Ultipor® VF Grade DV20 and DV50 Virus Removal Filter Membrane in Novasip™ Capsules product photo Primary L

Ultipor® VF Grade DV20 and DV50 Virus Removal Filter Membrane in Novasip™ Capsules

Novasip™ DV20 and DV50 Virus Removal Filter Capsules are disposable, Junior Style steamable assemblies designed to remove parvoviruses and other viruses from protein solutions. The Novasip DV20 grade capsule filter utilizes an Ultipor VF-grade DV20 grade pleated membrane cartridge to remove parvoviruses and other viruses as small as 20 nm from protein solutions up to 5 – 10 liters. The Novasip DV50 grade capsule filter incorporates an Ultipor VF DV50 grade membrane cartridge for removal of viruses 40 – 50 nm and larger. Novasip Ultipor VF capsule filters are supplied non-sterile and can also be gamma-irradiated.*

Features and Benefits

  •  3 Log Titer Reduction (LTR) for 20 nm viruses
  •   6 log LTR for 50 nm viruses
  • Robust size exclusion mechanism 
  • Narrow pore-size distribution
  • Low binding for high protein yields
  • Inherently water wettable
  • Very low extractables
  • Autoclavable or steamable in situ
  • Gamma-irradiatable
  • 100% integrity-tested
  • Individually serialized
  • Manufactured for use in conformance with cGMP
  • Pharmaceutical P optimized with certificate of test provided
  • Clear housing for easy venting
  • New design sanitary valves:
    • Non-removable for safety
    • Non-threaded for cleanliness
* For gamma-irradiated products and maximum allowable dosage, please contact Pall.

Quality and Bio-Safety Biological Tests

 

Integrity

 

  • Every 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 Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water

Autoclave Resistance

 

  • Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics

* Per lot samples soak or rinse-up flush aliquots

Products in this datasheet may be covered by one or more patents including :
US 7,273,550
EP 0 998 343



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Description

Novasip™ DV20 and DV50 Virus Removal Filter Capsules are disposable, Junior Style steamable assemblies designed to remove parvoviruses and other viruses from protein solutions. The Novasip DV20 grade capsule filter utilizes an Ultipor VF-grade DV20 grade pleated membrane cartridge to remove parvoviruses and other viruses as small as 20 nm from protein solutions up to 5 – 10 liters. The Novasip DV50 grade capsule filter incorporates an Ultipor VF DV50 grade membrane cartridge for removal of viruses 40 – 50 nm and larger. Novasip Ultipor VF capsule filters are supplied non-sterile and can also be gamma-irradiated.*

Features and Benefits

  •  3 Log Titer Reduction (LTR) for 20 nm viruses
  •   6 log LTR for 50 nm viruses
  • Robust size exclusion mechanism 
  • Narrow pore-size distribution
  • Low binding for high protein yields
  • Inherently water wettable
  • Very low extractables
  • Autoclavable or steamable in situ
  • Gamma-irradiatable
  • 100% integrity-tested
  • Individually serialized
  • Manufactured for use in conformance with cGMP
  • Pharmaceutical P optimized with certificate of test provided
  • Clear housing for easy venting
  • New design sanitary valves:
    • Non-removable for safety
    • Non-threaded for cleanliness
* For gamma-irradiated products and maximum allowable dosage, please contact Pall.

Quality and Bio-Safety Biological Tests

 

Integrity

 

  • Every 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 Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water

Autoclave Resistance

 

  • Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics

* Per lot samples soak or rinse-up flush aliquots

Products in this datasheet may be covered by one or more patents including :
US 7,273,550
EP 0 998 343

Specifications

Materials of Construction

 
Filter Medium   Hydrophilic polyvinylidenefluoride (PVDF) 
Support and Drainage    Polyester 
Core, Cage and Endcaps   Polypropylene 
Housing Shell     Polyetherimide 
O-rings¹ Silicone
 

¹ Other polymers available

Nominal Dimensions

 
  CLM05DV20 C3DV50
Length  84 mm (3.3 in.)  157 mm (6.18 in.)
Diameter 123 mm (4.8 in.)  123 mm (4.8 in.) 
Nominal Filter Area 0.07 m² (0.75 ft²)  0.4 m² (4 ft²)
 

Inlet and Outlet

 
26 – 38 mm (1 – 1½ in.) sanitary flange  
 

Virus Removal

 
DV20 TR > = 10³ for 25 nm PP7 bacteriophage
TR > =  106 for 53 nm PR772 bacteriophage
DV50 TR > =  106 for 53 nm PR772 bacteriophage
 

Operating Conditions

 
Recommended Operating Pressure 1 – 2 bard (15 – 29 psid) 
Maximum Differential* Pressure 3 bard (43.5 psid)
 

* Note: Maximum assembly pressure is 6.0 bard (90 psid) for short-term integrity testing

Aqueous Extractables (NVR)

 
< 5 mg/capsule (Deionized water at 20 °C [68 °F]) 
 

Flow/Pressure (Water, 25 °C [77 °F])

 
23 mL/min at 2 bar (29 psi) for CLM05DV20P1G 
0.3 L/min @ 2 bar (29 psi) for CL3DV50P1G 
 

Sterilization

 
Autoclavable and Steamable in situ for 3 x 1-hour cycles at up to 125 °C (257 °F) (non-irradiated product only). Gamma-irradiatable² 
 

² Contact Pall for recommended procedures

Effluent Quality Tests (P 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 USP Sterile Purified waters

Type

Filter Capsules

Use

Viral Safety

Ordering Information

 
Part Number Media Type Rating
CLM05DV20P1G  Hydrophilic PVDF  For viruses ≥ 20 nm 
CL3DV50P1G Hydrophilic PVDF For viruses ≥ 50 nm
 
Note: For suggested qualification protocols, test/validation discs, sizing and sterilizing recommendations, multi-element forward flow values or other information, please contact Pall or your local Pall representativeNovasip™ DV20 and DV50 Virus Removal Filter CapsulesCLM05DV20P1G CL3DV50P1G CL05DV20P1G CL3DV50P1R DV20 DV50 CLM CLM05 CL3 DV50 DV20 CL05
 
 

Product Summary

Ultipor® VF Grade DV20 and DV50 virus removal filter membrane in Novasip™ capsules are disposable, steamable assemblies designed to remove parvoviruses and other viruses from protein solutions. Grade DV20 media removes parvoviruses and other viruses as small as 20 nm from protein solutions up to 5 – 10 liters, with DV50 ideal for removal of viruses 40 – 50 nm and larger

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