Manufacturing Engineering
Permanent URI for this collectionhttps://hdl.handle.net/20.500.12475/53
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Item Wet Granulation End-Point Determination of a Drug Formulation(Polytechnic University of Puerto Rico, 2019) Merced Vega, Yaritza; González Miranda, Carlos J.Wet granulation is commonly used in oral solid dosage industry. The end-point is required to design a process that consistently meet products Critical Quality Attributes (CQAs) and the Critical Processing Parameters (CPPs). There are many methods available for end-point determination with their owns constraints of reproductivity and accuracy. Torque measurer was installed on the Low shear granulation and product “XA” was monitored. The results confirm that automated process provide better process control and reproducibility. Torque measurement demonstrate to be a reliable control method in relation to mass resistance. In order to determine wet granulation end-point the Project Management Institute (PMI®) methodology was used. PMI® comprise of five main steps in the process; initiating, planning, executing, monitoring and controlling, and closure. This research pursue to improve and determine the wet granulation end-point of a drug product. PMI® methodology brings a structure and the tool to identify and solve the problem. Key Terms ⎯ Automation, End-Point, Torque, Wet Granulation.Item Optimization of Tooling Design Process for Assembly of Motor Parts(Polytechnic University of Puerto Rico, 2019) Abreu Machado, Yamil; Nieves Castro, Rafael A.This project developed a DMAIC process to start improving the results of a new task been performed in the company [1]. The project will focus on improving the quality and turnaround time of the work performed. the quality is going to be improve by looking for the areas that produce waste, study those areas and look for alternatives to eliminate the waste produced and be leaner. by improving, the quality of the work provided to the customer by eliminating waste the turnaround time that takes to deliver the task is going to improve. as this is a new task, been performed the way that it is going to be improved is by designing a new standard work for all the designers to use it. Key Terms: Continuous Improvement, DMAIC, Lean, Turnaround time.Item Reducción de Desperdicio en el Proceso de una Pizzería(Polytechnic University of Puerto Rico, 2019) Santiago Rosado, Yadira; Morales, José A.Este proyecto se realizó en una pequeña pizzería en el pueblo de Ponce. Como parte del proyecto se observó y evaluó el proceso operacional de este comercio. Se identificaron desperdicios definidos en el sistema de lean manufacturing. Y se trabajó para reducir estos desperdicios. Se utilizó la herramienta de diagrama de espaguetti. El diagrama de espaguetti fue clave en el proceso de identificación de desperdicio y evaluación de alternativas. Se evaluaron las distintas alternativas y se hicieron pruebas piloto para asegurar el resultado de cada alternativa a ser recomendada. En conclusión, se le recomendaron dos alternativas al dueño de la pizzería. Una alternativa que utiliza los recursos ya poseídos y una alternativa que requiere de una inversión. Además se le recomendó como proyecto futuro una aplicación para automatizar las ordenes. Palabras Claves ⎯ Círculo de Deming, Diagrama de Espaguetti, Kaizen, Lean Manufacturing.Item Standardizing the Manufacturing Operation of a Multipurpose Cleaner in 32-Ounce Bottles in Order to Control the Process(Polytechnic University of Puerto Rico, 2019) Ortega Rodríguez, Nicole M.; Morales, José A.With the fast paste life we are currently living, manufacturers are always looking for innovative ways to simplify products, including cleaning and household products. With an allpurpose cleaner, there is no need to buy and store different bottles thus simplifying household chores. These products are designed to act as disinfectant, detergent, de-greaser, solvent or a combination to be used on different surfaces. In Puerto Rico, you can find many companies that are currently manufacturing these types of multi-purpose cleaners that are typically found in any household. This project is based on a multipurpose cleaner manufactured in Puerto Rico which has been in the market since 1997. It is a multipurpose cleaner capable of cleaning any surface without damage, strong against dirt and grease, but not harmful to the skin. It is a noncorrosive, non-abrasive and eco-friendly product used in many households today. Key Terms ⎯ Manufacturing Process Control, Multipurpose Cleaner, Reducing Process Variation, Standardizing Manufacturing Operation.Item Alternate Raw Material Supplier Validation(Polytechnic University of Puerto Rico, 2019) Valerín Díaz, Melissa; Nieves Castro, Rafael A.This article discusses the Process Validation of Over the Counter Pharmaceutical Product using alternate supplier of raw material. The primary ibuprofen drug substance supplier for GSK Ibuprofen family products informed that they have not recovered from a natural disaster that impacted their facilities. As a result of this natural disaster, the supplier shut down production of ibuprofen indefinitely. In order to alleviate ibuprofen drug shortage imposed by primary supplier’s facility shut down, GSK Puerto Rico has identified potential alternate supplier of Ibuprofen for the current Ibuprofen OTC products. To conduct this project, DMAIC methodology was used in order to have a better understanding of the process to increase efficacy and identify areas of opportunity to improve. GSK Puerto Rico is responsible for the 100% of the Ibuprofen family products for US domestic sales and Ibuprofen family represents 58% of GSK 2019 volume plan. The company will be able to supply the