Analysis of Residual Ethylene Oxide in Medical Devices by Headspace Gas Chromatography

Introduction

Ethylene oxide gas (EOG) is a flammable and colorless gas commonly used in a medical device sterilization. Its permitted maximum residual levels are set by a range of international and local organizations, including the International Organization for Standardization (i.e. ISO 10993-7:2008) and Japanese Industrial Standards (i.e. JIS T 0993-7:2012). In these standards, extraction can be either exhaustive or simulated-use. The exhaustive extraction entails a solvent extraction and allows a choice between the following two instrument configurations: the gas chromatograph (GC) and the headspace (HS) -GC. In this article, exhaustive extraction of residual EO by the HS-GC was performed in reference to the JIS and ISO section K.4.4 “Exhaustive Extraction with Ethanol Followed by Headspace Gas Analysis of the Ethanol Extract”.

June 15, 2023 GMT