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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorNieves Castro, Rafael A.
dc.contributor.authorBurgos Reyes, Louise
dc.date.accessioned2024-01-11T14:53:36Z
dc.date.available2024-01-11T14:53:36Z
dc.date.issued2023
dc.identifier.citationBurgos Reyes, L. (2023). Process Validation: Batch Size Increase in the Downstream Process [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/2003
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractThe worldwide demand for the drug substance has increased by 30%. The drug substance is an ingredient used in the final product formulation, which later becomes the medicine that will reach the patients. The challenge that is faced is production limitations, which is driven by customer demand increased compared to previous years. Engineering uses historical data from the process to analyze and forecast the impact of the improvement. Then, the team captured key metrics to measure the impact of the implementation to validate if it was providing the planned yield. As a result of the implementation and validation strategy, the findings showed that flexibility to change different parameters and equipment functionality by reducing the amount of testing to confirm that the process fulfills the acceptance criteria included in the testing protocols, which includes Operation Verification, Performance Verification and Process Validation. Key Terms - Batch Size, Capacity increase, Drug Substance (DS), Process Validation (PV).en_US
dc.language.isoenen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Competitiveness;
dc.relation.ispartofseriesFall-2023;
dc.relation.haspartSan Juanen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Researchen_US
dc.subject.lcshPharmaceutical industry--Quality controlen_US
dc.titleProcess Validation: Batch Size Increase in the Downstream Processen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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