expected volume of Ibuprofen family products to the customers and the volume plan will be achieved with the validation of alternate ibuprofen supplier for Ibuprofen family products. Key Terms - DMAIC, Process Validation, Raw Material, Supplier Qualification.Item Waste Elimination on a Printing Process(Polytechnic University of Puerto Rico, 2019) González Soto, Khalil; González Miranda, Carlos J.This project was focused on eliminating the MUDA or waste found (non-value added) in the Offset machines printing process. The DMAIC methodology was used. DMAIC is an acronym for a series of steps used to measure defects in business processes and improve profitability. The term DMAIC stands for the five main steps in the process; Define, Measure, Analyze, Improve and Control. DMAIC methodology brings a structure and the tools to improve a process by optimizing it. Keywords – DMAIC, Lean, MUDA, Offset, Quick Wins.Item Neuromodulator Device Scrap Reduction Using DMAIC Methodology(Polytechnic University of Puerto Rico, 2019) Fuentes Cruz, Ismael; González Miranda, Carlos J.This research project was focused in the Scrap reduction in a final electrical test area of a medical device company. The scrap is defined as the number of dollars per units resulting from the cost of rejected units coming out of a process divided by the number of units which are released successfully. Only good units (no retest & rework allowed) are counted as coming out of an individual process. In order to reduce the Scrap, the DMAIC methodology was used [1]. DMAIC is an acronym for a series of steps used to measure defects in business processes and improve profitability. The term DMAIC stands for the five main steps in the process: Define, Measure, Analyze, Improve and Control. This research seeks to reduce the Scrap on this manufacturing area where the neuromodulator device is finally verified electrically. This is important for the process because it will reduce unnecessary Scrap related to this false failure. DMAIC methodology brings a structure and the tool to identify and solve the problem. In this case, reduce the Scrap in a medical device company. Key Terms – Cost-Saving, DMAIC, Quality, Scrap.Item Optimización en el Proceso de Configuración de Recetas en los Sistemas de Serialización(Polytechnic University of Puerto Rico, 2019) De Jesús Avilés, Daniel; Nieves Castro, Rafael A.La serialización en la industria farmacéutica de Estados Unidos es uno de los nuevos procesos que lleva pocos años de implementado. En el mes de noviembre del 2018 fue efectivo que para poder vender y/o distribuir productos controlados, el mismo debe estar serializado. Este nuevo proceso replica un impacto en los procesos de empaque de productos farmacéuticos, también en el almacenamiento y distribución de los mismos. Este proyecto va enfocado en mejorar el proceso de actualizar recetas en los sistemas de serialización de las líneas de empaque. La manera en que se está actualizando las recetas de los sistemas de serialización debido a algún cambio de arte, está provocando mucho tiempo muerto en las líneas. La idea es poder implementar un proceso continuo cuando se tenga que actualizar alguna receta en los sistemas de serialización, eliminando así tareas y/o formas repetitivas que crean “waste” en el proceso. Términos claves ⎯ Recetas, Serialización, “Waste”.Item Material Qualification Process Improvement to Reduce the Cycle Time(Polytechnic University of Puerto Rico, 2019) Negrón Marín, Abidanese; González Miranda, Carlos J.This project was focused in improving the material qualification process, reducing the cycle time. A Documentation Checklist and Tracking Sheet System were created as part of the improvements. The Documentation Checklist is a checklist to request all the information required from the vendor and the company to complete all the material qualification documentation. The Tracking Sheet System is to know the status of the material qualification activities. The improvements were made using a combination of DMAIC and Kaizen methodologies. DMAIC is an acronym for a series of step used to measure defects in business process and improve profitability. DMAIC stands for Define, Measure, Analyze, Improve, and Control. DMAIC is a data-driven quality strategy used to improve process. In the other hand, Kaizen means continuous improvement. There are five fundamental Kaizen principles: know your customer, let it flow, go to Gemba, Empower People, and be transparent [1]. Key words ⎯ DMAIC, Improvement, Kaizen, Material Qualification.Item Structured Approach for Compliance Determination of FDA Regulated Tablet Compression Process(Polytechnic University of Puerto Rico, 2010) Madera, Juan Carlos; González Miranda, Carlos J.Tablets are the most popular unit dosage form used by the Pharmaceutical Industry to provide health treatment to patients in the United States. It is important to control process critical parameters (variables) such as weight, thickness and hardness of the unit dosage form to provide the patient with the same drug levels obtained during clinical studies. There are also quality attributes that are inherent to product quality such as shape, color, texture, and general appearance. Without robust in-process controls, it is very likely to have undesired effects such as manufacturing yield issues, rework or re-processing, customer complaints, and possible observations from regulatory agencies that may affect not only economically but also the company quality reputation. For this reason it was developed a comprehensive method, structured to help as a guideline to understand the current level of compliance for pharmaceutical tablet compression facilities regulated by the FDA. Key Terms - cGMP, process controls, recall, tablet compression.