5ml Ampoule Filling Machine

A 5ml ampoule filling machine is a specialized piece of equipment designed for filling and sealing 5ml glass ampoules, commonly used in pharmaceutical, biotech, cosmetic, veterinary, and chemical industries. Below is a detailed description of a typical 5ml ampoule filling machine based on current industry standards and available technology:

AMPOULE FILLING MACHINE VIDEO

Key Features and Description:

1. Purpose and Application:

   • Designed to fill and seal 5ml open-mouth or closed-mouth glass ampoules with liquid or semi-liquid products, such as injectable drugs, serums, or chemicals.

   • Ensures sterile, precise, and high-speed filling to meet Good Manufacturing Practices (cGMP) standards for pharmaceutical production.

2. Filling Capacity and Accuracy:

   • Suitable for filling volumes ranging from 0.5ml to 5ml in a single dose, with some models adjustable up to 25ml.

   • High fill accuracy of ±0.5% to ±1%, depending on the filling mechanism (e.g., piston pump, peristaltic pump, or servo-driven systems).

3. Construction and Materials:

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

   • Non-contact parts are typically made of SS 304, with a matte finish for easy cleaning and maintenance.

   • Features a large bottom opening for thorough cleaning and accessibility.

4. Filling and Sealing Process:

   • Filling: Utilizes volumetric piston pumps, peristaltic pumps, or servo-driven systems for precise dosing. Co-eccentric nozzles ensure quick and accurate filling without spillage.

   • Nitrogen Flushing: Includes pre- and post-nitrogen flushing stations to minimize contamination and ensure sterility by displacing oxygen.

   • Sealing: Employs oxygen and LPG (propane) flames for sealing, with pre-warming and sealing stations to ensure perfect closure. Specially designed rollers rotate ampoules for uniform sealing.

   • Slant Travel Principle: Ampoules move at an angle during filling and sealing to accommodate variations in neck dimensions, thickness, and ovality.

5. Production Capacity:
   • Output varies by model:

     • Single-head machines: ~15–40 ampoules per minute (900–2,400 per hour).

     • Two-head machines: ~40–100 ampoules per minute (2,400–6,000 per hour).

     • Four-head machines: ~80–150 ampoules per minute (4,800–9,000 per hour).

     • Six- or eight-head machines: Up to 200–300 ampoules per minute (12,000–18,000 per hour).

   • For 5ml ampoules, typical output for a four-head machine is around 100–150 ampoules per minute, depending on liquid viscosity and machine configuration.

6. Automation and Control:

   • Equipped with PLC (Programmable Logic Controller) and HMI (Human-Machine Interface) for automated fill volume adjustments and real-time monitoring.

   • Features like “No Ampoule, No Fill” and “No Ampoule, Machine Stop” prevent wastage and ensure operational safety.

   • Servo-driven models allow precise control of filling volume via touch-screen interfaces.

7. Additional Features:

   • Infeed and Outfeed: Ampoules are loaded via a hopper or infeed conveyor, moved through a star wheel to a transport rack, and collected in a dead tray or outfeed conveyor after sealing.

   • Pre-Warming Station: Ensures thick glass ampoules are adequately heated for sealing without cracking.

   • Waste Tip Collection: Sealed ampoules are separated from waste tips, which are collected in a separate container.

   • Laminar Air Flow (LAF): Optional for sterile class 100 filling to maintain aseptic conditions.

   • Safety Features: Includes safety clutches, pressure reducers, and stainless steel hoods to channel fumes during sealing.

8. Power and Dimensions:

   • Typical power requirements: 1–2 H.P., 230–380V, single or three-phase, 50 Hz (customizable per regional voltage standards).

   • Dimensions vary by model but are compact, e.g., ~915mm (L) x 760mm (W) x 965mm (H) for a two-head machine, up to ~2380mm (L) x 1200mm (W) x 1000mm (H) for larger models.

9. Customization and Compliance:

   • Supports ampoule sizes from 1ml to 30ml with minimal changeover parts, making it versatile for 5ml ampoules.

   • Complies with CE and 21 CFR Part 11 standards for regulatory requirements.

   • Can be integrated with upstream (e.g., washing, sterilizing tunnels) and downstream (e.g., inspection, labeling) equipment for a complete production line.

10. Advantages:

    • High-speed production with minimal human intervention, reducing labor costs and contamination risks.

    • Compact monoblock design combines filling and sealing on a single platform, saving space.

    • Flexibility to handle various ampoule types (Type B, C, or D) and liquid viscosities, from free-flowing to heavy oils.

    • Easy maintenance and quick changeover for different ampoule sizes, enhancing operational efficiency.

Typical Workflow:

1. Sterilized 5ml ampoules are loaded into a slant hopper or infeed conveyor.

2. A star wheel transfers ampoules to a transport rack in groups (1/2/4/8, depending on the number of heads).

3. Ampoules undergo pre-nitrogen flushing, filling with the precise 5ml volume, and post-nitrogen flushing.

4. Pre-warming prepares the ampoule neck for sealing, followed by flame sealing using oxygen and LPG.

5. Sealed ampoules are collected on a tray or outfeed conveyor, while waste tips are ejected separately.

Considerations for Selection:

• Production Needs: Choose the number of heads based on required output (e.g., four-head for medium-scale, eight-head for large-scale).

• Filling Mechanism: Peristaltic pumps are ideal for sterile applications, while piston pumps suit viscous liquids.

• Sterility Requirements: Opt for models with LAF or isolator systems for aseptic filling.

• Customization: Ensure the machine supports 5ml ampoules with minimal changeover time.

Types of Ampoule Filling Machines

We offer below mentioned different types of ampoule filling machines:

• Open Mouth Ampoule Filling Machine
• Closed Mouth 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 model.

• All contact parts made from high quality Stainless Steel 316 & other Non-contact parts made from Stainless Steel 304.

• “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.

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

Process Operation of  Ampoule Filling Machine

The sterilized ampoule tray directly loaded in to slant hopper of the unit. The Synchronized star wheel delivers ampoules, one by one on moving eccentric ampoule rack in single/double/four/six/eight. During the movement of ampoule machine perform below mentioned operations:

1. Pre-gassing with Nitrogen
2. Filling the product
3. Post Gassing with Nitrogen
4. Pre-heating with LPG & Oxygen combination
5. Sealing with LPG & Oxygen combination

At the end duly filled and sealed ampoules get collected automatically onto collection tray of the machine. Ampoules now can be collected for further inspection and/or sticker labeling operations.

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.