Automatic Ampoule Washer

Description

An Automatic Ampoule Washer is a specialized pharmaceutical machine designed to clean and sterilize the internal and external surfaces of ampoules (small sealed glass containers) before filling with pharmaceuticals, medical solutions, or other liquids. These machines ensure compliance with Good Manufacturing Practices (cGMP) by minimizing contamination risks and maintaining sterility, which is critical for pharmaceutical, veterinary, and biotech industries.

 

The Automatic Ampoule Washer is engineered to wash ampoules with minimal contact between machine parts and the containers to prevent contamination. It typically features a gripper system that holds ampoules by the neck, inverts them for cleaning, and returns them to an upright position after washing. The machine is designed to handle a range of ampoule sizes (commonly 1ml to 20ml) with the use of interchangeable parts, ensuring versatility for different production needs. It employs a combination of water and air jets to thoroughly clean both the internal and external surfaces of ampoules, removing impurities, dust, and microbes to ensure sterility.

The Automatic Ampoule Washer is a critical component in pharmaceutical manufacturing, ensuring ampoules are sterile and free of contaminants before filling. Its advanced gripper system, customizable washing cycles, and compliance with cGMP standards make it an essential tool for maintaining product quality, safety, and regulatory compliance in high-throughput production environments.

Working Principle of Automatic Ampoule Washer

Ampoules feed from the Infeed tray are received on an Infeed Feed worm then moves on Infeed starwheel. The Grippers picks up the Ampoule from Infeed Star Wheel and invert it in neck down position over washing needles and move along with the needle bar for Washing. Ampoules traveling in neck down position above washing needles and moves along with the Needle bar ensures maximum time for washing once the needle enter in the Ampoule neck. Machine having six different washing stations each of 6 needles for optimum Washing and the sequence can be adjusted as per requirements. Washer also having external wash for optimum washing of ampoules.

On completion of a cycle, washed Ampoules are again inverted to neck upward position and feed to output star wheel. Washed Ampoules received from output starwheel can be collected on Output Tray or can be pushed to tunnel. A separate pumping station (optional) gives the right quantum of water at the desired pressure. In the absent of separate pumping station, we can provide the re-circulation & siliconization system on request.

INTERNAL CLEANING:

The AVRW is equipped with 6 internal cleaning stations and each station has 6 cleaning needles making up a total of 36 cleaning needles. Each cleaning station is supplied via a pipe connected to the cleaning media-making washing area. This not only reduces the risk of particle generation, but also simplifies maintenance and cleaning efforts while saving time.

 

EXTERNAL CLEANING

The 3 external cleaning stations mounted in a stationary position above the ampoule can be easily adjusted for a specific height, angle and lateral position. Each cleaning station receives cleaning media-making through a pipe connected to the cleaning media-making washing area.

 

CLEANING MEDIA PRINCIPAL:

WFI, Purified water and air cleaning station are synchronized with the ampoule by reciprocating motion. Design is such that these media are put to use only when needles motion in forward direction. WFI consumption is further reduced by collecting the WFI in re-circulating water tank to be used later on in the pre-washing station.

Technical Specification of Automatic Ampoule Washer

Model

AVRW 120

AVRW 240

Production Output

Up to 100 per minute

Up to 200 per minute

Ampoule Diameter

9mm to 21.5mm

9mm to 21.5mm

Ampoule Height

60mm to 140mm

60mm to 140mm

Power Load

4 H.P.

5.5 H.P.

Power Voltage

440 Volts, 3 Phase 50 Hertz, 4 wire system

440 Volts, 3 Phase 50 Hertz, 4 wire system.

Optional Accessories

  • Programmable Logic Control (System) with HMI
  • Safety Cabinet with doors
  • Programmable Logic Control (System) with HMI
  • Safety Cabinet with doors

Utility

  • Air – 20 CFM
  • Water – 200 to 500 liters per hour depend upon ampoule size.
  • Air – 20 CFM
  • Water – 200 to 500 liters per hour depend upon ampoule size.

Water Tank & Pump

3 nos. each with 25 liters Capacity & Centrifugal pump

3 nos. each with 25 liters Capacity & Centrifugal pump

Overall Dimension:

2050mm (L) X 2000mm (W) X 1210mm (H) approx.

2450mm (L) X 2000mm (W) X 1300mm (H) approx.

Net Weight

700 kgs. approx.

900 kgs. approx.

Gross Weight

1000 kgs. approx.

