Work Item
ASTM WK87242

New 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. Scope

Guidance on best practices to apply in the development of test methods that apply automated membrane microscopy (AMM) to the measurement of particulate matter present in parenteral pharmaceutical manufacturing processes and drug products.


membrane filter; membrane microscopy; microscopy; particulate matter; pharmaceuticals; development


No standardized test methods exist using automated membrane microscopy (AMM) test methods to measure particulate matter in pharmaceuticals manufacturing. AMM are complicated test methods and there is little guidance on development in published literature. The audience for the standard will be analytical method developers working in process equipment and final containers manufacturing, along with method developers in parenternal drug product manufacturing.

The title and scope are in draft form and are under development within this ASTM Committee.


Developed by Subcommittee: E55.07

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 07-22-2023

Technical Contact: Klaus Wormuth