Containment Barrier Systems

Transcription

1 Containment Barrier Systems

2 As an international leader, focused on Quality, Telstar partners with clients to provide high value on a global basis through innovation, advanced technology, absolute reliability and expert project management. In house expertise in design (strengthened with 3D design skills) and manufacture of innovative/custom Barrier Isolation equipment, which requires research and development skills on a day to day basis. Telstar is constantly adapting and addressing ever changing industry needs, evolving inline with government regulations and industry standards. Recognised Leaders in Containment Barrier Technology Telstar rises to demands in pharmaceutical Containment Barrier Isolation equipment, providing solutions for specific challenges presented by clients individual requirements. Containment is an ever more important part of any pharmaceutical process. A clear understanding of the process is paramount to its success. Telstar Life Sciences UK Ltd, is the centre of excellence for the Barrier Containment Isolation technology of Telstar. Attention to detail makes all the difference when designing the right solution. Telstars hallmark at every stage: Exacting attention to detail and getting to know the process. Evaluating and understanding process equipment operations containment ergonomic issues, and stringent ergonomic trials are critical elements to success. Identifying critical issues and preventing potentially costly problems before they occur. A leading pharmaceutical company report stated almost 25% of all lost time illnesses were caused by ergonomic related issues. Telstar put great emphasis on the need to perform ergonomic trials, at the onset of all projects, to identify issues and prevent them becoming a problem. Models together with trials serve to simulate the process operations involved. Supported by continual investment in 3D software technology operated by design personnel from an engineering background. 3D design provides a clearer visualisation of the entire project preventing clashes and accurate production of 2D drawing elevations.

3 Dispensing & Transfer Isolators with WIP/DIP Skid Fully Compliant Telstar Containment Systems are guaranteed to comply with relevant standards and demands set by the regulatory bodies to ensure conformance and clients satisfaction, including: ISO Cleanroom & Associated Controlled Environment FS 209E Airborne Particulate Cleanliness cgmp Guidelines (current Good Manufacturing Practices) FDA (Food and Drug Administration) MCA (Medical Control Agency) ISPE guidelines (The Society of Pharmaceutical and Medical Device Professionals) American Glovebox Society Guidelines FDA 21CFR Part 11 Telstar provides a comprehensive validation service to clients providing FAT/SAT/DQ/IQ/OQ & PQ protocols if required. Telstar Barrier Containment Isolation Designed to provide operator protection from airborne particles and Potent APIs for a wide range of process applications, with and without integrated process equipment including: Dispensing / Weighing / Sampling Sieving / Blending Charging / API Addition Mixing / Granulation Centrifuge Freeze Dryer Off-Load / Pack-Off Filter Dryer Off-Load / Pack-Off Milling / Micronising Tabletting Final Packing / Blister Pack Isolators for API s and cytotoxic compounds have been independently verified to achieve operator protection levels down to 0.2ng/m3 ( µg/m3) With the accelerated production of highly potent pharmaceutical drugs, the need for containment technology and interest in Isolators is on the increase. Telstar has the expertise to meet the rising challenges by offering an impressive range of containment Isolators, from single chambers to multi chamber systems accommodating where necessary a wide range of process equipment. Telstar Isolators are designed to provide a locally controlled environment operating at negative pressure, with the ability to control and monitor all operating parameters. Providing protection to the operator and the external environment from the highly potent products. Designed, manufactured, supplied and installed - high quality stand alone or integrated systems with or without process equipment, offering cost efficient customised and standard solutions. Multi Chamber Weighing, Dispensing & Sampling Isolator

4 The Telstar Standard Range offers a choice of single working chambers featuring 2/3/4 glove port access. These standard ergonomically trialled base designs customised with various accessories provide cost effective tailored solutions to optimise capital outlay. The addition of a transfer chamber increases the flexibility for small scale processes such as: weighing, dispensing, sampling, charging, milling/ sieving, testing. Standard Range At Telstar we are alert to the vast requirements of the Pharmaceutical Industry and the ever increasing demand to provide cost efficient solutions for both small and large scale containment projects. Powder handling of HPAPI/API product is an area which constantly presents new challenges to safeguard the operator during pharmaceutical drug production. Telstar showcases simplicity at it s finest with regards to a Standard Range of containment Isolators. For more innovative/custom Barrier Isolation solutions Telstar offer purpose designed Isolators. Telstar excels in providing complete systems with fully integrated process equipment and specialised internal environment conditions to suit specific production requirements. R+D Laboratory Isolator Lab scale production of highly potent intermediates and active ingredients often require an extensive range of bench mounted process equipment to carry out procedures such as filtration and solution preparation. This Isolator was supplied fully integrated with lab scale glass reactors, complete with stirrer motor, glass condenser and cooling/heating via thermostat control and evaporator equipped with vacuum pump. Fully GMP compliant, the high specification of the Isolator system eliminates the need for part of the production to be carried out in clean room conditions and reduces time consuming gowning up procedures.

