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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 ...
Potable Water Quality Improvement in a Water Filtration Plant Facility
(Polytechnic University of Puerto Rico, 2013)
The processes used for treatment in
water plants depend on the quality of the source
and the desired quality of the water. The chemicals
selected for the treatment depend on the
effectiveness to obtain the desired ...
Compression Machines Relocation for Space Optimization
(Polytechnic University of Puerto Rico, 2013)
Pharmaceutical industries develop,
produce and market drugs for use as medications.
All pharmaceutical manufacturers are directed to
produce in a high optimization environment to
increase productivity and ensure product ...
Risk Prevention in Syringe Filling Line in a Pharmaceutical Manufacturing Plant
(Polytechnic University of Puerto Rico, 2013)
Risk prevention in syringe filling line
can be achieved through the implementation of
“Defense in Depth” concepts. Defense in Depth is
based on the integration of 3-layers of operational
controls which are Equipment, ...
Modifications to the Purified Water Storage and Distribution System Polytechnic University of Puerto Rico
(Polytechnic University of Puerto Rico, 2013)
The Purified Water is identified to play
an integral role in manufacturing operations.
Careful considerations and good manufacturing
practices must take place in order to minimize
contamination and bacterial load. It ...
Finished Goods Failure Reduction in a Wound Closure Medical Device Product Family
(Polytechnic University of Puerto Rico, 2013)
A corrective action and preventive
action plan was developed to address the increase
of Finished Goods failures in a wound closure
medical device product family. Following a DefineMeasure-Analyze-Improve-Control Six ...
Quality Risk Management for the Evaluation of Potable Water Final Rinse during the Cleaning Process of Granulator Jilter Bags
(Polytechnic University of Puerto Rico, 2013)
The objective of this article is to
describe the application of Quality Risk
Management (QRM) approach to assess and
manage the risk associated to the impact of using
Potable Water during the final rinse process used
to ...
Smart Camera Mimics Humans Decision Making Process in a Vial Crimp Quality Automated Inspection Process
(Polytechnic University of Puerto Rico, 2013)
Crimp quality is an important attribute
in the vial filling process. It protects the sterility of
the product from manufacturing until it is dispensed.
A pharmaceutical company performed a Failure
Mode and Effect ...
Medical Device Assembly Yield Improvement: Application of Quality Foundations
(Polytechnic University of Puerto Rico, 2013)
Quality foundations application is not a
new concept for medical device, manufacturing,
and service industries. The key quality concepts
have origins from the quality pioneers named as
“gurus” Joseph Juran, Deming and ...
Implementing a Compressed Air Leak Preventive and Repair Program
(Polytechnic University of Puerto Rico, 2013)
In recent years the energy cost in Puerto
Rico has been constantly increasing. The reasons
vary from more expensive fuel costs, new
environmental regulations requirements and
inefficiencies in the system. The major ...