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Preparation of New Drug Application (NDA)/Abbreviated New Drug Application (ANDA) Major and Moderate Post-Approval Changes for Parental Drug Products Site Transfer
(Polytechnic University of Puerto Rico, 2010)
Actually, the Food and Drug Administration is the United States Federal Agency responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products ...
Design of an Environmental Monitoring Program for a New Biotechnology Facility
(Polytechnic University of Puerto Rico, 2010)
A new biotechnology facility in Puerto Rico is in need of an Environmental Program to ensure the stability of room conditions for the manufacturing of their products. This environmental baseline study provided documented ...
High Density Plasma Nitriding on Stainless Steel Alloys at PUPR-MC Plasma Machine
(Polytechnic University of Puerto Rico, 2008)
A novel method of nitriding at high current levels at Polytechnic University of Puerto Rico Mirror Cusp plasma machine (PUPR-MC) has been performed. Nitrogen ions implantation or plasma nitriding increases the hardness at ...
Internet Security As An E-commerce Enabler
(Polytechnic University of Puerto Rico, 2000-06)
In the words of futurist Joel Arthur Barker "when the paradigms shift, everything starts from ground zero". The digital revolution is swiftly reshaping all aspects of life in society "in ways and forms we cannot fully ...
Improving Performance on Information and Technology Systems and Services at a Life Sciences Manufacturing Plant for the Graduate Programs at Polytechnic University of Puerto Rico
(Polytechnic University of Puerto Rico, 2010)
The establishment of a continuous improvement program and culture at a Life Sciences company has giving them great business results. By using Lean ,Six Sigma and Team involvement methodologies areas like Information ...
Production Optimization in the Packaging and Inspection Process at a Thermoforming Area
(Polytechnic University of Puerto Rico, 2010)
This research is conducted in a manufacturing packaging company that makes the packages (plastic trays) for medical device companies. It is intended to increase the packaging and inspection production line by considering ...
Estudio de los Aspectos Ergonómicos en Laboratorios de Control de Calidad en Industrias Farmacéuticas
(Polytechnic University of Puerto Rico, 2010)
El objetivo de esta investigación es conocer, cuan efectivo son los diseños ergonómicos en laboratorios de control de calidad de las industrias farmacéuticas. En esta investigación se realizó una evaluación de los diseños ...
Energy Efficiency Improvement of an Air Handling Unit at a Pharmaceutical Facility by Integration of an Economizer Cycle
(Polytechnic University of Puerto Rico, 2010)
This project presents the design of an economizer cycle for an existing Air Handling Unit (AHU) located at a pharmaceutical facility. At certain low temperatures, the integration of the economizer cycle will allow the AHU ...
Comparison of the Quality System Requirements of Code of Federal Regulations Part 820 and International Standard ISO 13485
(Polytechnic University of Puerto Rico, 2010)
This paper compares the quality system requirements of the Code of Federal Regulations 21 CFR part 820 with the quality system requirements of the International Standard ISO 13485. The medical devices industry that distributes ...
Experimental Design of a High Vacuum System for PUPR-MC Plasma Machine
(Polytechnic University of Puerto Rico, 2008)
In vacuum technology it is customary to divide a large pressure region (as of today, covering 16 orders of magnitude) into single, smaller regions. These divisions are somewhat arbitrary. Thus, the chemists frequently refer ...