Quantitative Suspension Test for the Evaluation of a Cold Sterilization System Based on Reducing Free Radicals Compared to Autoclave Sterilization Cycles

Sterilization of medical devices is a critical process to ensure patient safety. However, traditional steam autoclaves may be unsuitable for heat-sensitive materials. In this study, we evaluated an innovative cold sterilization system based on the controlled generation of free radicals with reducing properties. The system has already been validated and marketed following the completion of numerous microbiological tests in compliance with UNI EN standards (13727, 13624, 17126, 14476, 14348). A quantitative suspension test was conducted under controlled conditions, comparing the microbial reduction achieved with the cold system to that obtained with a standard autoclave cycle. The system demonstrated bactericidal efficacy exceeding 6 log10, comparable to that of the autoclave cycle. The results suggest that the free radical system represents a safe, rapid, and effective alternative for the sterilization of heat-sensitive materials, with potential applications in both healthcare and industrial settings.