Ampoule Filling and Sealing Machine

Q: What is an Ampoule Filling and Sealing Machine?

An Ampoule Filling and Sealing Machine is an automatic pharmaceutical packaging equipment used to fill sterile liquids (or powders) into pre-sterilized glass ampoules and then hermetically seal them using a high-temperature flame. It maintains complete sterility, prevents contamination, and ensures precise dosing. Our models (AFS-1 to AFS-8) are widely used for injectable drugs, vaccines, antibiotics, and other sterile products in the pharmaceutical, biotech, and cosmetic industries.

Q: Which industries use the Ampoule Filling and Sealing Machine?

This machine is primarily used in the pharmaceutical industry for filling injectable solutions, vaccines, antibiotics, and biological products. It is also suitable for: Biotech companies Veterinary medicines Cosmetic injectables (e.g., hyaluronic acid fillers) Chemical and research laboratories requiring sterile liquid packaging It helps meet stringent cGMP, WHO, and sterility requirements while delivering high output with minimal human intervention.

Description

Ampoule Filling and Sealing Machine is a specialized pharmaceutical device designed for the precise filling and sealing of glass ampoules, typically used to store sterile liquid or powder drugs for injections in industries like pharmaceuticals, biotech, cosmetics, and chemicals. Below is a detailed description of its design, operation, and features, based on standard industry practices:

Purpose: These machines fill glass ampoules (small, sealed vials) with precise volumes of liquid or powder and hermetically seal them to ensure sterility and prevent contamination. Ampoules are favored for their ability to protect contents from environmental factors like dust and microorganisms, ensuring high purity and precise dosing.

Working Principle: The machine operates on the slant travel mechanism (in traditional models) or vertical movement (in modern high-speed models). Ampoules are transported at an inclined angle (typically 45°) or vertically through various stations for filling and sealing. The process ensures compatibility with varying ampoule neck dimensions, thicknesses, and ovality.

Process Flow:
- Loading: Sterilized ampoules are loaded into an infeed hopper, often from a sterilizing tunnel, and fed onto a wire mesh conveyor or receiving rack via a starwheel or cassette.
- Pre-Gassing: Nitrogen is flushed into the ampoules to displace air and prevent chemical reactions with the contents.
- Filling: Precision filling needles or pumps (e.g., piston, peristaltic, or servo-driven) dispense a preset volume of liquid or powder (0.5ml to 30ml, depending on the model) into the ampoules with high accuracy (±0.5%). A “no ampoule, no fill” feature minimizes wastage.
- Post-Gassing: Additional nitrogen flushing may occur to ensure sterility.
- Pre-Heating: A low-pressure flame warms the ampoule neck to prepare for sealing, removing any droplets on the inner surface.
- Sealing: The ampoule neck is melted using oxygen and LPG (propane) flames or other methods (e.g., laser in advanced models), creating a hermetic seal. Ampoules are rotated 360° for uniform, dome-shaped sealing. Waste glass tips are clipped and collected separately.
- Collection: Filled and sealed ampoules are automatically discharged onto a collection tray without manual handling.

Salient Features of Ampoule Filling and Sealing Machine

Compact model as per cGMP standard.
Higher output up to 12000 Ampoules per hour.
Full accessibility allows easy maintenance.
Flow Meters for regulating flames easily.
“No Ampoule – No Filling” system.
Machine equipped with pre-warming station.

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 316L & Non-contact parts made from Stainless Steel 304.
Minimum change over parts from 1ml to 10ml ampoule size.
Minimum change over time, little maintenance, easy cleaning.

Working Principle of Ampoule Filling and Sealing 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 one/two/four/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 Filling and Sealing Machine

Model	AFS-1	AFS-2	AFS-4	AFS-8
No. of Head	Single	Two	Four	Eight
Syringes	One	Double	Four	Eight
Ampoule Sizes	1 ml to 30 ml	1 ml to 30 ml	1 ml to 20 ml	1 ml to 20 ml
Filling Speed	Up to 25 ampoules/minute	Up to 50 ampoules/minute	Up to 100 ampoules/minute	Up to 200 ampoules/minute
Filling Precision	± 1%	± 1%	± 1%	± 1%
Filling Pump	Piston Pump	Piston Pump	Piston Pump	Piston Pump
Burner Gas	LPG & Oxygen (O₂)	LPG & Oxygen (O₂)	LPG & Oxygen (O₂)	LPG & Oxygen (O₂)
Nitrogen Arrangement	Before & After Filling	Before & After Filling	Before & After Filling	Before & After Filling
Number of Fill Nozzles	One	Two	Four	Eight
Number of Nitrogen Nozzles	Two	Four	Eight	Sixteen
Number of Sealing Burners	Two	Four	Eight	Sixteen
Power Required	0.5 H.P.	1 H.P.	1 H.P.	2 H.P.
Power Voltage	230 Volts, Single Phase, 50 Hertz, 4 Wire System	230 Volts, Single Phase, 50 Hertz, 4 Wire System	230 Volts, Single Phase, 50 Hertz, 4 Wire System	230 Volts, Single Phase, 50 Hertz, 4 Wire System
Contact Parts	Made from Stainless Steel 316L	Made from Stainless Steel 316L	Made from Stainless Steel 316L	Made from Stainless Steel 316L
Overall Dimension	915mm (L) x 610mm (W) x 965mm (H) approx.	915mm (L) x 760mm (W) x 965mm (H) approx.	1200mm (L) x 1070mm (W) x 965mm (H) approx.	2200mm (L) x 1400mm (W) x 1100mm (H) 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 Ampoule Filling and Sealing Machine

High Precision: Ensures accurate dosing (±0.5% fill accuracy), critical for pharmaceuticals.

