Ampoule Filler and Sealer

An ampoule filler and sealer is a specialized machine used primarily in the pharmaceutical, biotech, cosmetic, and chemical industries to fill and seal glass ampoules with liquid or solid (powder) drugs or products. These machines ensure precise, sterile, and efficient filling and sealing of ampoules, maintaining product integrity and compliance with stringent regulatory standards such as cGMP (Current Good Manufacturing Practices). Below is a detailed description of an ampoule filler and sealer machine, its features, and its operational process:

Ampoule filler and sealer machines are designed to automate the process of filling glass ampoules (small sealed vials) with precise amounts of liquid or powder and then sealing them to protect contents from contamination, environmental dust, and microorganisms. They are critical for producing sterile injectable solutions, veterinary medicines, cosmetic serums, agro-insecticides, and other chemicals, ensuring accurate dosing and safe storage. These machines cater to various production scales, from small laboratory setups to high-volume industrial lines, and are built to handle a range of ampoule sizes (typically 1ml to 30ml) and types (open-mouth or closed/pre-sterilized Type D ampoules).

Automatic Ampoule Filler Videos

Key Features

1. Construction and Materials:

   • Frame: Built on a sturdy stainless steel (SS) square pipe frame, often with SS coverings in a matte finish for durability and aesthetic appeal.

   • Contact Parts: Made from high-quality AISI SS 316L to ensure compatibility with pharmaceutical standards and resistance to corrosion.

   • Non-Contact Parts: Typically constructed from AISI SS 304 for cost-effectiveness and durability.

   • Large Opening Area: Located at the bottom for easy cleaning and maintenance, ensuring compliance with hygiene standards.

2. Filling Mechanisms:

   • Operates on principles such as volumetric piston pumps, peristaltic pumps, or servo-driven systems for precise filling (accuracy of ±0.5%).

   • Capable of filling 0.5ml to 30ml in a single dose, with minimal changeover parts required for different ampoule sizes (e.g., 1ml to 10ml or up to 30ml in some models).

   • Features like “no ampoule, no filling” reduce product wastage and ensure accuracy.

3. Sealing Technology:

   • Uses oxygen and LPG (propane) or other combustible gases for flame-sealing, with flow meters to regulate flame intensity.

   • Includes pre-heating and sealing stations to warm ampoules and create secure seals, often with rotation of ampoule necks for uniform sealing.

   • Some models offer nitrogen flushing before, during, and after filling to minimize oxidation and contamination.

   • Specialized sealing options, such as onion skin sealing, are available for specific applications in pharmaceuticals and cosmetics.

4. Automation and Control:

   • Equipped with PLC (Programmable Logic Controller) and HMI (Human-Machine Interface) control panels for automated fill volume adjustments and easy operation.

   • Pendant-type electrical control panels enhance safety and accessibility.

   • Features like automatic error detection and HMI troubleshooting improve operational reliability.

5. Production Capacity:

   • Available in various configurations with single, two, four, six, or eight heads, catering to different production needs:

     • Single-head: Ideal for lab-scale production (e.g., 1500 ampoules/hour).

     • Multi-head (e.g., eight-head): Suitable for high-speed production (up to 36,000 ampoules/hour).

   • Output ranges from 15 to 300 ampoules per minute, depending on the model and head configuration.

6. Additional Features:

   • Neck Centering: Ensures accurate filling and sealing by aligning ampoule necks during gas flushing and liquid filling.

   • Cooling Systems: Prevent overheating, extending machine lifespan.

   • Stainless Steel Hood: Channels out fumes during the sealing process for safety.

   • Integration: Easily integrates with upstream (e.g., sterilization tunnels) and downstream (e.g., inspection or labeling machines) equipment.

   • Safety Features: Includes safety valves, pressure reducers, and laminar airflow or isolator options for sterile environments.

Operational Process

1. Ampoule Loading:

   • Sterilized ampoules (open or closed Type D) are loaded into an in-feed hopper or directly from a sterilization tunnel via a wire mesh conveyor.

