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Anti-inflammatory Drug Elution Rate Variability Reduction
(Polytechnic University of Puerto Rico, 2013)
This project was focused in the Drug
Elution Rate Variability of an Anti-inflammatory
Drug used in a Medical Device Company. The
project is based on the manufacturing and bonding
process of a DXA Drug Collar that is a ...
Quality Improvement in a Medical Device Manufacturing Process Applying Six Sigma Tools
(Polytechnic University of Puerto Rico, 2009)
Abstract - The current manufacturing process of a medical device product has great opportunities on scrap percent reduction, which has been impacting the material and labor costs of the product, as well as in defects per ...
Lean and Safe Manufacturing for an Antidepressant Tablets Coating Process
(Polytechnic University of Puerto Rico, 2009)
Abstract - The Lean and Safe Manufacturing Process (6S event) was selected for implementation in an antidepressant tablets coating manufacturing process. The coating process was identified due to the utilization of toxic ...
Manufacturing Expert System Development Guidelines in a Medical Device Manufacturing Company
(Polytechnic University of Puerto Rico, 2012)
Abstract - The medical device manufacturing company as well as other regulated industries can only perform manufacturing activities in a strictly controlled environment working area controlled by complex systems that ...
Determination of In-Processing Manufacturing Impact into Elution Rate of Drug Eluting Steroid Collars
(Polytechnic University of Puerto Rico, 2012)
Abstract - The Food and Drug Administration provides regulations for combination products. The medical device industry needs to comply with these regulations specifically in products containing drug. One of the many ...
Validation of a New Procedure for a Pacemaker Component
(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 ...
Development of Vaporized Hydrogen Peroxide (VHP) Decontamination Cycle for a Syringe Isolator
(Polytechnic University of Puerto Rico, 2009)
Abstract - A parenteral syring filling line inside a closed cabin isolator was installed in an existing manufacturing space. To increase sterility assurance the isolator must be effectively biodecontamined by means of Vapor ...