, Head of the Health Care Business Line, Evonik Industries.
Prior to this new cooperation agreement, Acryl-EZE was produced, distributed, marketed and supported solely by Colorcon. The new cooperation will result in enhanced global technical support to the pharmaceutical industry through the Evonik network as well as the established Colorcon channels. Furthermore, the cooperation will create value for customers who require highperformance enteric acrylic coating solutions. “Expanding our sales and marketing activities will enable us to reach and support more customers and offer them a broader technical service together with Evonik, a leading company in delayed release polymers. We are excited to enter this new cooperation,” affirmed Colorcon’s CEO Martti Hedman.
Evonik Industries AG +49 201 177 01 www.evonik.de Colorcon Inc. +1 215 256 7700 www.colorcon.com
Investments of Over £12 Mn Enhance Almac’s Commercial Facilities With the opening of a new commercial packaging facility in the US and enhanced processing capabilities at the company’s Headquarters in Craigavon, UK, investments in the past year have substantially transformed the commercial business unit of Almac. In February 2013, with FDA approval, Almac opened its US commercial packaging facility, providing quality driven, flexible packaging solutions for both solid oral dosage forms and biopharmaceutical products. Meanwhile, expansion continued at Almac’s UK commercial manufacturing and packaging facilities, with the completion of a US client-led capital project in support of a key global product launch. This expansion has added significant capacity for commercial fluid bed drying and high-speed encapsulation.
Additionally, in response to growing demand from a number of Japanese partners for enhanced flexibility related to larger blister sizes and requirement for non-permeability and environmental protection, investment has also been made in blistering technology with product humidity control. Owing to record sales, growth in one of Almac’s client’s key products and entry into new markets including China, the most recent commercial expansion completed at the UK site was a client-led second investment in dedicated facilities, doubling sachet output to 250 million sachets per annum. David Downey, VP, Commercial Operations, noted: “Almac continues to grow in partnership with our clients and is developing a strong reputation for the delivery of complex, time-sensitive
capital projects in support of growing, innovative products. This level of commercial investment demonstrates our commitment to building long-term, strategic relationships.” Almac Group Ltd +44 28 3833 2200 info@almacgroup.com www.almacgroup.com
Dechra Pharmaceuticals Expands LCO Division The manufacturing business of Dechra Pharmaceuticals, Dechra Pharmaceuticals Manufacturing (DPM), in Skipton, Yorkshire, UK, has initiated a significant investment programme to realise a major expansion of its Liquids, Creams and Ointments (LCO) department, with the aim of creating a globally cGMP compliant facility. The expansion will include refurbishment
of the existing building fabric, improved utilities and significant process equipment procurement. The new equipment will provide a major increase in manufacturing capability and capacity, estimated at five times the current level. Managing Director Mike Annice commented: “Following our earlier FDA approval for solid dose production and the recent refurbishment of our injections
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suite, focus is now moving to the LCO department and a major expansion of this area will be carried out in the first half of 2014. This is another step to DPM becoming a global supplier of pharmaceutical products.” Dechra Pharmaceuticals PLC +44 1606 814730 www.dechraplc.com
INGREDIENTS & CONTRACT SERVICES ROUNDUP Sprinkle Capsule Supports People with Swallowing Difficulties Capsugel is launching a capsule design to improve adherence to treatment regimens for patients with difficulties swallowing, including babies, children and older adults as well as patients with medical conditions such as Alzheimer’s, Parkinson’s and Multiple Sclerosis. The new Coni-Snap sprinkle capsule is expected to be available in 2014. “We recognise that patient populations are very diverse with different needs, which is challenging the traditional onesize-fits-all approach to drug formulation and development,” said Sven Stegemann, PhD, Director for Pharmaceutical Business Development at Capsugel. “Especially among very young and very old patients, there is a need for dose adjustments to account for the physiological differences in these patient populations. Easy-to-open capsule technology allows for accurate dosing at many different dose strengths of easy-toswallow multiparticulates and sprinkles, which may lead to improved adherence and minimise dispensing errors.” Encapsulated drug multiparticulates or sprinkles, containing a defined dose of medicine that can be sprinkled on food or beverages, is a known alternative for people with challenges swallowing. The major difficulty using standard capsules is that their strong locking mechanism requires sufficient grip strength and dexterity to reopen the capsule. Capsugel’s Coni-Snap sprinkle capsule was developed to provide easy-to-open capsules to caregivers and patients yet has a strong enough lock that allows for
Naturex Receives First Ever CEP Certification for Devil’s Claw Extract
Coni-Snap sprinkle capsule. processing in the manufacturing and distribution chain. Capsugel tested the new design with caregivers to gauge usability, ease of opening and user accuracy when sprinkling medications. More than 80% of participants described the new design as ‘easy’ or ‘very easy’ to open. Also, while most participants naturally opened the capsules horizontally, the evaluation determined that the most effective way to instruct users to open the capsules was with arrows printed directly on the capsule shell. “The easy-to-open capsule has the potential to make medication management simpler for patients and caregivers without compromising quality, safety or efficacy for patients,” said Dr. Stegemann. “Also, for the pharmaceutical industry, Coni-Snap sprinkle capsules offer a cost-effective solution for commercial products and line extensions based on existing and proven formulation and manufacturing technology.” Capsugel +1 610 680 6214 christina.chnaider@capsugel.com www.capsugel.com
