Single Needle Ampoule Filler

Q: How does the Single Needle Ampoule Filler work?

The machine operates on the slant traveling principle for gentle ampoule handling and reduced breakage. The automated process includes: Loading of sterilized ampoules into the hopper Nitrogen pre-flushing to remove oxygen Precise filling through a single needle with neck centering Nitrogen post-flushing Neck pre-warming Accurate flame sealing using LPG + Oxygen burners It features a “No Ampoule – No Filling” and “No Ampoule – No Seal” system to prevent wastage and ensure sterility.

Description

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:

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

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

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

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

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

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.

Salient Features of Single Needle Ampoule Filler

Compact cGMP model.
Production output up to 1800 ampoules/hour.
Full accessibility allows easy maintenance.
Flow Meters for regulating flames easily.
“No Ampoule – No Filling” system.
Equipped with pre-warming station for perfect sealing operations.

Ampoule neck centering during gas flushing and filling operations.
Possibility of nitrogen gas flushing before, during and after filling.
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.
Minimum change over time, little maintenance, easy cleaning.

Working Principle 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 Needle Ampoule Filler

Model	AFS-30
Production Output	Up to 25 ampules/minute
Ampoule Size	1ml to 30ml
Filling Accuracy	± 1%
Require Gas for Sealing	LPG & Oxygen (O₂)
Nitrogen Flushing	Pre & Post Nitrogen Flushing Available
Power Specification	0.5 H. P.
Electrical Characteristics	230 Volts, Single Phase, 50 Hertz
Contact Parts	Made from Stainless Steel 316L
Non Contact Parts	Made from Stainless Steel 304
Overall Dimension	915mm (L) x 610mm (W) x 965mm (H) approx.
Net Weight	150 Kgs. approx.
Gross Weight	225 Kgs. approx.

* 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.

Types of Ampoule Filling Machine

Automatic Ampoule Filling Sealing Machine

Laboratory Ampoule Filling Sealing Machine

Closed Ampoule Filling Machine

Open Mouth Ampoule Filling Machine

Onion Skin 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

Applications of Ampoule Filling Machine

Advantages of Single Needle Ampoule Filler

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.

Key Features of Single Needle Ampoule Filler

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.

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.

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.

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.

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.

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.

Customization and Compliance:

- Offers flexibility to handle a variety of ampoule sizes (1ml to 30ml) and neck dimensions.
- Some models include options for integration with upstream (e.g., sterilizing tunnels) and downstream equipment (e.g., inspection or labeling machines).

FAQ for Single Needle Ampoule Filler

What is a Single Needle Ampoule Filler?

A Single Needle Ampoule Filler (also known as Single Head or Single Stroke Ampoule Filler Sealer) is a compact, automatic monobloc machine designed for precise filling and flame sealing of sterile liquid injectables into glass ampoules. It uses a single filling needle (syringe) and integrates nitrogen flushing (pre- and post-filling), volumetric piston filling, neck pre-heating, and LPG + Oxygen flame sealing in one unit. This model is ideal for small to medium batch production, R&D labs, and pilot-scale manufacturing while meeting cGMP, USFDA, and WHO standards.

What is the production capacity of the Single Needle Ampoule Filler?

The Single Needle Ampoule Filler (Model AFS-1) has a production capacity of up to 25 ampoules per minute (approximately 1,500 ampoules per hour). It is perfect for low to medium output requirements. The machine supports ampoule sizes from 1ml to 30ml with a filling range of 0.5ml to 25ml and maintains a high filling accuracy of ±1%.

How does the Single Needle Ampoule Filler work?

The machine operates on the slant traveling principle for gentle ampoule handling and reduced breakage. The automated process includes:

Loading of sterilized ampoules into the hopper
Nitrogen pre-flushing to remove oxygen
Precise filling through a single needle with neck centering
Nitrogen post-flushing
Neck pre-warming
Accurate flame sealing using LPG + Oxygen burners

It features a “No Ampoule – No Filling” and “No Ampoule – No Seal” system to prevent wastage and ensure sterility.

What are the key features of the Single Needle Ampoule Filler?

Key features include:

Single head / single needle design with monobloc construction
Nitrogen flushing before, during, and after filling
Precision piston pump for accurate dosing
Tool-less quick changeover with minimal parts
All product contact parts made of SS 316L
Slant design for smooth movement and low glass particle generation
Pre-heating station and precise flame control
Compact footprint with easy cleaning and maintenance
Optional PLC/HMI control

Which industries use the Single Needle Ampoule Filler and what are its main benefits?

It is widely used in:

Pharmaceuticals (small-batch injectables, vaccines, and parenterals)
Biotechnology and R&D laboratories
Veterinary medicines
Cosmetics
Chemical and agro-insecticide industries

Main benefits include:

Ideal for pilot scale, R&D, and low-volume production
Lower initial investment and easy maintenance
High filling accuracy with minimal product wastage
Gentle handling reduces glass breakage
Compact design saves cleanroom space
Full cGMP compliance and easy validation
Fast format changeover and seamless integration into small production lines

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