Automatic Ampoule Washing Machine

An Automatic Ampoule Washing Machine is a specialized pharmaceutical device designed to clean and sanitize glass ampoules, ensuring they are free from contaminants before filling with pharmaceuticals, medical solutions, or other liquids. These machines are critical in pharmaceutical, veterinary, and biotech industries to maintain sterility and compliance with Good Manufacturing Practices (cGMP).

Automatic Ampoule Washing Machine Video

Description and Operation

Automatic Ampoule Washing Machines are engineered to clean both the internal and external surfaces of ampoules with minimal contact to reduce contamination risks. They typically feature a rotary or linear design and use high-pressure water and air jets for thorough cleaning. The process is automated, ensuring high throughput, precision, and compliance with stringent hygiene standards.

• Gripper System: A specialized gripper mechanism holds ampoules by the neck, inverts them for washing, and returns them to an upright position post-cleaning. This minimizes contact with machine parts, reducing contamination risks.

• Washing Process: Ampoules are fed from an infeed tray onto a feedworm, then transferred to an infeed starwheel. Grippers pick up the ampoules, invert them over washing needles, and move them through multiple washing stations. After cleaning, ampoules are re-inverted and sent to an output starwheel or tray for downstream processing (e.g., filling or sterilization).

• External Washing: Some machines, like the Automatic External Ampoule Washing Machine, focus on cleaning the external surface post-filling and sealing, using water spray jets and air jets for drying.

Key Features

• Material: Contact parts are made of AISI 316L stainless steel, while non-contact parts use AISI 304 or FDA-approved materials, ensuring durability and cGMP compliance.

• High Throughput: Capable of washing 50–400 ampoules per minute, depending on the model.

• Automation and Control: Equipped with PLC systems and user-friendly HMIs for precise control, monitoring, and password-protected settings. Features include digital speed indicators and container counters.

• Flexibility: Accommodates ampoule sizes from 1 ml to 20 ml (some up to 100 ml) with change parts for different sizes.

• Low Water Consumption: Uses 200–500 liters/hour, depending on ampoule size, with optional recirculation systems.

• Safety and Maintenance: Includes protective enclosures, emergency stop functions, and easy-to-dismantle components for cleaning and maintenance.

Applications

• Pharmaceutical Industry: Ensures ampoules are contaminant-free before filling with drugs or vaccines.

• Veterinary and Biotech: Maintains sterility for sensitive products.

• Integration: Can operate standalone or integrate with filling lines and sterilization tunnels.

Variants

• Rotary Ampoule Washing Machine: Continuous rotary motion for high-speed cleaning.

• Semi-Automatic Multijet Washing Machine: Suitable for smaller batches, using high-pressure spray nozzles for 2 ml to 100 ml ampoules.

• External Ampoule Washing Machine: Focuses on external cleaning post-filling.

Advantages

• Ensures sterility and compliance with cGMP and FDA standards.

• High efficiency with minimal operator intervention.

• Customizable washing sequences and compatibility with various ampoule sizes.

• Reduces contamination risks through minimal contact and advanced filtration systems.

Salient Features of Automatic 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 Automatic 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.

 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 Ampoule Washing Machine

* 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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