Automatic Glass Ampoule Washing Machine

An Automatic Glass Ampoule Washing Machine is specialized equipment designed for cleaning glass ampoules used in pharmaceutical, biotech, veterinary, and cosmetic industries. These machines ensure thorough internal and external cleaning of ampoules to remove contaminants, residues, or particles, maintaining sterility and compliance with Good Manufacturing Practices (cGMP).

Automatic Glass Ampoule Washing Machine Video

Key Features and Description:

1. Purpose and Application:

   • Designed to clean glass ampoules (typically 1 ml to 20 ml) before filling and sealing to ensure a sterile, contaminant-free environment for pharmaceutical products like injectables, vaccines, or other liquid medications.

   • Used in industries requiring high hygiene standards, such as pharmaceuticals, veterinary, and biotech, to prevent contamination and ensure patient safety.

2. Design and Construction:

   • Material: Constructed primarily from high-quality stainless steel (AISI SS 316L for contact parts, SS 304 for non-contact parts) to ensure durability, corrosion resistance, and compliance with cGMP standards.

   • Compact and Ergonomic: Features a sleek, enclosed design to minimize contamination risks and facilitate easy maintenance. Many models include acrylic covers for visibility and safety interlocks that stop operation if the cover is lifted.

   • Gripper System: Utilizes a specialized gripper mechanism to hold ampoules by the neck, inverting them during washing to ensure minimal contact with machine parts, reducing contamination risks and ensuring positive cleaning.

3. Washing Process:

   • Multi-Stage Cleaning: Typically includes multiple washing stations (e.g., 6–7 stations) with a combination of water and air washes:

     • Internal Washing: Uses purified water (WFI – Water for Injection), recycled water, or filtered water, delivered through pressurized jets or needles to clean the inner surface of ampoules.

     • External Washing: High-pressure water jets or air jets clean the outer surface to remove dust, particles, or residues. Some models include ultrasonic washing for enhanced cleaning.

     • Sequence: Common sequences include 2–3 water washes (e.g., recycled water, purified water, WFI) and 2–4 compressedSNSair washes to ensure thorough cleaning without excessive media consumption.

   • Reciprocating Nozzles: Spray needles move in sync with ampoules to optimize cleaning and reduce water usage. Some machines feature servo-driven nozzles for precise cleaning.

   • Drying: Post-washing, ampoules may pass through a drying zone to ensure they are dry before filling or sterilization.

4. Automation and Control:

   • PLC and HMI: Equipped with Programmable Logic Controllers (PLC) and Human-Machine Interface (HMI) touchscreens for automated control, fault monitoring, and customizable washing cycles.

   • No Container, No Wash: Systems prevent water and air wastage by activating washing only when ampoules are present.

   • Servo Technology: Advanced models use servo motors for precise gripper and nozzle movements, enhancing efficiency and reducing breakage.

5. Capacity and Flexibility:

   • High Throughput: Capable of washing 100–400 ampoules per minute, depending on the model (e.g., 120–240 ampoules/min for high-speed rotary machines).

   • Versatility: Can handle various ampoule sizes (1 ml to 20 ml) and sometimes vials (2 ml to 100 ml) with quick-change parts for flexibility.

   • Customizable Cycles: Washing sequences can be adjusted to meet specific requirements, such as additional air or water washes.

6. Key Models and Variants:

   • Rotary Ampoule Washing Machine: Operates in a continuous rotary motion, ideal for high-volume production. Ampoules are held by grippers, inverted, and passed through washing stations.

   • Multi-Jet Ampoule Washer: Uses multiple high-pressure jets for efficient cleaning with minimal water usage. Suitable for both small and large-scale operations.

   • Ultrasonic Washing: Some machines incorporate ultrasonic technology for enhanced cleaning of stubborn residues.

   • External Washing Machines: Specifically designed to clean outer surfaces of sealed ampoules to remove residues and prevent operator contamination, often used in oncology or aseptic lines.

7. Compliance and Safety:

   • cGMP Compliance: Designed to meet stringent pharmaceutical standards, ensuring sterility and hygiene.

   • Safety Features: Includes interlocks, alarms, and acrylic covers to protect operators and maintain a clean environment.

   • Validation Support: Many manufacturers provide IQ/OQ/DQ documentation and software validation per 21 CFR Part 11 for regulatory compliance.

8. Additional Features:

   • Energy Efficiency: Some models feature water recycling systems to reduce WFI consumption and energy-efficient drying systems.

   • Low Maintenance: Easy-to-clean designs with accessible components and minimal wear parts, such as adjustable brushes or nozzles.

   • Integration: Can be part of a complete production line, including sterilization tunnels, filling, and sealing machines for seamless operation.

Operational Benefits:

• High Efficiency: Automated systems reduce manual labor and increase throughput, with some models achieving up to 10,000–36,000 ampoules per hour.

• Sterility Assurance: Thorough cleaning and optional sterilization ensure ampoules meet strict hygiene standards.

• Reduced Breakage: Gentle handling via gripper systems and precise engineering minimizes ampoule damage.

• Cost-Effective: Low water and air consumption, along with durable materials, reduce operational costs.

Applications:

• Pharmaceuticals: Cleaning ampoules for injectables, vaccines, and other sterile liquids.

• Biotech and Veterinary: Ensuring contamination-free containers for sensitive biological products.

• Cosmetics and Chemicals: Preparing ampoules for cosmetic or chemical liquid packaging.

Salient Features of 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 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 Glass 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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