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.