Devil’s claw is the sixth botanical extract to join the short list of herbal drugs with Certification of Suitability to the monographs of the European Pharmacopoeia (CEP). By granting this certification, the European Directorate for the Quality of Medicines & Health Care (EDQM) recognises that Naturex’s devil’s claw extract is safe and fully compliant with the European Pharmacopoeia tests and specifications. As a prerequisite of the dossier, the manufacturing site operates under full pharmaceutical GMP (ICH Q7). “Being granted the first ever CEP certification for a devil’s claw extract is a fitting acknowledgement of the extensive work of our teams during the rigorous registration process,” stated Pierfrancesco Nannipieri, Global Pharmaceutical Regulatory Affairs Manager. “Beyond the compliance of the devil’s claw extract with the European Pharmacopoeia, this certification will fully benefit our customers,” said Maxime Angelucci, Head of Sales for Europe and Africa. “The CEP is widely accepted and helps to shorten the time-to-market for new drug developments because the API receives immediate approval. This removes a number of constraints for the client, as an individual assessment of the API by each national authority is no longer necessary. “Moreover, the CEP is not only relevant to the EU member states. A growing
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number of authorities acknowledge this certification as part of an expedited registration process in countries such as Canada, Australia, New Zealand, Tunisia and Morocco.” According to the monograph on harpagophytum procumbens from the European Medicines Agency (EMA), certain therapeutic indications are permitted for CEP-certified devil’s claw. For example, companies may promote it as a ‘traditional herbal medicinal product for relief of minor articular pain’. This certificate is a good complement to Naturex’s collection of over 30 APIs approved for sale in Europe. Naturex +33 4 90 23 96 89 a.dauby@naturex.com www.naturex.com
INGREDIENTS & CONTRACT SERVICES ROUNDUP Azelis Announces Pharma Partnership with JH Nanhang Speciality chemical distributor Azelis has partnered with JH Nanhang (JHNH) and signed an exclusive agreement to supply its range of polyvinylpyrolidones (PVPs) for all pharmaceutical applications across Europe, Turkey, Russia, Tunisia, Morocco and Algeria. JHNH is a leading PVP manufacturer in China with an annual production of 5,000 mt. The company meets all international standards for quality and safety, including cGMP, ISO 9001 and ISO 14001 certifications. The company’s pharmaceutical products, marketed under the trade name Povidone, are fully qualified, conforming to USP/EP/JP with drug master files available. This deal is seen as a very positive move from both sides. The two
companies have a shared vision to drive market expansion and sustainable business development by providing high quality products, backed by responsive customer care. Dr. Tan Tiow Lin, General Manager, Global Sales and Marketing JHNH, explained: “Azelis is recognised for dedicated sales, marketing, technical support and supply chain excellence in the pharmaceutical industry. At JHNH, we look forward to working with the Azelis pharma team to provide customers with in-depth application insight, helping to improve product performance and optimise cost effectiveness.” Matthew Dickman, International Business Director, Azelis Pharma,
added: “Azelis is excited about this opportunity to help drive JHNH’s strategy to penetrate Western markets. I am certain that this agreement will strengthen both our businesses across Europe, Russia, Turkey and North Africa, whilst at the same time give our customers access to all that this key Chinese manufacturer can offer.” The Povidone pharmaceutical range is suitable for a wide variety of applications, including binders and stabilisers for tablets, film formers and solubilisers for injection preparations and disintegrants for tablets, capsules and granules. To support their introduction, Azelis plans to provide prototype formulations and laboratory
support, inviting customers for product training days and laboratory visits. All products are covered by a confirmation letter of REACH pre-registration. Azelis matthew.dickman@azelis.com www.azelis.com
Silica-Based Excipient Delivers Enhanced Drug Solubility and Bioavailability Merck Millipore, the Life Science division of Merck, has introduced Parteck SLC, a new excipient with a surface structure that delivers significantly increased loadability for APIs. Featuring a reportedly unique pore structure, Parteck SLC for drug delivery enables loading of oral dosage forms with amorphously distributed API to the highest levels, dramatically increasing API solubility. “Many promising drug candidates fail during development due to poor bioavailability and represent a significant loss of time and resources invested in drug development,” noted Matthias Bucerius, Ph.D., Head of
Pharmaceutical Raw Materials. “With the addition of Parteck SLC to our extensive portfolio of excipients, drug developers now have a new option to help increase solubility and bioavailability and advance drug development. With Parteck SLC, molecules can also be reformulated, potentially extending the lifecycle of the drug.” Parteck SLC’s mesopores (2–7 µm) create a surface area of up to 1000 m2/g for depositing an API in its amorphous form needed for supersaturation. The internal surface area of Parteck SLC is also easily accessible and the API is always kept stable. Feasibility studies have proven the superior performance
on dissolution of Parteck SLC both in vitro and in vivo. A user-friendly particle size (5–25 µm) and bulk density (0.32 g/ml) allow easy loading, tabletting or capsule creation. In conjunction with Parteck ODT, a directly compressible excipient, Parteck SLC helps to produce stable and fast acting tablets. The loaded granulate retains its performance during dissolution in solid dosage forms. As an EMPROVE product, Parteck SLC comes with ready-to-use documentation in CTD-format, saving time and money in the registration of the final drug. Feasibility studies concerning loading and in vitro dissolution are also available.
