Azbil Telstar opens its new subsidiary in Bangladesh

. May 2014 Number 26 www.telstar.com CORPORATE Azbil Telstar opens its new subsidiary in Bangladesh The company reinforces its leading position in Asia The Azbil Telstar subsidiary in Dhaka, Bangladesh, was formally inaugurated on 2nd of April, 2014. The opening of Telstar's new center, which is specifically focused on reinforcing a professional and specialized service in Asia s pharmaceutical market, is in response to a requirement to promote growth in a region where the company has been active over the past 10 years. At the same time, Azbil Telstar is reinforcing its global activities in engineering, construction and m a n u f a c t u r i n g p r o c e s s e s f o r development of turnkey plants and installations for local and multinational pharmaceutical companies with high growth potential. Through the opening of the new center, the Telstar brand is now represented in this continent by three specialized production plants and engineering centers in China, Bangladesh and India. At the inauguration ceremony of the new center in Bangladesh, which was attended by 120 people, Azbil Telstar received the explicit support of the political authorities, institutional representatives and business leaders. The Minister of Health and Family Welfare of Bangladesh, Mohammed Nasim, acted as Chief Guest at the c e r e m o n y a n d e x t e n d e d congratulations for the interest and trust of Azbil Telstar in the Bangladeshi pharmaceutical industry, the flagship sector in Bangladesh, and for devising their own technological innovations to further develop the industry, with the help of a local team. In addition, the B a n g l a d e s h A s s o c i a t i o n o f Pharmaceutical Industries (BAPI)'s President, Salman F. Rahman, highlighted that Azbil Telstar is a such dynamic company that is involved in R+D and innovating newer technologies with the need of a constantly evolving pharmaceutical industry worldwide and we hope the company will further furnish to a great extent our beloved sector. Finally, Azbil Telstar's Chairman, Ton C a p e l l a, w h o e x p r e s s e d t h e commitment of the company to contribute to the development of the Bangladeshi society, also mentioned Square Pharmaceuticals and in particular its founder Samson H. Chowdhury and expressed gratitude for the support received during the past 12 years. Four production units have been successfully constructed for Square by Telstar: the Cephalosporin, Oral Solids Dose, Insulin and Large Volume Parenteral facilities. The ceremony also benefitted from the presence of the Ambassadors of Japan and Spain in Bangladesh, Shiro Sadoshima and Luis Tejada, respectively, the Secretary General of BAPI, Abdul Muktadir, and the Director General of Drug Administration, Mohammed Jahangir Hossain Mollik. Azbil Telstar's Chairman, Ton Capella, during his speech at the opening ceremony of Azbil Telstar subsidiary in Dhaka, Bangladesh Editorial. Telstar, the added value of its consultancy team Exhibitions and Conferences BACK COVER Life Science Solutions. Telstar provides a package of 63 compact safety cabinets to NUI Galway s Biomedical Science Research Facility. Telstar launches a new version of its LyoBeta freeze dryer. Telstar & Acmavolpak complete an aseptic filling line project for the packaging of children s food in the US market. Water-for-injection still integrated with storage and distribution system for pharma and biotech industries. Telstar s new automatic loading & unloading systems for lyophilizers offer improved robustness and flexibility. Telstar develops high containment barrier systems designed for API s manufacturing and research of new products by genetic technology

EDITORIAL Telstar, the added value of its consultancy team A global solutions provider like Telstar, m u s t h a v e a consultancy team behind them, and not just to close the circle The term added value is used so often in the business world, that I often ask myself if we are using it correctly or, simply, letting ourselves be influenced by the most commonly used phrases in a purely commercial field. You see, there are many definitions of the phrase added value. However, whichever definition we use, who really knows whether we have added value or not, is the CLIENT, and the best indicator for assessing this are SALES. There are three concepts that distinguish the Telstar Consultancy team: 1.DIFFERENCIAL VALUE Telstar is the only specialist company capable of offering complete solutions for turnkey projects in pharmaceutical plants. It is capable of completing the circle, not only by delivering the plant ready to be duly certified (GMP, ISO ), but also by providing services like consultancy in operational excellence (QbD, Lean Six-Sigma..), R+D consultancy, the introduction of products to be manufactured in a factory (product search, partners, CMO's ), as well as all the regulation and regulatory support regarding the plant and the products (laboratory authorisation, preparation and presentation of dossiers, contact with the Health Authorities ). We would say that it closes a larger circle, or a circle with a greater business strategy vision. 2.TRUST AND LOYALTY, In my opinion, there are two types of professionals that hugely damage the image of a consultant: the one focused on purely bureaucratic activities that does not contribute any knowledge to the diagnosis, and the one that charges large sums of money in exchange for submitting a very general report which usually ends up turning the client company upside down. At Telstar, which is neither of the two examples, the consultant shares his knowledge with the client so that the knowhow remains within the organisation once the project has finished. This makes our clients trust us, and many of them become loyal clients. 