Validation of ethylene oxide-sterilization using a new measuring system.

Area of Science:

• Sterilization processes
• Medical device manufacturing
• Analytical chemistry

Background:

• Parametric release of medical devices sterilized with ethylene oxide (EO) has been hindered by the absence of real-time monitoring methods.
• Accurate measurement of critical process parameters is essential for ensuring sterility and safety.

Purpose of the Study:

• To develop and validate a mobile system for online measurement of physical parameters during EO sterilization.
• To enable parametric release of medical devices sterilized with EO.

Main Methods:

• Development of a mobile system capable of online measurement of EO concentration, humidity, temperature, and pressure within the sterilization chamber.
• Validation of measurement accuracy for key parameters.

Main Results:

• The developed system allows for online measurement of all critical physical parameters during EO sterilization.
• Achieved measurement accuracy: EO concentration and humidity < +/- 1%, temperature < +/- 0.05°C, and pressure < 0.5% of the measured value.

Conclusions:

• The mobile system facilitates online monitoring of EO sterilization, paving the way for parametric release.
• This advancement enhances the efficiency and reliability of medical device sterilization processes.