Single Syringe Ampoule Filling Machine

A Single Syringe Ampoule Filling Machine is a specialized piece of equipment designed for the precise and sterile filling of liquid pharmaceuticals into single-use syringes or ampoules, primarily used in the pharmaceutical, biotech, and medical industries. These machines are engineered to ensure high accuracy, hygiene, and efficiency while minimizing contamination risks and maintaining compliance with stringent regulatory standards such as cGMP and US FDA.

Single Syringe Ampoule Filling Machine Video

Key Features and Description:

• Functionality: The machine automates the process of filling and sealing single syringes or ampoules with precise doses of liquid medication, ranging from water-thin to medium-viscosity fluids. It is ideal for small to medium-scale production, particularly for lab-scale or low-volume sterile injectable preparations.

• Capacity and Output: Depending on the model, it can fill syringes or ampoules with volumes typically ranging from 0.5ml to 25ml. For example, a single-head machine can achieve outputs of approximately 1,500 syringes or ampoules per hour, suitable for small-scale operations.

• Filling Mechanism: Utilizes advanced filling technologies such as volumetric piston pumps, peristaltic pumps, or pneumatic systems to ensure accurate dosing. The machine often incorporates a “no syringe/ampoule, no filling” system to prevent wastage.

• Sterility and Hygiene: Designed for aseptic processing, these machines often feature stainless steel (316L for contact parts, 304 for non-contact parts) construction for corrosion resistance and easy cleaning. Some models include laminar airflow or isolator options to maintain a sterile Class 100 environment.

• Sealing Process: For ampoules, the machine may include pre-warming and sealing stations using oxygen and LPG (propane) flames or vacuum stopper insertion for precise sealing. Syringes are typically sealed with plungers or stoppers, often under vacuum to ensure sterility.

• Flexibility: Capable of handling various syringe or ampoule sizes (e.g., 1ml to 30ml) with minimal changeover time due to tool-less format changes. Some models support nitrogen flushing before, during, and after filling to reduce contamination.

• Control Systems: Equipped with PLC systems and real-time monitoring for precise control of filling volumes, error detection, and process adjustments. In-process control (IPC) ensures consistent fill weight and stopper placement.

• Inspection and Safety: Includes features for detecting particles, fill volume accuracy, and container defects, often integrating high-voltage leak detection (HVLD) or headspace analysis (HSA) for quality assurance.

• Applications: Widely used for filling syringes or ampoules with pharmaceuticals (e.g., vaccines, insulin, analgesics), veterinary medicines, cosmetics, or agro-insecticides. It supports both open and closed ampoules and can be integrated into larger production lines with washing, sterilization, and labeling systems.

• Design: Compact and often tabletop or bench-top for small-scale operations, with ergonomic designs compatible with cleanrooms, bio-safety cabinets, or isolators. The machine may include a material hopper, filling needle, and automated ejection systems for filled containers.

Advantages:

• Precision: Ensures accurate dosing, critical for patient safety and treatment efficacy.

• Efficiency: Automates filling and sealing, significantly reducing manual labor and human error.

• Sterility: Maintains a contamination-free environment, essential for injectables.

• Versatility: Handles various container sizes and liquid types with quick changeovers.

• Durability: Stainless steel construction and efficient cooling systems enhance longevity.

Limitations:

• Output: Single-head machines have lower throughput (e.g., 1,500 units/hour) compared to multi-head models (e.g., 6,000–12,000 units/hour), making them less suitable for high-volume production.

• Cost: While more affordable than multi-head systems, initial investment and maintenance can be significant for small labs.

• Complexity: Requires trained operators for calibration, maintenance, and troubleshooting to ensure consistent performance.

Operational Process:

1. Loading: Empty, pre-sterilized syringes or ampoules are loaded into a hopper or conveyor.

2. Filling: A precise volume of liquid is dispensed via a pump or piston system, often with nitrogen flushing to maintain sterility.

3. Sealing: Syringes are stoppered, or ampoules are sealed using gas flames or vacuum systems, with pre-warming to ensure quality seals.

4. Inspection: Automated checks for fill accuracy, particle presence, and container integrity.

5. Ejection: Filled and sealed containers are collected in trays for further processing or packaging.

For further details or purchasing options, you can explore manufacturers like Adinath International.

Types of Ampoule Filling Machines

• Small Ampoule Filling Machine
• Ampoule Filling and Sealing Machine
• Onion Skin Ampoule Filling Machine
• Servo Driven Ampoule Filling Machine
• Peristaltic Pump type Ampoule Filling Machine
• Closed Ampoule Filling Machine
• Single Head Ampoule Filling Machine
• Two Head Ampoule Filling Machine
• Four Head Ampoule Filling Machine
• Six Head Ampoule Filling Machine
• Eight Head Ampoule Filling Machine

Salient Features of Single Syringe Ampoule Filling Machine

• Compact cGMP model.

• Production output up to 1800 ampoules/hour.

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

• Suitable to fill 1ml to 20ml ampoule size and minimum change over parts from one size to another.

• “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.

• Equipped with pre-warming station for perfect sealing operations.

• Flow Meters for regulating flames easily.

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

Process Operation of Single Syringe Ampoule Filling Machine

Empty washed & sterilized ampoules fed into in-feed hopper from the left hand side of the machine to receiving rack. The moving rack which moves horizontally collect one ampoule from the receiving rack and transfer the ampoule to the machine in left to right in an inclined position through pre-gassing. Pre-gassing, Filling, Post Gassing, Pre-heating & sealing stations completes filling & sealing operations. Filled & sealed ampoules are collected automatically in SS tray in upright position without hand touch.

The machine performs the following operations:

• Ampoule feeding by in-feed hopper, cassettes and ampoule transfer into transport rack.

• One ampoule advanced per machine stroke.

• Centering of ampoules necks during pre-heating, post heating, gas flushing and liquid filling.

• Rotation of ampoules neck in the pre- heating and heating station.

• Elimination of burdened-off ampoule tips by clippers and ejection into a separate container.

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.