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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 ...
Automatización de una Manejadora de Aire con Purificador Integrado
(Polytechnic University of Puerto Rico, 2021)
Un centro comercial tomóla decisión de automatizar su sistema de unidades de aire acondicionado. Esto se realizócon el fin de generar un ahorro energético en un periodo corto de tiempo. El númerode ...
Control Strategy design of a Continuous Direct Compression Process for Oral Solids Dosages using Resident Time Distribution Studies
(Polytechnic University of Puerto Rico, 2021)
In a continuous process any deviation from the intended process parameters can cause an unreliable product and economical losses.Residence time is a measure of how much time any given material or ...
Plc Modification for Fill and Close Stopping Sequence Improvement
(Polytechnic University of Puerto Rico, 2020)
From November 2020 to January 2021,
an analysis was made looking for the best way to
increase the yield of the machines in charge of the
dry process when making a contact lens. In this
analysis, it was discovered that ...
Molecular Weight Test Method Validation and HPLC System Qualification
(Polytechnic University of Puerto Rico, 2020)
The Molecular Weight (Mw) Test
Method is performed by a contract laboratory.
Performing the method externally affects the
product release timeframe and represents
additional costs when the results are required to ...
Final Device Quality Control Unit Operation Optimization
(Polytechnic University of Puerto Rico, 2020)
With the intent of achieving cost
reduction initiatives, the Quality Control Unit
operation regarding the final device release was
identified as a labor cost opportunity. Through
kaizen events done across site, it was ...
Improvements to Perfusion Skids 66501/66502/66503 Operations Used for Enbrel Product in AML-06
(Polytechnic University of Puerto Rico, 2020)
Amgen AML-06 Drug Product Plant is
a multi-product facility where therapies for chronic
diseases are manufactured. Its systems are
designed for the continuous improvement of the
processes, in order to comply with the ...