Sterile Ampoule Washing Machine

Q: What is the production capacity and which ampoule sizes does the Sterile Ampoule Washing Machine support?

We offer two models: AVRW 120 – Up to 100 ampoules per minute AVRW 240 – Up to 200 ampoules per minute It supports 1ml to 10ml glass ampoules (diameter 9mm to 21.5mm and height 60mm to 140mm). Quick-change parts allow fast and easy size changeover for different production needs.

Q: What utilities are required and is the Sterile 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 to 500 liters per hour (depending on model and ampoule size) Yes, it is fully cGMP compliant with polished SS 316L contact parts, safety interlocks, advanced filtration, and support for IQ/OQ/DQ validation documentation. Optional 21 CFR Part 11 compliant controls are available to meet stringent regulatory standards for sterile injectable production.

Description

A Sterile Ampoule Washing Machine is specialized equipment used in pharmaceutical, biotechnology, and related industries to clean and sterilize ampoules (small sealed glass or plastic vials) before they are filled with injectable drugs, vaccines, or other sensitive products. These machines ensure the ampoules are free from contaminants such as dust, particles, microbes, and endotoxins, maintaining the sterility and safety required for pharmaceutical production. The primary objective of a sterile ampoule washing machine is to remove impurities, particulate matter, and microorganisms from both the internal and external surfaces of ampoules. This ensures compliance with stringent regulatory standards, such as current Good Manufacturing Practices (cGMP) and FDA guidelines, preventing contamination of the final product and ensuring patient safety.

Sterile ampoule washing machines are critical for ensuring the cleanliness and sterility of ampoules in pharmaceutical and related industries. By combining advanced technology, precise cleaning processes, and regulatory compliance, these machines play a vital role in producing safe, high-quality injectable products. Their versatility, automation, and adherence to strict hygiene standards make them indispensable for modern pharmaceutical manufacturing. For further details or specific models, refer to manufacturer Adinath International, which offer a range of sterile washing solutions tailored to industry needs.

Loading: Ampoules are manually or automatically loaded onto an in-feed tray or conveyor, often via a turntable or star wheel.

Transport: A gripper system or conveyor (rotary or linear) transports ampoules through cleaning stations, often inverting them for internal washing.

Washing Cycle: Ampoules undergo a sequence of cleaning steps, typically including:
- Internal and External Wash: High-pressure jets of recycled water, purified water, or WFI clean both surfaces.
- Compressed Air Blow: Removes water and debris with filtered air.
- Final WFI Rinse: Ensures sterility with Water for Injection.
- Drying: Filtered air dries the ampoules to remove residual moisture.

Discharge: Cleaned ampoules are released to an out-feed system (e.g., conveyor or tray) for sterilization, filling, or further processing under laminar airflow to maintain sterility.

Salient Features of Sterile 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 Sterile 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 Sterile 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

Linear Ampoule Washing Machine

Applications of Ampoule Washing Machine

Advantages of Sterile Ampoule Washing Machine

Ensures high sterility and cleanliness, critical for injectable products.

Reduces risk of contamination, protecting patient safety.

Increases production efficiency with automated, high-speed options.

Flexible designs cater to various ampoule sizes and production scales.

Environmentally friendly with water recirculation systems to minimize waste.

Washing Cycle of Sterile 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

Validation and Quality Assurance

Cleaning Validation: Machines undergo rigorous validation to ensure consistent cleanliness, including tests for endotoxin reduction (e.g., 3-log reduction), chemical decontamination (e.g., sodium chloride challenge), and particulate removal (e.g., talc or glass particle tests).

Quality Control: Regular monitoring and documentation ensure compliance with regulatory standards.

Maintenance: Routine maintenance minimizes downtime and extends machine lifespan.

Operator Training: Essential for consistent operation and adherence to protocols.

Key Features of Sterile Ampoule Washing Machine

Construction and Materials:
- Made from high-quality stainless steel to ensure durability, corrosion resistance, and compliance with sanitary standards.
- Non-contact parts are often made from FDA-approved engineering plastics or AISI SS 304.
- Designed to minimize cross-contamination with smooth, easy-to-clean surfaces.

