Features and Benefits
- Intrinsically water wettable
- Fixed pores, non-shedding
- Resin and surfactant-free
- Broad solvent compatibility
- Low filter extractables
- High-area for long-life
- High protein recovery from most protein solutions
- Repeatedly steamable in situ
Note: These filters are also available in Kleenpak Nova capsule format.
Quality and Bio-Safety
- Integrity
- Every filter integrity tested during manufacture. Test correlated to microbial retention
Biological Tests
- Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
- Meets Cleanliness per USP Particulates in Injectables
- Non-Fiber-Releasing per 21 CFR
- Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL)
- Meets Total Organic Carbon and Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water
Steam Resistance
- Lot samples multi-cycle autoclave challenged
- Per lot samples soak or rinse-up flush aliquots.
