
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.
| Category | Specification / Feature |
|---|---|
| Detection Accuracy | ≥99.99%; detects ≥20μm impurities |
| Impurity Types | Glass shards, metal particles, fibers, black spots |
| Liquid Level Precision | ≤±0.1 mm; detects high/low levels, no liquid |
| Appearance Defect Detection | Cracks, scratches, deformations, oil stains, label misalignment |
| Repeatability | ≤±0.5% deviation within batches |
| Bubble Differentiation | Intelligent analysis; false judgment rate ≤0.01% |
| Detection Speed | Adjustable 50–600 bottles/min |
| Customization | Configurable thresholds based on formulation type and container material |
| Regulatory Compliance | GMP, FDA 21 CFR Part 11, EU GMP Annex 1 |
| Data Integrity | Tamper-proof EBR; logs speed, threshold, foreign matter types, operator data |
| Validation Documentation | Full IQ/OQ/PQ, detection precision, calibration certificate |
| Material Compatibility | 316L SS, PTFE; meets USP Class VI |
| Cleanroom Classification | Supports CIP online cleaning |
| Traceability | Barcode/QR links defect reasons |
| Certifications | CE, ISO 9001, FDA registered |
| Capacity Range | 50–600 bottles/min |
| Integrated Modules | Automatic rejection, re-inspection, data analysis |
| Changeover Time | ≤15 minutes |
| Special Functions | AI vision, multi-spectral detection |
| Modular Design | Scalable rejection unit, re-inspection station, data analysis module |
| Automation Level | Fully automatic loading → positioning → inspection → classification → rejection |
| Control System | PLC + color touchscreen; manual/auto modes |
| Remote Operation | Real-time monitoring via PC/mobile; multi-language support |
| Fault Diagnosis | Auto-detect camera faults, light source decay, fixture issues |
| Safety Features | Overload protection, anti-pinch protection, emergency stop, door interlock |
| Maintenance | Low-maintenance international components; detailed manuals & video tutorials |