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.
Keywords
membrane filter; membrane microscopy; microscopy; particulate matter; pharmaceuticals; development
Rationale
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.
Work Item Status
Date Initiated: 07-22-2023
Technical Contact: Klaus Wormuth