FEI Company and Malvern Instruments Ltd. have
released Quanta Morphologi, a powerful new solution combining the
performance of FEI’s Quanta FEG scanning electron microscope
and Malvern’s proven Morphologi particle characterization
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.
New equipment gives 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 characterize sub-micron particles. Combining the
magnification and resolving power of the Quanta scanning electron
microscope (SEM) with Malvern Instruments’ industry-leading
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 characterize 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
‘nanonization’ 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 characterization at Johnson &
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 recognize
the important benefits delivered by this solution.”
The low-vacuum capability of FEI’s Quanta SEMs offer
users the flexibility to analyze 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.
The Quanta Morphologi will be featured this week at
FEI’s booth 1447 at the Pittsburgh Conference (Pittcon),
March 1-7, in New Orleans. It will also be the focus of a special
webinar sponsored by FEI and Malvern Instruments on March 19 at 2:00
p.m. eastern daylight time. Interested parties can register in advance
for the webinar and obtain more information about the product at www.fei.com/ParticleAnalysis.