Optimization of pharmaceutical product production lots at granulation manufacturing stage

Abstract

The customer of ABD Company wants the CY product to meet 7% 40 mesh requirement in 80% of the lots requested. The company has two granulators that are used for the manufacturing of the product but one of them typically produces higher 40 mesh values than the other one. A project to understand the situation was proposed and tools from DMAIC methodology were used. It was found out with the investigation that the granulator that produced higher values had a different humidity setpoint which caused more water to be needed in the manufacturing process. It is understood that coarser particles are a result of water excess. A change in the humidity setpoint was recommended as a solution of the problem and to harmonize both equipment. Once the change is implemented it should be monitored to see the results after the change. Key Terms - DMAIC, Granulation, Improvements, Pharmaceutical Industry.