Abstract

A novel impermeable sterile pouch is developed to allow the forced convective heating mechanism for improving the sterilization cycle. The heating process is parametrically investigated to obtain an optimized condition in which a sterilization load is heated from 20 to 45 °C within 2min, and the forced convection is experimentally and numerically analyzed to find that the convection coefficient is dramatically increased to 450 W/m2K when compared with the conventional natural convection coefficient of 80 W/m2K. The optimized heating process is applied to a sterilization cycle using the impermeable pouch, and the overall sterilization cycle is found to be completed within 7.5min whose performance is validated by using a process challenge device.

Highlights

  • The need for appropriate disinfection is emphasized by various occurrences resulting from improperly decontaminated patientcare items

  • The ethylene oxide (EO) gas has been used as a sterilant of the low-temperature (37–63 ○C) chemical sterilizer since the 1950s, and it was considered as a representative of chemical sterilization method

  • The EO gas sterilization produces the effective decontamination for various medical devices at low temperature, the hospitals and clinics are gradually reducing the use of this kind of the toxic sterilization method

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Summary

INTRODUCTION

The need for appropriate disinfection is emphasized by various occurrences resulting from improperly decontaminated patientcare items. The low-temperature chemical sterilizer was developed for reusing heat sensitive medical devices where the sterilization cycles are processed by utilizing chemicals, such as ethylene oxide (EO) and hydrogen peroxide.. The EO gas sterilization produces the effective decontamination for various medical devices at low temperature, the hospitals and clinics are gradually reducing the use of this kind of the toxic sterilization method. It is important to emphasize that the heating process is not efficient especially under a vacuum condition in which the hydrogen peroxide sterilization is operated, and the overall sterilization cycles normally take about 1 h.14–17. A novel low-temperature sterilization system using an impermeable pouch is presented, which allows forced convective heating to complete an overall sterilization cycle within 7.5 min. The heating mechanism is investigated experimentally and numerically, and the overall sterilization cycles are validated by using a process challenge device (PCD)

EXPERIMENTAL SETUP
RESULTS AND DISCUSSION
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