Single Needle Ampoule Filler

A Single Needle Ampoule Filler is a specialized pharmaceutical machine designed for filling and sealing open-mouth glass ampoules with sterile liquids, such as injectable drugs, in a controlled and precise manner. It is commonly used in pharmaceutical, biotech, and cosmetic industries for small to medium-scale production or pilot-scale operations. Below is a detailed description based on available information:

Single Needle Ampoule Filler Video

Key Features and Description:

1. Purpose and Application:

   • The machine is used to fill and seal glass ampoules (typically 1ml to 30ml) with liquid or injectable solutions, ensuring sterility and accuracy.

   • Suitable for type B and type C open-mouth ampoules, commonly used in pharmaceutical industries for packing sterile liquids.

2. Construction and Materials:

   • Built with high-grade stainless steel 316L for filling contact parts to meet cGMP (Current Good Manufacturing Practice) standards, ensuring hygiene and durability.

   • Features a compact, monoblock design where the filler and sealer are integrated on a single platform, optimizing space and operation.

3. Filling Mechanism:

   • Operates on a volumetric piston-pump principle for precise filling, capable of delivering 0.5ml to 25ml in a single dose.

   • Includes nitrogen flushing (pre- and post-filling) to prevent oxidation and contamination, enhancing product stability.

   • The filling needle is designed to avoid contact with the ampoule walls, ensuring a clean fill and maintaining seal integrity.

4. Sealing Process:

   • Equipped with a sealing station that uses oxygen and combustible gases (e.g., LPG) to preheat and seal ampoules.

   • Features a rotation mechanism at the sealing station to ensure uniform heating and secure sealing of the ampoule neck.

   • Includes safety valves, pressure reducers, and a stainless steel hood to channel out fumes during the sealing process.

5. Operational Efficiency:

   • Can process 10 to 250 ampoules per minute, depending on the ampoule size, thickness, and neck dimensions.

   • Designed for minimal changeover time between different ampoule sizes, improving production flexibility.

   • Incorporates flow meters for flame regulation and an efficient cooling system to prevent overheating, extending machine lifespan.

6. Additional Features:

   • Ampoule Handling: Empty ampoules are loaded into a hopper and transferred to a traveling rack or conveyor system (often wire mesh) for filling and sealing.

   • Waste Management: Includes a waste tip collector made of high-quality stainless steel to handle discarded ampoule tips.

   • Pre-Heating Unit: For thicker glass ampoules, a pre-heating unit ensures proper sealing without thermal shock.

   • Dead Tray: Provided for upright placement of filled ampoules during collection, ensuring safe handling.

7. Customization and Compliance:

   • • Offers flexibility to handle a variety of ampoule sizes (1ml to 30ml) and neck dimensions.

     • Complies with FDA, CE, and cGMP standards, ensuring high-quality production suitable for global markets.

   • Some models include options for integration with upstream (e.g., sterilizing tunnels) and downstream equipment (e.g., inspection or labeling machines).

8. Advantages:

   • High accuracy in filling, preventing leaks, spills, or bubble formation.

   • Hygienic design with easy-to-clean surfaces, reducing contamination risks.

   • Nitrogen flushing and robust sealing ensure product safety and shelf life.

   • Compact size and single-motor synchronization make it suitable for small-scale or lab settings.

9. Applications:

   • Primarily used in pharmaceutical industries for filling sterile injectables, vaccines, or other liquid drugs.

   • Also applicable in biotech, chemical, and cosmetic industries for filling ampoules with liquid or semi-liquid products.

Operational Workflow:

1. Empty, washed, and sterilized ampoules are fed from a hopper or sterilizing tunnel onto a conveyor or rack.

2. Ampoules are flushed with nitrogen to remove oxygen and prevent contamination.

3. The single needle dispenses a precise volume of liquid into each ampoule.

4. Ampoules are rotated and preheated, then sealed using a flame (oxygen and combustible gas).

5. Filled and sealed ampoules are collected in a dead tray, while waste tips are ejected into a separate container.

Limitations:

• Single-head design limits output compared to multi-head machines (e.g., 2, 4, or 8 heads), making it more suitable for small-scale or pilot production.

• Manual or semi-automatic models may require more operator intervention compared to fully automated systems.

This description provides a comprehensive overview of the Single Needle Ampoule Filler, focusing on its design, functionality, and applications.

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 Single Needle Ampoule Filler

• 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 Needle Ampoule Filler

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 Single Head 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.