ASTM WK64938

    New Practice for the Calculation of Cleaning Validation Limits

    (What is a Work Item?)

    Developed by Subcommittee: E55.03 | Committee E55 | Contact Staff Manager



    WK64938

    1. Scope

    Pharmaceuticals, Biopharmaceuticals, Nutraceuticals, Cosmetics and Medical Devices


    Keywords

    Cleaning, Cleaning Validation, Acceptance Limit, Maximum Safe Carryover, MSC, Total Organic Carbon, TOC, Visual Residue Limit, VRL Visual Inspection, Process Capability, Statistical Process Control, SPC

    Rationale

    This standard will be used to provide guidance on implementing the E3106-18 Standard Guide Science-Based and Risk-Based Cleaning Process Development and Validation and for the upcoming Standard Guide for Derivation of Health Based Exposure Limits (HBELs)

    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:
    08-24-2018

    Technical Contact:
    Andrew Walsh

    Status:
    Draft Under Development