Manufacturing Competitiveness

Permanent URI for this collectionhttps://hdl.handle.net/20.500.12475/52

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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) 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.
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.
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.
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.
Lean Six Sigma Application to reduce cycle time in the waiting process for medical attention in patient with green categorization in adult emergency area in Hospital X
(Polytechnic University of Puerto Rico, 2010) Burgos Frontanés, Samuel J.; Rodríguez, José
The service area is one of the healthcare industries area that are in continuous search to optimize their process in order to provide a quality service to their customer (patient). In order to provide a total to quality service and reduce variable and eliminate waste in their process, many healthcare industries adopt the implementation of Lean Six Sigma methodology in their process. The Lean Six Sigma methodology is a useful tool based on maximizing value and minimizing waste. The design project focus in the implementation of lean six sigma tools from the Triage until medical treatment in the adult emergency department in order to reduce the variables and waste that make the waiting time process to be medical treated extended. This implementation aims to reduce the waiting cycle time in a 25% at the same time it seeks to eliminate the patient drains from the waiting area. Key Terms– Healthcare, Lean Six Sigma, Emergency Department
Process Optimization by Implementing Lean Six Sigma in an Optical Manufacturing Laboratory
(Polytechnic University of Puerto Rico, 2010) Arbona Arroyo, Carolina Marie; Pons Fontana, Carlos A.
The Design Project intends to be implemented in an Optical Manufacturing Laboratory. This laboratory is located at Mayagüez with the purpose of distributing ophthalmic lenses to different optical centers around the island as well as different ophthalmologists in the west area. After some weeks of research investigation it has been noticed that the laboratory is resulting in scraps, work tools are not accessible, inventory is not well organized, and orders are not being delivered within the time period. In this project Lean Manufacturing tools as well as DMAIC and/or Six Sigma tools will be implemented along with some recommendations to help the laboratory improve its processes. Some of the Lean / Six Sigma tools used will be the Cause and Effect Diagram, Work Standardization, Pareto Chart, and the 5S Methodology. At the end of this project it is expected to be reduced by 0.7% (from 1.7%) the scraps manufactured, improve quality and overall efficiency. Key Terms - laboratory, lean manufacturing, optical manufacturing, six sigma.
Reducción del Tiempo de Proceso para la Manufactura del Catéter de Bonanno
(Polytechnic University of Puerto Rico, 2011) Aguilar Cepeda, Myrelis; Morales, José A.
Abstracto - Este proyecto fue llevado a cabo en una planta de dispositivos médicos. Su propósito fue estudiar el proceso de manufactura del catéter del producto Bonanno para encontrar oportunidades reduciendo un 15% el tiempo de manufactura. Utilizando la metodología de DMAIC se estudió el proceso actual donde se identificaron cuatro áreas para mejorar en los procesos de drenaje, curva y horno. A través de la fase de análisis y mejora se determinó que existía un requisito mayor en el proceso de drenaje versus el requisito, se identificó la falta de mantenimiento preventivo para el equipo de drenaje y se confirmó que la capacidad del horno de curva era el más bajo y que el proceso corría en lote. Se ejecutaron e implementaron acciones, resultando en una reducción en el tiempo de proceso de la manufactura del catéter de dieciséis turnos de trabajo a tres turnos (más de 50% de reducción de tiempo). Terminos Claves - Bonanno, Cateter, DMAIC, Seis Sigma
Clean Steam Energy Conservation Process Design
(Polytechnic University of Puerto Rico, 2011) Guevara Brugman, Kenneth L.; Torres, Edgar
Abstract ― The objective of this article is to design the sterilization methodology and processes needed in a product or equipment that requires the injection of clean steam to create a sterile environment. Clean steam is preferred over plant steam which is created by the boilers carrying undesirable contaminants and additives that may be in contact with the product or equipment. The use of clean steam in pharmaceutical manufacturing is determine by Good Manufacturing Practices (GMP) and ruled by the Code of Federal Regulations CFR Title 21, Part 211[1]. These general rules will not provide any specific recommendation regarding the steam, but focusing on facility, operations, equipment, and systems requirements. The clean steam purity is defined by the purity of the condensate that is often referenced with water purity standards. Steam sterilization is injected to a piping to create a sterile environment or into an autoclave were components are exposed to it.
