Image Analysis for Pharma & Medical Industry
Drug concentration, dissolution and release rate depend on particle shape as much as particle size. Clemex automates the detection, sizing, classification and reporting of particles from 0.5 to 1000 microns, so results are reproducible between operators and traceable back to the raw data. The User Management module supplies the audit trail, role-based access and electronic signatures required under FDA 21 CFR Part 11.
Pharma analysis modules
See the modules in action
Analyses
Injections · Ophthalmics · Devices
USP 788 / 789 Particle Count
Fast, reliable scanning of membrane filters, with counts at each threshold size and automated pass or fail against the limits.
API · Excipients · Dry Powder
Particle Size & Shape
Size and shape measured on every particle from 0.5 to 1000 microns, reported as D10, D50 and D90 with Feret diameter, aspect ratio and circularity.
Circular · Flake · Acicular
Shape Classification
Particles sorted into shape categories, with statistically significant results for each one. Elongated crystals are measured on length and width, not a single diameter.
Suspensions · Blends · Milled Product
Touching Particles & Agglomerates
Deep learning segmentation separates touching and overlapping particles that confuse threshold-based methods, so counts reflect primary particles.
Emulsions · Creams · Gels
Droplets, Bubbles & Fibers
Size, shape, count and area percent for droplets, spheres, fibers, voids and bubbles, with each population reported separately.
In-House Specifications
Custom Routines
Send us your specification and our application specialists build the routine, with your own size classes, limits and report layout, then lock it for production use.
Key features
Built for Regulated Labs
Audit Trail & Electronic Signatures
The optional User Management module records every action with user, date and time, enforces role-based access and user groups, and supports secure electronic signatures, meeting FDA requirements for regulated environments.
21 CFR Part 11 with ClemexRaw Data Linked to Every Object
Each measurement stays linked to the particle it came from for validation, and the stage returns to that position on request. Raw data exports to Excel.
Clemex VisionNIST-Traceable Calibration
Each objective is calibrated automatically against a NIST-traceable stage micrometer, giving every reported dimension a traceable basis.
Stage Micrometer SlideOperator-Independent Results
The routine decides what counts as a particle and where to measure, so results are reproducible between operators, shifts and sites.
Clemex VisionFaint & Transparent Particle Detection
Contrast thresholding detects transparent particles, thin-walled cells and crystals of variable thickness that conventional methods miss.
Clemex VisionLocked PDF Reports
Reports generate automatically after each run and stay fully customizable: logo, captured images, distribution graphs, statistics and result tables in one locked PDF.
Clemex VisionFDA 21 CFR Part 11
Technical Controls, Mapped to the Requirement
Compliance is established by your organization through validation, procedures and training. Clemex supplies the technical controls that make it achievable.
Limited System Access
Named accounts and user groups determine who may run a routine, modify one, or approve a result.
Computer-Generated Audit Trail
Actions are time-stamped and attributed automatically, independently of the operator, and cannot be edited from the application.
Electronic Signatures
Signatures are applied under the signer's own credentials and bound to the record they approve.
Authority Checks
Validated routines are locked so parameters cannot be changed at the bench, and changes are recorded.
Record Retrieval
Images, per-object data, calibration records and the final report are retained together, so a result can be reconstructed.
Who uses it
Pharma, Biopharma & Medical Devices
Tailored systems
A Complete, Integrated Analysis System
Software, hardware and service, configured to your analysis needs.
Tailored Hardware Integration
An upright microscope, motorized stage and high-resolution camera, integrated by Clemex with on-site installation and training included.
Reproducible Powder Dispersion
A reliable, repeatable dispersion method for dry powder particles, depositing a well-separated monolayer on the slide.
Any Number of Routines
Run every analysis your lab needs on one system, and import images from SEMs or existing datasets for re-analysis.
See Clemex run on your samples
Talk to a specialist about your method and your acceptance limits. On-site demonstrations available.
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