Design Project Articles Master Degree

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Como parte de las Colecciones Especiales, la Biblioteca cuenta con los Artículos de Proyecto y Carteles de Investigación (Poster) sometidos para la obtención del grado de los estudiantes de la Escuela Graduada. Recursos disponibles: 1. Artículos de Proyectos - 2008 en adelante. 2. Carteles de Investigación - 2018 en adelante.

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Now showing 1 - 20 of 1589

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 Orlando
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 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, optimization
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.
High Volume Manufacturing Process Transfer
(Polytechnic University of Puerto Rico, 2008) Vargas, Gerardo L.; Rodríguez, José
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 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.
Improvement of Contact Lens Field Complaint Rate Using the DMAIC Approach
(Polytechnic University of Puerto Rico, 2009) Pietri, Emil A.; Pesante Santana, José A.
Contact lenses are susceptible to a defect call “tearing”. This is common but seldom condition detected in the field by the customer. The manufacturing process of a contact lens is a very precise method of combining an injection molding processes with a chemically bonded monomer. The liquid monomer is automatically placed between two half’s of plastic injected molds then forming the lens ,subsequent process of curing ,de-molding , hydration and packaging would form the final product for sale. The purpose of this study is to demonstrate that the application of the 6 sigma DMAIC approach to problem solving would provide a methodical and enriched conclusion to the root cause determination of contact lens “tearing” thus reducing the defect rate, subsequently customer complaints. Key Terms - Define, Measure, Analyze, Control
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) Carrión Vega, Jaime; Nieves Castro, Rafael A.
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 process of a non-validated process site with a validated process from the original site. The relevance of this project is to demonstrate the equivalence of the process to ensure the robustness, and quality of the product. During the compression process, the weight of multiple stages, thickness, and hardness were collected in both machine. The data collected was analyzed using One-Way-ANOVA and Kruskal-Wallis test. Based on the results obtained from the data, it was concluded that both multi layer compression process are equivalent. Key Terms ― Design of Experiment, Extended Release Tablets, Multi Layer Compression Process, One – Way – ANOVA.
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.
Tratamiento de Aguas Residual Domestica para el Complejo de Apartamentos “El Metro”, Villa Mella, Santo Domingo
(Polytechnic University of Puerto Rico, 2009) Padilla Gratereaux, Gisselle A.; Pimenta Oliveira, Aluisio O.
Resumen - El diseño de la planta de tratamiento de las aguas residuales domesticas para el complejo de apartamentos “El Metro”, surge de la necesidad del Ing. Juan Padilla de construir dicha planta para 416 viviendas, ya que, la Dirección General de Planeamiento Urbano (DGPU) de Santo Domingo, República Dominicana, así se lo requiere para otorgarle el permiso de construcción; en vista de esto, se busco la mejor opción costo/efectiva, para proveer mejor resultado a dicha necesidad, cubriendo así puntos esenciales al momento de construir, como son: Costo, tiempo de construcción, espacio disponible y facilidad de mantenimiento. Palabras Clave - Cloración, lodo activado, sedimentadores, tratamiento de fangos.
Cycle Time Reduction using Lean Manufacturing Techniques for a Solid Pharmaceutical Product
(Polytechnic University of Puerto Rico, 2009) Ocasio Ortiz, Ángel; Pons Fontana, Carlos A.
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 Pharmaceutical Product studied had 52 days of cycle time. The goal is to reduce the cycle time 25% or to 39 days. Lean Manufacturing tools used in this project was the process map to develop the required knowledge of the manufacturing process and the Value Stream Mapping where the values added and non-values added activities were identified. A Multidisciplinary team, essential for creation and implementation of new ideas, a list of improvements was generated and weighted for prioritization. This prioritization matrix is the foundation to start the implementation of improvements. After the Multidisciplinary team implemented the short term improvements in the Manufacturing Area, it was observed that the Product Cycle time decreased to 37 days in the third quarter of the 2008. After completion of the study, it was proved that the Lean Manufacturing techniques can be applied to a Solid Pharmaceutical Product and can radically reduce the cycle time. Key Terms ⎯ Kaizen, Value add (VA), Value Stream Map and Waste (muda).
