The Automatic Reagent Kit Assembly and Leak Testing Machine is specifically designed for the fully automated assembly and leak integrity testing of products such as In Vitro Diagnostic (IVD) kits, n
The Automatic Reagent Kit Assembly and Leak Testing Machine is specifically designed for the fully automated assembly and leak integrity testing of products such as In Vitro Diagnostic (IVD) kits, nucleic acid detection kits, and antigen test cards. This equipment integrates automatic feeding, precision assembly, high-sensitivity leak detection, visual inspection, and automated rejection of defective products into a single unit, enabling a completely unmanned workflow—from individual components to finished packaging—within a cleanroom environment.
Integrated Intelligent Assembly: Utilizing high-precision servo control and vision-guided positioning technologies, the system automatically performs the precise assembly and pressing of components—including the kit housing, inner tray, lid, and test strips—achieving an assembly accuracy of ±0.05 mm.
High-Precision Non-Destructive Leak Testing: Integrating imported, high-precision leak detectors based on vacuum decay or pressure decay principles, the system monitors the kit's sealing integrity in real-time. It is capable of identifying micron-level leak defects, ensuring that finished products are leak-free and contamination-free, with a yield rate of ≥99.8%.
Efficient and Stable Operation: Featuring multi-station parallel and collaborative operation, a single machine can achieve a maximum throughput of up to 900 units per hour—representing a multi-fold increase in efficiency compared to manual assembly. Its modular design facilitates rapid changeovers for various kit models, with a product changeover time of ≤15 minutes.
Intelligent Quality Control: The system integrates real-time pressure curve monitoring and visual inspection systems to automatically sort and reject defective products. Production data is seamlessly interfaced with the MES system in real-time, ensuring compliance with FDA 21 CFR Part 11 and GMP traceability requirements.
Centered on the core principles of high precision, high efficiency, and high cleanliness, the Automatic Reagent Kit Assembly and Leak Testing Machine provides enterprises in the In Vitro Diagnostics, Biopharmaceuticals, and Medical Consumables sectors with an integrated automated assembly and inspection solution that meets international standards.
Equipment Details:
Model Number: GST-SJH001A
Sizes: L396cm*W218cm*H210cm
Weight: 2500kg
Power: 4kW
Production Capacity: 900 units/hour
Voltage: 220V
Core Component: High-precision leak detector
Customized Support: Yes
