LifeASSURE™ 020SP series sterilizing grade filters cartridges are validated for absolute bacteria retention. In addition, the LifeASSURE 020SP series sterilizing grade filter cartridge contains a quaternary amine charge modified membrane to provide enhanced reduction of biological contaminants such as endotoxin fragments.
LifeASSURE™ 020SP series filters are qualified for absolute retention of B. diminuta (ATCC 19146) following American Society of Testing and Materials (ASTM) F838-05 at a minimum challenge level of 107 CFU/ cm2 of filter area. The results of bacteria challenge testing are correlated to non-destructive forward flow air diffusion integrity rates.
Our quaternary amine charge-modified, double-layer composite, Nylon 6,6 membrane provides enhanced particle retention, endotoxin reduction and reduces bioburden to the final sterilizing grade filter. The charged polymer is the same as that in our Zeta Plus ZB Series filter media making for a component system for combined contaminate removal.
Our robust construction of the LifeASSURE 020 SP series filter cartridges are tested to withstand mechanical and thermal stresses associated with those from multiple Sterilization-In-Place (SIP) operations.
A Validation Guide is available for ease of compliance with regulatory requirements. All product components comply with United States Pharmacopeia (USP) <88> Class VI Biological Reactivity Tests, in vivo.
Applications
Large volume parenterals
Purified water systems for endotoxin removal
Biologicals
Bioprocess-derived protein solutions
Vaccines
Diagnostics
Solvents
Ophthalmics
Blood and serum fractions
Cell culture media
Reagents & buffers
Pharmaceutical bulk chemical solutions
The combination of a validated bacteria retentive membrane, together with enhanced reduction of contaminants, make LifeASSURE 020SP series membrane a choice for pharmaceutical and biopharmaceutical sterilizing applications.
產品規格
Application
Bioburden Reduction, Endotoxin Removal for Biopharmaceutical Manufacturing, Sterilizing Grade Filtration (liquid and gas), Sterilizing Grade Filtration
Brands
LifeASSURE™
Component and Assembly Materials
End Caps: Polypropylene, Inner Core: Polypropylene, Outer Cage: Polypropylene, Upstream Support Layers: Polypropylene, Downstreem Support Layers: Polypropylene, Reinforcing Ring: Stainless Steel
Effective Filtration Area
8 ft²
End Configuration
222 O-Ring & Flat Cap, Bayonet Lock Single Open End (SOE) (226 O-Ring and Spear), 226 O-Ring and Spear, 222 O-Ring and Spear, Sanitary Fitting
TEL : 02-26030512
產品名稱:3M LifeASSURE 020SP
