Manufacturing Engineering
Permanent URI for this collectionhttps://hdl.handle.net/20.500.12475/53
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Item Improve Vision System Seal Presence Inspection(Polytechnic University of Puerto Rico, 2024) Luciano González, Anaisha I.; Nieves Castro, Rafael A.The sterile packaging of implantable medical devices is crucial for ensuring patient safety, preventing post-operative infections, and maintaining the integrity of the device until implantation. Given that these devices are placed within the body, contamination with harmful microorganisms can lead to serious complications, including implant failure and life-threatening infections. Sterile packaging acts as a barrier against pathogens, maintaining the sterility of the device during storage and transportation. Vision systems play a critical role in the sterile barrier inspection of implantable medical device packaging by ensuring the integrity and quality of the packaging, which is essential to maintaining sterility. In the manufacturing plant, inefficiencies in the packaging process, particularly in seal inspection, result in compromised product quality and potential contamination risks. Manual inspections and outdated quality control systems are prone to human error, leading to undetected seal defects, rework, and product recalls. In addition to the sterility issue, in the specific case being studied through this project, the sealing inspection inefficiencies create a productivity burden and operators’ burnout due to the extensive inspections. Key Terms - DMADV Method, Seal Inspection, Vision Systems.Item Implementation of a Change Control Process in a Pharmaceutical Industry(Polytechnic University of Puerto Rico, 2024) Ramos Feliciano, Paola C.; Nieves Castro, Rafael A.The pharmaceutical industry is monitored by the highest regulatory bodies such as the Food and Drug Administration (FDA) and other agencies to ensure compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). The quality of the product is demonstrated through data generated within the process and supporting documentation. The data should demonstrate consistency, accuracy and completeness for data integrity. At the same time the equipment, process and systems should be validated for the intended use. This project focuses on the implementation of a change control in a validated system emphasizing in the required documentation to demonstrate the system has the capacity to function as it is intended and continues to meet regulatory standards. Additionally, the project provides a solution to a problem that has the potential to have data integrity issues. Key Terms ⎯ Change Control, Computer System Validation, Pharmaceutical Industry.Item Reducción de Costos con Impacto Ambiental Positivo: Un Enfoque Sostenible en la Industria Manufacturera(Polytechnic University of Puerto Rico, 2024) Hernández Rosado, Manuel C.; Nieves Castro, Rafael A.Esta investigación se centra en la implementación de prácticas sostenibles para optimizar la eficiencia energética y reducir costos en una industria manufacturera. El objetivo principal es explorar estrategias innovadoras que mejoren la optimización de procesos, incorporen tecnologías verdes, gestionen eficientemente los residuos y utilicen los recursos naturales de manera responsable. Además, el estudio examina la viabilidad de iniciativas de energía renovable, como la integración de fuentes de energía limpias y sistemas avanzados de reciclaje, orientadas a mejorar tanto la sostenibilidad económica como la ambiental dentro de la operación manufacturera. El enfoque no solo busca lograr una reducción de costos a largo plazo, sino también reforzar la responsabilidad social corporativa y contribuir al desarrollo de modelos de producción más amigables con el medio ambiente. Al emplear tecnologías y procesos sostenibles, la investigación demuestra cómo las industrias manufactureras pueden disminuir significativamente los gastos operativos mientras mejoran su huella ecológica, lo que lleva, en última instancia, a una práctica industrial más responsable y sostenible. Palabras Claves - Eficiencia Energética, Energía Renovable, Gestión de Residuos, Industria Manufacturera, Optimización de Recursos, Prácticas Sostenibles, Reducción de Costos, Responsabilidad Social Corporativa, Sostenibilidad Ambiental, Tecnologías Verdes.Item Qualification of the Cold Chain System in Drug Logistics(Polytechnic University of Puerto Rico, 2024) Otero Torres, Yailyn; Nieves Castro, Rafael A.Distributions Centers for pharmaceutical products have experienced significant changes in recent years in terms of the cold chain, adapting to new social, economic, and technological structures. The main objective of this process is to maintain a constant cold temperature of refrigerated pharmaceutical products, which requires maintaining a refrigeration specification of 2°C to 8°C. This article aims to use DMAIC tools to help us ensure that deliveries from more distant routes to different customers consistently meet the required temperatures from their departure from the distribution center to delivery to the customer. Key Terms - Cold Chain System, Distribution Centers, DMAIC Method, Pharmaceutical Products.Item Improvement and Standardization of the Remuneration Process of Engineering Lecturer Professors(Polytechnic University of Puerto Rico, 2024) Samó Velázquez, Yahira M.; Nieves Castro, Rafael A.Human beings invest plenty of time carrying out various tasks for an employer or company to generate a salary. Salaries must satisfy the personnel who provide services to earn income [1]. After conducting a study on the remuneration processes of lecturers at a post-secondary institution using the DMAIC methodology, it was determined that the personnel in charge of the processes need to standardize it to satisfy professors’ needs, such as counting a highly efficient. This standardization should come into force for the semester from August to December 2024 and will take 30 days to 3 months to be fully implemented. According to the research, the time taken by the remuneration process will decrease from 4 weeks and five days to 14 days, and the receipt of the salary will go from one month after the professors sign the contract to 15 days after signing the contract. Key Terms - DMAIC method, Improvement Remuneration, Standardization.Item Design