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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorNieves Castro, Rafael A.
dc.contributor.authorGonzález Ramírez, Karen
dc.date.accessioned2020-07-16T15:59:29Z
dc.date.available2020-07-16T15:59:29Z
dc.date.issued2017
dc.identifier.citationGonzález Ramírez, K. (2017). Risk-based viable and non-viable monitoring sampling plan for microbial control program within ISO 7 cleanroom [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/410
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractThe project intends to present a sitespecific risk assessment in order to design a custom viable sampling plan for a compounding pharmacy, which aseptically prepares patient-specific therapies. Additionally, the project has the objective to streamline the current sampling plan by reducing non-value adding locations. The risk-based approach will consist of a touch point risk assessment and a traffic flow risk assessment during operational conditions. The compounding operations will be observed during operational conditions to identify frequently touched locations and traffic flow. A total of 15 samples derived from the risk assessments and analysis representing an 81.2% of reduction from the current sampling plan. Key Terms - Compounding, Environmental Monitoring Program (EMPQ), Parenteral, Touch Point, Traffic Flow, Viable/Non-Viable.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Competitiveness;
dc.relation.ispartofseriesWinter-2017;
dc.relation.haspartSan Juanen_US
dc.subject.lcshClean rooms--Microbiology
dc.subject.lcshDrugs--Dosage forms
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleRisk-Based Viable and Non-Viable Monitoring Sampling Plan for Microbial Control Program within ISO 7 Cleanroomen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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