Manufacturing Competitiveness
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Mejoras Al Diseño Establecido en el Proceso de Empaque para la Industria Biofarmacéutica con el fin de Minimizar Errores Humanos
(Polytechnic University of Puerto Rico, 2022)En una línea de manufactura, el 83.3% de los operadores concuerda con que el proceso de documentación es complejo, lo que aumenta la incidencia de errores humanos. El propósito de este estudio es identificar posibles ... -
Improvement in the Visibility of Nonconforming Product Inventory and Reduction
(Polytechnic University of Puerto Rico, 2022)One of the major problems reported in a company is the Nonconforming product inventory, reducing the availability to use space for new production lines and storage of conforming product. Company wants to understand why the ... -
Workflow Management in the Batch Record Review Process
(Polytechnic University of Puerto Rico, 2022)The review of Batch Records creates a story of the materials, manufacturing, and packaging involved in the production of biopharmaceuticals. The Master Batch Record details who, when, where, and how each process stage is ... -
Feasibility Study of Proposed Manufacturing Layout Re-design to Improve Process Capacity and Reduce Cycle Time of a Downstream Operation of Product A
(Polytechnic University of Puerto Rico, 2022)Lean Six Sigma tools and methodologies are widely used in today’s work environments. The use of a Lean Six Sigma approach provides organizations more flexibility and efficiency to improve their competitiveness. At the ... -
Optimization in the Account Registration Process in Automated Equipment
(Polytechnic University of Puerto Rico, 2022)Over the years technology has increased in the manufacturing areas. Companies have moved to obtain automated equipment for the manufacture of their products. In the pharmaceutical industry, this equipment has been implemented ... -
Designing a Standardized Process Flow for Regulatory R&D Service Center: A Design for Lean Six Sigma DMADV Case Study
(Polytechnic University of Puerto Rico, 2022)Lean Six Sigma has great impact in the removal of non-value-adding activities and improving business performance. It does so by applying tools and techniques to eliminate waste, and focus on implementing strategies to ... -
Mejoras de Calidad y Riesgos de EHS, mediante la Simplificación de Procesos y Detección Temprana para Minimizar Errores Humanos en los Procesos de la Industria de la Biotecnología
(Polytechnic University of Puerto Rico, 2022)Los errores cometidos en la industria farmacéutica son un hecho real el cual se debe atacar. Los equipos utilizados para la manufactura de medicamentos también requieren de un proceso de preparación, que incluyen limpieza ... -
Implementing Six Sigma Tools to Reduce Formulation Errors in a Compounding Pharmacy
(Polytechnic University of Puerto Rico, 2022)Formulation errors are medication errors that occur when a prescribed mixture is not performed as per the required medical order. Formulation errors in compounded total parenteral nutrition units represent an inherent ... -
Strategy for the Reduction of False Rejects in the Visual Inspection of Injectable Drug Products
(Polytechnic University of Puerto Rico, 2022)A hundred percent visual inspection is performed as part of the manufacturing process of injectable drug products as a regulatory requirement to detect and remove units with defects to protect the patients. The rejection ... -
Fiber Drums Reduction in Weighing & Dispensing Manufacturing Process
(Polytechnic University of Puerto Rico, 2022)Achieving overall efficiency within the manufacturing processes is the key goal among many organizations. Reducing waste enables manufactures to save money and take production up a notch. LEAN manufacturing and DMAIC are ... -
Internal Audit Program - Quality Inspection in the Manufacturing Process to Identify Improvements in Quality Control
(Polytechnic University of Puerto Rico, 2022)Implement a preventive operations in-process auditing system with final inspection points at Company J, that monitors product, packaging configuration, and documentation execution to assure product manufacturing specifications ... -
Lean Wastes Caused by Using Hard Copy Paper Forms on Manufacturing Processes
(Polytechnic University of Puerto Rico, 2022)The waste caused by using paper in manufacturing is a project to identify waste costs and possible solutions. In many ublications, the objective is to demonstrate how using an electronic tool instead of printed reports has ... -
Reducing Downtime Due to Glove Breakage in Manufacturing Areas
(Polytechnic University of Puerto Rico, 2022)Lean manufacturing was developed for maximizing resource utilization through the minimization of waste. During certain tasks in the Manufacturing Area, gloves tended to break. I propose that we need to reduce the walk ... -
Improving the flow of Sampling Analysis of Manufacturing Batches to reduce time and Increase the Capacity of the Process
(Polytechnic University of Puerto Rico, 2022)This research will focus on analyzing the flow of sample analysis of manufacturing batches to reduce time and increase the capacity of the process in the laboratories. A laboratory in the pharmaceutical industry receives ... -
Redesign of a Space in the Autopsy Room Assigned for the Preparation of Biological Samples for Toxicological Analysis by Using DMADV Technique
(Polytechnic University of Puerto Rico, 2022)The government agency of the Institute of Forensic Sciences recently received the necessary accreditations to be able to provide the essential service it offers to the citizens of Puerto Rico. The objective of this project ... -
Using Six Sigma in a Computer System Validation Project in a GMP environment
(Polytechnic University of Puerto Rico, 2022)Computer Systems Validation is a process used to test, validate, and formally document that a regulated computer-based system does exactly what it is designed to do in a consistent and accurate manner that is secure, ... -
Evaluation of Residual Protein ELISA Stability of Precoated Plates and Assay Control in a Hight Throughput Environment
(Polytechnic University of Puerto Rico, 2022)Evaluation of Enzyme Linked Immunoassay Sorbent Assay (ELISA) overall stability on precoated plates to appraise Residual Protein levels in a wide variety of drug substance samples and filtration process reduces turn around ... -
Using Six Sigma Methodology and Technology to Improve Quality Audit Process Cycle Time
(Polytechnic University of Puerto Rico, 2022)Currently, at the “Pharmaceutical Company Y”, the cycle for launching a product can take an average of 46.7 days. The proposal for this study seeks to reduce this cycle time to 30 days. This project illustrates the ... -
New flow route for the delivery of the to be cleaned filling equipment for the lot-to-lot changeover optimization using the lean manufacturing methodology
(Polytechnic University of Puerto Rico, 2022)Management demand to reduce downtime in manufacturing had increased in recent years. This led manufacturing to use the Lean Methodology and Six Sigma tools to optimize the process. Focused on process improvement and ... -
Optimization, Standardization and Revision of the Label Review Policies and Procedures Manual using Lean Six Sigma at Polytechnic University of Puerto Rico
(Polytechnic University of Puerto Rico, 2022)The Label Review Department focuses on reviewing other companies label for compliance with FDA regulations by providing a one-on-one service accompanied with a report with recommended changes and a print-ready graphic file. ...
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