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.
Large volume parenterals
Purified water systems for endotoxin removal
Bioprocess-derived protein solutions
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.