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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorPabón González, Miriam
dc.contributor.authorVázquez Amaro, Luis J.
dc.date.accessioned2020-07-08T16:44:17Z
dc.date.available2020-07-08T16:44:17Z
dc.date.issued2019
dc.identifier.citationVázquez Amaro, L. J. (2019). Clean room differential pressure monitoring improvements [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Riico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/305
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractManufacturing of oral solid dosage (OSD) forms, such tablets and capsules, is performed in a highly regulated environment. One of the guidelines used to provide the minimum requirements that a manufacturer must meet to assure that their products are safe for their intended use is the Good Manufacturing Practice (GMP). This practice gathers the data of the agencies that control the authorization and licensing of the manufacture and sale of food & beverages, pharmaceutical products, and others. A case study will be developed from a European Regulatory Agency recommendation to a Pharmaceutical Company to improve clean rooms differential pressure monitoring strategy, in order to meet the agency standard. Aspects and tools from Process, Automation, and Quality Engineering were used in order to comply with the standard. Additionally, a potential time saving project was identified. Key Terms ⎯ Clean Rooms, Data Historian, Differential Pressure Monitoring, Pharmaceutical.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesSpring-2019;
dc.relation.haspartSan Juan Campusen_US
dc.subject.lcshClean rooms
dc.subject.lcshAir pressure--Measurement
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Posters
dc.titleClean Room Differential Pressure Monitoring Improvementsen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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