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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 ...
Process Validation: Batch Size Increase in the Downstream Process
(Polytechnic University of Puerto Rico, 2023)
The worldwide demand for the drug substance has increased by 30%. The drug substance is an ingredient used in the final product formulation, which later becomes the medicine that will reach the patients. The challenge that ...