Compact Ampoule Washing Machine

A Compact Ampoule Washing Machine is a specialized pharmaceutical device designed to clean glass ampoules (1ml to 20ml) and sometimes vials (2ml to 100ml) with minimal contact to ensure sterility and compliance with cGMP standards. These machines are widely used in pharmaceutical, veterinary, and biotech industries for efficient, high-quality cleaning of small glass containers.

Ampoule Washing Machine Video

Key Features and Description:

1. Compact Design: The machine features a space-saving, enclosed structure, typically made of stainless steel (SS 304 for non-contact parts, SS 316L for contact parts with wash media), ensuring durability and hygiene.

2. Washing Process:

   • Utilizes a multi-stage cleaning process, often including ultrasonic washing, purified water wash, water for injection (WFI) wash, and compressed air blowing to remove particulate contamination (up to 3 log reduction).

   • Positive and pressurized jets deliver precise cleaning with minimal water usage, ensuring both internal and external surfaces are thoroughly cleaned.

   • Some models offer customizable washing sequences (e.g., 2 water and 2 air washes externally, 3 water and 4 air washes internally).

3. Gripper System: A specially designed gripper mechanism holds ampoules by the neck, inverts them for cleaning, and releases them in a vertical position post-washing, minimizing breakage and ensuring positive cleaning.

4. Automation and Control:

   • Available in semi-automatic or fully automatic models, with options for PLC-based control, HMI touchscreens, or timer-operated solenoid valve systems for precise cycle management.

   • Some machines feature password-protected process parameters and data logging for validation and compliance with GMP standards.

5. Capacity and Flexibility:

   • Suitable for ampoules (1ml to 20ml) and vials (2ml to 100ml) with interchangeable change parts for different container sizes.

   • Output varies by model, ranging from 30 trays/hour (semi-automatic) to high-speed models handling 100–240 ampoules per minute.

6. Additional Features:

   • Acrylic top covers for visibility of the washing process.

   • Low bottle breakage rate (≤0.5%).

   • Emergency stop buttons, safety interlocks (e.g., stops if cover is lifted), and vacuum insulation for motor protection.

   • Some models include drying cycles with adjustable temperature settings.

7. Compliance and Materials:

   • Designed to meet cGMP and ISO 14644-1 standards, ensuring an ISO 5 clean environment.

   • Contact parts are made of FDA-approved materials like SS 316L, silicone, or polycarbonate to prevent contamination.

Typical Applications:

• Cleaning ampoules and vials for injectable drugs in pharmaceutical production.

• Suitable for small to medium-scale injectable organizations, R&D labs, and high-speed production lines.

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.

Process Operation 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.

 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 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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