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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorNieves Castro, Rafael A.
dc.contributor.authorFigueroa Camuñas, Julio C.
dc.date.accessioned2020-10-28T11:28:24Z
dc.date.available2020-10-28T11:28:24Z
dc.date.issued2012
dc.identifier.citationFigueroa Camuñas, J. C. (2012). Determination of in-processing manufacturing impact into elution rate of drug eluting steroid collars [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/916
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractAbstract - The Food and Drug Administration provides regulations for combination products. The medical device industry needs to comply with these regulations specifically in products containing drug. One of the many regulations drug products need to comply with is the elution rate of the active ingredient. Due to the importance of this performance metric, regulations are becoming stricter regarding tolerances and the compliance with these. Combination products have the complexity of many different manufacturing processes that could have an impact on the elution performance, hence the challenge for medical device manufacturers, to get a good understanding of the different process variables that influence this metric and to establish the appropriate controls. The development work and the costs associated to testing, specification setting and lot release make this particular understanding to be critical for the future and success of the business. Key Terms - Dissolution Rate, Elution Rate Mass Fraction, Potency, Steroid Collar.en_US
dc.language.isoenen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesFall-2012;
dc.relation.haspartSan Juanen_US
dc.subject.lcshManufacturing processes--Quality controlen_US
dc.subject.lcshSix sigma (Quality control standard)en_US
dc.subject.lcshPharmaceutical industry--Quality controlen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleDetermination of In-Processing Manufacturing Impact into Elution Rate of Drug Eluting Steroid Collarsen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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