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Morphologi G3 image characterization extends Particle Analytical capabilities
While it looks like a conventional microscope, the Morphologi G3 is classed as a particle characterization system that measures the size and shape of particles using static image analysis. The system brings together hardware and software in a single integrated package to provide an advanced level of automation and validation of results. This analysis can be applied in R&D, process analysis or quality control.
“This instrument has some major advantages compared with manual microscopy,” said Particle Analytical CEO, Søren Lund Kristensen.
Identifying special characteristics
“Not only does it include a much larger number of particles in the analysis but also provides possibilities to identify special characteristics that might be highly valuable for optimizing the manufacturing process,” said Mr. Kristensen.
“In many cases, the customers want to know the size of the particles, both as average diameter and distribution: Are the main part of the particles ‘same size’ or does the powder contain many large and small particles? Further, it is useful to know whether the particles are needles, flakes or spheres, as this is very relevant with regard to properties during manufacturing,” he explained.
“With the Morphologi G3, data treatment is so much easier than with manual microscopy: You get an overview of a larger number of particles – and only imagination sets the limit for how analysis can be performed in order to understand the behavior of the powder. With the new equipment you can analyze in various ways on the same sample: How many needles compared to flakes? Does the large particles have different morphology than the small particles?”
“This type of analysis is especially relevant during development to answer questions such as whether a more optimal particle size shape could be obtained by varying, for instance, temperature or solvent composition during precipitation,” said Mr. Kristensen
The new instrument also provides Particle Analysis new capabilities in routine analysis. When a final production process has been defined, a validated method for determining particles sizes is essential in order to ensure the process in under full control. Due to the larger number of particles included in Morphologi G3 analysis, even small changes in particle characteristics can be identified.
About Particle Analytical
Particle Analytical ApS is a contract laboratory (CRO) that specializes in analysis of physical parameters of particles, powders or emulsions, using a range of advanced techniques.
Founded in year 2000, the laboratory has become one of Denmark’s most rapidly expanding companies, twice winning the national ‘Growth Gazelle’ award.
It is one of the few laboratories in Europe to offer a complete range of services dedicated to analysis of powders, including particle size, and all physical chemical properties. These services are primarily focused on the pharmaceutical industry, where particle and powder analysis are essential in controlling compound properties during development, both with regard to production process and behavior in vivo.
Unique analysis services include determination of refraction index, fast compatibility screenings of excipients and determination of the crystalline proportions of samples.
Particle Analytical’s leading-edge capabilities include laser diffraction, XRD, thermal analysis, dynamic light scattering, microscopy, BET, dynamic vapor sorption, density measurement and air permeability. The laboratory is fully certificated as cGMP compliant by the Danish authorities and is also registered with the US Food & Drug Administration (FDA).
Particle Analytical services can either be used in routine analysis, separately to solve specific problems, or in parallel to larger drug development programs. These services include particle size determination, examination of physical properties, polymorph screening, method development and validation.
About Morphologi G3
The Morphologi G3, manufactured by Malvern Instruments in Worcestershire, UK, is an advanced particle characterization instrument that can measure size and shape of particles ranging from 0.5 microns to several millimeters, using static image analysis. Morphologi G3 analysis follows a three stage process in which sample is spatially separated using integrated dry powder disperser, then image captured by scanning under microscope optics and finally analyzed in software, based on individually-stored gray scale images for each particle. Features of the system include:
- Automated SOP control for unattended operation and reproducible results
- High quality microscopic images for accurate characterization (wet and dry dispersions)
- Integrated dry powder dispersion with accurate dispersion energy control to automate sample preparation for repeatable and reproducible measurements
- Versatile sample presentation media for measuring suspended and filtered samples
- Rapid automatic particle counting on membrane filters
- Powerful software interface for both visual and statistical interpretation of data
More information from Malvern Instruments at: http://www.malvern.com/en/products/product-range/morphologi-range/morphologi-g3/