Automatic Ampoule Filling Line (Ampoule Compact Line)
Maximize your injectable production efficiency with the Harsiddh Automatic Ampoule Filling Line. This state-of-the-art “Compact Line” is an integrated, high-speed solution designed to handle the entire ampoule processing cycle—from washing and sterilization to precision filling and hermetic sealing.
Engineered for the rigorous demands of the global pharmaceutical industry, this line ensures a completely sterile environment, surgical dosing accuracy, and high throughput, all within a space-saving footprint.
Integrated Multi-Stage Processing
The Ampoule Compact Line synchronizes several critical machines into one seamless, automated workflow:
- Automatic Vertical Ultrasonic Ampoule Washing Machine: Uses high-frequency ultrasonic waves and multi-jet water/air cycles to ensure the interior and exterior of the ampoules are free from contaminants.
- Sterilizing & Depyrogenating Tunnel: Ampoules pass through a continuous laminar flow heating zone to eliminate pyrogens and moisture, ensuring absolute sterility.
- Automatic Ampoule Filling & Sealing Machine:
- Nitrogen Purging: Displaces oxygen before and after filling to prevent oxidation of sensitive drugs.
- Precision Dosing: High-accuracy volumetric piston pumps ensure exact fill volumes with a deviation of less than ± 1%.
- Pre-heating & Sealing: Utilizes specialized gas burners for uniform heating and a “pull-seal” mechanism for a flawless, leak-proof tip.
- Automatic Ampoule Labeling Machine: High-speed wrap-around labeling with integrated batch coding for full traceability.
The Harsiddh Ampoule Compact Line is an integrated, high-speed solution designed for the seamless transition of ampoules from washing to sterilization and final sealing. This line is engineered for high-throughput pharmaceutical environments where sterility and precision are non-negotiable.
1. High-Speed Ampoule Washing Machine
This unit ensures the highest standards of cleanliness using multi-jet washing cycles to eliminate all micro-particles.
- Output Speed: Up to 300 ampoules/minute.
- Versatility: Handles ampoule sizes from 1ml to 20ml (ISO standard).
- Washing Cycle: 8 – 10 stations providing comprehensive internal and external washing.
- Media: Utilizes WFI (Water for Injection) and filtered compressed air.
- Build Quality: SS316L for all contact parts with a robust SS304 frame.
2. Depyrogenation Tunnel (Sterilizing Tunnel)
The tunnel uses forced convection of hot air through HEPA filters to achieve a continuous, sterile, and pyrogen-free process.
- Performance: Synchronized capacity to match the washer output (300 APM).
- Thermal Treatment: Validated heating zone temperatures reaching up to 320°C.
- Cooling Zone: Integrated Laminar Airflow with H14 HEPA filters for rapid, sterile cooling.
- Monitoring: Advanced PLC control with real-time temperature profile recording.
- Safety: Fully insulated SS316L contact areas to prevent heat loss and ensure operator safety.
3. Ampoule Filling & Sealing Machine
The heart of the compact line, this machine provides surgical dosing accuracy and hermetic sealing.
- Dosing Precision: Achieves an accuracy of ±0.5% across a range of 1ml to 20ml.
- Configuration: 6 – 12 high-speed filling heads (available in rotary or linear formats).
- Advanced Sealing: Hermetic flame sealing utilizing an LPG/Oxygen mixture.
- Product Stability: Optional inert gas flushing (Nitrogen) before and after filling to protect oxygen-sensitive formulations.
- Mechanics: High-efficiency servo-driven indexing system for smooth ampoule transport.
4. Control, Intelligence & Compliance
Designed to meet the most stringent regulatory standards (FDA/MHRA/GMP).
- Automation: Fully centralized PLC control with an intuitive, multi-color HMI interface.
- Regulatory Ready: Optional software integration for 21 CFR Part 11 compliance.
- Validation Support: Full documentation provided, including DQ, IQ, OQ, and PQ.
- Design Philosophy: cGMP compliant, featuring a “slanted” and easy-to-clean design to prevent dust accumulation.
5. Technical Utilities Required
| Utility | Requirement |
|---|---|
| Electrical Supply | 415V, 3 Phase, 50Hz |
| Compressed Air | 6 bar (Dry, Oil-free) |
| WFI Supply | 2 – 3 bar pressure |
| Fuel Source | Oxygen & LPG (For sealing burners) |
Technical Specifications
| Feature | Specification |
|---|---|
| Output Speed | Up to 12,000 Ampoules / Hour (Depending on model) |
| Ampoule Size Range | 1ml to 10ml (Standard) |
| Filling Accuracy | ± 0.5% to 1.0% |
| Number of Heads | 2, 4, 6, or 8 Heads |
| Nitrogen Purging | Pre and Post-filling integrated |
| Sealing Type | Gas-based Pull-Sealing |
| Power Consumption | Variable (approx. 3.0 KW – 5.0 KW) |
| Construction | Stainless Steel 316L (Contact) & SS 304 (Non-contact) |
Frequently Asked Questions
How does the machine handle oxygen-sensitive injectable drugs?
To maintain the stability of sensitive formulations, the Harsiddh Compact Line features a multi-stage Nitrogen (N2) flushing system. This includes:
Pre-Gassing: Displaces atmospheric air before the liquid is filled.
Post-Gassing: Flushes the headspace of the ampoule before sealing. This ensures a near-zero oxygen environment, preventing oxidation and extending the shelf life of the medicine.
What is the dosing accuracy and production speed of this compact model?
Despite its smaller footprint, the machine is built for high-speed industrial output:
Accuracy: Utilizing high-precision SS 316L volumetric piston pumps, the machine achieves a filling accuracy of ±1%.
Speed: Depending on the number of heads (2, 4, 6, or 8 heads), the line can produce between 30 to 200 ampoules per minute (approximately 1,800 to 12,000 per hour).
How is the hermetic sealing achieved for different ampoule sizes?
The machine uses a sophisticated slant-traveling system that rotates the ampoules while they pass through the sealing station. Oxygen and LPG/Natural Gas burners soften the glass neck, while a mechanical gripper pulls off the tip (Tip-Seal method). The machine can process ampoules ranging from 1ml to 25ml with minimal changeover parts, ensuring a smooth, rounded, and leak-proof seal every time.
What are the key cGMP and safety features of the Harsiddh Compact Line?
As a cGMP-compliant unit for sterile environments, the machine includes:
Material Integrity: All contact parts are made of SS 316L, and the non-contact exterior is SS 304.
"No Ampoule – No Fill" System: Sensors prevent the discharge of expensive medication if an ampoule is missing or incorrectly positioned.
Safety Enclosure: A toughened glass cabinet with safety interlocks protects the operator and maintains the sterile zone under the LAF hood.
Centralized Control: A PLC-based system with a Touchscreen HMI allows for real-time monitoring of all parameters.
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