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 

Type

Filter Cartridges

Use

Viral Safety

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.

Product Summary

Ultipor VF Grade DV50 virus removal filters are a robust means to remove viruses from liquids by microfiltration, while permitting enhanced transmission of proteins. These 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

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