Pall Fluorodyne II filter cartridges feature a unique hydrophilic modified polyvinylidenefluoride (PVDF) membrane with ultra low binding properties, broad chemical and temperature resistance, and higher flows than competitive PVDF or other membrane cartridges. High-area pleated into single open-ended (SOE) AB sanitary style cartridges, Fluorodyne II filters are available 0.45 µm rated for stabilization, filtration of viscous fluids and membrane prefiltration, 0.2 µm rated for sterilization, and 0.1 µm rated for sterilization and mycoplasma removal. They are recommended for pharmaceuticals including ophthalmics and other dilute preservative solutions, biologicals including dilute protein solutions, cold and hot WFI, chemicals, aggressive solvents and sanitizing agents.
Features and Benefits
Higher flows per cartridge for smaller assemblies or reduced change-outs
DJL provides 0.1 µm retention with 0.2 µm flow
Lower extractables
Stable in 90 °C (184 °F) WFI
High protein recoveries
Rapid preservative recoveries
Inherently water wettable
Compatible with organic solvents, acids and chemicals.(1)
Resin and surfactant-free
Melt-sealed, non shedding
(1) Except ketones and amides.
Note: These filters are also available in Kleenpak Nova capsule format.
Built-in PVDF prefiltration layers
Repeatedly steamable in situ
100% integrity-tested
Individually serialized
Manufactured for use in conformance with cGMP
ISO 9000 Certified Quality System
Pharmaceutical P optimized
Certificate of Test provided
Validation Guide available
Quality and Bio-Safety
Biological Tests
Integrity
Every filter tested during manufacture.Test correlated to microbial retention
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
Steam Resistance
Lot samples multi-cycle autoclave challenged
* Per lot sample soak or rinse-up flush aliquots.
