Four Stroke Ampoule Filling Machine

Description

Four Stroke Ampoule Filling Machine is based on one of the most dependable and tested machine principles: slant travelling of ampoules during the sealing and filling process. This is also thought to be the most scalable and optimisable solution. This method has also been used since it handles a wide range of ampoules that are different from one another in terms of thickness, size, or composition. This cutting-edge machinery has a four-head ampoule filler that satisfies cGMP requirements and is constructed from premium Stainless Steel 316L. The device uses a single motor to control all of the principal drives and has a speed port for adjustment. It performs exceptionally well and has nitrogen-flushing mechanisms and pre- and post-nitrogen flushing units. Additionally, it contains a thick glass ampoule active pre-heating technology that increases the capacity of the glass tube filler.

With a single-dose filling capacity of 0.5 ml to 25 ml, this ampoule filling sealing machine can fill and seal ampoules ranging in volume from 1 ml to 25 ml. It can process 10 to 250 ampoules per minute using a volumetric piston-pump filling method. After ampoules are filled and sealed, the machine’s dead-tray comes in handy. It can fill and seal a variety of chemicals, including cosmetic ampoules, veterinary medications, and agro-insecticides, using either oxygen or LPG (propane) gas. The automatic four-head ampoule filler and sealer machine is ideal for any wide-mouth glass ampoule, demonstrating why Adinath Machine is a top producer and exporter of ampoule filling sealing machines.

Purpose and Application:

This machine is engineered for filling and sealing open-mouth or closed-mouth glass ampoules with liquid or powder formulations. It is widely used in industries such as pharmaceuticals, cosmetics, biotechnology, and chemical manufacturing for packaging injectable drugs, serums, or light-sensitive chemicals. The four-needle design enhances efficiency by allowing simultaneous filling of multiple ampoules, making it suitable for medium to large-scale production.

Construction and Design:
- Material: Built with a robust frame, typically made of stainless steel 316L for contact parts to ensure compliance with cGMP standards, ensuring durability and resistance to corrosion. Non-contact parts are often made of stainless steel 304.
- Compact Design: Features a monobloc design integrating filling and sealing units, minimizing space requirements and ensuring seamless operation.
- Nitrogen Flushing: Equipped with pre- and post-nitrogen flushing units to purge air and prevent contamination or oxidation of sensitive products.
- Slant Rack Movement: Ampoules are transported on an inclined rack system, allowing precise handling during filling and sealing processes.

Salient Features of Four Stroke Ampoule Filling Machine

Compact cGMP model.
Higher output up to 6000 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 Four Stroke 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.

Ampoule Loading: Sterilized ampoules are loaded into the infeed hopper and transferred via a starwheel or cassette to a traveling rack in groups of four.

Pre-Nitrogen Flushing: Nitrogen is flushed to remove air and maintain sterility.

Filling: Four filling needles dispense the precise volume of liquid into the ampoules.

Post-Nitrogen Flushing: Additional nitrogen flushing to protect the filled liquid.

Pre-Heating: A low-pressure flame prepares the ampoule for sealing by removing droplets.

Sealing: Ampoules are sealed using LPG/oxygen flames, with rollers ensuring uniform sealing.

Collection: Filled and sealed ampoules are automatically collected in a tray or dead tray without manual handling.

Technical Specification of Four Stroke Ampoule Filling Machine

Model Name	AFS-4
Production Speed	Up to 100 ampules/minute
Ampoule Sizes	1 ml to 10 ml
Filling Error	± 1%
Sealing Gas	LPG and Oxygen (O₂)
Nitrogen Gas	Pre & Post Nitrogen
Power Load	1 H. P.
Power Voltage	230 Volts, Single Phase, 50 Hertz
Contact Parts	Made from Stainless Steel 316L
Non-Contact Parts	Made from Stainless Steel 304
Machine Size	1200mm (L) x 1070mm (W) x 965mm (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 Four Stroke Ampoule Filling Machine

High precision and accuracy in filling and sealing.

Reduced contamination risk due to nitrogen flushing and sterile design.

Fast production rates with minimal maintenance.

Versatile for various ampoule sizes and liquid types.

Easy cleaning and accessibility for maintenance.

Key Features of Four Stroke Ampoule Filling Machine

Filling Mechanism:
- Four Nozzles: The machine uses four filling needles to dispense liquid or powder into ampoules simultaneously, increasing throughput. It supports filling volumes from 0.5 ml to 25 ml in a single dose, with flexibility for ampoule sizes ranging from 1 ml to 30 ml.
- Filling Options: Offers multiple filling mechanisms, including:
  - Peristaltic Pump: Ideal for sterile and low-viscosity liquids, minimizing contamination risks.
  - Piston Pump: Suitable for precise volumetric filling of thicker liquids.
  - Servo-Controlled: Provides high accuracy for customized filling requirements.
- Neck Centering: Ensures accurate alignment of ampoule necks during filling to prevent spillage or waste.
- No Ampoule, No Fill: A safety feature that stops liquid discharge if no ampoule is present, reducing waste.