The Effect of the Vaporized Hydrogen Peroxide Residues in a Trypticase Soy Agar Plates for a New Barrier Isolated Syringe Filling Machine
(Polytechnic University of Puerto Rico, 2011) Lebrón Santos, Ana Delma; Nieves Castro, Rafael A.
This study has been performed to evaluate the feasibility and adequacy of the Trypticase Soy Agar (TSA) plates in promoting growth after being exposed to Vapor Phase Hydrogen Peroxide (VPHP) decontamination cycle. This project has been successfully completed in two phases. Data obtained from Phase 1 demonstrated that the growth promotion properties of the Becton & Dickinson Sterile Triple bagged of TSA plates were not impacted after being exposed to up to three consecutive decontamination cycles in the new syringe filling line isolator at the established decontamination cycle parameters. The results obtained from Phase 2 as well demonstrates no impact in the growth promotion properties after being exposed to a decontamination cycle, unpacked and the individual plates exposed to 1 ppm VPHP residues up to two (2) hours in a simulated manufacturing process when using the Quality Control Work Center isolator. Key Terms - isolator decontamination cycles, Trypticase Soy Agar plates, vapour phase hydrogen peroxide.
The Application of Lean Tools Using the Plan-Do-Check-Act Cycle
(Polytechnic University of Puerto Rico, 2011) Rodriguez Muñoz, Felix R.; Nieves Castro, Rafael A.
Abstract - This kaizen event is going to illustrated how to apply Lean principles and tool using the PLAN-DO-CHECK-ACT methodology. Throughout the project it will be demonstrated how important the Lean principles are for the medical device industry in general. The labor cost, efficiency and the quality of the product are the most important aspects of production. This project was design to targets this areas of the manufacturing environment. The Next Generation Balloon cell was set up to produce certain quantity of units with the require demand at the time of it develop. At this moment the demand has change and some changes need to be made. After a team was build and all the data was recollected a new Takt Time was calculated and from that result many changes were executed. It will be demonstrated that not only the pre determined goals are achievable but how new goals were developed throughout the event. The benefits of this project will help the company to maintain it cost in control and to be more competitive in the market of the medical devices. The result will show how the PDCA help the implementation of Lean techniques. Key Terms - Lean manufacturing, Medical Device, PDCA, Space Maker Balloon.
Optimización en el Manejo del Inventario de Laboratorio en una Planta Química de Puerto Rico
(Polytechnic University of Puerto Rico, 2012) Ortiz Burgos, Legzulimar; Pabón González, Miriam
Sinopsis - Esta investigación desarrolló un sistema para mecanizar el inventario del laboratorio de una planta química de Puerto Rico. Utilizó el inventario de 3 laboratorios: “In-Process” - Materia Prima, Microbiología y Final. Para analizar utilizó la metodología “Lean Six Sigma” y el modelo DMAIC. Se inició en septiembre del 2011. Los resultados fueron los siguientes: se redujo el 15 % de los niveles de inventario del laboratorio, diseñó una estrategia de manejo de inventario de manera permanente, facilitó el control de inventario, redujeron los gastos de materiales y suministros en un 10 % y las horas de trabajo del personal dedicado a gestionar el inventario. La contribución principal fue desarrollar una estrategia para facilitar las solicitudes de suministros, materiales y consumibles en el recibo, almacenamiento, uso y reposición que se utilizará en el laboratorio y descubrir una forma costo efectiva para el beneficio del personal que trabaja en el mismo. Términos Claves - DMAIC (Define-Measure-Analyze-Improve-Control), Inventario, “Lean Six Sigma”, Sistema de Reposición 2-Bin.
