Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products

ASTM E3263-22

ASTM E3263-22

Superseded Historical

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

This product is not for sale, please contact us for more information

View more
ASTM E3418-23

ASTM E3418-23

Superseded Historical

Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices

This product is not for sale, please contact us for more information

View more
ASTM E2476-09

ASTM E2476-09

Superseded Historical

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

This product is not for sale, please contact us for more information

View more
ASTM E2629-11

ASTM E2629-11

Superseded Historical

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

This product is not for sale, please contact us for more information

View more
ASTM E2810-11

ASTM E2810-11

Superseded Historical

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

This product is not for sale, please contact us for more information

View more
ASTM E2537-08

ASTM E2537-08

Superseded Historical

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

This product is not for sale, please contact us for more information

View more
ASTM E2475-10

ASTM E2475-10

Superseded Historical

Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

This product is not for sale, please contact us for more information

View more
ASTM E2656-10

ASTM E2656-10

Superseded Historical

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

This product is not for sale, please contact us for more information

View more
ASTM E2500-07

ASTM E2500-07

Superseded Historical

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

This product is not for sale, please contact us for more information

View more
ASTM E2363-06a

ASTM E2363-06a

Superseded Historical

Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

This product is not for sale, please contact us for more information

View more
ASTM E2474-06

ASTM E2474-06

Superseded Historical

Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

This product is not for sale, please contact us for more information

View more
ASTM E1565-00(2006)

ASTM E1565-00(2006)

Superseded Historical

Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures

This product is not for sale, please contact us for more information

View more
ASTM E1566-00(2006)

ASTM E1566-00(2006)

Superseded Historical

Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen

This product is not for sale, please contact us for more information

View more
ASTM E2097-00(2006)

ASTM E2097-00(2006)

Superseded Historical

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

This product is not for sale, please contact us for more information

View more
ASTM E1564-00(2006)

ASTM E1564-00(2006)

Superseded Historical

Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials

This product is not for sale, please contact us for more information

View more