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High Volume Manufacturing Process Transfer
(Polytechnic University of Puerto Rico, 2008)
Transferring a high volume
manufacturing product line requires a detail level
of information and analysis which could result in
either success or failure. Knowledge of the process
and product is critical when new ...
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 ...
Production Optimization in the Packaging and Inspection Process at a Thermoforming Area
(Polytechnic University of Puerto Rico, 2008)
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 ...
Optimization of On-Line Automated Dissolution System for Solid Dose Control Release Tablets
(Polytechnic University of Puerto Rico, 2009)
Abstract ⎯ An optimization of an automated dissolution system for control release tablets has been accomplished by the implementation of several variables using Six Sigma tools. Variables under evaluation includes: filter ...
Development of Vaporized Hydrogen Peroxide (VHP) Decontamination Cycle for a Syringe Isolator
(Polytechnic University of Puerto Rico, 2009)
Abstract - A parenteral syring filling line inside a closed cabin isolator was installed in an existing manufacturing space. To increase sterility assurance the isolator must be effectively biodecontamined by means of Vapor ...
Statistical Analysis for the Development of a Mathematical Model for Liquid Phase Color Reproduction
(Polytechnic University of Puerto Rico, 2009)
Abstract - This study aims to develop a mathematical model, capable to give a receipt of the dies concentrations to be used to develop a desire color. The model helps to minimize, and in some cases eliminate, the trial and ...
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 ...
Development of General Guidelines for the Pharmaceutical Manufacture Company Reaction to a Consent Decree Emitted by the Federal Drug Administration (FDA)
(Polytechnic University of Puerto Rico, 2009)
Abstract ⎯ Consent Decrees have been very popular lately. The consent decree mandates that a company start initiating change, and that change is usually associated with the way the company is manufacturing a product; and, ...