Automatic Rotary Ampoule Washing Machine

An Automatic Rotary Ampoule Washing Machine is a specialized pharmaceutical device designed to clean glass ampoules internally and externally, ensuring sterility and compliance with cGMP standards. It minimizes contact between machine parts and ampoules to prevent contamination, making it ideal for pharmaceutical, veterinary, and biotech industries.

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 rotary 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 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 can be cleaned by either the automatic ampoule washer or the high-speed ampoule washer. For rotary ampoule washing machine validation and replacement components, we offer extended support.

Automatic Rotary Ampoule Washing Machine Video

Design and Operation

• Structure: The machine features a compact, enclosed design, typically constructed with 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 specially designed gripper system holds ampoules by their necks, inverts them for washing, and releases them in a vertical position post-washing, ensuring positive and thorough cleaning with minimal contact.

• Rotary Motion: Ampoules are fed via an infeed hopper or tray, aligned by a feedworm, and transferred to an infeed starwheel. The rotary system moves ampoules continuously or via indexing motion through multiple washing stations.

• Washing Process:

  • Ampoules are inverted (neck down) over washing needles, which enter the ampoule neck for internal cleaning.

  • Spray tubes or nozzles, synchronized with ampoule movement, deliver cleaning media (e.g., Water for Injection (WFI), purified water, or compressed air) to internal and external surfaces.

  • The machine typically features 6 washing stations, each with 6–8 needles (totaling 36–48 needles), providing 3–6 internal water washes (e.g., recycled water, purified water, WFI) and 3 air washes, plus 1–2 external water and air washes.

  • Washing sequences are customizable to meet specific requirements, with independent circuits for each washing zone to avoid cross-contamination.

• Output and Re-inversion: After washing, ampoules are re-inverted to a neck-up position, discharged via an output starwheel, and collected on trays or fed directly to a sterilizing tunnel. Optional pumping stations ensure precise water pressure, while recirculation systems reduce WFI consumption.

Key Features

• Capacity: Models like AVRW-120 (up to 100–120 ampoules/min), and AVRW-240 (up to 200 ampoules/min) cater to different production scales. Ampoule sizes range from 1ml to 20ml, with change parts for flexibility.

• Compliance: Meets cGMP, GAMP, and 21 CFR Part 11 standards, with optional IQ/OQ/DQ validation documentation and PLC-based controls for monitoring and automation.

• Efficiency: Features like quick-changeover parts, servo-driven nozzles, and PLC-controlled washing cycles reduce downtime and enhance flexibility for different batch sizes.

• Hygiene: External washing ensures thorough cleaning, while features like aseptic diaphragm valves, polycarbonate guards, and vapor exhaust systems maintain sterility. Some models include ultrasonic washing or siliconization options.

• Utilities: Typically requires 2–7 kW power (230V/415V, 50 Hz, 3-phase) and compressed air for drying stations. Dimensions vary, e.g., 3200mm x 2000mm x 1400mm for some models.

Applications

• Widely used for cleaning ampoules before filling with injectables, ensuring no contaminants (e.g., bacteria, mold, particles) remain.

• Suitable for high-volume production in pharmaceutical, biotech, and veterinary industries.

Advantages

• Minimizes contamination risk with low-contact gripper design.

• High precision and repeatability with PLC and HMI touch-screen controls.

• Reduced water consumption through recirculation systems.

• Easy maintenance with accessible, separable sections (mechanical drive, washing, filtration).

Salient Features of Rotary 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.

Process Operation of Rotary 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.

 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 Rotary Ampoule 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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