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Implementation of an alternate single use system used to store buffer solutions of Product X
(Polytechnic University of Puerto Rico, 2022)
This research project was focused on the implementation of an alternate material used in the preparation of buffers of the production for Product X in a biotechnology company. Buffers are solutions that can resist pH change ...
Implementación de Lean Six Sigma y las Buenas Prácticas de Almacenamiento en una Empresa Puertorriqueña
(Polytechnic University of Puerto Rico, 2022)
Las organizaciones de regulación y control han desarrollado normativas a nivel internacional que deben cumplirse en todos los establecimientos que lleven a cabo productos de uso humano. Es por esto, ...
Coating Process Improvement
(Polytechnic University of Puerto Rico, 2021)
An increase in the number of events associated to AQLfailure that resulted on partial batch rejections was observed in 2020 for Tablets/Caplets formulations due to cosmetic conditions ...
Design and Implementation of a Quota Tracker for a Pharmaceutical Sales Team
(Polytechnic University of Puerto Rico, 2022)
The pharmaceutical industry has undergone significant change in recent decades and has adapted to new social, economic, and technological structures. Thinking about the commercial area of ...
Implementación de Documentación GMP para el Area de Recibo
(Polytechnic University of Puerto Rico, 2022)
Este proyecto investigativo tiene como propósito mejorar el proceso de la documentación elaborada por parte del Área de Recibo para una Farmacéutica. El objetivo principal es mejorar el ...
Validation and Project Process Improvement Using DMAIC Methodology
(Polytechnic University of Puerto Rico, 2021)
Lean Six Sigma Methodology impacts positively the efficiency, customer satisfaction and quality for manufacturing and systematics process. This article provides a successful example of how the Sig Sigma ...
Implementación de programa para la prevención de mosquitos
(Polytechnic University of Puerto Rico, 2022)
Se utilizó la metodología DMAIC para implementar un programa para la prevención de mosquitos. Para el desarrollo del proyecto, fue necesario definirlos aspectos básicos para resolver el problema, identificar ...
Labeling and Packaging Process Improvement Using DMAIC Methodology
(Polytechnic University of Puerto Rico, 2022)
Medical Device Companies must ensure that each unit of product has unique identification and that it is labeled correctly. Labeling requirements include having the appropriate data on the label, not ...
Change Control Routed with Missing Information Delaying Approval and Implementation Date
(Polytechnic University of Puerto Rico, 2022)
The approval of manufacturing change control for MedDevice Inc., is currently acting lower than target(15 business days). Based on a 12-months data review, the lead time of approval of a change is approximately ...
Monomer’s Residuals Test Elimination for Soft Acrylic Buttons at Polytechnic University of Puerto Rico
(Polytechnic University of Puerto Rico, 2022)
In the cataract surgery, the natural lens in the eye is replace with an Intraocular Lens. Five monomers (EA/EMA, TFEMA, EGDMA, UV Chr) are mixed to produce the soft acrylic lens. Residual monomer testing ...