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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E1566-00(2019) Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen
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
E1286-00(2006) Standard Guide for Identification of Herpes Simplex Virus or Its DNA (Withdrawn 2014)
E1285-06 Standard Guide for Identification of Bacteriophage Lambda (λ) or Its DNA (Withdrawn 2014)
E1493-06 Standard Guide for Identification of Bacteriophage M13 or Its DNA (Withdrawn 2014)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
E3259-22 Standard Practice for Process to Remove Retroviruses by Small Virus Retentive Filters
E3251-23 Standard Test Method for Microbial Ingress Testing on Single-Use Systems
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)
E3106-22 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
E3177-18 Standard Guide on Sampling for Process Analytical Technology
E2898-20a Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications