• Buffer Formulation Vent Filter Re-Use at Parenteral Manufacturing Plant 

      Figueroa-Rodríguez, Jorge (Polytechnic University of Puerto Rico, 2020)
      For sterilization-in-place cycles that used vent filters as a redundant non-contact product, the filter membranes could be re-used several times without impacting their integrity neither compromising the sterilization ...
    • Carnauba Dispenser to Improve Coated Tablets Elegance 

      Negrón Romero, Mara Liz (Polytechnic University of Puerto Rico, 2021)
      This study describes the implementation of Six Sigma for improvement of the addition process of carnauba wax on coated tablets in a pharmaceutical industry. Due to the frequent complaints received from costumers for covered ...
    • Catheter bonding Process Improvements with High-intensity Ultraviolet Curing Systems 

      Ortega Meléndez, María del Mar (Polytechnic University of Puerto Rico, 2021)
      Ultraviolet (UV) curing is a common process used in medical devices manufacturing for bonding operations. Light-curable adhesives provide rapid cure, great adhesion, and good chemical resistance for sterilization processes. ...
    • Change Control Routed with Missing Information Delaying Approval and Implementation Date 

      Álvarez Rodríguez, Bianca (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 ...
    • Changeover Process Optimization for a Medical Device Manufacturer in Haina, Dominican Republic 

      Gutierrez, Claudia (Universidad Politécnica de Puerto Rico, 2020)
      The medical device industry has the critical mission of saving and sustaining lives of patients being affected by chronical diseases. To these companies, having more available time to produce will enable and facilitate ...
    • Changeover Reduction Time by Adjusting the Cleaning Critical Parameters in Automated CIP Systems 

      Garay Charleman, Lynnette (Polytechnic University of Puerto Rico, 2018)
      Clean-In-Place (CIP) is a widely use process to clean biotechnology vessels contact surfaces. CIP is an automated cleaning method that involve minimum to no equipment disassembling thereby reducing labor and time ...
    • Chromatography Skid 3 Automation Integration Layer Upgrade 

      Figueroa Agosto, Delianne N. (Polytechnic University of Puerto Rico, 2023)
      This research will focus on upgrading the Chromatography System 3 to reduce time and generate batch reports. In this way, system monitoring is more effective and documentation is more accurate. The system handles an excessive ...
    • Clasificación ABC del Inventario de Materias Primas 

      Peña Richardson, Javier E. (Universidad Politécnica de Puerto Rico, 2020)
      La investigación se realizó en una empresa que elabora productos farmacéuticos, y surgió de la necesidad de clasificar el inventario de materias primas y aprovechar una expansión que se va a realizar, la cual afecta la ...
    • Clean in Place Recipe Optimization 

      Marin Alvarez, Crystal (Polytechnic University of Puerto Rico, 2021)
      This improvement project was based in reduce the fixed tanks and transfer lines Clean in Place (CIP) recipe execution by consolidating the Water for Injection (WFI) rinse and the WFI CIP recipes into one single recipe. ...
    • Clean Steam Energy Conservation Process Design 

      Guevara Brugman, Kenneth L. (Polytechnic University of Puerto Rico, 2011)
      Abstract ― The objective of this article is to design the sterilization methodology and processes needed in a product or equipment that requires the injection of clean steam to create a sterile environment. Clean steam is ...
    • Cleaning Validation of a Manufacturing Line using CIP-100 Detergent and a Clean-in-place Skid System 

      Rivera Barreto, Deanceshka A. (Polytechnic University of Puerto Rico, 2022)
      Cleaning Validation is a prime element of control to the cross contamination and potential carry over topic at the manufacturing industry. This process must assure the quality, safety and efficiency of cleaning ...
    • Coating Process Improvement 

      Santos Pirela, Lorraine (Polytechnic University of Puerto Rico, 2021)
      An increase in the number of events associated to AQLfailure that resulted on partial batch rejections was observed in 2020 for Tablets/Caplets formulations due to cosmetic conditions ...
    • Coating Process Improvements in Solid Dose Form Manufacturing 

      Oquendo, María M. (Polytechnic University of Puerto Rico, 2013)
      Organization’s goals and objectives use strategic scorecards that include Quality, Economics, Speed and Culture to establish business metrics focused on building continuous future success and competitiveness to create ...
    • Commissioning and Qualification of Utilities in a new Filling Line Expansion Project 

      Rivera Rivera, Francet L. (Polytechnic University of Puerto Rico, 2017)
      As part of a project for a Parenteral Filling Line expansion, Commissioning and Qualification activities were performed in new and existing modified systems to provide documented evidence and ensure that all equipment, ...
    • Continuous Improvement in the Retention and Employment Placement – Link Between Both Processes 

      Rodríguez Bello, Nancy (Polytechnic University of Puerto Rico, 2013)
      For the last decade, the socialeconomic factors as violence, underground economy, the poverty level of living, high unemployment, generations depending on subsidies fund from the United States, has negatively impacted ...
    • Control licenses area optimization 

      García Beato, Iris Anel (Polytechnic University of Puerto Rico, 2019)
      When working in a company that contains processes regulated by state and federal agencies, any task performed by staff is critical. Especially when the company supplies products that are consumed by people. A controlled ...
    • Controlled Environmental Area Room B Relayout for Acuity X4 Subassemblies Manufacturing Line Transfer 

      Ramírez Quiles, Ashley (Polytechnic University of Puerto Rico, 2021)
      Boston Scientific is part of a competitive environment and strives to find methods to reduce cost, waste and improve quality. A methodology for reduction is Lean manufacturing. This methodology is used to reduce “muda” ...
    • Cost Improvement Tracking System to Promote a Stream Lined Program 

      Ramos Morales, Luis Rene (Polytechnic University of Puerto Rico, 2022)
      This project presents the development of a process supported by a technology mechanism to facilitate the tracking and management of programs implemented by organizations to lower the cost base and/or promote ...
    • Cost Reduction in a Pharmaceutical Industry: Application of DMAIC Tools to Improve the Preventive Maintenance Process for Effective Job Plans and Maintenance Frequencies 

      Nieves, Edwin J. (Polytechnic University of Puerto Rico, 2014)
      Pharmaceutical Company LCPR is committed to achieve their vision through a cultural adoption of continuous improvement. An opportunity has been identified and is aligned with the company continuous improvement ...
    • COVID-19 as a Stimulus for Remote Manufacturing Efforts 

      Montano Caraballo, Giselle B. (Polytechnic University of Puerto Rico, 2020)
      The Island of Puerto Rico currently encounters the same issue as the rest of the world but does not count with the proper technology in manufacturers to confront it Remote operations of manufacturing systems are needed ...