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For more information, visit www.merckmillipore.com/bioavailability and www.merckmillipore.com/parteckslc. Merck Millipore +1 781 533 5336 pegeen.dossantos@emdmillipore.com www.merckmillipore.com
INGREDIENTS & CONTRACT SERVICES ROUNDUP Aesica Targets Development Services at Inhalation Market Global CDMO Aesica has announced its intention to increase its range of inhalation services and products in development, with a new Lead Technical Centre also envisaged in the near future. A key part of this inhalation drive has been the company’s focus on the intake of skilled staff, coupled with the commercial development of several leading inhalation technologies, and the company is actively partnering with other companies and universities to discover and engineer new technologies for commercial applications. The plan marks a systemic shift in the wider market with clients now looking for CDMOs to have a wider range of development technologies, delivery expertise and the ability to take a project right through to commercialisation. Aesica currently has two new development technologies available to clients, including spray drying techniques delivered through a partnership with Upperton and a powder filling technology delivered through 3P’s Fill2Weight. Another key factor in the company’s growth within this market has been the
adoption of non IP protected products, which enables Aesica to concentrate with the client on developing the right formulation irrespective of delivery mechanism. These new technologies have provided a huge advantage to customers in terms of lowering costs, particularly for re-formulations of generic products, whereby the cost of set-up is highly prohibitive to new market entrants and this is forecast to be a rapidly expanding sector. Building on these successes, Aesica is researching both internally and externally for new innovations in formulation technologies to complement its suite of services, and the company envisages opening a new inhalation Lead Technical Centre by the end of 2014. The Nottingham site currently has over five years’ experience developing new generic inhalation products alongside many new chemical entities (NCEs) for trial. Aesica is increasingly looking to work with clients over the longer term and is concentrating on taking new drug targets right through to commercial stage, with the ability to switch easily between initial nebulised products (i.e. a
low cost entry to early clinical trials) and dry powder inhalers for use in later clinical trials. This flexible onsite approach also means that the company can reduce time to market with 24/7 capabilities, which has allowed it to deliver on every client clinical date. Ian Lafferty, Site Director for Aesica Nottingham, commented: The Next Generation Impactor (NGI) — the principle analytical tool “Inhalation is a rapidly used in the characterisation of inhaled products. growing market with many US companies in bringing products to market faster and looking to bring NCE production to developing the next generation of Europe, whilst we also see a dramatic technologies through our Lead Technical growth for products going into China and Southeast Asia, particularly amongst Centre.” generic formulations. We have largely Aesica Pharmaceuticals Ltd operated under the radar in terms of +44 191 218 1960 inhalation products, despite the wealth info@aesica-pharma.com of new technologies coming to market www.aesica-pharma.com here, and our intention is to take a lead
Micro Dosing Technology Improves Speed-to-Clinic for Oral and Inhalation Formulation Development Bend Research, part of Capsugel’s Dosage Form Solutions business unit, announced the addition of Capsugel’s Xcelodose precision powder-filling technology to its drug development process. This patented micro-dosing technology will further enhance Bend Research’s recently announced Rapid Advancement of Preclinical Compounds initiative. The technology will also facilitate fast and efficient scale up and transfer of powder-fill formulations within Capsugel’s global network of commercial production sites. The Xcelodose 600S precision powder micro-dosing system enables the dispensing of dose weights as low as 100 µg, without excipients or bulking agents. This technology is widely established within the pharmaceutical industry for early stage clinical trials and small-scale production. In addition to streamlining and speeding the process of preparing product for clinical trials, the technology can lower costs by reducing the need for additional costly
and time-consuming stability studies. It also gives the company the ability to fill capsules in a controlled environment. The Xcelodose technology will have specific applications in Bend Research’s oral and inhalation product development. “As leaders in bioavailability enhancement and modified release, we are utilising complementary technologies at Capsugel and Bend Research to improve our collective offerings and help our clients advance their best medicines,” explained Jim Nightingale, President of Bend Research. “For example, integrating Bend Research’s expertise in particle engineering for inhalation, Capsugel’s Xcelodose technology and Capsugel’s expertise in development of customised dry powder inhalation capsules will do just that in the area of inhalation drug development and delivery.” The rapid advancement of spray-dried dispersions (SDDs) to the clinic will also benefit from the Xcelodose technology
and the overall formulation flexibility of capsule technology. Precision capsule fill capability is imperative for dry powder inhalation drug products. The addition of the Xcelodose technology to the Bend Research drug development technology portfolio further ensures that inhalation drug development can progress from proof of concept (POC) through Phase 2 in 20 weeks or less. The use of capsules for early feasibility and first-in-human clinical trials is a key component of the Rapid Advancement of Preclinical Compound initiative. Specifically, this initiative includes POC, feasibility and scale up for IND supporting toxicity and stability study analysis as well as cGMP manufacturing capability. For a complete listing of Bend Research’s development and manufacturing equipment, visit: www.bendresearch.com/content/cgmpmanufacturing.
