Work Item
ASTM WK87243
New Guide for Visual Inspection of Single-Use Bioprocessing Equipment for Particulate Matter
1. Scope
Guidance on development and qualitifcation of visual inspection methods for the detection of particulate matter in single-use bioprocessing equipment (single-use systems)Keywords
singe-use systems; visual inspection; defect detection; particulate matterRationale
There is a lack of guidance on the development and qualitifcation of visual inspection methods for the detection of particulate matter in single-use systems applied in biopharmaceutical manufacturings. The Guide will be used by single-use system manufacturers to help in the development and qualification of robust visual inspection methods.
Work Item Status
Date Initiated: 07-22-2023
Technical Contact: Klaus Wormuth
Item: 000
Ballot:
Status: