FEI and Malvern Instruments have released Quanta Morphologi, combining the performance of FEI's Quanta FEG scanning electron microscope and Malvern's Morphologi particle characterisation software
For the first time ever, Quanta Morphologi users including pharmaceutical quality control method development labs will have direct analysis methods to obtain both size and shape information on sub-micron particles.
This powerful solution will provide pharmaceutical companies greater control over new products and drug formulations that require particle manufacture at increasingly smaller nanoscale dimensions for a wide variety of advanced therapeutic applications.
"In pharmaceutical manufacturing, quality assurance and control laboratories must ensure that quality standards are constantly met for raw materials, intermediates and final products," explained Matt Harris, vice president of FEI's nanobiology division.
"Particle size and shape can dramatically alter the physical and therapeutic properties of active pharmaceutical ingredients.
"Until now, there have been no direct methods to characterise sub-micron particles.
"Combining the magnification and resolving power of the Quanta scanning electron microscope (SEM) with Malvern Instruments's software provides a critical turnkey solution".
With Quanta Morphologi, users will be able to create reference methods for quality control process design, perform automated particle analysis, obtain surface detail, and perform statistical analysis to more fully characterise particle size and shape distributions.
The most important morphological parameters for differentiating a set of samples, such as good and bad sample batches, can be defined and subtle changes in a product or process can be readily identified.
"In today's pharmaceutical industry the 'nanonisation' of poorly soluble active pharmaceutical ingredients is one of the current strategies for developing new, more potent drugs," explains Arjen Tinke, principal scientist for particle characterisation at Johnson and Johnson pharmaceutical research and development in Europe.
"Obviously, the size distribution analysis of these products is essential in the R+D process as well as in quality control.
"With Quanta Morphologi the first absolute sizing technique has become available that routinely enables the size and shape analysis of individual nanoparticles in polydisperse products".
"Quanta Morphologi is the result of our joint development partnership with FEI and we are excited by its innovative performance," commented Ulf Willen, product manager for Malvern Instruments.
"We believe users will easily recognise the important benefits delivered by this solution".
The low-vacuum capability of FEI's Quanta SEMs offer users the flexibility to analyse materials without imposing many of the traditional SEM sample preparation constraints, thereby greatly extending the applicability for particle analysis.
Malvern's Morphologi particle image analysis software is a proven solution already used on Malvern systems that encompass traditional optical microscopes, such as the Morphologi G3, used by many research and industrial users around the world.
