Automatic Rotary Ampoule Washing Machine

Description

In the pharmaceutical manufacturing industry, maintaining impeccable hygiene and sterility is non-negotiable, especially for injectable products packaged in glass ampoules. An Automatic Rotary Ampoule Washing Machine is a specialized, high-tech solution designed to clean ampoules both internally and externally with precision, ensuring complete removal of contaminants while meeting stringent cGMP (Current Good Manufacturing Practice) standards.

 

This advanced pharmaceutical ampoule washing machine minimizes direct contact between machine components and glass ampoules, significantly reducing the risk of particle generation or cross-contamination. It has become an essential piece of equipment for pharmaceutical companies, veterinary medicine manufacturers, and biotech facilities that demand the highest levels of cleanliness before sterile filling operations.

 

Before any glass ampoule enters the sterile filling chamber, it must undergo thorough internal and external cleaning to eliminate dust, fibers, microbes, and residues. Any compromise in this stage can affect product safety and regulatory compliance. Leading manufacturers like Adinath have engineered reliable rotary ampoule washing machines that deliver consistent, validated cleaning results while optimizing production efficiency.

Working Principle of Automatic Rotary Ampoule Washing Machine

Ampoules fed from the infeed tray are received by an infeed worm and transferred to the infeed star wheel. Grippers then pick up each ampoule from the infeed star wheel, invert it into the neck-down position over the washing needles, and travel together with the needle bar during the washing cycle. This neck-down orientation above the washing needles maximises contact time once the needles enter the ampoule neck.

 

The machine is equipped with six independent washing stations, each fitted with six needles, to ensure thorough cleaning. The washing sequence can be adjusted according to specific requirements. An external wash station is also provided for optimum external cleaning of the ampoules.

 

On completion of the cycle, the washed ampoules are inverted back to the neck-up position and transferred to the output star wheel. From there they can be collected on an output tray or pushed directly into a tunnel.

 

An optional separate pumping station supplies the correct volume of water at the required pressure. In the absence of a separate pumping station, a re-circulation and siliconization system can be supplied on request.

 

INTERNAL CLEANING The machine is fitted with six internal cleaning stations, each carrying 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 and can be readily adjusted for height, angle and lateral position. Each station receives cleaning media through a pipe connected to the same media-preparation area.

 

CLEANING MEDIA PRINCIPLE The WFI, purified-water and air cleaning stations are synchronised with the ampoule by reciprocating motion. Media are delivered only during the forward stroke of the needles. WFI consumption is further reduced by collecting the water in a re-circulating tank for subsequent use 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

Yes — Adinath International Automatic Rotary Ampoule Washing Machine complies to cGMP, MHRA, FDA and WHO-GMP standards, with optional CE marked equipments and 21 CFR Part 11 software compliance for the HMI/PLC. Machine contact parts having Stainless Steel 316L grade materials with validation documents having IQ, OQ, DQ validation protocols as optional. Organization is ISO 9001:2015 certified.

Manufacturing lead time is generally 7 to 14 weeks from order confirmation. Further it takes 2 to 8 weeks for international shipping depending upon destination. Order can be expediate sooner or later as per specific buying requirements. Destination specific certifications like US FDA, EU, ANVISA, SFDA. CE can add 3 to 6 weeks additionally.

Yes, Adinath International Automatic Rotary Ampoule Washing Machine export this machine to more than 48 countries of this world including America, Europe, Asia, Middle East, Africa, CIS and Australia sub continents. Please visit our clientele page for complete list of our customers worldwide. Located at Ahmedabad, India having world class infrastructure.

Service of skilled engineers and technicians provided for technical support of supplied equipments. Installations, commissioning, training and IQ, OQ, DQ validations performed by qualified engineers. Remote support through video call, phone, email and other modes provided for international installations. Spare parts of “Machine name” stocked at our premises in Ahmedabad and shipped immediately after ordering. Standard 12 months manufacturing warranty included with supplied equipment.

Countries We Export to

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

Partner with Industry Experts

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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