PSA Guidebook
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1.81
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- Particle shape information- 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.
- Sensitivity and accuracy - PSA300 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.
- 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 - PSA300 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 - PSA300 allows the management of user rights, audit trail of critical interventions, electronic signatures as well as overwrite protection of all electronic documents produced by PSA300 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.
