ASTM WK43742

    New Practice for Characterizing Particulate burden from Single-Use Systems for End-user Impact Assessment

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



    WK43742

    1. Scope

    1.1 This practice is applicable to all product path components (fluid or powders) of pharmaceutical and biopharmaceutical Single-Use manufacturing systems used for parenteral applications that have the potential to affect product quality and patient safety. It can be also used for applications of lower criticality. 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 perform a particulates impact assessment for SuS. 1.4 This practice is applicable to both new and existing SuS. The approach may be used for the implementation of changes to existing SuS, and their continuous improvement during operation. 1.5 This practice is applicable throughout the life-cycle of the SuS from concept to retirement. 1.6 This practice is intended to be used by SuS end-users. 1.7 This practice is not intended to be used by SuS manufacturer (Vendors).


    Keywords

    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:
    10-21-2013

    Technical Contact:
    Patrick Evrard

    Status:
    Draft Under Development