Ampoule Filling Machine

Q: What utilities and power requirements does the Ampoule Filling Machine need?

The machine requires: Power : 0.5 H.P. (AFS-1) to 2 H.P. (AFS-8), 230 Volts, Single Phase, 50 Hz (customizable as per local requirements) Gases : Nitrogen for flushing, LPG and Oxygen (O₂) for sealing burners All product contact parts are made from AISI 316L Stainless Steel , while non-contact parts use SS 304, ensuring full cGMP compliance and easy sterilization. Optional integration with Laminar Air Flow (LAF), RABS, or isolators is available for enhanced sterility.

Q: What safety and advanced features does the machine offer?

Key features include: “No Ampoule – No Fill” system to prevent product wastage and contamination Flow meters for precise flame control and pre-heating station to eliminate droplets Safety valves, pressure regulators, and cooling systems Optional PLC with HMI for automation, real-time monitoring, and 21 CFR Part 11 compliance In-process check weighing and easy maintenance access The machine is fully cGMP compliant and designed for minimum human intervention in sterile environments, making it reliable for oxygen-sensitive and high-value injectable products.

Description

The pharmaceutical, biotech, cosmetic, and chemical industries are the main users of ampoule filling machine, which are specialised pieces of equipment used to fill and seal glass ampoules with liquids, powders, or other materials. Ampoules are tiny, hermetically sealed glass containers used to store and shield delicate materials from air, pollutants, and microbes. These devices are made to guarantee accurate, sterile, and effective filling and sealing of ampoules. Based on industry standards and available data, the following provides a thorough explanation of an ampoule filling machine, including its parts, functions, characteristics, and uses.

The machine is designed to accommodate a wide range of ampoule neck dimensions, thicknesses, and ovality of available ampoules by using the principle of slant travel of ampoules during filling and sealing. The unit is completely covered in stainless steel with a beautiful matt surface and is constructed on a square pipe frame made of stainless steel. The machine’s bottom side has large ports for thorough cleaning.

High Precision and Accuracy: Fill accuracy of ±0.5% ensures no over- or under-dosing, critical for pharmaceuticals.

Versatility: Handles ampoule sizes from 1 ml to 30 ml and various product types (liquids, powders, pellets).

High Output: Models range from 10–250 ampoules/min (up to 36,000/hour for high-speed).

Sterility: Operates in sterile class 100 environments with optional LAF or isolator systems to prevent contamination.

Automation: PLC and HMI systems allow easy operation, real-time monitoring, and error correction.

Durability: Stainless steel construction ensures longevity and compliance with cGMP standards.

Quick Changeover: Minimal downtime for format changes, with tool-less adjustments in some models.

Safety: Equipped with safety valves, pressure reducers, and cooling systems to prevent overheating and ensure operator safety.

Flexibility: Can process open-mouth and closed-mouth ampoules, with some models handling vials as well.

Nitrogen Flushing: Ensures product stability by replacing air with inert gas.

Integration: Easily integrates with upstream (washing, sterilization) and downstream (inspection, labeling) equipment.

Salient Features of Ampoule Filling Machine

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 Ampoule Filling 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.

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 Ampoule Filling 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 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

Advantages of Ampoule Filling Machine

Sterility and Protection: Ampoules protect contents from environmental dust, microorganisms, and air, ensuring product purity.

High Efficiency: Automated systems produce thousands of ampoules per hour, meeting high demand.

Precision: Accurate dosing eliminates wastage and ensures consistent drug delivery.

Ease of Maintenance: Accessible parts and CIP/SIP systems simplify cleaning and upkeep.

Regulatory Compliance: Designed to meet FDA, CE, ISO, and cGMP standards for pharmaceutical production.

Versatility: Suitable for a wide range of ampoule sizes, product types, and industries.

Long-Term Investment: Robust construction and efficient cooling systems extend machine lifespan.

Key Components of Ampoule Filling Machine

Infeed System:
- A hopper or feeding turntable where empty, pre-sterilized ampoules are loaded.
- A wire mesh conveyor belt or starwheel transports ampoules to the filling station, often connected to a sterilizing tunnel for continuous operation.
- vThe system ensures smooth and precise movement of ampoules, accommodating various sizes and shapes.

Filling Station:
- Equipped with high-precision dosing systems, such as:
  - Piston pumps (volumetric, servo-driven, or conventional) for accurate liquid filling.
  - Peristaltic pumps for gentle handling of sensitive liquids, with easy adjustment via HMI (Human-Machine Interface).
  - Mass-flow or time-pressure systems for customized filling.
- Filling needles or nozzles discharge precise volumes (0.5 ml to 25 ml in single dosing).
- Features like bottom-up filling or diving nozzles prevent foaming and ensure accuracy (±0.5% fill accuracy in some models).

