Injectable Glass Ampoule Washing Machine

Description

An Injectable Glass Ampoule Washing Machine is specialized pharmaceutical equipment designed to thoroughly clean and prepare glass ampoules used for injectable medications, vaccines, and other critical sterile substances. These high-precision machines ensure ampoules are completely free from contaminants, dust, microbes, pyrogens, and particulate matter before filling, maintaining the stringent sterility and safety standards required for parenteral products.

 

Injectable drugs demand the highest level of purity. Even minor contamination in glass ampoules can lead to product recalls, regulatory issues, or serious patient health risks. An injectable glass ampoule washing machine addresses this by delivering consistent, validated cleaning of both internal and external surfaces. It plays a vital role in the aseptic processing chain, preparing containers for filling, sealing, and final sterilization.

Working Principle of Injectable Glass Ampoule Washing Machine

Ampoules fed from the infeed tray are received by the infeed feed worm and then transferred to the infeed star wheel. Grippers pick up each ampoule from the infeed star wheel, invert it into the neck-down position over the washing needles, and move it along with the needle bar for washing. Traveling in the neck-down position above the washing needles and moving with the needle bar ensures maximum washing time once the needles enter the ampoule neck. The machine has six different washing stations, each equipped with six needles for optimum washing; the sequence can be adjusted as required. The washer also includes an external wash for thorough cleaning of the ampoules.

 

At the end of the cycle, the washed ampoules are inverted back to the neck-up position and transferred to the output star wheel. Ampoules received from the output star wheel can be collected on the output tray or pushed into a tunnel. An optional separate pumping station supplies the correct 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 AVRW is equipped with six internal cleaning stations, each having six cleaning needles, for a total of 36 cleaning needles. Each station is supplied through a pipe connected to the cleaning media-making washing area. 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 stationary position above the ampoules and can be easily adjusted for height, angle, and lateral position. Each station receives cleaning media through a pipe connected to the cleaning media-making washing area.

 

CLEANING MEDIA PRINCIPLE: WFI, purified water, and air cleaning stations are synchronized with the ampoule through reciprocating motion. The design ensures that these media are used only when the needles move in the forward direction. WFI consumption is further reduced by collecting the used WFI in a re-circulating water tank for later use 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.

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