Telstar ACE welcomes new Technical Manager
Transcripción
Telstar ACE welcomes new Technical Manager
July 2010 . Number 21 T G ELS RO T A U R P www.telstar.eu Telstar acquires Usifroid and takes a major step into the French market Telstar has acquired French company Usifroid, which is internationally recognized for the development and supply of GMP lyophilizers for the pharmaceutical market. Through this acquisition, on April 9th 2010, Telstar reinforces its position in the international life sciences market and consolidates its position in Europe with a French market share of 80% in freeze drying equipment solutions for the pharmaceutical industry. This acquisition will enable the Telstar Group to pursue its strategic growth plan while providing the backing and financial support to enable Usifroid in France to continue supplying and serving its customers on the French and international markets. Usifroid is internationally renowned for the development of GMP freeze dryers of pharmaceutical applications and is recognized for achievements in the field of innovation, most notably for pioneering and leading the use of liquid nitrogen (LN2) refrigeration technology in freeze drying. The reputation and significance of the Usifroid brand is reflected through the constant references to the activities of the company therefore the Telstar Group will retain the Usifroid brand and Usifroid products in all the markets. Usifroid will continue to provide new equipment under the Usifroid brand, with specifications and features that help characterize and define Usifroid. freeze drying technology, includes a wide range of solutions orientated towards the pharmaceutical industry such as clean air, containment, sterilisation and water treatment. In fact, the Telstar Group is recognized as one of the few companies in the world capable of supplying integrated process solutions through in-house technologies which address the needs of the pharmaceutical industry. The Telstar Group will incorporate the knowhow and experience of Usifroid so that Usifroid equipment becomes an integral part of the Telstar portfolio, which, in addition to Editorial Corporate Management of Key Accounts Life Science Solutions Telstar Group • Telstar reinforces its commercial structure for the life sciences market Back Cover • Exhibitions and Conferences Vacuum Solutions TPro • Telstar Vacuum Solutions supply leak detection equipment for Stirling motors. • Cristalia inaugurates a new multipurpose production plant. • Telstar incorporates Ferran Costas as General Manager of Telstar Vacuum Solutions. • The United Pharmaceutical Technologies Consortium for large process projects in the field of life sciences is being created in Brazil. LABORATORY • Telstar launches new generation of more compact biological safety cabinets that optimize laboratory space. • Telstar introduces into the international market the first minibioreactors allowing multiple simultaneous cell culture trials. PHARMA • Integrating ergonomic trials into the design process. • Telstar ACE welcomes new Technical Manager. • Telstar broadens its industrial freezedryer product range. • Telstar develops isolated lyophilizer loading/unloading system for bulk product. EDITORIAL TPRO Corporate Management of Key Accounts Cristalia inaugurates a new multipurpose production plant Telstar as a strategic technological partner of its clients. The pharmaceutical company Cristalia, founded in 1972 and based in the city of São Paulo, has invested in one of the most modern and innovative drug production plants in Brazil. The globalisation of the market has made commonplace the development of complex projects involving a large number of partners located across a number of countries. Good management of these projects requires the free flow of communication between each and every one of them, along with sound internal co-ordination to achieve the best outcome rapidly and efficiently. The current structure of the Telstar Group, with production plants covering different technologies in various countries with various representatives at the commercial level increases the need for co-ordination to convey information consistently and clearly. It is in this environment that the corporate key account manager is of utmost importance as the link between the client's organisation and Telstar, to provide and ensure communication, knowledge and, in short, client satisfaction. Telstar would like clients to see it as a strategic technological partner and not merely as an equipment and/or services provider. Telstar is growing, its clients are growing and its project base is growing. From this standpoint, the Telstar Group has enhanced its organisational model, placing particular importance on client-based management and the creation of synergies to serve client interests effectively and efficiently. This is an all-embracing function that had hitherto been developing separately but which is now being consolidated at a global level, promoting mutual co-ordination of all the activities of the various Telstar companies and centres in the field of Life Sciences and in particular everything in relation to the pharmaceutical and bio-technology sectors. The main objective is, therefore, client satisfaction through the implementation of procedures to ensure an unrivalled service. The Telstar motto: Focus on the client. Telstar wants to co-ordinate actions and projects and strive to guarantee that information flows correctly, not only within the Telstar organisation, but also to clients. “We will improve clients' knowledge of our organisation and the solutions that we can offer them, improving our knowledge of their organisations and requirements in order to cement the relationship seen in the long term. In short, we aim to create the ability to provide a quality solution that contributes to the growth and development of our clients”. Toni Lorente, Corporate Key Account Manager TELSTAR GROUP Telstar reinforces its commercial structure for the life sciences market To this end, two commercial teams working in the Pharmaceutical Industry and Laboratory fields will be responsible for the promotion and sale of the whole range of equipment, projects, systems and services and will be able to provide complete or individual solutions with a global and process perspective according to market requirements and client needs. Currently, Telstar is one of the few company groups in the world that can provide integrated solutions in the process field for the life sciences market. This new organisation is headed by the Corporate Sales and Marketing Director, Jordi Puig, along with a new management team. The Pharma team includes Toni Lorente as Corporate Major Accounts Director, Jordi Net as Commercial and Marketing Director for Pharmaceutical Industry Teams and Rafael Alvarez de Toledo as Commercial and Marketing Director for Project Development. The Laboratory team consists of Chantal Schoenmaker as Commercial Director for Central and Northern Europe and Roser Dalmau as Commercial Director for the Rest of the World. Cristalia continuously invests in offering innovative products for the Brazilian market. It has registered 117 patent applications and has patents for 21 technologies and 15 drugs, making it the national drug company with the largest number of patents. The management made the decision to expand production capacity five years ago, through the construction of a new unit in Itapira, São Paulo. It will be the second drug production plant on this site, where operation is already underway in the areas of R&D and innovation, biotechnology and pharmaceutics. This is in addition to the current drug plant, 2 which has over 53,000 m of constructed surface. In order to acquire the latest technologies for the new factory, company management participated in various international fairs and technical visits in 2003 and 2004. Through these actions, the company established the highest standards of architectural, material and equipment solutions. Conceptually, the aim was to construct a compact unit, with the maximum level of process