ASTM WK43741

    Work Item: ASTM WK43741 - New Practice for testing integrity of 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 testing the integrity of single-use systems consisting of single-use components used in pharmaceutical development and manufacturing notably biotechnology. 1.2 It is not intended to provide practice on how to make risk assessments on processes with regard to minimal requirements on system integrity notably the distinction between bioburden controlled and sterile operation.


    Keywords

    testing, integrity, single-use systems, biopharmaceuticals

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

    Citing ASTM Standards
    Back to Top
    Work Item Status

    Date Initiated:
    10-21-2013

    Technical Contact:
    Alain Pralong

    Status:
    Draft Under Development