Clemex Particle Sizing System
Particle Size and Shape Image Analysis Workstation
The Clemex Particle Sizing 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 Sizing
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 Sizing 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, colour 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
* Shape and Size Analysis
* True Particle Shape
* Accuracy
* Repeatability
* High Throughput
* Results Management
* Security and Compliance (21CFR Part 11)
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.
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 size and shape by image
analysis can significantly improve your company’s manufacturing efficiency. It can also
improve product performance for maximum effectiveness.
True Particles Shape
Clemex Particle Sizing 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 Sizing 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.
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 Sizing 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.
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.
Security and Compliance
Clemex Particle Sizing 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 Sizing 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.
