The Aseptic Glass Ampoule Washing Machine is a high-precision, cGMP-compliant cleaning system specifically engineered for the pharmaceutical industry. It ensures thorough internal and external decontamination of glass ampoules before they proceed to sterilization, filling, and sealing processes. Designed for aseptic production lines handling injectable formulations, this advanced equipment delivers superior cleanliness by effectively removing particles, residues, fibers, and microbial contaminants.
In injectable manufacturing, even microscopic contaminants can pose serious risks to patient safety and product efficacy. An aseptic glass ampoule washing machine plays a critical role by providing vali dated, repeatable cleaning that meets stringent regulatory standards from FDA, EMA, and WHO. It maintains the highest levels of sterility assurance, making it essential for producing vaccines, antibiotics, oncology drugs, and other parenteral preparations.
Ampoules from the infeed tray are transferred onto an infeed feed worm and then onto the infeed starwheel. Grippers pick up each ampoule from the infeed starwheel, invert it into the neck-down position over the washing needles, and move it along with the needle bar during the washing cycle. Travelling in the neck-down position above the washing needles maximises contact time once the needles enter the ampoule neck.
The machine has six independent washing stations, each fitted with six needles, for thorough cleaning. The sequence of stations can be adjusted according to process requirements. External washing is also provided for complete cleaning of the ampoules.
At the end of the cycle, the washed ampoules are inverted back to the neck-up position and transferred to the output starwheel. From there they can be collected on the output tray or transferred directly into a tunnel.
An optional separate pumping station supplies the required volume of water at the desired pressure. If a separate pumping station is not used, a re-circulation and siliconisation system can be provided on request.
Internal Cleaning The AVRW is equipped with six internal cleaning stations. Each station has six cleaning needles, giving a total of 36 needles. Every station is supplied through a dedicated pipe connected to the cleaning-media preparation area. This arrangement reduces the risk of particle generation, simplifies maintenance and cleaning, and saves time.
External Cleaning Three external cleaning stations are mounted in a fixed position above the ampoules. Each station can be adjusted for height, angle and lateral position. Cleaning media are supplied to each station through a pipe linked to the cleaning-media preparation area.
Cleaning Media Principle WFI, purified water and air cleaning stations operate in synchronisation with the ampoules through a reciprocating motion. The design ensures that media are dispensed only while the needles are moving forward. WFI consumption is further reduced by collecting used WFI in a re-circulating tank for reuse in the pre-washing station.
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 |
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Utility |
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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.
1st wash | Recycled Water (WFI) |
2nd wash | Compressed Air |
3rd wash | DM Water |
4th wash | Compressed Air |
5th wash | Water for Injection (WFI) |
6th wash | Compressed Air |
The machine is available in two main models:
It handles glass ampoules with diameters from 9mm to 21.5mm and heights from 60mm to 140mm (typically 1ml to 10ml). The washing sequence and speed are adjustable as per customer requirements.
Ampoules are automatically fed from the infeed tray to a starwheel. Grippers hold them by the neck, invert them (neck-down), and pass them over stationary washing needles across six internal washing zones. The process includes 3 water washes and 3 air washes with independent circuits to prevent cross-contamination. External washing is also performed simultaneously. After cleaning, ampoules are re-inverted (neck-up) and discharged to the output tray or connected tunnel. This ensures maximum cleaning efficiency with minimal risk of particle generation.
All product-contact parts are made of AISI 316L Stainless Steel, while non-contact parts use AISI 304 Stainless Steel and engineering plastics. The machine is a complete cGMP model with smooth finishes, polished welding joints, and easy-to-clean design. It comes with IQ/OQ/DQ validation documentation and optional 21 CFR Part 11 compliant PLC system with HMI and password protection.
Utilities required:
Optional accessories include:
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Connect with our engineering team to discuss your specific production requirements. We provide customized, cGMP-compliant machinery solutions designed to optimize your manufacturing facility and maximize output.
Adinath International manufactures high-precision vial powder filling machines and complete packaging lines, providing reliable, hygienic, and efficient solutions for global pharmaceutical industries.
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