Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products

ASTM E3231-19(2025)

ASTM E3231-19(2025)

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

€65.00

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ASTM E3219-25

ASTM E3219-25

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

€94.00

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ASTM E3470-25

ASTM E3470-25

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Standard Guide for Using FMECA and HACCP for Performing Risk Identification, Risk Analysis & Risk Control on Cleaning Processes for Pharmaceuticals and Medical Devices

€94.00

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ASTM E3443-24

ASTM E3443-24

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Standard Guide for Minimizing the Impact of Stability Testing on Batch Yield of Low Yield Biopharmaceutical Products

€65.00

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ASTM E2500-25

ASTM E2500-25

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Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment Science and Risk Based Approach

€65.00

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ASTM E3468-25

ASTM E3468-25

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Standard Practice for Validation of Test Methods for the Counting and Sizing of Particulate Matter on the Surfaces of Single-Use Bioprocessing Equipment

€65.00

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ASTM E3466-25

ASTM E3466-25

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Standard Guide for Development of Test Methods for the Counting and Sizing of Particulate Matter on the Surfaces of Single-Use Bioprocessing Equipment

€72.00

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ASTM E2656-25

ASTM E2656-25

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

€65.00

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ASTM E3051-25

ASTM E3051-25

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

€72.00

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