2ml Ampoule Filling Machine

A 2ml ampoule filling machine is a specialized pharmaceutical device designed for the precise filling and sealing of 2ml glass ampoules, commonly used for injectable drugs, serums, or other liquid medications in pharmaceutical, biotech, cosmetic, and chemical industries. Below is a detailed description based on available information:

Ampoule Filling Machine Video

Key Features and Description:

1. Purpose and Application:

   • Designed to fill and seal 2ml glass ampoules (open or closed type) with liquid drugs or serums, ensuring sterility and precision.

   • Widely used in pharmaceutical production for injectables, vaccines, or cosmetics like serums and anti-aging products.

2. Filling Mechanism:

   • Utilizes advanced filling technologies such as volumetric piston pumps, servo-driven pumps, or peristaltic pumps for accurate dosing (0.5ml to 25ml in single dosing, adjustable for 2ml).

   • Features co-eccentric nozzles for quick and precise filling, with a “No Ampoule – No Fill” system to prevent wastage.

   • Optional nitrogen flushing before and after filling to minimize contamination and ensure product stability.

3. Sealing Process:

   • Employs a high-precision sealing system using oxygen and LPG (propane) flames to hermetically seal ampoules, protecting contents from external contaminants.

   • Includes pre-warming and sealing stations with rollers to rotate ampoules for uniform sealing, reducing defects.

   • Some models feature two flame sets: one for preheating and another for final sealing, ensuring a secure melt of the ampoule neck.

4. Construction and Compliance:

   • Built with high-quality stainless steel (SS 316L for contact parts, SS 304 for non-contact parts) to meet cGMP standards, ensuring hygiene and durability.

   • Designed with a monoblock structure, combining filling and sealing in one unit for compactness and efficiency.

   • Features a toughened glass cabinet or laminar airflow for sterile class 100 environments in some models.

5. Automation and Control:

   • Fully or semi-automatic operation with minimal human intervention, often equipped with PLC-based control and touch-screen HMI for easy adjustment of fill volume, speed, and sealing parameters.

   • Includes safety features like automatic stop functions for malfunctions, no ampoule detection, or machine idle status to reduce waste and ensure safety.

6. Production Capacity:

   • Capable of filling 30 to 90 ampoules per minute (approximately 1,800 to 5,400 per hour) for 2ml ampoules, depending on the model (e.g., single, double, or multi-head).

   • Specific models, like the ZONESUN ZS-FSAB2, can achieve up to 3,500–4,500 ampoules per hour.

7. Ampoule Handling:

   • Features a slant travel design to accommodate variations in ampoule neck dimensions and thickness, ensuring compatibility with standard 2ml ampoules.

   • Includes an in-feed hopper and starwheel for automatic ampoule loading, with transport racks moving one, two, or more ampoules per cycle.

   • Post-sealing, ampoules are collected on a tray or conveyor without manual handling, minimizing contamination risks.

8. Additional Features:

   • Compact design with minimal floor space requirements, ideal for small to medium-scale production.

   • Easy maintenance with large openings for cleaning and tool-less format changes for different ampoule sizes (1ml to 30ml with change parts).

   • Energy-saving technology with automatic shut-off when idle.

   • Optional integration with washing and sterilization tunnels for a complete production line.

9. Customization and Variants:

   • Available in single-head, double-head (e.g., ZONESUN ZS-FSAB2), or multi-head (up to eight heads) configurations to suit production needs.

   • Can be customized for 1ml, 5ml, 10ml, or 20ml ampoules with minimal changeover time.

   • Some models offer combi functionality to handle both ampoules and vials.

10. Safety and Standards:

    • Complies with international standards like GMP, CE, and ISO, with some models offering 21 CFR Part 11 compliance for data integrity.

    • Equipped with safety features like pressure reducers, safety valves, and stainless steel hoods to manage fumes during sealing.

Typical Workflow:

1. Loading: Sterilized 2ml ampoules are loaded into a hopper and fed via a starwheel onto a transport rack.

2. Pre-Nitrogen Flushing: Nitrogen is flushed to displace oxygen and prevent contamination.

3. Filling: Precise liquid dispensing using piston or peristaltic pumps.

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

5. Pre-Warming: Ampoule necks are heated to prepare for sealing.

6. Sealing: Flames melt the ampoule neck for hermetic sealing, with rollers ensuring uniformity.

7. Collection: Sealed ampoules are automatically collected on a tray or conveyor.

Benefits:

• Accuracy: Ensures exact 2ml dosing, critical for pharmaceuticals.

• Efficiency: High-speed operation with minimal manual intervention.

• Sterility: Hermetic sealing and nitrogen flushing maintain product purity.

• Versatility: Handles various liquids, from free-flowing to viscous.

• Durability: Stainless steel construction resists corrosion and contamination.

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 Ampoule Filling Machine

• Compact cGMP model.

• Higher 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.

Working Principle of 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 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.

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.