Investigating the Trade-Off between Design and Operational Flexibility in Continuous Manufacturing of Pharmaceutical Tablets: A Case Study of the Fluid Bed Dryer

Abstract

Market globalisation, shortened patent lifetimes and the ongoing shift towards personalised medicines exert unprecedented pressure on the pharmaceutical industry. In the push for continuous pharmaceutical manufacturing, processes need to be shown to be agile and robust enough to handle variations with respect to product demands and operating conditions. In this paper we examine the use of operational envelopes to study the trade-off between the design and operational flexibility of the fluid bed dryer at the heart of a tablet manufacturing process. The operating flexibility of this unit is key to the flexibility of the full process and its supply chain. The methodology shows that for the fluid bed dryer case study there is significant effect on flexibility of the process at different drying times with the optimal obtained at 700 s. The flexibility is not affected by the change in volumetric flowrate, but only by the change in temperature. Here the method used a black box model to show how it could be done without access to the full model equation set, as this often needs to be the case in commercial settings.