Sterility and Contamination Control: Nitrogen flushing and hermetic sealing protect contents from environmental factors.

High Output: Automated systems reduce labor, increase production speed, and minimize human error.

Ease of Maintenance: Large openings and robust stainless steel construction simplify cleaning and upkeep.

Versatility: Suitable for liquids, powders, or pellets across multiple industries.

Key Features of Ampoule Filling and Sealing Machine

Capacity and Speed: Machines are available in single, two, four, six, eight, or twelve-head configurations, with outputs ranging from 10 to 30,000 ampoules per hour, depending on the model and production needs.

Materials: Contact parts are made of high-quality stainless steel for GMP compliance, while non-contact parts use stainless steel 304 for durability and easy cleaning.

Automation and Control: Modern machines feature PLC systems with HMI or touch-screen interfaces for real-time parameter adjustments, error detection, and troubleshooting.

Sterility: Operations are conducted in sterile class 100 environments, often under laminar airflow, RABS, or isolator enclosures to prevent contamination.

Flexibility: Machines accommodate ampoules from 1ml to 30ml and support various filling mechanisms (e.g., piston pumps, peristaltic pumps, or servo-driven systems). They can handle both open-mouth and closed (Type D) ampoules.

Safety and Efficiency: Features like flow meters for flame regulation, cooling systems to prevent overheating, and pressure reducers for gas circuits enhance safety and machine longevity.

Customization: Models are available for small, medium, or large-scale production, with options for integration with existing lines, laminar airflow cabinets, or CIP/SIP systems.

FAQ for Ampoule Filling and Sealing Machine

What is an Ampoule Filling and Sealing Machine?

An Ampoule Filling and Sealing Machine is an automatic pharmaceutical packaging equipment used to fill sterile liquids (or powders) into pre-sterilized glass ampoules and then hermetically seal them using a high-temperature flame. It maintains complete sterility, prevents contamination, and ensures precise dosing. Our models (AFS-1 to AFS-8) are widely used for injectable drugs, vaccines, antibiotics, and other sterile products in the pharmaceutical, biotech, and cosmetic industries.

What ampoule sizes and output capacities does your Ampoule Filling and Sealing Machine support?

Our Ampoule Filling and Sealing Machines support ampoule sizes from 1 ml to 30 ml (AFS-1 & AFS-2) and 1 ml to 20 ml (AFS-4 & AFS-8). Output capacities vary by model:

AFS-1 (Single head): up to 25 ampoules/min
AFS-2 (Two heads): up to 50 ampoules/min
AFS-4 (Four heads): up to 100 ampoules/min
AFS-8 (Eight heads): up to 200 ampoules/min (approx. 12,000 ampoules/hour)

Filling accuracy is ±1% with piston pumps, and changeover between sizes is quick and easy.

What are the key features of your Ampoule Filling and Sealing Machine?

Key features include:

cGMP-compliant design with Stainless Steel 316L contact parts
Nitrogen flushing before, during, and after filling for enhanced sterility
“No Ampoule – No Filling” safety system
Pre-warming station and precise ampoule neck centering
LPG & Oxygen flame sealing with flow meters for uniform sealing
Piston pump filling with ±1% accuracy
PLC control with HMI (in higher models)
Easy maintenance, minimum changeover time, and compact footprint

These features ensure high precision, low maintenance, and full compliance with regulatory standards.

How does the Ampoule Filling and Sealing process work?

The process follows these main steps:

Pre-sterilized ampoules are loaded into the hopper and fed automatically.
Nitrogen gas flushing removes oxygen before filling.
Precise filling occurs using piston pumps with neck centering.
Post-filling nitrogen flushing is done for added protection.
The ampoule neck is pre-heated and then sealed by rotating it under LPG-Oxygen flames, forming a perfect hermetic seal.
Sealed ampoules are automatically discharged.

The entire operation is continuous, synchronized, and designed to maintain sterility throughout.

Which industries use the Ampoule Filling and Sealing Machine?

This machine is primarily used in the pharmaceutical industry for filling injectable solutions, vaccines, antibiotics, and biological products. It is also suitable for:

Biotech companies
Veterinary medicines
Cosmetic injectables (e.g., hyaluronic acid fillers)
Chemical and research laboratories requiring sterile liquid packaging

It helps meet stringent cGMP, WHO, and sterility requirements while delivering high output with minimal human intervention.

Countries We Export to

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