CLAIRITY™ PARTICLE - Asbestos Identification | PLM System for Talc Testing

PLM-based asbestos identification in pharmaceutical talc.

CLAIRITY™ PARTICLE – Asbestos Identification is a digital solution for Polarized Light Microscopy (PLM)-based detection of asbestos in pharmaceutical talc. Purpose-built for pharmaceutical QC, contract testing, and raw material laboratories, the system standardizes fibre screening, optical characterization, and reporting in line with USP <901> and USP USP <1901>.

It integrates with polarized light microscopes, brightfield and cross-polarized microscopy setups, and manual or semi-automated microscopy systems, enabling reproducible identification of asbestiform fibres in talc used across pharmaceutical, cosmetic, and personal care formulations.

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Microscope & Optical Configuration

Since asbestos identification depends entirely on the optical properties, the microscope setup is central to accurate, reproducible PLM results not just the software layer on top of it.

CLAIRITY™ PARTICLE – Asbestos Identification runs on a high-end polarized trinocular microscope equipped with a rotating stage, configured for plane-polarized light (PPL), cross-polarized light (XPL), and central-stop dispersion staining. This configuration is what lets the system resolve the dispersion staining colors, extinction behavior, and Becke line movement that distinguish asbestiform fibres from talc and other interfering minerals.

Key Elements of the Optical Setup

Polarized trinocular microscope with rotating stage enables full 360° slide rotation for orthogonal scanning and confirmation of extinction angle and sign of elongation
Centered dispersion staining objective required for screening suspect particles in 1.550 and 1.605 RI liquids without a condenser lens
First-order (red) wave plate (RPL) accessory used to determine optical sign of elongation for amphibole and chrysotile fibres
High-resolution digital camera captures particle-level images at 100×–400× magnification for documentation and audit trails
Mechanical/motorized stage compatibility supports systematic, reproducible slide scanning across the full sample area

Compatible With

Polarized Light Microscopes (PLM) Brightfield & Cross-Polarized Microscopy Manual & Semi-Automated Microscopy Systems

Challenges We Address

Subjectivity in Manual PLM Analysis

Manual asbestos screening under polarized light depends heavily on analyst experience, and interpretation of dispersion staining colors, extinction behavior, and refractive index can vary between operators. CLAIRITY PARTICLE standardizes the optical characterization workflow so results are consistent across analysts and sites.

Distinguishing Asbestiform from Non-Asbestiform Fibres

Talc naturally contains mineral fibres that can resemble asbestos under casual inspection. The system supports documentation of aspect ratio, thin fibrils, parallel bundles, splayed ends, and fiber curvature the defined criteria used to confirm true asbestiform morphology and rule out look-alike particles.

Reproducibility Across Batches and Sites

Trace-level asbestos limits leave little room for inconsistency. CLAIRITY PARTICLE brings a repeatable, documented PLM workflow to fibre screening, helping labs produce comparable results across batches, instruments, and testing locations.

Regulatory-Ready Documentation

Compiling particle images, morphology data, and optical measurements into a submission-ready report is time-consuming when done manually. CLAIRITY PARTICLE automates report generation with measurement overlays, metadata, and export formats compatible with most laboratory systems, supporting LIMS integration and audit readiness.

Benefits

Advanced PLM-Based Fibre Characterization
USP <901> & <1901> Aligned Workflow
21 CFR Part 11 – Ready Architecture
Reliable, Standardized, Regulatory-Ready Results
Detailed Reporting & LIMS Integration

Advanced PLM-Based Fibre Characterization

Characterizes suspect particles by fibre morphology, geometry, and aspect ratio
Documents particle color and pleochroism under plane-polarized light (PPL)
Records extinction behavior and extinction angle under cross-polarized light (XPL)
Evaluates optical sign of elongation using XPL with a first-order wave plate (RPL)
Determines birefringence from maximum and minimum observed refractive indices

USP <901> & <1901> Aligned Workflow

Supports the standardized PLM workflow for asbestos fibre identification from sample preparation to documentation and reporting
Enables reproducible analysis consistent with pharmacopeial expectations for pharmaceutical talc

21 CFR Part 11 – Ready Architecture

Fully compliant regulatory framework with e-signature, audit trails, controlled access, and data integrity protocols
Built for GMP-regulated pharmaceutical QC and contract testing environmentsBuilt for GMP-regulated pharmaceutical QC and contract testing environments

Reliable, Standardized, Regulatory-Ready Results

Automatically records the number of detected particles with individual results for each
Captures and displays digital images of individual particles for visual documentation
Reports particle length and width in µm for quantitative characterization
Evaluates optical sign of elongation using XPL with a first-order wave plate (RPL)
Generates a clear summary remark on the presence and type of asbestos identified (e.g., Amphibole – Tremolite)

Detailed Reporting & LIMS Integration

Generates customizable, audit-ready reports with measurement overlays and metadata
Combines particle images, quantitative measurements, morphological parameters, and identification results in a structured report
Export formats compatible with most laboratory information management systems (LIMS)

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Asbestos Detection in Pharmaceutical Talc | PLM Testing as per USP <901> and USP <1901>

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CLAIRITY™ PARTICLE - Asbestos Identification

PLM-based asbestos identification in pharmaceutical talc.