3.INNOVATION Guaranteed survival: The recession has left us all with a new stage for competing, and when normality finally returns, nothing will be the same again. Today's challenge lies in offering more for less. The test is to be able to adapt to a new situation, detecting short-term opportunities. Our challenge is to innovate constantly. At Telstar, the Consultancy service has managed to adapt to this situation thanks to its flexibility vis-à-vis the client, by introducing new activities to its portfolio, its geographical growth, and naturally, because it is able not only to innovate but to launch this innovation onto the market. It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that is the most adaptable to change. Charles DARWIN MªAngeles Muñoz Business Division Director Consultancy & Customer Services LIFE SCIENCE SOLUTIONS Telstar provides a package of 63 compact safety cabinets to NUI Galway's Biomedical Science Research Facility The new, recently inaugurated research facility, which is directed towards cancer research, regenerative medicine and glycosciences, takes its place as one of five global hubs in the medtech sector A complete package comprising 63 cabinets developed by Telstar has been delivered to the new Biomedical Science Research Facility at the National University of Ireland in Galway (NUI Galway). The activities of NUI Galway's Biomedical Science Research Facility are specifically directed towards cancer research, regenerative medicine and glycosciences. The cabinets provided by Telstar have been designed considering specific bioprocessing applications in the medical and clinical research field. The suite of cabinets provided by Telstar represent a new generation of innovative biological safety cabinets designed to work in research environments such as tissue culture suites, radiochemistry, flow cytometry, screening core, sample p r e p a r a t i o n a n d biomimic areas. The cabinets developed by Telstar for NUI Galway's Biomedical Science Research Facility are more compact and optimize the usable work area in laboratories with limited space. The cabinet design offers a body 20% smaller than the market average while maintaining standard work space. Intended for the laminar flow manipulation of microorganisms with biological risk levels 2 and 3, the new range of Telstar safety cabinets offers an ergonomic design that adapts easily to small spaces, especially in laboratories with low ceilings and where several pieces of equipment need to be used in the same area. Of the total of cabinets designed by Telstar, 57 of them correspond to Telstar Bio II Advance range, the class II cabinet designed in accordance EN12469 standard, and 6 units of EF B range of class II B2 cabinets in accordance with NSF49 standard.

LIFE SCIENCE SOLUTIONS New! Telstar launches a new version of its LyoBeta freeze dryer Designed for formulation, research and development applications, the new version of pilot-scale freeze dryer incorporates improvements in control system architecture, management software, process control and interface features Telstar has launched a new version of the Pilot-scale Freeze Dryer, Lyobeta, specifically designed for small scale formulation, research and development work. The Telstar Lyobeta range of laboratory freeze-dryers is specially designed for the field of experimentation, research and formulation to develop recipes in pharmaceutical freeze-drying processes. The new version of the Lyobeta, which offers the flexibility, performance and small foot print required in a laboratory unit, incorporates developments related to process control, including a PLC-based control system and improvements to control and programming capabilities, management software and interface features, to make it the most complete, efficient and convenient pilot unit on the market. Lyobeta bridges the gap in the market that in the past was filled with largesize laboratory equipment. In addition to the features of previous Lyobeta, the new series is offering the following improvements: more user-friendly interface: wider 6,5 colour touch screen LCD; improved PLC control and programming capabilities; more extensive range of interfaces to external devices (USB, PC, ) for monitoring and archiving purposes; improved SCADA-based management software; new options, such as control of the process by means of weight variation of the product, additional temperature sensors and simplified installation procedure. The Lyobeta is produced in batches as a series product but designed with numerous options to configure the product to customer requirements. Telstar & Acmavolpak complete an aseptic filling line project for the packaging of children's food in the US market The completed equipment will be installed in the US and will have a production capacity of 20 million containers a year Telstar and AcmaVolpak have collaborated on the development a new aseptic filling line, which has been configured to package children's solid food for distribution in the USA. Telstar has developed a laminar air flow system for the filling and packaging line, comprised of seven custom pieces of equipment: three HEPA filtered laminar flow units from the 'CAM' series, three HEPA filtered laminar flow units from the 'UF' series and a Restricted Access Barrier system (RABs). The Restricted Access Barrier system provides an efficient plug loading process in the packaging line, while the sterile air supply units (UF) are located on the transfer tunnels/cowlings between two laminar flows and the filtered air supply modules in the CAM series are designed to protect the product once the filling and sealing process begins. This arrangement of equipment gives a surface area of filtered air covering approximately 12 m2. The vertical laminar air flow provides ISO 5 class air quality which enables working under aseptic conditions. Green technology is used throughout, thereby ensuring that the equipment runs efficiently. All of the equipment provided by Telstar is constructed in stainless steel and features two-stage filtration to assure air quality. In addition, the equipment is fitted with EC fans, which save energy and run efficiently. Developed with GreenTech EC technology, the fan system provides a 50% energy saving when compared to conventional fans. Through the development of this clean air technology equipment, which will be used to protect the working environment of the SMA-260 F2 machine in the AcmaVolpak packaging line, Telstar is strengthening its position in the filling line market for the food, pharmaceutical and related international industries. This follows on from Telstar's fiftyyear history of developing equipment to support the processing of liquids and solids for the nutritional and life science markets.

