|Millipores Three-Tier Approach to Assuring Integrity of Viresolve® NFP Filters|
|Viral filtration of plasma-derived human IgG|
|Validation of Virus Filtration|
Carter, Jeff and Herb Lutz
BioProcess International January 2003: 52-62 2003
|Removal of prion challenge from an immune globulin preparation by use of a size-exclusion filter|
VAN HOLTEN Robert W; AUTENRIETH Stephen; BOOSE Jeri Ann; HSIEH W T; DOLAN Sherri
Transfusion : (Philadelphia, PA), 2002, 42 (8) 999-1004 2002
|An overview of viral filtration in biopharmaceutical manufacturing|
Jeffrey Carter and Herbert Lutz, Millipore Corporation, Bedford, MA, USA; European Journal of Parenteral Sciences 2002; 7(3): 72–78 © 2002 Parenteral Society
European Journal of Parenteral Sciences 2002; 7(3): 72–78 © 2002 Parenteral Society 2002
|Development and Qualification of a Novel Virus Removal Filter for Cell Culture Applications|
Shengjiang Liu, Mark Carroll, Raquel Iverson, Christine Valera, Joann Vennari, Kimberly Turco, Robert Piper, Robert Kiss, Herbert Lutz
Biotechnology Progress 2000
|Filtration and the Removal of Viruses from Biopharmaceuticals|
Levy, Richard V., Michael W. Phillips, and Herbert Lutz
Chapter 20 in Filtration in the Biopharmaceutical Industry. New York: Marcel Dekker, Inc., 1998. 1998
|A Validatible Porosimetric Technique for Verifying the Integrity of Virus-Retentive Membranes|
Michael W. Phillips and Anthony J. DiLeo Advanced Separations Research Department, Millipore Corporation, 80 Ashby Road, Bedford MA 0 1 730, U.S.A.
Biologicals. 1996 Sep;24(3):243-53. 1996
|High Resolution Removal of Virus From Protein Solutions Using A Membrane of Unique Structure|
DiLeo, Anthony J., Anthony E. Allegrezza, and Stuart E. Builder
Bio/Technology (February 1992): 182-188; RP002 1992
|What is the hold-up volume of an Optiscale 25 NFP ?||Millipore does not have a published specification for the hold up volume for an Optiscale 25 NFP capsule. The approximate hold up volume is 300 ul.|
|Viresolve® NFP Filters|
Viresolve Prefilter Pod Disposable DevicesCustom protection for Viresolve NFP viral clearance filters
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Opticap XL and XLT Disposable Capsule Filters with Viresolve NFP MembraneViresolve NFP filters with Viresolve NFP (Normal Flow Parvovirus) membranes clear parvovirus from recombinant or human plasma sources, without compromising flow rates.
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OptiScale-25 Capsules with Viresolve NFP MembraneViresolve NFP filters with Viresolve NFP (Normal Flow Parvovirus) membranes clear parvovirus from recombinant or human plasma sources, without compromising flow rates.
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|Biopharmaceutical Manufacturing > Downstream Processing > Virus Safety > Virus Filtration > Viresolve Pro & Pro+ > Viresolve NFP|
Viresolve NFP filters with Viresolve NFP (Normal Flow Parvovirus) membranes clear parvovirus from recombinant or human plasma sources, without compromising flow rates. Viresolve NFP filters add speed and dependability to viral clearance in therapeutic drug manufacturing applications. Operated in normal flow filtration mode, these filters are ideal for monoclonal antibody polishing applications eliminating small virus contaminants from essential media and feed streams containing dilute peptides. When placed upstream of bioreactors, Viresolve NFP filters minimize infection risk caused by viruses common to mammalian cell expression systems.
For plugging streams Millipore recommends the Viresolve Prefilter for use with Viresolve NFP filters. This robust filter configuration improves NFP filter capacity significantly reducing your overall virus filtration costs.
Composed of a PVDF material, Viresolve NFP membranes possess a unique pore structure with characteristics that enhance filtration efficiency. Excellent flow-through qualities allow NFP membranes to provide highly efficient separations at flow rates 6 to 10 times faster than competitive products. Inherent sizeexclusion properties reliably retain specific-sized contaminants, improving product safety and protecting downstream processes.
The Viresolve Prefilter is available for use in series with Viresolve NFP filters. The prefilter effectively removes fouling material from biotech feeds and improves filtration economics by protecting the Viresolve NFP viral clearance filters.
All Viresolve NFP filters are designed, developed, and manufactured in accordance with good manufacturing practices under an ISO® 9001 Quality Management System.
Viresolve NFP small area devices, capsules and cartridges are integrity tested during manufacturing and supported by a Validation Guide to assist in compliance with regulatory requirements. For traceability and easy identification, each filter is labeled with the product name and identifying characteristics. Every Viresolve NFP filter is shipped with a Certificate of Quality.
Millipore has submitted a Biological Master File to the FDA and will submit it to other worldwide regulatory agencies needed to support customer applications. Please contact Millipore to obtain a Letter of Authorization to reference in your application.
Delivers High-Quality Filtered Protein
Unlike inactivation methods, filters are inert and do not degrade proteins. High protein passage and low protein binding provide >98% protein product yields. Low extractables ensure product quality.
Viresolve NFP size-exclusion membrane technology passes proteins up to 160 kDa in size and consistently clears parvovirus at >4 logs, without compromising flow rate.
Multiple Formats Available
Viresolve NFP membranes are offered in multiple device configurations that vary by filtration area and inlet/outlet connection type. Viresolve NFP filter units are available as OptiScale 25 mm devices, Opticap capsules, and cartridge filters that accommodate volumes ranging from 70 mL through thousands of liters at process scale.
Viresolve NFP 10-, 20- and 30-inch cartridge filters are ideally suited for processes that require maximum pressure differentials. Each cartridge is integrity tested during the manufacturing process. A range of filtration areas is available to suit medium and large volume requirements.
|Cartridge Filters (per 10-inch cartridge)|
|Materials of Construction|
|Filter||Modified Polyvinylidene Fluoride (Modified PVDF)|
|Cage; Core; Support||Polypropylene|
|Filtration Area||0.42 m²|
|Maximum Differential Pressure, bar (psid)||Forward: 5.5 bar (80 psid). Reverse: 3.4 bar (50 psid)|
|Bacterial Endotoxins||Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test|
|Sterilization||Water wet filter for 5 min @ 3.4 bar (50 psi); liquid cycle, slow exhaust @ 123 °C maximum 60 min|
|Toxicity||Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.|
|Non-Fiber Releasing||Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).|
|Good Manufacturing Practices||These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.|
|Air Diffusion at 23 °C||≤10 mL/min @ 3.45 bar (50 psig) in water|
|Wetting/Flushing||Water for 5 min at 3.4 bar (50 psi)|