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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 ...
Packaging Lines Minor & Minor/Major Changeover Time Reduction on a Pharmaceutical Company
(Polytechnic University of Puerto Rico, 2015)
Every company that wants to be
competitive has to implement SMED or changeover
reduction in every process that this technique could
be applied. The two major difficulties that
companies encounters are: Product ...
Determination of Punches’ Lubrication Parameters for a Tablet Press Machine Using Single Tip Tooling Configuration to Compress an Analgesic Consumer Healthcare Product
(Polytechnic University of Puerto Rico, 2012)
The main goal of this engineering study is to determine a proper set of values for the lubrication interval parameters used for the punches of a tablet press machine. The values obtained will be referred as the starting ...
Attribute Data Treatment of Automated Inspection Vision System For Product Mix-Up Detection
(Polytechnic University of Puerto Rico, 2012)
The pharmaceutical industry continues to grow at an exponential pace, with number of medications being mixed, molded, stamped, and packaged every day in the millions. Regardless of the amount, the margin for error never ...
Enhance Annual Product Review Process at Pharmaceutical Company in Puerto Rico
(Polytechnic University of Puerto Rico, 2014)
Annual Product Review (APR) is a
requirement from Good Manufacturing Practices
(cGMP) under the FDA (Food and Drug
Administration) and European Medicine Agency
(EMEA). The EMEA refers to Annual Product
Quality Review ...
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 ...
Reduction in Dissolution Test Results Variability of A/B Capsule Product
(Polytechnic University of Puerto Rico, 2013)
Since the origins of the agency, the
Food and Drugs Administration (FDA), a scientific,
regulatory, and public health agency had been
dedicated to consumer protection. The FDA,
provides standardized regulations and ...