Layer of Protection Analysis on Sterilization Process Using Ethylene Oxide

Gurkan Karakas¹, Woo Jong Shin² and Kyoshik Park*³

Received: January 17, 2018;   Published: January 29, 2018

DOI: 10.26717/BJSTR.2018.02.000698

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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.

Key words: Layer of protection analysis (LOPA); Sterilization Process; Ethylene Oxide; Independent Protection Layer (IPL); Risk

Abbreviations: LOPA: Layer of protection analysis; IPL: Independent Protection Layer; EO: Ethylene Oxide; FDA: Food and Drug Administration; PSM: Process Safety Management; HAP: Hazardous Air Pollutant; CAA: Clean Air Act; CNS: Central Nervous System; NIOSH: National Institute for Occupational Safety and Health; IARC: International Agency for Research on Cancer; OSHA: Occupational Safety and Health Administration; PEL: Permissible Exposure Limit; STEL: Short-Term Exposure Limit; PPE: Personal Protection Equipment; KETEP: Korea Institute of Energy Technology Evaluation and Planning; MOTIE: Ministry of Trade, Industry & Energy

Abstract| Introduction| EO sterilization process| Hazard Evaluation| Scenario Development| Likelihoods of Events| Determining The Frequency of Scenarios| Result and Discussion| Conclusion| Acknowledgment| References|