ASTM WK46236

    Withdrawal of E2097 - 00(2006) Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products

    (What is a Work Item?)

    Active Standard: E2097 - 00(2014)

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


    This standard is being balloted for withdraw because the subcommittee did not feel that the standard was currently being used and other guidance exists. The subcommittee welcomes volunteers to review the document to bring it to current practices. If it is still being used, please vote negative and provide the subcommittee where or by whom it is being used/referenced.


    biotechnology products; components; cytotoxicity; extractables; extraction; raw materials;
    Citing ASTM Standards
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    Work Item Status

    Date Initiated:

    Technical Contact:
    Robert Steininger II

    Draft Under Development