Cleaning Process:
- Utilizes a multi-stage washing cycle that includes:
  1. Pre-washing: Initial rinse to remove loose debris.
  2. Main washing: Uses high-pressure jets of recycled water, purified water, or Water for Injection (WFI) to clean internal and external surfaces.
  3. Rinsing: Purified water or WFI rinse to remove residual cleaning agents.
  4. Drying: Filtered compressed air or hot air to eliminate residual moisture, preventing contamination or product degradation.
- Some machines incorporate ultrasonic cleaning for enhanced removal of stubborn contaminants.

Sterilization Mechanisms:
- Equipped with Clean-in-Place (CIP) and Steam-in-Place (SIP) systems to maintain a sterile environment within the machine.
- Ensures ampoules meet aseptic standards, critical for injectable products.

Gripper System:
- Many machines feature a specially designed gripper mechanism that holds ampoules by their necks, inverts them for thorough cleaning, and releases them post-washing.
- Minimizes contact with machine parts, reducing the risk of damage or contamination.

Washing Parameters:
- Adjustable settings for water temperature, pressure, cycle duration, and number of washes to meet specific cleaning requirements.
- Precision control via Programmable Logic Controller systems for consistent performance.

Automation and Control:
- Available in automatic, semi-automatic, or compact models to suit different production scales.
- Automatic models require minimal operator intervention, ideal for high-volume production.
- User-friendly interfaces with digital controls for monitoring and adjusting parameters.
- Some models include data logging for validation and compliance with regulatory requirements.

Drying System:
- Integrated air-drying systems using 0.22µm filtered compressed air to ensure no residual moisture remains, which could lead to contamination.

Regulatory Compliance:
- Designed to meet cGMP, FDA, and ISO standards.
- Supports validation processes with documentation for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Versatility:
- Capable of handling various ampoule sizes (e.g., 1ml to 20ml) and materials (glass or plastic) with interchangeable parts.
- Some models can clean both ampoules and vials, offering flexibility for manufacturers.

Safety Features:
- Equipped with interlocks, alarms, and emergency switches to ensure operator safety.
- Acrylic covers or Laminar Air Flow (LAF) systems to maintain a clean environment during operation.

FAQ for Sterile Ampoule Washing Machine

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

A Sterile Ampoule Washing Machine is a high-speed automatic rotary washer designed for aseptic internal and external cleaning of glass ampoules. It removes dust, particles, fibers, microbes, endotoxins, and other contaminants to ensure the ampoules are completely sterile before filling with injectable drugs, vaccines, or other sensitive pharmaceutical products. It is widely used in pharmaceutical, biotechnology, veterinary, and cosmetic industries to maintain strict sterility standards and comply with cGMP and FDA guidelines.

What are the key features of the Sterile 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 and reduced contamination risk, 6 internal washing stations with 18 jets (total 36 needles), 3 external washing stations, 3 water washes + 3 air washes with independent circuits to prevent cross-contamination, fully adjustable washing sequence, water recirculation for reduced WFI consumption, automatic infeed and exit, digital speed indicator, container counter, acrylic safety covers with interlocks, and quick-change parts. Optional PLC with HMI, printing facility, and 21 CFR Part 11 compliance are available.

What is the production capacity and which ampoule sizes does the Sterile Ampoule Washing Machine support?

We offer two models:

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

It supports 1ml to 10ml glass ampoules (diameter 9mm to 21.5mm and height 60mm to 140mm). Quick-change parts allow fast and easy size changeover for different production needs.

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

Ampoules are loaded from the infeed tray onto a star wheel or feed worm. Grippers hold them by the neck, invert them neck-down, and move them over reciprocating washing needles across 6 internal stations. The machine performs a customizable 3 water + 3 air wash cycle (typically: Recycled WFI → Air → DM Water → Air → Fresh WFI → Air) with simultaneous external spraying. Independent circuits ensure no cross-contamination. After washing, ampoules are re-inverted upright and automatically discharged, ready for sterilization or filling under aseptic conditions.

What utilities are required and is the Sterile 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 to 500 liters per hour (depending on model and ampoule size)

Yes, it is fully cGMP compliant with polished SS 316L contact parts, safety interlocks, advanced filtration, and support for IQ/OQ/DQ validation documentation. Optional 21 CFR Part 11 compliant controls are available to meet stringent regulatory standards for sterile injectable production.

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