optimization and functionality in space. This was achieved by incorporating the most modern concepts and equipment. In the outcome, TPRO was designated by Cristalia as the specialised company for this development. The pharmaceutical 2 plant covers close to 11,800 m of constructed production surface, from 2 which 3,100 m correspond to classified areas, and the rest to technical surfaces and controlled areas. The new facility will allow Cristalia to double its current production capacity. In general terms, there are four specific areas: sterile freeze-dried products, sterile liquids (eyedrops), oral solids and semi-solids (ointments). On the first floor, most of the space is used for the production of freeze-dried (lyophilized) products. This comprises close to 2 1,470 m , 540 of which correspond to classified areas and 930 to non-classified areas. The solids production unit is the largest of all; the production line occupies 2 2,600 m , of which 1,500 correspond to Grade D and the rest to non-classified areas. The new facility of Cristalia is among the most modern and efficient in the world and the final result is a world class production plant. The United Pharmaceutical Technologies Consortium for large process projects in the field of life sciences is being created in Brazil Combining the synergies that exist between Pharmaster, Tpro and SVS will bring greater competitive value to large scale projects in the pharmaceutical industry. The Telstar Group is reinforcing its commercial structure for the Pharmaceutical Industry and Laboratory divisions by incorporating the various commercial teams that hitherto have been separated along product or geographical lines into a single sales and marketing force. This new strategy, which enhances the Group's ability to provide a global response to market requirements, will bring increased efficiency, depth and coverage to the growing presence of the Telstar Group in the international life sciences market. The facility, which was officially inaugurated last March, has increased the production capacity of the company and readied it for further challenges. R. Alvarez de Toledo T. Lorente J. Puig R. Dalmau The companies Pharmaster, Tpro Engenharia do Brasil and SVS Consulting Services have reached an agreement to create the United Pharmaceutical Technologies Consortium in order to provide highly competitive solutions for projects associated with the Life Sciences industries. J. Net The combination of synergies and the complementary attributes of the three companies will enable the rapid development of sound technical solutions for the design, installation, commissioning and evaluation of systems critical to the pharmaceuticals, biotechnologies, cosmetics and veterinary industries, directed in particular towards larger and more complex projects. C. Schoemaker The companies making up the consortium have a substantial penetration and presence in the Brazilian market. Complementary resources and know-how will bring particular benefits to medium and large volume projects, providing competitive advantages derived from the combination of synergies of the three companies. The United Pharmaceutical Technologies Consortium can provide the design, installation, evaluation and commissioning of not only a specific unit, but also a complete plant, including engineering, installation, evaluation and certification and management services. This partnership agreement does not signify the loss of identity of any of the companies making up the consortium. Each one will maintain its independence and its own commitments. In fact, each one of the companies of the consortium will continue to operate autonomously and independently in the market, supporting projects of small and medium sized companies, just as they have been doing up to now. VACUUM SOLUTIONS LIFE SCIENCE SOLUTIONS - Laboratory Efficient Home Energy, belonging to the Mondragón group, manufactures the Stirling energy microgeneration boiler. This is a normal-sized domestic boiler with a combined heat and electricity microgenerating system, running on gas, which besides covering domestic heating and hot water needs also generates electricity. Its impellers are capable of reducing home energy bills by over 20%, and cutting CO2- emissions by up to a tonne a year per household. The Stirling principle comes from an invention in 1816 by a Scottish religious minister of that name. Basically it is a motor which runs on hot air. The expansion induced within a gas moves a working piston which drives a dynamo. With domestic heating boilers, use is made of the combustion exhaust gases which are lost up the flue. The movement of the pistons is converted into electricity generation which is fed into the grid. It is therefore an “energy saving” system which means energy can be saved in every home. Telstar launches new generation of more compact biological safety cabinets that optimize laboratory space ! ew N Telstar Vacuum Solutions supply leak detection equipment for Stirling motors Telstar has released an innovative cabinet design, which maintains work space while making the chassis up to 20% smaller than the market average. Telstar has developed a new generation of biological safety cabinets, which are more compact and optimise the usable work area in laboratories with limited space. Intended for the laminar flow manipulation of microorganisms with biological risk levels 2 and 3, the new range of Telstar Bio II Advance cabinets offers an ergonomic design that adapts easily to small spaces, especially in laboratories with low ceilings and where various pieces of equipment need to be used in the same area. With all the features of a high-end cabinet, the Bio II Advance is designed to protect the user, the sample and the environment, and is notable for its reduced external dimensions while maintaining an optimum inner work space. With a width of 759 mm, the height of the Bio II Advance is up to 20% less than the market average. The Bio II Advance also incorporates improvements in airflow efficiency. The reduction of the air path in an optimised plenum, combined with automatic microprocessor control, keeps the laminar flow constant and avoids energy loss, reducing heat dissipation and extending the useful life of the filter. As for energy efficiency, this range of cabinets has an Eco Mode function, whereby the cabinet can be put on standby, which keeps the sample protected inside the cabinet while the user performs other tasks, saving energy, reducing residual heat and prolonging the useful life of the filters. Finally, in this range of biosafety cabinets, Telstar has incorporated the 4F system (Fast, Friendly and eFFicient), a patented system that makes it possible to replace the filter in just five minutes thanks to quick access via the front of the cabinet. N ew ! Telstar introduces into the international market the first minibioreactors allowing multiple simultaneous cell culture trials Telstar incorporates Ferran Costas as General Manager of Telstar Vacuum Solutions Ferran Costas has joined the Telstar Group as general manager of Telstar Vacuum Solutions. Ferran is a Telecommunications Engineer specialising in the development of specific projects for the aerospace sector, with an MBA from Esden (Madrid). Ferran brings with him a wealth of experience in the design and development of RF/microwave equipment and sub-systems for satellites such as Hispasat-Amazonas, Galileo, SMOS, ICO, Terrestar, Globalstar-2, etc. His professional career includes positions with Mier Communications, which designs and produces radio frequency communication equipment and systems, as well as with Ingenieria de Radiofrecuencias (Radio Frequency Engineering) – IRSA, TRACOR SA, Radiación Microondas SA (Microwave Radiation) – RYMSA, where he acted as deputy general manager, and Arthur Andersen. In his new role with Telstar Vacuum Solutions, Ferran will direct Group strategy in the field of high vacuum and ultra high vacuum project development to consolidate the Group's position in the international market and reinforce the growth plans in the hightechnology