Pharmaceutical Ampoule Washer

A Pharmaceutical Ampoule Washer is specialized equipment used in the pharmaceutical and biotech industries to clean and sterilize ampoules—small, sealed glass or plastic vials—before they are filled with injectable drugs, vaccines, or other sensitive products. These machines ensure ampoules meet stringent cleanliness and sterility standards, critical for product safety and efficacy, by removing contaminants such as dust, particles, microorganisms, endotoxins, and chemical residues.

Pharmaceutical Ampoule Washer Video

Key Features and Functionality:

1. Purpose: Ampoule washers remove contaminants from both the internal and external surfaces of ampoules to prevent contamination of the filled product, ensuring compliance with regulatory standards like cGMP and FDA guidelines.

2. Cleaning Process:

   • Internal Cleaning: High-pressure jets of purified water, Water for Injection (WFI), and sometimes cleaning agents are used to clean the inner surfaces, targeting residues and microorganisms.

   • External Cleaning: Jets or cleaning baths remove surface contaminants like dust or grease, often using water or specialized media for toxic products.

   • Washing Sequence: Typically involves multiple stages, such as:

     • Pre-washing with recycled water

     • Internal and external washing with purified water or WFI

     • Compressed air blows to remove water and debris

     • Final drying with filtered air to eliminate residual moisture

3. Types of Ampoule Washers:

   • Rotary Ampoule Washers: High-speed, automatic machines with a rotating platform, ideal for large-scale production. Ampoules are held by grippers and cleaned with minimal machine contact.

   • Multijet Ampoule Washers: Semi-automatic, compact machines using high-pressure jets for thorough cleaning, suitable for medium to small-scale operations.

   • Linear Ampoule Washers: Use a conveyor system for continuous cleaning, suitable for specific production layouts.

   • Aseptic Washers: Incorporate sterilization processes like steam-in-place (SIP) or clean-in-place (CIP) for maximum sterility.

   • External Washers: Focus on decontaminating the outer surface post-filling, often used for toxic products to prevent cross-contamination.

4. Key Components:

   • Gripper Systems: Hold ampoules by the neck to minimize contact and ensure stability during washing.

   • Spray Nozzles/Needles: Deliver precise jets of cleaning media, often tracking the ampoule for thorough cleaning.

   • Filtration Systems: Use polyethersulfone or PTFE filters (e.g., 0.22µm for WFI, 0.2µm for air) to ensure sterile cleaning media.

   • Conveyor Systems: Transport ampoules through washing stations, often with star wheels or feed screws for precise movement.

   • PLC and HMI Controls: Programmable logic controllers and human-machine interfaces allow precise control, monitoring, and repeatability of washing cycles.

5. Sterility and Validation:

   • Machines incorporate sterilization features like SIP/CIP to maintain a sterile environment.

   • Validation studies (e.g., endotoxin, chemical, and particulate decontamination) ensure consistent cleaning performance, targeting a minimum three-log reduction in endotoxins and no detectable residues.

   • Compliance with cGMP, FDA, and WHO standards is standard, with documentation for validation processes.

6. Applications:

   • Pharmaceutical Industry: Cleans ampoules for injectable drugs and vaccines.

   • Biotechnology: Sterilizes ampoules for biopharmaceuticals like monoclonal antibodies.

   • Healthcare: Prepares ampoules for syringes and diagnostic reagents.

   • Vaccine Manufacturing: Ensures sterility for vaccine packaging.

   • Veterinary, Cosmetics, and Food Industries: Used for sterile packaging of serums, additives, or reagents.

7. Advantages:

   • High-speed, automated cleaning reduces manual intervention and labor.

   • Minimizes contamination risks, ensuring product safety.

   • Flexible designs accommodate various ampoule sizes and materials.

   • Compact models save space, while high-speed models meet large-scale demands.

8. Maintenance and Operation:

   • Regular maintenance is required to ensure optimal performance and longevity.

   • Operator training is essential for consistent and effective use.

   • Safety features like acrylic covers and automatic shut-off prevent contamination and ensure operator safety.

Importance:

Ampoule washers are critical for maintaining sterility in pharmaceutical production, particularly for injectables, where any contamination can compromise patient safety. By ensuring ampoules are free of endotoxins, chemicals, and particles, these machines uphold the integrity of the final product, meeting rigorous regulatory standards and protecting public health.

Salient Features of Pharmaceutical 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 Pharmaceutical 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 Pharmaceutical 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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