Pall Ultipor VF Grade DV50 virus removal filters are a robust means to remove viruses from liquids by microfiltration, while permitting enhanced transmission of proteins. SBF Junior Style pleated membrane mini-cartridges are designed for small-scale qualification and validation studies and for small process batches up to 10 – 20 liters. Typical applications for these easy-to-use direct flow filters include purification of BioPharmaceuticals, plasmaderivatives, protein or serum containing cell-culture media and diagnostic reagents.

Features and Benefits

 6 log Titer Reduction (TR) for 50 nm viruses
 Robust size exclusion mechanism
 Narrow pore-size distribution
 Easy-to-validate direct flow use
 Linear scale-up to larger batches
 Low protein binding
 Low filter extractables
 100% integrity-tested
 Pre-use testable with WFI
 Manufactured for use in conformance with cGMP
 ISO 9000 Certified Quality System
 Pharmaceutical P optimized
 Certificate of Test provided
 Validation Guide available
 SBF style also available with 0.2 µm Ultipor® N66, Bio-Inert®, Posidyne®, Fluorodyne® II and Emflon® II media

Quality and Bio-Safety Biological Tests

Integrity (100% Unit Release Test)

 Correlated to viral (phage) 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 per 21 CFR
 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.

Autoclave Resistance

 Lot samples multi-cycle autoclave challenged
* Per lot samples soak or rinse-up flush aliquots.