Aseptic Washing Machine

Q: What is an Aseptic Washing Machine?

An Aseptic Washing Machine (also called Aseptic Vial Washer or Sterile Washing Machine) is a specialized pharmaceutical equipment designed to clean and decontaminate vials, ampoules, syringes, or bottles under strictly controlled sterile conditions. It removes particulates, pyrogens, and microbial contaminants using WFI (Water for Injection) before the containers enter the depyrogenation tunnel or aseptic filling line.

Q: What are the key features of Aseptic Washing Machines?

Uses WFI (Water for Injection) at elevated temperatures for effective cleaning and pyrogen removal Maintains ISO 5 / Class 100 sterile environment with laminar flow and HEPA filtration CIP/SIP capable (Clean-In-Place / Sterilize-In-Place) design with no dead legs Mirror-polished SS 316L contact parts for easy sterilization Multiple washing cycles including recirculated WFI, fresh WFI rinse, and sterile air/nitrogen blow Fully drainable design to prevent recontamination Integration with RABS or isolator technology

Q: What is the typical production capacity?

Aseptic Washing Machines are available in various models with outputs ranging from 60 to 200+ containers per minute, depending on the configuration (e.g., rotary or linear). They commonly handle vials and bottles from 2 ml to 1000 ml with quick change parts.

Q: Why is an Aseptic Washing Machine critical in injectable manufacturing?

It ensures containers are particulate-free and pyrogen-free (typically achieving <0.1 EU/container) while maintaining sterility throughout the process. This is essential for sterile injectable products to prevent contamination that could compromise patient safety and regulatory compliance. The machine enables seamless transfer to filling lines without breaking the sterile chain.

Q: What are the main benefits of using an Aseptic Washing Machine?

Superior particulate and endotoxin reduction Maintains strict aseptic conditions with laminar flow and isolator compatibility High efficiency with validated cleaning cycles Reduced risk of recontamination through closed sterile design Compliance with cGMP and international regulatory standards Versatile for vials, ampoules, syringes, and other sterile containers Supports high-speed sterile production lines

Description

Aseptic Washing Machine (also known as an aseptic vial washer, aseptic bottle washer, or sterile washing machine) is a specialized piece of pharmaceutical equipment designed to clean and decontaminate vials, ampoules, syringes, bottles, or other primary packaging components under strictly aseptic (sterile) conditions before they enter the sterile filling process.

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Salient Features of Bottle Washing Machine

Geneva mechanism.
Four inner, one outer and one air wash.
Sequence of washes of washes to customer’s choice
Stationary nozzles eliminate contamination of water cycles.
Easy loading and unloading with two rows.
Individual solenoid valve for each washing sequence.
Pumps and tanks are mounted on parable stand for easy maintenance.

Easy operation.
Higher capacity centrifugal pumps to wash bigger bottles.
The stationary nozzles avoid chipping of bottle necks.
Bottle guide system especially for lightweight bottle.
Pumps and Tanks are mounted on portable stand for easy maintenance.
Separate panel control to avoid any short circuit due to spraying of water.
S.S. glycerin fill pressure meter.

Working Principle of Aseptic Washing Machine

The bottles are loaded on the subsequent indexing part of rotating platform and are cleared in series of operations. Specially designed bottle holders are provided to hold bottles with neck diameter. The bottles are placed in an inverted position in these cup shaped holders. Spraying showers does the external cleaning of the bottles. Solenoid valves are provided to enable the regulation of wash timings, it also spraying water when bottle are stopped means ensure saving of water and sequence of various washing media to suit specific requirement.

Loading: Containers are loaded (manually or automatically) into the machine.

Pre-cleaning: External cleaning with purified water or air.

Internal Washing Cycles:
- Recirculated WFI (Water for Injection) sprays
- Fresh WFI rinsing
- Clean compressed air or nitrogen blowing to remove water droplets
- Silicone oil application (for syringes, if needed)

Sterile Environment: Entire washing zone is under laminar flow (HEPA-filtered air) and surrounded by isolator or RABS to prevent recontamination.

Discharge: Clean, sterile, and dry containers are directly transferred (via conveyor or robotic arm) into the depyrogenation tunnel or filling line without exposure to the outside environment.

