Four Syringe Ampoule Filling Machine

Q: How does the Four Syringe Ampoule Filling Machine work?

The machine operates on the slant traveling principle for gentle ampoule handling and minimal glass breakage. The automated process includes: Automatic loading of sterilized ampoules from the hopper Nitrogen pre-flushing to remove oxygen Simultaneous filling through four syringes with neck centering Nitrogen post-flushing Neck pre-warming Accurate flame sealing using LPG + Oxygen burners It is equipped with “No Ampoule – No Filling” and “No Ampoule – No Seal” safety systems to eliminate wastage and ensure high sterility.

Description

Four Syring Ampoule Filling Machine is an advanced piece of pharmaceutical equipment designed for high-speed, precise filling and sealing of glass ampoules, primarily used in the pharmaceutical, biotech, cosmetic, and chemical industries. Below is a detailed description based on the latest available information: The Four Syring Ampoule Filling and Sealing Machine is engineered to streamline the filling and sealing of glass ampoules, accommodating a wide range of ampoule sizes and liquid types. It operates on the principle of slant travel, where ampoules move at an angle through various stations to account for variations in neck dimensions and thicknesses of standard ampoules. This ensures accurate filling and secure sealing while maintaining sterility and compliance with cGMP (current Good Manufacturing Practice) standards.

Being a top producer of Four Head Ampoule Filling Machines, we offer reliable, user-friendly devices that require minimum maintenance. This machine ensures compliance with cGMP standards for sterile injectable filling. If you need details on specific models, pricing, or comparisons with multi-head machines, let me know!

Salient Features of Four Syringe Ampoule Filling Machine

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

Technical Specification of Four Syringe 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

Benefits of Four Syringe Ampoule Filling Machine

High Precision: Achieves fill accuracy of ±0.5%, critical for costly or potent drugs.

Sterility: Nitrogen flushing and aseptic processing minimize contamination risks.

Flexibility: Handles both syringes and ampoules, with adjustable settings for various container sizes and filling volumes.

Efficiency: High output rates and minimal changeover time enhance productivity.

Compliance: Meets cGMP and FDA standards, ensuring regulatory compliance.

Key Features of Four Syringe Ampoule Filling Machine

Construction and Materials:
- Frame and Contact Parts: Built with a robust stainless steel (often SS 316L) frame for durability and compliance with cGMP standards. Contact parts (e.g., filling nozzles, syringes/pumps) are made of pharmaceutical-grade stainless steel to prevent contamination and ensure compatibility with sterile liquids.
- Non-Contact Parts: Typically made from SS 304 or other corrosion-resistant materials for hygiene and ease of cleaning.
- Compact Design: Many models feature a compact footprint, making them suitable for cleanrooms, laminar airflow hoods, or isolator systems.

Filling Mechanism:
- Versatile Filling Systems: Supports multiple filling technologies, such as:
  - Peristaltic Pumps: Ideal for low-shear filling of sensitive biologics, using single-use fluid paths to minimize cross-contamination.
  - Piston Pumps: Common for precise volumetric filling, suitable for a wide range of viscosities.
  - Time/Pressure Filling: Used for specific applications requiring high accuracy.
- Filling Capacity: Typically handles volumes from 0.5 ml to 25 ml in a single dose, with some models adjustable for 1 ml to 10 ml syringes or ampoules. Accuracy is often within ±0.5% to ensure consistent dosing.
- No Container, No Fill: Equipped with sensors to prevent liquid discharge if no syringe or ampoule is present, reducing waste and contamination risks.

Syringe and Ampoule Handling:
- Syringe Processing: Designed to handle pre-filled syringes (glass or plastic, e.g., COC) with capacities ranging from 3 ml to 180 ml. Automated de-nesting and re-nesting systems ensure gentle handling and minimal operator intervention, reducing contamination risks.
- Ampoule Processing: Supports both open (Type B, C) and closed (Type D) ampoules, typically ranging from 1 ml to 30 ml. The machine can process ampoules with varying neck dimensions and thicknesses using a slant travel mechanism for precise centering during filling and sealing.
- Nitrogen Flushing: Includes pre- and post-nitrogen flushing stations to maintain an inert environment, preventing oxidation and contamination of sensitive drugs.

