Researchers aim to develop effective automated strategies for process control
A Parsum in-line particle-sizing probe from Malvern Instruments is being used in granulation research at Ghent University in Belgium. Professor Thomas De Beer’s Process Analytical Technology (PAT) group at the university is using the instrument to monitor granulation processes continuously and to develop effective automated strategies for process control.
The PAT group is part of the faculty of Pharmaceutical Sciences and focuses on identifying robust and relevant PAT tools, researching how they can be applied to improve manufacturing efficiency. Granulation trials have shown that real-time particle size measurements, in combination with other analytical data, support consistent production of granules to a defined specification.
De Beer said: ‘In our research we look at all aspects of PAT. We focus not only on assessing different technologies and instrumentation for monitoring, but also on applying the resulting data to process control. Using Parsum we have tracked the evolution of particle size in real time during fluidised bed granulations. The data provide detailed information during Design of Experiment (DoE) studies and enable us to develop models for real-time batch evaluation. These models help drive effective automated process control and reduce batch release times, both of which are important goals for pharmaceutical processors.’
PAT has an important role to play in achieving the pharmaceutical industry’s stated aims of moving away from batch operation and off-line monitoring towards continuous, integrated processing and real-time release. Granulation is widely used in tablet production, but its control can be challenging.
Using Parsum we have tracked the evolution of particle size in real time during fluidised bed granulations
De Beer’s research shows that by correlating particle size data – and other process variables such as binder addition rate and inlet air temperature – with granule quality defined in terms of density, it is possible to develop predictive process models. These can be used to define and control processing conditions to deliver a successful outcome.1
The Parsum probe measures particle size from 50 to 6,000 microns using the technique of spatial particle velocimetry. Available in a number of probe lengths it is specifically for in-process use and can be installed directly into a line or vessel for real-time monitoring.1. A. Burggraeve et al. ‘Batch statistical process control of a fluid bed granulation process using in-line spatial filter velocimetry and product temperature measurements.’ European Journal of Pharmaceutical Sciences 42 (2011) 584–592