Four Head Ampoule Filling Machine

Q: What is the production capacity of the Four Head Ampoule Filling Machine?

The Four Head Ampoule Filling Machine (Model AFS-4) can fill and seal up to 100 ampoules per minute, which translates to approximately 6000 ampoules per hour. It processes four ampoules simultaneously in each cycle, making it ideal for medium to high-volume sterile liquid production while maintaining high accuracy and efficiency.

Q: What industries is the Four Head Ampoule Filling Machine suitable for?

It is primarily designed for the pharmaceutical industry (injectables, vaccines, antibiotics, etc.) and biotech sector for sterile liquids. It is also widely used in cosmetics (serums), veterinary , chemical , and agrochemical industries. The machine is perfect for any application requiring precise, contamination-free single-dose liquid filling and sealing in glass ampoules.

Q: Is Four Head Ampoule Filling Machine cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Four Head Ampoule Filling Machine complies to cGMP, MHRA, FDA and WHO-GMP standards, with optional CE marked equipments and 21 CFR Part 11 software compliance for the HMI/PLC. Machine contact parts having Stainless Steel 316L grade materials with validation documents having IQ, OQ, DQ validation protocols as optional. Organization is ISO 9001:2015 certified.

Q: Does Adinath International provide Four Head Ampoule Filling Machine internationally?

Yes, Adinath International Four Head Ampoule Filling Machine export this machine to more than 48 countries of this world including America, Europe, Asia, Middle East, Africa, CIS and Australia sub continents. Please visit our clientele page for complete list of our customers worldwide. Located at Ahmedabad, India having world class infrastructure .

Description

Four Head 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 Head 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. One of the top exporters of Ampoule Filling Machines from India is Adinath International.

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.

Salient Features of Four Head 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 Head 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 Head 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 Head Ampoule Filling Machine

High Efficiency: High-speed operation with minimal downtime and waste.

Sterility and Compliance: cGMP-compliant design with SS 316L contact parts and nitrogen flushing for sterile filling.

Versatility: Handles a wide range of ampoule sizes and liquid types, with customizable filling mechanisms.

Low Maintenance: Robust construction and minimal changeover parts reduce maintenance needs.

User-Friendly: Simplified controls, tool-less adjustments, and accessible design for ease of use.

Key Features of Four Head Ampoule Filling Machine

Construction and Materials:
1. Frame: Built on a sturdy stainless steel (SS) square pipe frame, often encased in SS 304 coverings with a matte finish for aesthetic appeal and durability.
2. Contact Parts: Made from high-quality SS 316L to ensure compatibility with injectable liquids and maintain sterility.
3. Non-Contact Parts: Typically constructed from SS 304, mild steel, or brass, depending on the manufacturer.
4. Vibration-Free Design: Incorporates cam mechanisms or synchronized motors to minimize vibrations during operation, ensuring smooth ampoule handling.

Filling Capacity:
1. Capable of filling ampoules ranging from 0.5 ml to 25 ml in a single dose, depending on the model.
2. Production output ranges from 50 to 250 ampoules per minute, with some models achieving up to 6,000 ampoules per hour for medium-scale production.

Filling Mechanisms:
1. Offers multiple filling options to suit different liquid viscosities and production needs:
  1. Piston Pump Filling: Ideal for consistent dosing of liquids.
  2. Servo-Driven Filling: Enhances precision and allows adjustments via touch-screen controls.
  3. Peristaltic Pump Filling: Ensures sterile and smooth filling, particularly for sensitive liquids.
2. Filling accuracy is typically ±1%, ensuring minimal wastage and high precision.

Nitrogen Flushing:
1. Equipped with pre- and post-nitrogen flushing nozzles to maintain product sterility by preventing oxidation and contamination.
2. Nitrogen purging occurs before and after filling to protect the liquid from environmental exposure.

Sealing Process:
1. Features a two-stage sealing unit:
  1. Pre-Heating Stage: Uses a low-pressure flame to warm the ampoule and remove residual droplets, ensuring clean sealing.
  2. Sealing Stage: Employs LPG (propane) and oxygen or gas burners to seal the ampoule, with rollers rotating the ampoule for a uniform 360-degree seal.
2. Some models include a waste tip collector made of SS for safe disposal of glass remnants.

Ampoule Handling:
1. Slant Travel Mechanism: Ampoules move on an inclined rack or via a synchronized starwheel, ensuring precise neck centering during filling, gas flushing, and sealing.
2. No Ampoule, No Fill System: Automatically stops liquid discharge if no ampoule is present, reducing waste and enhancing efficiency.
3. Capable of handling both open-mouth and closed-mouth ampoules (with specific models for each).

Ease of Operation and Maintenance:
1. Minimal Changeover Time: Requires minimal changeover parts for ampoule sizes from 1 ml to 10 ml, and some models support up to 25 ml with quick adjustments.
2. Tool-Less Format Changes: Simplifies switching between ampoule sizes without specialized tools.
3. Accessible Design: Features large openings at the bottom for easy cleaning and maintenance.
4. Pendant-Type Control Panel: Lifted from the machine for safe and user-friendly operation.

