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 1-5 of 5 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

    WK43742 New Practice for characterizing particulates burden from single-use systems

    E1285-06 Standard Guide for Identification of Bacteriophage Lambda (λ) or Its DNA (Withdrawn 2014)

    E1286-00(2006) Standard Guide for Identification of Herpes Simplex Virus or Its DNA (Withdrawn 2014)

    E1298-06 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)

    E1470-92(2006) Standard Test Method for Characterization of Proteins by Electrophoretic Mobility (Withdrawn 2014)

    E1493-06 Standard Guide for Identification of Bacteriophage M13 or Its DNA (Withdrawn 2014)

    E1531-00(2006) Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Growth on Agarose Medium (Withdrawn 2014)

    E1532-00(2006) Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-Binding Fluorochrome (Withdrawn 2014)

    E1533-00(2006) Standard Practice for Indirect Detection of Mycoplasma in Cell Culture by 4`-6-Diamidino-2-2 Phenylindole (DAPI) Staining (Withdrawn 2014)

    E1536-00(2006) Standard Practice for Detection of Mycoplasma Contamination of Bovine Serum by Large Volume Method (Withdrawn 2014)

    E1759-95(2003) Standard Test Method for Isoaspartic Acid in Proteins: Method for the Determination of Asparagine Deamidation Products (Withdrawn 2003)

    E1873-06 Standard Guide for Detection of Nucleic Acid Sequences by the Polymerase Chain Reaction Technique (Withdrawn 2014)

    E2048-99(2006) Standard Guide for Detection of Nucleic Acids of the Mycobacterium Tuberculosis Complex and Other Pathogenic Mycobacteria by the Polymerase Chain Reaction Technique (Withdrawn 2014)