ASTM E3425-24

Standard Guide for Development of Automated Membrane Microscopy Test Methods for the Counting and Sizing of Particulate Matter Present in Parenteral Pharmaceutical Manufacturing Processes and Final Drug Products

Published by	Publication Date	Number of Pages
ASTM	2024	17

Category ASTM Industry Pharmaceutical Standards

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ASTM E3425 – Standard Guide for Development of Automated Membrane Microscopy Test Methods for the Counting and Sizing of Particulate Matter Present in Parenteral Pharmaceutical Manufacturing Processes and Final Drug Products

1.1Â This guide provides guidance on the development of test methods that apply automated membrane microscopy (AMM) to the measurement of extraneous solid insoluble particulate matter present in parenteral pharmaceutical manufacturing processes and drug products. For the validation requirements for AMM test methods see Practice E3411.