Ampoule Filler Sealer for Liquid Injection

An Ampoule Filler Sealer for Liquid Injection is a specialized pharmaceutical machine designed to fill and seal glass ampoules with liquid drugs, primarily for injectable use. These machines ensure high precision, sterility, and efficiency in the packaging process, adhering to cGMP standards. Below is a detailed description based on their typical features and functionality:

Automatic Ampoule Filler Sealer Videos

Key Features:

1. Purpose and Application:

   • Used to fill and seal glass ampoules (1ml to 30ml) with liquid injectables, such as pharmaceuticals, biotech products, veterinary medicines, or cosmetics.

   • Ensures the contents remain sterile, non-reactive, and free from contaminants due to the hermetic sealing of glass ampoules.

2. Construction:

   • Built with a stainless steel (SS 316L) frame and contact parts to ensure durability, corrosion resistance, and compliance with cGMP standards.

   • Compact, monoblock design integrating filling and sealing operations on a single platform for efficiency.

   • Often includes a stainless steel hood to channel out fumes during sealing.

3. Filling Mechanism:

   • Utilizes volumetric piston pumps, servo-driven systems, or peristaltic pumps for precise filling (0.5ml to 25ml per dose).

   • Features like “No Ampoule – No Fill” and “No Ampoule – Machine Stop” prevent wastage and ensure accuracy.

   • Supports nitrogen purging before and after filling to minimize oxidation and maintain sterility.

4. Sealing Process:

   • Employs oxygen and LPG (propane) flames for hermetic sealing, with pre-heating and sealing stations to ensure a secure seal.

   • Uses tip sealing (for liquid-filled ampoules) or pull sealing (for powder-filled ampoules) methods, with rollers to rotate ampoules for uniform sealing.

   • Includes safety valves and pressure reducers for safe handling of combustible gases.

5. Operation and Automation:

   • Automatic loading of pre-sterilized ampoules via hoppers or conveyors, with slant travel to accommodate variations in ampoule neck dimensions.

   • Features neck centering during filling, gas flushing, and sealing for precision.

   • Waste ampoule tips are clipped and collected separately to maintain cleanliness.

6. Production Capacity:

   • Available in single-head, two-head, four-head, six-head, or eight-head models, with outputs ranging from 1,500 to 30,000 ampoules per hour, depending on the model and scale (lab, medium, or large-scale production).

   • High-speed models can handle up to 500 ampoules per minute.

7. Additional Features:

   • Tool-less format changes for quick adaptation to different ampoule sizes (1ml to 30ml).

   • Optional laminar airflow or isolator systems for enhanced sterility in Class 100 environments.

   • Servo-controlled filling volume adjustments via PLC for precision and ease of use.

   • Toughened glass cabinets for safety and visibility.

Working Process:

1. Loading: Pre-sterilized ampoules are loaded into a hopper and transferred to a transport rack via a starwheel or cassette.

2. Nitrogen Purging: Inert gas (nitrogen) is flushed to remove oxygen from the ampoule.

3. Filling: Liquid is precisely dispensed using piston or peristaltic pumps, with neck centering for accuracy.

4. Post-Nitrogen Flushing: Additional nitrogen is flushed to ensure sterility.

5. Pre-Heating and Sealing: Ampoules are warmed at a pre-heating station, then sealed using flames and rollers for a uniform, hermetic seal.

6. Collection: Filled and sealed ampoules are automatically collected in an upright position on a tray for further processing.

Advantages:

• High Accuracy: Ensures precise dosing (±0.5% fill accuracy) for liquids, minimizing wastage.

• Sterility: Hermetic sealing and nitrogen flushing protect contents from contamination and oxidation.

• Versatility: Suitable for open-mouth (Type B/C) or closed-mouth (Type D) ampoules, with flexibility for various liquid viscosities.

• Efficiency: High-speed models and minimal changeover time boost productivity.

• Ease of Maintenance: Accessible design with minimal parts for cleaning and upkeep.

Applications:

• Primarily used in the pharmaceutical industry for injectable drugs, but also in biotech, cosmetics, and agrochemicals for filling ampoules with liquids, powders, or pellets.

Considerations for Selection:

• Ampoule Size: Ensure compatibility with desired ampoule sizes (1ml to 30ml).

• Production Scale: Choose single-head for lab-scale or multi-head (e.g., eight-head) for high-volume production.

• Sterility Requirements: Opt for models with isolators or laminar airflow for enhanced sterility.

• Customization: Look for machines with adjustable filling volumes and tool-less changeovers for flexibility.

Types of Ampoule Fillers

• 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 Sealer

• 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 Sealer

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 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.