Ampoule Washing Drying Machine

An Ampoule Washing and Drying Machine is a specialized piece of pharmaceutical equipment designed to clean and dry glass ampoules to ensure they are sterile and free from contaminants before filling. These machines are critical in pharmaceutical, biotech, and cosmetic industries, adhering to stringent cGMP standards for sterility and hygiene.

Ampoule washing and drying machines are automated systems that clean and sterilize small glass vials (typically 1-20 ml) used for injectable drugs, vaccines, or other sensitive products. They combine multiple processes to remove impurities, dust, microbes, and pyrogens, ensuring ampoules meet high purity and sterility requirements. The machines can operate independently or as part of a production line with filling and sealing units.

Ampoule Washing Drying Machine Video

Key Processes

1. Washing:

   • Ultrasonic Cleaning: Uses high-frequency sound waves to dislodge particles from the inner and outer surfaces of ampoules.

   • Water and Air Jets: Alternating sprays of purified water, Water for Injection (WFI), and compressed air clean both internal and external surfaces. Some machines use recycled water for initial rinsing to save resources.

   • Customizable Washing Cycles: Typically include pre-washing, main washing with purified water or WFI, and final rinsing to ensure no residual contaminants. The sequence can often be adjusted to meet specific needs.

   • High-Pressure Cleaning: Ensures thorough removal of spills or residues, with some machines featuring multi-jet systems for enhanced cleaning efficiency.

2. Drying and Sterilization:

   • Hot Air Drying: Utilizes filtered, heated air (often at 300-350°C) to dry ampoules, preventing residual moisture that could lead to contamination or product degradation.

   • Sterilization: Employs hot air laminar flow or dry heat sterilization to eliminate microbes and pyrogens, often maintaining a Class 100 cleanliness level (per U.S. standards).

   • Cooling: A cooling zone gradually reduces the temperature of sterilized ampoules to prepare them for filling, ensuring product stability.

Key Features

• Automation: Fully or semi-automated systems with PLC (Programmable Logic Controller) and human-machine interface (HMI) for precise control and monitoring. Some machines feature password-protected settings for validation and supervisory access.

• Material Compatibility: Contact parts are typically made of AISI 316L stainless steel, high-quality silicone, or borosilicate glass to prevent corrosion and ensure compatibility with pharmaceutical standards. Non-contact parts may use AISI 304 stainless steel or FDA-approved engineering plastics.

• Low Breakage Rate: Advanced gripping mechanisms (e.g., star wheels or rotary grippers) hold ampoules by the neck, inverting them for cleaning and minimizing breakage (typically ≤0.5%).

• Versatility: Can handle various ampoule sizes (1-20 ml) and sometimes vials (2-100 ml) with minimal changeover parts. Some machines can switch between ampoule and vial processing with simple mold or star wheel adjustments.

• Sterile Environment: Incorporates ultra-filtration technology, laminar flow hoods, or open-RABS (Restricted Access Barrier Systems) to maintain a clean environment and prevent cross-contamination.

• Energy Efficiency: Features like recycled water systems, hot air circulation, and optimized sterilization reduce energy and water consumption.

• Validation and Compliance: Machines are designed to meet cGMP, PIC/S GMP, and 21 CFR Part 11 standards, with validation documentation (IQ/OQ/DQ) available for regulatory compliance.

Operational Workflow

1. Ampoule Feeding: Ampoules are loaded via an infeed conveyor, tray, or hopper and fed into a star wheel or rotary system.

2. Washing: Ampoules are inverted and cleaned using ultrasonic waves, water, and air jets in multiple stations (e.g., 2 water and 2 air cycles for external cleaning, 3 water and 4 air for internal cleaning).

3. Sterilization and Drying: Ampoules pass through a tunnel with preheating, high-temperature sterilization (300-320°C for ~5 minutes), and cooling zones.

4. Discharge: Cleaned and dried ampoules are inverted to their upright position and discharged for filling or further processing.

Specific Features by Model

• Rotary Ampoule Washing Machines: Use continuous or intermittent rotary motion for high-speed cleaning (up to 240-300 ampoules per minute). Grippers hold ampoules by the neck, ensuring minimal contact and positive washing.

• Multijet Ampoule Washers: Employ high-pressure jet sprays for efficient cleaning with lower water usage, suitable for R&D or smaller-scale operations.

• External Washing and Drying: Some machines focus on cleaning the outer surface of sealed ampoules to remove product spillage, using water and air jets followed by drying (e.g., 300 ampoules/min for 1-10 ml sizes).

• Compact Lines: Integrated systems combine washing, drying, filling, and sealing, offering a seamless production process with reduced footprint and higher automation.

Applications

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

• Biotech and Cosmetic Industries: Sterilizing containers for sensitive liquids or serums.

• Veterinary and Agricultural Sectors: Ensuring sterile packaging for related products.

Advantages

• High throughput (up to 36,000 ampoules/hour for advanced models like Syntegon’s ALF 5000).

• Minimal human intervention reduces contamination risks.

• Customizable washing and drying parameters for specific product needs.

• Low maintenance and robust design for continuous operation.

• Energy-efficient features reduce operational costs.

Salient Features of Ampoule Washing Drying 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 Drying 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 Drying 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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