12/02/2005 • Laboratory appliances • Microscopy / Imaging

Extended range for Morphologi G2 beneficial for studying granulation processes

Malvern Instruments’ extended range accessory kit for the Morphologi G2 high sensitivity particle size and shape analyzer is helping customers in the pharmaceutical industry who are studying granulation processes. The accessory kit, which was launched earlier this year, comprises a low magnification objective and wide field of view condenser element. It widens the dynamic range of the Morphologi G2 considerably by extending the upper limit from the standard 1000 microns to 3000 microns.

The Morphologi G2 incorporates the latest Nikon CFI60 optics and a high resolution digital camera to deliver particle size and shape data, and images. Based on digital image analysis and automated microscopy, the system measures particle size across a wide range, from 0.5 to 3000 microns, using circle equivalent diameter; it employs a variety of parameters for particle shape analysis. This allows determination and quantification of even subtle differences between particles. Since every particle in a sample can be individually measured and recorded, the analyzer also has applications in counting and foreign particle detection.

The analyzer provides both microscope-quality images and statistically significant data through the rapid analysis of hundreds of thousands of particles. The ability to see and record images of all particles allows visual verification and detection of phenomena such as broken particles, agglomerates and the presence of fines. Full automation using Standard Operating Procedures (SOP) eliminates any user bias inherent in manual microscopy methods, and enables straightforward method development and easy electronic transfer.

Automatic calibration, conformance to 21CFR part 11 requirements and the availability of full IQ/OQ documentation ensure that the system is accurate and repeatable, and all data is secure and validated. As well as SOP-driven, automated operation, Morphologi’s powerful software package enables the generation of customer reports, allows the user to sort, filter and classify captured particle images, plot trends between multiple records, and overplot and compare multiple data sets.
For more information and a demonstration the ease of use of Morphologi G2 visit

http://www.malvern.co.uk/morphologi

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