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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 ...
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 ...
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 ...
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 ...
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 ...
Evaluación Ergonómica de las Sub-Tareas Montaje y Desmontaje de un Filtro de Proceso
(Polytechnic University of Puerto Rico, 2010)
Estudio ergonómico aplicando la ecuación de levantamiento de NIOSH y Análisis biomecánico a las sub tareas montaje y desmontaje de un filtro de proceso en las etapas iniclal, intermedia y final, considerando las percentilas ...
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 ...
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 ...
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 ...