Automatic Ampoule Vial Washer

An Automatic Ampoule Vial Washer is a specialized pharmaceutical machine designed to clean and sterilize glass ampoules and vials, ensuring they meet stringent cGMP (current Good Manufacturing Practices) standards for sterility and hygiene in pharmaceutical, biotech, and veterinary applications.

The Automatic Ampoule Vial Washer is a high-precision, automated system engineered to wash ampoules (typically 1ml to 20ml) and vials (2ml to 100ml) with minimal contact between machine parts and containers to prevent contamination. It is designed to clean both the internal and external surfaces of containers, ensuring they are sterile and free of contaminants before filling with injectables or other pharmaceutical products. The machine is commonly used in high-volume production lines, offering efficient, reliable, and repeatable cleaning processes.

Automatic Ampoule Vial Washer Video

Key Features:

1. Rotary or Linear Design:

   • Rotary Washers: Utilize a rotary mechanism (e.g., Geneva mechanism or servo-driven systems) where ampoules/vials are held by grippers, inverted, and passed through multiple washing stations in a continuous motion. This design maximizes washing time and throughput, with models like the AVRW-120 (up to 100 containers/min) and AVRW-240 (up to 200 containers/min).

   • Linear Washers: Process containers in a straight-line configuration, ideal for high-speed aseptic filling lines, with outputs ranging from 120 to 240 vials per minute.

2. Washing Process:

   • Internal Cleaning: Uses pressurized jets of Water for Injection (WFI), purified water, or sterile air delivered through washing needles that penetrate the container without touching the interior walls, ensuring thorough cleaning. Typically includes multiple stations (e.g., 6 internal cleaning stations with 36 needles total).

   • External Cleaning: Employs water and air jets to clean the outer surface, removing residual product or contaminants, critical for cytotoxic materials or post-filling processes.

   • Customizable Wash Sequence: Allows flexibility to adjust washing cycles (e.g., recycled water, purified water, WFI, and air washes) based on customer requirements.

3. Gripper System:

   • A specialized gripper holds ampoules/vials by the neck, inverts them for washing, and releases them in a vertical position post-washing, ensuring positive cleaning with minimal contact.

4. Material and Construction:

   • Contact Parts: Made from AISI 316L stainless steel or FDA-approved materials (e.g., polycarbonate, HDPE) to ensure compatibility with cleaning media and prevent corrosion.

   • Non-Contact Parts: Constructed from AISI 304 stainless steel or engineering plastics for durability and compliance with cGMP standards.

5. Automation and Control:

   • Equipped with PLC (Programmable Logic Controller) and HMI (Human-Machine Interface) for automated operation, cycle control, and monitoring. Some models include password-protected programming and compliance with 21 CFR Part 11 for software validation.

   • Features like “No Vial – No Washing” systems and automatic stoppage when the acrylic cover is lifted enhance safety and efficiency.

6. Washing Media Efficiency:

   • Incorporates low WFI consumption through recirculation systems or pressure tanks for continuous supply.

   • Some models feature air-vacuum pre-cleaning and segregated washing stations to prevent cross-contamination.

7. Capacity and Versatility:

   • Suitable for a range of container sizes (1ml to 20ml for ampoules, 2ml to 100ml for vials) with change parts for quick adaptability.

   • High-speed models can process up to 30,000 vials per hour, while standard models handle 100–240 containers per minute.

8. Additional Features:

   • Optional ultrasonic washing for enhanced cleaning of stubborn residues.

   • External washing stations for thorough cleaning of container exteriors.

   • Modular designs for scalability and integration with filling and sealing lines.

Applications:

• Pharmaceutical Industry: Cleaning ampoules and vials for injectables, ensuring sterility before filling.

• Biotech and Veterinary: Washing containers for vaccines, biologics, and veterinary drugs.

• Aseptic Processing: Integrated into sterile production lines to meet regulatory requirements for injectables.

Benefits:

• Compliance: Meets cGMP, GAMP, and 21 CFR Part 11 standards, ensuring regulatory adherence.

• Efficiency: High throughput and automation reduce manual labor and increase productivity.

• Sterility: Minimizes contamination risks through non-contact washing and segregated stations.

• Flexibility: Adjustable washing sequences and change parts accommodate various container sizes and production needs.

Typical Models:

• AVRW-120: Automatic washer with up to 100 containers per minute.

• AVRW-240: High-speed washer with up to 200 containers per minute.

• LI MW 340: Semi-automatic model for versatile operations, handling 1ml to 20ml ampoules and 2ml to 100ml vials.

Salient Features of Automatic Ampoule Vial 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 Automatic Ampoule Vial Washer

Ampoules and vials 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 and vials.

On completion of a cycle, washed Ampoules and vials 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 Automatic Ampoule Vial 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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