Manufacturing Competitiveness
Permanent URI for this collectionhttps://hdl.handle.net/20.500.12475/52
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Item Statistical Analysis for the Development of a Mathematical Model for Liquid Phase Color Reproduction(Polytechnic University of Puerto Rico, 2009) Rodríguez Rivera, Wilson; Nieves Castro, Rafael A.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 error technique. This study investigates the effect of the color coordinates vector such as L, a and b in order to evaluate if there exist a correlation by using the FD&C dies such as FD&C Yellow 5 FD&C Yellow 6, FD&C Blue 1 and FD&C Red 40. A 2k factorial experiment was performed, to identify those dies that have a significant effect within the color coordinates. Results obtained revealed that of the four FD&C studied, three of them have significant effect within the color coordinates. The FD&C dies used, showed a significant effect when is used alone or when are mixed. A correlation of the color coordinates and the factors was found. Three linear formulas were obtained from the L, a, and b vectors. Those formulas were introduced in a matrix model to developing or matching colors. Key Terms -Color space (L, a and B)[4], Lightness (L), a (position of green red axis), b (position of blue-yellow axis).Item Estudio de los Aspectos Ergonómicos en Laboratorios de Control de Calidad en Industrias Farmacéuticas(Polytechnic University of Puerto Rico, 2009) Figueroa Colón, Marielis; Pabón González, MiriamAbstracto - 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 ergonómicos en laboratorios de Control Calidad en industrias farmacéuticas. Se realizó un análisis cualitativo y un análisis cuantitativo. El análisis cualitativo consistió en una encuesta. Se entregó un cuestionario a 32 empleados de laboratorios de control de calidad de dos industrias farmacéuticas. En el análisis cuantitativo se diseñaron planos de piso donde se estudió la organización del laboratorio. También se estudiaron aspectos ambientales tales como iluminación y temperatura. Luego de evaluar y comparar cada uno de los análisis se llegó a la conclusión que el diseño ergonómico en los laboratorios de control de calidad en las farmacéuticas no son muy efectivos. Por tal razón, se efectuaron una serie de recomendaciones relacionadas a cada una de las áreas estudiadas. Obteniendo de esta manera empleados que se sientan más cómodos en sus áreas de trabajo, produciendo así un trabajo de mayor calidad y productividad.Item Development of Vaporized Hydrogen Peroxide (VHP) Decontamination Cycle for a Syringe Isolator(Polytechnic University of Puerto Rico, 2009) Ruiz Vargas, José J.; Pabón González, MiriamAbstract - 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 Hydrogen Peroxide (VHP) to provide a minimum of 6 log-reductions and a residual concentration of VHP of less than 1ppm. During the cycle development phase the operating characteristic and parameters for the decontamination were tested and optimized following the proposed methodology in this article. Final adjustment of the injection quantities was based upon results of the worst case biological indicator tests performed during the study. Based on the results, parameters and validation testing were established to provide for complete destruction of all biological indicators. Key Terms - H2O2 decontamination, cycle development, biological indicator (BI), chemical indicator (CI)Item 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) Pérez Moyeno, Janet; Nieves Castro, Rafael A.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, it will involve the company re-constitute the manufacturing practices to bring it in alignment with the Food and Drug Administration (FDA’s) Good Manufacturing Practices. This project main purpose is to give guides on how pharmaceutical industries should react when a Consent Decree is given. Based on all information gathered from different sources, the consequences that bring the consent decree, the review of FDA inspectional process, and the hints required to effectively interact with the FDA are given. Finally, the guide will assist the companies to manage important events regarding compliance with the Good Manufacturing Practices and with the requisites of the consent decree. Key Terms ⎯ cGMP, consent decree, FDA inspections, regulatory issues, warning letters.Item Optimization of On-Line Automated Dissolution System for Solid Dose Control Release Tablets(Polytechnic University of Puerto Rico, 2009) Marrero Teruel, Cruz M.; Nieves Castro, Rafael A.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 retention, baselines verification and addition of system suitability parameters. The implementation of the analyzed variables were compare before and after the optimization within 95% confidence interval generating statistically difference between them for three (3) out of four (4) sampling points. Additionally, after the statistical evaluation of the changes the dissolution profiles were evaluated by dissolution similarity factor (f2) test, where the improvements shows an increase of fifteen (15) units against the same test before the implementation of the optimization. Key Terms ⎯ Control Release Tablets, Dissolution profile, UV/VIS Spectroscopy.Item Are cleaning faults, really, quality or administrative issues?: Cleaning Validation Program optimization for a Pharmaceutical plant(Polytechnic University of Puerto Rico, 2008) Arizmendi Figueroa, Rose Mary; Rivera, José OrlandoThe 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 clean prior to its use for manufacturing, processing, packing, holding of a drug product and/ or when sampling a raw material. Currently, some pharmaceutical plants have failed to design a good manual cleaning process. In regards to this, the Management Theory is crucial to manage effectively a cleaning procedure with the optimization of the Cleaning Process Validation. The application of the management functions contributed on the development of a guide to correct these faults and/or prevent further occurrence. By implementing the Administrative Management Theory a cleaning validation program is without a doubt optimized. Key Terms — Administrative Management Theory, Cleaning validation, crucial, optimizationItem High Volume Manufacturing Process Transfer(Polytechnic University of Puerto Rico, 2008) Vargas, Gerardo L.; Rodríguez, JoséTransferring 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 technology for the manufacturing process is required. In addition, forecast of a product, especially in high volume product lines, plays a decisive factor determining the moment of equipment investment. Automation has an important role in this environment by maintaining a competitive market as well as higher quality with a stable and robust process. Not only quantity but also quality is a key factor in the medical device and pharmaceutical industries. Company’s reputations are based on the manufacturing culture which is reflected by the customer. At the end of the day, what is important is what the customer thinks about the product in his hands and not where it was made. It must be manufactured under the regulations and manufacturing standards that he trusts. Key Terms ⎯ Proper Approach, Clear Analysis, Accurate Forecast, Detailed Implementation And Contingency Plan.Item Production Optimization in the Packaging and Inspection Process at a Thermoforming Area(Polytechnic University of Puerto Rico, 2008) Carrión Román, Beatriz; Morales, José A.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 a new layout design and utilization of the resources. The methodology used in this project was the Lean Six Sigma including the DMAIC model. The objective was to increase the total production by 10%. Results showed an incremental percent of 15.25%. The takt time for the production line for packaging and inspection was proficiently decreased. Within the new arrangement the company has the capability of a crew reduction of an average of 4.5 unnecessary operators. After calculating the cost opportunity, in terms of incremental output, the saving was $24,246 plus the applied personnel reduction saving was $60,000. The total savings for the implemented project of $84,246 was applied to direct labor costs. Key Terms - DMAIC, Lean Six Sigma, Packaging and Inspection Optimization, Production line, Thermoforming.