Bend Research, Inc. +1 541 382 4100 www.bendresearch.com
SCM Pharma Appoints Business Development Director UK CDMO SCM Pharma has strengthened its commercial management team after the appointment of experienced new director Simon Bellamy. Bellamy joins the sterile manufacturing specialist as Business Development Director and will be primarily responsible for bringing in new clinical trials business as well as looking for small commercial opportunities for the company’s new £6 million facility in Newburn. He brings 30 years’ experience in the pharmaceutical industry with his most recent business development roles at Catalent Pharma Solutions and Piramal Healthcare. Dianne Sharp, Managing Director at SCM Pharma, said: “Attracting Simon to our business is a major coup given his past experience in the contract manufacturing arena and he will no
doubt add a huge amount of value to our exciting growth plans. “We now have two of the finest sterile filling facilities in Europe catering for development, clinical trial projects and commercial supply, which gives Simon and his team a compelling service offering to take to the market.” Having graduated with a First Class honours degree in Chemistry from Sheffield University, Bellamy is the latest high-profile director to join SCM Pharma. He said: “The sterile market is one of the highest growth areas in pharmaceutical outsourcing at the moment so offers incredible opportunity for growth for SCM Pharma, which was a major factor in joining this exciting business. “Having worked for the big CMOs, it is exciting to be working within a more specialised company at a relatively early stage of its growth. SCM Pharma has an
incredible culture, which is markedly different from others within this market. “I am very much looking forward to the challenge of growing the business and learning more about the parenteral dosage forms applications we can offer, most of which have a direct impact on patients in critical care areas such as oncology.” SCM Pharma specialises in the sterile production of products for clinical trials along with the supply of licensed drugs in niche markets. Its new facility was given the go ahead for production following a successful inspection from the MHRA this summer, which reinforces its expertise in vial, ampoule and syringe
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filling, particularly when dealing with potent products requiring high containment. SCM Pharma Ltd +44 1661 833 693 info@scmpharma.com www.scmpharma.com
SHOWCASE HIGH POTENCY
CARBOGEN AMCIS Continues to Expand High Potency Capabilities
SAFC Invests in Commercial-Scale ADC Conjugation Manufacturing and Services
To meet rising demand for high potency active pharmaceutical ingredients (HPAPIs) spurred by the growing targeted therapy approach in the treatment of diseases, in particular oncology, Switzerland-based CARBOGEN AMCIS has completed a capital investment project to upgrade its high potency capabilities. An industry leader in the production of HPAPIs, CARBOGEN AMCIS offers drug developers the full range of high potency services, from development, manufacturing and chromatography, to antibody drug conjugates (ADCs), fill and finish, lyophilisation and lifecycle management. The enhancements will include: • A dedicated chromatography suite for Category 3 and 4 compounds at its niche-scale commercial facility for highly potent APIs in Bubendorf, Switzerland. The 55 m2 grade D area features three walk-in barrier hoods for safe handling of highly potent material and a 15 cm internal diameter (ID) high performance liquid chromatography (HPLC) column for the purification of highly potent APIs in the range of 50–500 g/day. • A new, Class 100,000, high potency kilo-lab with 110 m2 of floor space at its large-scale commercial facility for highly potent APIs in Bavla, India. The kilo-lab features multiple glass-lined and stainless steel reactors and agitated nutsche filter driers (ANFDs) equipped with charging/discharging isolators. A negative pressure cascade and the highefficiency particulate air (HEPA) filters allow the safe production of highly potent APIs at exposure limit values (OELs) between 1 µg/m3 and 50 ng/m3 at eighthour time weighted average (TWA). “The expansions in India and Switzerland continue CARBOGEN AMCIS’s investment in building out a global, high potency platform to meet the growing demand for high potency APIs for oncology applications. This move,
Sigma-Aldrich Corporation’s custom manufacturing services business unit, SAFC Commercial (www.sigmaaldrich.com/safc), is expanding two of its manufacturing facilities in the US to support drug manufacturers in efficiently bringing new targeted and cytotoxic therapies to market. As a direct result of increasing customer demand, SAFC is investing in commercial-scale manufacturing capacity for antibody drug conjugates (ADCs) in St. Louis, Missouri, and expanding its high potency active pharmaceutical ingredient (HPAPI) manufacturing and storage at the Verona facility near Madison, Wisconsin. “These strategic investments are the result of ongoing dialogue with customers. We are directly addressing their needs for supply chain continuity when sourcing the high-quality manufacturing materials, technologies and services that drive the performance of their end products,” said Gilles Cottier, President of SAFC. “Bringing commercialscale ADC capacity to St. Louis and augmenting the offer at Verona