Aseptic Glass Ampoule Washing Machine

Q: What is the production capacity and suitable ampoule sizes for this machine?

The machine is available in two main models: AVRW 120 : Up to 100 ampoules per minute AVRW 240 : Up to 200 ampoules per minute It handles glass ampoules with diameters from 9mm to 21.5mm and heights from 60mm to 140mm (typically 1ml to 10ml). The washing sequence and speed are adjustable as per customer requirements.

Q: What utilities are required and what optional accessories are available?

Utilities required : Power: 4–5.5 H.P. (440 Volts, 3 Phase, 50 Hz) Compressed Air: 20 CFM Water: 200–500 liters per hour (depending on ampoule size) Optional accessories include: PLC with HMI and printing facility Separate pumping station with 3 tanks (25 liters each) and pumps Safety cabinet with doors Recirculation and siliconization system

Description

The Aseptic Glass Ampoule Washing Machine is a high-precision, cGMP-compliant cleaning system specifically engineered for the pharmaceutical industry to ensure thorough internal and external decontamination of glass ampoules prior to sterilization, filling, and sealing processes. Designed for aseptic production lines handling injectable formulations, this machine delivers superior cleanliness by effectively removing particles, residues, fibers, and microbial contaminants from 1ml to 25ml (or higher, depending on model) glass ampoules, maintaining the highest standards of sterility and product safety.

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.

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 Aseptic 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 Aseptic 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

Injectable Glass Ampoule Washing Machine

Lab Scale Ampoule Washing Machine

Multijet Ampoule Washing Machine

Rotary Ampoule Washer

Applications of Ampoule Washing Machine

Benefits of Aseptic 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.

Washing Cycle of Aseptic 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

FAQ for Aseptic Glass Ampoule Washing Machine

What is an Aseptic Glass Ampoule Washing Machine?

The Aseptic Glass Ampoule Washing Machine is a high-precision, cGMP-compliant rotary washing system designed to thoroughly clean the internal and external surfaces of glass ampoules (1ml to 10ml or higher) before they proceed to sterilization, filling, and sealing. It effectively removes particles, fibers, residues, and microbial contaminants using multiple water and air wash cycles, ensuring the highest level of cleanliness required for injectable pharmaceutical products.

What is the production capacity and suitable ampoule sizes for this machine?

The machine is available in two main models:

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

It handles glass ampoules with diameters from 9mm to 21.5mm and heights from 60mm to 140mm (typically 1ml to 10ml). The washing sequence and speed are adjustable as per customer requirements.

How does the Aseptic Glass Ampoule Washing Machine work?

Ampoules are automatically fed from the infeed tray to a starwheel. Grippers hold them by the neck, invert them (neck-down), and pass them over stationary washing needles across six internal washing zones. The process includes 3 water washes and 3 air washes with independent circuits to prevent cross-contamination. External washing is also performed simultaneously. After cleaning, ampoules are re-inverted (neck-up) and discharged to the output tray or connected tunnel. This ensures maximum cleaning efficiency with minimal risk of particle generation.

What materials are used in the construction and does it comply with cGMP standards?

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, polished welding joints, and easy-to-clean design. It comes with IQ/OQ/DQ validation documentation and optional 21 CFR Part 11 compliant PLC system with HMI and password protection.

What utilities are required and what optional accessories are available?

Utilities required:

Power: 4–5.5 H.P. (440 Volts, 3 Phase, 50 Hz)
Compressed Air: 20 CFM
Water: 200–500 liters per hour (depending on ampoule size)

Optional accessories include:

PLC with HMI and printing facility
Separate pumping station with 3 tanks (25 liters each) and pumps
Safety cabinet with doors
Recirculation and siliconization system

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