Abstract
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.
Highlights
Ozonization is an alternative sterilization process for heat-sensitive medical devices
We evaluate the effects of ozone sterilization in the most common disposable medical device packagings, namely crepe paper, nonwoven fabric sheet, medical grade paper‐plastic pouch and Tyvec -plastic pouch, aiming to establish the ozone sterilization compatibility criteria for common disposable medical device packaging
No color change was visible after sterilization, but, differently than medical grade paper, the tactile verification revealed that the Tyvec ’s mechanical resistance was affected by ozone, generating a fragile and crumbly surface, which could compromise the microbiological barrier after sterilization during manipulation and transportation stress
Summary
Ozonization is an alternative sterilization process for heat-sensitive medical devices. 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. The gas penetration through the microbiological barrier was measured Other packaging properties, such as chemical composition, color, tactile and mechanical resistance, were evaluated after sterilization, by using characterization techniques, namely microbiological indicators, infrared spectroscopy, tensile test and optical microscopy. 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. Evaluation of disposable medical device packaging materials under ozone sterilization.
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