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Clemex
Regulatory Module

Technical Cleanliness of Automotive Components as per ISO 16232

Residual particulate contamination in automotive fluid-carrying components — metallic chips, non-metallic debris, and fibers — is a leading cause of premature wear, valve failure, and system malfunction in fuel injection, hydraulic, and transmission assemblies. Traditional cleanliness evaluation relies on manual microscopic counting, subjective particle classification, and operator-dependent results that vary between analysts and labs. Clemex's ISO 16232 module automates the full particle analysis workflow: detecting, sizing, and classifying every particle on the extraction membrane, binning results into ISO size classes, and computing the Cleanliness Code Class (CCC) automatically, objectively, and traceably.

Stop classifying particles by hand. Clemex automates metallic, non-metallic, and fiber discrimination with full ISO 16232 CCC traceability.

ISO 16232 Compliant Automated CCC Generation Metallic / Non-Metallic / Fiber Classification Normalized Particle Count

Analytical Workflow

From Image Acquisition to Compliant Report

Clemex integrates into your existing ISO 16232 membrane filtration workflow, automating the microscopic counting and classification steps that traditionally require a trained analyst at the eyepiece for every size class and particle type.

STEP 1

Acquire / Load Images

Capture images live from the microscope or import existing membrane images in batch.

STEP 2

Particle Detection

Every particle on the membrane is automatically detected and segmented across the full ISO 16232 size range.

STEP 3

Particle Analysis & Classification

Each particle is measured by ECD, classified as Metallic, Non-Metallic, or Fiber, and normalized per extraction volume or surface area.

STEP 4

Generation of Cleanliness Evaluation Report

A fully traceable report is generated with CCC code, normalized count grid, largest particle images, and filter mosaic.

Measurement Output

ISO 16232 Particle Count & Classification Metrics

Clemex reports all parameters required by ISO 16232 for a complete cleanliness evaluation. Particle sizing, type classification, and CCC generation are performed simultaneously in a single automated analysis pass.

Size Class Binning

Particles automatically binned into ISO 16232 classes B (5–15 µm) through K (≥ 1000 µm). Each class receives its own normalized count and CL level.

Equivalent Circle Diameter (ECD)

Standard ISO 16232 size dimension — diameter of a circle with the same projected area as the particle. Used for all size class assignments and CCC computation.

Normalized Count — Volume or Surface Area

Particle counts normalized per extraction volume (mL) or component surface area (cm²). Normalization method and denominator are entered at run setup and applied automatically.

CL Level & Cleanliness Code Class (CCC)

CL level per size class assigned automatically from the ISO 16232 table. The full CCC string — e.g. V(B12/C12/D12/E11/…/K2) — is computed and printed in the report without manual lookup.

Covered Area & Coverage Ratio

Total scanned area (mm²) and ratio of covered area to effective filtration area, confirming complete membrane scanning per ISO 16232 Part 8.

Particle Area Coverage %

Total particle area (mm²) and percentage of filter area covered, reported as a complementary contamination indicator alongside the normalized count grid.

Module Capabilities

Built for Automotive Technical Cleanliness

Every feature of the ISO 16232 module is designed around the requirements of automotive component cleanliness testing, from fuel injection systems to hydraulic assemblies and transmission components.

Full ISO 16232 Standard Compliance

The module is pre-configured to ISO 16232 size classes, CL level tables, and CCC coding conventions. Analysis parameters, normalization methods, and reporting fields match Parts 8 and 10 of the standard without manual setup or formula entry.

ISO 16232 Compliant

Fully Automated Membrane Scanning

Motorized stage integration scans the entire effective filtration area in a defined raster pattern. No manual field selection, no missed areas. Scan completion is verified and logged per run, ensuring full membrane coverage.

Motorized Stage

Three-Class Particle Discrimination

Metallic, non-metallic, and fiber particles are automatically distinguished using reflectance thresholding and morphological analysis. The three-class breakdown is applied per size class simultaneously with the count, without a separate classification pass.

Automated Classification

Traceable Cleanliness Evaluation Report

Every report includes sample ID, analyst, date, magnification, calibration, filter area, covered area ratio, CCC code, normalized count grid by type and size class, largest particle images per type, and a filter mosaic — all in a single locked PDF with electronic signature support.

Customer-Ready

Flexible Normalization Methods

Normalization by extraction volume (mL) or component surface area (cm²) is selectable at run setup. Clemex automatically applies the correct denominator and produces the standardized normalized count used for CL level and CCC assignment.

Volume & Area Methods

Dedicated to Automotive Quality Labs

The ISO 16232 module is purpose-built for quality control laboratories and production environments in the automotive supply chain, designed to integrate seamlessly into existing cleanliness testing workflows at OEM and Tier 1 supplier sites.

