Subcommittee E55.04 on General Biopharmaceutical Standards


    Showing results 1-5 of 5 matching ACTIVE standards under the jurisdiction of E55.04     E55 Home

    E1564-00(2006) Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials

        See also WK46230 proposed withdrawal

    E1565-00(2006) Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures

        See also WK46232 proposed withdrawal

    E1566-00(2006) Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen

        See also WK46233 proposed withdrawal

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

        See also WK46236 proposed withdrawal

    E2888-12 Standard Practice for Process for Inactivation of Rodent Retrovirus by pH

    Showing results 1-8 of 8 matching Proposed New Standards under the jurisdiction of E55.04     E55 Home

    WK43975 New Practice for for determining and characterizing extractables from materials used in single-use applications

    WK39883 New Practice for Process for Inactivation of Enveloped Viruses Using Detergent

    WK43739 New Practice for Process to Remove Virus by Filtration using 20-nm Retentive Viral filter

    WK43741 New Practice for Testing Integrity of Single-Use Systems at Vendors Manufacturing Facilities

    WK43742 New Practice for Characterizing Particulate burden from Single-Use Systems for End-user Impact Assessment

    WK47355 New Practice for Controlling Integrity of Single-Use Systems during Biopharmaceutical manufacturing process at End-user factory

    WK47356 New Practice for Characterizing Particulates Burden from Single-Use Systems at Vendor Factory

    WK47357 New Practice for Application of Single-use System in Pharmaceutical and Biopharmaceutical manufacturing