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Diagnostic Reagent Filling Line

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Diagnostic Reagent Filling Line

BRIEF INTRODUCTION

Diagnostic Reagent Filling Line is a GMP-compliant automated system designed for in vitro diagnostic (IVD), biochemical, and immunological liquid products, covering the full production process from bottle feeding, air washing, filling, capping to bottle discharge. The line optionally supports visual inspection, labeling, and cartoning, ensuring efficient, stable, and fully traceable production. The system features a compact structure and easy operation, with core equipment including bottle orienting machine, air-washing unit, servo filling machine, servo capping machine, and robotic bottle discharge platform. The line is compatible with multiple packaging types, including round plastic bottles, vials, cartridge bottles, test tubes, and eye-drop bottles, with a capacity range of 2–500 mL. Under 10 mL plastic bottle water-based conditions, the line can reach a peak output of 4,800 bottles per hour.

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Product Positioning

Designed to meet GMP-compliant production requirements for products such as in vitro diagnostic (IVD) reagents, biochemical reagents, immunological products, covering the entire process of bottle unscrambling / air rinsing / filling / capping / discharge.

Applicable Packaging Types & Specifications

Container types: Round plastic bottles, vials, cartridge bottles, test tubes, ophthalmic dropper bottles
Filling volume range: 2 – 500 mL
Maximum output: 4,800 bottles/hour
(Measured under operating conditions of 10 mL plastic bottles filled with aqueous solution)

Process Flow

Manual bottle loading → Bottle unscrambling: turntable + elevator → Air rinsing: clean compressed air, 0.5 MPa × 3 s → Filling: servo-driven peristaltic pump, accuracy ±1% → Cap sorting: vibrating bowl + vacuum cap pick-up → Servo capping: adjustable torque 0.3–1.2 N·m → Bottle discharge: automatic robotic unloading → Optional: vision inspection + labeling + cartoning

Core Modules

Control System & Data Integrity

Siemens PLC + Siemens 10" touchscreen HMI, three-level user access control, 21 CFR Part 11–compliant audit trail.
Recipe management for ≥100 product formats, with one-click changeover.
Automatic batch record generation with electronic signatures, USB/PDF export, and OPC UA interface for MES integration.

Cleaning & Sterilization Strategy

Whole-machine CIP: 304 stainless steel quick-release structure, online circulation cleaning with coverage ≥ 99%.
Peristaltic / ceramic pumps: offline SIP (121 °C × 30 minutes).
Air rinsing nozzles are detachable for cleaning; compressed air filters support online integrity testing.