Requirements for development and validation of procedures for the visual inspection of 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 validation of visual inspection procedures for the detection of defects in single-use systems applied in biopharmaceutical manufacturings. The new standard will be used by single-use system manufacturers to help in the development and validation of robust visual inspection procedures.
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