E55

ASTM E2097-00(2014)

ASTM E2097-00(2014)

Withdrawn Most Recent

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Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products (Withdrawn 2022)

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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Superseded Historical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 E3263-22

ASTM E3263-22

Superseded Historical

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

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ASTM E3326-22

ASTM E3326-22

Active Most Recent

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

€72.00

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ASTM E3244-23

ASTM E3244-23

Active Most Recent

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

€72.00

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ASTM E3060-23

ASTM E3060-23

Active Most Recent

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

€72.00

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ASTM E2500-20

ASTM E2500-20

Superseded Historical

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

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ASTM E3251-23

ASTM E3251-23

Active Most Recent

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

€65.00

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ASTM E3336-22

ASTM E3336-22

Active Most Recent

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

€72.00

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ASTM E3250-21

ASTM E3250-21

Active Most Recent

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

€72.00

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ASTM E2475-23

ASTM E2475-23

Active Most Recent

Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

€65.00

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ASTM E2810-23

ASTM E2810-23

Active Most Recent

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

€72.00

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ASTM E2629-20

ASTM E2629-20

Active Most Recent

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

€65.00

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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 E3106-18e1

ASTM E3106-18e1

Superseded Historical

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

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