Injection Ampoule Filling Machine

Description

Injection Ampoule Filling Machine is a specialized piece of pharmaceutical equipment designed to fill and seal glass ampoules with injectable liquid drugs, ensuring precision, sterility, and compliance with industry standards. These machines are widely used in pharmaceutical, biotech, chemical, and cosmetic industries to handle liquids ranging from free-flowing to viscous oils, typically in ampoules of 1ml to 30ml capacity. Injection Ampoule Filling Machines are critical for high-precision, sterile, and efficient production of injectable pharmaceuticals and other sensitive liquids. Their robust design, advanced automation, and compliance with global standards make them indispensable in modern pharmaceutical manufacturing. Below is a detailed description based on the operational principles, features, and advantages of these machines:

  • Designed to meet cGMPUS FDACE, and ISO 9187-1:2010 standards for injectable equipment.

 

  • Contact parts use FDA-approved materials to ensure safety and non-reactivity with drugs.

 

  • Optional 21 CFR Part 11 compliance for electronic records and signatures.

Working Principle of Injection 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.

  • Purpose: The machine automates the filling and sealing of glass ampoules, which are small, sealed vials used to store injectable pharmaceuticals, vaccines, or other sensitive liquids. The hermetic sealing protects contents from air, contaminants, and microorganisms, ensuring sterility and extended shelf life.

 

  • Operation: The machine operates on the principle of slant travel of ampoules during filling and sealing to accommodate variations in ampoule neck dimensions, thickness, and ovality. Ampoules are transported via a wire mesh conveyor belt or starwheel system, ensuring precise movement through various stations:

 

    • Loading: Sterilized, empty ampoules are fed automatically from a hopper or tray onto a conveyor or rack.
    • Pre-Nitrogen Flushing(optional): Nitrogen gas is injected to displace air, reducing oxidation and contamination risks.
    • Filling: Liquid is precisely dosed using filling mechanisms such as piston pumps, peristaltic pumps, or servo-driven systems. Nozzles center the ampoule neck for accurate filling, with volumes adjustable from 0.5ml to 25ml in a single dose.
    • Post-Nitrogen Flushing(optional): Additional nitrogen is injected post-filling to further ensure sterility.
    • Sealing: Ampoules are sealed using combustible gases (e.g., oxygen and LPG) to melt the glass neck, forming an airtight seal. Pre-warming and rotation units ensure perfect sealing without glass damage.
    • Collection: Sealed ampoules are collected in trays or discharged for inspection and labeling.

Technical Specification of Injection 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 Injection Ampoule Filling Machine

Precision and Accuracy: Ensures exact dosing, minimizing over/under-dosing and material wastage.

Sterility: Automated processes and nitrogen flushing reduce contamination risks, critical for injectables.

High Output: Multi-head configurations (2, 4, 8, or 16 heads) enable high-speed production to meet large-scale demands.

Versatility: Suitable for various industries (pharmaceutical, biotech, cosmetics, chemicals) and liquid types (aqueous, viscous, or powders).

Ease of Use: User-friendly interfaces and minimal training requirements, with detailed documentation provided by manufacturers.

Durability: Stainless steel construction ensures long-term reliability and compliance with regulatory standards.

Flexibility: Tool-less changeovers and adjustable filling volumes accommodate diverse ampoule sizes and production needs.

Safety: Automated sealing with combustible gases is managed with safety valves and cooling systems to prevent overheating.

Key Features of Injection Ampoule Filling Machine

  • Construction: Built with stainless steel 316L for contact parts and stainless steel 304 for non-contact parts, ensuring durability, corrosion resistance, and compliance with cGMP. The machine often features a matt finish for aesthetic appeal and ease of cleaning.

 

  • Filling Systems: Offers flexibility with multiple filling options:
    • Piston Pumps: Volumetric filling for high precision (±1% accuracy).
    • Peristaltic Pumps: Ideal for sterile, contamination-free filling.
    • Servo-Driven Systems: Allow touch-screen volume adjustments for enhanced precision and automation.
    • Output Capacity: Varies by model:
      • Single-head machines: ~1,500 ampoules/hour (lab-scale).
      • Four-head machines: ~6,000–7,200 ampoules/hour (medium-scale).
      • Eight-head machines: Up to 12,000–28,000 ampoules/hour (high-speed production).

 

  • Automation: Fully automatic models minimize human intervention, featuring PLC systems and touch-screen HMIs for real-time parameter control, error detection, and fill volume adjustments. Semi-automatic or manual models are available for smaller operations.

 

  • Ampoule Compatibility: Handles open-mouth (Type B/C) and closed-mouth (Type D) ampoules, with tool-less changeover for sizes from 1ml to 30ml.

 

  • Sterility Features: Includes nitrogen flushing, laminar flow compatibility, and isolator systems to maintain Class 100 sterile conditions.

 

  • Safety and Maintenance: Equipped with safety valves, pressure reducers, and stainless steel hoods to channel fumes during sealing. Large bottom openings and tool-less format changes ensure easy cleaning and maintenance.

 

  • Additional Features:
    • Pre-warming stations for perfect sealing.
    • No-ampoule-no-fill sensors to prevent wastage.
    • Waste tip collectors for clean operation.
    • Optional integration with washing, sterilization tunnels, inspection, and labeling systems for a complete production line.

FAQ for Injection Ampoule Filling Machine

We offer four standard models:

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

Custom high-speed models are available up to 36,000 ampoules per hour. Filling range is 0.5ml to 25ml with ±1% accuracy. Ampoule size compatibility: 1ml–30ml (AFS-1) and 1ml–20ml (higher models).

The machine operates on the slant traveling principle, which gently handles ampoules and reduces glass breakage and particle contamination. The process includes:

  • Automatic loading of sterilized ampoules from the hopper
  • Nitrogen pre-flushing to remove oxygen
  • Precise volumetric filling using piston pumps with neck centering
  • Nitrogen post-flushing
  • Neck pre-warming
  • Flame sealing with LPG + Oxygen burners

It features a “No Ampoule – No Filling” system and automatic collection of sealed ampoules. The slant design and automated steps ensure high sterility and minimal human intervention.

Key features include:

    • Nitrogen flushing before, during, and after filling to prevent oxidation
    • SS 316L product contact parts and SS 304 non-contact parts
    • Tool-less quick changeover with minimal parts
    • Ampoule neck centering during flushing and filling
    • Pre-warming station and flame flow meters for perfect sealing
    • “No Ampoule – No Fill/Seal” safety system
    • Compatibility with laminar airflow and isolator systems
    • Optional PLC/HMI and SCADA for advanced control
    • Easy cleaning, low maintenance, and full cGMP compliance

It is widely used in:

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

Main benefits:

  • Excellent filling accuracy (±1%) with very low product wastage
  • Reduced risk of contamination and glass particles due to slant design
  • Fast format changeover and easy validation
  • Compact footprint with high output
  • Enhanced sterility through automation and nitrogen flushing
  • Robust, durable construction with easy maintenance

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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