Posidyne™ membrane in Kleenpak™ capsules

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 TestsMeets 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