LIFE SCIENCE SOLUTIONS Water-for-injection still integrated with storage and distribution system for pharma and biotech industries The compact unit is easy to operate and can realize a saving in space of up to 35% 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- For-Injection 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 Water-For-Injection production and storage and distribution skid operates to current GMP 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. Telstar's new automatic loading and unloading systems for lyophilizers offer improved robustness & flexibility New! Telstar has developed various configurations of vial alignment systems suitable for unloading processes of up to 400 vials per minute. Telstar has developed a new generation of vial loading and unloading systems that can be integrated into freeze dryers and which offer greater robustness, efficiency, reliability and accuracy in the vial transport and transfer process, in addition to easier cleaning and simplified maintenance. Modular vial transport system Telstar has developed a standard range of modules that combine easy installation and accurate alignment between conveyor systems, which ensures that the vials move smoothly and continuously between the modules and makes the vial transition process more robust and reliable. Designed to be applied to any vial loading system, this system developed by Telstar provides greater efficiency in the transition process, and reduces vial losses during transport due to breakages or falls. Telstar has developed and tested longitudinal transitions, sliding longitudinal transitions, active and passive 90 rotations, transitions with curved belts, with T-shaped belts and other various other geometrical arrangements required to accommodate the configuration of loading systems. By combining modules, the transport system can be readily configured to any layout. Vial single-lining system This is a complex element for accepting vials unloaded from the freeze dryer in random packets and aligning them at high-speed so that they can be transferred in a single line towards the capping machine. Since there are many applications where unloading vials onto a rotary accumulation module, Telstar has developed an alternative based on different single-liner system configurations that enable unloading the shelves of the freeze dryer while preserving as much as possible the row order followed during the loading process. The new Telstar vial descrambling modules are suitable for unloading processes at up to 400 per minute with a typical rejection rate of 0.01%. Telstar has developed a range of single-liner modules to address the various speed and layout requirements of specific clients. More compact pusher loading mechanism Telstar has developed a loading mechanism with a 40% shorter length than the conventional systems. It is primarily intended for installation in freeze dryers which, due to clean room space constraints, need to have a fixed loading system with a compact footprint. The new design, which also features a built-in HMI screen that offers improved ergonomics and cleaner construction compared to screens supported on floating columns. Due to its compact and robust design, the mechanism can be integrated with freeze drying equipment with shelf widths of up to 1500 mm, thereby increasing the loading capacity per row by 25% over earlier designs.

