Rotary Ampoule Washer

Q: What is the production capacity and which ampoule sizes does the Rotary Ampoule Washer support?

We offer two models: AVRW 120 – Up to 100 ampoules per minute AVRW 240 – Up to 200 ampoules per minute It handles 1ml to 10ml glass ampoules with diameters from 9mm to 21.5mm and heights from 60mm to 140mm. Quick-change parts allow fast and easy size changeover.

Q: What utilities are required and is the Rotary Ampoule Washer cGMP compliant?

Utilities required: Power: 4 HP (AVRW 120) or 5.5 HP (AVRW 240), 440V, 3 Phase, 50 Hz (customizable) Compressed Air: 20 CFM Water: 200 to 500 liters per hour (depending on model and ampoule size) Yes, it is fully cGMP compliant with SS 316L contact parts, polished finishes, safety interlocks, and support for IQ/OQ/DQ validation documentation. Optional 21 CFR Part 11 compliant PLC + HMI controls are available.

Description

A Rotary Ampoule Washer is a specialized, high-speed pharmaceutical machine designed to aseptically clean glass ampoules and vials, typically used for injectable medications, vaccines, or other sterile substances. It ensures compliance with cGMP (current Good Manufacturing Practices) standards by minimizing contact between machine parts and containers to prevent contamination. Rotary Ampoule Washers are critical for ensuring the sterility and cleanliness of ampoules and vials in pharmaceutical production. Their rotary design, automated gripping systems, and customizable washing cycles make them efficient and versatile for high-speed, aseptic cleaning, meeting the stringent demands of the industry.

Infeed: Ampoules are loaded from a tray onto an infeed worm or star wheel.

Gripping and Inversion: A specially designed gripper mechanism holds ampoules by the neck, inverts them, and positions them over washing needles.

Washing: Ampoules undergo sequential internal and external cleaning with water and air jets across multiple stations.

Discharge: Cleaned ampoules are reinverted to an upright position and transferred to an output star wheel or tray, often feeding into a tunnel oven for sterilization or filling.

Salient Features of Rotary Ampoule Washer

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.

Working Principle of Rotary Ampoule Washer

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 Rotary Ampoule Washer

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

Ampoule Vial Washing Machine

Automatic Ampoule Washer

Automatic Rotary Ampoule Washing Machine

Automatic External Ampoule Washing Machine

High Speed Ampoule Washing Machine

Lab Scale Ampoule Washing Machine

Multijet Ampoule Washing Machine

Linear Ampoule Washing Machine

Applications of Ampoule Washing Machine

Advantages of Rotary Ampoule Washer

High-Speed Continuous Production

Superior Cleaning Efficiency with Multi-Station & Inverted Washing

Excellent Contamination Control and Sterility Assurance

Gentle Handling with Reduced Breakage and Flexibility

Resource Efficiency and Lower Operating Costs

Washing Cycle of Rotary Ampoule Washer

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

Benefits of Rotary Ampoule Washer

High Efficiency: High-speed operation with minimal breakage due to rotary design.

Sterility: Meets stringent hygiene standards for injectable products.

Flexibility: Adjustable for various ampoule/vial sizes with quick changeovers.

Low Resource Use: Optimized water and air consumption, with recirculation options.

Reliability: Robust stainless steel construction and GMP-compliant materials ensure long-term performance.

Key Features of Rotary Ampoule Washer

Structure: Made of stainless steel (SS 304 for the frame, SS 316 for contact parts), ensuring durability, hygiene, and resistance to corrosion.

Rotary Mechanism: Ampoules are fed into a rotating platform via an infeed tray, worm, or star wheel. A gripper system holds ampoules by their necks, inverts them for cleaning, and returns them to an upright position for discharge.

Capacity: Suitable for washing 1 ml to 100 ml ampoules or 2 ml to 100 ml vials, with output speeds ranging from 70 to 400 units per minute, depending on the model.

Washing Process: Features multiple cleaning stations that use a combination of:
- Internal Cleaning: High-pressure jets of purified water, Water for Injection (WFI), or compressed air delivered through needles to clean the inside of ampoules.
- External Cleaning: Stationary or adjustable nozzles spray cleaning media (e.g., WFI, purified water, or air) on the exterior.
- Customizable Cycles: Cycles can include air wash, recycled water, DM (demineralized) water, WFI, and compressed air for drying, tailored to specific requirements.

Aseptic Design: Minimizes cross-contamination with efficient movement between stations and segregation of recycled and virgin cleaning solutions.

Additional Features:
- Acrylic covers for visibility and safety, with automatic stop if the cover is opened.
- Quick changeover systems for different ampoule/vial sizes using change parts.
- Water-saving mechanisms, such as recirculation tanks for pre-washing.
- Optional ultrasonic stations for precise cleaning and water filtration units for purity.

FAQ for Rotary Ampoule Washer

What is a Rotary Ampoule Washer and what is it used for?

The Rotary Ampoule Washer is a high-speed, fully automatic rotary washing machine designed for aseptic internal and external cleaning of glass ampoules (and vials) used in injectable production. It removes dust, particles, fibers, and residues to ensure high cleanliness and sterility before filling with medications, vaccines, or other sterile products. It is widely used in pharmaceutical, biotech, veterinary, cosmetic, and chemical industries for cGMP-compliant high-volume production lines.

What are the key features of the Rotary Ampoule Washer?

Key features include a complete cGMP model with AISI SS 316L contact parts, neck-gripping system that inverts ampoules for minimal contact, 6 internal washing stations with 36 needles (18 jets), 3 external washing stations, 3 water washes + 3 air washes with independent circuits to prevent cross-contamination, adjustable washing sequence, water recirculation for reduced WFI consumption, digital speed indicator, container counter, acrylic safety covers with interlocks, and quick-change parts. It can be used standalone or inline with filling and sealing machines. Optional PLC with HMI and 21 CFR Part 11 compliance is available.

What is the production capacity and which ampoule sizes does the Rotary Ampoule Washer support?

We offer two models:

AVRW 120 – Up to 100 ampoules per minute
AVRW 240 – Up to 200 ampoules per minute

It handles 1ml to 10ml glass ampoules with diameters from 9mm to 21.5mm and heights from 60mm to 140mm. Quick-change parts allow fast and easy size changeover.

How does the washing process work in the Rotary Ampoule Washer?

Ampoules are loaded from the infeed tray onto a feed worm or star wheel. Grippers pick them up by the neck, invert them neck-down, and move them over reciprocating washing needles across 6 internal stations. The machine performs a customizable sequence of 3 water washes + 3 air washes (typically: Recycled WFI → Air → DM Water → Air → Fresh WFI → Air) with simultaneous external spraying. Independent circuits and synchronized media flow ensure thorough cleaning. After the cycle, ampoules are re-inverted upright and discharged automatically via the output star wheel.

What utilities are required and is the Rotary Ampoule Washer cGMP compliant?

Utilities required:

Power: 4 HP (AVRW 120) or 5.5 HP (AVRW 240), 440V, 3 Phase, 50 Hz (customizable)
Compressed Air: 20 CFM
Water: 200 to 500 liters per hour (depending on model and ampoule size)

Yes, it is fully cGMP compliant with SS 316L contact parts, polished finishes, safety interlocks, and support for IQ/OQ/DQ validation documentation. Optional 21 CFR Part 11 compliant PLC + HMI controls are available.

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