New Tool For Malvern's Morphologi G3 Helps Identify Powder Batch Differences

A new statistical data analysis tool for the Morphologi G3 high sensitivity particle characterization system from Malvern Instruments 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 website.www.malvern.com

About Malvern Instruments
Malvern Instruments provides a range of complementary materials characterization tools that deliver inter-related measurements reflecting the complexities of particulates and disperse systems, nanomaterials and macromolecules. Analytical instruments from Malvern are used in the characterization of a wide variety of materials, from industrial bulk powders to the latest nanomaterials and delicate macromolecules. A broad portfolio of innovative technologies is combined with intelligent, user-friendly software. These systems deliver industrially relevant data enabling our customers to make the connection between micro (such as particle size) and macro (bulk) material properties (rheology) and chemical composition (chemical imaging).

Particle size distribution, particle shape information, zeta potential, molecular weight, chemical composition, and bulk materials properties can all be determined with instruments from the Malvern range. The company's laboratory, at-line, on-line and in-line solutions are proven in sectors as diverse as cement production and pharmaceutical drug discovery.

Headquartered in Malvern, UK, Malvern Instruments has subsidiary organizations in all major European markets, North America, China, Korea and Japan, a joint venture in India, a global distributor network and applications laboratories around the world. www.malvern.com.

SOURCE: Malvern Instruments