ASTM WK43975

    New Practice for for determining and characterizing extractables from materials used in single-use applications

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



    WK43975

    1. Scope

    1.1This practice provides a standardized approach for determining the most likely extractables profile from materials used in single-use applications, including the assays for these materials. 1.2The scope of this practice is limited to materials and process practices used in biopharmaceutical development and manufacturing. 1.3 It is not intended to provide information on the impact of any leached material on product compatibility or process performance. Nor is it intended to provide information on any leached material resulting from interaction of final formulation with finished packaging material.


    Keywords

    extractables, leachables, single-use applications, SUT, biopharmaceuticals, pharmaceuticals, risk assesssment, toxicological

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

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    11-07-2013

    Technical Contact:
    James Bray

    Status:
    Draft Under Development