Abstract

The sterilization of medical devices is critical in the prevention of infections in healthcare settings. Ethylene oxide (EtO), gamma irradiation, and steam sterilization have been the standard sterilization processes in healthcare settings, where the packaging system remains the most important barrier between the sterilized instrument/device. Safety concerns and regulatory pushback on conventional sterilization methods have pushed for further research on new sterilization techniques. Among the emerging sterilization technologies, one candidate that has garnered considerable attention is Supercritical CO2 sterilization. However, there is a lack of literature to support the compatibility between scCO2 and common medical packaging materials. The present study evaluated the mechanical performance and seal strength of various medical packaging configurations before and after the scCO2 sterilization process. After evaluating the effect of scCO2 sterilization on the tensile properties, seal strength, and visible condition of several medical packaging configurations, it is apparent that the response to scCO2 sterilization varied considerably among the materials tested. Some structures retained a majority of their mechanical performance, while others experienced substantial reductions in tensile or seal strength. The Tyvek/nylon–PE pouch demonstrated a stable overall performance, while the BOPA/EZ Peel pouch experienced the greatest reductions in multiple mechanical properties and seal strength. Visible dimensional and surface changes were also observed in selected packaging formats such as the thermoformed PETG trays. These findings demonstrate that compatibility depends on the complete packaging structure, including the porous material, coating, sealant, multilayer film, sealed interface, and package geometry. The results should be considered as a preliminary evaluation rather than a complete validation of the sterile barrier systems. However, the results provided a good screening for the necessary validation of compatibility between packaging materials and scCO2 sterilization in order for it to have a wider application and become a more established sterilization method in the future.

Publication Date

8-3-2026

Document Type

Thesis

Student Type

Graduate

Degree Name

Packaging Science(MS)

Department, Program, or Center

Packaging Science

College

College of Engineering Technology

Advisor

Carlos Diaz-Acosta

Advisor/Committee Member

Alison Tyler

Advisor/Committee Member

Christopher Donnelly

Campus

RIT – Main Campus

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