Evaluation of disposable medical device packaging materials under ozone sterilization

Abstract

Introduction

Ozonization is an alternative sterilization process for heat-sensitive medical devices. However, the side effects of this process on packaging materials should be verified.

Methods

Four types of commercial disposable packaging for medical devices were evaluated after undergoing ozone sterilization: crepe paper sheet, non-woven fabric sheet (SMS), medical grade paper-plastic pouch and Tyvec©-plastic pouch. For each material, the gas penetration through the microbiological barrier was measured. Other packaging properties, such as chemical composition, color, tactile and mechanical resistance, were also evaluated after sterilization, by using characterization techniques, namely microbiological indicators, infrared spectroscopy, tensile test and optical microscopy.

Results

All commercial disposable packaging showed good ozone penetration. Crepe paper and SMS were chemically and mechanically modified by ozone, while Tyvec© only suffered mechanical modification. Paper-plastic pouch was the packaging material which just experienced an acceptable reduction in tensile resistance, showing no variations on chemical or visual properties.

Conclusion

The results suggest that medical grade paper-plastic pouch is the most appropriate disposable medical device packaging to be sterilized by ozone when compared to other materials.

Keywords
Ozone; Packaging; Medical device; Sterilizer; FTIR; Tensile test