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Implementation of a Calibration Wireless System in a Pharmaceutical Facility
(Polytechnic University of Puerto Rico, 2012)
Abstract - Regulated industries such as Pharmaceutical, Biotechnology and Medical Devices require a Calibration Program, to guarantee the product quality. The objective of this project was to design Calibration Wireless ...
Buffer Formulation Vent Filter Re-Use at Parenteral Manufacturing Plant
(Polytechnic University of Puerto Rico, 2020)
For sterilization-in-place cycles that
used vent filters as a redundant non-contact
product, the filter membranes could be re-used
several times without impacting their integrity
neither compromising the sterilization ...
Alternate Raw Material Supplier Validation
(Polytechnic University of Puerto Rico, 2019)
This article discusses the Process Validation of Over the Counter Pharmaceutical Product using alternate supplier of raw material. The primary ibuprofen drug substance supplier for GSK Ibuprofen family products informed ...
Evaluation of Reagents Used in Solution Preparation to Reduce Reworks in Research and Development Laboratories
(Polytechnic University of Puerto Rico, 2019)
Research and development laboratories
are working with improvements and discovery of
new drugs. As part of their activities, they need
solutions such as Buffers and Mobile Phases for
analytical testing. It was found ...
Improving Customer Process Effectiveness in a Facebook-Based Clothing Supplier
(Polytechnic University of Puerto Rico, 2013)
Any organization needs to incorporate
feedback from its customers in order to have a
successful business. As an emerging Facebookbased clothing supplier it has never been evaluated
upon its effectiveness. In this project, ...
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 ...
A Strategically Systematic Approach to Acquire Improvement Project Prospects in a Medical Device Company
(Polytechnic University of Puerto Rico, 2012)
Abstract - Numerous companies begin their manufacturing improvement journey lacking an overall game plan. This results in a not strategized and structured improvement implementation with results less than optimal and if ...
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 ...
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 ...