QC & Production Ready

Method Validation

Supporting Your System Qualification Documentation

Implementing Clemex for ISO 16232 technical cleanliness includes a structured validation package designed to support qualification at automotive OEM and Tier 1 supplier sites.

IQ Documentation

Installation Qualification templates covering hardware specifications, software version, microscope calibration verification against NIST-traceable micrometer slides, and motorized stage accuracy confirmation.

OQ / PQ Support

Operational and Performance Qualification protocols with defined acceptance criteria. Reference particle count standards and round-robin comparison data are provided for method repeatability demonstration.

System Suitability Tests

Per-run system suitability checks using certified particle standards confirm the analysis system is operating within validated parameters before each analytical sequence begins.

Change Control Support

Software updates are versioned and documented. Impact assessments and re-qualification protocols are provided for any software change that could affect particle count or classification results.

Frequently Asked Questions

What is ISO 16232 and which automotive components does it apply to?

ISO 16232 (Road vehicles — Cleanliness of components of fluid circuits) defines the methodology for assessing the contamination level of fluid-carrying components. It covers fuel injection systems, braking systems, power steering, hydraulic systems, cooling systems, and automatic transmissions. The standard specifies extraction methods (Parts 3–7), particle analysis by microscopy (Part 8), and reporting via the Cleanliness Code Class (Part 10). Clemex automates the Part 8 analysis and generates the Part 10 compliant report.

Applicable to all fluid-carrying automotive components.

What is the Cleanliness Code Class (CCC) and how does Clemex compute it?

The CCC is a standardized string that encodes the cleanliness level of a component across all relevant particle size classes. For each size class (B through K), the normalized particle count is compared to the ISO 16232 CL level table, and the corresponding level is assigned. These are assembled into a string of the form V(B12/C12/D12/E11/…/K2), where V indicates volume-normalized counts. Clemex computes the CCC automatically — no manual lookup or formula entry required.

Automatic CCC generation from normalized count data.

How does Clemex distinguish metallic from non-metallic particles and fibers?

Classification is performed using reflected light microscopy. Metallic particles appear bright under incident illumination due to high surface reflectance, while non-metallic particles appear dark or grey. Fibers are classified by morphological criteria — elongated shape with aspect ratios that distinguish them from compact particles. Clemex applies these criteria simultaneously, producing three separate count columns (Metallic, Non-Metallic, Fiber) per size class in the normalized count grid.

Reflected light + morphology: three-class discrimination in one pass.

What normalization methods does ISO 16232 support, and does Clemex handle both?

ISO 16232 supports normalization by extraction volume (per mL or per 100 mL) and by component surface area (per cm²), depending on the extraction procedure used. Clemex supports both modes, with the normalization method and denominator entered at run setup. The normalized count is then applied to the CL level table automatically to produce the CCC, regardless of which normalization method was selected.

Volume and area normalization both supported.

Can Clemex be used for both ISO 16232 and VDA 19.1 cleanliness analysis?

Yes. ISO 16232 and VDA 19.1 (the German automotive industry standard it was largely harmonized with) share the same fundamental methodology: extraction of residual contamination onto a filter membrane, microscopic particle analysis, and reporting via a standardized cleanliness code. Clemex's ISO 16232 module is compatible with both standards, as their particle classification criteria, size classes, and CCC coding are aligned.

Harmonized with VDA 19.1 — same analytical engine.

Can the same system be used for both ISO 16232 and other cleanliness standards?

Yes. Clemex's image analysis engine is the same platform used across multiple particle measurement standards. The ISO 16232 module is a pre-configured application profile on the Clemex platform. Labs can also run ISO 4406 (hydraulic fluid cleanliness), USP 788/789, or custom methods on the same hardware, with method separation enforced through role-based access and separate method files.

Multi-standard platform: ISO 16232, ISO 4406, USP, and more on shared infrastructure.

How long does a typical ISO 16232 membrane analysis take compared to manual counting?

Manual ISO 16232 analysis requires an analyst to scan the membrane field by field, count and classify each particle by eye, and enter data into a spreadsheet — a process that typically takes 60–120 minutes per membrane, and is susceptible to operator fatigue and classification subjectivity. Clemex completes the full motorized scan, automated detection, three-class classification, normalization, and CCC generation in approximately 10–20 minutes per membrane. For high-throughput supplier validation campaigns, the time and consistency gains are substantial.

10–20 min automated vs. 60–120 min manual, with consistent, objective classification.

Peer-reviewed literature: particle size analysis ISO 16232 by Clemex Vision software — Google Scholar →

Ready to Automate Your ISO 16232 Cleanliness Testing?

Talk to a Clemex automotive specialist and see the module running on representative filter membrane images. Validation support included.