Gas Flushing System:
- Nitrogen purging stations flush ampoules with inert gas (e.g., nitrogen) before and/or after filling to remove atmospheric air and prevent chemical reactions or contamination.
- This is critical for oxygen-sensitive or air-sensitive products like pharmaceuticals or radiopharmaceuticals.

Sealing Station:
- Pre-warming and sealing stations use combustible gases (oxygen and LPG/propane) to heat and melt the thin glass neck of the ampoule for hermetic sealing.
- Specially designed rollers rotate ampoules during sealing to ensure uniform closure.
- Safety valves, pressure reducers, and flow meters regulate flame intensity for precise sealing.
- A stainless steel hood channels out fumes during heating, maintaining a clean environment.

Collection and Rejection System:
- Filled and sealed ampoules are automatically collected in trays.
- Defective ampoules (e.g., improperly filled or sealed) are rejected and ejected into a separate container.
- Waste ampoule tips are clipped and discarded to avoid contamination.

Control Systems:
- PLC (Programmable Logic Controller) and HMI systems for real-time monitoring, parameter adjustment, and error detection.
- In-process control (IPC) systems for 0–100% check-weighing to ensure accurate dosing and adjust pump settings automatically.
- Optional integration with SCADA (Supervisory Control and Data Acquisition) or 21 CFR Part 11 compliance for data logging and regulatory adherence.

Frame and Materials:
- Constructed with stainless steel to meet cGMP standards.
- Compact, monoblock design for space efficiency and easy maintenance.
- Large openings and accessible parts for quick cleaning and minimal downtime.

Optional Features:
- Laminar Air Flow (LAF) or Restricted Access Barrier Systems (RABS) for sterile class 100 environments.
- Isolator enclosures for enhanced aseptic conditions.
- CIP/SIP (Clean-in-Place/Sterilize-in-Place) systems for automated cleaning without disassembly.
- Combination machines that handle both ampoules and vials for increased flexibility.

FAQ for Ampoule Filling Machine

What is the Ampoule Filling Machine and what is its primary application?

The Ampoule Filling Machine is a high-precision automatic system designed to fill sterile liquid formulations into glass ampoules and hermetically seal them using flame sealing. It is widely used in the pharmaceutical, biotech, and veterinary industries for producing injectable products. The machine incorporates nitrogen flushing (pre-gassing and post-gassing) to minimize oxidation and ensure product stability. Available in single to eight-head configurations (AFS-1 to AFS-8), it suits both medium and high-volume sterile production while maintaining Class 100 environmental compatibility.

What is the production capacity and which ampoule sizes does it support?

Production capacity depends on the model:

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

It handles glass ampoules from 1 ml to 30 ml (model dependent) with a filling range of 0.5 ml to 30 ml in a single dose. The machine delivers excellent filling accuracy of ±1% (achievable up to ±0.5% under optimized conditions) and supports quick changeover with minimal change parts.

How does the Ampoule Filling and Sealing process work?

Sterilized ampoules are loaded into the infeed hopper and transferred via starwheel. The automated process includes:

Nitrogen pre-gassing to remove oxygen
Precise volumetric filling using piston pumps with diving nozzles and neck centering
Nitrogen post-gassing for added protection
Pre-heating of the ampoule neck
Flame sealing with LPG and Oxygen burners while the ampoule rotates 360° for a uniform, leak-proof hermetic seal
Automatic collection of sealed ampoules and rejection of defective ones

The entire operation occurs in a slant position under controlled conditions to maintain sterility and prevent contamination.

What utilities and power requirements does the Ampoule Filling Machine need?

The machine requires:

Power: 0.5 H.P. (AFS-1) to 2 H.P. (AFS-8), 230 Volts, Single Phase, 50 Hz (customizable as per local requirements)
Gases: Nitrogen for flushing, LPG and Oxygen (O₂) for sealing burners

All product contact parts are made from AISI 316L Stainless Steel, while non-contact parts use SS 304, ensuring full cGMP compliance and easy sterilization. Optional integration with Laminar Air Flow (LAF), RABS, or isolators is available for enhanced sterility.

What safety and advanced features does the machine offer?

Key features include:

“No Ampoule – No Fill” system to prevent product wastage and contamination
Flow meters for precise flame control and pre-heating station to eliminate droplets
Safety valves, pressure regulators, and cooling systems
Optional PLC with HMI for automation, real-time monitoring, and 21 CFR Part 11 compliance
In-process check weighing and easy maintenance access

The machine is fully cGMP compliant and designed for minimum human intervention in sterile environments, making it reliable for oxygen-sensitive and high-value injectable products.

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