Automatic Ampoule Washer

An Automatic Ampoule Washer is a specialized pharmaceutical machine designed to clean and sterilize the internal and external surfaces of ampoules (small sealed glass containers) before filling with pharmaceuticals, medical solutions, or other liquids. These machines ensure compliance with Good Manufacturing Practices (cGMP) by minimizing contamination risks and maintaining sterility, which is critical for pharmaceutical, veterinary, and biotech industries.

he Automatic Ampoule Washer is engineered to wash ampoules with minimal contact between machine parts and the containers to prevent contamination. It typically features a gripper system that holds ampoules by the neck, inverts them for cleaning, and returns them to an upright position after washing. The machine is designed to handle a range of ampoule sizes (commonly 1ml to 20ml) with the use of interchangeable parts, ensuring versatility for different production needs. It employs a combination of water and air jets to thoroughly clean both the internal and external surfaces of ampoules, removing impurities, dust, and microbes to ensure sterility.

Automatic Ampoule Washer Video

Key Features

• cGMP Compliance: Constructed with materials like AISI 316L stainless steel for contact parts and AISI 304 or FDA-approved materials for non-contact parts, ensuring durability and regulatory compliance.

• Gripper Mechanism: A specially designed system holds ampoules by the neck, inverts them for washing, and minimizes contact to reduce contamination risks.

• Customizable Washing Cycles: Typically includes multiple washing stages, such as:

  • Recycled water (e.g., WFI – Water for Injection)

  • Demineralized water

  • Compressed air washes

  • Optional detergent or heated water cycles

  • The sequence can be adjusted based on specific requirements.

• High Throughput: Capable of processing up to 120–400 ampoules per minute, depending on the model, making it suitable for large-scale production.

• PLC-Based Control System: Equipped with a Programmable Logic Controller (PLC) and user-friendly interface for precise monitoring, control, and customization of washing parameters. Features like digital speed indicators and container counters enhance operational efficiency.

• Low Water and Air Consumption: Designed for efficiency with independent circuits for each washing zone to prevent cross-contamination.

• Safety and Maintenance: Includes emergency stop functions, easy-to-clean components, and protective enclosures for operator safety and reduced downtime.

Working Principle

1. Infeed Process: Ampoules are fed from an infeed tray onto a feedworm or conveyor, then transferred to an infeed star wheel.

2. Gripper Operation: Grippers pick up ampoules by the neck, invert them (neck down) over washing needles, and move them through the cleaning process.

3. Washing Stages: Ampoules undergo a series of cleaning cycles, typically involving:

   • Water jets (e.g., recycled water, WFI, or demineralized water) to clean internal and external surfaces.

   • Compressed air jets to remove water and dry the ampoules.

   • Optional detergent or heated water for specific cleaning needs.

4. Outfeed Process: After washing, grippers invert the ampoules back to an upright position and release them onto an output star wheel or tray for collection or further processing (e.g., transfer to a sterilization tunnel or filling machine).

5. Optional Features: Some models include separate pumping stations for precise water pressure control, recirculation systems, or siliconization for enhanced cleaning.

Applications

The Automatic Ampoule Washer is widely used in:

• Pharmaceutical Industry: For cleaning ampoules before filling with injectable drugs or vaccines.

• Veterinary and Biotech Industries: To ensure sterile containers for sensitive biological products.

• Cosmetic and Chemical Industries: For cleaning ampoules used in specialized applications.

Advantages

• Sterility and Hygiene: Ensures ampoules are free from contaminants, critical for patient safety.

• Efficiency: High-speed operation and automation reduce manual intervention and increase productivity.

• Flexibility: Adjustable washing sequences and compatibility with various ampoule sizes.

• Compliance: Meets stringent regulatory standards.

• Ease of Integration: Can operate standalone or be integrated with filling, sealing, or labeling lines.

Conclusion

The Automatic Ampoule Washer is a critical component in pharmaceutical manufacturing, ensuring ampoules are sterile and free of contaminants before filling. Its advanced gripper system, customizable washing cycles, and compliance with cGMP standards make it an essential tool for maintaining product quality, safety, and regulatory compliance in high-throughput production environments.

Salient Features of Automatic Ampoule Washer

• Complete cGMP model.

• Production output capacity up to 200 ampoules per minute.

• All contact parts with the internal surface of Container and the wash media are made from AISI 316L Stainless Steel.

• Non-contact parts are made from engineering plastic, AISI SS 304 materials.

• All finishes, welding joints are processed, treated & equipment selected in accordance with cGMP standards.

• Machine provides 3 water washes & 3 Air washes.

• Complete flexibility with user for washing cycle.

• 18 Jets for 6 internal washing zones.

• 15 Cassette of Grippers each having 2 Grippers.

• Suitable for 1ml to 10ml ampoules.

• Washing sequence can be adjusted as per customer’s requirements.

• 3 Pumps and 3 Tanks of 25 liters each. (Optional)

• Each washing zone with independent circuit to avoid contamination.

• Automatic Infeed and Exit of containers.

• Machine is equipped with PLC system & printing facility with passwords. (Optional)

• Container unit counter with display in the control panel

• Machine can use as a sole machine or inline.

• Digital speed indicator for current output

• IQ/OQ/DQ validation documentation can be provided.

• Programming and software validation as per 21 CFR Part 11 can be done on demand.

Process Operation of Automatic Ampoule Washer

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.

 Washing Cycle of Ampoule Washing Machine

• 1^st wash            –           Recycled Water (WFI)
• 2^nd wash          –           Compressed Air
• 3^rd wash           –           DM Water
• 4^th wash           –           Compressed Air
• 5^th wash           –           Water for Injection (WFI)
• 6^th wash           –           Compressed Air

Technical Specification of Automatic Ampoule Washer

* 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.

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