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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 ...
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 ...
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 ...
PPAP Process and Correlation Study for Vision Systems
(Polytechnic University of Puerto Rico, 2021)
The Production Part Approval Process (PPAP) is being adopted by Medical Device companies to qualify raw material. To standardized qualification processes between multiple supplies and help ...
Handling and Managing of Vial Rejects
(Polytechnic University of Puerto Rico, 2021)
A large accumulation of filled vial
rejects generated in an aseptic filling line of a
parenteral medication was identified to be in the
custody of the Quality Assurance department
indefinitely. Using the DMAIC methodology ...
Optimizing an Airplane Generator in the Manufacturing Stage
(Polytechnic University of Puerto Rico, 2022)
Developing an airplane generator is an engineering challenge that takes planning, designing, brainstorming and, manufacturing of the final design. After all the planning is done, the manufacturing process sequence is ...
Reducing Documentation Errors by Designing a Continuous Workflow for the In-Process of Spinal Needles
(Polytechnic University of Puerto Rico, 2022)
Good Documentation Practices are essential to maintain a robust Quality System. Many documentation errors were constantly found on acceptance records at the Product Release-to-Packaging stage. ...
Design Project for Process Improvement of the Manufacturing of Electrode Ring –Monolithic Controlled Released Devices (MCRDs)
(Polytechnic University of Puerto Rico, 2021)
Medtronic Rice Creek Pharmaceutical Operations at Fridley, Minnesota currently build the Electrode Ring, Monolithic Controlled Released Device (MCRD) assembly which is sent to Medtronic Villalba ...