Ultipor® VF Grade DV20 Virus Removal Filter Cartridges by Pall Life Sciences Products - Biopharmaceutical Division

Pall Ultipor VF grade DV20 filter cartridges are integrity-testable, direct flow filters for size exclusion removal of viruses as small as 20 nm from biological solutions. The innovative DV20 hydrophilic PVDF microporous membrane also enables > 95% transmission of proteins up to 160 kiloDaltons. Using a standard single open-ended (SOE) AB sanitary style cartridge design, Ultipor VF DV20 filters achieve practical flows and pressure drops in process-scale purification of BioPharmaceuticals, tissue and plasma derivatives and protein additives. Where required, suitable prefilters employing the same PVDF membrane material are available, simplifying process optimization and filtration system validation.

Features and Benefits

• Sanitary direct flow cartridges
• Robust size exclusion mechanism
• ≥ 3 log TR for > 20 nm viruses
• ≥ 6 log TR for > 50 nm viruses
• Low binding for high protein yields
• High transmission of albumin and IgG
• Very low extractables
• Autoclavable and Steamable in situ (SIP)
• 100% integrity-tested (correlated to virus retention)
• Manufactured for use in conformance with cGMP
• Pharmaceutical P optimized with Certificate of Test provided
• Validation Guide available
• Claims based on challenges with bacteriophage (bacterial viruses) PP7 (25 nm) and PR772 (53 nm) in 1% Bovine Serum Albumin in phosphate-buffered saline at pH 7.4, 20 °C (68 °F).
• Note: These filters are also available in Kleenpak Nova capsule format.

Quality and Bio-Safety Biological Tests
Integrity
Every DV20 grade filter integrity tested during manufacture. Test correlated to viral (phage) removal

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 Conductivity per USP Purified Water; pH per Sterile Purified Water

Autoclave Resistance
Lot samples multi-cycle autoclave challenged
* Per lot sample or rinse-flush aliquots.

Forward Flow Integrity Test

• Diffusional flow integrity test, carried out by standard upstream or downstream methods
• Correlated to 3 log TR for 25 nm PP7 phage and ≥ 6 log TR for 53 nm PR772 phage
• Test Wetting Fluid: 30% IPA (20% EtOH values also available)
• Water or buffer-wet values for installation confirmation can also be provided
• Test Pressure: 85 psi (air test gas)