High Precision Cleanliness Analysis
Particulate contamination in manufacturing and pharmaceutical components causes costly machinery damage and safety risks. Clemex automates the detection, sizing, classification, and reporting of particles collected on membrane filters, with full compliance to internationally recognized standards. Analyses are completed up to 10 times faster than manual counting, delivering objective, reproducible results every time.
Standard-specific modules
One Platform, Every Cleanliness Standard
Clemex ships with dedicated analysis profiles for the most widely adopted cleanliness standards. Each module is pre-configured with the correct size classes, normalization formulas, limit tables, and report format — no manual setup required.
Automotive · ISO Standard
ISO 16232 — Technical Cleanliness of Automotive Components
The standard for residual particulate contamination in fluid-carrying automotive components: fuel injection, hydraulic, transmission, and braking systems. Clemex automates Equivalent Circle Diameter (ECD) sizing, three-class particle discrimination (metallic, non-metallic, fiber), and automatic Cleanliness Code Class (CCC) generation per Parts 8 and 10.
Hydraulic & Fluid Power
ISO 4406 / 4407 — Hydraulic Fluid Cleanliness
The primary standard for monitoring particulate contamination in hydraulic and fluid power systems. Clemex automates the ISO 4407 microscopic membrane method, counting particles in the three ISO 4406 channels (≥4 µm, ≥6 µm, ≥14 µm), computing scale numbers, and generating the final three-part cleanliness code with fiber identification and spatial mapping of large particles.
Aerospace & Defense
IEST-STD-CC1246E — Aerospace & Defense Cleanliness
The IEST standard for product and component cleanliness levels in aerospace, defense, and precision manufacturing. Clemex automates particle detection across all ten size classes (5 µm to 1250 µm+), normalizes counts to the 0.1 m² reference area, assigns cleanliness and fallout levels, and computes UCL/LCL bounds — all in a single traceable run.
Pharmaceutical
USP 788 / 789 — Particulate Matter in Injections & Ophthalmic
The pharmacopeial standards for particulate matter in parenteral and ophthalmic preparations. Clemex automates the microscopic particle count (MPC) method at both USP threshold sizes (≥10 µm, ≥25 µm for 788; with ≥50 µm for 789), delivers automated pass/fail determination, and supports 21 CFR Part 11 / Annex 11 compliance for GMP environments.
AI-Powered · Cross-Industry
Particle Size Analysis — AI-Powered Measurement Module
Beyond compliance, Clemex provides a deep-learning particle size analysis module for research and quality control across pharmaceuticals, ceramics, metal powders, abrasives, and more. Deep learning segmentation separates touching and overlapping particles that confuse threshold-based methods, delivering D10/D50/D90, Feret diameter, circularity, convexity, and full morphological statistics per particle.
Custom · In-House
Custom & In-House Standards
Clemex is fully configurable for in-house cleanliness specifications or OEM-specific requirements. Define your own size classes, limit tables, normalization methods, particle types, and report templates. Routine creation is available as a service: provide your analysis specifications and our specialists will configure and validate the complete routine for you.
Key features
Built for Precision Cleanliness Compliance
Automated Membrane Scanning
Motorized stage integration scans the full effective filtration area in a defined raster pattern. Coverage and field count are logged per run, ensuring no area is missed and every scan is reproducible.
Motorized Microscope Stages & Controllers
Large Fiber Detection
Fibers exceeding the field of view are seamlessly reconstructed using the automated mosaic function. Both large fibers and small particles are detected within a single automated run.
Clemex Vision
Contrast Threshold Detection
Contrast thresholding detects faint particles on filters, including transparent particles, thin-walled cells, and crystals with variable thickness that are difficult to distinguish by conventional means.
Clemex Vision
21 CFR Part 11 / Annex 11
The optional User Management Module provides full audit trail, user groups, role-based access, and secure electronic signature support, meeting FDA and EMA requirements for regulated environments.
Custom Image Analysis & 21 CFR Part 11 Compliance
Automated Reporting
Reports are automatically generated after each analysis and fully customizable: company logo, captured images, size distribution graphs, statistics, and standard-compliant result tables in one locked PDF.
Clemex Vision
NIST-Traceable Auto Calibration
Using a NIST-traceable stage micrometer, Clemex automatically calibrates each objective, eliminating operator subjectivity and ensuring accurate, reproducible, and fully traceable measurements across all magnifications.
Microscope Stage Micrometer Slide
Multi-Sample Batch Analysis
Analyze up to six samples automatically in a single run without user intervention. All data is collected in a unified interface and individual reports are generated per sample with no manual steps between runs.
Stage Accessories & Sample Holders
Mosaic Creation
Adjacent fields of view are automatically stitched into a seamless mosaic image covering the entire membrane surface. This ensures complete filter coverage and allows large particles and fibers spanning multiple fields to be measured accurately as a single object.
Industries served
Wherever Contamination Has Consequences
Clemex is deployed across industries where particle contamination directly affects product reliability, safety, or regulatory approval.
Tailored systems
A Complete, Integrated Analysis System
Clemex provides the complete solution — software, hardware, and service — configured to your specific analysis needs.
Tailored Hardware Integration
Typically an upright microscope, a motorized stage, and a high-resolution camera, selected to fit your analysis needs. Clemex ensures seamless integration of all components, with on-site installation and training included. Microscopy Systems & Imaging Hardware
Third-Party Image Import
Import images from various sources, including SEMs, flatbed scanners, and existing datasets. Clemex analyzes any digital image without proprietary hardware requirements or vendor lock-in.
Brochures & Documentation
Detailed documentation is available for Aerospace, Medical Devices, Oil Analysis, and general Cleanliness applications. Download the brochures from the top of this page.
Ready to automate your cleanliness testing?
Talk to a Clemex specialist and see Clemex running on your sample type. On-site demonstrations available.
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