CLAIRITY™ is an advanced artificial intelligence/machine learning (AI/ML) powered particle characterization and visualization software platform designed to simplify and enhance the understanding of pharmaceutical products through improved data acquisition and interpretation for image-based particle analysis.
Features, Benefits, and Specifications
CLAIRITY™ provides characterization and visualization of particles in powders, liquids, suspensions, and granulations on virtually any microscope or particle image. It is a simple, cost-effective, compliant, and accurate image analytics software system to assist drug product formulation and manufacture by using AI/ML.
The software establishes functional relationships between critical material attributes (CMA) and critical process parameters (CPP) to confirm critical quality attributes (CQA). Available as a single- or multi-user system with LIMS integration or cloud installation CLAIRITY™ supports global stakeholders at the point of analysis for formulation development, manufacturing, product quality and assessment. The platform is fully automated and integrated for measuring under both ambient and thermally stressed conditions. CLAIRITY™ is a fully 21CFR-compliant software package for the pharmaceutical industry, ensuring data quality and integrity.
Applications
The primary application for CLAIRITY™ is the analysis and interpretation of particular content found in pharmaceutical and biopharmaceutical drug products. To improve product knowledge, and aid in the development, formulation, and manufacturing of dosage forms as well as the assessment of product quality, safety, and efficacy. Specific applications include characterization of drug product and drug substance, excipients for particle and/or globule size analysis as well as shape, texture, and other morphological parameters providing component-specific identification of particulates. This software platform can be used to perform analysis of samples for both particle counting and classification according to USP standards <776>, <695>, <788>, <789>, and <790>, <1776> with full 21 CFR – Part 11 compliance.