Work Item
ASTM WK74514

New Practice for Measurement of Particulate Matter in Pharmaceuticals using Automated Membrane Microscopy

1. Scope

The proposed standard practice focuses on the measurement of particulate matter extracted from pharmaceutical processes and products. Described is the procedure for preparation of samples of particles on filter membranes, and the procedures required to reliably analyze the number of particles along with the size parameters of the particles on the filter membrane using automated microscopy methods (microscopic scanning and image analysis of particles on a filter membrane).


microscopy; pharmaceutical


no existing standard practice for this topic

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: 10-26-2020

Technical Contact: Klaus Wormuth

Item: 001

Ballot: E55 (23-04)

Status: In Balloting