energy, aerospace and scientific research industries market. The focus will be on development of high added value products and projects with an engineering and innovation component, specifically in the area of space simulators for space companies, agencies and institutions, and of large scientific installations in various fields: nuclear fusion, particle accelerators (synchrotrons, neutron sources, etc.) and large telescopes (for example, reflector recoating plants). Also, within the framework of this new step, there will be a commitment from Telstar Vacuum Solutions to promote the development of vacuum and high vacuum technology equipment for industrial applications, in particular those incorporating high levels of technology. Telstar has developed a sound track record in the development of space technology, high vacuum and ultra-high vacuum technology following involvement in large scale projects that have taken place in recent years which have earned it international recognition and distinction. Of particular note is its participation in the development of international projects, such as synchrotrons (ESRF, ALBA), space simulation chambers and the experimental nuclear fusion reactor, ITER. In fact, Telstar was the first company in the world to design and manufacture the mechanical manipulator for the future international reactor, ITER and recently developed the largest space simulation chamber in the southern hemisphere for the Government of Brazil (INPE). Telstar is introducing into the market a completely innovative minibioreactor model to perform animal cell culture screening studies on a scale applicable to R&D. Planned for 2010, this equipment will be launched on the market under the brand name of Telstar Hexascreen. It is the first minibioreactor on the market to enable animal cell culture trials and experiments on a scale of 10 to 15 m, with the capacity to handle six cultures at a time, and a workstation accommodating single-use interchangeable plates to guarantee sterility and speed up the start of the bioprocess. The launch of this new bioreactor reinforces Telstar's activity in the field of R&D equipment for biotechnology applications. The new minibioreactor will be included in the technological development line Telstar Cell Culture, where Telstar has plans for future growth. Telstar is currently designing, manufacturing and marketing other equipment designed for pharmaceutical, biotechnological and biomedical research, to which it will be adding the new range of Telstar Hexascreen minibioreactors. The development of these minibioreactors is the result of an alliance of synergies between Telstar and the technology oriented company Hexascreen Culture Technologies, which specializes in bioreactor applications for animal cell based processes, which Telstar recently joined through a shareholding acquisition. Innovative equipment These units offer change of medium, monitoring and control facilities similar to those of laboratory reactors, which enable the collection of information on the main culture variables, such as the temperature, dissolved oxygen/oxygen consumption, pH, optical density and measurement of the spectrum in the visible range, while simultaneously monitoring growth (absorbance) and metabolism (indirectly from acidification/ oxygen consumption). All these features make the Telstar Hexascreen the most innovative equipment for the pharmaceutical and biotechnology industry market and research centers because: • It offers the user reduced cost by being able to carry out the first trials on a minimum scale in order to ensure that the results obtained in its cultures will be reproducible on a production scale. • It speeds up the bioprocess and multiples the opportunities for experimentation by being able to develop six simultaneous cultures. • It facilitates the start of the bioprocess by the use of replaceable plates which ensure sterility, requiring the user merely to inoculate the cultures before placing the plate in the workstation. This innovation overcomes the complexity of use usually found in bioreactors, which involve laborious preparation, sterilization and calibration processes before the start of the cultures, often requiring highly qualified personnel. During 2010, Telstar will develop a new stage in the Telstar Hexascreen minibioreactor by incorporating the fed-batch model for growth and increased productivity of the cell culture. Collaboration with universities and technological leadership Telstar's leadership in the innovation and development of new technologies in the field of life sciences is the result of an ongoing policy of collaboration between the company and the universities and technological centers. In fact Telstar has become part of the Hexascreen Culture Technologies university spinoff, which has an advisory scientific committee formed by researchers connected to the “Universidad Autónoma de Barcelona” and “Universidad Politécnica de Cataluña”. This alliance will enable Telstar to strengthen its ties with the scientific community, identify advances in research and development in the sector, provide guidance on approaches and technological improvements associated with research and development in the sector, and provide guidance on approaches and improve technologies associated with animal cell research in the sectors associated with life sciences. LIFE SCIENCE SOLUTIONS - Pharma LIFE SCIENCE SOLUTIONS - Pharma Integrating ergonomic trials into the design process Telstar develops isolated lyophilizer loading/unloading system for bulk product The Centre of Technology for Telstar's Containment equipment solutions is based in Telstar ACE, in Dewsbury (near Leeds) in the UK. Containment involves separating production operators from the potential hazards of the material being handled, necessitating close attention at the design stage to the human aspects of the process which is to be carried out. Central to the design process is an evaluation of process containment ergonomic issues. In one report a leading pharmaceutical company stated that almost 25% of all lost time illnesses were caused by issues related to ergonomics. Telstar ACE places great emphasis on the need to perform ergonomic trials and recommends they be used at an early stage in projects to identify potential issues prior to designs being frozen. The trials involve construction of a full-scale model of the containment equipment. Representatives of the user-group then configure the model as closely as possible with the required tooling and instruments and perform the process steps on a trial basis. Such models were constructed and utilized in a recently awarded project involving a series of aseptic processing steps for the freeze-drying and final packing of a bulk sterile antibiotic. The production line includes process equipment integrated with RABs and isolator units which assure the ISO 5 environment required. The ergonomic trials for the project were conducted at the Telstar ACE factory in Dewsbury during which all operational and functional requirements were agreed with the client prior to detailed design stage. Telstar ACE welcomes new Technical Manager The ongoing growth of Telstar ACE has necessitated a continuous recruitment drive and the latest addition to the management team is Michael Mellor in the role of Technical Manager at the Telstar ACE centre of technology in Dewsbury, UK. Michael joins the Telstar ACE team from competitor Howorth Air Technology and brings with him over 15 years of experience in the containment industry. Michael has successfully managed large scale installations providing innovative solutions to containment problems for a variety of pharmaceutical clients in various locations around the world, Michael has already been hard at work establishing a program of technical developments focused on improving quality and extending functionality of Telstar ACE isolators from design through manufacturing and assembly methods. Throughout 2010, as part of the Telstar Group R & D plans, Telstar ACE will contribute to the development of a new range of Sterile