Sealing and Closing:
- Ampoule Sealing: Features pre-warming and sealing stations using combustible gases (e.g., LPG and oxygen) with rollers to rotate ampoules for uniform sealing. Safety features like gas shut-off valves and exhaust fume aspiration ensure operator safety.
- Syringe Stoppering: Integrates vacuum stoppering or rod insertion systems for precise placement of plungers or stoppers, ensuring an airtight seal. Some models combine rod insertion and labeling in a single platform for efficiency.
- Quick Changeover: Tool-less format changes minimize downtime when switching between syringe and ampoule sizes or types.

Output and Speed:
- Production Capacity: Depending on the model, these machines can process 50 to 120 ampoules per minute or up to 6,000 to 12,000 ampoules per hour for medium-scale production. Syringe filling rates vary but are typically lower due to handling complexity.
- High-Speed Models: Some advanced models, like vertical servo-based systems, can achieve up to 280 ampoules per minute with precise PLC-controlled filling.

Automation and Control:
- PLC and HMI: Equipped with Programmable Logic Controllers (PLCs) and Human-Machine Interfaces (HMIs) for real-time monitoring, parameter adjustment, and error detection.
- In-Process Control (IPC): Ensures filling accuracy through constant weight checks and stopper position verification. Statistical or 100% IPC options are available for syringes and ampoules.
- Aseptic Processing: Compatible with Laminar Air Flow (LAF), Restricted Access Barrier Systems (RABS), or isolators to maintain sterility. Automated bag and tub openers minimize operator contact.

Additional Features:
- Cleaning and Sterilization: Supports Clean-in-Place (CIP) and Sterilize-in-Place (SIP) systems for easy maintenance and compliance with aseptic standards.
- Safety and Ergonomics: Includes safety cabinets, emergency stop buttons, and ergonomic designs for operator comfort. Toughened glass or acrylic enclosures protect the process area.
- Integration: Can be part of a complete filling line, including washing, sterilization tunnels, inspection, and labeling machines for end-to-end production.

FAQ for Four Syringe Ampoule Filling Machine

What is a Four Syringe Ampoule Filling Machine?

A Four Syringe Ampoule Filling Machine (also known as Four Head Ampoule Filler Sealer) is a fully automatic monobloc machine designed for high-precision filling and flame sealing of sterile liquid injectables into glass ampoules. It uses four syringes (piston pumps) working simultaneously and integrates nitrogen flushing (pre- and post-filling), accurate volumetric filling, neck pre-heating, and LPG + Oxygen flame sealing in one compact unit. This model is ideal for medium to large-scale pharmaceutical injectable production and complies with cGMP, USFDA, WHO, and international standards.

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

The Four Syringe Ampoule Filling Machine has a production capacity of up to 100 ampoules per minute (approximately 6,000 ampoules per hour). It supports ampoule sizes from 1ml to 20ml with a filling range of 0.5ml to 25ml and delivers excellent filling accuracy of ±1%. This makes it a perfect choice for medium to high-volume sterile injectable manufacturing.

How does the Four Syringe Ampoule Filling Machine work?

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

Automatic loading of sterilized ampoules from the hopper
Nitrogen pre-flushing to remove oxygen
Simultaneous filling through four syringes with neck centering
Nitrogen post-flushing
Neck pre-warming
Accurate flame sealing using LPG + Oxygen burners

It is equipped with “No Ampoule – No Filling” and “No Ampoule – No Seal” safety systems to eliminate wastage and ensure high sterility.

What are the key features of the Four Syringe Ampoule Filling Machine?

Key features include:

Four syringe / four head monobloc design for higher output
Nitrogen flushing before, during, and after filling to prevent oxidation
Precision piston pumps (syringes) for accurate volumetric 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 with SCADA compatibility

What are the main benefits of the Four Syringe Ampoule Filling Machine?

Main benefits include:

High production speed of up to 100 ampoules per minute
Excellent filling accuracy (±1%) with minimal product wastage
Gentle handling that reduces glass breakage and contamination risk
Ideal for medium to large batch production
Fast format changeover and easy validation
Compact design suitable for cleanroom environments
Full cGMP compliance and reliable performance

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