Work Item
ASTM WK71734

New Guide for Standard Guide for Operational Qualification of Ethylene Oxide Chambers used for Terminal Sterilization

1. Scope

1.1 This document provides guidance on operational qualification tests for Ethylene Oxide (EO) sterilizers . The tests are not requirements but may help the user gain an increased understanding of operational aspects of their EO chamber. Based on facility-specific assessments for routine operation, certain tests listed in this document may be deemed to be unnecessary and omitted. 1.2 Requirements for Operational Qualification are dependent on the application of the irradiation process and fall not under the scope of this document. For example, requirements for OQ when sterilizing healthcare products can be found in ISO 11135.. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. 1.4 A change to the EO chamber or operation is a component of the change control process. The OQ testing following the change is determined and required to be part of the change control documentation.

Keywords

Ethylene Oxide Sterilization; EO; EO Chamber;

Rationale

There is no standardized approach for operational qualification of an ethylene oxide chamber used for terminal sterilization of healthcare products. This will be used to support the requirements for EO sterilization of healthcare products as defined in ISO 11135.

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

Details

Developed by Subcommittee: E61.06

Committee: E61

Staff Manager: Stephen Mawn

Work Item Status

Date Initiated: 01-31-2020

Technical Contact: Kenneth Aston

Item: 001

Ballot: E61.06 (22-01)

Status: In Balloting