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Alternate Raw Material Supplier Validation
(Polytechnic University of Puerto Rico, 2019)
This article discusses the Process Validation of Over the Counter Pharmaceutical Product using alternate supplier of raw material. The primary ibuprofen drug substance supplier for GSK Ibuprofen family products informed ...
Material Qualification Process Improvement to Reduce the Cycle Time
(Polytechnic University of Puerto Rico, 2019)
This project was focused in improving
the material qualification process, reducing the
cycle time. A Documentation Checklist and Tracking
Sheet System were created as part of the
improvements. The Documentation Checklist ...
Optimización en el Proceso de Configuración de Recetas en los Sistemas de Serialización
(Polytechnic University of Puerto Rico, 2019)
La serialización en la industria
farmacéutica de Estados Unidos es uno de los
nuevos procesos que lleva pocos años de
implementado. En el mes de noviembre del 2018
fue efectivo que para poder vender y/o distribuir
productos ...
Neuromodulator Device Scrap Reduction Using DMAIC Methodology
(Polytechnic University of Puerto Rico, 2019)
This research project was focused in the
Scrap reduction in a final electrical test area of a
medical device company. The scrap is defined as the
number of dollars per units resulting from the cost of
rejected units ...
Improving the custom-built applications computerized system validation lifecycle for a medical device company
(Polytechnic University of Puerto Rico, 2019)
This research project was focused in the
improvement of the Custom-Built Applications
Computerized System Validation Lifecycle for a
Medical Device Company. A Computerized System
Validation is the process of documenting ...
Yield improvement for anesthesia product at filling & packaging line
(Polytechnic University of Puerto Rico, 2019)
In the manufacturing process of
anesthesia, the yield for Fluxane product,
manufactured at ANESTHER Healthcare, is
consistently performing lower than target (2.785
bottles/kg) from tank F-SV-001 in comparison to
tank ...
Mejoras de Proceso en una Línea de Producción
(Polytechnic University of Puerto Rico, 2019)
El siguiente proyecto se llevó a cabo mediante la implementación de la metodología DMAIC en conjunto a la de 6S, buscando como resultado aumentar la eficiencia en una línea de producción. Este proyecto forma parte de la ...
Particle detection tool for liquid product inspection machines
(Polytechnic University of Puerto Rico, 2019)
Improvements opportunities were found
during the inspection process of recent
manufactured lots in new manufacturing single-use
technology, which was validated due to expected
increase in product demand. An increase ...
Validation Documents Process Optimization and Cost Reduction
(Polytechnic University of Puerto Rico, 2019)
Every manufacturing and regulated site, performs multiple Validation Documents; being this area one of the most material cost and man hour consuming of the site. FMEA and Design Documents are constantly generated and revised ...
Improvements of the US Army’s Maintenance Management GCSS Accounts Registration Process
(Polytechnic University of Puerto Rico, 2019)
This project explores the pattern of
active and effective accounts within the Global
Combat Support System, the Army’s maintenance
software, among key users and how in-proper
practices related to decreased mission ...