10ml Ampoule Filling Machine

A 10ml ampoule filling machine is a specialized pharmaceutical device designed to fill and seal 10ml glass ampoules with liquid drugs or other substances. These machines are widely used in industries such as pharmaceuticals, biotechnology, cosmetics, and chemicals, ensuring precise, sterile, and efficient filling and sealing processes. Below is a detailed description based on industry standards and available information:

Automatic Ampoule Filling Videos

Key Features of a 10ml Ampoule Filling Machine:

1. Capacity and Compatibility:

   • Designed to handle 10ml open-mouth or closed glass ampoules, with flexibility to accommodate sizes ranging from 1ml to 30ml in some models.

   • Filling capacity typically ranges from 0.5ml to 25ml in a single dose, with precise volumetric control.

2. Construction:

   • Built with high-quality stainless steel (AISI 316L for contact parts, AISI 304 for non-contact parts) to meet cGMP standards, ensuring durability and compliance with sterile production requirements.

   • Features a robust stainless steel square pipe frame with a matte finish and large bottom openings for easy cleaning and maintenance.

3. Filling Mechanism:

   • Operates on the principle of slant travel, allowing precise handling of ampoules despite variations in neck dimensions, thickness, or ovality.

   • Utilizes volumetric piston pumps, peristaltic pumps, or ceramic pumps for accurate filling with minimal product waste.

   • Equipped with a “no ampoule, no fill” system to prevent liquid wastage.

4. Sealing Process:

   • Sealing is performed using combustible gases (oxygen and LPG/propane) at pressures of approximately 1kg/cm² for oxygen and 0.5kg/cm² for LPG.

   • Features pre-warming and sealing stations, with rollers to rotate ampoules for uniform sealing and a waste tip clipper for clean ejection of excess glass.

   • Some models include pre- and post-nitrogen flushing to ensure sterility and prevent contamination.

5. Production Capacity:

   • Output varies by model and number of filling heads (single, two, four, six, or eight heads). For 10ml ampoules, high-speed models like the eight-head vertical machines can process 80–280 ampoules per minute (approximately 4,800–16,800 per hour).

   • Specific output for 10ml ampoules is around 150–200 ampoules per minute, depending on machine configuration and ampoule diameter.

6. Automation and Control:

   • Equipped with PLC (Programmable Logic Control) and HMI (Human-Machine Interface) systems for real-time monitoring, error detection, and automated fill volume adjustments.

   • Servo-driven systems or brushless motors ensure precise and gentle movements.

   • Features like flow meters for flame regulation and safety valves in gas circuits enhance operational safety.

7. Additional Features:

   • Nitrogen flushing before and after filling to maintain sterility.

   • Optional laminar airflow or RABS (Restricted Access Barrier System) for class 100 sterile filling.

   • Minimal changeover time for different ampoule sizes, with tool-less format changes in some models.

   • Waste tip collection and dead tray for upright ampoule placement during collection.

8. Applications:

   • Suitable for filling liquid drugs, veterinary medicines, agro-insecticides, cosmetics, and chemicals into 10ml glass ampoules.

   • Ensures high purity and protection from environmental contaminants, making it ideal for injectable pharmaceuticals.

9. Safety and Ergonomics:

   • Pendant-style electrical control panels for safe and easy operation.

   • Stainless steel hoods to channel fumes during sealing and ergonomic designs for operator comfort.

Operational Process:

• Loading: Sterilized ampoules are loaded into a slant hopper or fed via a conveyor from a sterilizing tunnel. A star wheel transfers ampoules to an eccentric or vertical rack.

• Nitrogen Flushing: Pre-flushing with nitrogen to remove air and ensure sterility.

• Filling: Liquid is dispensed via filling nozzles with precise volume control, often using piston or peristaltic pumps.

• Post-Nitrogen Flushing: Additional nitrogen flush to maintain sterility.

• Pre-Warming and Sealing: Ampoules are warmed at a pre-heating station, then sealed by melting the neck with an open flame, with rollers ensuring uniform sealing.

• Collection: Filled and sealed ampoules are automatically collected on a tray without manual handling.

Advantages:

• High precision and minimal product wastage due to advanced filling systems.

• Compact, monobloc design integrates filling and sealing, reducing contamination risks.

• Fast changeover and easy maintenance minimize downtime.

• Compliance with cGMP and CE standards ensures safety and quality.

Limitations:

• Machines may require specific gases (oxygen, LPG) and precise pressure settings, increasing operational complexity.

• Initial setup and calibration for 10ml ampoules may need skilled technicians.

• No machine is 100% error-free, so regular maintenance is critical to avoid inefficiencies.

Types of Ampoule Filling Machine

• Laboratory Ampoule Filling Machine
• Closed Ampoule Filling Machine
• Single Head Ampoule Filling Machine
• Double Head Ampoule Filling Machine
• Four Head Ampoule Filling Machine
• Six Head Ampoule Filling Machine
• Eight Head Ampoule Filling Machine
• Onion Skin Ampoule Filling Machine

Salient Features of Automatic Ampoule Filling

• Compact model as per cGMP standard.

• Higher production output up to 12000 Ampoules per hour.

• All contact parts made from High Quality Stainless Steel 316L & Non-contact parts made from Stainless Steel 304.

• Minimum change over parts from 1ml to 10ml ampoule size.

• “No Ampoule – No Filling” system.

• Ampoule neck centering during gas flushing and filling operations.

• Possibility of nitrogen gas flushing before, during and after filling.

• Full accessibility allows easy maintenance.

• Machine equipped with pre-warming station.

• Flow Meters for regulating flames easily.

• Minimum change over time, little maintenance, easy cleaning.

Process Operation of Automatic Ampoule Filling Machine

Empty washed & sterilized ampoules loaded onto infeed hopper of the machine. From where it has been received to receiving rack through starwheel/cassette. The moving rack which moves horizontally collect one/two/four/eight ampoules from the receiving rack and transfer the ampoule to the machine in left to right in an inclined position. During ampoule movement Pre-gassing, Filling, Post Gassing, Pre-heating & Sealing Station perform filling and sealing operations. At the end duly filled and sealed ampoules get collected automatically onto collection tray of the machine. For detailed working process please explore automatic ampoule filler video in top right section of this page.

Technical Specification of Ampoule Filling Machine

* Power voltage can be adjusted as per customer’s domestic power voltage requirements.
* Rights of technical improvements & modification reserved.
* Illustrations & dimensions are shown for information purpose only.