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 val-idated 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.