STP1260

    Validation of Filters Used for Sterilizing Liquids

    Published: Jan 1996


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    Abstract

    Validation of sterilizing grade filters in biopharmaceutical production is necessary to assure the filter's efficiency or performance as part of a process, and to ensure the safety and reliability of both the process and its end product. A review of different aspects of validating filters used for sterilizing liquids, taking into account potential influences of process conditions and product formulations is presented.

    Keywords:

    Sterilization, Filtration, Validation, Filter Integrity


    Author Information:

    Martin, JM
    Senior Vice President, Marketing, Healthcare Group, Pall Ultrafine Filtration Company, East Hills, NY

    Cole, S
    Staff Scientist, Scientific and Laboratory Services, Pall Europe Ltd., Portsmouth,

    Geerligs, G
    Staff Scientist, Scientific and Laboratory Services, Pall GmbH, Frankfurt,

    Howard, G
    Associate Director, Scientific and Laboratory Services, Pall Corporation, Port Washington, NY

    Jaenchen, R
    Director, Scientific and Laboratory Services, Pall GmbH, Frankfurt,


    Paper ID: STP14706S

    Committee/Subcommittee: E48.03

    DOI: 10.1520/STP14706S


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