Ampoule Vial Washing Machine

Description

An Ampoule Vial Washing Machine is a specialized, high-precision piece of equipment widely used in the pharmaceutical, biotechnology, veterinary, and injectable manufacturing industries. It is designed to thoroughly clean and sterilize glass ampoules (small sealed vials) and standard vials before they are filled with medications, vaccines, biologics, or other sensitive sterile products. By effectively removing contaminants such as dust, particles, chemical residues, endotoxins, fibers, and microorganisms, these machines play a critical role in maintaining product safety, efficacy, and regulatory compliance.

 

In an industry where even microscopic contamination can lead to serious health risks or product recalls, an ampoule vial washing machine ensures that every container meets stringent Good Manufacturing Practices (GMP) and cGMP standards set by regulatory bodies like the FDA, EMA, and WHO.

 

Ampoules and vials serve as primary containers for injectable drugs, vaccines, and high-value biologics. Any residual contaminants on internal or external surfaces can compromise the sterility, stability, and potency of the final product. Manual cleaning methods are inconsistent, time-consuming, and prone to introducing new contaminants. Automated pharmaceutical ampoule vial washing machines eliminate these risks through validated, repeatable processes that deliver superior cleanliness and sterility assurance.

Working Principle of Ampoule Vial Washing Machine

Ampoules and vials are transferred from the infeed tray onto an infeed feed worm and then onto the infeed star wheel. Grippers pick up each ampoule from the infeed star wheel and invert it into a neck-down position over the washing needles. The ampoules travel in this neck-down orientation along with the needle bar, allowing maximum washing time once the needles enter the ampoule neck.

 

The machine is equipped with six independent washing stations, each fitted with six needles, for thorough internal cleaning. The washsing sequence can be adjusted according to process requirements. In addition, the washer provides external washing to ensure complete cleaning of both ampoules and vials.

 

After the washing cycle is completed, the ampoules and vials are inverted back to the neck-up position and transferred to the output star wheel. Washed containers can either be collected on the output tray or pushed directly into a sterilization tunnel. An optional separate pumping station supplies the required volume of water at the desired pressure. In the absence of a separate pumping station, a re-circulation and siliconization system can be provided on request.

 

Internal Cleaning

The machine features six internal cleaning stations, each with six cleaning needles, giving a total of 36 needles. Each station is supplied through a dedicated pipe connected to the cleaning media manifold. This design reduces the risk of particle generation, simplifies maintenance and cleaning, and saves time.

 

External Cleaning

Three external cleaning stations are mounted in a fixed position above the ampoules. These stations can be easily adjusted for height, angle, and lateral position. Each station receives cleaning media through a pipe connected to the washing media manifold.

 

Cleaning Media Principle

WFI (Water for Injection), purified water, and air cleaning stations operate in synchronization with the ampoule movement through a reciprocating motion. The system is designed so that the media are dispensed only when the needles move in the forward direction. WFI consumption is further reduced by collecting used WFI in a re-circulating water tank, which is then reused 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.

Yes — Adinath International Ampoule Vial Washing Machine complies to cGMP, MHRA, FDA and WHO-GMP standards, with optional CE marked equipments and 21 CFR Part 11 software compliance for the HMI/PLC. Machine contact parts having Stainless Steel 316L grade materials with validation documents having IQ, OQ, DQ validation protocols as optional. Organization is ISO 9001:2015 certified.

Manufacturing lead time is generally 7 to 14 weeks from order confirmation. Further it takes 2 to 8 weeks for international shipping depending upon destination. Order can be expediate sooner or later as per specific buying requirements. Destination specific certifications like US FDA, EU, ANVISA, SFDA. CE can add 3 to 6 weeks additionally.

Yes, Adinath International Ampoule Vial Washing Machine export this machine to more than 48 countries of this world including America, Europe, Asia, Middle East, Africa, CIS and Australia sub continents. Please visit our clientele page for complete list of our customers worldwide. Located at Ahmedabad, India having world class infrastructure.

Service of skilled engineers and technicians provided for technical support of supplied equipments. Installations, commissioning, training and IQ, OQ, DQ validations performed by qualified engineers. Remote support through video call, phone, email and other modes provided for international installations. Spare parts of “Machine name” stocked at our premises in Ahmedabad and shipped immediately after ordering. Standard 12 months manufacturing warranty included with supplied equipment.

Countries We Export to

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

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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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