to feature expanded HPAPI manufacturing and storage capabilities are direct reflections of SAFC’s commitment to investing in support of our customers.” The ADC expansion at the St. Louis site is expected to be completed by mid-2015. The updated facility will feature segregated areas for highly potent solids handling, manufacturing and aseptic bulk filling of product. Batches up to 600 l/3 kg can be manufactured under ISO 7 classification and the facility is suitable for HPAPI containment for SafeBridge Category 4 compounds. Additional commercial-scale manufacturing capacity has also been designed to seamlessly accommodate future growth in demand for ADC production. “Once complete, the St. Louis expansion will enable continuous scale-up of ADCs from preclinical to clinical phases and into commercial-scale production,” said Head of Global Strategic Marketing
along with parallel investments in the ADC arena in France and Switzerland, is a reflection of CARBOGEN AMCIS’s continued commitment to providing a broad range of personalised expert services, capabilities and geographic choices to our clients to help them develop the next-generation cancer treatments,” commented Mark Griffiths, CEO, CARBOGEN AMCIS and the Dishman Group. Choosing the right outsourcing partner for the development and manufacture of high potency APIs is a critical consideration for pharmaceutical companies that seek partners with expertise in chemistry, cutting-edge containment engineering technology and risk reduction in the handling of highly potent cytotoxic drugs. Since 2003, high potency APIs have been a core specialisation for CARBOGEN AMCIS and the recent investments underscore the company’s commitment to offering strong technical expertise in the development and commercialisation of new chemical entities (NCEs) and APIs, which resulted in the launch of more than 12 commercial products worldwide. Thanks to its excellent R&D and manufacturing infrastructure and expertise in high potency APIs, CARBOGEN AMCIS is well positioned to contribute to the development of nextgeneration cancer treatments and other therapies. CARBOGEN AMCIS AG +41 61 935 53 53 www.carbogen-amcis.com
Almac’s Strengthened Facilities Accommodates Demand for Late Stage API Manufacture The expansion of Almac’s API manufacturing facilities has allowed significant growth in the company’s late stage manufacturing service. The facility upgrade included installation of two 1,000 l reactors and a pressure filter dryer that now allows production of highly potent API manufacture up to 500 kg with a dedicated nitrogen jet mill for micronisation. Denis Geffroy, VP Business Development, commented: “Over the past few years, Almac’s API business has continued to grow at a double digit
pace. The facility expansion was much needed and the results are already striking with several Phase III and Commercial projects awarded.” Almac’s clients also leverage Almac’s API and Drug Product integrated offering where API manufacture and finished drug production is carried out on the same site, ensuring reduction in costs and timelines whilst maintaining scientific continuity. This year, Almac has completed its first joint commercial API and Drug Product manufacture, which
demonstrated the advantages of integrated operations. “Today, our API business is made up of 30% late phase and commercial projects, compared with just 5% three years ago, which gives a clear indication that our strategy to invest through expansion was the right one,” added Geffroy. Almac Group Ltd +44 28 3833 2200 info@almacgroup.com www.almacgroup.com
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for Contract Manufacturing Services & Solutions at SAFC Andreas Weiler. “ADC technologies have shown exceptional promise in targeted therapies for chronic diseases such as cancer, so strategic investments in this facility made sense to support our customers through all phases of ADC innovation.” “The investments at the St. Louis and Verona sites are complementary and allow SAFC to offer continuity for customers’ drug development and commercialisation programmes,” said Dave Bormett, Director of Operations for SAFC. “Verona’s HPAPI handling and containment standards (< 0.1 µm) enable the site to manufacture the high-potency toxins and linkers that the St. Louis site uses to conjugate biological molecules and develop ADCs. It is all part of our drive to provide customers with complete solutions based on our expertise in niche technologies.” Online since mid-2010 and SafeBridge certified in October 2011, Verona was originally constructed as an add-on to the Madison facility for cGMP manufacture of late-phase and commercial HPAPIs requiring 200 to 4,000 l capacity. By mid2014, the site will have a new warehouse with storage capacity for raw materials as well as three new cGMP manufacturing areas to support projects. Two of the areas will be designated for smaller laboratory-scale manufacturing in the kilo range, while the other will accommodate larger-scale manufacturing up to 800 l. The facility expansion will also provide space for growth of SAFC’s product stability sample storage and testing service as well as a process scale-up laboratory to support GMP production. Sigma-Aldrich Corporation www.sigmaaldrich.com/safc
INGREDIENTS & CONTRACT SERVICES ROUNDUP
IN THE SPOTLIGHT PENN PHARMA’S COO PROVIDES BEHIND-THE-SCENES TOUR OF HIGH POTENCY FACILITY
Mark Dean-Netscher, Chief Operations Officer.
