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.

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.

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General Biopharmaceutical Standards

E2097-00(2014) Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products (Withdrawn 2022)

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

E1564-00(2019) Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials

E1566-00(2019) Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen

E1565-00(2019) Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures

E2888-12(2019) Standard Practice for Process for Inactivation of Rodent Retrovirus by pH

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

E3230-20 Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-Use Components and Assemblies Designed for Use in Biopharmaceutical Manufacturing

E3251-20 Standard Test Method for Microbial Ingress Testing on Single-Use Systems

E1286-00(2006) Standard Guide for Identification of Herpes Simplex Virus or Its DNA (Withdrawn 2014)

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Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-Binding Fluorochrome (Withdrawn 2014)

E1536-00(2006) Standard Practice for Detection of Mycoplasma Contamination of Bovine Serum by Large Volume Method (Withdrawn 2014)

E1873-06 Standard Guide for Detection of Nucleic Acid Sequences by the Polymerase Chain Reaction Technique (Withdrawn 2014)

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Standard Test Method for Isoaspartic Acid in Proteins: Method for the Determination of Asparagine Deamidation Products (Withdrawn 2003)

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

E1298-06 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)

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Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Growth on Agarose Medium (Withdrawn 2014)

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

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

E3336-22 Standard Test Method for Physical Integrity Testing of Single-Use Systems

E3326-22 Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry

E3259-22 Standard Practice for Process to Remove Retroviruses by Small Virus Retentive Filters

General Pharmaceutical Standards

E2500-20 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

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

E2656-16 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute

E2537-16 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing

E3106-18e1 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation

E3077-17e2 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers

E2810-19 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units

E2503-13(2020) Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus

E3219-20 Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)

F838-20 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

E3263-22 Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

Lyophilization

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

Process Understanding and PAT System Management, Implementation and Practice

E2629-20 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems

E2968-14 Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry

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

E3177-18 Standard Guide on Sampling for Process Analytical Technology

E2474-14 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)

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

Terminology

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