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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 ...
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 ...
Handling and Managing of Vial Rejects
(Polytechnic University of Puerto Rico, 2021)
A large accumulation of filled vial
rejects generated in an aseptic filling line of a
parenteral medication was identified to be in the
custody of the Quality Assurance department
indefinitely. Using the DMAIC methodology ...
Mejoras al Proceso de Empaque parala Jurisdicción de China
(Polytechnic University of Puerto Rico, 2022)
En los últimos dieciocho meses, el mundo ha confrontado retos con el suministro de materia prima. En esta empresa no es la excepción, además, la productividad redujo, los desperdicios aumentaron y el tiempo de ...
Optimization in the Account Registration Process in Automated Equipment
(Polytechnic University of Puerto Rico, 2022)
Over the years technology has increased in the manufacturing areas. Companies have moved to obtain automated equipment for the manufacture of their products. In the pharmaceutical industry, this equipment has been implemented ...
Workflow Management in the Batch Record Review Process
(Polytechnic University of Puerto Rico, 2022)
The review of Batch Records creates a story of the materials, manufacturing, and packaging involved in the production of
biopharmaceuticals. The Master Batch Record details who, when, where, and how each process stage is ...
Feasibility Study of Proposed Manufacturing Layout Re-design to Improve Process Capacity and Reduce Cycle Time of a Downstream Operation of Product A
(Polytechnic University of Puerto Rico, 2022)
Lean Six Sigma tools and methodologies are widely used in today’s work environments. The use of a Lean Six Sigma approach provides organizations more flexibility and efficiency to improve their competitiveness. At the ...