Handling Regulatory Inspections
(Polytechnic University of Puerto Rico, 2012) Muñiz Mercado, Yadira; Rodríguez, José
Abstract - As per the International Harmonization Guidelines (ICH) a regulatory inspection is the act by a regulatory authority (ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority (ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or CRO’s facilities, or at the other establishment deemed appropriate by the regulatory authority (ies). An inspection can happen at any time in any city or state. The mission is to protect consumers and enhance public health by maximizing compliance of regulated products and minimizing the risk associated with those policies. Inspections can cover finished human and veterinary drugs and biologics [9]. Key Terms - Board of Health (BoH), Inspections, Regulatory agencies
Validation and Implementation of a New Enterprise Resource Planning (ERP QAD) on Receiving Area
(Polytechnic University of Puerto Rico, 2012) Rosario Vázquez, Ida R.; Nieves Castro, Rafael A.
Abstract - In this competitive world people need to be in vanguard; therefore a better Enterprise Resource Planning (ERP) system will help them to do a better work. V group implement a new ERP system for the improvement the financial process and get a better scheduling program to comply with Code of Federal Regulations. V Group has determined that all plants operating on the QAD ERP will operate in the same manner with limited exception. The validation and implantations of QAD systems is very extensive and complex, therefore this investigation will be focus on the area of Material Receiving & Incoming Inspection. A Material Receiving & Incoming Inspection is an administrative function that involves checking of the quality, quantity, and condition of the incoming goods followed by identifying, sampling handling, inspecting and disposal of raw material received at V Group. Key Terms - Enterprise Resource Planning (ERP), Implantations, Material Receiving & Incoming Inspection, Validation.
Process Optimization for the Suction Low Runners Family Products
(Polytechnic University of Puerto Rico, 2012) Rosado Pabon, Maria del Mar; Torres, Edgar
Nowadays the first thought of many manufacturing companies is to increase the headcount number in the manufacturing line once it is found with inconsistency of results in productions or quality problems, this rational sometimes bring inefficiencies to the manufacturing process and creates process variation. In recent years the concept of the Six Sigma has become the standard way to solve operational and design problems in manufacture, however this tool can be used together with the concept of Lean Manufacturing, creating an infusion of both concepts called: Lean Six Sigma. This synergized managerial concept results in the elimination of waste and reduces process variation. Through this article we will discuss how the use of Lean Six Sigma methodology focusing on DMAIC tool will help to do a process redesign to standardize three manufacturing lines. The idea is to convert waste into value using different lean techniques, resulting in cost reductions and reduction in the variation of quality problems. Key Terms - DMAIC, Efficiencies, Lean Six Sigma, Manufacturing Process.
Diseño de un Sistema Automatizado de Lotes para una Fábrica de Productos de Consumo
(Polytechnic University of Puerto Rico, 2013) Gutiérrez Santos, Gisela; Nieves Castro, Rafael A.
Una fábrica de jugos tenía un área de oportunidad relacionada a la falta de abasto a la demanda debido a la poca capacidad de manufacturar jugos a grandes escala. Este proyecto tiene como objetivo reducir el tiempo de producción y aumentar las cantidades producida fusionando la manufactura y el empaque de jugos en un mismo lugar. La idea es crear un sistema de control automático el cual realice tanto la manufactura como el empaque de forma rápida y uniforme. Para este trabajo se realizó un proyecto para unir y automatizar el proceso completo de la producción de jugos. Para corroborar si la implementación de este sistema fue exitoso se programaron unos estudios comparativos del tiempo que le toma al producto estar listo para la venta para determinar si hay adelanto en el proceso de producción de jugos. El resultado fue que las tres pruebas a pesar que se le añadió un poco más de tiempo a la producción local, esta es más constante lo cual permitió que la producción básicamente se duplicara y así poder satisfacer la demanda de jugo. Términos Claves – Automatización, Lote, Proyecto, Sistema.