Piedras Blancas Landslide: Mitigation Works
(Polytechnic University of Puerto Rico, 2009) Rendón Ferrer, Janet; Collazos, Omaira
Abstract - The Puerto Rico Highway and Transportation Authority has conducted since the 1980s several geotechnical investigations about the Piedras Blancas Landslide in the Municipality of San Sebastian. This landslide has brought damages during various decades, presenting cracks and sinking of the highway PR-111, and settlements of nearby residences and commerce. The failure area has a creek, a natural depression pond, a springs’ history, and a sensitive geology, San Sebastian Formation. Also, it is bounded uphill by the Lares Escarpment, a high limestone cliff rich in sinkholes. Through this paper it is possible to appreciate a number of contributing factors that could trigger this landslide and then take care of it through a gabion terraces design. This proposal deals with the topographic and hydrologic impacts to the terrain produced by fill and cut construction works. Soil survey information comes from Puerto Rico Highway and Transportation Authority (PRHTA) reports. Key Terms - back analysis, colluvium, gabions, landslide.
R: Color Package
(Polytechnic University of Puerto Rico, 2009) Rivera Negrón, Eurípides; Duffany, Jeffrey
Abstract - R is a software language mostly used of statistical and mathematical purporses. R capabilities are extended by user’s submitted packages. The gColor Package provides R Language a method to solve Systems of Inequation (represented as a matrix) in files created by the Discrete Mathematics and Theoretical Computer Science (SIMACS). The advantange of the gColor Package is the import fo DIMACS files which supports compress (binary) and uncompress (ASCII) format, currently not available in R Language,and the conversion of the data imported from vertices and edges into a an adjacency matrix; allowing users to import graphs from other systems and use it as a matrix object. This document is divided in four sections. The Introduction provides and overviedw of the problem and the justification to the development of this project. The R Language brings an introduction to R. The system of Inequation explains briefly what is it and how can be representd in R. The gColor Package explains the structure of the package. How the package was build and integrated with R is explained in section Building the Package. Key Terms - ASCII, CRAN, DIMACS, Dynamic Link Library (DLL)
Application of DMAIC Methodology to Improve the Utilization of an Industrial Glassware Washer System in a Biopharmaceutical Industry
(Polytechnic University of Puerto Rico, 2009) Colón Santiago, Cindy; Pons Fontana, Carlos A.
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 Industry. The application of this methodology results in a deep understanding of the cleaning process. Sources of variation were identified and a root cause analysis conducted allows for the identification of potential solutions as well as selection and implementation of improvements. The implementation of improvements in the control phase reflect reductions in the amount of cleaning loads required to satisfy manufacturing needs on a weekly basis, reducing in 40% the amounts of loads,increasing by 20% the utilization of the cleaning system and providing tools to the support area staff that will allow them to have a better understanding of the logistic involved along the cleaning process. Key Terms ⎯ DMAIC methodology, cleaning system utilization.
Comparación de Eficiencia en Cuanto a Comportamiento y Costo Entre el Diseño ASD y LRFD para el Edificio UNILOPEZ
(Polytechnic University of Puerto Rico, 2009) Veras Meléndez, Leonardo; Guzmán De La Cruz, Alberto L.
Abstracto - Este documento consistió en el análisis estructural del edificio de oficinas UNILOPEZ (estructura de acero), mediante el uso de un programa de computadoras llamado ETABS, el cual se especializa en el análisis y diseño interactivo de edificaciones. Se consideraron los códigos UBC 97 y ASCE 7-02. Dos diseños por separado fueron realizado tomando el criterio LRFD y ASD provenientes del AISC 13ra Edición. Mediante los resultados obtenidos se determinó que el diseño utilizando el criterio ASD presentó un incremento de aproximadamente 14% mínimo en el costo de la estructura y diferencias de desplazamientos entre un piso y otro, que fluctuaron entre un 2% y un 78% más (ver Tabla 5) en relación a los resultados obtenidos al usar el criterio LRFD. Términos Claves - Allowable Strength Design, American Institute of Steel Construction, Estructuras de Acero, Load and Resistance Factor Design.
