Prof. dr. ir. Ingmar Nopens - Ghent University
Prof. dr. Thomas De Beer - Ghent University
Traditionally, production of pharmaceuticals is realized using batch processing steps which can be fairly inefficient, time-consuming and poorly upscalable. Recent clarification by the regulatory authorities as well as the industry have accelerated the search for new manufacturing technologies. Consequently, a transition towards continuous manufacturing which includes real-time process monitoring and closed-loop control, has gained tremendous attention over the past few years. This because of the economic, environmental, safety and product-related advantages of a continuous manufacturing line. Driven by this change in mind-set, an innovative continuous from powder-to-tablet line (ConsiGmaTM-25, ColletteTM, GEA Pharma Systems) was developed for secondary manufacturing of pharmaceutical tablets.
After wet granulation in the ConsiGmaTM-25, a drying step improves the processability and strength of the produced granules. A semi-continuous fluid bed dryer achieves this process step, in which a continuous inflow of wet granules is sequentially partitioned over six drying cells, in which parallel batch drying is performed. Part of the research objective consists of modelling drying and breakage in the system. Moreover, in describing the drying kinetics, attention is paid the effect of granule size.
A second part of the research involves the implementation of OED for pharmaceutical applications. The aim of this technique is to improve the predictive value of the models.