Ethylene Oxide Sterilization

Abstract

This chapter explores the principles and validation approaches used for Ethylene Oxide (ETO) sterilization and delineates the necessary routine process control requirements. In ETO sterilization processes used for medical devices, there are protective layers surrounding the device and supportive packaging present requiring extensive pre-humidification of the load to ensure that adequate humidity permeates the load to the target location. The typical ETO sterilization processes in contemporary use are defined by their extensive usage for medical devices and are minimally adapted for other applications. The growing awareness of ETO’s safety and toxicity concerns in the 1980s resulted in changes of a different sort. Pharmaceutical manufacturers that once employed ETO in-house for equipment and other sterilization gradually changed their practices. ETO sterilization is ordinarily carried out in jacketed chambers much like those utilized for steam sterilization. The safety and toxicity concerns ETO are such that contract sterilization firms provide the majority of the global capacity.