ASTM WK43741

    New Practice for Testing Integrity of Single-Use Systems at Vendors Manufacturing Facilities

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



    WK43741

    1. Scope

    1.1.This practice is applicable to all Single-Use Systems of pharmaceutical and biopharmaceutical manufacturing processes including but not limited to: bag chambers, tubing, connectors, sensors, filter capsules, membranes, containers, bioreactors, and cell factories that have the potential to affect patient safety with regard to system integrity. 1.2.For brevity, these are referred to throughout the rest of this practice as SUS (Single-Use Systems). 1.3.This practice provides a standardized approach to test the integrity of SuS based on a risk assessment with regard to patient safety. 1.4.This practice is applicable throughout the life-cycle of the SuS from concept to retirement. 1.5.This practice is intended to be used by SuS vendors.


    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
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    Work Item Status

    Date Initiated:
    10-21-2013

    Technical Contact:
    Alain Pralong

    Item:
    001

    Ballot:
    E55.04 (14-02)

    Status:
    In Balloting