List of Pharmaceutical Application Standards

• ASTM F838 – Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
• ASTM E3326 – Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry
• ASTM E3336 – Standard Test Method for Physical Integrity Testing of Single-Use Systems
• ASTM E3244 – Standard Practice for Integrity Assurance and Testing of Single-Use Systems
• ASTM E3250 – Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze Drying
• ASTM E3251 – Standard Test Method for Microbial Ingress Testing on Single-Use Systems
• ASTM E3263 – Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
• ASTM E3230 – Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-Use Components and Assemblies Designed for Use in Biopharmaceutical Manufacturing
• ASTM E3231 – Standard Guide for Cell Culture Growth Assessment of Single-Use Material
• ASTM E3219 – Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)
• ASTM E3177 – Standard Guide on Sampling for Process Analytical Technology
• ASTM E3106 – Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
• ASTM E3077 – Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
• ASTM E3051 – Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing
• ASTM E3060 – Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy
• ASTM E3042 – Standard Practice for Process Step to Inactivate Rodent Retrovirus with Triton X-100 Treatment
• ASTM E2968 – Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry
• ASTM E2898 – Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
• ASTM E2888 – Standard Practice for Process for Inactivation of Rodent Retrovirus by pH
• ASTM E2891 – Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications
• ASTM E2810 – Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
• ASTM E2656 – Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
• ASTM E2629 – Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
• ASTM E2537 – Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
• ASTM E2503 – Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus
• ASTM E2500 – Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
• ASTM E2474 – Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)
• ASTM E2475 – Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
• ASTM E2476 – Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
• ASTM E2363 – Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
• ASTM E2097 – Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products (Withdrawn 2022)
• ASTM E2048 – Standard Guide for Detection of Nucleic Acids of the Mycobacterium Tuberculosis Complex and Other Pathogenic Mycobacteria by the Polymerase Chain Reaction Technique (Withdrawn 2014)
• ASTM E1873 – Standard Guide for Detection of Nucleic Acid Sequences by the Polymerase Chain Reaction Technique (Withdrawn 2014)
• ASTM E1759 – Standard Test Method for Isoaspartic Acid in Proteins: Method for the Determination of Asparagine Deamidation Products (Withdrawn 2003)
• ASTM E1564 – Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
• ASTM E1565 – Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures
• ASTM E1566 – Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen
• ASTM E1531 – Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Growth on Agarose Medium (Withdrawn 2014)
• ASTM E1532 – Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-Binding Fluorochrome (Withdrawn 2014)
• ASTM E1533 – Standard Practice for Indirect Detection of Mycoplasma in Cell Culture by 4`-6-Diamidino-2-2 Phenylindole (DAPI) Staining (Withdrawn 2014)
• ASTM E1536 – Standard Practice for Detection of Mycoplasma Contamination of Bovine Serum by Large Volume Method (Withdrawn 2014)
• ASTM E1493 – Standard Guide for Identification of Bacteriophage M13 or Its DNA (Withdrawn 2014)
• ASTM E1470 – Standard Test Method for Characterization of Proteins by Electrophoretic Mobility (Withdrawn 2014)
• ASTM E1285 – Standard Guide for Identification of Bacteriophage Lambda (λ) or Its DNA (Withdrawn 2014)
• ASTM E1286 – Standard Guide for Identification of Herpes Simplex Virus or Its DNA (Withdrawn 2014)
• ASTM E1298 – Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)