Light Inspection Machine

A GMP-compliant inspection system with ≥99.99% accuracy for detecting ≥20μm impurities, ensuring compliance with USP/EP/ChP standards and real-time traceability for liquid formulations.

This advanced inspection system is designed to meet the stringent requirements of pharmaceutical and biotech industries by ensuring high detection accuracy, comprehensive defect identification, and full traceability for liquid formulations. It achieves an accuracy rate of ≥99.99% in detecting impurities as small as ≥20μm, including glass shards, metal particles, fibers, and black spots, meeting the clarity standards set by USP/EP/ChP.

The system utilizes AI vision coupled with multi-spectral detection technology (visible light + infrared + ultraviolet) to enhance the detection rate by 30% compared to traditional manual inspection, effectively avoiding missed or false detections. The liquid level detection precision ≤±0.1mm ensures comprehensive coverage of anomalies such as high/low levels or empty bottles. Additionally, it offers comprehensive bottle appearance defect detection, identifying cracks, scratches, deformations, oil stains, and label misalignment, achieving a screening accuracy of ≥99.9% for visual quality.

With excellent repeatability, the system maintains a deviation of ≤±0.5% within batches for consistent product quality. It also features intelligent bubble differentiation using dynamic trajectory analysis to prevent compliant bubbles from being incorrectly identified as foreign matter, resulting in a false judgment rate ≤0.01%. The adjustable detection speed (50-600 bottles/min) allows for high-speed, high-precision inspection, suitable for various production capacities. Customizable thresholds for foreign matter detection are available based on the type of liquid formulation (clear liquids/suspensions) and container material (glass/plastic), adapting to complex formulations.

Fully compliant with GMP, FDA 21 CFR Part 11, EU GMP Annex 1, the system includes tamper-proof electronic batch records (EBR), storing parameters like speed, threshold, foreign matter types, and operator data. IQ/OQ/PQ validation packages and calibration certificates ensure rapid GMP certification. Defective products are automatically marked and stored, with barcode/QR code linking defects for full traceability and quality analysis.

Designed for flexibility, the system supports multiple types of liquid formulations including injections, biological agents, vaccines, oral solutions, syrups, and suspensions. It is compatible with various container sizes and materials, allowing automatic recognition and switching between detection modes. Modular design enables integration with automatic rejection units, re-inspection stations, and data analysis modules, fitting different workshop layouts and capacity needs.

Operated via PLC + touchscreen controls, it offers 100+ programmable inspection recipes, real-time monitoring, and self-diagnosis features, enabling remote management and quick fault resolution. Energy-saving technologies like LED lighting and smart sleep modes reduce energy consumption by over 30%, making it environmentally friendly while ensuring low maintenance costs and long service life.

CategorySpecification / Feature
Detection Accuracy≥99.99%; detects ≥20μm impurities
Impurity TypesGlass shards, metal particles, fibers, black spots
Liquid Level Precision≤±0.1 mm; detects high/low levels, no liquid
Appearance Defect DetectionCracks, scratches, deformations, oil stains, label misalignment
Repeatability≤±0.5% deviation within batches
Bubble DifferentiationIntelligent analysis; false judgment rate ≤0.01%
Detection SpeedAdjustable 50–600 bottles/min
CustomizationConfigurable thresholds based on formulation type and container material
Regulatory ComplianceGMP, FDA 21 CFR Part 11, EU GMP Annex 1
Data IntegrityTamper-proof EBR; logs speed, threshold, foreign matter types, operator data
Validation DocumentationFull IQ/OQ/PQ, detection precision, calibration certificate
Material Compatibility316L SS, PTFE; meets USP Class VI
Cleanroom ClassificationSupports CIP online cleaning
TraceabilityBarcode/QR links defect reasons
CertificationsCE, ISO 9001, FDA registered
Capacity Range50–600 bottles/min
Integrated ModulesAutomatic rejection, re-inspection, data analysis
Changeover Time≤15 minutes
Special FunctionsAI vision, multi-spectral detection
Modular DesignScalable rejection unit, re-inspection station, data analysis module
Automation LevelFully automatic loading → positioning → inspection → classification → rejection
Control SystemPLC + color touchscreen; manual/auto modes
Remote OperationReal-time monitoring via PC/mobile; multi-language support
Fault DiagnosisAuto-detect camera faults, light source decay, fixture issues
Safety FeaturesOverload protection, anti-pinch protection, emergency stop, door interlock
MaintenanceLow-maintenance international components; detailed manuals & video tutorials

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