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Evolutionary vs. Revolutionary: a Snap Shot of the Current Tendencies in Pharmaceutical Industry and the Impact of Process Analytical Technology and Continuous Manufacturing Processes
(Polytechnic University of Puerto Rico, 2013)
Food and Drug Administration (FDA)
challenges the pharmaceutical industry to innovate
itself and introduce ever higher quality standards
through the use of technology. Development of
continuous manufacturing systems ...
Raw Material Sampling Process Optimization using Lean Six Sigma Methodology
(Polytechnic University of Puerto Rico, 2014)
Pharmaceutical Industry needs reduce
the costs without impact the quality of the product.
The principal objective of this project is the
reduction of the cycle time of a raw material
sampling process from 8 days to 2 ...
Coating Process Improvements in Solid Dose Form Manufacturing
(Polytechnic University of Puerto Rico, 2013)
Organization’s goals and objectives
use strategic scorecards that include Quality,
Economics, Speed and Culture to establish business
metrics focused on building continuous future
success and competitiveness to create ...
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 ...
H&K Capsule Filling Equipment Reliability
(Polytechnic University of Puerto Rico, 2013)
Encapsulation is a process whereby the
dose is charged into a hard gelatin capsule;
powder, pellets, tablets or combinations of two or
more of these may be filled into the capsules.
Capsules provide a convenient way ...
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 ...
Optimization of Chemical Manufacturing Process Area
(Polytechnic University of Puerto Rico, 2014)
“Industry X” does not have a detailed
and effective plan for chemical weighing process
which considers optimal number of operators and
shifts necessary to accomplish the desired
production. The products process flow ...
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 ...
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 ...