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Audit Process Optimization in the Manufacturing Area
(Polytechnic University of Puerto Rico, 2021)
This project was developed to demonstrate a viable audit process optimization in the manufacturing area. The AbbVie site ubicated in Barceloneta, Puerto Rico,started with only one product back in ...
Handling and Managing of Vial Rejects
(Polytechnic University of Puerto Rico, 2021)
A large accumulation of filled vial
rejects generated in an aseptic filling line of a
parenteral medication was identified to be in the
custody of the Quality Assurance department
indefinitely. Using the DMAIC methodology ...
Vial Leak Test Optimization
(Polytechnic University of Puerto Rico, 2021)
This paper describes the testing performed to determine the optimum operational parameters that will be used to operate the Mar-Tre Leak Testerfor the 12Z vial configurations. Based on the results obtained, ...
Strategy for the Reduction of False Rejects in the Visual Inspection of Injectable Drug Products
(Polytechnic University of Puerto Rico, 2022)
A hundred percent visual inspection is performed as part of the manufacturing process of injectable drug products as a regulatory
requirement to detect and remove units with defects to protect the patients. The rejection ...
Process Validation: Batch Size Increase in the Downstream Process
(Polytechnic University of Puerto Rico, 2023)
The worldwide demand for the drug substance has increased by 30%. The drug substance is an ingredient used in the final product formulation, which later becomes the medicine that will reach the patients. The challenge that ...