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.