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Recomendaciones para la Mitigación de Eventos de Control de Plagas en Áreas de Manufactura de Industria Farmacéutica Ubicada en Gurabo, PR
(Polytechnic University of Puerto Rico, 2022)
Debido al alza en eventos de control de plagas en una industria farmacéutica ubicada en el área de Gurabo es que se realizó esta investigación. La palabra plaga significa cualquier animal o insecto no deseado ...
Strategy for the Reduction of False Rejects in the Visual Inspection of Injectable Drug Products
(Polytechnic University of Puerto Rico, 2022)
A hundred percent visual inspection is performed as part of the manufacturing process of injectable drug products as a regulatory
requirement to detect and remove units with defects to protect the patients. The rejection ...
Design Project for Process Improvement of the Manufacturing of Electrode Ring –Monolithic Controlled Released Devices (MCRDs)
(Polytechnic University of Puerto Rico, 2021)
Medtronic Rice Creek Pharmaceutical Operations at Fridley, Minnesota currently build the Electrode Ring, Monolithic Controlled Released Device (MCRD) assembly which is sent to Medtronic Villalba ...
Improvement of Paterson Kelly V-Blender Ventilation System
(Polytechnic University of Puerto Rico, 2019)
This paper presents the successful
improvement and implementation of ventilation
system modifications in a Patterson Kelly VBlender used in Upjohn (Pfizer Division)
Pharmaceutical located at Barceloneta, Puerto
Rico. ...
Optimización del Proceso de Revisión de los Registros de Manufactura
(Polytechnic University of Puerto Rico, 2018)
La consistencia en la ejecución de las tareas en la industria farmacéutica es uno de los factores más importantes para obtener un producto de calidad. Se utilizó el concepto Lean y la metodología DMAIC para optimizar el ...
Computer System Validation CSV in Data Integrity Implementation Strategies for Pharmaceutical Industry
(Polytechnic University of Puerto Rico, 2018)
Computer System Validation CSV in Data Integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original ...
Optimization of pharmaceutical product production lots at granulation manufacturing stage
(Polytechnic University of Puerto Rico, 2018)
The customer of ABD Company wants
the CY product to meet 7% 40 mesh requirement in
80% of the lots requested. The company has two
granulators that are used for the manufacturing of
the product but one of them typically ...
Shipping and Transportation Studies to Evaluate Drug Product Quality
(Polytechnic University of Puerto Rico, 2015)
Many pharmaceutical or
biotechnological products require transport using
temperature-controlled systems to maintain their
therapeutic properties. There are presently no
official guidelines for testing pharmaceutical
products ...
Development of a Generic Pharmaceutical Solid Dosage Form Using Quality by Design (QbD)
(Polytechnic University of Puerto Rico, 2014)
The Pharmaceutical Generic Sector
has been growing over the past years and it is
expected to surpass brand drugs in sale over next
years. The FDA now recommends Quality by
Design to develop Generic Drugs. The present
work ...
Enhancement of Batch Review Report for Annual Product Reviews in the Pharmaceutical Industry
(Polytechnic University of Puerto Rico, 2015)
The pharmaceutical industry is required
to comply with various regulatory agencies which
determine the industry capabilities for compliance
and allow the marketing of their products.
Regardless the regulatory agency ...