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

de Souza Botelho-Almeida, T; Lourenço, FR; Kikuchi, IS; Awasthi, R; Dua, K; Andreoli Pinto, TDJ

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

de Souza Botelho-Almeida, T Lourenço, FR Kikuchi, IS Awasthi, R Dua, K

Andreoli Pinto, TDJ

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Publication Type:: Journal Article
Citation:: Journal of Pharmaceutical Innovation, 2018, 13 (2), pp. 87 - 94
Issue Date:: 2018-06-01

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Field	Value	Language
dc.contributor.author	de Souza Botelho-Almeida, T	en_US
dc.contributor.author	Lourenço, FR	en_US
dc.contributor.author	Kikuchi, IS	en_US
dc.contributor.author	Awasthi, R	en_US
dc.contributor.author	Dua, K https://orcid.org/0000-0002-7507-1159	en_US
dc.contributor.author	Andreoli Pinto, TDJ	en_US
dc.date.issued	2018-06-01	en_US
dc.identifier.citation	Journal of Pharmaceutical Innovation, 2018, 13 (2), pp. 87 - 94	en_US
dc.identifier.issn	1872-5120	en_US
dc.identifier.uri	http://hdl.handle.net/10453/128300
dc.description.abstract	© 2018, Springer Science+Business Media, LLC, part of Springer Nature. 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 106 CFU/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 < 106 CFU/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.	en_US
dc.relation.ispartof	Journal of Pharmaceutical Innovation	en_US
dc.relation.isbasedon	10.1007/s12247-017-9308-7	en_US
dc.subject.classification	Pharmacology & Pharmacy	en_US
dc.title	Evaluating the Potential, Applicability, and Effectiveness of Ozone Sterilization Process for Medical Devices	en_US
dc.type	Journal Article
utslib.citation.volume	2	en_US
utslib.citation.volume	13	en_US
utslib.for	1115 Pharmacology and Pharmaceutical Sciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Graduate School of Health
utslib.copyright.status	closed_access
pubs.issue	2	en_US
pubs.publication-status	Published	en_US
pubs.volume	13	en_US

Abstract:

© 2018, Springer Science+Business Media, LLC, part of Springer Nature. 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 106 CFU/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 < 106 CFU/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.

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http://hdl.handle.net/10453/128300