Cytiva, KA3NTZP1, Posidyne™ membrane in Kleenpak™ capsules

Posidyne membrane in Kleenpak capsule, 0.1 µm removal rating, 2000 cm² EFA, 1½ in. sanitary flange connections Kleenpak™ capsules with Posidyne™ membrane, part of our Pall filtration portfolio, incorporate a covalent charge-modified Nylon 6,6 membrane that provides enhanced retention of fine particles smaller than the membrane’s rating. Posidyne membrane in Kleenpak capsule meet cleanliness requirement per USP Particulates in Injectable. It features positive Zeta potential for enhanced efficiency in aqueous solutions. Capsules contain a double-layer sterilizing membrane for high reliability and high-quality product. Filters are self-contained and designed for small sterile filtration systems throughout a range of acidic to basic solutions. Kleenpak liquid capsule filters with intrinsically hydrophilic positive zeta potential Posidyne membrane are rugged, self-contained sanitary filters designed for small-batch sterile filtration of aqueous pharmaceutical solutions. With a net positive charge in most aqueous solutions from pH 3 to 10, Kleenpak Capsules with Posidyne Membrane Assemblies can effectively remove contaminants such as cell debris and endotoxin smaller than the filter rating. Features and benefits Positive Zeta potential for enhanced efficiency in aqueous solutions Double-layer sterilizing membranes for high reliability 100% integrity and pressure-tested High protein recovery from serum and most protein solutions 0.2 µm NF grade for sterilization 0.1 µm NT grade for diminutive bacteria and mycoplasma removal Low filter extractables Sanitary vent and drain valves with non-twist hose barbs Upstream hold-up volumes (< 1 mL) Repeatedly autoclavable Manufactured for use in conformance with cGMP IS0 9000 Certified Quality System Pharmaceutical P optimized Certificate of Test provided
Quality and Bio-Safety Biological Tests Meets USP Biological Reactivity Test, in vivo, for Class VI-121°C Plastics
Effluent Quality Tests* Meets Cleanliness per USP Particulates in Injectables
Non-Fiber-Releasing
Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
Meets Total Organic Carbon and Water Conductivity per USP Purified Water; pH per Sterile Purified Water
* Per lot sample soak or rinse-up flush aliquots. Autoclave Resistance Lot samples multi-cycle autoclave challenged