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Development of a New Medical Device Production Line Using Systems Engineering
(Polytechnic University of Puerto Rico, 2012)
Abstract - The design and development of a production line to manufacture a new medical device for clinical trials requires the establishment of a very precise implementation plan. This is especially important since we are ...
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 ...
Development of Bulk Shipping Studies in Pharmaceutical Industry
(Polytechnic University of Puerto Rico, 2012)
Abstract ⎯ A bulk shipping study in the pharmaceutical industry consists in monitoring and analyzing the environmental conditions (e.g. temperature and relative humidity) during shipping and transportation of the drug ...
Implementation of Innovative Automated Coating Technology in a Medical Device Facility
(Polytechnic University of Puerto Rico, 2012)
Abstract - As part of new products development in a medical device plant, an innovative coating technology known as Physical Vapor Deposition (PVD) will be implemented for the electrode coating process. Current process is ...
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 ...
Vision System Selection Requirements & Implementation In Industrial Automation
(Polytechnic University of Puerto Rico, 2012)
Abstract - The vision systems are part of a new revolution in automation. With the capability of
being implemented practically to any application, the benefit of using this kind of systems are multiple but the ones which ...
Implementing a Preventive Maintenance to Complement Standards 6.3 and 7.1 of ISO 9001:2008
(Polytechnic University of Puerto Rico, 2012)
Abstract - The recycling process turns materials that would otherwise become waste into valuable resources, and it’s know many companies around the world do this process to produce a raw material that will be used to create ...
Manufacturing Process Continuous Flow Implementation with Quality Control Inspection and Bill of Material Standardization in a Medical Devices Company
(Polytechnic University of Puerto Rico, 2012)
The Manufacturing Area was composed of seventeen (17) product families around 191 Stock Keeping Units. Most of these families were manufactured in batch mode, while others in continuous flow. This project improved the value ...
Equipment Validation Standardization for Project Implementation Time Reduction of Automated Manufacturing Platforms
(Polytechnic University of Puerto Rico, 2012)
Abstract - Medical Device regulated industry requires extensive validation work. Using the latest automation technology for the process equipment to eliminate the operator interaction brings the challenge of how fast the ...
Development of an Automated System for the Monitoring and Control pH and Conductivity of a Dampening Solution
(Polytechnic University of Puerto Rico, 2012)
The influence of dampening solution parameters on the final printing quality has been remarked on many researches during the last decades. There are many parameters that need to be controlled on a fountain solution as pH, ...