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.
Date Initiated: 10-26-2020
Technical Contact: Klaus Wormuth
Item: 001
Ballot: E55 (23-04)
Status: In Balloting