Automatic Ampoule Vial Washer

Description

Automatic Ampoule Vial Washer is a specialized pharmaceutical machine designed to clean and sterilize glass ampoules and vials, ensuring they meet stringent cGMP (current Good Manufacturing Practices) standards for sterility and hygiene in pharmaceutical, biotech, and veterinary applications. The Automatic Ampoule Vial Washer is a high-precision, automated system engineered to wash ampoules (typically 1ml to 20ml) and vials (2ml to 100ml) with minimal contact between machine parts and containers to prevent contamination. It is designed to clean both the internal and external surfaces of containers, ensuring they are sterile and free of contaminants before filling with injectables or other pharmaceutical products. The machine is commonly used in high-volume production lines, offering efficient, reliable, and repeatable cleaning processes.

Typical Models

 

  • AVRW-120: Automatic washer with up to 100 containers per minute.

 

  • AVRW-240: High-speed washer with up to 200 containers per minute.

 

  • LI MW 340: Semi-automatic model for versatile operations, handling 1ml to 20ml ampoules and 2ml to 100ml vials.

Working Principle of Automatic Ampoule Vial Washer

Ampoules and vials 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 and vials.

On completion of a cycle, washed Ampoules and vials 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 Vial 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 Automatic Ampoule Vial Washer

Applications of Automatic Ampoule Vial Washer

Benefits of Automatic Ampoule Vial Washer

Compliance: Meets cGMP, GAMP, and 21 CFR Part 11 standards, ensuring regulatory adherence.

Efficiency: High throughput and automation reduce manual labor and increase productivity.

Sterility: Minimizes contamination risks through non-contact washing and segregated stations.

Flexibility: Adjustable washing sequences and change parts accommodate various container sizes and production needs.

Key Features of Automatic Ampoule Vial Washer

  • Rotary or Linear Design:
    • Rotary Washers: Utilize a rotary mechanism (e.g., Geneva mechanism or servo-driven systems) where ampoules/vials are held by grippers, inverted, and passed through multiple washing stations in a continuous motion. This design maximizes washing time and throughput, with models like the AVRW-120 (up to 100 containers/min) and AVRW-240 (up to 200 containers/min).
    • Linear Washers: Process containers in a straight-line configuration, ideal for high-speed aseptic filling lines, with outputs ranging from 120 to 240 vials per minute.

 

  • Washing Process:
    • Internal Cleaning: Uses pressurized jets of Water for Injection (WFI), purified water, or sterile air delivered through washing needles that penetrate the container without touching the interior walls, ensuring thorough cleaning. Typically includes multiple stations (e.g., 6 internal cleaning stations with 36 needles total).
    • External Cleaning: Employs water and air jets to clean the outer surface, removing residual product or contaminants, critical for cytotoxic materials or post-filling processes.
    • Customizable Wash Sequence: Allows flexibility to adjust washing cycles (e.g., recycled water, purified water, WFI, and air washes) based on customer requirements.

 

  • Gripper System:
    • A specialized gripper holds ampoules/vials by the neck, inverts them for washing, and releases them in a vertical position post-washing, ensuring positive cleaning with minimal contact.

 

  • Material and Construction:
    • Contact Parts: Made from AISI 316L stainless steel or FDA-approved materials (e.g., polycarbonate, HDPE) to ensure compatibility with cleaning media and prevent corrosion.
    • Non-Contact Parts: Constructed from AISI 304 stainless steel or engineering plastics for durability and compliance with cGMP standards.

 

  • Automation and Control:
    • Equipped with PLC (Programmable Logic Controller) and HMI (Human-Machine Interface) for automated operation, cycle control, and monitoring. Some models include password-protected programming and compliance with 21 CFR Part 11 for software validation.
    • Features like “No Vial – No Washing” systems and automatic stoppage when the acrylic cover is lifted enhance safety and efficiency.

 

  • Washing Media Efficiency:
    • Incorporates low WFI consumption through recirculation systems or pressure tanks for continuous supply.
    • Some models feature air-vacuum pre-cleaning and segregated washing stations to prevent cross-contamination.

 

  • Capacity and Versatility:
    • Suitable for a range of container sizes (1ml to 20ml for ampoules, 2ml to 100ml for vials) with change parts for quick adaptability.
    • High-speed models can process up to 30,000 vials per hour, while standard models handle 100–240 containers per minute.

 

  • Additional Features:
    • Optional ultrasonic washing for enhanced cleaning of stubborn residues.
    • External washing stations for thorough cleaning of container exteriors.
    • Modular designs for scalability and integration with filling and sealing lines.

FAQ for Automatic Ampoule Vial Washer

The machine is suitable for a wide range of glass containers:

  • Ampoules: 1ml to 10ml (and up to 20ml with change parts)
  • Vials: 2ml to 30ml (standard pharmaceutical vial sizes)

It supports ampoule/vial diameters from 9mm to 25mm and heights up to 140mm (depending on the model). Change parts are available for different container sizes.

We offer two standard models:

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

Output speed is variable and adjustable according to container size and cleaning requirements. The machine is designed for low breakage rate (≤ 0.5%) thanks to its gentle neck-holding system.

Containers are loaded onto the infeed tray or conveyor and transferred to the infeed starwheel. Special grippers hold them by the neck, invert them (neck downward), and carry them over multiple washing needles. The washing cycle typically includes 3–4 water washes (recycled water, DM water, WFI) and 3 air washes with independent circuits. After washing, containers are re-inverted to the upright position and discharged via the output starwheel, ready for sterilization or filling.

All product-contact and wash media parts are made from AISI 316L stainless steel, while non-contact parts use AISI 304 stainless steel. The machine is a complete cGMP model and comes with IQ/OQ/DQ documentation (21 CFR Part 11 compliant controls optional).

Utilities required:

  • Power: 4 HP (AVRW 120) or 5.5 HP (AVRW 240), 440V, 3 Phase, 50 Hz
  • Compressed Air: 20 CFM
  • Water consumption: 200–500 liters/hour (model & size dependent)

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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