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Pall Fluorodyne® II filter cartridges feature a unique hydrophilic modified polyvinylidenedifluoride (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
• 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

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