Pharmaceutical Ampoule Washing Machine

Q: What is a Pharmaceutical Ampoule Washing Machine and what is it used for?

A Pharmaceutical Ampoule Washing Machine is a high-speed, automatic rotary washer designed to thoroughly clean glass ampoules both internally and externally before filling with injectable drugs, vaccines, or sterile products. It removes dust, particles, fibers, chemical residues, and microorganisms to ensure high cleanliness and sterility. It is widely used in pharmaceutical, biotech, veterinary, and cosmetic industries for cGMP-compliant injectable manufacturing lines.

Q: What are the key features of the Pharmaceutical Ampoule Washing Machine?

Key features include a complete cGMP-compliant design with AISI SS 316L contact parts, neck-gripping system that inverts ampoules for minimal contact, 6 internal washing stations with 18 jets (total 36 needles), 3 water washes + 3 air washes with independent circuits, adjustable washing sequence, water recirculation option, PLC with HMI and printing facility (optional), 'No Container – No Wash' system, digital speed indicator, container counter, and acrylic safety covers with interlocks. It can operate standalone or inline with filling lines.

Q: What is the production capacity and which ampoule sizes does it 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 (diameter 9mm to 21.5mm and height 60mm to 140mm). Quick-change parts allow easy size changeover.

Q: How does the washing process work in the Pharmaceutical Ampoule Washing Machine?

Ampoules are loaded from the infeed tray onto a feed worm and starwheel. Grippers pick them up, invert them neck-down, and pass them over reciprocating washing needles. The machine performs 6 internal washing zones and external sprays using a flexible sequence (e.g., Recycled Water → Air → DM Water → Air → Fresh WFI → Air). Independent circuits prevent cross-contamination. After washing, ampoules are re-inverted neck-up and discharged automatically for further processing.

Q: What utilities are required and is the Pharmaceutical Ampoule Washing Machine 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: 200–500 liters per hour (depending on model and 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 controls are available.

Description

A Pharmaceutical Ampoule Washing Machine is specialized equipment used in the pharmaceutical and biotech industries to clean and sterilize glass ampoules (small sealed vials) before they are filled with injectable drugs, vaccines, or other sensitive products. These machines ensure ampoules are free from contaminants, particulates, and microorganisms, maintaining the sterility and quality required for pharmaceutical products. The primary function of an ampoule washing machine is to remove impurities such as dust, chemical residues, endotoxins, and microorganisms from the internal and external surfaces of ampoules. This ensures the ampoules are sterile and safe for filling with medications, preventing contamination that could compromise product safety and efficacy.

Pharmaceutical ampoule washing machines are critical for ensuring the cleanliness and sterility of ampoules used in sensitive applications. With advanced automation, precise cleaning mechanisms, and compliance with stringent regulatory standards, these machines play a vital role in maintaining the safety and efficacy of injectable medications and other products. Their versatility across industries and ability to handle various ampoule types make them indispensable in modern pharmaceutical manufacturing.

Choosing the right ampoule washing machine depends on:

Production volume (high-speed for large-scale, compact for small-scale).

Ampoule size and material (glass/plastic, 1ml–20ml).

Space constraints.

Automation level (automatic vs. semi-automatic).

Sterility and regulatory requirements.

Salient Features of 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.

Working Principle of Pharmaceutical 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 Pharmaceutical 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

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

Rotary Ampoule Washer

Applications of Ampoule Washing Machine

Cleaning Process of Pharmaceutical Ampoule Washing Machine

Pre-Washing: Initial rinsing to remove loose contaminants.

Main Washing: High-pressure jets of purified water, water for injection (WFI), or cleaning agents clean the internal and external surfaces.

Rinsing: Multiple rinses with purified water or WFI to ensure no residual cleaning agents remain.

Drying: Filtered compressed air or heated air dries the ampoules to eliminate residual moisture, which could lead to contamination or product degradation.

