Application note: In-line PAT solutions for understanding and controlling fluidised bed granulation (FBG) processes

Determining CPP’s in DoE using Eyecon particle characteriser and Multieye Multipoint NIR.

Presented here is a study using an in-line NIR and an in-line particle characteriser to determine the effects of three Process Parameters, on moisture content and particle size over the duration of a FBG process. Inlet Air Temperature (oC), Atomisation Pressure (Bar) and Spray Rate (g/min) are typical process parameters optimised to achieve the required granulate characteristics for a given product and were analysed in this study. The moisture content was determined by the Multieye multipoint NIR, and particle size was determined by the Eyecon, a real-time imaging technology. Both instruments were developed by Innopharma Labs as PAT tools.

Experiment Design

The trial was designed based on a 23 factorial DOE with the Process Parameters varied across the design space of the granulation process. The study was conducted using a Glatt WSCombo250 FBG with process end point determined by product temperature. The in-line moisture content determined by the Multieye was verified by offline LOD Analysis using a Mettler Toledo LJ16 Moisture Analyzer.