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Now showing items 21-30 of 30
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 ...
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 ...
Evolutionary vs. Revolutionary: a Snap Shot of the Current Tendencies in Pharmaceutical Industry and the Impact of Process Analytical Technology and Continuous Manufacturing Processes
(Polytechnic University of Puerto Rico, 2013)
Food and Drug Administration (FDA)
challenges the pharmaceutical industry to innovate
itself and introduce ever higher quality standards
through the use of technology. Development of
continuous manufacturing systems ...
Risk Prevention in Syringe Filling Line in a Pharmaceutical Manufacturing Plant
(Polytechnic University of Puerto Rico, 2013)
Risk prevention in syringe filling line
can be achieved through the implementation of
“Defense in Depth” concepts. Defense in Depth is
based on the integration of 3-layers of operational
controls which are Equipment, ...
Implementation of a Calibration Wireless System in a Pharmaceutical Facility
(Polytechnic University of Puerto Rico, 2012)
Abstract - Regulated industries such as Pharmaceutical, Biotechnology and Medical Devices require a Calibration Program, to guarantee the product quality. The objective of this project was to design Calibration Wireless ...
Smart Camera Mimics Humans Decision Making Process in a Vial Crimp Quality Automated Inspection Process
(Polytechnic University of Puerto Rico, 2013)
Crimp quality is an important attribute
in the vial filling process. It protects the sterility of
the product from manufacturing until it is dispensed.
A pharmaceutical company performed a Failure
Mode and Effect ...
Development of Effectiveness Program through the Use of Productivity Metrics
(Polytechnic University of Puerto Rico, 2014)
The Overall Plant Effectiveness
Program has the purpose to improve the production
capacity and optimize operations performance in
an Active Pharmaceutical Ingredient (API)
manufacturing plant. It requires a complete
analysis ...
Quality System Management for Process Analytical Technology Applications
(Polytechnic University of Puerto Rico, 2013)
Commonly the pharmaceutical industry
uses a system known as the traditional or
conventional process for the manufacturing of their
products. Now, it has been shown that the use of
other systems not only benefits in ...
Modifications to the Purified Water Storage and Distribution System Polytechnic University of Puerto Rico
(Polytechnic University of Puerto Rico, 2013)
The Purified Water is identified to play
an integral role in manufacturing operations.
Careful considerations and good manufacturing
practices must take place in order to minimize
contamination and bacterial load. It ...
Quality Risk Management in the Pharmaceutical Air Compressed Equipment Qualification Process
(Polytechnic University of Puerto Rico, 2013)
In the pharmaceutical industry every
product and every process associated with risks.
To maintain product quality throughout the product
life cycle, too much time and resources are
allocated. Risk is described in recent ...