   • A starwheel or cassette transfers ampoules to a moving rack, often in a slant position to accommodate variations in neck dimensions and thicknesses.

2. Pre-Gassing:

   • Nitrogen is flushed into the ampoules to remove atmospheric air and prevent oxidation.

3. Filling:

   • Ampoules are filled with a precise volume of liquid or powder using piston pumps, peristaltic pumps, or servo-driven systems.

   • Neck centering ensures accurate filling without spillage.

4. Post-Gassing:

   • Additional nitrogen flushing may occur to further protect the contents.

5. Pre-Heating and Sealing:

   • Ampoules are pre-heated with low-pressure flames to prepare the glass for sealing.

   • The sealing station uses high-pressure flames (oxygen + LPG) to melt and seal the ampoule necks, with rollers rotating the ampoules for uniform sealing.

   • Waste ampoule tips are clipped and ejected into a separate container.

6. Collection:

   • Filled and sealed ampoules are automatically collected in an upright position on a tray or dead plate for further processing (e.g., inspection or labeling).

Benefits

• Accuracy and Precision: Ensures exact dosing (±0.5% fill accuracy), critical for pharmaceuticals.

• Sterility: Nitrogen flushing and sealed designs prevent contamination.

• High Efficiency: Automated processes reduce manual intervention, labor costs, and errors.

• Versatility: Handles various ampoule sizes (1ml to 30ml) and materials (liquids, powders, pellets).

• Compliance: Meets cGMP, FDA, CE, and ISO standards for safety and hygiene.

• Fast Changeover: Minimal parts changes for different ampoule sizes, reducing downtime.

• Durability: Stainless steel construction ensures long-term reliability.

Applications

• Pharmaceuticals: Filling injectable drugs, vaccines, and sterile solutions.

• Cosmetics: Packaging serums and essential oils (e.g., 2ml closed ampoules).

• Biotech and Chemicals: Handling agro-insecticides, veterinary medicines, and other sensitive liquids.

• Laboratory Use: Small-scale production with single-head machines.

Types of Machines

• Single-Head: For lab-scale or small-scale production (e.g., 1500 ampoules/hour).

• Multi-Head (2, 4, 6, 8): For medium to high-volume production (up to 36,000 ampoules/hour).

• Closed Ampoule Fillers: Designed for pre-sterilized Type D ampoules, with specialized opening and sealing mechanisms.

• High-Speed Models: Equipped with advanced automation for large-scale operations.

• Monoblock Design: Combines filling and sealing in a single unit for compactness and efficiency.

Considerations for Selection

• Production Volume: Choose the number of heads based on required output (e.g., single-head for labs, eight-head for mass production).

• Ampoule Type: Ensure compatibility with open or closed ampoules.

• Filling Mechanism: Select piston pumps for viscous liquids, peristaltic pumps for sterile solutions, or servo-driven systems for precision.

• Regulatory Compliance: Verify adherence to cGMP, FDA, or other standards.

• Maintenance and Accessibility: Opt for machines with large openings and minimal changeover parts for ease of maintenance.

Challenges and Solutions

• Uneven Filling: Ensure the machine is on a flat surface and calibrate filling mechanisms.

• Incomplete Sealing: Adjust flame pressure and sealing angle for consistent results.

• Conveyor Issues: Use correct spacers and calibrate the conveyor for smooth ampoule transfer.

• Contamination Risk: Incorporate laminar airflow or isolators for sterile environments.

Types of Ampoule Filler and Sealer

• Small Ampoule Filler
• Ampoule Filler and Sealer
• Onion Skin Ampoule Filler
• Servo Driven Ampoule Filler
• Peristaltic Pump type Ampoule Filler
• Closed Ampoule Filler
• Single Head Ampoule Filler
• Two Head Ampoule Filler
• Four Head Ampoule Filler
• Six Head Ampoule Filler
• Eight Head Ampoule Filler

Salient Features of Automatic Ampoule Filler

• 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 Filler

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 Filler

* 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.