At the heart of every Kleenpak filter with HDC II media is a high-performance pleated cartridge with polypropylene filter medium. The HDC II medium is produced by a proprietary technique, varying the fiber diameter continuously to provide a pore-size distribution from coarse (upstream) to fine (downstream) while maintaining constant void-volume throughout the depth of the filter medium. The varied fiber diameter means extraordinary contaminant-holding capacity, maximum flow rate, and low costs per liter of filtered fluid The fixed pore structure means that contaminants will not unload under variations in flow or pressure differential, and fibers will not migrate or become dislodged to contaminate process fluids
The Kleenpak filter uses well-proven proprietary Pall techniques for filter construction and heat sealing. The highest possible security against filter bypass is ensured, even under conditions of pulsed flow High-strength design allows multiple autoclave cycles for extended use and maximum filter economy Polypropylene outer shell is designed to provide long-term assurance of pressure and temperature ratings Internal hold-up volume and dead space is minimized for maximum product recovery A total absence of glues, binder resins and surfactants results in very low filter extractables and extremely clean filtrate All filter materials of construction have met the specifications for USP Class VI biological tests for plastics at 121 °C and meet FDA requirements for food contact use 21 CFR parts 170-199
Meets USP Biological Reactivity, In Vivo, for Class VI-121 °C plastics
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 USP Sterile Purified Water* Per lot sample soak or rinse-up flush aliquots.
The self-contained design of each Kleenpak filter means that operator intervention and exposure during filter installation and change-out are minimized. Integrally molded inlet and outlet connections Maximum convenience and security Vent and drain connections with seal protected threads and precision molded valves Exceptionally simple and reliable operation Available in three standard sizes. Flexibility in batch size or flow rate requirements