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Are cleaning faults, really, quality or administrative issues?: Cleaning Validation Program optimization for a Pharmaceutical plant
(Polytechnic University of Puerto Rico, 2008)
The cleaning procedure process validation has generated considerable discussion when executing a US Food and Drug Administration (FDA) inspection at Pharmaceutical Plants. In general, the FDA requires the equipment to be ...
Cycle Time Reduction using Lean Manufacturing Techniques for a Solid Pharmaceutical Product
(Polytechnic University of Puerto Rico, 2009)
Abstract ⎯ The purpose of this project was to demonstrate that the Lean Manufacturing techniques could be applied to a Solid Pharmaceutical Product in order to reduce the cycle time. During the year 2007, the Solid ...
Application of DMAIC Methodology to Improve the Utilization of an Industrial Glassware Washer System in a Biopharmaceutical Industry
(Polytechnic University of Puerto Rico, 2009)
Abstract ⎯ This article describe how the problem solving approach of Define, Measure, Analyze, Implement and Control (DMAIC) is applied to increase the utilization of an industrial glassware washer system in a Biopharmaceutical ...
Estudio de los Aspectos Ergonómicos en Laboratorios de Control de Calidad en Industrias Farmacéuticas
(Polytechnic University of Puerto Rico, 2009)
Abstracto - 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 ...
Application of Design of Experiment to Demonstrate Equivalency of Two Multi Layer Compression Process for an Extended Release Tablets Product
(Polytechnic University of Puerto Rico, 2009)
Abstract ― A design of experiment (DOE) was performed to a multi layer compression process that is going to be transferred from facility A to facility B. This study demonstrates and compared the equivalence of the compression ...