ASTM WK43742

    New Practice for characterizing particulates burden from single-use systems

    (What is a Work Item?)

    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.


    particulates, single-use, biopharmaceuticals, impact, manufacturing

    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:

    Technical Contact:
    Patrick Evrard

    Draft Under Development