Ampoule Washing Machine

An Ampoule Washing Machine is a specialized piece of equipment designed for the pharmaceutical, veterinary, and biotech industries to clean glass ampoules (and sometimes vials) with high precision, ensuring sterility and compliance with cGMP standards. These machines are critical for removing contaminants, such as particles, fibers, or residues, from ampoules before they are filled with injectable or sensitive pharmaceutical products.

Ampoule Washing Machine Video

Key Features and Description:

1. Design and Operation:

   • Rotary or Linear Systems: Most ampoule washing machines operate on a rotary system, where ampoules are fed from an infeed tray, transferred via a feedworm or starwheel, and held by grippers that invert them for cleaning. Some machines use linear systems for specific applications.

   • Minimal Contact: Machines are engineered to minimize contact between machine parts and ampoules, reducing the risk of contamination. Grippers typically hold ampoules by the neck, invert them for washing, and return them to a vertical position post-washing.

   • Washing Process: The cleaning process involves multiple stations (typically 3–6) that use high-pressure jets of purified water, Water for Injection (WFI), and compressed air to clean both internal and external surfaces. Some machines incorporate ultrasonic cleaning for enhanced particle removal.

   • Drying: Post-washing, ampoules are dried using compressed air, often with adjustable temperature settings to ensure no residual moisture remains.

2. Capacity and Versatility:

   • Machines can handle ampoules ranging from 1 ml to 20 ml (some up to 100 ml for vials) with interchangeable parts for different sizes.

   • Output capacities vary, with standard models processing 100–300 ampoules per minute, and high-speed models reaching up to 400 ampoules per minute.

   • Some machines, like the Ampoule Vial Combi Washing Machine, can clean both ampoules and vials, enhancing flexibility.

3. Materials and Compliance:

   • Contact Parts: Made of AISI 316L stainless steel to ensure compatibility with wash media and prevent corrosion.

   • Non-Contact Parts: Typically constructed from AISI 304 stainless steel or FDA-approved engineering plastics.

   • All finishes and welds adhere to cGMP standards to ensure hygiene and sterility.

   • Machines often include validation documentation (IQ/OQ/DQ) and comply with 21 CFR Part 11 for software and data integrity.

4. Advanced Features:

   • Gripper System: A specially designed gripper holds ampoules by the neck, inverts them for washing, and ensures precise alignment with washing nozzles.

   • PLC Control: Programmable Logic Controllers (PLCs) and Human-Machine Interfaces (HMIs) allow for automated operation, customizable washing sequences, and real-time monitoring.

   • Filtration Systems: Include high-quality filters (e.g., 10-micron nylon cartridges) to ensure clean wash media.

   • Safety Features: Emergency stop buttons, vacuum insulation, and heat shielding protect the machine and operators.

   • Optional Features: Ultrasonic cleaning, siliconization, inline integration with filling and sealing machines, and data logging for process validation.

5. Applications:

   • Widely used in pharmaceutical manufacturing for cleaning ampoules before filling with sterile injectables.

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

   • Ensures ampoules meet strict cleanliness standards (e.g., removal of at least 3 log of particulate contamination).

6. Standard Operating Procedure:

   • Ampoules are typically subjected to three washing cycles using purified water, WFI, and compressed air, with external washing via jets.

   • Quality checks involve filling a sample (e.g., 20 ampoules) with filtered water and inspecting for particles or contaminants.

Benefits:

• Ensures sterility and cleanliness critical for pharmaceutical safety.

• High-speed operation improves production efficiency.

• Customizable washing sequences and modular designs cater to diverse needs.

• Reduces manual handling, minimizing contamination risks.

Salient Features of 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 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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