Medical Device manufacturers need to ensure their processes are validated to meet specific regulatory criteria before releasing a new medical device or product into the market.
The process involves exposing products to a gas mixture of ethylene oxide (ETO) and nitrogen within a vacuum-filled chamber with each cycle consists of five stages – preconditioning and humidification, gas introduction, exposure, evacuation and air washes, approximately 2.5 hours to complete, excluding aeration time. The ETO gas acts as a surface sterilant and the vacuum environment aids the gas to reach most aspects of the device requiring sterilization.
ISO 11135 specify requirements for validation and routine control of an Ethylene Oxide Sterilization Process, whilst U.S. Food and Drug Administration (FDA) requires temperature and relative humidity to be recorded at different intervals during routine ETO processing or validation. As the ETO chamber is airtight, wireless data loggers are the best option.
MadgeTech’s RHTemp1000IS, Temp1000IS data loggers are certified Intrinsically Safe for hazardous conditions and is the No. 1 choice, amongst ETO chamber users, worldwide.
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