Rotary Ampoule Washer

A Rotary Ampoule Washer is a specialized, high-speed pharmaceutical machine designed to aseptically clean glass ampoules and vials, typically used for injectable medications, vaccines, or other sterile substances. It ensures compliance with cGMP (current Good Manufacturing Practices) standards by minimizing contact between machine parts and containers to prevent contamination.

Rotary Ampoule Washer Video

Key Features and Design

• Structure: Made of stainless steel (SS 304 for the frame, SS 316 for contact parts), ensuring durability, hygiene, and resistance to corrosion.

• Rotary Mechanism: Ampoules are fed into a rotating platform via an infeed tray, worm, or star wheel. A gripper system holds ampoules by their necks, inverts them for cleaning, and returns them to an upright position for discharge.

• Capacity: Suitable for washing 1 ml to 100 ml ampoules or 2 ml to 100 ml vials, with output speeds ranging from 70 to 400 units per minute, depending on the model.

• Washing Process: Features multiple cleaning stations that use a combination of:

  • Internal Cleaning: High-pressure jets of purified water, Water for Injection (WFI), or compressed air delivered through needles to clean the inside of ampoules.

  • External Cleaning: Stationary or adjustable nozzles spray cleaning media (e.g., WFI, purified water, or air) on the exterior.

  • Customizable Cycles: Cycles can include air wash, recycled water, DM (demineralized) water, WFI, and compressed air for drying, tailored to specific requirements.

• Aseptic Design: Minimizes cross-contamination with efficient movement between stations and segregation of recycled and virgin cleaning solutions.

• Additional Features:

  • Acrylic covers for visibility and safety, with automatic stop if the cover is opened.

  • Quick changeover systems for different ampoule/vial sizes using change parts.

  • Water-saving mechanisms, such as recirculation tanks for pre-washing.

  • Optional ultrasonic stations for precise cleaning and water filtration units for purity.

  • PLC (Programmable Logic Controller) and HMI (Human-Machine Interface) for automated control and customizable washing sequences.

Working Process

1. Infeed: Ampoules are loaded from a tray onto an infeed worm or star wheel.

2. Gripping and Inversion: A specially designed gripper mechanism holds ampoules by the neck, inverts them, and positions them over washing needles.

3. Washing: Ampoules undergo sequential internal and external cleaning with water and air jets across multiple stations. For example:

   • 1st: Recycled WFI
   • 2nd: Compressed air
   • 3rd: DM water
   • 4th: Compressed air
   • 5th: Fresh WFI
   • 6th: Compressed air for drying

4. Discharge: Cleaned ampoules are reinverted to an upright position and transferred to an output star wheel or tray, often feeding into a tunnel oven for sterilization or filling.

Applications

• Widely used in pharmaceutical, veterinary, and biotech industries for cleaning ampoules and vials before filling with sterile liquids.

• Suitable for high-volume production due to its high-speed, continuous-motion design.

Benefits

• High Efficiency: High-speed operation with minimal breakage due to rotary design.

• Sterility: Meets stringent hygiene standards for injectable products.

• Flexibility: Adjustable for various ampoule/vial sizes with quick changeovers.

• Low Resource Use: Optimized water and air consumption, with recirculation options.

• Reliability: Robust stainless steel construction and GMP-compliant materials ensure long-term performance.

Conclusion

Rotary Ampoule Washers are critical for ensuring the sterility and cleanliness of ampoules and vials in pharmaceutical production. Their rotary design, automated gripping systems, and customizable washing cycles make them efficient and versatile for high-speed, aseptic cleaning, meeting the stringent demands of the industry.

Salient Features of Rotary Ampoule Washing Machine

• 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 Rotary 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.

Technical Specification of Rotary 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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