Technical Specification of Aseptic Washing Machine

Model No	ARBW – 64	ARBW – 100
Production Output	Up to 60 Bottles / Minute (Depending on Bottle Size)	Up to 100 Bottles / Minute (Depending on Bottle Size)
Input Specification	Diameter of the container: 25 mm to 100mm Outside Diameter of Neck: 20 mm to 38 mm (with the help of change parts) Height of the container: Up to 280 mm (with the help of change parts)	Diameter of the container: 25 mm to 100mm Outside Diameter of Neck: 20 mm to 38 mm (with the help of change parts) Height of the container: Up to 280 mm (with the help of change parts)
Power Supply	Main Unit: 0.75 H.P., 380 Volt, 3 Phase, 4 Wire System, 50 Hz Optional Accessories (2 Pumps – Pumping Station) 0.75 H.P., 380 Volt, 3 Phase, 4 Wires System, 50 Hz Electric Heater Tank: 2 K.W.	Main Unit: 0.75 H.P., 380 Volt, 3 Phase, 4 Wire System, 50 Hz Optional Accessories (2 Pumps – Pumping Station) 0.75 H.P., 380 Volt, 3 Phase, 4 Wires System, 50 Hz Electric Heater Tank: 2 K.W.
Overall Dimension	1550 mm (L) x 1700 mm (W) x 1300 mm (H) approx.	1800 mm (L) x 1700 mm (W) x 1300 mm (H) approx.
Air Consumption	30 CFM @ 5 bar	30 CFM @ 5 bar
Net Weight	650 kgs. approx.	750 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 Washing and Cleaning Machine

Automatic Airjet Bottle Cleaning Machine

Multijet Ampoule Washing Machine

Automatic External Ampoule Washing Machine

Inverter Type Airjet Cleaning Machine

Inverter type Airjet Cleaning Machine

Automatic Linear Bottle Washer

Applications of Washing and Cleaning Machine

Pharmaceutical Industry
Nutraceutical Industry
Herbal Industry
Ayurvedic Industry
Biotech Industry
Cosmetic Industry
Chemical Industry

Critical Design Aspects of Aseptic Washing Machine

Made of 316L stainless steel (mirror-polished, <0.4 μm Ra) for easy cleaning and sterilization.

Uses WFI at 60–80°C for washing and pyrogen removal.

No dead legs, fully drainable, CIP/SIP capable (Clean-In-Place / Sterilize-In-Place).

Validated for particulate and endotoxin reduction (typically <0.1 EU/container after washing + depyrogenation).

Key Features of Aseptic Washing Machine

Primary Goal: Remove particulate matter, pyrogens, endotoxins, and microbial contamination from containers while maintaining a sterile environment (typically ISO 5 / Class 100 or better).

Used in sterile injectable manufacturing (vials, pre-filled syringes, cartridges, ampoules, etc.).

Ensures the containers are clean and pyrogen-free before sterilization (usually by depyrogenation tunnel or autoclave) and aseptic filling.

FAQ for Aseptic Washing Machine

What is an Aseptic Washing Machine?

An Aseptic Washing Machine (also called Aseptic Vial Washer or Sterile Washing Machine) is a specialized pharmaceutical equipment designed to clean and decontaminate vials, ampoules, syringes, or bottles under strictly controlled sterile conditions. It removes particulates, pyrogens, and microbial contaminants using WFI (Water for Injection) before the containers enter the depyrogenation tunnel or aseptic filling line.

What are the key features of Aseptic Washing Machines?

Uses WFI (Water for Injection) at elevated temperatures for effective cleaning and pyrogen removal
Maintains ISO 5 / Class 100 sterile environment with laminar flow and HEPA filtration
CIP/SIP capable (Clean-In-Place / Sterilize-In-Place) design with no dead legs
Mirror-polished SS 316L contact parts for easy sterilization
Multiple washing cycles including recirculated WFI, fresh WFI rinse, and sterile air/nitrogen blow
Fully drainable design to prevent recontamination
Integration with RABS or isolator technology

What is the typical production capacity?

Aseptic Washing Machines are available in various models with outputs ranging from 60 to 200+ containers per minute, depending on the configuration (e.g., rotary or linear). They commonly handle vials and bottles from 2 ml to 1000 ml with quick change parts.

Why is an Aseptic Washing Machine critical in injectable manufacturing?

It ensures containers are particulate-free and pyrogen-free (typically achieving <0.1 EU/container) while maintaining sterility throughout the process. This is essential for sterile injectable products to prevent contamination that could compromise patient safety and regulatory compliance. The machine enables seamless transfer to filling lines without breaking the sterile chain.

What are the main benefits of using an Aseptic Washing Machine?

Superior particulate and endotoxin reduction
Maintains strict aseptic conditions with laminar flow and isolator compatibility
High efficiency with validated cleaning cycles
Reduced risk of recontamination through closed sterile design
Compliance with cGMP and international regulatory standards
Versatile for vials, ampoules, syringes, and other sterile containers
Supports high-speed sterile production lines

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