1300 kgs. 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 Washing Machine

Applications of Automatic Ampoule Washer

Advantages of Automatic Ampoule Washer

Sterility and Hygiene: Ensures ampoules are free from contaminants, critical for patient safety.

Efficiency: High-speed operation and automation reduce manual intervention and increase productivity.

Flexibility: Adjustable washing sequences and compatibility with various ampoule sizes.

Compliance: Meets stringent regulatory standards.

Ease of Integration: Can operate standalone or be integrated with filling, sealing, or labeling lines.

Washing Cycle of Automatic Ampoule Washer

1st wash           

Recycled Water (WFI)

2nd wash

Compressed Air

3rd wash          

DM Water

4th wash

Compressed Air

5th wash

Water for Injection (WFI)

6th wash

Compressed Air

Process Operation of Automatic Ampoule Washer

  • Infeed Process: Ampoules are fed from an infeed tray onto a feedworm or conveyor, then transferred to an infeed star wheel.

 

  • Gripper Operation: Grippers pick up ampoules by the neck, invert them (neck down) over washing needles, and move them through the cleaning process.

 

  • Washing Stages: Ampoules undergo a series of cleaning cycles, typically involving:
    • Water jets (e.g., recycled water, WFI, or demineralized water) to clean internal and external surfaces.
    • Compressed air jets to remove water and dry the ampoules.
    • Optional detergent or heated water for specific cleaning needs.

 

  • Outfeed Process: After washing, grippers invert the ampoules back to an upright position and release them onto an output star wheel or tray for collection or further processing (e.g., transfer to a sterilization tunnel or filling machine).

 

  • Optional Features: Some models include separate pumping stations for precise water pressure control, recirculation systems, or siliconization for enhanced cleaning.

Key Features of Automatic Ampoule Washer

  • cGMP Compliance: Constructed with materials like AISI 316L stainless steel for contact parts and AISI 304 or FDA-approved materials for non-contact parts, ensuring durability and regulatory compliance.

 

  • Gripper Mechanism: A specially designed system holds ampoules by the neck, inverts them for washing, and minimizes contact to reduce contamination risks.

 

  • Customizable Washing Cycles: Typically includes multiple washing stages, such as:
    • Recycled water (e.g., WFI – Water for Injection)
    • Demineralized water
    • Compressed air washes
    • Optional detergent or heated water cycles
    • The sequence can be adjusted based on specific requirements.

 

  • High Throughput: Capable of processing up to 120–400 ampoules per minute, depending on the model, making it suitable for large-scale production.

 

  • PLC-Based Control System: Equipped with a Programmable Logic Controller (PLC) and user-friendly interface for precise monitoring, control, and customization of washing parameters. Features like digital speed indicators and container counters enhance operational efficiency.

 

  • Low Water and Air Consumption: Designed for efficiency with independent circuits for each washing zone to prevent cross-contamination.

 

  • Safety and Maintenance: Includes emergency stop functions, easy-to-clean components, and protective enclosures for operator safety and reduced downtime.

FAQ for Automatic Ampoule Washer

We offer two models:

  • AVRW 120: Up to 100 ampoules per minute
  • AVRW 240: Up to 200 ampoules per minute

Both models are suitable for ampoules with diameters of 9mm to 21.5mm and heights of 60mm to 140mm. The output speed is adjustable, and the machine features low breakage rates with gentle neck-holding grippers.

Ampoules are loaded from an infeed tray onto a feed worm and transferred to an infeed starwheel. Grippers pick them up by the neck, invert them (neck down), and move them over washing needles. The machine performs 6 internal washing stations (with 36 needles total) and 3 external washing stations. A typical cycle includes 3 water washes and 3 air washes using independent circuits for recycled water, DM water, WFI, and compressed air. After washing, ampoules are re-inverted to an upright position and discharged via the output starwheel.

All product-contact parts and wash media parts are made from AISI 316L stainless steel, while non-contact parts use AISI 304 stainless steel and engineering plastics. The machine is a complete cGMP model with smooth finishes and welding as per pharmaceutical standards. It comes with IQ/OQ/DQ validation documentation and optional 21 CFR Part 11 compliant PLC & HMI systems with password protection and printing facility.

The machine requires:

  • Power: 4 H.P. (AVRW 120) or 5.5 H.P. (AVRW 240) — 440 Volts, 3 Phase, 50 Hz (customizable)
  • Compressed Air: 20 CFM
  • Water: 200 to 500 liters per hour (depending on ampoule size and model)

It also supports 3 optional 25-liter water tanks with centrifugal pumps. A separate pumping station and recirculation system are available on request.

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

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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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