Clemex Particle Size System
Particle Size and Shape
Image Analysis Workstation
 The Clemex Particle Size System is an automated image
analysis solution combining Clemex’s powerful particle characterization
software, with an automated microscope and high resolution camera, all seamlessly
integrated into an intuitive easy-to-use imaging workstation.
Addressing a need in the field of particle characterization,
the Clemex Particle Size System is a versatile
particle size and particle shape analysis tool that
can be used in a wide range of applications in the
pharmaceutical industries and material science.
 Lab Unit
The Lab Unit is a self-contained automated
image analysis solution that combines Clemex's powerful particle characterization
software with an automated microscope and high resolution camera.
It is a turnkey solution for labs that want to maintain an analytical microscopy
environment with minimum intervention by the operator yet still yield maximum
detail in the results.
 Research Unit
The Clemex Particle Size System Research Unit is a more traditional microscopy solution. It
is a highly integrated system that combines image analysis software, up to two
digital cameras (for example, color and monochrome), a microscope, a high-performance
PC, a motorized x/y/z stage, and has the flexibility of adjusting parameters
(such as various light filters). This system has been designed to serve the scientist
that must analyze various samples and, according to the best optical settings,
develop methods of analysis for each one.
Image Analysis by Microscopy
Recently, the use of microscopy
and image analysis is increasingly being recognized
as the most reliable technique to characterize particle
shape and characterize a particle size and volume distribution.
Traditional methods, such as laser diffraction, although
highly efficient, give limited information on particle
shape proving image analysis as the best tool for performing
particle analysis.
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Original gray image |
Binary Operations |
Outline of detected particles |
Shape and Size Analysis
Industry experts, especially pharmaceutical, are now looking to characterize
particle shape in addition to particle size, to gain a better understanding of
how shape can effect the various properties of a product. More are recognizing
the significance of particle size and shape as well as their impact on the physical
characteristics of many particulate materials. Process problems with drug substances
can often be attributed to the particle size or shape of the active material.
The ability to accurately analyze and characterize particle by
image analysis can significantly improve your company’s manufacturing efficiency.
It can also improve product performance for maximum effectiveness.
Crossed Fibers Algorithm
A unique algorithm to improve accuracy when defining the length and shape of fibers. Older algorithms would define crossed fibers as either an x-shaped particle, or break the fibers into four or five segments. Using this new algorithm, the PSA300 separates crossing fibers as individual particles and assigns each one accurate size and shape parameters. This is the first image analysis system capable of proper characterization of fibers or elongated crystals, a very important control issue in the pharmaceutical industry.
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Original image |
Identyfied Cross Fibers |
Fibers seperated |
True Particles Shape
Clemex Particle Size System provides true
particle shape information. Information is not determined
by “correction factors” rather it is
based on exactly what is seen in the microscope.
Measurements are possible for individual or mixtures
of different textured particles (opaque, semi-transparent,
crystalline, etc).
Accuracy
Clemex Particle Size System features excellent resolution and detection of micronized particles
as small as 0.5 microns. Our unique automated calibration routine assures complete validation of measurement accuracy, in accordance with NIST standards. Particle volume determination is based on absolute 2D measurements and thus not limited to spheroids. Accurate volume measurements can be performed on elongated cylinders, acicular or irregular shaped objects.
Real Volume vs. Spherical Volume |
Repeatability
Microscope parameters and camera settings are saved as properties in the routine associated with each sample. In conjunction with an automated workstation, an image analysis routine can be executed multiple times with no deviation from the initial results. This guarantees reproducibility and traceability of analysis, ensuring accurate results and conforming to 21 CFR Part 11 requirements.
High Throughput
Data collection is achieved through multiple field analysis using a Clemex 4-slide sample holder and motorized stage. Our robotic
image analysis system will allow the user to measure large number of slides simultaneously without any operator intervention.
Results Management
Clemex Particle Size System automatically calculates various measurements simultaneously on thousands of individual particles. It is capable of generating statistically significant results in an amazingly short time. The powerful report generator allows speedy data processing and flexible reporting capabilities.
Security and Compliance
Clemex Particle Size System allows the management of user rights, audit trail of critical interventions, electronic signatures as well as overwrite protection of all electronic documents produced by Clemex Particle Size System imaging workstation (images, stage patterns, image analysis routines, raw binary data, image analysis report in PDF). Traceability is assured by saving all analysis settings, data, results, and images (if required) in the same protected file. All of these security features are designed to conform to regulatory requirements such as FDA 21 CFR part 11 ensuring data integrity.
For more information you can consult the brochure or contact
us
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