Manufacturer of Ampoule Filling Machine

Description

Manufacturer of Ampoule Filling Machine designs and produces automated equipment used for filling and sealing glass ampoules, primarily for pharmaceutical, biotech, cosmetic, and chemical industries. These machines ensure precise filling of liquids (0.5ml to 30ml) into ampoules, often incorporating advanced technologies like piston or peristaltic pumps, nitrogen purging, and flame sealing to maintain sterility and accuracy. Key features include:

  • 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.
    • The 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 (SS 316L for contact parts, SS 304 for non-contact parts) 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.

Working Principle of Manufacturer 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. For detailed working process please explore Automatic Ampoule Filler Video in top right section of this page.

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 Manufacturer 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 Precision

± 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 Arrangement

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

Applications of Ampoule Filling Machine

Advantages of Manufacturer 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 Features of Manufacturer of Ampoule Filling Machine

  • High Precision: Utilizes volumetric piston pumps or servo-driven systems for accurate dosing, with fill accuracy up to ±0.5%.

 

  • Versatility: Handles open or closed-mouth ampoules (1ml to 30ml) with adjustable settings for various neck dimensions, thicknesses, and ovalities.

 

  • Sterility Compliance: Built with stainless steel 316L for contact parts and 304 for non-contact parts, adhering to cGMP and FDA standards.

 

  • Automation: Offers PLC-based controls, touch-screen interfaces, and features like “No Ampoule – No Filling” to minimize waste and ensure safety.

 

  • Production Capacity: Ranges from 15 to 400 ampoules per minute, with models like single, two, four, six, or eight-head fillers to suit small to large-scale production.

 

  • Additional Features: Includes pre- and post-nitrogen flushing, laminar airflow options, and integration with washing, sterilization, and labeling systems for complete production lines.

 

  • Durability: Constructed with robust stainless steel frames, designed for easy maintenance and long-term reliability.

FAQ for Manufacturer of Ampoule Filling Machine

We manufacture a wide range of Ampoule Filling Machines, including:

  • Automatic Ampoule Filling and Sealing Machine
  • Single Head, Two Head, Four Head, and Eight Head models
  • Laboratory scale and high-speed production models
  • Machines for open mouth, closed mouth, and onion skin ampoules
  • Compact and custom-designed variants

All models support ampoule sizes from 1ml to 30ml and are available in different output capacities to suit small, medium, and large-scale production needs.

Our standard models offer the following capacities:

  • AFS-1 (Single Head): Up to 25 ampoules/min (~1,500/hour)
  • AFS-2 (Two Heads): Up to 50 ampoules/min
  • AFS-4 (Four Heads): Up to 100 ampoules/min (~6,000/hour)
  • AFS-8 (Eight Heads): Up to 200 ampoules/min (~12,000/hour)

Higher custom models can achieve up to 36,000 ampoules per hour. Filling accuracy is maintained at ±1% with a filling range of 0.5ml to 25ml.

Our machines are built with advanced features such as:

  • Nitrogen flushing before, during, and after filling
  • Slant traveling principle for gentle handling and reduced glass breakage
  • “No Ampoule – No Filling/Seal” safety system
  • SS 316L product contact parts
  • Tool-less quick changeover and easy cleaning
  • PLC/HMI control with optional 21 CFR Part 11 compliance
  • Pre-warming station and precise flame sealing

They fully comply with cGMP, USFDA, WHO, CE, ISO, and ISO 9187-1:2010 standards, making them suitable for sterile injectable production.

Our Ampoule Filling Machines are widely used in:

  • Pharmaceuticals (injectables, vaccines, and parenterals)
  • Biotechnology
  • Veterinary medicines
  • Cosmetics
  • Chemical and agro-insecticide industries

Why choose us?

  • Proven manufacturer with robust, low-maintenance machines
  • High sterility and minimal product wastage
  • Fast format changeover and compact footprint
  • Complete line integration (washing, sterilization, inspection, labeling)
  • Reliable after-sales support and easy validation
  • Cost-effective solutions with global export experience

Countries We Export to

United States | Canada | Mexico | Brazil | Argentina | Chile | Colombia | Peru | Germany | United Kingdom | France | Italy | Spain | Netherlands | Belgium | Switzerland | Sweden | Austria | Denmark | Norway | Poland | Finland | Czech Republic | Hungary | Portugal | Ireland | Greece | Slovakia | Romania | Bulgaria | China | Japan | India | South Korea | Indonesia | Vietnam | Thailand | Malaysia | Philippines | Singapore | Bangladesh | Pakistan | Saudi Arabia | United Arab Emirates | Israel | Turkey | Iran | Qatar | Kuwait | South Africa | Nigeria | Egypt | Algeria | Morocco | Kenya | Ghana | Tunisia | Australia | New Zealand | Russia | Ukraine | Belarus | Kazakhstan | Taiwan | Hong Kong | South Sudan | Uzbekistan | Oman | Jordan | Bahrain | Sri Lanka | Myanmar | Lebanon | Mongolia | Ethiopia | Libya | Angola | Zambia | Zimbabwe | Mozambique | Ivory Coast | Senegal | Uganda | Tanzania | Botswana | Ecuador | Venezuela | Bolivia | Paraguay | Uruguay | Trinidad and Tobago | Panama | Guatemala | Costa Rica | Honduras | El Salvador | Nicaragua | Dominican Republic | Haiti | Cuba

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.

Adinath International manufactures high-precision vial powder filling machines and complete packaging lines, providing reliable, hygienic, and efficient solutions for global pharmaceutical industries.

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