Optional Features:
1. PLC with Touch Screen HMI: For precise control and fill volume adjustments.
2. Variable Frequency Drive (VFD): Allows easy speed regulation.
3. Laminar Air Flow or Safety Cabinet: Ensures a sterile Class 100 environment for filling.
4. Servo-Based Filling Systems: For enhanced accuracy and automation.
5. Blower for Flame Heat: Directs heat away from the sterile room.

FAQ for Four Head Ampoule Filling Machine

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

The Four Head Ampoule Filling Machine (Model AFS-4) can fill and seal up to 100 ampoules per minute, which translates to approximately 6000 ampoules per hour. It processes four ampoules simultaneously in each cycle, making it ideal for medium to high-volume sterile liquid production while maintaining high accuracy and efficiency.

Which ampoule sizes can the Four Head Ampoule Filling Machine handle?

This machine supports ampoule sizes from 1 ml to 10 ml (with some configurations handling 0.5 ml to 25 ml). It features minimum change-over parts and quick format change, allowing easy switching between sizes with minimal downtime. The slant travel mechanism ensures gentle handling across different neck dimensions and thicknesses.

What is the filling accuracy and how is sterility maintained?

The machine offers a filling accuracy of ±1%. Sterility is maintained through several features: pre- and post-nitrogen flushing, a “No Ampoule – No Filling” system, neck centering during gas flushing and filling, pre-warming station, and cGMP-compliant design with Stainless Steel 316L contact parts. It uses LPG & Oxygen for sealing and supports laminar airflow options for Class 100 environments.

What materials are used in the Four Head Ampoule Filling Machine and why?

All product contact parts are made from high-quality Stainless Steel 316L, while non-contact parts use Stainless Steel 304. The sturdy frame is constructed from stainless steel square pipes with a matte finish. These materials ensure corrosion resistance, easy cleaning, compliance with pharmaceutical standards, and long-term durability with minimal maintenance.

What industries is the Four Head Ampoule Filling Machine suitable for?

It is primarily designed for the pharmaceutical industry (injectables, vaccines, antibiotics, etc.) and biotech sector for sterile liquids. It is also widely used in cosmetics (serums), veterinary, chemical, and agrochemical industries. The machine is perfect for any application requiring precise, contamination-free single-dose liquid filling and sealing in glass ampoules.

Is Four Head Ampoule Filling Machine cGMP, MHRA, FDA and WHO-GMP Compliant?

Yes — Adinath International Four Head Ampoule Filling Machine complies to cGMP, MHRA, FDA and WHO-GMP standards, with optional CE marked equipments and 21 CFR Part 11 software compliance for the HMI/PLC. Machine contact parts having Stainless Steel 316L grade materials with validation documents having IQ, OQ, DQ validation protocols as optional. Organization is ISO 9001:2015 certified.

What is the lead time for Four Head Ampoule Filling Machine?

Manufacturing lead time is generally 7 to 14 weeks from order confirmation. Further it takes 2 to 8 weeks for international shipping depending upon destination. Order can be expediate sooner or later as per specific buying requirements. Destination specific certifications like US FDA, EU, ANVISA, SFDA. CE can add 3 to 6 weeks additionally.

Does Adinath International provide Four Head Ampoule Filling Machine internationally?

Yes, Adinath International Four Head Ampoule Filling Machine export this machine to more than 48 countries of this world including America, Europe, Asia, Middle East, Africa, CIS and Australia sub continents. Please visit our clientele page for complete list of our customers worldwide. Located at Ahmedabad, India having world class infrastructure.

Does After Sales Support provided for Four Head Ampoule Filling Machine?

Service of skilled engineers and technicians provided for technical support of supplied equipments. Installations, commissioning, training and IQ, OQ, DQ validations performed by qualified engineers. Remote support through video call, phone, email and other modes provided for international installations. Spare parts of Four Head Ampoule Filling Machine stocked at our premises in Ahmedabad and shipped immediately after ordering. Standard 12 months manufacturing warranty included with supplied equipment.

Four Head Ampoule Filling Machine

Description

Salient Features of Four Head Ampoule Filling Machine

Working Principle of Four Head Ampoule Filling Machine

Technical Specification of Four Head Ampoule Filling Machine

Types of Ampoule Filling Machine

Applications of Ampoule Filling Machine

Benefits of Four Head Ampoule Filling Machine

High Efficiency: High-speed operation with minimal downtime and waste.

Sterility and Compliance: cGMP-compliant design with SS 316L contact parts and nitrogen flushing for sterile filling.

Versatility: Handles a wide range of ampoule sizes and liquid types, with customizable filling mechanisms.

Low Maintenance: Robust construction and minimal changeover parts reduce maintenance needs.

User-Friendly: Simplified controls, tool-less adjustments, and accessible design for ease of use.

Key Features of Four Head Ampoule Filling Machine

FAQ for Four Head Ampoule Filling Machine

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