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(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

    Showing results 1-19 of 19 matching Proposed New Standards under the jurisdiction of E55.04     E55 Home

    WK51896 Aseptic processing of Biopharmaceutical and Pharmaceutical Drug products in sterile packaging under controlled environment

    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

    WK51892 Application of Fill, Finish, and Distribution Steps of Biopharmaceutical and Pharmaceutical Products

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

    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

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

    WK47635 New Test Method for Determining Retention of Large Viruses by Membrane Filters Used in Aqueous Liquid Filtration

    WK47636 New Test Method for Determining Retention of Small Viruses by Membrane Filters Used in Aqueous Liquid Filtration

    WK47637 New Practice for Enumeration of PP7 Bacteriophage

    WK47638 New Practice for Preparation of PP7 Viral Stock

    WK47639 New Practice for Enumeration of PR772 Bacteriophage

    WK47640 New Practice for Preparation of PR772 Viral Stock

    WK48956 New Practice for Biocompatibility of Single-use System at End-user Factory

    WK48957 New Practice for Purity, Biocompatibility and Toxicity of Raw Materials used in the manufacturing of Single-use System

    WK51753 Performing Microbial Ingress Test in Liquid Immersion for Single-use System application

    WK51754 Microbial Ingress Test in Aerosolization for Single-use System application

    WK51755 Standard Practice for Single-use Systems Change Control Management

    WK54630 Standard Test Method for Measurement of Sub-Visible Particulate Contamination in 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)