GMP-konforme Abfüll- und Verschließmaschine für pharmazeutische Reagenzien
The GMP 1ML Reagent Testing Tubes Filling and Capping Machine is a fully automated fill-and-finish solution designed for pharmaceutical, diagnostic, and biotechnology applications. Built with GMP standards and FDA-compliant materials, it delivers high-precision filling, reliable capping, and consistent production performance for 1ml reagent tubes.
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Technische Daten
Beschreibung
The diagnostic reagent filling line is a GMP-grade automated filling system for liquid pharmaceuticals such as in vitro diagnostic reagents (IVD), biochemical reagents, and immunological reagents. It covers the entire process from bottle unscrambling, air washing, filling, capping to bottle dispensing, and supports optional visual inspection, labeling, and cartoning functions, achieving efficient, stable, and traceable production. The entire line has a compact structure and is easy to operate. Core equipment includes a bottle unscrambler, air washing machine, servo filling machine, servo capping machine, and a robotic bottle dispensing platform.
The production line is suitable for various packaging formats, including round plastic bottles, vials, cartridges, test tubes, and eye drop bottles, with a capacity range of 2–500 mL. In 10 mL plastic bottle aqueous solutions, peak capacity can reach 4,800 bottles/hour.
Packing Line
| Filling Packing Line | Function | Main Configurations | GMP Point | |
| 1 | Unscrambler Machine | Sorting and feeding bottles | sorting and counting for containers, rejection station | Lack bottle, fall-over bottle, machine stop |
| 2 | Waschmaschine | Clean inside and outside of bottles | Air or water rinser | No shedding particles; verifiable residues |
| 3 | Abfüll- und Verschließmaschine | Dosing liquid into containers and cap close by servo torque system | Servo drive for dosing pump, servo control for torque program. 316L for all contact parts | 100% weight feedback; no filling without a bottle. No-cap rotation; torque recording. |
| 4 | Etikettiermaschine | Apply labels on bottles, print batch numbers | Servo label apply system, ±1mm labeling precision | Label counting, vision inspection for label apply and printing quality inspection |
Control System:
- Siemens PLC + Siemens 10″ touchscreen, three-level access control, 21 CFR Part 11 audit trail.
- Recipe management: ≥100 groups, one-click specification switching.
- Automatic batch record generation: electronic signature, USB/PDF export, OPC UA integration with MES.
Cleaning/Sterilization
- Overall CIP: 304 stainless steel quick-release structure, allows for online circulating cleaning, coverage ≥99%.
- Peristaltic pump/ceramic pump can be offline SIP (121℃×30 minutes).
- Air washing nozzles are removable and washable; compressed air filter undergoes online integrity testing.
Technische Daten
| 1 | Anwendung | Plastic Bottle 0.5ml~150ml/500ml | ||
| 2 | Modell | RVF-ZD1 | RVF-ZD2 | RVF-ZD4 |
| 3 | Abfüllsystem | Ceramic Pump, Peristaltic Pump | ||
| 4 | Dosing Range | 0. 5ml- 150ml | ||
| 5 | Kapazität | 20-30 Bottle/Min | 20-40 Bottle/Min | 20-60 Bottle/Min |
| 6 | Precision | ±0.5% to ±2% | ||
| 7 | Power | 2,5 kW
380V/50HZ |
3.5KW
380V/50HZ |
4,5 kW
380V/50HZ |
Häufig gestellte Fragen
1. What is a Multi-Dose IVD Reagent Filling Machine?
It is an automatic machine designed to accurately fill multi-dose IVD reagents into containers and heat-seal them for reliable storage and use.
2. What products can the machine handle?
It is suitable for IVD reagents, diagnostic reagents, biological reagents, laboratory solutions, and other liquid formulations.
3. Can the filling volume be customized?
Yes. The IVD reagent filling machine can be customized for different filling volumes, container sizes, and production speeds.
4. How does the heat sealing system work?
The machine uses controlled sealing temperature, pressure, and time to achieve consistent and reliable container sealing.
5. Can defective containers be automatically rejected?
Yes. Optional inspection systems can detect filling errors, sealing defects, missing containers, and other abnormalities, with automatic rejection of defective products.
Flow Chart
Manual bottle placement → Bottle handling: turntable + elevator → Air washing: clean compressed air 0.5 MPa × 3 s → Filling: servo peristaltic pump ±1% → Cap handling: vibratory feeder + vacuum cap removal → Servo capping: torque adjustable 0.3–1.2 N·m → Bottle ejection: robotic arm automatically ejects tubes → Optional: vision inspection + labeling + cartoner Machine
Control System & Data Integrity
1. Siemens PLC + Siemens 10″ touchscreen, three-level access control, 21 CFR Part 11 audit trail.
2. Recipe management: ≥100 groups, one-click specification switching.
3. Automatic batch record generation: electronic signature, USB/PDF export, OPC UA integration with MES.
