Auflistung Manufacturing Competitiveness nach Erscheinungsdatum
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Labeling and Packaging Process Improvement Using DMAIC Methodology
(Polytechnic University of Puerto Rico, 2022)Medical Device Companies must ensure that each unit of product has unique identification and that it is labeled correctly. Labeling requirements include having the appropriate data on the label, not ... -
Change Control Routed with Missing Information Delaying Approval and Implementation Date
(Polytechnic University of Puerto Rico, 2022)The approval of manufacturing change control for MedDevice Inc., is currently acting lower than target(15 business days). Based on a 12-months data review, the lead time of approval of a change is approximately ... -
Monomer’s Residuals Test Elimination for Soft Acrylic Buttons at Polytechnic University of Puerto Rico
(Polytechnic University of Puerto Rico, 2022)In the cataract surgery, the natural lens in the eye is replace with an Intraocular Lens. Five monomers (EA/EMA, TFEMA, EGDMA, UV Chr) are mixed to produce the soft acrylic lens. Residual monomer testing ... -
Mejoras al Proceso de Empaque parala Jurisdicción de China
(Polytechnic University of Puerto Rico, 2022)En los últimos dieciocho meses, el mundo ha confrontado retos con el suministro de materia prima. En esta empresa no es la excepción, además, la productividad redujo, los desperdicios aumentaron y el tiempo de ... -
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 ... -
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 ... -
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 ... -
¿Cómo se puede mejorar el sistema de calidad y seguimiento de un producto a nivel corporativo?
(Polytechnic University of Puerto Rico, 2022)El sistema de calidad en todos los ámbitos laborales es muy necesario ya que las compañías pueden probar que están cumpliendo con las regulaciones y requisitos de los clientes. Las compañías necesitan mejorar y crear ... -
Gestión eficiente del inventario difícil en la Industria Farmacéutica
(Polytechnic University of Puerto Rico, 2022)En la industria farmacéutica, el flujo efectivo de inventario asegura que los medicamentos manufacturados se fabriquen, distribuyan y entreguen a los pacientes según sea requerido de acuerdo con su necesidad. La cadena de ... -
Filling Line Improvements to avoid the Defect of Product on the Stopper for Sterile Syringes
(Polytechnic University of Puerto Rico, 2022)This research aims to optimize the syringes filling line at the facility to not exceed the action limits because of the defect of syringes with product on the stopper. The product or liquid on the stopper of the syringe ... -
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 ... -
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, ... -
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 ... -
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 ... -
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 ... -
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 ... -
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. ... -
Unidirectional Flow Gasket
(Polytechnic University of Puerto Rico, 2022)To reduce the number of deviations that occur annually in the plant, through a design, it is expected to reduce this problem taking into consideration the cost factor, lead time and the quality of the products made. Using ...