On 26 September, CMO Penn Pharma celebrated the official opening of its £14 million high containment facility for oral solid dosage products in Tredegar, Wales, UK. Editor Elizabeth Valero spoke to Penn Pharma’s Chief Operations Officer Mark Dean-Netscher about the facility’s success since its operations began in March, its equipment and capabilities and the company’s long-term strategy. Penn Pharma’s impressive 1,394 m2 purpose-built facility is dedicated entirely to the development and manufacture of tablets and capsules containing highly potent compounds, with a design for manufacture to scale from 1 kg development batches up to 120 kg commercial scale batches. It provides containment down to an OEL of 0.01 µg per m3 and all equipment is either fully cleanable in place or can be washed offline. As Mark explained: “A lot of the big pharma companies are moving away
The entrance to Penn’s new, purpose-built contained manufacturing facility.
from contract manufacturers that rely on PPE (personal protection equipment).” With over a million hours free of a reportable accident on site, Penn Pharma considers the safety of its staff to be paramount. So it comes as no surprise that safety has been central to the new facility design and equipment selection. There is no requirement for PPE during routine operations and all equipment has been independently tested to the latest ISPE guidelines using SMEPAC (Standardized Measurement of
GEA’s Pharmaflex suite of equipment, with development capability up to 10 kg.
Equipment. Particulate Airborne Concentration.). £14 million is indeed a large investment and — as Mark reeled off some of the leading pharmaceutical equipment brand names: GEA, Bosch and O’Hara — it is clear that no expense has been spared and no compromises made. “What we’ve got is GEA R&D granulation equipment that’s able to handle small-scale, high-shear mixing and fluid bed drying, and it’s also able to blend raw materials,” he said. “Then we’ve got the same but larger version of that equipment to allow us to scale up to 120 kg batch sizes. There’s also tablet compression machinery from Courtoy and two tablet coaters, one for R&D and one for commercial.” A primary focus of the facility is of course oncology products — and there are a significant number of combination treatments in the cancer treatment market — hence the company’s decision to incorporate Bosch’s latest capsule filling machine, offering a micro dosing capability and used to produce combination therapies that accommodate powders and beads or mini tablets and powders in the same dosage. Keen to highlight the competitive edge this gives Penn Pharma, Mark said: “It’s Bosch’s first reengineered, fully contained HiProtect commercial line in operation in the world and we are proud to have it within Penn.” The capsule filler has a dual dosing station, so whereas with tablets, two different powders are simultaneously fed and then compressed together, one powder is fed into the capsule, followed by either another powder, micro tablet or spheronic bead, or a spheronic bead can be followed by a micro tablet or
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powder, or a micro tablet can be followed by a spheronic bead or powder. These combinations are all made possible using the facility’s new machinery. It is well-known that there are a number of aging facilities with outdated equipment in the outsourcing market and, according to Mark, this is where Penn Pharma supercedes many of its competitors: “All the new technology is controlled by very accurate computer systems, which allows us to a manage the development and scale-up very closely and, in turn, helps us achieve high yields for our customers. We’ve also invested in expert design software that allows us to model what the batch sizes will look like at a larger scale. Then there’s the disposable technologies we’ve invested in for those customers concerned about costs and validation or speed and cleaning processes. Again, I think that affords us a unique position in the outsourcing market.” Once predominantly used in the biopharmaceutical market, the disposable route is becoming increasingly popular amongst pharmaceutical manufacturers looking to reduce manufacturing times and costs. A firm advocate for incorporating disposable technologies in the manufacturing process of high potency drugs, Mark highlighted the main advantages: “Most outsource manufacturers go from one kilogramme to 10 kilos, then up to 50 kilos using rigid containers, stainless steel vessels or IBCs (intermediate bulk containers), and every time you use one of these you have to go through a rigorous cleaning cycle. If you’re a multi-API facility, you have to carry out more complicated cleaning validation. We’ve introduced
INGREDIENTS & CONTRACT SERVICES ROUNDUP disposable containers on our API isolator and, together with the integrated cleaning cycle, this makes the process much faster. “Another clever bit of GEA technology we use is the Hicoflex bag, which is filled with the powder to be turned into the tablet or capsule, and all we need be concerned with is disposal of the bag. “Also, because one of the risks when loading and unloading tablets from tablet coaters in a high potency facility is of course contamination, we’ve designed disposable isolators into our O’Hara coating machines, which means we can safely load and unload the machines, then conveniently dispose of the isolators. “With the disposable option, our clients don’t have to worry about cleaning or cleaning validation or a lot of quality reviews, it’s just very simple.” Although the official opening took place at the end of September, the facility produced its first batch of coated tablets in February, less than one year after ‘breaking ground’ on the building. Large-scale granulation and fluid bed drier, which provides final batch sizes up to 120 kg.
