Overview

　　The Guanshentai automated production line for antigen reagent filling and capping is an integrated system designed specifically for the fully automated production of antigen/antibody test kits (including cassette-based, tube-based, and lysis buffer tube formats) in the in vitro diagnostics (IVD) sector. The equipment combines automatic tube feeding, precision micro-volume filling, lysis buffer/reagent dispensing, automatic capping, finished product inspection, and collection into a single unit. It enables a one-stop, fully automated process transforming bulk consumables into finished test kits, achieving production speeds of 3,000 to 6,000 units per hour.

　　Key Advantages:

　　High-Precision Micro-Volume Filling: Utilizes a precision ceramic piston pump or micro-syringe pump metering system, maintaining filling accuracy within ±0.5%. The dispensing volume per tube ranges from 50μL to 5mL, meeting the rigorous volume requirements of various test reagents and eliminating result inaccuracies caused by volume deviations.

　　Anti-Splash and Anti-Contamination Design: The filling nozzle features a side-discharge structure and dynamic vertical tracking; it descends to the tube bottom and dispenses while retracting, effectively preventing splashing and bubble formation. An independent suck-back system ensures no residual droplets remain on the nozzle tip, eliminating cross-contamination between tubes.

　　Precise and Reliable Capping: Employs a servo-driven capping mechanism with a closed-loop torque control system. Capping torque can be customized based on cap specifications, ensuring each cap is securely tightened without damaging threads, thereby guaranteeing a leak-proof seal. Includes detection for tilted or missing caps, with automatic rejection of non-conforming products.

　　High-Efficiency, Stable Output: Features a rotary or linear multi-station synchronous design where stations operate in coordination without interference. It supports stable, continuous 24-hour operation with a failure rate of less than 1%, effectively ensuring production deadlines are met.

　　Superior Material Quality: All fluid-contact components are made from SUS316L stainless steel and PTFE/ceramic materials. These materials offer excellent resistance to acid/alkali corrosion and wear, ensuring compatibility with lysis buffers, reagents, and sample diluents across a wide pH range, while meeting IVD industry cleanliness and hygiene standards.

　　Data Traceability: Equipped with a real-time production data acquisition and recording system, the line allows for the querying and exporting of data—such as batch yield, average fill volume, and qualified product count—thereby meeting production traceability requirements under ISO 13485, IVDR, and FDA 21 CFR Part 11 regulations.

　　Rapid Changeover: Features a modular, quick-release design that allows for tool-free replacement of contact consumables (e.g., filling needles, fluid lines, and capping heads). Switching between different reagent tube specifications can be completed within 20 minutes, accommodating the flexible production needs of diverse, small-batch operations.

　　Application Scenarios:

　　Ideally suited for large-scale, standardized aseptic filling and capping operations across sectors such as in vitro diagnostics (IVD)—including COVID-19 antigen test kits, influenza test reagents, early pregnancy test kits, and cardiac marker reagents—as well as biopharmaceuticals (nucleic acid lysis buffer tubes, sample preservation tubes, and PCR master mix tubes) and life science laboratories (sample collection tubes, cryovials, and centrifuge tube aliquoting). With its exceptional performance characterized by precision, efficiency, and cleanliness, the Guanshentai antigen reagent filling and capping production line empowers IVD manufacturers to achieve automated upgrades and compliant mass production of testing reagents.

　　Technical parameters:

　　Model Number: GST-SJGZ100A

　　Sizes: L3800*W1400*H1800mm

　　Production Capacities: 300pcs/min

　　Power (Output): 0.75KW

　　Reagent Tube Capacity:0.2-20ml

　　Customized Support: Yes