|Application Note - Ensuring Compliance: Regulatory guidance for virus clearance validation|
|Viresolve® 180 Modules with CorrTest Integrity Test Kits|
|Validation of Virus Filtration|
Carter, Jeff and Herb Lutz
BioProcess International January 2003: 52-62 2003
|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
|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 are the materials of construction and certification for the gaskets that are supplied with each Viresolve module?||The gaskets used in Viresolve TFF process area modules are all silicona and compliant with CFR 21 paragraph 177.2600 specifications.|
|Viresolve® Virus Removal Module User Guide|
Viresolve® Process Area ModulesSelf-contained, single-use disposable modules designed to remove viruses from protein solutions at process scale.
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CorrTest Integrity Testing KitsReliably and reproducibly predict the PhiX-174 retention of a given Viresolve product.
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|Biopharmaceutical Manufacturing > Downstream Processing > Virus Safety > Virus Filtration > Viresolve Pro & Pro+ > Viresolve 180|
Viresolve® standard modules are self-contained, single-use disposable modules designed to remove viruses from protein solutions. Viresolve® modules are fabricated from a single material of construction, polyvinylidene fluoride (PVDF). The modules are thermally bonded and no solvents are used in fabricating the units.
Viresolve® modules achieve efficient virus removal while maximizing protein recoveries and minimizing hold-up volumes. The modules are used in a tangential flow filtration mode with two peristaltic pumps for superior transmembrane pressure control.
Each module is supplied with a medical-grade silicone tubing set and gaskets for easy connection to a variety of peristaltic pumps. The modules can be supplied in a number of configurations to meet a variety of process needs. For example, modules are available with accessories suitable for pressure monitoring or diafiltration processes.
Viresolve® modules are available with membranes for use with larger protein products (typically ≤ 180 kD). They offer excellent virus retentive capabilities, and are consistently capable of protein recoveries exceeding 90%.
Each unit is 100% integrity tested during manufacturing by CorrTest to assure integrity.
- Monoclonal antibodies including murine, human and hybrids
- Larger recombinant or transgenic proteins
- Larger plasma fractionation products
Typical Membrane Viral Retention (in Buffer)*
|Polio Virus||2 logs|
|Hepatitis A||4 logs|
|Simian Virus (SV-40)||**|
|Sindbis (sin)||4.5 logs|
|Reovirus 3 (Reo)||5.5 logs|
|Murine Leukemia Virus (MuLV)||6.0 logs|
|Human Immunodeficiency Virus (HIV)||**|
|*Retention in protein is higher
**Testing not done
|Module||Length, cm (inch)||Width, cm (inch)||Height, cm (inch)||Weight, kg (lb)|
|150 cm2 (1/6 ft2)||17.5 cm (6.9 in.)||9.3 cm (3.7 in.)||0.9 cm (0.35 in.)||0.107 kg (0.236 lb.)|
|0.1 m2 (1 ft2)||17.5 cm (6.9 in.)||9.3 cm (3.7 in.)||2.5 cm (0.98 in.)||0.405 kg (0.893 lb.)|
150 cm2 (0.16 ft2)
0.1 m2 (1 ft2)
|Materials of Construction|
|Membrane||Polyvinylidene Fluoride (PVDF)||Polyvinylidene Fluoride (PVDF)|
|pH Range||pH4 – pH8||pH4 – pH8|
|Effective Filtration Area, m2 (ft2)|
|cm2 (ft2) for 1-Stack||150 cm²||0.1 m²|
|Minimum Working||150 mL||1000 mL|
|Pressures, bar (psig)|
|Typical Permeate Water Flow Rates, mL/min||2 mL/min–10 mL/min||2 mL/min–60 mL/min|
|Gravimetric Extractables||The extractables level was equal to or less than 7 mg after 24 hours in water at controlled room temperature.||The extractables level was equal to or less than 14 mg after 24 hours in water at controlled room temperature.|
|Oxidizable Substances||Meet the current requirements of USP WFI oxidizable substances after a 100 mL water flush|
|Toxicity||Component materials meet the current requirements of the USP Class VI Biological Test for Plastics|
|Sterilization||Water wet filter, use liquid cycle slow exhaust. Autoclavable @ 121 °C for 60 min 1 time; not steam sterilizable|
|Viresolve® 180||≥ 1.1 @ 1030 mbar (15 psig)|
Medical-grade silicone gasket seal and platinum-cured silicone tube set with fractional sanitary connections
A sterile, medical-grade silicone tube set is provided with each Viresolve® standard module. Each tube set consists of three segments: a feed, retentate, and permeate line. Each tube set has provisions for diafiltration.
Two peristaltic pumps required (not included)
For more information on Viresolve® system accessories, please call Millipore