The National University of Singapore's pharmacy department has carried out pilot-scale research that demonstrates the value of Malvern's Insitec in-line particle size analyser.
The analyser is used for monitoring and controlling spray drying processes.
Pharmaceutical manufacturers are using process analytical technology (PAT) options, such as the Insitec, at the pilot plant stage to enable quality by design.
The analyser was installed at this stage to monitor the performance of a spray drier producing oil-loaded microspheres of 10 - 35 microns.
Spray-drying is a technique commonly used to modify product properties.
The particle size of the resulting material is typically a key performance variable and is routinely measured by off-line analysis.
The microspheres produced by the research group in this study were oily and prone to agglomeration, making measurement challenging.
The Insitec laser diffraction in-line continuous analyser measured the complete product stream, optimising the data's statistical relevance.
The measurement data provided insight into the process dynamics, allowing, for example, start-up time to be accurately determined so that no in-specification material was wasted.
The research team preferred this technique to light microscopy, which is time-consuming and ill-suited to the process environment.
Insitec technology can be used at-, in- or on-line to measure wet and dry systems containing particles in the 0.1 to 1000 micron range.
At- and on-line analyses allow sample treatment, prior to measurement, which can help accurately characterise the materials prone to agglomeration.
Data acquisition rates are as high as four complete measurements per second, so the analyser can monitor even the most rapidly changing processes.
The real-time measurements produced are ideal for monitoring, and for the automated control of, a wide range of processes.
