Aseptic Barrier Systems
6Pages

From full filling lines to stand alone single Isolators, barrier systems are designed to provide solutions adhering to regulatory standards and guidelines. Running at positive pressure during normal conditions with auto change to negative in the unlikely event of system breech, when toxic products are involved. Full consideration and design planning is applied to the product and equipment entry and exit from the system to ensure the aseptic conditions are maintained throughout the process. Scope Mobile transfer systems/carts are available with dedicated air handling capabilities. Providing a ISO 5 aseptic environment the cart is complete with a shelf indexing arrangement for the loading/ unloading and transfer of sterile trays from the tray sterilising tunnel to the process Barrier/Isolator. The carts feature a connection port with an inflatable seal, docking takes place under the Isolators unidirectional flow canopy to ensure aseptic conditions. The carts also feature connections and necessary valve arrangement to allow bio-decontamination via a hydrogen peroxide generator. Mobile transfers Fully Compliant Telstar Aseptic Barrier Isolation Systems Telstar Aseptic Barrier Systems are guaranteed to comply with relevant standards and demands set by the regulatory bodies to ensure conformance and clients satisfaction, including: Designed for sterile product and Potent API’s either with low or high OEL requirements. Airflow systems may be uni-directional or turbulent. Interfaced with H2O2 generators to provide validated automated surface sterilisation internal to the Isolator. • ISO 14644-1 Cleanroom & Associated Controlled Environment • FS 209E Airborne Particulate Cleanliness • cGMP Guidelines (current Good Manufacturing Practices) • ISPE guidelines (The Society of Pharmaceutical and Medical Device Professionals) • FDA (Food and Drug Administration • MCA (Medical Control Agency) • American Glovebox Society Guidelines • Autoclave Interface Purpose designed screens ensure Telstar systems are user friendly, whilst availability of password controlled access to different user levels and customisation of operation parameters allow secure management according to client protocols and company quality procedures. Control Systems • Liquid & Powder Filling (vials & trays) Telstar contained transfer system (CTS), independently tested to below 5 nanograms offers ultimate safety, simplicity of operation and is easy to decontaminate. • Lyophiliser Auto Load & Un-Load • Product Transfer • Dirty Tray transfer, Wetting & Removal • Bulk Powder Filling (into kegs) • Bunging / Stoppering / Crimping • Over bagging & Heat Sealing Telstar provides a comprehensive validation service to clients providing FAT/SAT/DQ/IQ/OQ & PQ protocols if required. Telstar Aseptic Barrier systems are supplied with PLC control platforms supported by the latest software and Human machine Interface. The HMI provides full integration with the process equipment. Contained transfer • Sterility Testing Telstar’s standard range of five Sterility Test Isolators are designed to accommodate the rising demand within the Pharmaceutical industry and can be supplied with various industry standard decontamination generators according to choice. Telstar, the only international company offering a complete aseptic production process for the pharmaceutical industry worldwide utilizing in-house technology. Providing product protection in all process areas against external environment, operator and bacterial growth contamination. The active port can be used with a passive canister or bag in/ bag out grommet connection. The purpose of the port is to allow aseptic transfer of materials to and from the Isolator or waste out of the Isolator in a controlled manner, ensuring the integrity of the Isolators internal environment remains intact at all times. Sterility testing Telstar also offers its own in house plasma charged bio-decontamination system, which was developed by Telstar for use in Isolators, providing a unique cost effective alternative. For more information on this range please refer to Telstar’s dedicated brochure available for download from the website. The production site where the products are made has been assessed and given ISO 9001:2008 approval. Designed, manufactured and supplied - high quality integrated systems offering: All equipment is manufactured to allow it to be CE marked in accordance with 98/37/EC Machinery Directive. • Increased efficiency • Automation • Flexibility • Protected critical zones • Environment free from pathogenic micro organisms Custom systems both large & small designed to specific client requirements operating at positive pressure and having controlled environmental internal conditions. Unit 4, Shaw Cross Business Park Dewsbury West Yorkshire WF12 7RF (UK) T. + 44 (0) 1924 455 339 F. + 44 (0) 1924 452 295 BR-ASEPTIC-BARRIER-SYSTEMS-EN-1113 Telstar reserves the right to improvements and specifications changes without notice. Aseptic Barrier Systems

Vacuum transfer chamber Operators work through gloves using a vacuum lance to aseptically transfer the freeze dried product from trays, via a high efficiency cyclone transfer system mounted on a frame above the receiving IBC. 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...

From full filling lines to stand alone single Isolators, barrier systems are designed to provide solutions adhering to regulatory standards and guidelines. Running at positive pressure during normal conditions with auto change to negative in the unlikely event of system breech, when toxic products are involved. Full consideration and design planning is applied to the product and equipment entry and exit from the system to ensure the aseptic conditions are maintained throughout the process. Scope Mobile transfer systems/carts are available with dedicated air handling capabilities. Providing...