Work Item
ASTM WK87243

New Practice for Visual Inspection of Single-Use Bioprocessing Equipment

1. Scope

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.


Developed by Subcommittee: E55.07

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 07-22-2023

Technical Contact: Klaus Wormuth