Evaluating the Potential, Applicability, and Effectiveness of Ozone Sterilization Process for Medical Devices

de Souza Botelho-Almeida, Túlia; Lourenço, Felipe Rebello; Kikuchi, Irene Satiko; Awasthi, Rajendra; Dua, Kamal; Andreoli Pinto, Terezinha de Jesus

Title: Evaluating the Potential, Applicability, and Effectiveness of Ozone Sterilization Process for Medical Devices
Creator: de Souza Botelho-Almeida, Túlia; Lourenço, Felipe Rebello; Kikuchi, Irene Satiko; Awasthi, Rajendra; Dua, Kamal; Andreoli Pinto, Terezinha de Jesus
Relation: Journal of Pharmaceutical Innovation Vol. 13, Issue 2, p. 87-94
Publisher Link: http://dx.doi.org/10.1007/s12247-017-9308-7
Publisher: Springer
Resource Type: journal article
Date: 2018
Description: Purpose: Ozone (O₃) can be considered the most potent natural germicide against microorganisms (in vegetative and spore forms) with high efficiency and speed, because of its highly oxidizing activity. Despite this, there are a few studies describing the application of ozone as a sterilizing agent of medical devices. The aim of this communication was to describe the development and validation of a sterilization cycle applied to medical devices. Methods: The sterilization process was challenged using Geobacillus stearothermophilus ATCC 7953 spores, which have shown great resistance. The sterilizing effect of ozone was measured using carriers inoculated with 10⁶CFU/mL spores, introduced into a 3-mL syringe and lumens of tubes of different sizes and diameters simulating hospital medical products, which have undergone a half-cycle or complete cycle. Results: The results of sterilization process studied in active vegetative form of microorganisms showed that the ozone sterilization was effective with a bioburden between 10⁵ to 10⁷ CFU/mL with one pulse sterilizing action. The validation of the process was confirmed by the satisfactory results for the half-cycle, corresponding to a treatment with four pulses allowed sterilizing the material with bioburdens < 10⁶CFU/mL spores which indicate an appropriate sterility assurance level. Conclusion: The results showed that the ozone may be considered as effective and promising alternative for sterilization of thermosensitive materials and medical devices.
Subject: low temperature; medical devices; ozone; sterilization
Identifier: http://hdl.handle.net/1959.13/1472357
Identifier: uon:48812
Identifier: ISSN:1872-5120
Language: eng
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