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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorPabón González, Miriam
dc.contributor.authorRuiz Vargas, José J.
dc.date.accessioned2020-11-12T17:58:11Z
dc.date.available2020-11-12T17:58:11Z
dc.date.issued2009
dc.identifier.citationRuiz Vargas, J. J. (2009). Development of vaporized hydrogen peroxide (VHP) decontamination cycle for a syringe isolator [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/943
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractAbstract - A parenteral syring filling line inside a closed cabin isolator was installed in an existing manufacturing space. To increase sterility assurance the isolator must be effectively biodecontamined by means of Vapor Hydrogen Peroxide (VHP) to provide a minimum of 6 log-reductions and a residual concentration of VHP of less than 1ppm. During the cycle development phase the operating characteristic and parameters for the decontamination were tested and optimized following the proposed methodology in this article. Final adjustment of the injection quantities was based upon results of the worst case biological indicator tests performed during the study. Based on the results, parameters and validation testing were established to provide for complete destruction of all biological indicators. Key Terms - H2O2 decontamination, cycle development, biological indicator (BI), chemical indicator (CI)en_US
dc.language.isoenen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Competitiveness;
dc.relation.ispartofseriesSpring-2009;
dc.relation.haspartSan Juanen_US
dc.subject.lcshMedical instruments and apparatus industry--Quality controlen_US
dc.subject.lcshDecontamination--methodsen_US
dc.subject.lcshManufacturing processes--Quality controlen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleDevelopment of Vaporized Hydrogen Peroxide (VHP) Decontamination Cycle for a Syringe Isolatoren_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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