ASTM WK43742

    Work Item: ASTM WK43742 - New Practice for characterizing particulates burden from single-use systems

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    Developed by Subcommittee: E55.04 | Committee E55 | Contact Staff Manager



    1. Scope

    1.1 This practice provides a standardized approach for determining particulates burden from single-use systems for applications in pharmaceutical development and manufacturing, notably biotechnology. 1.2 It describes what information is required to be able to assess impact of these particulates to the pharmaceutical manufacturing process.


    Keywords

    particulates, single-use, biopharmaceuticals, impact, manufacturing

    The title and scope are in draft form and are under development within this ASTM Committee.

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    Work Item Status

    Date Initiated:
    10-21-2013

    Technical Contact:
    Patrick Evrard

    Status:
    Draft Under Development