A part of Merck

Módulos Viresolve para Proceso

Self-contained, single-use disposable modules designed to remove viruses from protein solutions at process scale.

Descripción

Especificaciones

Información para pedidos

    Documentation

    Licencias necesarias e Información técnica

    Cargo
    Application Note - Ensuring Compliance: Regulatory guidance for virus clearance validation
    Diffusion Test Protocol for Viresolve® 10-stack and 20-stack Modules

    Referencias bibliográficas

    Visión general referencias
    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

    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

    Preguntas frecuentes

    PreguntaRespuesta
    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.

    Manuales del usuario

    Cargo
    Viresolve® Virus Removal Module User Guide

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    Familias de productos

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    Categorías

    Biopharmaceutical Manufacturing > Downstream Processing > Virus Safety > Virus Filtration > Viresolve Pro & Pro+ > Viresolve 180