The fully contained Bosch GKF HiProtect combination dose capsule filler.
Penn is already carrying out development work with a number of companies globally. “We’ve got a Japanese client, the first client into the facility, who placed an order straight after their visit, as well as US and European-based clients,” outlined Mark. “As you can imagine, we were extremely pleased to already have multiple global projects live this soon after officially opening the new facility.” Penn Pharma has been running for 33 years and takes its name from the little village of Penn in Buckinghamshire where the company was started. The company then moved to Wales a few years later in 1986. There are no plans to invest in facilities abroad and it seems that the company ethos is to stay loyal to Wales. Keen to endorse this perspective, Mark said: “The Tredegar site’s got a 20-year history for potent molecules and we’ve had great support from all our staff over the years. We’ve partnered very closely with the Welsh Government, which gave us a grant to help with our investment, and Welsh Secretary Edwina Hart delivered the facility investment announcement together with our CEO Richard Yarwood.” It is clear that Penn Pharma is grounded in its overall outlook, looking to compete sensibly in the market and be awarded projects on account of its reputation and expertise. Contrastingly, prior to his appointment at Penn Pharma, Mark worked for a well-known CMO that had 30 global manufacturing sites around the world. “Clearly it’s not our goal to be in 30 different countries from a manufacturing facility point of view,” he said. “We believe we can serve the market, and certainly the growth of the high potency market, with our existing operations.” That said, expansion to meet market demand is certainly an ongoing strategy for Penn Pharma, the company having already obtained outline planning approval from the local authority for an additional high potency facility on the site. Both the new and planned high containment facilities, investment in the very latest technology and high-quality machinery, as well as a flexible approach to accommodating customers’ requirements, are all testament to the company’s growing commitment to the market. Mark summarised the goals and achievements of the project: “A lot of oncology and high potency products are for niche treatments of diseases, so where there are those customers wanting one million or a hundred million
tablets for big generic blockbusters, it’s not unusual to have requests for tens of thousands of tablets in a batch size for these much more targeted treatments. To have an operation that is flexible enough to do both is what a lot of customers are looking for. “We’ve tried to innovate throughout; the whole facility was designed with a lean six-sigma approach, featuring geometric scale-up and thoroughly flexible systems from start to finish. GEA,
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The API isolator with rapid transfer ports and flexibility to use disposable Hicoflex technology.
Bosch and O’Hara were suppliers that gave us the ability to innovate — we didn’t go for the cheapest, we went for the ones we felt best in the market.” Penn Pharma Ltd +44 1495 711 222 www.pennpharm.co.uk
Events REGULATORY AFFAIRS With over 30 years’ experience in WHAT IS A WELLregulatory affairs and ESTABLISHED pharmacovigilance, Dr. Biffingnandi is USE APPLICATION an Advisory Board member of the panAND WHEN CAN European pharmaceutical regulatory IT BE USED? affairs organisation ELC Group, a past president and now fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA), an overseas fellow of the Royal Society of Medicine and a renowned physician with PhDs in endocrinology and pharmacology. During his career, he has held CEO positions with major European pharmaceutical organisations, lectured on regulatory affairs at international symposia and published extensively on European regulatory affairs.
