Automatic External Ampoule Washing Machine

Q: What utilities are required and what are the key features?

Utilities Required: Power: 0.75 H.P. (440V, 3 Phase, 50 Hz) Compressed Air: Filtered air at 6 bar and sterile filtered air at 4 bar (0.01 μm) Water: Recycled water, DM Water, or WFI as per washing sequence Key Features: 2 water + 2 air wash stages with flexible sequence Special bottom-side drying arrangement Easy integration with filling & sealing machines Acrylic safety cabinet for process visibility Low power consumption and minimal maintenance PLC control with advanced parameter display

Description

An Automatic External Ampoule Washing Machine is a specialized pharmaceutical device designed to clean the outer surface of cylindrical containers, such as ampoules, after filling and sealing. It ensures the removal of contaminants like dust, dirt, residues, or spilled liquids to maintain sterility and quality for pharmaceutical, biotech, and injectable applications.

Loading: Ampoules are loaded in bulk via trays or a wire mesh conveyor.

Washing: Ampoules are fed through a continuous rotary system, where they are inverted and cleaned using water spray jets (detergent, tap water, or WFI) and air jets from specialized nozzles or knife blocks.

Drying: Sterile hot air is blown to dry the ampoules, with adjustable parameters for precision.

Unloading: Cleaned and dried ampoules are collected in an outfeed tray or sent to downstream processes like labeling.

Salient Features of Ampoule Washing Machine

cGMP compliant
Provision of 2 water and 2 air washes.
Acrylic cabinet for washing stations for clear view of process.
Easily connected to filling and sealing machine.

Control Panel based on PLC concept.
Top-end gear box
Equipped with A.C frequency drive.
Advanced display of parameters.

Working Principle of Automatic External Ampoule Washing Machine

This advanced ampoule external washing machine automates the entire process with sheer ease and includes 4 key stages of cleaning. The stages include cleaning with a washing medium such as recycled water, air wash, Demineralized Water/Water for Injection and final air wash. Known for its flexibility the machine allows the user to change the sequence according to his or her specific needs. This machine is profusely uses in the pharmaceutical and injectable industries.

The machine comprises wire mesh conveyor on which ‘to be cleaned’ ampoules are properly fed. These ampoules are then transported from the in-feed worm for the washing process. Now the ampoules are washed using a water jet and dried using an air jet. A set of spray nozzles is fitted on conveyor for water jet. Besides, a set of knife blocks are provisioned on each conveyor for air-jet. These knives are used for the purpose of spraying air. Once the washing and drying process is over, the ampoules are forwarded to the outfeed collection tray. Ampoule external washer is also facilitated with a special arrangement to ensure proper drying of each ampoule from the bottom side.

Technical Specification of Automatic External Ampoule Washing Machine

Input Specification	1ml to 20ml ampoules
Application	Decontamination, external washing and drying
Operation mode	Continuous motion
MOC	Contact Part SS 316L or Food Grade Material. Non contact parts SS 304 or MS cladded with SS 304
Output	Up to 50 ampoules/minute (Either On-line or with Tray Collection System)
Required Line Pressure	1.5 kgs.
Dimensions	As per Layout
Working height	900 mm ± 50mm
Power Supply	0.75 H.P.
Electric Characteristics	440 volts, 3 phase, 50hertz, 4 Wire system with separate earthing
Compressed Air supply	Filtered Air at 6. bar g. for instrumentation sterile filtered air (0.01um) at 4 bar g. (To be provided by Customer)

* 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 Ampoule Washing Machine

High Efficiency: Processes up to 21,000 containers/hour, reducing production time.

Sterility and Quality: Ensures compliance with stringent pharmaceutical standards.

Flexibility: Customizable cycles and quick size changeovers for various container sizes.

Cost-Effective: Optional recycling stations and energy-efficient cleaning needles reduce operational costs.

Ease of Use: Minimal maintenance, easy dismantling, and user-friendly PLC controls.

Key Features of Automatic External Ampoule Washing Machine

Purpose: Cleans the external surface of ampoules (typically 1ml to 20ml) to ensure compliance with Current Good Manufacturing Practices (cGMP) and to prepare them for labeling or further processing.

Operation: Fully automated, continuous rotary motion system for high efficiency and throughput.

Washing Process: Typically involves multiple stages (e.g., 2–4 stages), including:
- Detergent Water: Removes initial contaminants and residues.
- Tap Water/Recycled Water: Rinses off detergent or additional debris.
- Demineralized Water/Water for Injection (WFI): Ensures thorough cleaning for sterility.
- Compressed Air Wash: Blows off water and dries the ampoules, often with sterile hot air.
- Heating: Facilitates drying and ensures no water droplets remain, critical for proper labeling.