and Implementation of a Green Light Signal Process for Regulatory PMO Team(Polytechnic University of Puerto Rico, 2024) Luciano González, Virginia; Nieves Castro, Rafael A.The Project Management Office (PMO) Regulatory Team, manages regulatory projects that include in the scope all countries globally that can import and distribute their products. The Master Regulatory Schedule (MRS) is prepared with the countries’ outcome to provide visibility to the Franchise and Supply Chain (SC) of the projects that are in the process of being implemented. Challenges for Supply Chain to provide accurate data into the Master Regulatory Schedule and for countries to review the data provide and align dates have been evaluated to identify the risks for restricted countries that cannot receive the previous product after submitting or approving the new product. The main goal is to achieve supply continuity in all countries and avoid any disruptions in product supply by implementing a Green Light Signal. The Project Management Office team started gathering feedback to improve the process, reduce workload, identify priorities, and avoid and mitigate risks. Key Terms ⎯ Green Light Signal, PMO, Restricted countries, Supply Continuity.Item Implementation and Validation of Automated Blasting Machine for the DRMAS Head in the DRMAS Automated Cell(Polytechnic University of Puerto Rico, 2024) Santiago Pérez, Oscar; Nieves Castro, Rafael A.The Wet Blaster blasting system is one of the multiple computerized systems that compose the DRMAS Automation Cell at the Medtronic Humacao site as part of the Project Transfer strategy. This equipment can execute one subprocess without human intervention. However, manual intervention is performed to perform part inspection and ensure it meets standard criteria in the final manufacturing of the product. The objective of this project should be the completion of an Installation Qualification to test that the equipment complies with the standard of manufacturing production and an Operational and Performance Qualification process Report that examines the capabilities of the current process in producing a safe, high-quality product under simulated conditions. To reduce huma dependency, an opportunity to automate part of the blasting process was identified and integrated into the DRMAS Automated Cell. After this phase of the blasting process, an ABB robot takes the part from point A to point B and places it in an exit chute for final inspection. Key Terms - Automation, Installation Qualification, Process Development Report Chronic, Spinal.Item Design and Implementation Process to Optimize the Inspection Method at Machining Process to product of 100 % Inspection(Polytechnic University of Puerto Rico, 2024) Reyes Rivera, Omar; Nieves Castro, Rafael A.This study focuses on the development of a Sampling Plan to implement an improved inspection process in machining. The goal is to optimize the efficiency of the inspection process without compromising quality standards, reducing inspection time and associated costs. Using the implementation of DMAVD (Define, Measure, Analyze, Design and Verify) in which a performance qualification is conducted to assess the capability of the existing inspection process and determine an optimal sampling plan to improve efficiency. The results indicate that the current process is stable and capable, allowing the implementation of a sampling plan to reduce inspection time. A plan based on the Ppk of the critical characteristics of the EDO is proposed, ensuring the quality of the product while optimizing the efficiency of the inspection process. This strategy contributes significantly to the optimization of the production process and compliance with quality standards. Key Terms ⎯ EDO, Inspection Method, Ppk Sampling Plan; Quality.Item Biotechnology Ion Exchange Chromatography Improvement(Polytechnic University of Puerto Rico, 2024) Nieves Ortiz, Miguel A.; Nieves Castro, Rafael A.This research investigates the influence of different stop collection percentages on ion exchange chromatography in laboratory-scale separations. A direct association was seen between reduced stop collection (percentages of peak max) and increased chromatographic area under the curves, resulting in enhanced substance elution. Four (4) experimental runs showed linear behavior (97%, 95%, 93%, 90%, and 88% peak max). The presence of variability among runs serves to emphasize the susceptibility of outcomes, hence it is important to consider the control of key parameters such as chromatography process conditions and sample stability. The suggestions for future research include (1) adjusting column conditions and (2) investigating causes of variability to enhance reproducibility. This study offers significant contributions to the productivity of a blockbuster drug, by enhancing the uses of ion exchange chromatography. The supporting data was generated using a scaled-down model of the large-scale process operations. Key Terms ⎯Chromatography, Ion Exchange, Scale-Down Model, Stop Collection.Item Integrating ThoughtSpot for Real-Time Analysis and Proactive Handling of Non Conformance and CAPA(Polytechnic University of Puerto Rico, 2024) Ortiz Cabrera, José; Nieves Castro, Rafael A.This study addresses quality management issues at Ethicon, a Johnson & Johnson subsidiary in Guaynabo, Puerto Rico, utilizing advanced analytics and process optimization methods. Through the integration of the ThoughtSpot AI-powered platform and the DMAIC paradigm, the study achieves its objectives. ThoughtSpot enables real-time data analysis, facilitating swift assessment of non-conformances globally. Extensive stakeholder involvement and precise data gathering identify areas for optimizing the quality management system. Time studies reveal significant efficiency gains, with a yearly reduction of 468 analyst hours attributed to ThoughtSpot. Detailed time analysis graphics pinpoint process inefficiencies, enabling targeted improvements. ThoughtSpot's implementation accelerates problem detection and resolution, enhancing operational effectiveness and quality standards adherence. The study highlights the potential of AI-driven analytics to transform the medical device sector by streamlining decision-making and boosting operational efficiency. Key Terms - CAPA, Data Analysis, DMAIC Method, Nonconformance, ThoughtSpot.