Optional Sterilization: Some machines incorporate clean-in-place (CIP) or steam-in-place (SIP) systems for additional sterility assurance.

Washing Cycle of Pharmaceutical 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

Operational Mechanism of Pharmaceutical Ampoule Washing Machine

Loading: Ampoules are manually or automatically loaded onto an in-feed tray or conveyor.

Transport: A rotary or linear system (e.g., star wheel, grippers, or conveyor) moves ampoules through washing stations.

Washing: Nozzles or needles enter the ampoule necks, delivering high-pressure jets of cleaning media (e.g., WFI, purified water, compressed air) in a programmed sequence.

Drying: Filtered air or heated air removes residual moisture.

Discharge: Cleaned ampoules are transferred to a sterile tunnel or collection tray under laminar airflow to maintain sterility.

Key Features of Pharmaceutical Ampoule Washing Machine

Material Compatibility: Constructed from stainless steel (SS 316L for contact parts, SS 304 for non-contact parts) to handle glass or plastic ampoules of various sizes (typically 1ml–20ml).

Automation and Control: PLC-based systems with human-machine interfaces for precise control of washing parameters (e.g., water temperature, pressure, cycle duration).

Gripper System: Many machines use grippers to hold ampoules by the neck, minimizing contact and ensuring accurate positioning during washing.

High-Pressure Jets: Utilize needles or nozzles for targeted internal and external cleaning, often with adjustable pressure and flow.

Water and Air Filtration: Equipped with filters (e.g., 0.22µm for compressed air, 3µm for water) to ensure sterile cleaning media.

Recirculation Systems: Optimize water usage by recycling WFI through storage tanks, reducing waste.

Safety Features: Acrylic covers with interlocks stop the machine if opened during operation, preventing contamination.

Low Breakage Rate: Advanced designs (e.g., star wheels, grippers) minimize ampoule damage (<0.3%–0.5% breakage rate).

Regulatory Compliance: Adheres to cGMP, FDA, and WHO standards, with validation documentation for cleaning processes.

FAQ for Pharmaceutical Ampoule Washing Machine

What is a Pharmaceutical Ampoule Washing Machine and what is it used for?

A Pharmaceutical Ampoule Washing Machine is a high-speed, automatic rotary washer designed to thoroughly clean glass ampoules both internally and externally before filling with injectable drugs, vaccines, or sterile products. It removes dust, particles, fibers, chemical residues, and microorganisms to ensure high cleanliness and sterility. It is widely used in pharmaceutical, biotech, veterinary, and cosmetic industries for cGMP-compliant injectable manufacturing lines.

What are the key features of the Pharmaceutical Ampoule Washing Machine?

Key features include a complete cGMP-compliant design with AISI SS 316L contact parts, neck-gripping system that inverts ampoules for minimal contact, 6 internal washing stations with 18 jets (total 36 needles), 3 water washes + 3 air washes with independent circuits, adjustable washing sequence, water recirculation option, PLC with HMI and printing facility (optional), “No Container – No Wash” system, digital speed indicator, container counter, and acrylic safety covers with interlocks. It can operate standalone or inline with filling lines.

What is the production capacity and which ampoule sizes does it 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 (diameter 9mm to 21.5mm and height 60mm to 140mm). Quick-change parts allow easy size changeover.

How does the washing process work in the Pharmaceutical Ampoule Washing Machine?

Ampoules are loaded from the infeed tray onto a feed worm and starwheel. Grippers pick them up, invert them neck-down, and pass them over reciprocating washing needles. The machine performs 6 internal washing zones and external sprays using a flexible sequence (e.g., Recycled Water → Air → DM Water → Air → Fresh WFI → Air). Independent circuits prevent cross-contamination. After washing, ampoules are re-inverted neck-up and discharged automatically for further processing.

What utilities are required and is the Pharmaceutical Ampoule Washing Machine 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: 200–500 liters per hour (depending on model and 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 controls are available.

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