ASTM WK73120
Revision of E3106 - 18e1 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
Active Standard: E3106 - 18e1
Developed by Subcommittee: E55.03 | Committee E55 | Contact Staff Manager
WK73120
Keywords
acceptance limits; CIP; cleaning development; cleaning validation; PAT; risk-based; science-based;;Rationale
With the approval and publication of E3219, along with new publications, and some new regulatory guidance coming out, the cleaning team has been seeing the need to update the E3106 to include references to the E3219 and these other items. Some definitions need to be added. Some sections need additional text for clarification.
Back to TopWork Item Status
Date Initiated:
05-23-2020
Technical Contact:
Andrew Walsh
Status:
Draft Under Development