The Guanshengtai Automated Reagent Kit Assembly and Leak Detection Machine is an integrated specialized device designed for the automated assembly and leak testing of in vitro diagnostic (IVD) reage
The Guanshengtai Automated Reagent Kit Assembly and Leak Detection Machine is an integrated specialized device designed for the automated assembly and leak testing of in vitro diagnostic (IVD) reagent kits (test cartridges, reagent strip housings, etc.). The equipment integrates automatic feeding of the base card/cover, automatic assembly of test strips/filter pads/desiccants, cover pressing and tightening, leak testing, and automatic sorting and unloading of qualified/unqualified kits. The entire line achieves one-stop fully automated assembly and leak testing from bulk components to finished reagent kits, with a production speed of 1800-3600 kits/hour, effectively replacing traditional manual assembly and leak testing.
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
Core Advantages:
Integrated Design: The equipment highly integrates assembly and leak testing functions on a single platform. Each process achieves efficient flow through a synchronous transfer mechanism, sequentially completing base card positioning and feeding, precision installation of test strips/filter pads and other components, cover pressing and tightening, leak testing, and automatic unloading and sorting of finished products. This eliminates the need for multiple machines operating in sections, significantly shortening production cycle time and reducing intermediate turnaround times.
Precise Leak Detection for Airtightness: Employing a high-precision differential pressure or flow-rate airtightness detection module, a preset (adjustable) air pressure is applied to the reagent kit, and pressure decay or leakage is monitored in real time to accurately determine whether the product's sealing performance meets standards. Detection parameters (test pressure, holding time, leakage threshold) are adjustable and controllable, providing objective and accurate results, effectively eliminating defective products caused by poor casing fit, ultrasonic welding defects, etc.
Precision Assembly Mechanism: Utilizing high-precision servo positioning and flexible clamping technology, components such as test strips/filter pads are precisely placed into designated slots on the base card, with a positional accuracy of ±0.1mm. The faceplate fastening uses a servo press-fit system, with controllable and adjustable mold closing pressure, ensuring a tight casing fit, uniform gaps, and no damage to the internal test strips.
Rapid Switching Between Specifications: By changing the positioning fixture, track module, and detection clamp, different specifications and shapes of reagent kits (such as strips, plates, and inserts) can be quickly adapted, with changeover time controlled within 30 minutes, meeting the needs of multi-variety production.
Online 100% Inspection and Automatic Sorting: Leak detection results are linked with visual inspection results. The equipment automatically distinguishes between good and defective products, and a pneumatic rejection mechanism separates defective products to a designated collection area, while good products are neatly discharged, ensuring that 100% of the products leaving the factory have undergone sealing tests and assembly quality confirmation.
Cleanroom Design: The entire machine uses a SUS304 stainless steel frame and a transparent protective structure. The assembly area is clean and controllable, allowing operation in a Class 100,000 cleanroom, meeting IVD and medical device GMP standards and ISO13485 quality management system requirements.
Easy Operation: Utilizing a PLC and touchscreen human-machine interface, assembly parameters and leak detection parameters for each station are centrally set. Multiple product formulas are built-in for one-click recall during product changeovers. Real-time monitoring of operating status and fault alarms with code prompts ensure quick and convenient maintenance.
Applicable Scenarios: Widely applicable to the large-scale, standardized automated assembly and sealing testing of test kits in the in vitro diagnostics (IVD) industry (early pregnancy test kits, infectious disease test kits, drug test kits, tumor marker test kits, myocardial marker test kits, food safety test kits) and animal disease testing (rapid pet disease test kits, livestock and poultry disease test kits). Guanshengtai's automated reagent kit assembly and leak detection machine, with its highly efficient integrated assembly and leak detection, helps IVD manufacturers achieve comprehensive automation upgrades in their test kit production processes, effectively ensuring product sealing reliability and guaranteeing the performance stability of test kits during storage, transportation, and use.