and Aseptic systems constructed to modular designs with pre-engineered options able to address a broad range of applications. Increasing and developing the engineering capability is also a priority for Michael, who has already brought in additional resource to broadening the experience base of the engineering team. This entire program is bringing fresh and innovative technology to the Telstar ACE portfolio of equipment solutions, helping assure Telstar's reputation as a global leader in the field of containment in the years ahead. Telstar broadens its industrial freeze-dryer product range Telstar has broadened its industrial freeze-dryer product range to better address the increasing diversity of GMP pharmaceutical production on a global scale. The new range of equipment and associated options enable Telstar to more rapidly develop a solution to match a client application. Due to the increasing requirements to automate the loading and unloading of freeze-dryers in combination with the use of isolation technology to protect the operator and help assure aseptic conditions, the freeze-dryer has become only one element of an integrated processing system. Lyonomic 3D image. Telstar is in a unique position to address this demand by bringing together its own in-house technologies in the form of the new Lyomega; a full customized, integrated and automated aseptic freeze-drying solution. At the same time Telstar has recognized that some clients require a more standard approach, so that freeze-drying capacity can be provided quickly and cost effectively. To address this type of applications Telstar has developed the Lyonomic, a new standard series of freeze-dryer which provides a very reliable and proven solution made economical through modular design configurable with a broad range of preengineered options and easy to install. Lyomega and Lyonomic are two new and unique concepts: Lyomega represents complete customized solutions while Lyonomic facilitates cost-effective standard production. Together they provide a broad family of solutions to address all GMP industrial freeze-drying applications in the globally diverse and dynamic pharmaceutical market. Lyomega 3D image. Products processed by lyophilization are becoming increasingly potent, necessitating strict segregation between the operator and the processing area in order to mitigate the health risk. One practical method by which this can be achieved is by placing a physical barrier known as a containment isolator between product and operator. Telstar has just delivered an automated system for the lyophilization of a bulk polypeptide which is hazardous to operators. The system enables an OEL 3 (Operator Exposure Level) of 1 µg/m to be achieved over an eight-hour shift. The system provided is comprised of a GMP productionscale lyophilizer and a loading unloading system housed within a three-chamber mobile Isolator system. After the product has been lyophilized the dry product is removed from the trays using vacuum, which transports the product to a cyclone where it is separated from the airstream and collected in a hopper for transfer to the next step in the production process. Telstar was uniquely suited to providing this system; being able to develop a process solution and then provide all of the required technology using the resources of the Telstar Group. The technology developed is able to be applied to both aseptic and non-aseptic environments and the solution has already attracted the attention of other Telstar clients who have also placed orders for similar equipment. Implementation of this complex integrated project was achieved through the close collaboration of three Telstar Technology Centers: Lyophilization, based in Terrassa, Spain; Containment, based in Dewsbury, UK, and; Loading Systems, based in Bristol, Pennsylvania in the USA. In addition, one of Telstar's partners, the Danish company Flexicon, provided the peristaltic filling technology used to dispense the liquid product into stainless steel trays. 2. The Operator places trays at each of two filling stations within the Transfer Chamber. The trays are automatically filled with the required volume of product and then automatically transferred through the Pizza Door onto the shelf of the Lyophilizer (which is equipped to position each of its shelves at a constant height for loading). This process continues until the entire Lyophilizer has been filled. 3. The Pizza Door is closed and the Lyophilization Cycle is performed. At the end of the cycle the Isolator system is closed (if they were open during the loading process) the environmental control is made operational and a leak test is carried out. 4. The chamber of the Lyophilizer is brought to the same pressure as the Isolator system, the Pizza Door is opened and pairs of trays are automatically removed from the Lyophilizer and positioned in front of the operator. Using a vacuum wand and working through Glove Ports, the Operator removes the dry product from the trays and then places the empty trays into storage racks in the Tray Storage Chambers. Figure 1: The three-chamber mobile Isolator houses the Loading/Unloading System which is shown attached to the front of the Lyophilizer. The central 'Transfer Chamber' contains the mechanisms which automatically transfer the trays of product into and out of the process chamber of the Lyophilizer through an automatic sliding door referred to as a 'Pizza Door'. On each side of the Transfer Chamber are separate 'Tray Storage Chambers'. The Transfer Chamber docks to a flange on the front of the Lyophilizer and is made leak tight by an inflatable gasket. The Tray Storage Chambers are similarly attached to the Transfer Chamber and once connected the three chambers make up the Isolator system, with integrated environmental control provided to all three chambers. product to be handled is safe in liquid form and hazardous only in dry form then it is possible to perform the loading operation without the need for containment.) Figure 2: The internal surfaces of the Loading System are decontaminated using a misting process. 5. This process continues until all of the trays have been removed from the Lyophilizer, after which the Pizza Door is closed. At this point in the process the product has been removed and securely stored. 6. The internal surfaces of the Isolator system and the Lyophilizer are potentially contaminated with hazardous product. While all Chambers are still docked in place and leak-tight the entire internal surface of the equipment and the trays are decontaminated using an atomized misting process (see Figure 2). Any gross spillage of product can be removed by the operator using a hand-held spray nozzle (see Figure 3). Figure 3: Manual cleaning operations. The Process Steps... 1. The Transfer Chamber is docked to the front of the Lyophilizer and in turn the two Tray Storage Chambers are docked to the sides of the Transfer Chamber. (Note: If the 7. The loading equipment has now been made safe and the elements can be undocked for thorough manual cleaning. The Lyophilizer is subjected to fully automated Clean-in-Place and Steam Sterilization cycles. 