Ultipor® VF Grade DV50 Virus Filter Cartridges - SBF Junior Style product photo Primary L

Ultipor® VF Grade DV50 Virus Filter Cartridges - SBF Junior Style

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



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Description
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

Specifications

Materials of Construction

Membrane  Hydrophilic low protein binding polyvinylidenefluoride (PVDF) 
Support and Drainage       Polyester 
Core, Cage and End Caps       Polypropylene 
O-ring     Silicone¹
¹ Other polymers available

Virus Removal Ratings²

TR ≥ 106 for viruses ≥ 50 nm 
² Lot samples retain log 106 TR of 53 nm spherical non-enveloped bacteriophage PR772

Nominal Filter Area

0.074 m² (0.8 ft²) 

Nominal Dimensions

Length    62 mm (2.4 in.) 
Diameter 43 mm (1.7 in.)

Configuration

Single open-ended cartridge, sanitary style plug adapter, double 116 O-ring

Autoclave and Steaming in situ³

Autoclavable at 125 °C
³ Contact Pall for recommended procedures

Operating Conditions

Maximum Differential Pressure*  3 bard (43.5 psid) 
Recommended Operating Pressure     1 - 2 bard (15 – 29 psid) 
Maximum Differential Pressure for Integrity Test Performance (Short-term)     6.0 bard (90 psid)
* Viral TR pressure-independent

Aqueous Extractables (NVR)

1 mg per element in deionized water at 20 – 25 °C after autoclaving 

Ordering Information
Part Number
SBF1DV50PH4* 
* H4 suffix = Silicone O-rings (standard). Ethylene Propylene and Fluoropolymer Elastomer O-rings available. P in part number indicates optimized and qualified for pharmaceutical use including 100% integrity test and Certificate of Test.

Note: For suggested qualification protocols, test and validation discs, sizing and sterilizing recommendations, SBF style cartridges with 0.2 µm or other grade, please contact Pall.

Application
Filters - Specialist
Segment
Viral Clearance