Pharmaceutical Application Standards

    ASTM's pharmaceutical application standards cover process control, design, and performance, as well as quality acceptance/assurance tests for the pharmaceutical manufacturing industry. These pharmaceutical application standards are valuable to manufacturers of pharmaceuticals and pharmaceutical equipment, federal agencies, design professionals, professional societies, trade associations, financial organizations, and academia.

    List of pharmaceutical application standards developed by ASTM:

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    General Biopharmaceutical Standards

    E1564 - 00(2019) Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
    E1565 - 00(2019) Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures
    E1566 - 00(2019) 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(2019) 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
    E3230 - 20 Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-Use Components and Assemblies Designed for Use in Biopharmaceutical Manufacturing
    E3231 - 19 Standard Guide for Cell Culture Growth Assessment of Single-Use Material
    E3244 - 20 Standard Practice for Integrity Assurance and Testing of Single-Use Systems
    E3251 - 20 Standard Test Method for Microbial Ingress Testing on Single-Use Systems

    General Pharmaceutical Standards

    E2500 - 20 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
    E2503 - 13(2020) Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus
    E2537 - 16 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
    E2656 - 16 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
    E2810 - 19 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
    E3051 - 16 Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing
    E3060 - 16 Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy
    E3077 - 17e2 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
    E3106 - 18e1 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
    E3219 - 20 Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)
    E3263 - 20 Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues
    F838 - 20 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration


    E3250 - 21 Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze Drying

    Process Understanding and PAT System Management, Implementation and Practice

    E2475 - 10(2016) Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
    E2476 - 16 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
    E2629 - 20 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
    E2891 - 20 Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications
    E2898 - 20a Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
    E2968 - 14 Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry
    E3177 - 18 Standard Guide on Sampling for Process Analytical Technology


    E2363 - 14 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

    Other standards developed by ASTM committees:

    3D Imaging Standards

    Additive Manufacturing Standards

    Adhesive Standards

    Aerospace Material Standards

    Analytical Chemistry Standards

    Asset Management Standards

    Atmospheric Analysis Standards

    Biotechnology Standards

    Construction Standards

    Business Copy Product Standards

    Carbon Standards

    Catalyst Standards

    Cement Standards and Concrete Standards

    Coal Standards and Gas Standards

    Composite Standards

    Computerized System Standards

    Consumer Product Evaluation Standards

    Copper Standards

    Corrosion Standards and Wear Standards

    Durability of Nonmetallic Material Standards

    Electrical Insulating Material Standards

    Electrical Standards and Magnetic Conductor Standards

    Electronics Standards

    Environmental Standards

    Fastener Standards

    Fatigue Standards and Fracture Standards

    Fire Standards and Flammability Standards

    Forensic Science Standards

    Geotechnical Engineering Standards

    Glass Standards and Ceramic Standards

    Industrial Chemical Standards

    Industrial Hygiene Standards and Safety Standards

    Laboratory Testing Standards

    Leather Standards

    Masonry Standards

    Medical Device Standards and Implant Standards