Subcommittee E55.04 on General Biopharmaceutical Standards


    Showing results 1-6 of 6 matching ACTIVE standards under the jurisdiction of E55.04     E55 Home

    E1564-00(2014) Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials

    E1565-00(2014) Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures

    E1566-00(2014) Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen

    E2097-00(2014) Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products

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

    E3042-16 Standard Practice for Process Step to Inactivate Rodent Retrovirus with Triton X-100 Treatment

    Showing results 1-6 of 6 matching Proposed New Standards under the jurisdiction of E55.04     E55 Home

    WK43975 New Practice for Determining and Characterizing BioProcess Extractables from Components, Subassemblies, and Assemblies Used in Single-Use Applications: Part 1-Preparation of Extractables Test Solutions

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

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

    WK48084 New Practice for Determining and Characterizing Leachables Released from Materials Used in Single-Use Systems under Bioprocess Operating Conditions

    WK57807 Characterizing Particulate Matter from Single-Use Systems at Supplier Factory

    WK54630 Extraction of Particulate Contamination from Single Use Components

    Showing Results 1-12 of 12 matching WITHDRAWN standards under the jurisdiction of E55.04     E55 Home

    E1285-06 Standard Guide for Identification of Bacteriophage Lambda (λ) or Its DNA (Withdrawn 2014)

    E1286-00(2006) Standard Guide for Identification of Herpes Simplex Virus or Its DNA (Withdrawn 2014)

    E1298-06 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)

    E1470-92(2006) Standard Test Method for Characterization of Proteins by Electrophoretic Mobility (Withdrawn 2014)

    E1493-06 Standard Guide for Identification of Bacteriophage M13 or Its DNA (Withdrawn 2014)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