Customization: Flexible washing sequences that can be adjusted based on specific requirements (e.g., type of contaminants or industry standards).

Construction:
- Materials: Contact parts made of SS 316L (stainless steel) for corrosion resistance and compliance with cGMP; non-contact parts often SS 304 or MS cladded with SS 304.
- Frame: Robust, often made of AISI 304 pipes, welded and ground, covered with SS 304 sheets.

Automation and Control:
- Equipped with PLC-based control panels and A.C. variable frequency drives for precise operation.
- Temperature control systems for water and compressed air, displaying set and actual parameters.
- Auto-draining facility for water lines to maintain cleanliness and prevent contamination.

Throughput: Varies by model, ranging from 50 to 350 ampoules per minute (e.g., 14,400–21,000 ampoules/hour for high-speed models).

Gripper Mechanism: Often uses Delrin or similar materials for secure holding of ampoules during high-pressure washing.

Additional Features:
- Acrylic enclosures for clear visibility of the washing process.
- Easy dismantling and cleaning for maintenance.
- Optional integration with labeling or downstream processing systems.
- Some models include recycling stations for reconditioning cleaning agents, enhancing cost-effectiveness and eco-friendliness.

FAQ for Automatic External Ampoule Washing Machine

What is an Automatic External Ampoule Washing Machine and why is it required?

The Automatic External Ampoule Washing Machine is a cGMP-compliant system designed to clean only the outer surface of filled and sealed glass ampoules. It removes dust, dirt, product residues, or spilled liquid from the exterior, ensuring a clean appearance, preventing contamination during labeling/packaging, and maintaining sterility for injectable products. It is typically installed after the filling and sealing machine (online) or used with a tray collection system.

What is the production capacity and ampoule size range of the machine?

The machine offers a production capacity of up to 50 ampoules per minute (online or with tray collection). It is suitable for 1ml to 20ml ampoules. The system uses a continuous motion wire mesh conveyor with adjustable speed via AC frequency drive, making it ideal for medium-scale pharmaceutical injectable lines.

How does the Automatic External Ampoule Washing Machine work?

Ampoules are fed onto a wire mesh conveyor via an infeed worm. They pass through 2 water washes using spray nozzles and 2 air washes using knife blocks for jet drying. A special arrangement ensures proper drying of the bottom side of each ampoule. The washing sequence (water + air) is flexible and can be adjusted as needed. After washing and drying, ampoules are discharged to an outfeed collection tray or directly to the next process. The entire operation is continuous and fully automatic.

What materials and compliance standards does the machine follow?

All contact parts are made of AISI 316L Stainless Steel or food-grade materials, while non-contact parts use AISI 304 Stainless Steel. The machine is fully cGMP compliant with smooth finishes and an acrylic cabinet for clear visibility of the washing process. It features a PLC-based control panel with variable frequency drive. Optional features include 21 CFR Part 11 compliant HMI, password protection, printing facility, and IQ/OQ/DQ documentation.

What utilities are required and what are the key features?

Utilities Required:

Power: 0.75 H.P. (440V, 3 Phase, 50 Hz)
Compressed Air: Filtered air at 6 bar and sterile filtered air at 4 bar (0.01 μm)
Water: Recycled water, DM Water, or WFI as per washing sequence

Key Features:

2 water + 2 air wash stages with flexible sequence
Special bottom-side drying arrangement
Easy integration with filling & sealing machines
Acrylic safety cabinet for process visibility
Low power consumption and minimal maintenance
PLC control with advanced parameter display

Countries We Export to

Partner with Industry Experts

Connect with our engineering team to discuss your specific production requirements. We provide customized, cGMP-compliant machinery solutions designed to optimize your manufacturing facility and maximize output.

GET A QUOTE!

Automatic External Ampoule Washing Machine

Description

Salient Features of Ampoule Washing Machine

Working Principle of Automatic External Ampoule Washing Machine

Technical Specification of Automatic External Ampoule Washing Machine

Types of Ampoule Washing Machine

Injectable Glass Ampoule Washing Machine

Lab Scale Ampoule Washing Machine

Applications of Ampoule Washing Machine

Benefits of Ampoule Washing Machine

High Efficiency: Processes up to 21,000 containers/hour, reducing production time.

Sterility and Quality: Ensures compliance with stringent pharmaceutical standards.

Flexibility: Customizable cycles and quick size changeovers for various container sizes.

Cost-Effective: Optional recycling stations and energy-efficient cleaning needles reduce operational costs.

Ease of Use: Minimal maintenance, easy dismantling, and user-friendly PLC controls.

Key Features of Automatic External Ampoule Washing Machine

FAQ for Automatic External Ampoule Washing Machine

Countries We Export to

Partner with Industry Experts

Group Websites

Products

Contact Us