Statistical data analysis tool for the Morphologi G3 high sensitivity particle characterisation system makes it quicker and easier to investigate batch-to-batch variation in a powder feed or product
From the database of size and shape measurements generated by the Morphologi G3, the data comparison tool rapidly identifies the parameters responsible for batch-to-batch variation.
The results, in combination with process or product performance data, make it easy to identify those parameters that are 'critical to quality' and set appropriate criteria for QC.
Widely applicable, this new tool is particularly relevant for the pharmaceutical industry, with its current focus on more effective specification setting, as encouraged by QbD.
The Morphologi G3 measures particle size and shape parameters for tens of thousands of particles in a sample in just minutes, generating significant quantities of information.
The new comparison tool allows selected sets of data to be compared on the basis of any recorded variable.
It produces a parameter variability bar chart that shows which properties vary most across the selected records, and has a dendrogram function that clusters sets that are similar in terms of any chosen parameter.
If certain batches are known to perform well then they can be manually clustered, as an input, prior to analysis.
The software will identify the linking parameter that is similar for all successful batches, and the value of this variable that defines success.
Alternatively an undirected investigation of six batches of material, for example, may reveal that circularity, a shape parameter, varies most between batches and that batches 1, 3, 4 and 6 are similar in terms of this parameter, while 2 and 5 are different from the rest but similar to each other.
An application note detailing use of the data comparison tool for the analysis of pharmaceutical excipients is available from the Malvern website.
