Validation of ethylene oxide sterilization of disposable electronic analgesia infusion pumps

Abstract

IntroductionTo validate the effect of ethylene oxide sterilization of disposable electronic analgesia infusion pumps and determine the residual amount.MethodsAccording to ISO 11135：2014 Sterilization of Healthcare Products⁃Ethylene Oxide⁃Requirements for the Development， Validation and Routine Control of Sterilization Process for Medical Devices， qualification of physical cycle performance and microbial cycle performance were conducted on disposable electronic analgesia infusion pumps， and sterilization effect was then validated by using sterility test. According to ISO 10993⁃7：2008 Biological Evaluation of Medical Devices—Part 7： ethylene oxide sterilization residuals， the residual amount of ethylene oxide were further measured.ResultsThe sterilization effect fulfilled the requirements under the physical conditions of 38.0‒45.4 ℃ and 46%‒81% humidity. When the temperature was lower than 35 ℃ and the humidity was higher than 71%， the bacterial tablets remained fully activated after the sterilization with ethylene oxide. The shortest survival time without biological indicator after exposure to ethylene oxide was 8h. Furthermore， the residual amount of ethylene oxide after the sterilization was lower than the minimum detection limit.ConclusionAll tested products are sterilized. Sterilization equipment and sterilization process fulfilled the requirements of ISO 11135：2014. Additionally， the sterilization residual amount conforms to the limit values of ISO 10993⁃7：2008.

Keywords

• ethylene oxide
• sterilization
• residual amount
• validation