ABSTRACT

The first ethylene oxide (EtO) commercial application was related to spices sterilization and/or fumigation. EtO is predominantly used in the sterilization process of medical devices, such as intravenous sets, cardiopulmonary and anesthesiology devices. The activity of EtO, similar to many other disinfectants, preservative, and sterilizing agents, such as formaldehyde, beta-propiolactone, methylbromide, and ethylenimine, depends on an alkylation reaction. The major source of worker exposure to EtO in the plant is the degassing operation after removal from the sterilizer. Pressures may be balanced and a modern computer that controls 100% EtO sterilizer is a very versatile piece of equipment. The use of 100% EtO sterilization techniques offers low residuals due to the more efficient EtO removal from the package by the deep vacuum. According to the standard, the sterilization process using EtO shall include preconditioning and/or conditioning, sterilization cycle, and aeration. A double check for EtO concentration is required during sterilization.