Ampoule Vial Washing Machine

Description

Ampoule Vial Washing Machine is specialized equipment used in pharmaceutical, biotechnology, and related industries to clean and sterilize ampoules (small sealed glass vials) and vials before they are filled with medications, vaccines, or other sensitive products. These machines ensure the removal of contaminants such as dust, particles, chemical residues, and endotoxins to meet stringent Good Manufacturing Practices (GMP) standards and ensure product safety and quality.

The primary purpose of an Ampoule Vial Washing Machine is to clean the internal and external surfaces of ampoules and vials to eliminate contaminants, including particulate matter, microorganisms, chemical traces, and endotoxins. This ensures the containers are sterile and safe for filling with injectable drugs, vaccines, or other sterile solutions, preventing contamination that could compromise product efficacy or patient safety.

Ampoule Vial Washing Machines are critical for ensuring the sterility and cleanliness of containers in pharmaceutical and biotech production. Available in rotary, linear, multijet, and high-speed variants, these machines use advanced jet-washing technology, multiple cleaning stations, and GMP-compliant materials to achieve high-quality cleaning. With features like automated control, low breakage rates, and efficient water/air usage, they meet the rigorous demands of sterile manufacturing while supporting validation and regulatory compliance.

 

  • Recycled Water: Used for initial internal and external washes, filtered through 3µm polyethersulfone filters.

 

  • Purified Water: Used for subsequent washes to ensure cleanliness.

 

  • Water for Injection (WFI): Used for final internal wash to achieve sterility.

 

  • Compressed Air: Filtered through 0.22µm PTFE filters for drying and removing water residues.

 

  • Optional Siliconization: Applied as per customer requirements for specific vial types.

Working Principle of Ampoule Vial Washing Machine

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 Ampoule Vial Washing Machine

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 Ampoule Vial Washing Machine

Washing Cycle of Ampoule Vial Washing Machine

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

Performance Qualification of Ampoule Vial Washing Machine

Endotoxin Decontamination: Achieves at least a three-log reduction in endotoxin levels.

Particulate Decontamination: Removes insoluble particles, with limits of ≤25 particles (10µm) and ≤3 particles (25µm).

Glass Particle Challenge: Ensures no glass particles remain post-washing.

Chemical Decontamination: Removes soluble contaminants like sodium chloride, confirmed by the absence of precipitation or chloride content.

Key Components of Ampoule Vial Washing Machine

  • In-feed Tray/Conveyor: Facilitates loading of ampoules/vials.

 

  • Gripper System: Holds containers by the neck, inverts them for washing, and releases them post-washing.

 

  • Washing Unit: Equipped with multiple nozzles (e.g., 18–36 jets) for internal and external cleaning.

 

  • Transport System: Includes conveyors, star wheels, or rotary gripper rings for moving containers.

 

  • Pumps and Tanks: Typically 3 pumps and tanks (25 liters each) for recirculated water, purified water, and WFI.

 

  • Filters: Use polyethersulfone (3µm for recycled water, 0.22µm for WFI) and PTFE (0.22µm for compressed air) filters to ensure sterility.

 

  • Control System: PLC and HMI for automated control, monitoring, and compliance with cGMP and 21CFR Part 11 standards.

 

  • Needle Anti-Shake Device: Improves accuracy and reduces breakage during high-speed operations.

 

  • Stainless Steel Construction: Contact parts made of AISI 316L SS, non-contact parts of AISI 304 SS or FDA-approved materials for GMP compliance.

FAQ for Ampoule Vial Washing Machine

The machine is available in two main models:

  • AVRW 120: Up to 100 ampoules/vials per minute
  • AVRW 240: Up to 200 ampoules/vials per minute (high-speed model)

Output is adjustable with a digital speed indicator, making it suitable for medium to large-scale production.

It handles:

  • Glass ampoules: 1ml to 10ml (diameter 9mm to 21.5mm, height 60mm to 140mm)
  • Glass vials: Similar range with interchangeable change parts

The machine uses a gripper system that holds containers by the neck, allowing flexible washing of both ampoules and vials with quick changeover.

Containers are fed via an infeed tray and starwheel. Grippers hold them by the neck, invert them neck-down, and pass them over 6 internal washing stations (3 water washes + 3 air washes). External washing is done simultaneously with 3 adjustable stations. Each zone has independent circuits to prevent cross-contamination. A typical sequence includes Recycled Water → Air → DM Water → Air → WFI → Air. After washing, containers are re-inverted upright and discharged. Features like needle anti-shake and recirculation reduce breakage and media consumption.

All product-contact parts are made of AISI 316L Stainless Steel, while non-contact parts use AISI 304 Stainless Steel and FDA-approved engineering plastics for full cGMP compliance. Utilities required:

  • Power: 4 HP (AVRW 120) / 5.5 HP (AVRW 240), 440V, 3 Phase, 50 Hz
  • Compressed Air: 20 CFM (filtered)
  • Water: 200–500 liters per hour (Recycled Water, DM Water, WFI)

Optional features include PLC with HMI, separate pumping station with 3 tanks, recirculation system, siliconization, safety cabinet, and No-Vial-No-Wash system.

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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