5 Custom built Formulation Isolator interfaced with a fixed glass lined reactor vessel located at the rear. Formulation Isolator Access to glove ports assisted by operator platform designed for hard fixing to facility wall. Fully integrated internal weigh system and external vessel load cells allows powder product to be weighed before being charged into reactor. Some liquefied products, which may be harmless to the operator before the lyophilising process, may present an issue in powder format due to it s toxic content. Interfacing with a containment Isolator then becomes paramount for operator protection. Tray storage carts are used for transfer of autoclaved trays to the Isolator for filling/loading & removal of used trays. Lyophiliser Tray Load/ Unload Isolator The Telstar automatic tray load/unload system (ATLUS) facilitates the loading and unloading of trays filled with liquefied product into the Telstar Lyophiliser. Successful design and manufacture of production scale containment systems demand a complete understanding of the actual process. Telstar has accumulated over 20 years experience specialising in providing high level customised systems to ISO 7 & ISO 8 classification. Running at negative pressure to the surrounding environment/room to provide operator protection during manual handling operations. Electrically controlled raise / lower operator platform, provides a comfortable ergonomic working position throughout the process operations. Multi Chamber Sub-division, Dispensing & Sampling Isolator For high containment multiple drum batch campaigns a rear chamber is recommended with automatic drum manipulation. Available in electric or pneumatic versions.

6 Product loading is a critical process in all barrier containment systems. At Telstar we are familiar with the many specific requirements and challenges presented during Pharmaceutical API production. Drum loading via an inflatable seal with an internal door is just one of a variety of solutions available, providing an airtight seal to ensure the integrity of the Isolators internal negative pressure conditions. PLC based control systems utilising a Siemens PLC platform is offered as standard complete with I/O according the specific equipment providing a fully automated system, supported by Ethernet communication enabling critical parameters to be communicated to an external DCS system. A fully compatible Touch Panel HMI provides operator interface, for control, indications, display of Isolator conditions and alarm handling. Located in a suitable position on the Isolator service plenum it is easy to reach and observe by operators. The Telstar Glove Tester device enables both in situ and off line testing of gloves, if fitted to a Telstar glove ring. This simple device works solely on air to test the glove integrity. The system consists of a glove port test plug with inflatable seal, which is inserted into the glove port. The seal is inflated making an air tight seal to the glove port. The glove is inflated to a test pressure and the pressure decay of the glove is monitored over a period of time. At the end of this test period the pressure decay is recorded and the leakage rate of the glove determined. The Telstar Glove Tester is available as an integrated device (Isolator dedicated) and alternatively a mobile device to serve multiple Isolators. Telstar contained transfer system (CTS), independently tested to below 0.2 nanograms offers ultimate safety, simplicity of operation and is easy to decontaminate. The active port is designed to be used with a passive canister and or bag in / bag out grommet connection. The purpose of the port is to allow contained transfer of materials to and from the Isolator or waste out of the Isolator in a controlled manner, without breaking containment, ensuring operator protection from the internal environment at all times. Spray guns and rotating spray balls for WIP are offered as an option for manual cleaning / decontamination of the Isolator. Available in PFA or stainless steel the wash guns are suitable for use in all Telstar Isolators handling pharmaceutical compounds. Triclover service entries complete with manually operated ball valves will be supplied in the wall of the Isolator for connection of the clients WIP media and in the base of the Isolator for connection of the clients WIP drain outlet. The production site where the products are made has been assessed and given ISO 9001:2008 approval All equipment is manufactured to allow it to be CE marked in accordance with 98/37/EC Machinery Directive. ISO 9001: Certified Company BR-CONTAINMENT-BARRIER-SYSTEMS-EN-0214 Telstar reserves the right to improvements and specifications changes without notice. Unit 4, Shaw Cross Business Park Dewsbury West Yorkshire WF12 7RF (UK) T (0) F (0) Headquarters Av. Font i Sagué, Terrassa (Spain) T F Grundy s Lane Bristol PA 19007, USA T +1 (215) F +1 (215)