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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorMorales, José A.
dc.contributor.authorAdams Monell, Glorynette
dc.date.accessioned2020-12-15T13:39:11Z
dc.date.available2020-12-15T13:39:11Z
dc.date.issued2010
dc.identifier.citationAdams Monell, G. (2010). Reliability of operators performing the visual inspection of parenteral drug products [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/988
dc.descriptionDesign Project Article for the Graduate Programs at Polytecnic University of Puerto Ricoen_US
dc.description.abstractThe visual inspection of parenteral product filled vials is performed to assure that any damaged or defective unit is detected and removed prior to packaging. This investigation evaluated the visual inspection process of parenteral products with manual handling to enhance actual process and reduce regulatory exposure. It challenged the probabilistic inspection results due to variability within operators and inspection time. A total of three (3) different standard sets of 100 vials each were evaluated by three (3) inspectors of high, medium and low experience level. The study concluded with a 95% confidence level that there is no significant difference between the results obtained at forty (40) and fifty (50) seconds inspection time neither between the interaction of inspectors and inspection time but that there is significant difference between operators. Consequently, initial and continuous training are essential elements for the quality assurance of the visual inspection process. Key Terms – analysis of variance, operators reliability, parenteral products, visual inspectionen_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesSpring-2010;
dc.relation.haspartSan Juanen_US
dc.subject.lcshAnalysis of varianceen_US
dc.subject.lcshPharmaceutical technology--Quality control
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleReliability of Operators performing the Visual Inspection of Parenteral Drug Productsen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic Universy of Puerto Rico, Graduate Schoolen_US


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