Automatic Liquid Vial Filling Line (Liquid Vial Compact Line)
The Harsiddh Liquid Vial Compact Line is a high-performance, fully integrated solution designed for the seamless transition of vials from washing to sterilization, precision filling, and final capping. Engineered to meet the most stringent cGMP and FDA standards, this line is the ideal choice for pharmaceutical injectable production, ensuring absolute sterility and dosing accuracy.
Line Configuration & Core Components
1. High-Speed Vial Washing Machine
Utilizes advanced multi-jet cleaning technology to ensure vial interiors and exteriors are free from contaminants.
- Output Speed: Up to 300 vials/minute.
- Versatility: Handles ISO standard vials from 2 ml to 100 ml.
- Washing Cycle: Features 8–12 washing stations using WFI, purified water, and oil-free compressed air.
- Build Quality: SS316L contact parts with a robust SS304 frame.
2. Depyrogenation Tunnel (Sterilizing Tunnel)
A continuous sterilization system that uses forced hot-air convection to achieve deep depyrogenation.
- Performance: Synchronized capacity to match the washer output (300 VPM).
- Thermal Validation: Heating zones maintain temperatures between 250°C and 320°C.
- Cooling Zone: ISO 5 (Class 100) laminar airflow zone ensures sterile cooling before filling.
- Monitoring: PLC-based control with real-time temperature recording and safety alarms.
3. Vial Filling & Stoppering Machine
The heart of the line, providing surgical dosing accuracy and immediate protection via rubber stoppering.
- Dosing Accuracy: ±0.5% precision via servo-driven piston or peristaltic pumps.
- Filling Heads: Configurable with 4 to 12 heads to meet specific production speeds.
- Stoppering: Capable of full or partial stoppering (for lyophilization) under a Class 100 laminar airflow environment.
4. Automatic Vial Capping Machine
Ensures a hermetic seal with consistent torque to maintain the integrity of the injectable drug.
- Cap Sizes: Compatible with 13mm, 20mm, 28mm, and 32mm aluminum/flip-off caps.
- Sealing Type: Available in rotary pick-and-place or spinning roller configurations.
- Safety Rejection: In-line sensor automatically rejects vials with missing or improperly applied caps.
Technical Specifications & Compliance
| Feature | Specification |
|---|---|
| Output Speed | Up to 300 Vials / Minute (VPM) |
| Filling Range | 2 ml to 100 ml |
| Automation | Fully PLC Controlled with HMI Touch Screen |
| Compliance | cGMP, GAMP 5, 21 CFR Part 11 (Optional) |
| Validation Support | Complete DQ, IQ, OQ, PQ Documentation |
| Electrical Supply | 415V, 3 Phase, 50/60 Hz |
| Compressed Air | 6 bar (Dry & Oil-free) |
Frequently Asked Questions
How does the machine ensure dosing accuracy for high-value injectables?
Precision is critical in vial filling to prevent product loss and ensure patient safety. The Harsiddh Compact Line utilizes:
Volumetric Piston Pumps: High-precision SS 316L syringes provide an accuracy of ±1%.
Peristaltic Pump Option: For biotech or highly sensitive products, peristaltic pumps can be used to ensure the liquid only touches medical-grade tubing, making cleaning and validation easier.
Diving Nozzles: To prevent foaming and splashing, the nozzles descend into the vial and retract as the liquid rises.
How is the "Stoppering" (Bunging) process managed in a sterile environment?
Immediately after filling, vials move to the stoppering station. The machine uses a vibratory bowl feeder to orient the rubber stoppers and a "pick-and-place" or "vacuum" mechanism to press them into the vial neck. To maintain sterility, this entire zone is typically operated under a Laminar Air Flow (LAF) unit, and the machine is designed with "Sleek Designs" to prevent air turbulence and dust accumulation.
What is the production capacity and vial size range?
The line is built for high-speed industrial output and is highly scalable:
Capacity: Depending on the number of heads (2, 4, 6, 8, or 12), the line can achieve speeds from 30 to 250 vials per minute.
Vial Range: It can handle vial sizes from 2ml to 100ml (glass or plastic) with minimal changeover parts. The "No Vial – No Fill" and "No Vial – No Stopper" sensors ensure that expensive medication and components are not wasted.
What are the key cGMP and safety features of the Harsiddh Compact Line?
As a cGMP-compliant unit for pharmaceutical use, the machine includes:
Material Integrity: All product contact parts are SS 316L, and the exterior structure is polished SS 304.
Safety Enclosure: A toughened glass or acrylic cabinet with safety interlocks protects the operator and maintains the integrity of the sterile zone.
Advanced Control: Controlled via a centralized PLC with a Touchscreen HMI, allowing for real-time monitoring of production counts, filling speed, and error logs.
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