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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 ...
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 ...
Data Integrity Implementation Strategy for Pharma Industry
(Polytechnic University of Puerto Rico, 2017)
Data integrity is fundamental in a
pharmaceutical quality system which ensures that
medicines are of the required quality as decisions
on product quality are made based on the data.
Electronic data and computerized ...
Implementación de Estrategias para lograr Cero- Errores o Defectos En las Operaciones durante Proceso de Granulación
(Polytechnic University of Puerto Rico, 2012)
Sipnósis- Un producto realizado con errores en documentación, pone en riesgo la efectividad, autenticidad y la integridad del mismo. Es por esto que debemos evitar cualquier desviación en el proceso, realizando una ...
Reduction of Time in a Manufacturing Process for a Pharmaceutical Company Located in Puerto Rico
(Polytechnic University of Puerto Rico, 2012)
Abstract - The project is developed in a chemical plant of a pharmaceutical company in Puerto Rico. In 2011 the company had an increase in market demand of the active ingredient of one product. To ensure the profit plan, ...
Engineering Study for the Feeding Operation Process of a Continuous Manufacturing Line
(Polytechnic University of Puerto Rico, 2016)
The use of continuous operations in
solid-dosage manufacturing is growing rapidly and
bringing benefits within pharmaceutical industry.
One of the benefits that the continuous operation
provides is that the development ...
Serialization and the Future of Product Traceability
(Polytechnic University of Puerto Rico, 2016)
Since the beginning of pharmaceutical
products and drugs, counterfeiting has been a
worldwide issue. Packed with minimal punishment,
illegal internet sales and unsecured physical
packaging, it has grown into an estimate ...
Manufacture and Evaluation of an Experimental 37.5 kg Scale Batch of 0.103% w/w Ethinyl Estradiol Triturate (Formulation Number WC3074-01I)
(Polytechnic University of Pueto Rico, 2016)
Actavis Fajardo, is a Pharmaceutical
company dedicated to the manufacturing and
packaging of oral contraceptive products. Ethinyl
Estradiol is an intermediate product used to
incorporate Ethinyl Estradiol active in ...
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 ...
Implementation of a Special USB Device for the Reduction of Time to Access Computers Remotely in HVAC Testing
(Polytechnic University of Puerto Rico, 2012)
Abstract ⎯ This article describes the application of the five Six Sigma methodologies known as the five DMAIC phases Define, Measure, Analyze, Improve and Control using the application of HVAC (Heating, Ventilation and Air ...