Injectable Glass Ampoule Washing Machine

An Injectable Glass Ampoule Washing Machine is specialized pharmaceutical equipment designed to thoroughly clean and sterilize glass ampoules used for injectable medications, vaccines, or other critical substances. These machines ensure ampoules are free from contaminants, dust, microbes, and pyrogens before filling, maintaining the sterility and safety required for injectable products.

The primary function of an injectable glass ampoule washing machine is to clean the internal and external surfaces of ampoules (typically 1-20ml in size) to eliminate impurities, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards like FDA, EMA, and WHO. This is critical to prevent contamination that could compromise the integrity of the pharmaceutical formulation.

Injectable Glass Ampoule Washing Machine Video

Key Features

1. Construction and Materials:

   • Built with stainless steel (SS 316L for contact parts, SS 304 for non-contact parts) to ensure durability, corrosion resistance, and compliance with GMP standards.

   • Equipped with high-quality grippers or manipulators (often made of non-toxic materials like polyamine) to securely hold and invert ampoules during washing, minimizing breakage.

   • Acrylic or polycarbonate covers for visibility and safety, with mechanisms to stop operation if the cover is lifted.

2. Washing Mechanism:

   • Ultrasonic Cleaning: Utilizes ultrasonic waves to dislodge particles and contaminants from the ampoule surfaces, followed by jet washing.

   • Multi-Stage Washing Process: Typically involves 6-9 washing cycles, including:

     • Recycled Water Wash: Initial cleaning with filtered recirculated water.

     • Compressed Air Blow: Removes water and debris from internal and external surfaces.

     • Purified Water Wash: Further cleaning with purified water.

     • Water for Injection (WFI) Wash: Final rinse with highly purified WFI to ensure sterility.

     • Final Air Drying: Uses 0.22µm filtered compressed air to dry the ampoules.

   • Independent needles for water, compressed air, and WFI prevent cross-contamination, with nozzles inserted into ampoules for precise internal cleaning.

3. Types of Machines:

   • Rotary Washing Machines: Operate in a rotary motion, suitable for high-output production (up to 600 ampoules per minute). Ampoules are held by grippers, inverted, and cleaned in a continuous process.

   • Linear Washing Machines: Automatically load ampoules onto a conveyor with pockets for washing, ideal for automated high-throughput lines.

   • Multijet Ampoule Washers: Semi-automatic machines for small to medium-scale operations, suitable for R&D or laboratories, handling 30-160 ampoules per minute.

4. Operational Features:

   • Gripper System: Holds ampoules by the neck, inverts them for washing, and releases them post-cleaning via a feed worm system for upright discharge.

   • Transport System: Uses conveyors, star wheels, or feed screws for precise ampoule movement, ensuring stability and minimal breakage (breakage rate ≤0.5%).

   • PLC and HMI Control: Programmable Logic Controllers (PLC) and Human-Machine Interfaces (HMI) allow precise control, monitoring, and adjustment of washing cycles. Some models include timer-operated solenoid valves or microprocessor-controlled sequences.

   • Filtration Systems: Incorporate 3µm polyethersulfone filters for recycled water, 0.22µm filters for WFI, and 0.22µm PTFE filters for compressed air to ensure sterile cleaning media.

5. Additional Features:

   • Energy Efficiency: Independent needle systems reduce water and air loss, saving energy.

   • Sterile Environment: Operates under Laminar Air Flow (LAF) or in cleanrooms with open/closed Restricted Access Barrier Systems (oRAB/cRAB) to minimize contamination risks.

   • Versatility: Can wash vials or oral liquid bottles with minimal change parts. Some models can be adapted for penicillin bottles.

   • Low Maintenance: Simple structure with accessible parts for easy cleaning and maintenance.

Working Principle

Ampoules are loaded manually or automatically onto an infeed tray or conveyor. The transport system (e.g., feed screw or star wheel) moves them to the washing station, where grippers or clamps invert the ampoules. A series of high-pressure jet washes (using recycled water, purified water, WFI, and compressed air) clean the internal and external surfaces. Nozzles track and insert into ampoules for precise cleaning, controlled by solenoid valves or PLC. After washing, ampoules are dried with filtered compressed air and discharged via an outfeed system (e.g., feed worm or conveyor) to a sterilization tunnel or filling line under sterile conditions.

Importance in Injectable Manufacturing

• Sterility and Safety: Ensures ampoules are free from microbial contaminants and pyrogens, critical for injectable drugs.

• Regulatory Compliance: Meets stringent standards with features like SCADA integration for data accuracy and traceability.

• Efficiency: High-speed models support large-scale production, while small-batch machines cater to R&D needs.

• Reduced Contamination: Advanced filtration and sterile environments minimize contamination risks.

Applications

• Primarily used in pharmaceutical factories for cleaning ampoules before filling with injectables.

• Also suitable for vials, oral liquid bottles, and other glass containers in pharmaceutical, biotech, cosmetic, and chemical industries.

Salient Features of Injectable Glass 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 Glass 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 Glass 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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