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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorNieves Castro, Rafael A.
dc.contributor.authorMartínez Zeno, Héctor
dc.date.accessioned2020-09-17T12:36:00Z
dc.date.available2020-09-17T12:36:00Z
dc.date.issued2014
dc.identifier.citationMartínez Zeno, H. (2014). Major cleaning periodic monitoring reduction in a solid dosage pharmaceutical plant [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/716
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractRegulatory agencies expected that pharmaceutical industries must demonstrated with a high degree of assurance the effectiveness, consistency and reproducibility of the cleaning process in producing visually clean surfaces and reducing microbial levels, active ingredient and detergent residues to acceptable limits. Also, once the cleaning processes are validated, it is required to periodically assess to evaluate if the cleaning process maintained its validated state. An evaluation of the cleaning process for Pharmaceutical Company XYZ was performed. Using a risk based approach and groping strategies for active ingredient and equipment, the periodic monitoring exercise was reduced for more than 50%. Key Terms – Cleaning Validation, Periodic Monitoring, Risk Based Approach, Worse Case Scenario.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesWinter-2014;
dc.relation.haspartSan Juanen_US
dc.subject.lcshCleaning
dc.subject.lcshDrug factories
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleMajor Cleaning Periodic Monitoring Reduction in a Solid Dosage Pharmaceutical Planten_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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