The legal basis of the application has a profound impact on the extent and nature of the data provided in the dossier and it is therefore of critical regulatory importance. For applications made under Article 10a, the applicant should justify the eligibility of the drug substance to be of well-established use (WEU). Under the European regulatory framework, a bibliographic application is admissible if the applicant can demonstrate that the API of the medicinal product was in well-established medicinal use within the EU for at least 10 years, with recognised efficacy and an acceptable level of safety. In that event, the pre-clinical and clinical-trial data normally required for an application may be replaced by appropriate scientific literature. If the dossier includes both published and own data, the submission would be considered a mixed marketing authorisation application and should be made under Article 8.3 of Directive 2001/83/EC. All the above specifically excluded any study performed by the applicant, by definition, when the proposed product claimed for the same pharmaceutical form, strength(s) and indications. Chapter 1 of Volume 2A of the Notice to Applicants, on the contrary, placed a particular emphasis on the literature search strategy and on the definition of published literature. However, recently, the attitude of the competent authorities has changed and now it is not uncommon to receive requests to bridge the literature data, which can or cannot have been obtained with the European reference product, with the proposed formulation. This implies some in vitro and/or in vivo data very similar if not identical to a bioequivalence study, i.e. an application according to Article 10(1), thus undermining the basis of the WEU. Since this attitude from regulators now seems consolidated, the question arises: is it not the right time to re-define the basic concept of the WEU legal basis or, maybe, to cancel this option from the Dr. Paolo Biffignandi paolo@elc-group.com regulatory scene?
RIM Conference Addresses Key Challenges Faced by Regulatory Personnel The risk of regulatory non-compliance and the inability to find accurate and upto-date regulatory information are key challenges facing teams across industry; operating globally and under limited resources further intensifies these challenges. Taking place at the Radisson Blu Hotel, Berlin, Germany, on 1–2 April, the fourth annual Regulatory Information Management conference — RIM 2014 — is a chance to benchmark against leading international companies and discover how they are managing these challenges. According to event organiser Informa Life Sciences, with over 120 attendees and more industry speakers than any other electronic document management event, RIM is the mustattend conference in this field. Key features of the event include: • industry benchmarking — gain case study insight into the RIM systems of eight different international companies • strategic advice on key industry drivers, including master data management, ISO IDMP and cloud solutions • valuable high level networking with two thirds of the audience being heads, directors or managers of their departments • meet and gain essential updates from the vendor community with top industry vendors discussing their strategies for the future of RIM.
Eighty-seven percent of attendees come from industry, with 67% being department heads, directors or managers. RIM 2014 includes specific features for the benefit of small- and medium-sized pharmaceutical, generics and biotech companies: • an SME breakfast briefing • specific SME challenges discussion tables at experience exchange sessions • SME case studies and discussion tables at the RIM World Café • speakers and panel members from four different companies representing pharmaceutical, generics and biotech SMEs. Informa Life Sciences +44 20 7017 7481 registrations@informa-ls.com www.informa-ls.com/cq5226epmp
PHARM Connect Congress Reveals Impressive Speaker Lineup TEG The Events Group has announced the date of the fourth annual PHARM Connect Congress, claimed to be the largest and most important pharmaceutical and biotechnology business summit for the CEE and CIS region. The Congress will again be held at the five-star Corinthia Grand Hotel Royal, Budapest, Hungary, on 26–27 February 2014, bringing together more than 500 senior decision makers from over 20 countries. The conference programme offers upto-date market insights into R&D, production, engineering, supply chain and quality management related topics, pre-scheduled business meetings and specially organised plant visits to major pharmaceutical manufacturing centres in the region. The conference programme has yet to be finalised, but confirmed conference topics and speakers so far include: • ‘Responding to Stricter Regulatory Requirements and Practical Approach — The New GDP Guideline’, Yoram Eshel, Senior Director, Global Transportation and Logistics, TEVA • ‘Pharma Companies from Emerging Market & Asia Pacific (EMAP) — Opportunity or Threat?’, István Király, Managing Director, GlaxoSmithKline Biologicals • ‘Preparing for Regulatory Inspections — The Do’s, the Don’ts and the Best Practices’, Amer Alghabban, Director, Global Quality Assurance Auditing, Merck • ‘Driving Process Excellence and Productivity in Pharma Manufacturing’, EPM 34
Attila Mile, General Manager, Xellia Pharmaceuticals • ‘Smart Factories: The Future of BioProduction’, Dr. Barbara Paldus, CEO and founder, Finesse Solutions • ‘Unpreserved Multidose Systems — New Trends in Ophthalmic Drug Delivery, Matthias Birkhoff, Vice President, Marketing CHC Division, Aptar Pharma • ‘Real-time Operational Intelligence (RtOI) — The Right Information, in the Right Hands at the Right Time’, Terry Siggins, Director Software & Services European Channels, GE Intelligent Platforms. Over the two days of the congress, leading pharmaceutical and biotechnology product and service providers will showcase their offerings — from APIs and contract manufacturing to processing, biopharma solutions, biopharmaceuticals and biologicals, drug delivery systems, cleanrooms, laboratory equipment, monitoring systems, inspection systems, quality control, measurement systems, data loggers, packaging and labelling, automation, plant engineering and maintenance, logistics, cold chain storage and distribution, warehousing and many others. Places are limited and available on a first-come, first-served basis — as soon as the last seat is booked, registration for the event will be closed. TEG The Events Group +36 1 219 57 25 marketing@tegevents.eu www.pharmconnect.eu
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