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Optimization, Standardization and Revision of the Label Review Policies and Procedures Manual using Lean Six Sigma at Polytechnic University of Puerto Rico
(Polytechnic University of Puerto Rico, 2022)
The Label Review Department focuses on reviewing other companies label for compliance with FDA regulations by providing a one-on-one service accompanied with a report with recommended changes and a print-ready graphic file. ...
Unidirectional Flow Gasket
(Polytechnic University of Puerto Rico, 2022)
To reduce the number of deviations that occur annually in the plant, through a design, it is expected to reduce this problem taking into consideration the cost factor, lead time and the quality of the products made. Using ...
Evaluation of Residual Protein ELISA Stability of Precoated Plates and Assay Control in a Hight Throughput Environment
(Polytechnic University of Puerto Rico, 2022)
Evaluation of Enzyme Linked Immunoassay Sorbent Assay (ELISA) overall stability on precoated plates to appraise Residual Protein levels in a wide variety of drug substance samples and filtration process reduces turn around ...
Incremento del proceso productivo, línea PMK1 en Edwards Lifesciences, Santo Domingo, R. D. Mediante las herramientas de Lean Manufacturing
(Universidad Politécnica de Puerto Rico, 2020)
El objetivo de este proyecto fue investigar el proceso productivo o "productividad" de la línea PMK1, de Edwards Lifesciences en Santo Domingo, República Dominicana, para proponer mejoras apropiadas con un alto impacto del ...
Registros de Calidad en la Industria de Dispositivos Médicos: Uso Electrónico o Manual/Papel
(Universidad Politécnica de Puerto Rico, 2020)
ste reporte intenta comprobar planteamientos relacionados a ventajas del uso de los registros electrónicos versus los registros manuales/papel en empresas de dispositivos médicos, al identificar indicadores clave del negocio ...
Productivity Increase by Means of Critical Process Automation for Edwards Lifesciences
(Universidad Politécnica de Puerto Rico, 2020)
Due to the boom in exports of medical devices, the effort to maintain product quality has increased, but productivity has remained unchanged. In the free zone industries, direct labor is one of the variation factors that ...
Impacto de la Terminación de las Superficies del Material Base Para la Adherencia en el Proceso de Sobremoldeo
(Universidad Politécnica de Puerto Rico, 2020)
El sobremoldeo consiste en el moldeo por inyección de una sustancia sobre otra. El propósito de estas tecnologías es producir componentes multifuncionales con una variedad de colores y/o materiales y unir las características ...
Changeover Process Optimization for a Medical Device Manufacturer in Haina, Dominican Republic
(Universidad Politécnica de Puerto Rico, 2020)
The medical device industry has the critical mission of saving and sustaining lives of patients being affected by chronical diseases. To these companies, having more available time to produce will enable and facilitate ...
Improvement in the Visibility of Nonconforming Product Inventory and Reduction
(Polytechnic University of Puerto Rico, 2022)
One of the major problems reported in a company is the Nonconforming product inventory, reducing the availability to use space for new production lines and storage of conforming product. Company wants to understand why the ...
Internal Audit Program - Quality Inspection in the Manufacturing Process to Identify Improvements in Quality Control
(Polytechnic University of Puerto Rico, 2022)
Implement a preventive operations in-process auditing system with final inspection points at Company J, that monitors product, packaging configuration, and documentation execution to assure product manufacturing specifications ...