Designed for sterile product and Potent API’s either with low or high OEL requirements.
The aseptic barrier systems from Telstar Life-Sciences work providing product protection in all process areas against external environment, operator and bacterial growth contamination. Airflow systems may be unidirectional or turbulent. Interfaced with H2O2 generators to provide validated automated surface sterilization internal to the Isolator.
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.
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: 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), and American Glovebox Society Guidelines.
Telstar Life Science Solutions designs and manufactures GMP lyophilizers with integrated automatic loading/unloading systems, equipment for contamination control and production of water for injection and pure steam, moist heat autoclaves, dry heat ovens, water stills, pure steam generators, industrial down-flow booths, containment isolators and weighing cabinets.