6 June 1997 New sterilization technologies alternative to ethylene oxide
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Abstract
Sterilization of biomedical devices may induce bulk and surface modification, responsible for the decrease or loss of their biofunctionality. Pure ethylene oxide (EO) at low temperature and new alternative techniques such as cold gas plasma sterilization have been developed for heat-sensitive polymers. There is a lack of the knowledge concerning their safety in terms of materials damage and consequences on the biofunctionality of sterilized devices. The objective of our work consists in studying bulk and surface changes in biomedical devices induced by these two sterilization techniques. Samples from PVC, Polyurethane, Polyacrylate and Polyethylene-based medical devices are subjected to 1, 5, and 10 sterilization cycles by Steri-Vac-3M (pure EO), Sterrad-100$TM, J&J (gas plasma + H2O2), and studied by X-rays photoelectron spectroscopy. Preliminary results show an increasing in Oxygen/Carbon ratio by a factor of 1.3 to 4.4 between the first and tenth cycle indicating the surface oxidation by gas plasma sterilization processes. Some changes in C-C chemical bounding are associated with EO sterilization.
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Maryam Tabrizian, Sophie Lerouge, Anne Debrie, L'Hocine Yahia, "New sterilization technologies alternative to ethylene oxide", Proc. SPIE 3042, Smart Structures and Materials 1997: Smart Sensing, Processing, and Instrumentation, (6 June 1997); doi: 10.1117/12.275767; https://doi.org/10.1117/12.275767
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