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H&K Capsule Filling Equipment Reliability
(Polytechnic University of Puerto Rico, 2013)
Encapsulation is a process whereby the
dose is charged into a hard gelatin capsule;
powder, pellets, tablets or combinations of two or
more of these may be filled into the capsules.
Capsules provide a convenient way ...
Determination of In-Processing Manufacturing Impact into Elution Rate of Drug Eluting Steroid Collars
(Polytechnic University of Puerto Rico, 2012)
Abstract - The Food and Drug Administration provides regulations for combination products. The medical device industry needs to comply with these regulations specifically in products containing drug. One of the many ...
Development of Bulk Shipping Studies in Pharmaceutical Industry
(Polytechnic University of Puerto Rico, 2012)
Abstract ⎯ A bulk shipping study in the pharmaceutical industry consists in monitoring and analyzing the environmental conditions (e.g. temperature and relative humidity) during shipping and transportation of the drug ...
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 ...