Work Item
ASTM WK80611

Withdrawal of E2097-00(2014) Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products


This standard is being balloted for withdrawal with no replacement because the content does not reflect current thinking or practice in the industry. Moreover, the BioPhorum extractables protocol has assumed de facto standard status.


Developed by Subcommittee: E55.04

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 01-20-2022

Technical Contact: Jeffrey Carter

Item: 002

Ballot: E55 (22-01)

Status: Ballot Item Approved

Item: 000