Glass Ampoule Washer

A Glass Ampoule Washer is a specialized machine used primarily in the pharmaceutical, veterinary, and biotech industries to clean glass ampoules (and sometimes vials) before filling them with injectable or sensitive substances. These machines ensure that ampoules are sterile, free from contaminants, and comply with Good Manufacturing Practice (cGMP) standards.

Glass Ampoule Washers are designed to thoroughly clean and sterilize glass ampoules (typically ranging from 1ml to 25ml) to remove contaminants such as dust, particles, fibers, or residues. This ensures a sterile environment for filling pharmaceuticals, chemicals, or other sensitive liquids, maintaining product integrity and patient safety.

Glass Ampoule Washer Video

Key Features:

1. Material and Construction:

   • Made of high-quality stainless steel (often AISI SS 316L for contact parts and SS 304 for non-contact parts) to prevent corrosion and ensure durability.

   • Designed to meet cGMP standards, with smooth, polished surfaces to minimize contamination risks and facilitate cleaning.

   • Compact design to integrate into existing production lines, often with a small footprint to save space.

2. Washing Mechanism:

   • Rotary Ampoule Washer: A common type that uses a rotary system where ampoules are held by grippers (from the neck) and inverted for washing. This minimizes contact with machine parts, reducing contamination risks. The ampoules rotate through multiple washing stations for thorough cleaning.

   • Multi-Jet System: Utilizes multiple high-pressure jets to deliver cleaning media (e.g., purified water, water for injection (WFI), or compressed air) to the interior and exterior of the ampoules.

   • Linear Washer: An alternative design where ampoules move in a straight line through washing stations, suitable for high-volume production.

3. Gripper System:

   • Specially designed grippers hold ampoules by the neck, invert them during washing, and release them in a vertical position post-washing. This ensures minimal contact and precise cleaning of the ampoule’s interior and exterior.

   • Grippers are adjustable to accommodate various ampoule sizes (e.g., 1ml to 25ml) with change parts.

4. Automation and Control:

   • Automatic Models: Feature Programmable Logic Controller (PLC) systems, touch-screen Human-Machine Interfaces (HMI), and servo-driven mechanisms for precise control of washing cycles.

   • Semi-Automatic Models: Use motorized cam-operated valves or solenoid valves for washing sequences, suitable for smaller-scale operations.

   • Individual solenoid valves for each washing zone prevent cross-contamination.

5. Capacity and Speed:

   • Output ranges from 100 to 400 ampoules per minute, depending on the model (e.g., 120 ampoules/min for standard models, up to 240–400 ampoules/min for high-speed models).

   • Machines can handle ampoules from 1ml to 25ml and vials from 2ml to 100ml with appropriate change parts.

6. Washing Media:

   • Utilizes purified water, WFI, and compressed air. Some models include recycling tanks to collect and reuse WFI for pre-washing, reducing water consumption.

   • Segregated washing circuits ensure no cross-contamination between different cleaning media.

7. Additional Features:

   • Compliance with Standards: Adheres to ISO 9187-1:2010 for ampoule dimensions and pharmaceutical requirements.

   • Quality Control: Visual inspection post-washing to ensure no glass particles, fibers, or particulate matter remain. Some machines include filtration systems to reduce glass particle contamination.

   • Maintenance: Designed for easy maintenance with portable pumps and tanks, and separate control panels to prevent water-related short circuits.

   • External Decontamination: Certain models (e.g., IMA Vega 400) are designed for external washing post-filling to remove product residues, especially for toxic substances.

8. Applications:

   • Primarily used in pharmaceutical industries for cleaning ampoules before filling with injectables, vaccines, or other sterile products.

   • Also used in veterinary, biotech, and cosmetic industries for similar purposes.

   • Suitable for both small-scale (laboratory) and large-scale (industrial) operations.

9. Types of Washers:

   • Rotary Ampoule Washer: High-speed, continuous cleaning with minimal machine contact, ideal for large-scale production.

   • Multi-Jet Ampoule Washer: Uses multiple jets for efficient cleaning with less water, suitable for small to medium-scale operations.

   • Semi-Automatic Washer: Compact and versatile, often used in smaller facilities or for variable batch sizes.

   • Linear Washer: Moves ampoules linearly through washing stations, suitable for high-throughput lines.

10. Safety and Efficiency:

    • Designed to minimize glass particle contamination, a critical concern in parenteral administration (e.g., intravenous injections).

    • Features like stationary nozzles reduce the risk of chipping ampoule necks.

    • High-capacity centrifugal pumps ensure effective washing of larger containers if needed.

Operational Process (Rotary Washer Example):

1. Ampoules are fed from an infeed tray onto a feedworm and transferred to an infeed starwheel.

2. Grippers pick up ampoules from the starwheel, invert them (neck down), and move them over washing needles.

3. The ampoules undergo sequential washing cycles (e.g., purified water, compressed air, WFI) as they rotate through stations.

4. External jets clean the outer surface simultaneously.

5. After washing, ampoules are inverted back to a neck-up position and transferred to an output starwheel or tray for further processing (e.g., sterilization or filling).

Maintenance and Specifications:

• Power Requirements: Typically 220–380V, adjustable to local standards.

• Weight and Dimensions: Vary by model (e.g., 100–200 kg, dimensions like 2550 x 1050 x 1550 mm).

• Maintenance Tips: Regular cleaning of nozzles, inspection of grippers, and calibration of PLC systems to ensure consistent performance.

• Quality Checks: Post-washing visual inspection of 20 ampoules per batch (or every 10,000 ampoules) to confirm cleanliness.

Benefits:

• Ensures sterility and compliance with stringent pharmaceutical standards.

• Reduces manual handling, minimizing contamination risks.

• High throughput and efficiency for large-scale production.

• Versatile for various ampoule sizes with quick-change parts.

• Reduces water and media consumption through recycling systems.

Limitations:

• Glass particle contamination remains a concern, though mitigated by filtration and careful design.

• Initial investment and maintenance costs can be high for advanced models.

• Change parts required for different ampoule sizes may increase setup time.

Salient Features of Glass 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 Glass 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 Glass 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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