Sealing Process:
- Two-Stage Sealing:

- 1. Pre-Heating: A low-pressure flame warms the ampoule to remove residual droplets and prepare it for sealing.
  2. Sealing: Uses a combination of LPG (propane) and oxygen gas with clippers or rollers to rotate ampoules, ensuring a 360-degree flame for a secure, uniform seal.
- Sealing Flexibility: Can handle both open-mouth (Type B) and closed-mouth (Type C) ampoules, with some models offering flame sealing, crimp sealing, or snap-off sealing options.

Production Capacity:
- Capable of filling 50 to 100 ampoules per minute (approximately 6,000 ampoules per hour), depending on the model and liquid viscosity. High-speed versions can achieve up to 12,000 ampoules per hour.
- The machine processes four ampoules per cycle, advancing them through synchronized starwheel or cassette systems.

Features:
- cGMP Compliance: Meets stringent pharmaceutical standards for hygiene and quality.
- Minimal Changeover Time: Tool-less format changes for different ampoule sizes, enhancing operational efficiency.
- Pre-Warming Station: Ensures consistent sealing for thick glass ampoules.
- Flow Meters: Regulate flames for precise sealing.
- Laminar Air Flow (Optional): Provides a sterile Class 100 environment for filling.
- Waste Tip Collection: Clipped ampoule tips are ejected into a separate stainless steel container.
- Cooling System: Prevents overheating, extending machine lifespan.
- PLC Integration: Modern models feature programmable logic controllers (PLCs) for real-time monitoring and parameter adjustments.

Operational Workflow:

1. Loading: Sterilized, empty ampoules are loaded into an infeed hopper and transferred via a starwheel or cassette to a moving rack.
2. Pre-Gassing: Nitrogen is flushed to remove oxygen from the ampoule.
3. Filling: Four needles dispense the precise volume of liquid or powder.
4. Post-Gassing: Additional nitrogen flushing to ensure sterility.
5. Pre-Heating: A low-pressure flame prepares the ampoule for sealing.
6. Sealing: Rollers rotate the ampoule while a high-pressure flame seals it.
7. Collection: Filled and sealed ampoules are collected upright on a tray for further processing.

Applications:

- Pharmaceuticals: Filling injectable drugs, vaccines, and parenterals.
- Cosmetics: Packaging serums, oils, or high-end liquid products.
- Chemicals: Storing light- or air-sensitive substances.
- Food and Beverage: Filling single-dose liquid preservatives or flavorings.

Customization and Flexibility:
- Adjustable power voltage to meet regional requirements.
- Optional features like inbuilt laminar airflow, safety cabinets, or isolators for enhanced sterility.
- Can be integrated with upstream (washing, sterilization tunnels) and downstream (labeling, inspection) equipment for a complete production line.

FAQ for Four Stroke Ampoule Filling Machine

What is a Four Stroke Ampoule Filling Machine?

The Four Stroke Ampoule Filling Machine (Model AFS-4) is a compact, fully automatic, cGMP-compliant machine designed for high-speed filling and sealing of glass ampoules containing sterile injectable liquids. It works on a four-stroke (slant travelling) mechanism where ampoules move in groups of four through synchronized stations for nitrogen flushing, filling, pre-heating, and flame sealing. It is widely used in pharmaceutical, veterinary, cosmetic, and chemical industries for reliable and contamination-free ampoule packaging.

What is the production capacity of the Four Stroke Ampoule Filling Machine?

This machine delivers an output of 50 to 100 ampoules per minute (approximately 3,000 to 6,000 ampoules per hour), depending on ampoule size, fill volume, and liquid viscosity. The four-stroke design allows simultaneous processing of four ampoules per cycle, making it highly efficient for medium to high-volume sterile production while maintaining excellent accuracy.

Which ampoule sizes and fill volumes does the machine support?

The Four Stroke Ampoule Filling Machine handles 1 ml to 10 ml ampoules as standard (with support up to 30 ml in certain configurations). It can fill volumes ranging from 0.5 ml to 25 ml in a single dose. Changeover between different sizes is quick and requires minimal parts, thanks to the neck-centering system and volumetric piston pump design.

Does the machine provide nitrogen flushing and sterile operation?

Yes. The machine is equipped with pre- and post-nitrogen flushing (and during filling in some setups) to remove oxygen, prevent oxidation, and maintain product stability and sterility. It also features a “No Ampoule – No Filling” system, a pre-warming station, and SS 316L product contact parts. The entire design is fully cGMP compliant, making it suitable for sensitive injectable formulations, vaccines, and other sterile liquids.

What are the key features and benefits of the Four Stroke Ampoule Filling Machine?

Key features include:

Slant travelling (four-stroke) mechanism for smooth and precise ampoule movement
Volumetric piston pump filling with ±1% accuracy
Pre- and post-nitrogen flushing with neck centering
Pre-heating station and accurate LPG + Oxygen flame sealing
“No Ampoule – No Filling” system to eliminate wastage
Compact monobloc cGMP model with SS 316L contact parts
Easy maintenance, low changeover time, and pendant control panel

Benefits: High output with minimal product loss, superior sterility, consistent sealing quality, easy operation, and suitability for both open-mouth and closed-mouth ampoules. Optional PLC/HMI, servo filling, and laminar airflow are also available.

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