Layer of Protection Analysis on Sterilization Process Using Ethylene Oxide

Abstract

Layer of protection analysis (LOPA) was conducted on toxic and flammable hazard of sterilization process using ethylene oxide. Hazard associated with the process were studied using HAZOP and scenarios were developed by applying the HAZOP result. For each scenario, independent protection layers (IPLs) were identified and their frequencies were estimated. Three additional IPLs were considered such as personal protection equipment, monitoring device, and ventilation window. By adding such IPLs, the risk was estimated to be reduced to less than chances per million.