• Validación de Limpieza: Extensión Largo de Campaña para una Tómbola de Sellado y Equipos Auxiliares 

      Hernández Figueroa, Magdalena (Polytechnic University of Puerto Rico, 2019)
      La validación de los procesos de limpieza, tiene un rol fundamental en la reducción de contaminación en los equipos de fabricación industrial de medicamentos. La misma nos ayuda a demostrar que nuestros procedimientos ...
    • Validation Documents Process Optimization and Cost Reduction 

      Simonetti Roche, Arelys (Polytechnic University of Puerto Rico, 2019)
      Every manufacturing and regulated site, performs multiple Validation Documents; being this area one of the most material cost and man hour consuming of the site. FMEA and Design Documents are constantly generated and revised ...
    • Validation Exercise for a Vial Secondary Serialization Packaging Line Upgrade 

      Fargas Landrau, Carlos M. (Polytechnic University of Puerto Rico, 2018)
      Serialization has been the focus during the past years due to the new worldwide regulation related to the track and trace of pharmaceutical products. Companies dedicated all their efforts incorporating new technology ...
    • Validation Exercise for Facility GMP HVAC System 

      De la Torre Vázquez, Damilette (Polytechnic University of Puerto Rico, 2019)
      The client developed Technology Transfer Project to retrofit out of use manufacturing existing facilities and utilities to provide adequate area for the commercial manufacturing of new products. To achieve the Technology ...
    • Validation Exercise for Upgrade of the Systech’s Serialization Program v8.01 at a Packaging Line 

      Soto Cruz, Alexandra (Polytechnic University of Puerto Rico, 2017)
      Serialization has been the focus during the past years due to the new worldwide regulation related to the track and trace of pharmaceutical products. Companies dedicated all their efforts incorporating new technology ...
    • Validation Machine Process of “Crosslink, Low Profile Break-off” On Tornos Deco 20 

      Rodríguez Vázquez, Luis Adnel (Polytechnic University of Puerto Rico, 2016)
      The United States (U.S.) medical device manufacturing sector is a highly diversified industry that produces a range of products designed to diagnose and treat patients in healthcare systems worldwide. Process validation is ...
    • Validation of a New Procedure for a Pacemaker Component 

      Farahmand, Marguerite (Polytechnic University of Puerto Rico, 2012)
      Abstract - Company X manufactures pacemakers in Puerto Rico. Over the past years, Company X has been having a significant amount of complaints due to the septum component contained in its pacemakers. Doctors have claimed ...
    • Vial Leak Test Optimization 

      Chávez Salazar, Ronald (Polytechnic University of Puerto Rico, 2021)
      This paper describes the testing performed to determine the optimum operational parameters that will be used to operate the Mar-Tre Leak Testerfor the 12Z vial configurations. Based on the results obtained, ...
    • Vision System Selection Requirements & Implementation In Industrial Automation 

      Rodríguez, Miguel (Polytechnic University of Puerto Rico, 2012)
      Abstract - The vision systems are part of a new revolution in automation. With the capability of being implemented practically to any application, the benefit of using this kind of systems are multiple but the ones which ...
    • Visual Basic as a Tool for the Automation of Engine Health Monitoring Systems in the Aerospace Industry 

      Velázquez Morales, Jesús Adrián (Polytechnic University of Puerto Rico, 2014)
      The aerospace industry presents many challenges when it comes to provide quality and reliability to its users. Many lives depend on the appropriate maintenance and on-time delivery of products and services on a daily ...
    • Waste Elimination on a Printing Process 

      González Soto, Khalil (Polytechnic University of Puerto Rico, 2019)
      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 ...
    • Water Efficiency Improvement Using DMADV Methodology 

      Cruz Moreta, Gilbert (Polytechnic University of Puerto Rico, 2017)
      Water utility optimization using manufacturing methodology to investigate ways we can generate more revenue and a more efficient service. Considering different types of manufacturing process which could have a ...
    • Wet Granulation End-Point Determination of a Drug Formulation 

      Merced Vega, Yaritza (Polytechnic University of Puerto Rico, 2019)
      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 ...
    • Workmanship Error at Assembly Line in a Medical Device Company 

      Madrigal Negrón, Pamela (Polytechnic University of Puerto Rico, 2012)
      Abstract — In a Medical Device Company a production line had an increase of non-conformances in 2011. The category for the increase was workmanship error. These failures result in cost of poor quality due to quality holds. ...
    • Yield improvement for anesthesia product at filling & packaging line 

      Álvarez Rodríguez, Marietta (Polytechnic University of Puerto Rico, 2019)
      In the manufacturing process of anesthesia, the yield for Fluxane product, manufactured at ANESTHER Healthcare, is consistently performing lower than target (2.785 bottles/kg) from tank F-SV-001 in comparison to tank ...