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…
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.
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.