Automatic Ampoule Vial Washing Machine

An Automatic Ampoule Vial Washing Machine is a specialized pharmaceutical equipment designed to clean ampoules and vials (1ml to 100ml) with minimal machine contact, ensuring compliance with cGMP standards. It is widely used in pharmaceutical, biotech, and veterinary industries for high-performance, sterile cleaning of glass containers before filling.

When filling and packing pharmaceuticals, complete sanitation and hygienic conditions are crucial. This is especially true when injectables are placed within glass ampoules. Before an ampoule is placed in the sterile filling chamber, it must 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 hygiene requirements of today.

A specifically made Gripper holds the ampoule from its neck, inverts it, and moves it further on a rotating moving system for the cleaning process. The ampoule feeds through feedworm to infeed Star Wheel. When a needle enters an ampoule neck, it travels in a neck-down position above the cleaning needles and moves with the needle bar to ensure that the greatest amount of washing time is achieved. Machine with six standard washing stations, each with six needles for optimal cleaning; the order can be altered to suit the needs of the customer. For the best possible Ampoule and vial washing, the machine also has an exterior wash. In this machine, we have two distinct models. While the AVRW-240 High Speed Ampoule Washing Machine could produce up to 200 ampoules per minute, the AVRW-120 Automatic Ampoule Washing Machine could only produce up to 100 ampoules per minute. One milliliter to twenty milliliter ampoules and vials can be cleaned by either the automatic ampoule and vial washer or the high-speed ampoule and vial washer. For ampoule vial combi washing machine validation and replacement components, we offer extended support.

Automatic Ampoule Vial Washing Machine Video

Key Features:

• Construction: Made of AISI 316L stainless steel for contact parts and AISI 304 or FDA-approved engineering plastics for non-contact parts, ensuring durability and hygiene.

• Gripper System: A specialized gripper holds containers by the neck, inverts them for washing, and releases them in a vertical position post-washing, minimizing contamination.

• Washing Process: Typically includes 3 water washes (e.g., recycled water, purified water, Water for Injection – WFI) and 3 air washes for internal and external cleaning. Washing sequences are customizable.

• Capacity: Models like AVRW-120 (up to 100 ampoules/vials per minute) and AVRW-240 (up to 200 ampoules/vials per minute) cater to different production needs.

• Operation: Fully automatic with PLC control, optional printing facilities, and safety features like automatic stop if the acrylic cover is lifted. No-vial-no-wash systems reduce water and air wastage.

• Cleaning Efficiency: Uses pressurized jets via multiple washing stations (e.g., 6 stations with 6 needles each) for thorough internal and external cleaning. WFI consumption is optimized via recirculation tanks.

• Flexibility: Handles various container sizes (1ml to 20ml ampoules, 2ml to 100ml vials) with change parts. External washing stations are adjustable for precise cleaning.

• Compliance: Designed to meet cGMP, GAMP, and 21 CFR Part 11 standards, with IQ/OQ/DQ validation documentation available.

Working Process:

1. Infeed: Ampoules/vials are fed from a tray or turntable to a starwheel/feedworm.

2. Washing: Grippers invert containers over washing needles, which spray water and air in a synchronized sequence. Needles enter the container neck for maximum cleaning time.

3. Outfeed: Washed containers are re-inverted to an upright position and transferred to an output tray or sterilization tunnel.

Applications:

Ideal for cleaning pharmaceutical glass containers used for injectables, ensuring sterility and eliminating particles or contaminants before filling.

Additional Features:

• Optional Systems: Ultrasonic baths, siliconization, or separate pumping stations for precise water pressure.

• Maintenance: Easy-to-clean design with minimal particle generation and low maintenance requirements.

This machine ensures high throughput, hygiene, and flexibility for pharmaceutical production lines. For pricing or specific models, refer to manufacturers like Adinath International.

Salient Features of Automatic Ampoule Vial 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.

Process Operation of Ampoule Vial Washing Machine

Ampoules and vials 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 and vials.

On completion of a cycle, washed Ampoules and vials 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.

 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

Technical Specification of Ampoule Vial Washing Machine

* 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.

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