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dc.contributor.authorMcEvoy, Brian
dc.date.accessioned2022-12-07T11:38:06Z
dc.date.available2022-12-07T11:38:06Z
dc.date.copyright2022
dc.date.issued2022-09
dc.identifier.citationMcEvoy, B. (2022). Critical studies on the novel development and implementation of Vaporized Hydrogen Peroxide (VH2O2) for terminal sterilization of medical devices encompassing use of flow cytometry for the real-time commensurate monitoring of microbial inactivation. Thesis (Doctor of Philosophy - PhD). Technological University of the Shannon: Midlands Midwest.en_US
dc.identifier.urihttps://research.thea.ie/handle/20.500.12065/4331
dc.description.abstractAims and Rationale: Sterilization microbiology relies on determining the linearity of microbial survivor curves for calculating decimal reduction times (D-values) that is used to inform sterility assurance levels (SAL), critical to efficacious sterilization of medical device for patient care application. Medical devices play an important role in the provision of healthcare, with a global market estimated at $432bn and expected to surpass $650bn by 2028. Terminal sterilization of medical devices is currently provided by established methods including Gamma, E-beam and X-ray radiation with Ethylene Oxide gas sterilization continuing to be the method of choice due to wide ranging material compatibility. Given the hazards associated with EO gas, alternative methods are actively being pursued by the global medical device industry. Furthermore, there is an increasing opportunity to develop sustainable sterilization microbiology processes necessary to meet emerging needs including evolution of device features containing heat sensitive polymers, inclusion of sensor technology and biologics. This constitutes the first, and timely study to (i) establish and alternative method using vaporized hydrogen peroxide (VH2O2) at an industrial sterilization scale and (ii) report on the linearity of microbial inactivation plots for treated Geobacillus stearothermophilus and Bacillus atrophaeus spores to demonstrate the appropriateness of process validation as a means of confidently determining SAL.en_US
dc.formatPDFen_US
dc.language.isoengen_US
dc.publisherTechnological University of the Shannon: Midlands Midwesten_US
dc.rightsAttribution-Non-Commercial-Share-Alike-3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-sa/3.0/us/*
dc.subjectVaporized Hydrogen Peroxide (VH2O2)en_US
dc.subjectMedical devices - Sterilizationen_US
dc.subjectFlow cytometryen_US
dc.subjectMicrobial inactivationen_US
dc.titleCritical studies on the novel development and implementation of Vaporized Hydrogen Peroxide (VH2O2) for terminal sterilization of medical devices encompassing use of flow cytometry for the real-time commensurate monitoring of microbial inactivationen_US
dc.typeinfo:eu-repo/semantics/doctoralThesisen_US
dc.contributor.affiliationTechnological University of the Shannon: Midlands Midwesten_US
dc.description.peerreviewyesen_US
dc.identifier.orcidhttps://orcid.org/0000-0003-4644-9009en_US
dc.rights.accessrightsinfo:eu-repo/semantics/openAccessen_US
dc.subject.departmentDepartment of Pharmaceutical Sciences and Biotechnology TUS:MMen_US


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