Work Item
ASTM WK92599

New Guide for Using Total Organic Carbon (TOC) Analysis in Cleaning Validation

1. Scope

This standard will describe best practices for the development and implementation of TOC Analysis as a method for analyzing swab and rinse samples in cleaning validation studies.

Keywords

Total Organic Carbon; TOC; Cleaning Validation

Rationale

There is currently no guidance on how to use TOC Analysis in Cleaning Validation although it is now in wide spread use. Many misconceptions about its use need to be dispelled and clarified. This standard also supports the guidance in E3106.

The title and scope are in draft form and are under development within this ASTM Committee.

Details

Developed by Subcommittee: E55.14

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 10-23-2024

Technical Contact: Andrew Walsh

Item: 000

Ballot:

Status: