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Ultipor® VF Grade DV50 Virus Removal Filter Cartridges

Ultipor® VF Grade DV50 Virus Removal Filter Cartridges
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Ultipor® VF Grade DV50 Virus Removal filter cartridges  feature innovative hydrophilic PVDF microporous membranes to remove significant levels of viruses from biological solutions, while enabling > 95% transmission of proteins up to 300 kD or larger. Using patented Ultipleat® crescent-shaped pleated elements, the filters to incorporate 1.6 m² (17.5 ft²) of filter area per 10 in. (254 mm) element in standard single open-ended (SOE) AB sanitary style cartridges. Ultipor VF cartridges achieve practical flows and pressure drops while effectively removing nanometer-size viral contaminants with high protein yields. An optional sub-0.1 µm rated prefilter (Grade DVD) and Fluorodyne® II filters enhance throughputs and employ the same PVDF membrane material for ease of validation. Typical applications include purification of biopharmaceuticals, tissue and plasma derivatives, protein additives, culture media, diagnostic reagents, buffers and diluents.

Features and Benefits

 

  • Sanitary direct flow cartridges
  • 6 log Titer Reduction (TR) for 50 nm viruses (DV50 grade)
  • Robust size exclusion mechanism
  • PVDF microporous membranes
  • Narrow pore-size distribution
  • Inherently water wettable
  • Low binding for high protein yields
  • Very low extractables
  • 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
  • Discs and mini-cartridges (SBF Junior Style) available

Quality and Bio-Safety Biological Tests

 

Integrity

 

  • Every DV50 grade filter integrity tested during manufacture. 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
  • 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

Products in this datasheet may be covered by one or more patents including :
EP 0 667 800
EP 0 982 061
EP 1 380 331
US 5,543,047
US 5,690,765
US 5,725,784
US 6,113,784
US 7,083,564
US 7,318,800
US 5,736,051