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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 ...
Reduce Scrap Loss of a Pacemaker Lead Applying Lean-Six Sigma
(Polytechnic University of Puerto Rico, 2010)
A pacemaker is an electronic device that is placed under the skin to help control abnormal heart rhythms. It consists of a battery, a computerized generator, and lead (wires) with electrodes on one end. in a pacemaker leads ...
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 ...
Design of a Cleaning Monitoring Methodology for a Clean in Place (CIP) Fluid Bed Dryer (FBD) using "Rapid Testing" Applications
(Polytechnic University of Puerto Rico, 2010)
Over the past years, rapid testing technologies have been developed for the purpose of changing the way microbiology and chemical analysis is done. Rapid testing technologies are a valuable tool for the pharmaceutical ...
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 ...
Lean and Safe Manufacturing for an Antidepressant Tablets Coating Process
(Polytechnic University of Puerto Rico, 2010)
The Lean and Safe Manufacturing Process (6S event0 was selected for implementation in an antidepressant tablets coating manufacturing process. The coating process was identified due to the utilization of toxic ingredients ...
Manufacturing Improvements using Lean Manufacturing Tools
(Polytechnic University of Puerto Rico, 2010)
This project was executed in a Pharmaceutical Company in Guayama PR. The process selected is the manufacturing of a new product produced since July 2008. It is a solid dosage drug or tablets. The manufacturing consists of ...
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 ...
Faster Sample Delivery to the Microbiology Laboratory using Lean Six Sigma
(Polytechnic University of Puerto Rico, 2010)
This article presents the Lean Six Sigma tools used to identify the factors that impact the timely arrival of environmental water samples to a Microbiology Laboratory in a biotechnology industry. The inherent variations ...
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 ...