Olympus CIX100 Integrated Cleanliness Analysis System
| Brand | Olympus |
|---|---|
| Origin | Japan |
| Manufacturer | Olympus Corporation |
| Import Status | Imported |
| Model | CIX100 |
| Pricing | Upon Request |
Overview
The Olympus CIX100 Integrated Cleanliness Analysis System is a fully motorized, high-precision optical platform engineered for standardized particulate contamination assessment in critical manufacturing environments—particularly automotive, aerospace, hydraulic, and medical device production. Built upon advanced reflected- and transmitted-light microscopy combined with polarization-enhanced contrast, the system enables real-time, automated detection, classification, and metrological characterization of particles ranging from 2.5 µm to 42 mm on filter membranes. Its core measurement principle relies on high-resolution digital imaging coupled with intelligent segmentation algorithms trained to distinguish reflective (e.g., metallic shavings) and non-reflective (e.g., rubber, fiber, oxide) contaminants under controlled illumination conditions. Designed to comply with ISO 16232, VDA 19.1 (2015), and ISO 4406, the CIX100 delivers traceable, auditable, and GLP/GMP-aligned cleanliness data—supporting full regulatory traceability from acquisition through reporting.
Key Features
- Fully automated scanning workflow with intuitive guided user interface—minimizes operator dependency and reduces inter-user variability
- Polarized dual-illumination optics optimized for simultaneous high-contrast imaging of both reflective and non-reflective particles
- Real-time particle visualization during scanning: thumbnail preview pre-scan, live counting, size binning (≥12 user-defined classes), and dynamic reprocessing capability
- Automated image stitching for accurate morphological reconstruction of oversized particles exceeding single-field-of-view dimensions
- Pre-calibrated optical train and sensor assembly—factory-aligned for consistent magnification, depth of field, and pixel-to-micron scaling
- Integrated calibration & maintenance suite including focus drift compensation, illumination uniformity verification, and stage positioning diagnostics
- Seven-language UI support (English, German, French, Spanish, Italian, Chinese, Japanese) with context-aware tooltips and procedural prompts
Sample Compatibility & Compliance
The CIX100 accommodates standard filtration media per ISO 16232 Annex A—including mixed cellulose ester (MCE), polyvinylidene fluoride (PVDF), and polycarbonate track-etch membranes—across diameters of 25 mm, 47 mm, and 100 mm. All hardware components meet IEC 61000-6-3 (EMC) and IEC 61000-6-2 (immunity) standards. Software architecture supports audit trail functionality compliant with FDA 21 CFR Part 11 requirements when deployed with optional electronic signature modules. System validation documentation—including IQ/OQ protocols and traceable calibration certificates—is provided per ISO/IEC 17025 guidelines. Optional height measurement module (VDA 19.1 Annex D-compliant) enables confocal-based topographic profiling of selected particles with sub-micron vertical resolution.
Software & Data Management
Olympus CIX software features a relational database backend supporting concurrent multi-user access with role-based permissions (administrator, analyst, reviewer). Every detected particle is stored with its full metadata: XY coordinates, bounding box dimensions, equivalent circular diameter (ECD), aspect ratio, intensity histogram, and—where enabled—Z-height. Image archives are saved in lossless TIFF format with embedded EXIF tags containing acquisition parameters (exposure time, gain, objective ID, filter position). Reporting leverages Microsoft Word–compatible templates conforming to ISO 16232-8 structure; reports include summary statistics, particle distribution histograms, annotated thumbnails, and compliance statements. All data exports are timestamped, digitally signed, and support CSV, PDF/A-2, and XML formats for LIMS integration.
Applications
- Validation of machining, grinding, and deburring processes in powertrain component manufacturing
- Verification of cleaning efficacy for fuel injectors, brake calipers, and transmission valves
- Quality gate inspection for hydraulic systems prior to assembly or shipment
- Root cause analysis of wear debris in lubricant filtration studies
- Regulatory submission support for ISO/TS 16949 and IATF 16949 audits
- Method transfer between R&D, QA, and supplier labs using identical analytical parameters and pass/fail criteria
FAQ
Does the CIX100 support automated height profiling of particles?
Yes—when equipped with the optional VDA 19.1 height measurement module, the system performs automated confocal Z-stack acquisition and surface reconstruction for up to 50 selected particles per membrane.
Can historical filter images be re-analyzed with updated classification rules?
Yes—archived TIFF images retain raw pixel data and full metadata, enabling retrospective reprocessing with modified thresholds, bin definitions, or algorithm versions without rescanning.
Is the system compatible with laboratory information management systems (LIMS)?
Yes—via standardized RESTful API and configurable CSV/XML export routines, the CIX100 integrates with major LIMS platforms including LabWare, Thermo Fisher SampleManager, and Siemens Opcenter Quality.
What calibration standards are supplied with the system?
Each unit ships with NIST-traceable stage micrometer (10 µm pitch), photometric reference slide, and certified particle size standard set (PSL spheres: 5 µm, 10 µm, 25 µm, 50 µm).
How does the system ensure long-term measurement stability across shifts and operators?
Through integrated daily verification routines, auto-compensated illumination drift correction, and persistent user-specific profile storage—including objective lens selection, exposure presets, and report template preferences.
