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| Place of Origin | Shanghai |
| Brand Name | Quanstar |
| Certification | ISO |
| Document | Product Brochure PDF |
Medical device assembly machine
Rotary table machine for medical products assembly and test
| Category | Parameter | Description/Value |
|---|---|---|
| General Specifications | Line Length | 5-30 meters (modular design) |
| Production Speed | 50-300 pieces/min (depending on product type) | |
| Workstation Number | 5-20 stations (flexible configuration) | |
| Power Supply | 220V/380V AC, 50/60Hz | |
| Cleanroom Compatibility | ISO Class 5-8 (optional HEPA filtration) | |
| Assembly Module | Assembly Accuracy | ±0.1 mm |
| Gripper Type | Medical-grade silicone/pneumatic (FDA compliant) | |
| Ultrasonic Welding | 20-40 kHz (for plastic components) | |
| Component Size Range | 5-300 mm | |
| Inspection Module | Vision System Resolution | 5-10 MP (with 10-30 μm/pixel) |
| Defect Detection | Particulate contamination, surface defects, dimensional accuracy | |
| Leak Test Sensitivity | ≥1 μm (for syringes, IV bags) | |
| Sterility Verification | Optional ATP bioluminescence detection | |
| Material Handling | Conveyor Type | FDA-approved belt/chain (anti-static options) |
| Positioning Accuracy | ±0.2 mm | |
| Material Compatibility | PP, PE, PVC, silicone (medical-grade) | |
| Control System | PLC | Siemens (S7-1200/1500), Rockwell Automation |
| HMI | 10"-15" touchscreen (21 CFR Part 11 compliant) | |
| Traceability System | Barcode/RFID (UDI compliance) | |
| Data Integrity | Audit trail, electronic signatures (GMP requirements) | |
| Quality Metrics | False Rejection Rate | ≤0.1% |
| First-Pass Yield | ≥99.8% | |
| AQL Level | 0.65 (standard sampling plan) | |
| Environmental | Operating Temperature | 18-26°C (controlled environment) |
| Humidity Range | 30-60% RH | |
| Noise Level | ≤65 dB | |
| Safety & Compliance | Regulatory Standards | ISO 13485, FDA 21 CFR Part 820, EU MDR |
| Safety Features | Emergency stop, interlocks, cleanroom-grade materials | |
| Validation Package | IQ/OQ/PQ documentation available |
Sterility Assurance: Optional gamma irradiation/EtO compatible materials
Changeover: <10 minutes for different product formats
Materials: All contact parts USP Class VI or ISO 10993 certified
Optional: Vision-guided robots for precise assembly of micro-components
Syringes and injection pens
IV sets and infusion devices
Surgical kits and disposable instruments
Diagnostic test cartridges
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