Automatic Ampoule Filler

Q: What are the available models and their production capacities?

The Automatic Ampoule Filler is available in four models: AFS-1 (Single Head) : Up to 25 ampoules per minute AFS-2 (Double Head) : Up to 50 ampoules per minute AFS-4 (Four Head) : Up to 100 ampoules per minute AFS-8 (Eight Head) : Up to 200 ampoules per minute (up to 12,000 ampoules per hour) Higher output depends on ampoule size, product viscosity, and operator settings. The machine supports quick changeover with minimal change parts.

Q: What utilities, power requirements, and compliance features does it have?

Power : 0.5 H.P. (AFS-1) to 2 H.P. (AFS-8), 230 Volts, Single Phase, 50 Hz (customizable) Utilities : Nitrogen gas for flushing, LPG and Oxygen for sealing burners All product contact parts are made of AISI 316L Stainless Steel and non-contact parts of SS 304 for easy cleaning and sterilization. Key features include: “No Ampoule – No Fill” system cGMP compliance Flow meters and safety valves for gas control Optional PLC + HMI with 21 CFR Part 11 compliance Compatibility with Laminar Air Flow (LAF), RABS, or isolators

Description

Automatic Ampoule Filler, commonly known as an ampoule filling machine, is a specialized pharmaceutical equipment used to accurately fill and seal glass ampoules with liquid medications, injectables, and other sterile formulations. Our AFS Series Automatic Ampoule Filling Machines are designed to meet the stringent demands of the pharmaceutical industry, delivering precise filling and perfect sealing while maintaining complete sterility. Available in multiple models, these machines offer flexible production speeds ranging from 25 to 300 ampoules per minute, depending on your specific requirements. With easy-to-change parts and tooling, our ampoule fillers can efficiently handle a wide range of fill volumes from 1ml to 20ml, making them highly versatile for different product types and batch sizes.

Our automatic ampoule filling machines offer flexible filling options to suit different product requirements. Depending on your needs, the ampoule filler can be equipped with highly accurate filling mechanisms such as mechanical pump, servo-driven filling, or peristaltic pump systems. Peristaltic pump filling is especially preferred when complete isolation between the product and machine parts is required to eliminate cross-contamination risks.
Designed as a monobloc unit, the machine performs all critical operations on a single platform — pre-gassing, product filling, post-gassing, pre-heating, and sealing — ensuring smooth, high-speed operation and better process control. Every model complies with cGMP regulations for pharmaceutical manufacturing.

The sealing station works in two stages: the first stage preheats the ampoule to remove any droplets, while the second stage uses a precisely controlled LPG + Oxygen flame to create a perfect hermetic seal. During sealing, ampoules are rotated 360 degrees to achieve uniform, high-quality dome-shaped seals.

Salient Features of Automatic Ampoule Filler

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

All contact parts made from High Quality Stainless Steel 316L & Non-contact parts made from Stainless Steel 304.
Ampoule neck centering during gas flushing and filling operations.
Minimum change over parts from 1ml to 10ml ampoule size.
Possibility of nitrogen gas flushing before, during and after filling.
Minimum change over time, little maintenance, easy cleaning.

Working Principle of Automatic Ampoule Filler

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.

The operation of an ampoule filling machine follows a systematic, automated process to ensure sterility, precision, and efficiency:

Sterilization and Loading:
- Empty ampoules are washed, sterilized (often in a depyrogenation tunnel), and loaded into the machine’s hopper or infeed system.
- A starwheel or conveyor belt aligns and transports ampoules (1, 2, 4, 6, or 8 at a time, depending on the machine’s head configuration) to the processing stations.

Pre-Gassing (Optional):
- Ampoules are flushed with nitrogen to displace atmospheric air, reducing the risk of oxidation or contamination.

Filling:
- The filling station dispenses a precise volume of liquid or powder into each ampoule using piston or peristaltic pumps.
- Neck centering ensures accurate filling, and diving nozzles minimize foaming.
- In-process control (IPC) systems may weigh ampoules before and after filling to verify accuracy.

Post-Gassing (Optional):
- Additional nitrogen flushing after filling to further protect the contents.

Pre-Warming and Sealing:
- Ampoules move to a pre-warming station where a low-pressure flame warms the glass neck.
- At the sealing station, a high-temperature flame (using oxygen and LPG) melts the thin glass top to create a hermetic seal.
- Rollers rotate the ampoules during sealing for uniform closure, and waste glass tips are clipped and ejected.

Collection:
- Sealed ampoules are collected on a tray, while defective units are rejected.
- The process is continuous, with minimal manual intervention, ensuring high throughput and sterility.

The machine operates on the principle of slant traveling, where ampoules move at an inclined angle during filling and sealing to accommodate variations in neck size, thickness, and shape, ensuring consistent results.

Technical Specification of Automatic Ampoule Filler

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 Precison	± 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 Arranegment	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

Benefits of Automatic Ampoule Filler

High Accuracy: Ensures exact dosing, critical for pharmaceuticals and injectables.

Sterility: Nitrogen flushing and stainless steel construction prevent contamination.

Efficiency: High-speed models meet large-scale production demands with minimal downtime.

Ease of Use: Automated processes and minimal changeover reduce operator effort and maintenance.

Versatility: Handles a wide range of liquids, from free-flowing to viscous, and supports various ampoule sizes.

Key Features and Functionality

Purpose and Applications:
- Fills and seals glass ampoules (open or closed mouth) with liquids or, in some cases, solids, such as vaccines, antibiotics, cosmetics, or agrochemicals.
- Suitable for ampoule sizes ranging from 1ml to 30ml, with filling capacities from 0.5ml to 25ml in a single dose.

