Glass Ampoule Washing Machine

Q: What washing stages and key features does the Glass Ampoule Washing Machine have?

The machine features 6 internal washing stations (3 water + 3 air washes) with 36 needles (6 per station) and 3 external washing stations. Typical washing sequence: Recycled Water / WFI Compressed Air DM / Purified Water Compressed Air Final Water for Injection (WFI) Final Compressed Air Key features include: Automatic infeed/outfeed with gripper system that inverts ampoules neck-down Independent washing circuits to prevent cross-contamination All contact parts in AISI 316L Stainless Steel Digital speed indicator and container counter cGMP design with low WFI consumption through recirculation Can be used standalone or inline with sterilizing tunnel and filling machine

Description

Glass Ampoule Washing Machine are specially made devices that use air and water to clean ampoules. The Gripper mechanism on rotary machines is specifically designed to support and hold the ampoules from their necks while they are inverted during the washing process. Once the washing is over, the ampoules can be released. After being cleaned, they are released through an outfeed system called a feed worm system. To ensure that ampoules are successfully cleaned, these feed worm systems are kept upright. These washing machines can clean ampoules with a volume of 1 ml to 10 ml by using interchangeable parts. Through the feed worm, Ampoule enters the interior chamber, grabs it by the neck, and starts the washing process.

When it comes to pharmaceutical filling and packaging procedures, complete sanitation and cleanliness are crucial. This is especially true when injectables are loaded into glass ampoules. Before entering the sterile filling room, each ampoule needs to be completely sterile. A high-precision ampoule washing machine that satisfies the strict sterility and hygienic requirements of today is available from Adinath, the industry leader in high-tech pharmaceutical equipment.

Since our founding, we have remained committed to providing Ampoule Washing Machine in order to achieve total client satisfaction. Our valued clientele have praised the machine for its outstanding performance and extended lifespan. The pharmaceutical business uses it extensively for ampoule cleaning. Under the direction of our hard-working specialists, the given machine is produced by our experts employing top-notch parts and cutting-edge methods.

Salient Features of Glass 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 Glass 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 Glass 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

Washing Cycle of Glass 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

Benefits of Glass Ampoule Washing Machine

Ensures high cleanliness and sterility, critical for injectable drug production.

Reduces contamination risks, protecting operators and patients.

High-speed operation with minimal resource wastage.

Flexible for various ampoule sizes and customizable washing sequences.

Key Features and Description of Glass Ampoule Washing Machine

Purpose and Application:
- Used to clean glass ampoules (typically 1ml to 20ml) for pharmaceutical, biotech, veterinary, or chemical applications.
- Ensures removal of at least 3 log of particulate contamination, preparing ampoules for sterile filling.

Washing Process:
- Rotary Washing: Ampoules are held by grippers, inverted, and rotated through multiple washing stations in a continuous motion. Servo-driven nozzles clean the interior with recycled water, purified water, and Water for Injection (WFI), followed by compressed air to remove residual water. External surfaces are cleaned with water and air jets.
- Linear Washing: Ampoules move in a straight line through washing stations, including ultrasonic cleaning, compressed air, and water washes.
- Typical washing cycle includes:
  - Ultrasonic washing to dislodge particles.
  - Multiple internal washes (e.g., recycled water, purified water, WFI).
  - External washing with pressurized water jets.
  - Compressed air blowing for drying.

Design and Construction:
- Made of high-quality stainless steel (SS 316L for contact parts, SS 304 for non-contact parts) for durability and compliance with cGMP standards.
- Compact design for integration into filling lines, often paired with sterilizing tunnels for continuous processing.
- Features like stationary nozzles reduce contamination risks, and some models include ultrasonic pre-washing systems.

Sterility and Compliance:
- Designed for cleanroom integration, often with laminar airflow to maintain aseptic conditions.
- Complies with GMP, FDA, and 21 CFR Part 11 standards, ensuring traceability and quality control.
- Some models feature HEPA filters and glove ports for enhanced sterility.

Maintenance and Operation:
- Easy-to-clean design with large openings and removable parts for sterilization.
- Stationary nozzles and separate solenoid valves for each washing cycle reduce contamination and simplify maintenance.
- High-capacity centrifugal pumps and portable stands for pumps/tanks enhance accessibility.

Integration:
- Can operate as a standalone unit or as part of a complete ampoule production line, including sterilizing tunnels, filling, and sealing machines.
- Compatible with upstream and downstream equipment like depyrogenation tunnels and inspection systems.

FAQ for Glass Ampoule Washing Machine

What is a Glass Ampoule Washing Machine?

A Glass Ampoule Washing Machine is a high-precision, rotary-type cGMP-compliant pharmaceutical equipment designed to thoroughly clean the internal and external surfaces of glass ampoules. It removes dust, particles, fibers, and contaminants using multiple high-pressure jets of recycled water, purified/DM water, Water for Injection (WFI), and compressed air. Ampoules are automatically inverted neck-down during washing for maximum cleaning efficiency, making them ready for sterilization and filling in sterile injectable production lines.

What are the main applications of the Glass Ampoule Washing Machine?

This machine is widely used in the pharmaceutical industry for cleaning glass ampoules before filling injectable drugs, vaccines, and sterile solutions. It is also suitable for:

Biotechnology
Veterinary medicines
Cosmetic industry (serums and injectable cosmetics)
Chemical industry

It ensures the highest cleanliness standards required for aseptic manufacturing of parenterals and other sterile products.

What is the output capacity and ampoule size range supported?

Our Glass Ampoule Washing Machine is available in two main models:

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

It handles 1 ml to 10 ml glass ampoules (extendable up to 20 ml with change parts). Size range: Diameter 9 mm to 21.5 mm, Height 60 mm to 140 mm. Changeover for different sizes is quick and easy with interchangeable parts, and speed is adjustable via a digital indicator.

What washing stages and key features does the Glass Ampoule Washing Machine have?

The machine features 6 internal washing stations (3 water + 3 air washes) with 36 needles (6 per station) and 3 external washing stations. Typical washing sequence:

Recycled Water / WFI
Compressed Air
DM / Purified Water
Compressed Air
Final Water for Injection (WFI)
Final Compressed Air

Key features include:

Automatic infeed/outfeed with gripper system that inverts ampoules neck-down
Independent washing circuits to prevent cross-contamination
All contact parts in AISI 316L Stainless Steel
Digital speed indicator and container counter
cGMP design with low WFI consumption through recirculation
Can be used standalone or inline with sterilizing tunnel and filling machine

How does the Glass Ampoule Washing Machine ensure compliance and sterility?

Built as a complete cGMP model, the machine uses AISI 316L Stainless Steel for all product-contact parts and SS 304 for non-contact parts. It minimizes contamination risk with inverted neck-down washing, independent zone circuits, and synchronized media application. IQ/OQ/DQ validation documents are provided, and optional PLC with HMI + 21 CFR Part 11 compliance is available. This ensures it meets stringent regulatory standards for injectable pharmaceutical production while offering operator safety and easy cleanroom integration.

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