8. The equipment is now ready for the next production batch. LIFE SCIENCE SOLUTIONS - Pharma LIFE SCIENCE SOLUTIONS - Pharma Integrating ergonomic trials into the design process Telstar develops isolated lyophilizer loading/unloading system for bulk product The Centre of Technology for Telstar's Containment equipment solutions is based in Telstar ACE, in Dewsbury (near Leeds) in the UK. Containment involves separating production operators from the potential hazards of the material being handled, necessitating close attention at the design stage to the human aspects of the process which is to be carried out. Central to the design process is an evaluation of process containment ergonomic issues. In one report a leading pharmaceutical company stated that almost 25% of all lost time illnesses were caused by issues related to ergonomics. Telstar ACE places great emphasis on the need to perform ergonomic trials and recommends they be used at an early stage in projects to identify potential issues prior to designs being frozen. The trials involve construction of a full-scale model of the containment equipment. Representatives of the user-group then configure the model as closely as possible with the required tooling and instruments and perform the process steps on a trial basis. Such models were constructed and utilized in a recently awarded project involving a series of aseptic processing steps for the freeze-drying and final packing of a bulk sterile antibiotic. The production line includes process equipment integrated with RABs and isolator units which assure the ISO 5 environment required. The ergonomic trials for the project were conducted at the Telstar ACE factory in Dewsbury during which all operational and functional requirements were agreed with the client prior to detailed design stage. Telstar ACE welcomes new Technical Manager The ongoing growth of Telstar ACE has necessitated a continuous recruitment drive and the latest addition to the management team is Michael Mellor in the role of Technical Manager at the Telstar ACE centre of technology in Dewsbury, UK. Michael joins the Telstar ACE team from competitor Howorth Air Technology and brings with him over 15 years of experience in the containment industry. Michael has successfully managed large scale installations providing innovative solutions to containment problems for a variety of pharmaceutical clients in various locations around the world, Michael has already been hard at work establishing a program of technical developments focused on improving quality and extending functionality of Telstar ACE isolators from design through manufacturing and assembly methods. Throughout 2010, as part of the Telstar Group R & D plans, Telstar ACE will contribute to the development of a new range of Sterile and Aseptic systems constructed to modular designs with pre-engineered options able to address a broad range of applications. Increasing and developing the engineering capability is also a priority for Michael, who has already brought in additional resource to broadening the experience base of the engineering team. This entire program is bringing fresh and innovative technology to the Telstar ACE portfolio of equipment solutions, helping assure Telstar's reputation as a global leader in the field of containment in the years ahead. Telstar broadens its industrial freeze-dryer product range Telstar has broadened its industrial freeze-dryer product range to better address the increasing diversity of GMP pharmaceutical production on a global scale. The new range of equipment and associated options enable Telstar to more rapidly develop a solution to match a client application. Due to the increasing requirements to automate the loading and unloading of freeze-dryers in combination with the use of isolation technology to protect the operator and help assure aseptic conditions, the freeze-dryer has become only one element of an integrated processing system. Lyonomic 3D image. Telstar is in a unique position to address this demand by bringing together its own in-house technologies in the form of the new Lyomega; a full customized, integrated and automated aseptic freeze-drying solution. At the same time Telstar has recognized that some clients require a more standard approach, so that freeze-drying capacity can be provided quickly and cost effectively. To address this type of applications Telstar has developed the Lyonomic, a new standard series of freeze-dryer which provides a very reliable and proven solution made economical through modular design configurable with a broad range of preengineered options and easy to install. Lyomega and Lyonomic are two new and unique concepts: Lyomega represents complete customized solutions while Lyonomic facilitates cost-effective standard production. Together they provide a broad family of solutions to address all GMP industrial freeze-drying applications in the globally diverse and dynamic pharmaceutical market. Lyomega 3D image. Products processed by lyophilization are becoming increasingly potent, necessitating strict segregation between the operator and the processing area in order to mitigate the health risk. One practical method by which this can be achieved is by placing a physical barrier known as a containment isolator between product and operator. Telstar has just delivered an automated system for the lyophilization of a bulk polypeptide which is hazardous to operators. The system enables an OEL 3 (Operator Exposure Level) of 1 µg/m to be achieved over an eight-hour shift. The system provided is comprised of a GMP productionscale lyophilizer and a loading unloading system housed within a three-chamber mobile Isolator system. After the product has been lyophilized the dry product is removed from the trays using vacuum, which transports the product to a cyclone where it is separated from the airstream and collected in a hopper for transfer to the next step in the production process. Telstar was uniquely suited to providing this system; being able to develop a process solution and then provide all of the required technology using the resources of the Telstar Group. The technology developed is able to be applied to both aseptic and non-aseptic environments and the solution has already attracted the attention of other Telstar clients who have also placed orders for similar equipment. Implementation of this complex integrated project was achieved through the close collaboration of three Telstar Technology Centers: Lyophilization, based in Terrassa, Spain; Containment, based in Dewsbury, UK, and; Loading Systems, based in Bristol, Pennsylvania in the USA. In addition, one of Telstar's partners, the Danish company Flexicon, provided the peristaltic filling technology used to dispense the liquid product into stainless steel trays. 2. The Operator places trays at each of two filling stations within the Transfer Chamber. The trays are automatically filled with the required volume of product and then automatically transferred through the Pizza Door onto the shelf of the Lyophilizer (which is equipped to position each of its shelves at a constant height for loading). This process continues until the entire Lyophilizer has been filled. 3. The Pizza Door is closed and the Lyophilization Cycle is performed. At the end of the cycle the Isolator system is closed (if they were open during the loading process) the environmental control is made operational and a leak test is carried out. 4. The chamber of the Lyophilizer is brought to the same pressure as the Isolator system, the Pizza Door is opened and pairs of trays are automatically removed from the Lyophilizer and positioned in front of the operator. Using a vacuum wand and working through Glove Ports, the Operator removes the dry product from the trays and then places the empty trays into storage racks in the Tray Storage Chambers. Figure 1: The three-chamber mobile Isolator houses the Loading/Unloading System which is shown attached to the front of the Lyophilizer. The central 'Transfer Chamber' contains the mechanisms which automatically transfer the trays of product into and out of the process chamber of the Lyophilizer through an automatic sliding door referred to as a 'Pizza Door'. On each side of the Transfer Chamber are separate 'Tray Storage Chambers'. The Transfer Chamber docks to a flange on the front of the Lyophilizer and is made leak tight by an inflatable gasket. The Tray Storage Chambers are similarly attached to the Transfer Chamber and once connected the three chambers make up the Isolator system, with integrated environmental control provided to all three chambers. product to be handled is safe in liquid form and hazardous only in dry form then it is possible to perform the loading operation without the need for containment.) Figure 2: The internal surfaces of the Loading System are decontaminated using a misting process. 5. This process continues until all of the trays have been removed from the Lyophilizer, after which the Pizza Door is closed. At this point in the process the product has been removed and securely stored. 