Operation Process:
- Loading: Sterilized ampoules are loaded into an infeed hopper and transferred via a starwheel or cassette to a moving rack.
- Pre-Gassing: Nitrogen gas is flushed into ampoules to displace oxygen, ensuring product stability.
- Filling: Liquid is dispensed with high precision using filling mechanisms like:
  - Peristaltic pumps (ideal for sterile or viscous liquids).
  - Servo-driven systems (for precise volume control).
  - Piston pumps (volumetric dosing for consistent filling).
- Post-Gassing: Additional nitrogen flushing post-filling to prevent contamination.
- Pre-Heating and Sealing: Ampoule necks are heated using oxygen and LPG (propane) flames and sealed to ensure an airtight closure.
- Collection: Filled and sealed ampoules are automatically collected in a tray without manual handling.

Design and Construction:
- Monobloc Design: Integrates all operations (pre-gassing, filling, post-gassing, pre-heating, sealing) on a single platform for efficiency.
- Materials: Contact parts are made of AISI 316L stainless steel for sterility and corrosion resistance; non-contact parts use AISI 304 stainless steel.
- Frame: Built on sturdy stainless steel square pipes with a matte finish for durability and aesthetic appeal.
- Accessibility: Large bottom openings and ergonomic designs allow easy cleaning and maintenance.
- Safety Features: Includes safety valves, pressure reducers for gas circuits, and a stainless steel hood to channel fumes during sealing.

Performance:
- Output: Varies by model, ranging from 25 to 36,000 ampoules per hour (e.g., single-head for lab-scale at 1,500/hour, high-speed models up to 12,000–36,000/hour).
- Precision: Accurate dosing minimizes product wastage and ensures consistent fill volumes.
- Flexibility: Adjustable for various ampoule sizes (1ml to 30ml) with minimal changeover parts.

Advanced Features:
- Neck Centering: Ensures precise alignment during gas flushing and filling to accommodate variations in ampoule neck dimensions or ovality.
- Automation: Fully automated systems reduce manual intervention, with options for PLC-based controls and pendant-type electrical panels for ease of operation.
- Sterility and Compliance: Equipped with pre-warming stations, flow meters for flame regulation, and optional safety cabinets or laminar airflow systems to maintain sterility.
- Customization: Available in single-head, two-head, four-head, six-head, or eight-head configurations to suit small, medium, or large-scale production.

Optional Features:
- Integration with upstream (e.g., washing/sterilization tunnels) and downstream equipment (e.g., inspection or labeling machines).
- Combination machines to process both ampoules and vials for enhanced flexibility.
- High-voltage leak detection (HVLD) or other inspection systems for quality assurance.

FAQ for Automatic Ampoule Filler

What is the Automatic Ampoule Filler and what is it used for?

The Automatic Ampoule Filler (AFS series) is a monobloc automatic machine that fills and hermetically seals glass ampoules in one continuous operation. It performs nitrogen pre-gassing, precise liquid filling, post-gassing, pre-heating, and flame sealing. This machine is ideal for sterile injectable products in the pharmaceutical, biotech, veterinary, cosmetic, and chemical industries. It handles oxygen-sensitive liquids like vaccines, antibiotics, and other high-value formulations while maintaining sterility with minimal human intervention.

What are the available models and their production capacities?

The Automatic Ampoule Filler is available in four models:

AFS-1 (Single Head): Up to 25 ampoules per minute
AFS-2 (Double Head): Up to 50 ampoules per minute
AFS-4 (Four Head): Up to 100 ampoules per minute
AFS-8 (Eight Head): Up to 200 ampoules per minute (up to 12,000 ampoules per hour)

Higher output depends on ampoule size, product viscosity, and operator settings. The machine supports quick changeover with minimal change parts.

Which ampoule sizes and filling volumes does it support?

The machine handles glass ampoules from 1 ml to 30 ml (AFS-1 & AFS-2) and 1 ml to 20 ml (AFS-4 & AFS-8). Filling range: 0.5 ml to 30 ml in a single dose. It delivers high filling accuracy of ±1% (up to ±0.5% under optimized conditions) using piston pumps, diving nozzles, and neck centering to reduce foaming and ensure precision.

How does the filling and sealing process work?

Empty, washed, and sterilized ampoules are loaded into the infeed hopper and transferred via starwheel in a slant/inclined position. The automated cycle includes:

Nitrogen pre-gassing (to remove oxygen)
Volumetric filling with neck centering
Nitrogen post-gassing
Pre-heating to eliminate droplets
Flame sealing using LPG + Oxygen burners while ampoules rotate 360° for a perfect dome-shaped hermetic seal
Automatic collection of sealed ampoules and ejection of glass tips

The entire process ensures sterility and protects sensitive products.

What utilities, power requirements, and compliance features does it have?

Power: 0.5 H.P. (AFS-1) to 2 H.P. (AFS-8), 230 Volts, Single Phase, 50 Hz (customizable)
Utilities: Nitrogen gas for flushing, LPG and Oxygen for sealing burners

All product contact parts are made of AISI 316L Stainless Steel and non-contact parts of SS 304 for easy cleaning and sterilization. Key features include:

“No Ampoule – No Fill” system
cGMP compliance
Flow meters and safety valves for gas control
Optional PLC + HMI with 21 CFR Part 11 compliance
Compatibility with Laminar Air Flow (LAF), RABS, or isolators

Countries We Export to

Partner with Industry Experts

Connect with our engineering team to discuss your specific production requirements. We provide customized, cGMP-compliant machinery solutions designed to optimize your manufacturing facility and maximize output.

GET A QUOTE!