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Performance evaluation of bactericidal effect and endotoxin inactivation by low‐temperature ozone/hydrogen peroxide mixed gas exposure
Author(s) -
Nomura Yusuke,
Yamamura Junji,
Fukui Chie,
Fujimaki Hideo,
Sakamoto Kazuyuki,
Matsuo Kenichi,
Kuromatsu Hisashi,
Kikuchi Yutaka,
Haishima Yuji
Publication year - 2021
Publication title -
journal of biomedical materials research part b: applied biomaterials
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.665
H-Index - 108
eISSN - 1552-4981
pISSN - 1552-4973
DOI - 10.1002/jbm.b.34840
Subject(s) - sterilization (economics) , chemistry , hydrogen peroxide , limulus amebocyte lysate , geobacillus stearothermophilus , microbiology and biotechnology , food science , chromatography , biochemistry , medicine , immunology , biology , thermophile , lipopolysaccharide , enzyme , foreign exchange , monetary economics , economics , foreign exchange market
This study evaluated the performance of a new O 3 /H 2 O 2 mixed gas sterilization instrument for killing microorganisms and inactivating bacterial endotoxin at low temperatures. Sterility assurance level was achieved by an over 6‐log reduction of Geobacillus stearothermophilus ATCC 12980, and the decimal reduction value was 0.77 min in sterilization mode. A reduction of over 3 logs in Limulus amebocyte lysate coagulation activity of purified endotoxin from Escherichia coli was observed after treatment in endotoxin‐inactivation mode. The same inactivation ability was observed when treating dried bacterial cells. Biomaterials made of polymer or metal did not exhibit cytotoxicity after gas exposure at O 3 concentrations below 200 ppm. As the results of human cell‐based pyrogen testing, significant amounts of endotoxin that were over the limit for medical devices contacting cerebrospinal fluid (2.15 EU/device) were detected on scissors washed with a washer‐disinfector and sterilized with ethylene oxide or autoclaving. In contrast, endotoxin decreased to 0.29 ± 0.05 EU/device after O 3 /H 2 O 2 mixed gas sterilization in endotoxin‐inactivation mode. Compared to conventional gas sterilization methods, O 3 /H 2 O 2 mixed gas has high sterilization ability and a strong capacity to inactivate endotoxin. It is expected that this sterilization technology will improve the safety of reusable medical devices and utensils for regenerative medicine.