• Risk Prevention in Syringe Filling Line in a Pharmaceutical Manufacturing Plant 

      Caballero Rodríguez, Alvin (Polytechnic University of Puerto Rico, 2013)
      Risk prevention in syringe filling line can be achieved through the implementation of “Defense in Depth” concepts. Defense in Depth is based on the integration of 3-layers of operational controls which are Equipment, ...
    • 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 ...