Kleenpak™ Capsules with Posidyne® Membrane Assemblies by Pall Life Sciences Products - Biopharmaceutical Division

Pall Kleenpak 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 be effective in removing 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

Autoclave Resistance:
Lot samples multi-cycle autoclave challenged

* Per lot sample soak or rinse-up flush aliquots.