LIFE SCIENCE SOLUTIONS Telstar develops high containment barrier systems designed for API s manufacturing and research of new products by genetic technology Specially orientated to the manufacture of oncological pharmaceutical products and research in the Biotechnology field Telstar has successfully developed two high containment barrier systems for the Korean Komipharm Pharmaceuticals Co Ltd, one of the largest producers of products from anticancer drugs in human oral dosage form to veterinary medicines in Asia. The systems, one for API Sampling and the other for QC Sample Handling will be used in Komipharm's new facility, built in the South K o r e a n c i t y o f C h e o n g w o n, Chungcheongbuk-do. The purpose of the systems is to provide a high level of containment to protect operators during the manufacturing process using API's (Active Pharmaceutical Ingredients). Additionally, the systems will be utilised in research in the biotechnology field aimed to develop vaccines by genetic technology. Specifically designed for handling hazardous products, these containment systems run at negative pressure to the surrounding room providing operator protection during the manual product handling process and environmental protection for the product by virtue of the standard ISO 7 classification inside the isolator. This project has been carried out by the Technology Centre for Barrier Isolation Systems of Telstar, located in Dewsbury (UK). For handling APIs containing raw arsenic or Sodium Arsenite The two containment barrier systems developed by Telstar have been specially designed to handle API's during pharmaceutical manufacturing and analytical testing of product containing raw arsenic. One of the Isolator systems is for API Sampling and the other for QC Sample Handling. Both systems are based around the Telstar standard containment range to optimise cost efficiency, thus minimising design and assembly hours. Because of the standard design, the routine maintenance and every day running procedures are simplified and more cost efficient. Additionally, many of the featured parts are common, versatile and inter-changeable, which enables the client to avoid the over stocking of spares. The development of the isolator design took into account aesthetics, ease of c l e a n i n g a n d g e n e r a l maintenance together with operator safety / efficiency. Integration of internal equipment is made possible via simple glands and tri-clamp connections. The forethought of including a spare port provides provision for future add on services and can also be utilised for DOP testing of filters during annual service. The API Sampling Isolator includes single sided operator access to the main working chamber with mobile frame and onboard main control panel. Siemens PLC/HMI, materials transfer chamber for continuous batch processing, an integrated weigh system, integral Telstar glove tester, safe change HEPA filtration, contained transfer port, vacuum system and temperature/rh monitoring, are specifically attributed to this process Isolator. The addition of double sided access within its main working chamber, graphic data management for critical data storage via a modbus link, sockets to power a density tester, friability tester, hardness tester, sieve shaker, moisture detection and PH meter, completes the main characteristics specifically attributed to the QC Sample Handling Isolator. The barrier containment system supplied to Komipharm stands out by its simplicity regarding the base design and control system, coupled with optional accessory enhancement to offer flexibility and adaptation if required in the future. Ergonomically trialled base designs were employed ensuring suitability of the final design to the required operations. Whilst providing cost savings this approach ensures that a high containment solution with operator comfort of equal priority is achieved. Relationship, is the key to success A close working relationship was key in surmounting differences with the client in regards to both time zones and culture. Regular communication and face to face meetings together with willingness to adapt: r e v i s i n g t h e p r o j e c t s c o p e a n d accommodating new requirements were paramount to the success of the project. Establishing this close working relationship resulted in seamless incorporation of project changes and ensured any issues or concerns were quickly resolved without determent to the budget or equipment delivery. This Project has culminated in Telstar expanding its market base, of containment equipment using barrier containment technology into South Korea. Face to face meetings with Telstar was crucial in understanding our initial requirements together with special attention to particular details paramount in arriving at a fixed project scope, according to Kyung Seok, Kong, General Manager at Komipharm's new facility in Cheongwon, Chungcheongbuk-do.

EXHIBITIONS AND CONFERENCES VWR European Sales Conference Bonn (Germany) WOTS Utrecht (Holland) Analytica Munich (Germany) PharmTech, Moscow (Russia) ISPE Annual Meeting Las Vegas (USA) 23rd Aseptic Conference Washington (USA) Interphex NYC Nueva York (USA) CGMP Conference Baltimore (USA) Interpack Pharma Congress Düsseldorf (Germany) A3P Lyon & Biarritz (France) SETS Oviedo (Spain) AEFI Farmaforum Madrid (Spain) Expoquimia Congreso de Fertilidad Barcelona (Spain) GMP Summit Valencia (Spain) ISCT Paris (France) ArabLab, Dubai (UAE) ETIF Buenos Aires (Argentina) FCE Pharma Sao Paulo (Brazil) Interphex New York (USA) Farmaforum Madrid (Spain) Arablab, Dubai (UAE) Analytica, Munich (Germany) A3P, Lyon (France) Pharma Process, Düsseldorf (Germany) Edited by: AZBIL TELSTAR TECHNOLOGIES, S.L.U. Photographs: AZBIL TELSTAR TECHNOLOGIES, S.L.U. National Book Catalogue Number: B-31419-1999 AZBIL TELSTAR TECHNOLOGIES, S.L.U. Av/ Font i Sagué, 55-08227 Terrassa (España) T +34 937 361 600 F +34 937 861 380 telstar@telstar.com www.telstar.com