6. The internal surfaces of the Isolator system and the Lyophilizer are potentially contaminated with hazardous product. While all Chambers are still docked in place and leak-tight the entire internal surface of the equipment and the trays are decontaminated using an atomized misting process (see Figure 2). Any gross spillage of product can be removed by the operator using a hand-held spray nozzle (see Figure 3). Figure 3: Manual cleaning operations. The Process Steps... 1. The Transfer Chamber is docked to the front of the Lyophilizer and in turn the two Tray Storage Chambers are docked to the sides of the Transfer Chamber. (Note: If the 7. The loading equipment has now been made safe and the elements can be undocked for thorough manual cleaning. The Lyophilizer is subjected to fully automated Clean-in-Place and Steam Sterilization cycles. 8. The equipment is now ready for the next production batch. VACUUM SOLUTIONS LIFE SCIENCE SOLUTIONS - Laboratory Efficient Home Energy, belonging to the Mondragón group, manufactures the Stirling energy microgeneration boiler. This is a normal-sized domestic boiler with a combined heat and electricity microgenerating system, running on gas, which besides covering domestic heating and hot water needs also generates electricity. Its impellers are capable of reducing home energy bills by over 20%, and cutting CO2- emissions by up to a tonne a year per household. The Stirling principle comes from an invention in 1816 by a Scottish religious minister of that name. Basically it is a motor which runs on hot air. The expansion induced within a gas moves a working piston which drives a dynamo. With domestic heating boilers, use is made of the combustion exhaust gases which are lost up the flue. The movement of the pistons is converted into electricity generation which is fed into the grid. It is therefore an “energy saving” system which means energy can be saved in every home. Telstar launches new generation of more compact biological safety cabinets that optimize laboratory space ! ew N Telstar Vacuum Solutions supply leak detection equipment for Stirling motors Telstar has released an innovative cabinet design, which maintains work space while making the chassis up to 20% smaller than the market average. Telstar has developed a new generation of biological safety cabinets, which are more compact and optimise the usable work area in laboratories with limited space. Intended for the laminar flow manipulation of microorganisms with biological risk levels 2 and 3, the new range of Telstar Bio II Advance cabinets offers an ergonomic design that adapts easily to small spaces, especially in laboratories with low ceilings and where various pieces of equipment need to be used in the same area. With all the features of a high-end cabinet, the Bio II Advance is designed to protect the user, the sample and the environment, and is notable for its reduced external dimensions while maintaining an optimum inner work space. With a width of 759 mm, the height of the Bio II Advance is up to 20% less than the market average. The Bio II Advance also incorporates improvements in airflow efficiency. The reduction of the air path in an optimised plenum, combined with automatic microprocessor control, keeps the laminar flow constant and avoids energy loss, reducing heat dissipation and extending the useful life of the filter. As for energy efficiency, this range of cabinets has an Eco Mode function, whereby the cabinet can be put on standby, which keeps the sample protected inside the cabinet while the user performs other tasks, saving energy, reducing residual heat and prolonging the useful life of the filters. Finally, in this range of biosafety cabinets, Telstar has incorporated the 4F system (Fast, Friendly and eFFicient), a patented system that makes it possible to replace the filter in just five minutes thanks to quick access via the front of the cabinet. N ew ! Telstar introduces into the international market the first minibioreactors allowing multiple simultaneous cell culture trials Telstar incorporates Ferran Costas as General Manager of Telstar Vacuum Solutions Ferran Costas has joined the Telstar Group as general manager of Telstar Vacuum Solutions. Ferran is a Telecommunications Engineer specialising in the development of specific projects for the aerospace sector, with an MBA from Esden (Madrid). Ferran brings with him a wealth of experience in the design and development of RF/microwave equipment and sub-systems for satellites such as Hispasat-Amazonas, Galileo, SMOS, ICO, Terrestar, Globalstar-2, etc. His professional career includes positions with Mier Communications, which designs and produces radio frequency communication equipment and systems, as well as with Ingenieria de Radiofrecuencias (Radio Frequency Engineering) – IRSA, TRACOR SA, Radiación Microondas SA (Microwave Radiation) – RYMSA, where he acted as deputy general manager, and Arthur Andersen. In his new role with Telstar Vacuum Solutions, Ferran will direct Group strategy in the field of high vacuum and ultra high vacuum project development to consolidate the Group's position in the international market and reinforce the growth plans in the hightechnology energy, aerospace and scientific research industries market. The focus will be on development of high added value products and projects with an engineering and innovation component, specifically in the area of space simulators for space companies, agencies and institutions, and of large scientific installations in various fields: nuclear fusion, particle accelerators (synchrotrons, neutron sources, etc.) and large telescopes (for example, reflector recoating plants). Also, within the framework of this new step, there will be a commitment from Telstar Vacuum Solutions to promote the development of vacuum and high vacuum technology equipment for industrial applications, in particular those incorporating high levels of technology. Telstar has developed a sound track record in the development of space technology, high vacuum and ultra-high vacuum technology following involvement in large scale projects that have taken place in recent years which have earned it international recognition and distinction. Of particular note is its participation in the development of international projects, such as synchrotrons (ESRF, ALBA), space simulation chambers and the experimental nuclear fusion reactor, ITER. In fact, Telstar was the first company in the world to design and manufacture the mechanical manipulator for the future international reactor, ITER and recently developed the largest space simulation chamber in the southern hemisphere for the Government of Brazil (INPE). Telstar is introducing into the market a completely innovative minibioreactor model to perform animal cell culture screening studies on a scale applicable to R&D. Planned for 2010, this equipment will be launched on the market under the brand name of Telstar Hexascreen. It is the first minibioreactor on the market to enable animal cell culture trials and experiments on a scale of 10 to 15 m, with the capacity to handle six cultures at a time, and a workstation accommodating single-use interchangeable plates to guarantee sterility and speed up the start of the bioprocess. The launch of this new bioreactor reinforces Telstar's activity in the field of R&D equipment for biotechnology applications. The new minibioreactor will be included in the technological development line Telstar Cell Culture, where Telstar has plans for future growth. Telstar is currently designing, manufacturing and marketing other equipment designed for pharmaceutical, biotechnological and biomedical research, to which it will be adding the new range of Telstar Hexascreen minibioreactors. The development of these minibioreactors is the result of an alliance of synergies between Telstar and the technology oriented company Hexascreen Culture Technologies, which specializes in bioreactor applications for animal cell based processes, which Telstar recently joined through a