Pharmaceutical Ampoule Washing Machine

A Pharmaceutical Ampoule Washing Machine is specialized equipment used in the pharmaceutical and biotech industries to clean and sterilize glass ampoules (small sealed vials) before they are filled with injectable drugs, vaccines, or other sensitive products. These machines ensure ampoules are free from contaminants, particulates, and microorganisms, maintaining the sterility and quality required for pharmaceutical products.

The primary function of an ampoule washing machine is to remove impurities such as dust, chemical residues, endotoxins, and microorganisms from the internal and external surfaces of ampoules. This ensures the ampoules are sterile and safe for filling with medications, preventing contamination that could compromise product safety and efficacy.

Pharmaceutical Ampoule Washing Machine Video

Cleaning Process

Ampoule washing machines employ a multi-stage cleaning process, typically involving:

1. Pre-Washing: Initial rinsing to remove loose contaminants.

2. Main Washing: High-pressure jets of purified water, water for injection (WFI), or cleaning agents clean the internal and external surfaces.

3. Rinsing: Multiple rinses with purified water or WFI to ensure no residual cleaning agents remain.

4. Drying: Filtered compressed air or heated air dries the ampoules to eliminate residual moisture, which could lead to contamination or product degradation.

5. Optional Sterilization: Some machines incorporate clean-in-place (CIP) or steam-in-place (SIP) systems for additional sterility assurance.

The washing sequence often includes:

• Internal Cleaning: High-pressure jets or needles inserted into the ampoule’s neck to clean the interior.

• External Cleaning: Jets or brushes to clean the outer surface, removing dust, grease, or handling residues.

• A typical washing cycle may include compressed air blows, recycled water washes, purified water rinses, and WFI washes, with air drying as the final step.

Types of Ampoule Washing Machines

Ampoule washing machines are categorized based on automation, scale, and design to suit different production needs:

1. Automatic Ampoule Washing Machine: Fully automated with minimal operator intervention, ideal for high-volume production (up to 200–240 ampoules per minute). Equipped with multiple washing stations for thorough cleaning.

2. Semi-Automatic Ampoule Washing Machine: Requires manual loading/unloading, suitable for medium-scale operations or smaller batches.

3. High-Speed Ampoule Washing Machine: Designed for rapid cleaning in large-scale pharmaceutical facilities, often with advanced automation.

4. Compact Ampoule Washing Machine: Space-efficient models for smaller facilities or labs with limited space.

5. Rotary Ampoule Washing Machine: Uses a rotating platform to transport ampoules through cleaning stations, known for high-speed and continuous operation.

6. Linear Ampoule Washing Machine: Employs a linear conveyor system, suitable for specific production layouts.

7. Aseptic Ampoule Washing Machine: Designed for the highest sterility standards, incorporating CIP/SIP systems.

8. Multijet Ampoule & Vial Washing Machine: Versatile machines that clean both ampoules and vials (1ml–100ml), ideal for manufacturers producing multiple container types.

Key Features

• Material Compatibility: Constructed from stainless steel (SS 316L for contact parts, SS 304 for non-contact parts) to handle glass or plastic ampoules of various sizes (typically 1ml–20ml).

• Automation and Control: PLC-based systems with human-machine interfaces for precise control of washing parameters (e.g., water temperature, pressure, cycle duration).

• Gripper System: Many machines use grippers to hold ampoules by the neck, minimizing contact and ensuring accurate positioning during washing.

• High-Pressure Jets: Utilize needles or nozzles for targeted internal and external cleaning, often with adjustable pressure and flow.

• Water and Air Filtration: Equipped with filters (e.g., 0.22µm for compressed air, 3µm for water) to ensure sterile cleaning media.

• Recirculation Systems: Optimize water usage by recycling WFI through storage tanks, reducing waste.

• Safety Features: Acrylic covers with interlocks stop the machine if opened during operation, preventing contamination.

• Low Breakage Rate: Advanced designs (e.g., star wheels, grippers) minimize ampoule damage (<0.3%–0.5% breakage rate).

