Aseptic Glass Ampoule Washing Machine

An Aseptic Glass Ampoule Washing Machine is specialized equipment designed for the pharmaceutical industry to clean glass ampoules before filling, ensuring they meet stringent hygiene and sterility standards. These machines are critical for aseptic processing, removing contaminants such as particulates (glass, fibers), pyrogens, and residues to ensure patient safety and compliance with Good Manufacturing Practice (GMP) standards.

Ampoule Washing Machine Video

Key Features and Description:

1. Purpose and Application:

   • Used to clean glass ampoules (typically 1ml to 20ml) for pharmaceutical, biotech, veterinary, or chemical applications.

   • Ensures removal of at least 3 log of particulate contamination, preparing ampoules for sterile filling.

2. Washing Process:

   • Rotary Washing: Ampoules are held by grippers, inverted, and rotated through multiple washing stations in a continuous motion. Servo-driven nozzles clean the interior with recycled water, purified water, and Water for Injection (WFI), followed by compressed air to remove residual water. External surfaces are cleaned with water and air jets.

   • Linear Washing: Ampoules move in a straight line through washing stations, including ultrasonic cleaning, compressed air, and water washes.

   • Typical washing cycle includes:

     • Ultrasonic washing to dislodge particles.

     • Multiple internal washes (e.g., recycled water, purified water, WFI).

     • External washing with pressurized water jets.

     • Compressed air blowing for drying.

3. Design and Construction:

   • Made of high-quality stainless steel (SS 316L for contact parts, SS 304 for non-contact parts) for durability and compliance with cGMP standards.

   • Compact design for integration into filling lines, often paired with sterilizing tunnels for continuous processing.

   • Features like stationary nozzles reduce contamination risks, and some models include ultrasonic pre-washing systems.

4. Key Specifications:

   • Capacity: Can handle high volumes, up to 10,000 ampoules per hour, depending on the model.

   • Ampoule Size: Suitable for 1ml to 20ml ampoules, with change parts for flexibility.

   • Washing Stations: Typically 6–7 stations for internal and external cleaning, customizable based on requirements.

   • Control Systems: Equipped with PLC and touch-screen interfaces for automated control, monitoring water/air pressure, temperature, and fault diagnostics.

   • Safety Features: “No Ampoule – No Washing” system to prevent resource wastage, and automatic shut-off if acrylic covers are opened.

5. Sterility and Compliance:

   • Designed for cleanroom integration, often with laminar airflow to maintain aseptic conditions.

   • Complies with GMP, FDA, and 21 CFR Part 11 standards, ensuring traceability and quality control.

   • Some models feature HEPA filters and glove ports for enhanced sterility.

6. Maintenance and Operation:

   • Easy-to-clean design with large openings and removable parts for sterilization.

   • Stationary nozzles and separate solenoid valves for each washing cycle reduce contamination and simplify maintenance.

   • High-capacity centrifugal pumps and portable stands for pumps/tanks enhance accessibility.

7. Integration:

   • Can operate as a standalone unit or as part of a complete ampoule production line, including sterilizing tunnels, filling, and sealing machines.

   • Compatible with upstream and downstream equipment like depyrogenation tunnels and inspection systems.

Benefits:

• Ensures high cleanliness and sterility, critical for injectable drug production.

• Reduces contamination risks, protecting operators and patients.

• High-speed operation with minimal resource wastage.

• Flexible for various ampoule sizes and customizable washing sequences.

Salient Features of Aseptic Glass 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 Aseptic 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.

 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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