Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products

ASTM E3231-19

ASTM E3231-19

Superseded Historical

Standard Guide for Cell Culture Growth Assessment of Single-Use Material

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ASTM E3251-20

ASTM E3251-20

Superseded Historical

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

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ASTM E3051-16

ASTM E3051-16

Superseded Historical

Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing

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ASTM E3060-16

ASTM E3060-16

Superseded Historical

Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy

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ASTM E3177-18

ASTM E3177-18

Superseded Historical

Standard Guide on Sampling for Process Analytical Technology

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ASTM E3042-16

ASTM E3042-16

Superseded Historical

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

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ASTM E2968-14

ASTM E2968-14

Superseded Historical

Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry

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ASTM E3244-20

ASTM E3244-20

Superseded Historical

Standard Practice for Integrity Assurance and Testing of Single-Use Systems

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ASTM E3219-20

ASTM E3219-20

Superseded Historical

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

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ASTM E3230-20

ASTM E3230-20

Superseded Historical

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

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ASTM E2656-16

ASTM E2656-16

Superseded Historical

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

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ASTM E2537-16

ASTM E2537-16

Superseded Historical

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

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ASTM E2363-14

ASTM E2363-14

Superseded Historical

Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

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ASTM E2475-10(2016)

ASTM E2475-10(2016)

Superseded Historical

Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

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ASTM E2476-16

ASTM E2476-16

Superseded Historical

Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture

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