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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorNieves Castro, Rafael A.
dc.contributor.authorCaballero Rodríguez, Alvin
dc.date.accessioned2020-10-13T15:06:41Z
dc.date.available2020-10-13T15:06:41Z
dc.date.issued2013
dc.identifier.citationCaballero Rodríguez, A. (2013). Risk prevention in syringe filling line in a pharmaceutical manufacturing plant [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/843
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractRisk prevention in syringe filling line can be achieved through the implementation of “Defense in Depth” concepts. Defense in Depth is based on the integration of 3-layers of operational controls which are Equipment, Procedure, and Well-Trained Staff. This project will be conducted through all stages of a syringe filling process area in a pharmaceutical company. The objective of this project is to mitigate critical errors and threat to operations through the establishment of the Defense in Depth and thus avoiding costly errors. This project has three main contributions which include evaluating the current state of control of Critical Process Parameters, providing an assessment of the current operational states, and lastly setting the expectation that all future modification to equipment, procedures or staff qualification should consult the methodology to ensure continuous improvement. Through Defense in Depth, this company was able to identify and strengthen vulnerable and high risk areas in a syringe filling line. Key Terms - CAP Analysis, Defense in Depth, FMEA, Risk Assessment.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesSpring-2013;
dc.relation.haspartSan Juanen_US
dc.subject.lcshRisk assessmenten_US
dc.subject.lcshPharmaceutical industry--Quality control
dc.subject.lcshSyringes
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleRisk Prevention in Syringe Filling Line in a Pharmaceutical Manufacturing Planten_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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