Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products

ASTM E2629-20

ASTM E2629-20

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

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ASTM E3077-17

ASTM E3077-17

Superseded Historical

Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers

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ASTM E2898-20

ASTM E2898-20

Superseded Historical

Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

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ASTM F838-15a

ASTM F838-15a

Superseded Historical

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

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ASTM E1564-00(2014)

ASTM E1564-00(2014)

Superseded Historical

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

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ASTM E1565-00(2014)

ASTM E1565-00(2014)

Superseded Historical

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

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ASTM E1566-00(2014)

ASTM E1566-00(2014)

Superseded Historical

Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen

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ASTM E2503-13e1

ASTM E2503-13e1

Superseded Historical

Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus

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ASTM F838-15

ASTM F838-15

Superseded Historical

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

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ASTM E2475-23

ASTM E2475-23

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Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

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ASTM E2810-23

ASTM E2810-23

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

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ASTM E3042-16(2024)

ASTM E3042-16(2024)

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

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ASTM E3418-23e1

ASTM E3418-23e1

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

€94.00

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ASTM E3177-24

ASTM E3177-24

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Standard Guide on Sampling for Process Analytical Technology

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ASTM E2363-23

ASTM E2363-23

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Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry

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