UK-based Malvern Instruments have developed a new comparison tool that speeds up the identification of batch differences between powder batches more quickly.
This new statistical data analysis tool, which is particularly relevant for the pharmaceutical industry, uses size and shape measurements generated by the Morphologi G3 to rapidly identify 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 quality control.
The Morphologi G3 measures the size and shape parameters for tens of thousands of particles in a sample in minutes.
The 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 website.