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Quality Alerts Notifications Evaluation and Response Solution for Sites to Communicate Computer Systems Potential Issues in an Alignment Form and Integrated Process
(Polytechnic University of Puerto Rico, 2020)
The Quality Alert Process is used
to communicate IT or computer system related
situations that have the potential to adversely impact
regulatory requirements (e.g. product quality,
patient safety, record integrity and ...
Enhancements to Cardinal Health NPS Lab to USP-787 Standards
(Polytechnic University of Puerto Rico, 2020)
As the world develops and populations
expand, new diseases arise at an exponential rate.
This research is based on employing new
modifications to NPS (Nuclear Pharmacy Services)
Laboratory at Cardinal Health, Inc. ...
Setup Time Reduction in the Water for Injection Sampling Process on the Pharmaceutical Industry
(Polytechnic University of Puerto Rico, 2020)
This work consists in the development of
a new WFI sampling route that will bring several
important benefits to the pharmaceutical industry.
Reduction in the setup time will improve daily
operations in terms of efficiency, ...
Granulation Area Capacity Increase
(Polytechnic University of Puerto Rico, 2020)
Manufacturing pharmaceuticals are
continuously looking for waste reduction to
improve their processes and increase the
manufacturing output. Granulation area capacity
increase was evaluated for a solid dosage
pharmaceutical ...
Improvements to Perfusion Skids 66501/66502/66503 Operations Used for Enbrel Product in AML-06
(Polytechnic University of Puerto Rico, 2020)
Amgen AML-06 Drug Product Plant is
a multi-product facility where therapies for chronic
diseases are manufactured. Its systems are
designed for the continuous improvement of the
processes, in order to comply with the ...
Global Supplier Quality Performance Monitoring Scorecard
(Polytechnic University of Puerto Rico, 2020)
Monitoring the performance of
suppliers in any industry ensures the continuous
improvement of the relationship between a
supplier-customer through the identification of
gaps between the current performance and the
customer ...
Manual Process to Semi Automation Process for Electrical Discharge of Sterile Pack Tray
(Polytechnic University of Puerto Rico, 2020)
During fiscal year 2018, sterile pack
manufacturing business identified a manual
ionization process with its manufacturing line that
was affecting output and yield. This resulted in a
problem-solving session to identified ...
Business Expansion Design for Challenge Fitness Studio Using DMADV Methodology
(Polytechnic University of Puerto Rico, 2021)
Challenge Fitness Studio is a fitness center incorporated in 2019. The organization’s goal is to gain market penetration and increase members enrollment through partnership with private entities, citizen service centers, ...
Estructura para Reconciliación de Lotes en Área de Encapsulación Utilizando la Metodología Esbelta (“Lean”)
(Polytechnic University of Puerto Rico, 2021)
La industria farmacéutica ha enfrentado muchos cambios con el paso del tiempo. La necesidad de adaptarse a estos cambios ha provocado que las farmacéuticas hayan tenido que adoptar diferentes metodologías para mantener la ...
Clean in Place Recipe Optimization
(Polytechnic University of Puerto Rico, 2021)
This improvement project was based in reduce the fixed tanks and transfer lines Clean in Place (CIP) recipe execution by consolidating the Water for Injection (WFI) rinse and the WFI CIP recipes into one single recipe. ...