Guidance on development and qualitifcation of visual inspection methods for the detection of particulate matter in single-use bioprocessing equipment (single-use systems)
singe-use systems; visual inspection; defect detection; particulate matter
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.
The title and scope are in draft form and are under development within this ASTM Committee.
Date Initiated: 07-22-2023
Technical Contact: Klaus Wormuth
Item: 000
Ballot:
Status: