WK74514 - New Practice for Measurement of Particulate Matter in Pharmaceuticals using Automated Membrane Microscopy

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).

Keywords

microscopy; pharmaceutical

Rationale

no existing standard practice for this topic

Details

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Status: Withdrawn From Balloting

Item: 003

Ballot: E55 (23-07)