The Automated Antigen Reagent Filling and Capping Production Line is specifically designed for the automated manufacturing of in vitro diagnostic (IVD) products, including novel coronavirus antigen
The Automated Antigen Reagent Filling and Capping Production Line is specifically designed for the automated manufacturing of in vitro diagnostic (IVD) products, including novel coronavirus antigen test kits, influenza virus detection reagents, and respiratory pathogen test kits. This equipment integrates automatic feeding, high-precision filling, servo-driven capping, visual inspection, and defect rejection into a single unit. Operating within a cleanroom environment, it achieves a fully automated, unmanned workflow—from empty bottle loading to finished product output—while strictly adhering to GMP standards and the quality management system requirements for medical device manufacturing.
Microliter-Scale High-Precision Filling: Utilizes a non-contact ceramic piston pump or peristaltic pump filling system. It achieves a filling precision with a CV value of ≤1.0% and supports minimum filling volumes as low as 20µL. Compatible with liquids and micro-suspensions with viscosities up to 500 cps, the system ensures precise and consistent liquid content in every reagent bottle.
Intelligent Torque Capping System: Equipped with a servo-driven capping unit and pressure sensors, the system monitors and dynamically adjusts capping torque in real-time (range: 0.1–5 N·m) to guarantee cap sealing integrity. An optional vacuum leak detection module is available for inline verification of bottle seal integrity, enabling the automatic rejection of defective products.
High-Efficiency and Stable Operation: A single production line boasts a maximum output capacity of 200–300 bottles per minute. Capable of continuous, stable operation for 24 hours a day, it fully meets the demands of large-scale mass production. The modular design facilitates rapid changeovers for various bottle specifications (ranging from 1 mL to 30 mL), with product changeover times of ≤30 minutes.
Comprehensive Quality Control: Integrates multiple quality checks, including weight verification, detection of liquid residue on bottle necks, visual inspection of cap integrity, and airtightness testing. Production data is interfaced in real-time with the MES system, ensuring compliance with FDA 21 CFR Part 11 regulations and Unique Device Identification (UDI) traceability requirements for medical devices.
Cleanroom-Compliant Design: Critical workstations are equipped with Class A laminar flow protection and inline particle monitoring systems. The entire machine is constructed from 304 stainless steel, featuring a design free of sanitary dead zones to ensure full compliance with GMP standards and ISO manufacturing guidelines for medical consumables.
Centered on the core principles of high precision, high efficiency, and high cleanliness, this Automated Antigen Reagent Filling and Capping Production Line provides IVD and biopharmaceutical enterprises with intelligent filling and packaging solutions that meet rigorous international standards.
Technical parameters:
Model Number: GST-SJGZ100A
Sizes: L3800*W1400*H1800mm
Production Capacities: 300pcs/min
Power (Output): 3KW
Reagent Tube Capacity:0.2-20ml
Customized Support: Yes
