Automatic Rotary Ampoule Washing Machine

Description

Automatic Rotary Ampoule Washing Machine is a specialized pharmaceutical device designed to clean glass ampoules internally and externally, ensuring sterility and compliance with cGMP standards. It minimizes contact between machine parts and ampoules to prevent contamination, making it ideal for pharmaceutical, veterinary, and biotech industries. When filling and packing pharmaceuticals, complete sanitation and hygienic conditions are crucial. This is especially true when injectables are placed within glass ampoules. Before an ampoule is placed in the sterile filling chamber, it must be completely sterile. The industry leader in high-tech pharmaceutical equipment, Adinath, provides a highly accurate rotary ampoule washing machine that satisfies the strict sterility and hygiene requirements of today.

 

A specifically made Gripper holds the ampoule from its neck, inverts it, and moves it further on a rotating moving system for the cleaning process. The ampoule feeds through feedworm to infeed Star Wheel. When a needle enters an ampoule neck, it travels in a neck-down position above the cleaning needles and moves with the needle bar to ensure that the greatest amount of washing time is achieved. Machine with six standard washing stations, each with six needles for optimal cleaning; the order can be altered to suit the needs of the customer. For the best possible Ampoule washing, the machine also has an exterior wash. In this machine, we have two distinct models. One milliliter to twenty milliliter ampoules can be cleaned by either the automatic ampoule washer or the high-speed ampoule washer. For rotary ampoule washing machine validation and replacement components, we offer extended support.

Working Principle of Automatic Rotary 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.

Technical Specification of Automatic Rotary 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.

Types of Ampoule Washing Machine

Applications of Ampoule Washing Machine

Advantages of Ampoule Washing Machine

Minimizes contamination risk with low-contact gripper design.

High precision and repeatability with PLC and HMI touch-screen controls.

Reduced water consumption through recirculation systems.

Easy maintenance with accessible, separable sections (mechanical drive, washing, filtration).

Washing Cycle of Ampoule Washing Machine

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

Design and Operation of Automatic Rotary Ampoule Washing Machine

  • Structure: The machine features a compact, enclosed design, typically constructed with AISI 316L stainless steel for contact parts and AISI 304 or FDA-approved engineering plastics for non-contact parts, ensuring durability and hygiene.

 

  • Gripper System: A specially designed gripper system holds ampoules by their necks, inverts them for washing, and releases them in a vertical position post-washing, ensuring positive and thorough cleaning with minimal contact.

 

  • Rotary Motion: Ampoules are fed via an infeed hopper or tray, aligned by a feedworm, and transferred to an infeed starwheel. The rotary system moves ampoules continuously or via indexing motion through multiple washing stations.

 

  • Washing Process:
    • Ampoules are inverted (neck down) over washing needles, which enter the ampoule neck for internal cleaning.
    • Spray tubes or nozzles, synchronized with ampoule movement, deliver cleaning media (e.g., Water for Injection (WFI), purified water, or compressed air) to internal and external surfaces.
    • The machine typically features 6 washing stations, each with 6–8 needles (totaling 36–48 needles), providing 3–6 internal water washes (e.g., recycled water, purified water, WFI) and 3 air washes, plus 1–2 external water and air washes.
    • Washing sequences are customizable to meet specific requirements, with independent circuits for each washing zone to avoid cross-contamination.

 

  • Output and Re-inversion: After washing, ampoules are re-inverted to a neck-up position, discharged via an output starwheel, and collected on trays or fed directly to a sterilizing tunnel. Optional pumping stations ensure precise water pressure, while recirculation systems reduce WFI consumption.

Key Features of Ampoule Washing Machine

  • Capacity: Models like AVRW-120 (up to 100–120 ampoules/min), and AVRW-240 (up to 200 ampoules/min) cater to different production scales. Ampoule sizes range from 1ml to 20ml, with change parts for flexibility.

 

  • Compliance: Meets cGMP, GAMP, and 21 CFR Part 11 standards, with optional IQ/OQ/DQ validation documentation and PLC-based controls for monitoring and automation.

 

  • Efficiency: Features like quick-changeover parts, servo-driven nozzles, and PLC-controlled washing cycles reduce downtime and enhance flexibility for different batch sizes.

 

  • Hygiene: External washing ensures thorough cleaning, while features like aseptic diaphragm valves, polycarbonate guards, and vapor exhaust systems maintain sterility. Some models include ultrasonic washing or siliconization options.

 

  • Utilities: Typically requires 2–7 kW power (230V/415V, 50 Hz, 3-phase) and compressed air for drying stations. Dimensions vary, e.g., 3200mm x 2000mm x 1400mm for some models.

FAQ for Automatic Rotary Ampoule Washing Machine

The machine is available in two models:

  • AVRW-120: Up to 100 ampoules per minute
  • AVRW-240: Up to 200 ampoules per minute

It handles 1ml to 20ml glass ampoules with diameters from 9mm to 21.5mm and heights from 60mm to 140mm. The washing sequence and speed can be easily adjusted as per requirement.

Ampoules are fed automatically via an infeed starwheel. Special grippers pick them up, invert them (neck down), and move them over six washing stations equipped with needles. The standard cycle includes 3 water washes and 3 compressed air washes in independent circuits to prevent cross-contamination:

  1. Recycled Water (WFI)
  2. Compressed Air
  3. DM Water
  4. Compressed Air
  5. Water for Injection (WFI)
  6. Compressed Air

After washing, ampoules are re-inverted (neck up) and discharged. An external wash is also provided for complete cleaning.

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 and treated welding joints. It can be supplied with IQ/OQ/DQ documentation and optional 21 CFR Part 11 compliant PLC & HMI system for validation and regulatory requirements.

The machine requires:

  • Power: 4–5.5 H.P., 440V, 3 Phase, 50 Hz
  • Compressed Air: 20 CFM
  • Water: 200–500 liters/hour (depending on ampoule size)

Optional accessories include:

  • PLC system with HMI and printing facility
  • Safety cabinet with doors
  • Separate pumping station with tanks
  • Recirculation and siliconization system

Countries We Export to

United States | Canada | Mexico | Brazil | Argentina | Chile | Colombia | Peru | Germany | United Kingdom | France | Italy | Spain | Netherlands | Belgium | Switzerland | Sweden | Austria | Denmark | Norway | Poland | Finland | Czech Republic | Hungary | Portugal | Ireland | Greece | Slovakia | Romania | Bulgaria | China | Japan | India | South Korea | Indonesia | Vietnam | Thailand | Malaysia | Philippines | Singapore | Bangladesh | Pakistan | Saudi Arabia | United Arab Emirates | Israel | Turkey | Iran | Qatar | Kuwait | South Africa | Nigeria | Egypt | Algeria | Morocco | Kenya | Ghana | Tunisia | Australia | New Zealand | Russia | Ukraine | Belarus | Kazakhstan | Taiwan | Hong Kong | South Sudan | Uzbekistan | Oman | Jordan | Bahrain | Sri Lanka | Myanmar | Lebanon | Mongolia | Ethiopia | Libya | Angola | Zambia | Zimbabwe | Mozambique | Ivory Coast | Senegal | Uganda | Tanzania | Botswana | Ecuador | Venezuela | Bolivia | Paraguay | Uruguay | Trinidad and Tobago | Panama | Guatemala | Costa Rica | Honduras | El Salvador | Nicaragua | Dominican Republic | Haiti | Cuba

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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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