Sterilizing Grade Filter Cartridges & Capsules: LifeASSURE™ SP SeriesSource: 3M Purification, Inc.
LifeASSURE SP series sterilizing grade filters and capsules are validated for absolute bacteria retention and provide reliable sterile filtration performance.
3M Purification Inc. pioneered the development of positively charge modified Nylon 6,6 filters for the pharmaceutical industry. LifeASSURE SP series sterilizing grade filters and capsules are validated for absolute bacteria retention and provide reliable sterile filtration performance. In addition to a fixed bacteria retentive pore structure, LifeASSURE SP series 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 retentive membrane, together with enhanced reduction of negatively charged contaminants, make LifeASSURE SP series membrane an ideal choice for pharmaceutical and iopharmaceutical sterilizing applications.
Each LifeASSURE SP series cartridge and capsule filter is supplied with a Certificate of Quality. A Validation Guide is available for ease of compliance with regulatory requirements. The Quality Management System is approved by an internationally recognized accrediting body to an ISO 9001:2008 Registered Quality System Standard.
- Large volume parenterals
- Bioprocess-derived protein solutions
- Purified water systems
- Blood and serum fractions
- Cell culture media
- Reagents & buffers
- Pharmaceutical bulk chemical solutions
Features & Benefits
- 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, longer service life for reduced filtration costs
- Reliable 0.2 µm validated performance
- Meets FDA definition of 0.2 µm 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