Lean and Safe Manufacturing for an Antidepressant Tablets Coating Process
(Polytechnic University of Puerto Rico, 2009) Torres Santiago, Meraris; Zárate, Patricia
Abstract - The Lean and Safe Manufacturing Process (6S event) was selected for implementation in an antidepressant tablets coating manufacturing process. The coating process was identified due to the utilization of toxic ingredients and hazardous materials during the coating solution preparation and during the coating application. In addition, lost time and productivity were identified in the process. The tool selected to perform a Lean and Safe Manufacturing Process in this coating process was 6S (Sort, Set in Order, Shine, Schedule, Score and Safety). Contributions, like the creation of a system that will be used to maintain an organized, clean, safe, and efficient setting that enables the highest level of value-added performance, were achieved during the 6S event implementation. In addition, a decrease in cycle time, in operators needed in the process execution, and minimization of injuries risk, were very important contributions achieved. Key Terms - 6S, Coating Process, Lean and Safe Manufacturing, Manufacturing Process.
Anticipando la Crisis
(Polytechnic University of Puerto Rico, 2009) Blanco Colón, Luis A.; Ramírez, Juan
Abstracto - Este proyecto tiene como meta orientar sobre los objetivos necesarios que una empresa debe establecer, para implementar un plan de contingencia para evitar interrupciones parciales o prolongadas de sus actividades de negocio. En el ambiente riesgoso y competitivo en que vivimos, muchas empresas están optando por establecer planes de continuidad de negocio, para mejorar su habilidad de responder o mitigar estas interrupciones. Este plan es una herramienta que permite a las empresas reconocer sus vulnerabilidades, e implementar procesos que le permitan responder de manera eficiente para mantener operando a una empresa, antes, durante o después de un desastre o evento que pueda afectar sus operaciones de negocio.
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).
Development of Vaporized Hydrogen Peroxide (VHP) Decontamination Cycle for a Syringe Isolator
(Polytechnic University of Puerto Rico, 2009) Ruiz Vargas, José J.; Pabón González, Miriam
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 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)
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.
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, Miriam
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 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.
Quality Improvement in a Medical Device Manufacturing Process Applying Six Sigma Tools
(Polytechnic University of Puerto Rico, 2009) Rondón Nieves, Luis Daniel; Zárate, Patricia
Abstract - The current manufacturing process of a medical device product has great opportunities on scrap percent reduction, which has been impacting the material and labor costs of the product, as well as in defects per million (DPMs) reduction, to improve the quality of this product. The current scrap percent has been affecting the production yield and complaints from clients (surgeons) have been increasing during the last Fiscal Year. The Six Sigma structure DMAIC: Define, Measure, Analyze, Improve, and Control, will be the key for the success of this project. The expected benefits are the evaluation, recommendation, and implementation of any opportunity of quality improvement that results in a positive impact to the clients at a low cost of production for the company. The main research contribution is that this project provides the customers (surgeons and their patients) an instrument that always actuate as established in the specifications to save humans lives. Key Terms  Medical Devices, Process Optimization, Quality Improvement, Six Sigma.
Use of Experimental Design for the Characterization of a Depyrogenation Machine
(Polytechnic University of Puerto Rico, 2010) Cabrera, Migdalis; Torres, Edgar
Depyrogenation tunnel are used in pharmaceutical filling lines to sterilize glass containers before they are aseptically filled. These tunnels use unidirectional hot air at temperatures up to 350°C and can be used to sterilize and depyrogenated glass vials and glass containers. The experimental design presented in this project describes the performance qualification activities process in the dry heat depyrogenation tunnel at worst case conditions ensuring the integrity of the HEPA filters. The parameters considered were: belt speed, temperature and endotoxin reduction. The parameters identified after analyzing the measurement are to be improved by applying DMAIC methodology from Six Sigma. Key Terms - DMAIC, experimental design, performance qualification, HEPA filters.