Particle Size Analysis - Clemex PSA System

Industry experts, especially pharmaceutical, are now looking to characterize particle size in addition to particle shape, to gain a better understanding of how size 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.

Recently, the use of microscopy and image analysis is increasingly being recognized as the most reliable technique to characterize particle size and characterize a particle shape 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.

Original gray image	Binary Operations	Outline of detected particles

New Clemex PS³ – Particle Size Analysis

Addressing a need in the field of particle characterization, the Clemex PS³ imaging workstation is a versatile tool that can be used in a wide range of applications in the material science and pharmaceutical industries

True Particles Shape
Clemex PS³ 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 PS³ 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 PS³ 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 PS³ 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 PS³ 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.

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