Vial Line
Fully Automated Washing, Drying, Filling & Stoppering Line for Infusion/Injection Vials
Introducing our state-of-the-art Integrated Vial Line, a seamless, high-speed automation solution designed for the sterile production of large-volume parenterals (LVPs) and small-volume parenterals (SVPs) in syringe and infusion bottles. This complete Vial Line Machine integrates four critical aseptic processes—precision washing, depyrogenation drying, aseptic filling, and sterile stoppering—into one continuous, synchronized operation. Engineered to function as a high-capacity Vial Filling and Capping Machine (with stoppering), it is the ultimate turnkey solution for pharmaceutical manufacturers requiring uncompromising sterility assurance, operational efficiency, and regulatory compliance for injectable formulations.
A Complete, Closed-Loop Aseptic Processing Core
This integrated line represents the pinnacle of sterile manufacturing technology, eliminating manual interventions and transfer points that pose contamination risks. The process begins with a high-efficiency Vial Washing Machine that thoroughly cleans bottles with WFI (Water for Injection) and filtered air. Vials are then transferred into a Depyrogenation Tunnel where validated dry-heat cycles eliminate pyrogens. The sterile vials enter a Class A protected zone where an Aseptic Piston Filler accurately doses the liquid formulation. Finally, the line incorporates a fully automatic Stoppering Machine that precisely inserts rubber stoppers under aseptic conditions. This seamless integration creates a robust, continuous Vial Line, dramatically reducing particulate and microbial ingress while maximizing throughput.
Engineered for Sterile Manufacturing Excellence
Built to meet the most stringent global cGMP standards and the enhanced guidelines of EU Annex 1, every component is designed for sterility assurance. The line features 316L stainless steel construction, fully automatic HEPA-filtered laminar airflow protection over critical zones (filling & stoppering), and a design fully compatible with CIP/SIP systems. As a sophisticated Vial Line Machine, it provides comprehensive environmental monitoring interfaces and employs technologies such as particle monitoring ports and uni-directional air flow principles to maintain the highest grade of aseptic processing.
Core Technical Features & Operational Benefits
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Fully Integrated Continuous Process: Synchronized transfer between washing, drying, filling, and stoppering modules creates a true "linked" Vial Line, optimizing flow and minimizing bottlenecks.
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High-Capacity Aseptic Filling: Piston-based filling technology ensures volumetric accuracy (±0.5%) for large and small volumes (50ml to 1000ml+), critical for infusion solutions.
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Automatic Sterile Stoppering: The integrated stopper handling system (including bowl feeder, orienter, and insertion head) completes the container closure, functioning as the critical sealing component of this Vial Filling and Capping Machine system.
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Advanced Process Control & Data Integrity: A centralized, GMP-compliant SCADA system provides unified control, real-time monitoring of all parameters (temperature, pressure, speed), and complete electronic batch records with 21 CFR Part 11 compliance.
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Scalable & Validatable Design: The line is designed to support full validation (IQ, OQ, PQ), with clearly defined performance qualifications for each module and the integrated system.
Ideal Applications
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Large Volume Parenterals (LVPs): Saline solutions, dextrose infusions, irrigation fluids, and parenteral nutrition bags/bottles.
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Small Volume Parenterals (SVPs): Antibiotic vials, analgesic injections, and other liquid injectables in vials.
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Diagnostic & Dialysis Solutions: Sterile water and solutions for diagnostic or hemodialysis applications.
Your Partner in Building Sterile Manufacturing Capacity
We provide a complete partnership, from initial line design and factory acceptance testing (FAT) to on-site installation, commissioning, and comprehensive performance qualification (PQ) support. Our validation experts ensure this integrated Vial Line Machine meets all regulatory expectations for the production of sterile injectables.
| Washing machine Technical Parameters | |||||
|---|---|---|---|---|---|
| Model | Capacity (bottles/min) | Power (kW) | Power Supply | Qualification Rate | Dimensions (L×W×H) (mm) |
| MIC-18 | 30-50 | 1.5 | 380V 60Hz | ≥ 99.9% | 1300 × 1350 × 1700 |
| MIC-24 | 60-100 | 1.5 | 380V 60Hz | ≥ 99.9% | 1500 × 1550 × 1700 |
| MIC-32 | 100-200 | 2.0 | 380V 60Hz | ≥ 99.9% | 1800 × 1750 × 1800 |
| MIC-48 | 200-300 | 2.0 | 380V 60Hz | ≥ 99.9% | 2000 × 1950 × 1800 |
| drying oven Technical Parameters | |||||
|---|---|---|---|---|---|
| Model | Capacity (bottles/min) | Power (kW) | Power Supply | Filling Accuracy | Dimensions (L×W×H) (mm) |
| 4/1 | 30-50 | 30.0 | 380V 60Hz | ≥ 99% | 10500 × 1500 × 2000 |
| 8/2 | 60-80 | 35.0 | 380V 60Hz | ≥ 99% | 11500 × 1600 × 2000 |
| 12/10 | 120-180 | 46.0 | 380V 60Hz | ≥ 99% | 12500 × 1600 × 2000 |
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