• Regulatory Compliance: Adheres to cGMP, FDA, and WHO standards, with validation documentation for cleaning processes.

Operational Mechanism

• Loading: Ampoules are manually or automatically loaded onto an in-feed tray or conveyor.

• Transport: A rotary or linear system (e.g., star wheel, grippers, or conveyor) moves ampoules through washing stations.

• Washing: Nozzles or needles enter the ampoule necks, delivering high-pressure jets of cleaning media (e.g., WFI, purified water, compressed air) in a programmed sequence.

• Drying: Filtered air or heated air removes residual moisture.

• Discharge: Cleaned ampoules are transferred to a sterile tunnel or collection tray under laminar airflow to maintain sterility.

Applications

Ampoule washing machines are used in:

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

• Biotechnology: Sterilizing ampoules for biopharmaceuticals like monoclonal antibodies.

• Vaccine Manufacturing: Ensuring sterility for vaccine ampoules.

• Healthcare/Hospitals: Preparing ampoules for IV medications or diagnostic reagents.

• Research and Development: Small-batch cleaning for experimental purposes.

• Veterinary Medicine: Sterilizing ampoules for animal healthcare products.

• Cosmetics/Personal Care: Cleaning ampoules for high-end serums or formulations.

• Food and Beverage/Chemical Industries: Packaging sterile liquid ingredients or reagents.

Validation and Quality Assurance

• Cleaning Validation: Machines undergo studies to confirm consistent removal of endotoxins, chemical residues, and particulates (e.g., sodium chloride or talc tests). A minimum three-log reduction in endotoxins is typically required.

• Performance Qualification: Ensures reproducible cleaning under normal and worst-case conditions.

• Documentation: Provides GA drawings, P&ID, and DQ/IQ documents to meet regulatory requirements.

Maintenance and Operator Training

• Maintenance: Regular upkeep is essential to minimize downtime and extend machine lifespan.

• Operator Training: Ensures proper operation and consistent cleaning results, critical for regulatory compliance.

Selection Considerations

Choosing the right ampoule washing machine depends on:

• Production volume (high-speed for large-scale, compact for small-scale).

• Ampoule size and material (glass/plastic, 1ml–20ml).

• Space constraints.

• Automation level (automatic vs. semi-automatic).

• Sterility and regulatory requirements.

Conclusion

Pharmaceutical ampoule washing machines are critical for ensuring the cleanliness and sterility of ampoules used in sensitive applications. With advanced automation, precise cleaning mechanisms, and compliance with stringent regulatory standards, these machines play a vital role in maintaining the safety and efficacy of injectable medications and other products. Their versatility across industries and ability to handle various ampoule types make them indispensable in modern pharmaceutical manufacturing.

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

Model	AVRW 120	AVRW 240
Production Output	Up to 100 per minute	Up to 200 per minute
Ampoule Diameter	9mm to 21.5mm	9mm to 21.5mm
Ampoule Height	60mm to 140mm	60mm to 140mm
Power Load	4 H.P.	5.5 H.P.
Power Voltage	440 Volts, 3 Phase 50 Hertz, 4 wire system	440 Volts, 3 Phase 50 Hertz, 4 wire system.
Optional Accessories	Programmable Logic Control (System) with HMI Safety Cabinet with doors	Programmable Logic Control (System) with HMI Safety Cabinet with doors
Utility	Air – 20 CFM Water – 200 to 500 liters per hour depend upon ampoule size.	Air – 20 CFM Water – 200 to 500 liters per hour depend upon ampoule size.
Water Tank & Pump	3 nos. each with 25 liters Capacity & Centrifugal pump	3 nos. each with 25 liters Capacity & Centrifugal pump
Overall Dimension:	2050mm (L) X 2000mm (W) X 1210mm (H) approx.	2450mm (L) X 2000mm (W) X 1300mm (H) approx.
Net Weight	700 kgs. approx.	900 kgs. approx.
Gross Weight	1000 kgs. approx.	1300 kgs. approx.

* 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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