Ampoule Washing Machine

Q: What washing stages and features does the Ampoule Washing Machine offer?

The machine provides 6 internal washing stations (3 water washes + 3 air washes) and external cleaning. Typical sequence includes: Recycled water / WFI Compressed air Purified / DM water Compressed air Final WFI Final compressed air Key features include: 36 needles (6 per station) for thorough internal cleaning Independent circuits per zone to prevent cross-contamination All contact parts in AISI 316L Stainless Steel cGMP-compliant design with low maintenance PLC control with HMI (optional) and 21 CFR Part 11 compliance on demand Recirculation tanks to reduce WFI consumption

Description

The purpose of ampoule washing machine is to continuously rotate while cleaning the internal and external surfaces of ampoules. In order to allow servo-driven nozzles to move vertically and wash ampoules from the inside, grippers that hold ampoules flip their position. It contains six dome-covered washing stations that offer three different types of internal water washes, including recycled water wash, purified water wash, and WFI wash, as well as three air washes. One PLC-controlled water and air wash is used to clean external surfaces. We offer extended support for ampoule washing machine validation and replacement parts.

The equipment, which was constructed in accordance with cGMP rules, has a sturdy design, requires little upkeep, and integrates easily into production lines. For injectable production facilities looking for dependable performance, efficiency, and regulatory compliance, it is perfect. The machines’ small size guarantees that the washing process is clearly visible.

When it comes to pharmaceutical filling and packaging procedures, complete cleanliness and sanitation are crucial. This becomes even more crucial when injectables are loaded into glass ampoules. Before entering the sterile filling room, each ampoule needs to be completely sterile. The industry leader in high-tech pharmaceutical equipment, Adinath, provides a highly accurate ampoule washing machine that satisfies the strict sterility and hygienic requirements of today.

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 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 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 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 Ampoule Washing Machine

Ensures sterility and cleanliness critical for pharmaceutical safety.

High-speed operation improves production efficiency.

Customizable washing sequences and modular designs cater to diverse needs.

Reduces manual handling, minimizing contamination risks.

Key Features and Description of Ampoule Washing Machine

Design and Operation:
- Rotary or Linear Systems: Most ampoule washing machines operate on a rotary system, where ampoules are fed from an infeed tray, transferred via a feedworm or starwheel, and held by grippers that invert them for cleaning. Some machines use linear systems for specific applications.
- Minimal Contact: Machines are engineered to minimize contact between machine parts and ampoules, reducing the risk of contamination. Grippers typically hold ampoules by the neck, invert them for washing, and return them to a vertical position post-washing.
- Washing Process: The cleaning process involves multiple stations (typically 3–6) that use high-pressure jets of purified water, Water for Injection (WFI), and compressed air to clean both internal and external surfaces. Some machines incorporate ultrasonic cleaning for enhanced particle removal.
- Drying: Post-washing, ampoules are dried using compressed air, often with adjustable temperature settings to ensure no residual moisture remains.

Capacity and Versatility:
- Machines can handle ampoules ranging from 1 ml to 20 ml (some up to 100 ml for vials) with interchangeable parts for different sizes.
- Output capacities vary, with standard models processing 100–300 ampoules per minute, and high-speed models reaching up to 400 ampoules per minute.
- Some machines, like the Ampoule Vial Combi Washing Machine, can clean both ampoules and vials, enhancing flexibility.

Materials and Compliance:
- Contact Parts: Made of AISI 316L stainless steel to ensure compatibility with wash media and prevent corrosion.
- Non-Contact Parts: Typically constructed from AISI 304 stainless steel or FDA-approved engineering plastics.
- All finishes and welds adhere to cGMP standards to ensure hygiene and sterility.
- Machines often include validation documentation (IQ/OQ/DQ) and comply with 21 CFR Part 11 for software and data integrity.

Advanced Features:
- Gripper System: A specially designed gripper holds ampoules by the neck, inverts them for washing, and ensures precise alignment with washing nozzles.
- PLC Control: Programmable Logic Controllers (PLCs) and Human-Machine Interfaces (HMIs) allow for automated operation, customizable washing sequences, and real-time monitoring.
- Filtration Systems: Include high-quality filters (e.g., 10-micron nylon cartridges) to ensure clean wash media.
- Safety Features: Emergency stop buttons, vacuum insulation, and heat shielding protect the machine and operators.
- Optional Features: Ultrasonic cleaning, siliconization, inline integration with filling and sealing machines, and data logging for process validation.

Applications:
- Widely used in pharmaceutical manufacturing for cleaning ampoules before filling with sterile injectables.
- Also used in veterinary and biotech industries for similar purposes.
- Ensures ampoules meet strict cleanliness standards (e.g., removal of at least 3 log of particulate contamination).

Standard Operating Procedure:
- Ampoules are typically subjected to three washing cycles using purified water, WFI, and compressed air, with external washing via jets.
- Quality checks involve filling a sample (e.g., 20 ampoules) with filtered water and inspecting for particles or contaminants.

FAQ for Ampoule Washing Machine

What is an Ampoule Washing Machine?

An Ampoule Washing Machine is a fully automatic, rotary-type pharmaceutical equipment designed to thoroughly clean the internal and external surfaces of glass ampoules. It uses high-pressure jets of recycled water, purified water, Water for Injection (WFI), and compressed air to remove dust, particles, fibers, and contaminants. This ensures ampoules are particle-free and ready for sterilization and filling in injectable production lines. The machine features a gripper system that inverts ampoules for effective neck-down washing.

What are the main applications of the Ampoule Washing Machine?

This machine is primarily used in the pharmaceutical industry for cleaning glass ampoules before they are filled with injectable drugs, vaccines, or sterile solutions. It is also widely applied in:

Biotechnology
Veterinary medicines
Cosmetic industry (for serums and ampoules)
Chemical industry

It plays a critical role in ensuring high cleanliness standards required for sterile injectable manufacturing.

What is the output capacity and ampoule size range of your Ampoule Washing Machine?

Our Ampoule Washing Machine is available in different models:

AVRW 120: Up to 100 ampoules per minute
AVRW 240: Up to 200 ampoules per minute (Higher speeds up to 300–400 ampoules/min available on request)

It handles 1 ml to 10 ml ampoules (extendable up to 20 ml) with diameters from 9 mm to 21.5 mm and heights from 60 mm to 140 mm. Change parts are interchangeable for quick size switching, and output speed is adjustable via a digital indicator.

What washing stages and features does the Ampoule Washing Machine offer?

The machine provides 6 internal washing stations (3 water washes + 3 air washes) and external cleaning. Typical sequence includes:

Recycled water / WFI
Compressed air
Purified / DM water
Compressed air
Final WFI
Final compressed air

Key features include:

36 needles (6 per station) for thorough internal cleaning
Independent circuits per zone to prevent cross-contamination
All contact parts in AISI 316L Stainless Steel
cGMP-compliant design with low maintenance
PLC control with HMI (optional) and 21 CFR Part 11 compliance on demand
Recirculation tanks to reduce WFI consumption

How does the Ampoule Washing Machine ensure compliance and product safety?

The machine is built as a complete cGMP model with contact parts made from AISI 316L Stainless Steel and non-contact parts from SS 304 or FDA-approved engineering plastics. It minimizes contamination risk through automatic infeed/outfeed, inverted neck-down washing, and independent washing circuits. IQ/OQ/DQ validation documents are provided, and optional 21 CFR Part 11 compliant software is available. This ensures the highest sterility standards for injectable products while offering easy integration into washing–sterilization–filling lines.

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