CLAIRITY™ PARTICLE is a high-performance software solution for particle size analysis, shape profiling, and distribution quantification. Purpose-built for pharmaceutical, biotech, and other regulated industries, the platform supports detailed, reproducible microscopic particulate analysis in line with USP and standards.
It seamlessly integrates with microscope image analysis software, optical microscopes, SEM, and other imaging systems, enabling precise detection of faint, transparent, or multimodal particles across dosage forms.
The system fully complies with 21 CFR Part 11, incorporating audit trails, e-signatures, and secure, role-based access for GMP-regulated labs. Its AI engine classifies isolated particles, agglomerates, APIs, excipients, and globules with consistency and speed, while delivering a wide range of morphological parameters such as size, shape, circularity, solidity, texture, and intensity.
Optimized for high-throughput settings, CLAIRITY PARTICLE automates particle classifier tasks, processes large datasets with minimal manual input, and accelerates quality control and regulatory validation for pharmaceutical R&D and manufacturing.
Precise, repeatable particle size analysis is critical to drug formulation, efficacy, and stability. Variations in sample preparation, instrumentation, and analyst judgment often introduce inconsistency. CLAIRITY PARTICLE helps standardize distribution particle size measurement by implementing consistent calibration procedures across instruments and studies.
The software eliminates ambiguity between similar features, such as air bubbles and liquid globules, or isolated particles vs. agglomerates. Its AI models distinguish between APIs, excipients, and mixed populations, enabling precise classification even in multimodal distributions. This reduces subjectivity and drives consistency in QC, research, and foreign matter inspection.
Modern labs require tools that keep pace with data volume. CLAIRITY PARTICLE automates particulate matter counting, efficiently manages high-volume datasets, and adapts across different microscope settings, minimizing manual intervention while maintaining accuracy.
Low-contrast particles often result in missed boundaries and misclassification. CLAIRITY PARTICLE fine-tunes contrast and brightness settings and supports method validation by benchmarking image-based data against traditional techniques like laser diffraction. This makes it a reliable solution for deformulation analysis, process development, and regulatory submissions.
