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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorMorales, José A.
dc.contributor.authorFigueroa-Rodríguez, Jorge
dc.date.accessioned2020-12-23T17:29:51Z
dc.date.available2020-12-23T17:29:51Z
dc.date.issued2020
dc.identifier.citationFigueroa-Rodríguez, J. (2020). Buffer formulation vent filter re-use at parenteral manufacturing plant [Unpublished manuscript]. Graduate Schoolen_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/1038
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractFor sterilization-in-place cycles that used vent filters as a redundant non-contact product, the filter membranes could be re-used several times without impacting their integrity neither compromising the sterilization cycle. At a parenteral manufacturing plant in Puerto Rico, the vent filter is discarded after exposed to a one-single sterilization-in-place cycle. With the implementation of this project, the vent filter used during the sterilization-in-place as part of the buffer formulation at Manufacturing Plant can be re-used up to 50 times. With DMAIC (Define, Measure, Analysis, Improve and Control) quality strategy, the use of vent filters during buffer formulation at Manufacturing Plant was improved. Under DMAIC, the sterilization conditions of the filter’s manufacturers was identified as the worstcase sterilization scenario. Also, validation activities were executed to confirm no moisture residual particles were found in the vent filter membrane after multiples consecutives sterilization cycles. At the end, this project implementation will provide better manufacturing flexibility and costsavings for up to USD 105,000 yearly. Key Terms ⎯ reuse filter, steaming, sterilization-in-place, vent filteren_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Competitiveness;
dc.relation.ispartofseriesSpring-2020;
dc.relation.haspartSan Juanen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Researchen_US
dc.subject.lcshSix sigma (Quality control standard)
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Posters
dc.titleBuffer Formulation Vent Filter Re-Use at Parenteral Manufacturing Planten_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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