Injectable Glass Ampoule Washing Machine

Description

Injectable Glass Ampoule Washing Machine is specialized pharmaceutical equipment designed to thoroughly clean and sterilize glass ampoules used for injectable medications, vaccines, or other critical substances. These machines ensure ampoules are free from contaminants, dust, microbes, and pyrogens before filling, maintaining the sterility and safety required for injectable products.


The primary function of an injectable glass ampoule washing machine is to clean the internal and external surfaces of ampoules (typically 1-20ml in size) to eliminate impurities, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards like FDA, EMA, and WHO. This is critical to prevent contamination that could compromise the integrity of the pharmaceutical formulation.

Ampoules are loaded manually or automatically onto an infeed tray or conveyor. The transport system (e.g., feed screw or star wheel) moves them to the washing station, where grippers or clamps invert the ampoules. A series of high-pressure jet washes (using recycled water, purified water, WFI, and compressed air) clean the internal and external surfaces. Nozzles track and insert into ampoules for precise cleaning, controlled by solenoid valves or PLC. After washing, ampoules are dried with filtered compressed air and discharged via an outfeed system (e.g., feed worm or conveyor) to a sterilization tunnel or filling line under sterile conditions.

Working Principle of Injectable Glass Ampoule Washing Machine

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 Injectable Glass Ampoule 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 Washing Machine

Advantages of Injectable Glass Ampoule Washing Machine

Superior Cleaning Efficiency for Injectables

cGMP & Regulatory Compliance

High Production Capacity & Speed

Minimal Risk of Cross-Contamination

Robust & Durable Construction

Washing Cycle of Injectable Glass Ampoule 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

Importance in Injectable Manufacturing

  • Sterility and Safety: Ensures ampoules are free from microbial contaminants and pyrogens, critical for injectable drugs.

 

  • Regulatory Compliance: Meets stringent standards with features like SCADA integration for data accuracy and traceability.

 

  • Efficiency: High-speed models support large-scale production, while small-batch machines cater to R&D needs.

 

  • Reduced Contamination: Advanced filtration and sterile environments minimize contamination risks.

Key Features of Injectable Glass Ampoule Washing Machine

  • Construction and Materials:
    • Built with stainless steel (SS 316L for contact parts, SS 304 for non-contact parts) to ensure durability, corrosion resistance, and compliance with GMP standards.
    • Equipped with high-quality grippers or manipulators (often made of non-toxic materials like polyamine) to securely hold and invert ampoules during washing, minimizing breakage.
    • Acrylic or polycarbonate covers for visibility and safety, with mechanisms to stop operation if the cover is lifted.

 

  • Washing Mechanism:
    • Ultrasonic Cleaning: Utilizes ultrasonic waves to dislodge particles and contaminants from the ampoule surfaces, followed by jet washing.
    • Multi-Stage Washing Process: Typically involves 6-9 washing cycles, including:
      • Recycled Water Wash: Initial cleaning with filtered recirculated water.
      • Compressed Air Blow: Removes water and debris from internal and external surfaces.
      • Purified Water Wash: Further cleaning with purified water.
      • Water for Injection (WFI) Wash: Final rinse with highly purified WFI to ensure sterility.
      • Final Air Drying: Uses 0.22µm filtered compressed air to dry the ampoules.
    • Independent needles for water, compressed air, and WFI prevent cross-contamination, with nozzles inserted into ampoules for precise internal cleaning.

 

  • Types of Machines:
    • Rotary Washing Machines: Operate in a rotary motion, suitable for high-output production (up to 600 ampoules per minute). Ampoules are held by grippers, inverted, and cleaned in a continuous process.
    • Linear Washing Machines: Automatically load ampoules onto a conveyor with pockets for washing, ideal for automated high-throughput lines.
    • Multijet Ampoule Washers: Semi-automatic machines for small to medium-scale operations, suitable for R&D or laboratories, handling 30-160 ampoules per minute.

 

  • Operational Features:
    • Gripper System: Holds ampoules by the neck, inverts them for washing, and releases them post-cleaning via a feed worm system for upright discharge.
    • Transport System: Uses conveyors, star wheels, or feed screws for precise ampoule movement, ensuring stability and minimal breakage (breakage rate ≤0.5%).
    • PLC and HMI Control: Programmable Logic Controllers (PLC) and Human-Machine Interfaces (HMI) allow precise control, monitoring, and adjustment of washing cycles. Some models include timer-operated solenoid valves or microprocessor-controlled sequences.
    • Filtration Systems: Incorporate 3µm polyethersulfone filters for recycled water, 0.22µm filters for WFI, and 0.22µm PTFE filters for compressed air to ensure sterile cleaning media.

 

  • Additional Features:
    • Energy Efficiency: Independent needle systems reduce water and air loss, saving energy.
    • Sterile Environment: Operates under Laminar Air Flow (LAF) or in cleanrooms with open/closed Restricted Access Barrier Systems (oRAB/cRAB) to minimize contamination risks.
    • Versatility: Can wash vials or oral liquid bottles with minimal change parts. Some models can be adapted for penicillin bottles.
    • Low Maintenance: Simple structure with accessible parts for easy cleaning and maintenance.

FAQ for Injectable Glass Ampoule Washing Machine

The machine is available in two main models:

  • AVRW 120: Output up to 100 ampoules per minute
  • AVRW 240: Output up to 200 ampoules per minute

It is suitable for medium to large-scale pharmaceutical production of injectable products.

The machine handles glass ampoules ranging from 1ml to 10ml (extendable up to 20ml in some configurations).

  • Ampoule Diameter: 9 mm to 21.5 mm
  • Ampoule Height: 60 mm to 140 mm

Change parts are provided for different sizes, and the washing sequence can be customized as per requirement.

Ampoules are fed via an infeed tray and star wheel. Grippers pick them up, invert them neck-down, and move them over stationary washing needles across 6 internal washing stations (with 3 water washes + 3 compressed air washes). External washing is also performed simultaneously. Independent circuits for each zone prevent cross-contamination. After washing, ampoules are re-inverted neck-up and discharged to an output tray or directly to a sterilization tunnel. The typical cycle is: Recycled Water → Air → DM Water → Air → WFI → Air.

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

  • Power: 4 HP (AVRW 120) / 5.5 HP (AVRW 240), 440V, 3 Phase, 50 Hz
  • Compressed Air: 20 CFM
  • Water consumption: 200–500 liters per hour (depending on ampoule size)

Optional features include PLC with HMI, separate pumping station with 3 tanks, recirculation system, and safety cabinet.

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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