shareholding acquisition. Innovative equipment These units offer change of medium, monitoring and control facilities similar to those of laboratory reactors, which enable the collection of information on the main culture variables, such as the temperature, dissolved oxygen/oxygen consumption, pH, optical density and measurement of the spectrum in the visible range, while simultaneously monitoring growth (absorbance) and metabolism (indirectly from acidification/ oxygen consumption). All these features make the Telstar Hexascreen the most innovative equipment for the pharmaceutical and biotechnology industry market and research centers because: • It offers the user reduced cost by being able to carry out the first trials on a minimum scale in order to ensure that the results obtained in its cultures will be reproducible on a production scale. • It speeds up the bioprocess and multiples the opportunities for experimentation by being able to develop six simultaneous cultures. • It facilitates the start of the bioprocess by the use of replaceable plates which ensure sterility, requiring the user merely to inoculate the cultures before placing the plate in the workstation. This innovation overcomes the complexity of use usually found in bioreactors, which involve laborious preparation, sterilization and calibration processes before the start of the cultures, often requiring highly qualified personnel. During 2010, Telstar will develop a new stage in the Telstar Hexascreen minibioreactor by incorporating the fed-batch model for growth and increased productivity of the cell culture. Collaboration with universities and technological leadership Telstar's leadership in the innovation and development of new technologies in the field of life sciences is the result of an ongoing policy of collaboration between the company and the universities and technological centers. In fact Telstar has become part of the Hexascreen Culture Technologies university spinoff, which has an advisory scientific committee formed by researchers connected to the “Universidad Autónoma de Barcelona” and “Universidad Politécnica de Cataluña”. This alliance will enable Telstar to strengthen its ties with the scientific community, identify advances in research and development in the sector, provide guidance on approaches and technological improvements associated with research and development in the sector, and provide guidance on approaches and improve technologies associated with animal cell research in the sectors associated with life sciences. EDITORIAL TPRO Corporate Management of Key Accounts Cristalia inaugurates a new multipurpose production plant Telstar as a strategic technological partner of its clients. The pharmaceutical company Cristalia, founded in 1972 and based in the city of São Paulo, has invested in one of the most modern and innovative drug production plants in Brazil. The globalisation of the market has made commonplace the development of complex projects involving a large number of partners located across a number of countries. Good management of these projects requires the free flow of communication between each and every one of them, along with sound internal co-ordination to achieve the best outcome rapidly and efficiently. The current structure of the Telstar Group, with production plants covering different technologies in various countries with various representatives at the commercial level increases the need for co-ordination to convey information consistently and clearly. It is in this environment that the corporate key account manager is of utmost importance as the link between the client's organisation and Telstar, to provide and ensure communication, knowledge and, in short, client satisfaction. Telstar would like clients to see it as a strategic technological partner and not merely as an equipment and/or services provider. Telstar is growing, its clients are growing and its project base is growing. From this standpoint, the Telstar Group has enhanced its organisational model, placing particular importance on client-based management and the creation of synergies to serve client interests effectively and efficiently. This is an all-embracing function that had hitherto been developing separately but which is now being consolidated at a global level, promoting mutual co-ordination of all the activities of the various Telstar companies and centres in the field of Life Sciences and in particular everything in relation to the pharmaceutical and bio-technology sectors. The main objective is, therefore, client satisfaction through the implementation of procedures to ensure an unrivalled service. The Telstar motto: Focus on the client. Telstar wants to co-ordinate actions and projects and strive to guarantee that information flows correctly, not only within the Telstar organisation, but also to clients. “We will improve clients' knowledge of our organisation and the solutions that we can offer them, improving our knowledge of their organisations and requirements in order to cement the relationship seen in the long term. In short, we aim to create the ability to provide a quality solution that contributes to the growth and development of our clients”. Toni Lorente, Corporate Key Account Manager TELSTAR GROUP Telstar reinforces its commercial structure for the life sciences market To this end, two commercial teams working in the Pharmaceutical Industry and Laboratory fields will be responsible for the promotion and sale of the whole range of equipment, projects, systems and services and will be able to provide complete or individual solutions with a global and process perspective according to market requirements and client needs. Currently, Telstar is one of the few company groups in the world that can provide integrated solutions in the process field for the life sciences market. This new organisation is headed by the Corporate Sales and Marketing Director, Jordi Puig, along with a new management team. The Pharma team includes Toni Lorente as Corporate Major Accounts Director, Jordi Net as Commercial and Marketing Director for Pharmaceutical Industry Teams and Rafael Alvarez de Toledo as Commercial and Marketing Director for Project Development. The Laboratory team consists of Chantal Schoenmaker as Commercial Director for Central and Northern Europe and Roser Dalmau as Commercial Director for the Rest of the World. Cristalia continuously invests in offering innovative products for the Brazilian market. It has registered 117 patent applications and has patents for 21 technologies and 15 drugs, making it the national drug company with the largest number of patents. The management made the decision to expand production capacity five years ago, through the construction of a new unit in Itapira, São Paulo. It will be the second drug production plant on this site, where operation is already underway in the areas of R&D and innovation, biotechnology and pharmaceutics. This is in addition to the current drug plant, 2 which has over 53,000 m of constructed surface. In order to acquire the latest technologies for the new factory, company management participated in various international fairs and technical visits in 2003 and 2004. Through these actions, the company established the highest standards of architectural, material and equipment solutions. Conceptually, the aim was to construct a compact unit, with the maximum level of process optimization and functionality in space. This was achieved by incorporating the most modern concepts and equipment. In the outcome, TPRO was designated by Cristalia as the specialised company for this development. The pharmaceutical 2 plant covers close to 11,800 m of constructed production surface, from 2 which 3,100 m correspond to classified areas, and the rest to technical surfaces and controlled areas. The new facility will allow Cristalia to double its current production capacity. In general terms, there are four specific areas: sterile freeze-dried products, sterile liquids (eyedrops), oral solids and semi-solids (ointments). On the first floor, most of the space is used for the