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Now showing items 11-20 of 27
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 ...
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 ...
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 ...
Quality Improvement of a Paint and Restoration Process in the Remanufacturing Industry
(Polytechnic University of Puerto Rico, 2013)
In a remanufacturing operation it was
required to improve the first pass yield of a Paint
and Restoration process that handles plastic and
metallic parts. The raw material for the process is
recovered from used household ...
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 ...
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 ...
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 ...
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 ...
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 ...