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 matter

Rationale

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.

Details

Developed by Subcommittee: E55.07

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 07-22-2023

Technical Contact: Klaus Wormuth

Item: 000

Ballot:

Status: