Sanitary direct flow cartridges 6 log Titer Reduction (TR) for 50 nm viruses (DV50 grade) Robust size exclusion mechanism PVDF microporous membranes Narrow pore-size distribution Inherently water wettable Low binding for high protein yields Very low extractables Steamable in situ 100% integrity-tested Individually serialized Manufactured for use in conformance with cGMP ISO 9000 Certified Quality System Pharmaceutical P optimized Certificate of Test provided Validation Guide available Discs and mini-cartridges (SBF Junior Style) availableNote: These filters are also available in Kleenpak Nova capsule format.
Every DV50 grade filter integrity tested during manufacture. Test correlated to viral (phage) retention.
Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
Meets Cleanliness per USP Particulates in Injectables Non-Fiber-Releasing Non-Pyrogenic per USP Bacterial
Meets Total Organic Carbon and Conductivity per USP Purified Water; pH per Sterile Purified Water
Lot samples multi-cycle autoclave challenged* Per lot sample or rinse-flush aliquots.