production of freeze-dried (lyophilized) products. This comprises close to 2 1,470 m , 540 of which correspond to classified areas and 930 to non-classified areas. The solids production unit is the largest of all; the production line occupies 2 2,600 m , of which 1,500 correspond to Grade D and the rest to non-classified areas. The new facility of Cristalia is among the most modern and efficient in the world and the final result is a world class production plant. The United Pharmaceutical Technologies Consortium for large process projects in the field of life sciences is being created in Brazil Combining the synergies that exist between Pharmaster, Tpro and SVS will bring greater competitive value to large scale projects in the pharmaceutical industry. The Telstar Group is reinforcing its commercial structure for the Pharmaceutical Industry and Laboratory divisions by incorporating the various commercial teams that hitherto have been separated along product or geographical lines into a single sales and marketing force. This new strategy, which enhances the Group's ability to provide a global response to market requirements, will bring increased efficiency, depth and coverage to the growing presence of the Telstar Group in the international life sciences market. The facility, which was officially inaugurated last March, has increased the production capacity of the company and readied it for further challenges. R. Alvarez de Toledo T. Lorente J. Puig R. Dalmau The companies Pharmaster, Tpro Engenharia do Brasil and SVS Consulting Services have reached an agreement to create the United Pharmaceutical Technologies Consortium in order to provide highly competitive solutions for projects associated with the Life Sciences industries. J. Net The combination of synergies and the complementary attributes of the three companies will enable the rapid development of sound technical solutions for the design, installation, commissioning and evaluation of systems critical to the pharmaceuticals, biotechnologies, cosmetics and veterinary industries, directed in particular towards larger and more complex projects. C. Schoemaker The companies making up the consortium have a substantial penetration and presence in the Brazilian market. Complementary resources and know-how will bring particular benefits to medium and large volume projects, providing competitive advantages derived from the combination of synergies of the three companies. The United Pharmaceutical Technologies Consortium can provide the design, installation, evaluation and commissioning of not only a specific unit, but also a complete plant, including engineering, installation, evaluation and certification and management services. This partnership agreement does not signify the loss of identity of any of the companies making up the consortium. Each one will maintain its independence and its own commitments. In fact, each one of the companies of the consortium will continue to operate autonomously and independently in the market, supporting projects of small and medium sized companies, just as they have been doing up to now. EXHIBITIONS AND CONFERENCES Conferencia Farmacéutica, Lodz PharmTech, Moscow Biotechnica, Hannover Analytica, Munich Congreso de Ingeniería Hospitalaria, Santiago de Compostela SECAL Congress, Salamanca VWR European Interphex NYC, Sales Meeting, Madrid Nueva York International ISPE CASA, Congress on Raleigh Occupational Risk on Health Care Sector, Madrid ASEBIR, Interphex Congress Puerto Rico, Valencia San Juan ISPE Annual Meeting, San Diego June 2010 . Number 21 Powtex, Osaka www.telstar.eu China Pharm, Shanghai ArabLab, Dubai P-MEC, Mumbai T G ELS RO T A U R P Bio International Convention, Chicago (USA) Telstar has acquired French company Usifroid, which is internationally recognized for the development and supply of GMP lyophilizers for the pharmaceutical market. FCE Pharma, Sao Paulo (Brazil) Expo Arpia, Buenos Aires 2010 • Interphex Puerto Rico: 4 - 5 March, San Juan (Puerto Rico) • ISPE CASA: 23 March, Raleigh (EEUU) Through this acquisition, on April 9th 2010, Telstar reinforces its position in the international life sciences market and consolidates its position in Europe with a French market share of 80% in freeze drying equipment solutions for the pharmaceutical industry. • Analytica Munich: 23 - 26 March, Munich (Germany) • Bio International Convention: 3 - 6 May, Chicago (USA) • FCE Pharma: 25 - 27 May, Sao Paulo (Brazil) • Interphex NYC: 20 - 22 April, New York (EEUU) • ArabLab: 9 - 12 January , Dubai (UAE) • VWR European Sales Meeting: 22 - 23 January, Madrid (España) Coming Exhibitions June 2010 M 7 September 2010 T W T F S S 1 2 3 4 5 6 8 9 10 11 12 13 14 15 16 17 18 19 20 M 6 T 7 Telstar acquires Usifroid and takes a major step into the French market October 2010 W T F S S 1 2 3 4 5 8 9 10 11 12 Analytica China, Shanghai (China) M 4 T 5 W 6 T 7 F S S 1 2 3 8 9 10 Chillventa, Nuremberg (Germany) 13 14 15 16 17 18 19 11 12 13 14 15 16 17 21 22 23 24 25 26 27 20 21 22 23 24 25 26 18 19 20 21 22 23 24 28 29 30 27 28 29 30 Expopack, Mexico D.F. (Mexico) This acquisition will enable the Telstar Group to pursue its strategic growth plan while providing the backing and financial support to enable Usifroid in France to continue supplying and serving its customers on the French and international markets. Usifroid is internationally renowned for the development of GMP freeze dryers of pharmaceutical applications and is recognized for achievements in the field of innovation, most notably for pioneering and leading the use of liquid nitrogen (LN2) refrigeration technology in freeze drying. The reputation and significance of the Usifroid brand is reflected through the constant references to the activities of the company therefore the Telstar Group will retain the Usifroid brand and Usifroid products in all the markets. Usifroid will continue to provide new equipment under the Usifroid brand, with specifications and features that help characterize and define Usifroid. freeze drying technology, includes a wide range of solutions orientated towards the pharmaceutical industry such as clean air, containment, sterilisation and water treatment. In fact, the Telstar Group is recognized as one of the few companies in the world capable of supplying integrated process solutions through in-house technologies which address the needs of the pharmaceutical industry. The Telstar Group will incorporate the knowhow and experience of Usifroid so that Usifroid equipment becomes an integral part of the Telstar portfolio, which, in addition to Farma Cosmetica, Bogota (Colombia) Process Teknik, Goteburgo (Sweden) 25 26 27 28 29 30 31 China Pharm, Pekin (China) Editorial Corporate Management of Key Accounts Life Science Solutions Telstar Group • Telstar reinforces its commercial structure for the life sciences market Back Cover • Exhibitions and Conferences BioChicago 2010. Edited by: TELSTAR TECHNOLOGIES, S.L. Photographs: TELSTAR TECHNOLOGIES, S.L National Book Catalogue Number: B-31419-1999 ArabLab 2010. TELSTAR TECHNOLOGIES S.L. Av. Font i Sagué, 55 - 08227 Terrassa (Spain) T +34 937 361 600 F +34 937 859 342 [email protected] – www.telstar.eu Analytica Munich 2010. Vacuum Solutions TPro • Telstar Vacuum Solutions supply leak detection equipment for Stirling motors. • Cristalia inaugurates a new multipurpose production plant. • Telstar incorporates Ferran Costas as General Manager of Telstar Vacuum Solutions. • The United Pharmaceutical Technologies Consortium for large process projects in the field of life sciences is being created in Brazil. LABORATORY • Telstar launches new generation of more compact biological safety cabinets that optimize laboratory space. • Telstar introduces into the international market the first minibioreactors allowing multiple simultaneous cell culture trials. PHARMA • Integrating ergonomic trials into the design process. • Telstar ACE welcomes new Technical Manager. • Telstar broadens its industrial freezedryer product range. • Telstar develops isolated lyophilizer loading/unloading system for bulk product.