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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 ...
Time Cycle Reduction of the Scrap Process in a Medical Device Company
(Polytechnic University of Puerto Rico, 2011)
As part of an assessment performed for continuous improvement it was identified that the Nonconformance (NC) Timeline metric shows 23% over the goal of 30 days closure. From the list of NC Reports (NCR) impacting this ...
PRM Operations Cores Cell Takt Time Kaizen
(Polytechnic University of Puerto Rico, 2015)
This article refers to, how UTAS handles
the optimization of a CORE a cell in the
manufacturing process. Companies have waste that
can be reduce with an optimization of the
manufacturing process. Steps to accomplish ...
Installation of a New Cognex Vision System for Quality Inspection on PDS (ATS5889) Machine at Surgical Device Company in the Eastern Region of Puerto Rico
(Polytechnic University of Puerto Rico, 2014)
There is a 4-6% scrap on PDS
(Protected Disposable Scalpel) machine actual
vision system. It is important for the company to
manage more efficiently and try to reduce scrap
percentage through the entire process of the ...
Reduction of Scrap in Manufacturing Line B-1 Using Six Sigma Manufacturing Methodology
(Polytechnic University of Puerto Rico, 2012)
Abstract - In this research, the focus was in a manufacturing production line of receptacles assembly. The receptacles are the finish good of this production line. In this process the receptacle is build completely starting ...
Enhancement of a Distribution Center Process using Lean Six Sigma
(Polytechnic University of Puerto Rico, 2015)
The competition between manufacturing
& distribution companies increases every day, in the
present world of competitive business, cost
minimization and efficient management of
manufacturing unit is not an easy task. ...
Packaging Line Efficiency Improvements with the Implementation of a Centralized Packaging Line Control System
(Polytechnic University of Puerto Rico, 2015)
Efficiency is a process measurement of
the ability of generating a required output with the
minimum amount of resources. A high efficiency is
crucial for a packaging line as it is an important
aspect of cost control ...
An Application of Project Management Methodology for the Development of an Advance Identity Product within Budget and On Time Delivery
(Polytechnic University of Puerto Rico, 2012)
Abstract - In an Advanced Identity Management Technology Company the purpose is to create solutions to identifying individuals in a system (such as a country, a network, or an enterprise) and controlling their access to ...
Combination Products Regulation – A Guide to Compliance
(Polytechnic University of Puerto Rico, 2015)
The Food and Drug Administration
(FDA or Agency) has issued a regulation on the
current good manufacturing practices (CGMP’s)
requirements applicable to combination products.
The new rule is intended to promote the ...