Assessment of Performance Qualification of UV-C LED Disinfection and Hydrogen Peroxide Mist-Based Systems Against Geobacillus stearothermophilus

UV-C LED systems have emerged as a chemical-free alternative to hydrogen peroxide (H2O2) mist-based technologies. This study assesses the sporicidal efficacy of a UV-C LED HLD system under clinically relevant conditions using performance qualification (PQ) and compares its outcomes with two established H2O2 mist devices. The effectiveness of Lumicare ONE® UV-C LED system and two H2O2 mist systems (trophon® EPR and trophon®2) in achieving a 6 log10 reduction was evaluated using Geobacillus stearothermophilus spores as challenge test. Tests were conducted under three conditions: bare-metal non-flamed, bare-metal flamed, and packaged (glassine or Tyvek®), with indicators positioned at both upper and lower chamber locations. AOAC 966.04 carrier tests using bacterial spores were also performed to confirm log-reduction performance. Under clinically representative bare-metal conditions, both non-flamed and flamed, Lumicare ONE achieved complete sporicidal efficacy at all chamber positions, matching the performance of the H2O2 mist systems. Under non-relevant (packaged) conditions, only the H2O2 systems passed the test, which is consistent with packaging materials that allowed H2O2 penetration, but blocked UV-C. AOAC carrier testing confirmed > 6 log10 reductions following a 90 s UV-C cycle. Overall, when evaluated using appropriate PQ criteria, the UV-C LED system delivered efficacy equivalent to H2O2 systems while providing a fast and chemical-free HLD option for semi-critical probes.