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    Area of Science:

    • Medical Device Sterilization
    • Industrial Microbiology
    • Process Engineering

    Background:

    • Ethylene oxide (EO) sterilization relies on biological indicators or parametric release (PR) per ISO 11135:2014.
    • Current PR methods face challenges with gas analyzer probes for measuring EO concentration and humidity.
    • ISO 11135:2014 limits PR based on control parameters like EO concentration and humidity.

    Purpose of the Study:

    • To evaluate statistical process control for detecting deviations in EO sterilization.
    • To demonstrate the use of reliable process data for PR.
    • To explore alternative methods for measuring critical parameters.

    Main Methods:

    • Analysis of process data from 100 routine EO sterilization cycles.
    • Trending of chamber relative humidity (RH), temperature, and EO concentration.
    • Comparison of process-derived data with gas analyzer probe measurements.

    Main Results:

    • Statistical process control effectively predicted process failures.
    • Calculating EO/water concentration via pressure increment proved a viable alternative to gas analyzer probes.
    • Reduced variability in key parameters allows for decreased sterilant usage.

    Conclusions:

    • Statistical process control enhances the reliability of EO sterilization monitoring.
    • Process-derived data, particularly via pressure increment, can support PR.
    • Optimized parameter control leads to more efficient and potentially safer sterilization processes.