LifeASSURE™ 020SP series sterilizing grade filters and capsules are validated for absolute bacteria retention and provide relable sterile filtration performance.
Charge-modified Nylon 6,6 filter medium. Retention of negatively-charged biological and particulate contaminants including endotoxins. Inherently hydrophilic membrane for easy wet-out.
High area, pleated membrane design. High flow rates, low pressure drop. Smaller filter systems, and longer service life for reduced filtration costs.
Reliable 0.2 micron validated performance. Meets FDA definition of 0.2 micron sterilizing grade filter (107CFU/cm2 B. diminuta retention). Integrity test correlated with sterile filtration performance data and supported by Validation Guide.
Robust cartridge construction. Cartridges withstand mechanical and thermal stress including Steam in Place operations.
Cartridges 100% integrity tested. Ensures consistent performance to specifications, integrity testable pre- and post-use.
ISO 9001:2008 - Registered Quality System. Quality Management System approved by an accrediting body to an ISO 9001:2008
Quality Systems Standard.
Tested and optimized for pharmaceutical and biological processing. Materials of construction tested for biological safety (USP Class VI) and listed in Drug Master File (DMF) at FDA
Low extractable levels, no surfactants or adhesives used in manufacturing. Minimal effect on filtrate quality and purity.
The LifeASSURE 020SP series microporous membrane is charge modified to provide enhanced reduction of negatively charged biological contaminants such as endotoxin, virus and nucleic acid fragments. The combination of a validated bacteria rententive membrane, together with enhanced reduction of negatively charged contaminants, make the LifeASSURE 020SP series microporous membrane an ideal choice for pharmaceutical and biopharmaceutical sterilizing applications.