Anti-inflammatory Drug Elution Rate Variability Reduction

Abstract

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 component of a lead manufacturing company. As part of the Lot Acceptance testing for drug collars, elution testing is performed. Results must comply both individual and mean values in order to be considered acceptable. A failure in a drug collar lot could result in a cost of scrapping or a field action. Therefore, there is a need to implement changes that reduce the variability of the elution testing. The methodology selected for this project is DMAIC. A process map will be developed to identify elements that could be providing variability in elution rate and provide recommendations for manufacturing process enhancement. An implementation plan will be create for proposed changes implementation. Key Terms - DMAIC (Define, Measure, Analyze, Implement, Control), DXA (Dexamethasone Acetate), FDA (Federal Drug Administration), Lot Acceptance Test.