Ultipor® N66 Sterilizing-grade Filter Cartridges by Pall Life Sciences Products - Biopharmaceutical Division

Pall Ultipor N66 sterilizing-grade filter cartridges feature high-strength pure Nylon 6,6 membranes for higher sterility assurance. In wide use for almost 20 years, these filters have a proven record of performance in the production of sterile biologicals and pharmaceuticals. High-area pleated into single open-ended (SOE) AB sanitary style cartridges, Ultipor N66 sterilizing-grade filter cartridges are available with ratings from 0.45 µm for LVPs, reagents and viscous fluids, 0.2 µm for sterile products and intermediates, 0.1 µm for sterilization and mycoplasma removal from biologicals, to 0.04 µm for sterilization and virus reduction from biologicals.

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