GE Healthcare's PolyVENT and SteriVENT
These devices contain a built-in hydrophobic 0.2 μm PTFE membrane, which retains > 107 CFU/cm2 Brevundimonas diminuta per ASTM F838-83 standards. This microbial retention is correlated to 100% integrity testing during manufacturing (rated in liquid). 100% integrity testing is only carried out on the capsules.
PolyVENT and SteriVENT are integral filter products for sterile venting of vessels and tanks. The devices are constructed from a single, standardized set of materials – PTFE membrane and PP housing – to simplify the approval process.
Features and benefits of GE Healthcare's PolyVENT and SteriVENT
• Pass the HIMA Challenge Test for Sterilizing Grade
• Retain > 107 CFU/cm2 Brevundimonas diminuta per ASTM F838-83 standards; this microbial retention is correlated to 100% integrity testing during manufacturing (rated in liquid). (100% integrity testing is carried out only on the capsules).
• Membrane made of hydrophobic 0.2 µm PTFE membrane
• Validated for 50 steam autoclave cycles; compatible with EtO
• Testable by Water Break Through (WBT) test or bubble point testing
• Pass USP Class VI biosafety tests for plastics
• Manufactured in clean room facilities
• Bidirectional and autoclavable
Applications of GE Healthcare's PolyVENT and SteriVENT
• Venting (filling)
• Isolation (incubators, autoclaves, lyophilizers, EtO sterilizers, fermenters)
• Electronics (gases)