Ethylene Oxide Gas Sterilizer

At HEDONE USA, we specialize in the design and manufacturing of advanced ethylene oxide (EtO) gas sterilizers, providing a reliable and efficient solution for the sterilization of medical devices and consumables. Ethylene oxide gas sterilization is widely recognized as one of the most effective methods for sterilizing sensitive medical products that cannot withstand high heat or moisture.

Chamber Details

Fast and Smooth Operation: Pneumatic actuators provide quick and smooth door movements, reducing the time required for opening and closing, which is essential in high-traffic areas
Superior Sealing Performance: The double inflatable gasket system provides an exceptional seal by using two gaskets that can be inflated to conform to surfaces, ensuring an airtight and watertight closure
Energy Efficiency: Proper heat isolation reduces heat loss or gain, minimizing the need for additional heating or cooling. This leads to significant energy savings and lower operational costs
Precise Temperature Control: Water jacket system allows for precise regulation of temperature, which is essential for processes requiring specific thermal conditions
Inner Chamber material: SS 316L
Remaining Structure material: SS 304
Single or Double Door Options
Automatic locking system in doors

Recirculation System

Uniform Gas Distribution: A chamber interior blower system ensures even distribution of EtO gas throughout the sterilization chamber, leading to consistent and effective sterilization of all items
Enhanced Sterilization Efficiency: By promoting thorough mixing of the EtO gas, the blower system helps achieve faster and more efficient sterilization cycles, improving throughput
Temperature Uniformity: The blower system aids in maintaining uniform temperature within the chamber, which is crucial for optimal sterilization conditions and preventing cold spots
Improved Gas Penetration: Enhanced circulation of the EtO gas allows for better penetration into complex instruments and porous materials, ensuring comprehensive sterilization
Reduced Cycle Time: With efficient gas distribution and temperature control, the blower system can help shorten the overall sterilization cycle time, increasing operational efficiency

Vaporizer Skid

Consistent Sterilization Quality: A vaporizer skid ensures the precise control of EtO gas concentration, temperature, and pressure, leading to consistent and reliable sterilization outcomes
Improved Safety: Vaporizer skid is equipped with safety features such as automatic shutoff controls, pressure relief valves, and leak detection systems, which enhance the safety of the sterilization process by minimizing the risk of gas leaks and over-pressurization
Zero risk of explosion with ATEX certified components
Precise Control: Advanced control systems allow for precise monitoring and regulation of gas flow, temperature, and pressure, ensuring the effective and efficient delivery of EtO gas during the sterilization cycle

Heating Skid

Consistent Temperature Control: The closed-loop design allows for precise temperature regulation, ensuring consistent heating performance and reducing temperature fluctuations, operated by ATEX certified sensors and SCADA software
Reduced Water Usage: Since the water in a closed-loop system is reused, there is less need for fresh water, which can lead to significant water savings
Improved Sterilization Efficiency: By maintaining consistent and optimal temperatures, the heating skid helps to reduce sterilization cycle times, increasing throughput and productivity
Safety: The contained nature of a closed-loop system reduces the risk of leaks and spills, which can enhance safety in the workplace
Energy Efficiency: Closed-loop systems are designed to minimize energy loss. The heat generated is recirculated within the system, which reduces the amount of energy needed to maintain the desired temperature

Steam Generator

Enhanced Sterilization Efficacy: Steam generator produces consistent, high-quality steam, which is essential for the effective sterilization process. The combination of steam and ethylene oxide ensures thorough penetration and microbial kill
Precise Humidity Control: Steam generator allows for accurate control of humidity levels within the sterilization chamber. Proper humidity is crucial for the optimal performance of ethylene oxide gas sterilization
Energy Efficiency: Modern steam generator is designed to be energy-efficient, reducing operational costs. It can quickly generate steam as needed, minimizing energy waste
Fast Startup and Shutdown: Steam generator can quickly reach the desired operating conditions, allowing for faster startup and shutdown times. This increases overall productivity and reduces downtime.
Compact and Space-Saving: Steam generator is designed to be compact and can be integrated into existing sterilization system without requiring excessive space
Consistent Temperature Maintenance: Steam generator helps maintain a consistent temperature within the sterilization chamber, ensuring uniform conditions for effective sterilization cycles

Technical Specifications

Chamber Volume: Custom made chambers are designed between 1 m3 to 100 m3
Chamber Material: Inner chamber 316L SS, remaining components are 304 SS
Cycle Time: The duration of a complete sterilization cycle, which can vary depending on the load and specific sterilization requirements
Gas Concentration: The concentration of ethylene oxide gas used during the sterilization process varies: %100 ETO, %90 ETO - %10 CO2, %50 ETO - %50 CO2
Temperature Range: The operating temperature range for the sterilization process, typically between 37°C to 55°C (98.6°F to 131°F)
Relative Humidity: The required relative humidity level during the sterilization process, usually maintained between 30% and 85%

Technical Specifications

Vacuum System: Water and oil ring vacuum pumps provide proper deep vacuum in mbar
Control System: The type of control system used is programmable logic controllers (PLCs) with user-friendly interfaces for monitoring and controlling the sterilization process and SCADA Software
Safety Features: Built-in safety features such as leak detection, overpressure protection, and emergency shut-off mechanisms
Compliance Standards: Compliance with relevant standards and regulations, such as ISO 11135 for ethylene oxide sterilization of medical devices, EN 1422, ATEX 2014/34/UE, ANSI/AAMI/ISO 13485, CFR 21 PART 11, EN 550, ISO 10993-7, ISO 14937, ANSI/AAMI ST41, 21 CFR Part 820
Documents: IQ, OQ, PQ, Software Validation, Technical Drawing, Manual, Spare Part list, Trouble Shootings.

Technical Specifications

Seals and Gaskets: High-quality, chemical-resistant seals and gaskets to prevent leaks and maintain chamber integrity
Temperature Control Range: Precise control over a wide temperature range, typically between 30°C to 60°C.
Vacuum Range: Capability to achieve and maintain high vacuum levels, typically down to 1-5 Torr
Pressure Regulation: Accurate pressure control systems to maintain the desired pressure during the sterilization cycle
EtO Gas Concentration: Ability to accurately control EtO gas concentration, typically ranging from 200 to 800 mg/L

Technical Specifications

Circulation System: Efficient blower to ensure even gas distribution throughout the chamber
Data Logging: Comprehensive data logging capabilities for recording and storing sterilization cycle data
Emergency Venting: Systems for safely venting EtO gas in case of emergency
Loading Systems: Customizable racking and shelving to optimize load configuration and gas exposure, Euro and US pallet dimensions compatibility

What Can Be Sterilized with Ethylene Oxide?

Many types of medical products, particularly those made from plastics, polymers, and delicate materials, rely on ethylene oxide sterilization to ensure they are free from harmful bacteria, viruses, and microorganisms. Some of the common medical consumables and devices that can be sterilized with EO gas include:

Surgical Instruments: Complex, delicate instruments, including those with intricate parts or narrow lumens.
Catheters: Used in various medical procedures, catheters must be fully sterilized to ensure patient safety.
Surgical Sutures: Both absorbable and non-absorbable sutures, which are sensitive to heat and moisture.
Pacemakers and Electronics: Medical electronics and devices that can be damaged by steam sterilization methods.
IV Sets and Tubing: Products made from plastic or rubber materials that cannot endure high temperatures.
Wound Dressings and Bandages: Particularly those with adhesive layers, which can degrade under other forms of sterilization.
Implants: Including artificial joints, stents, and other implants that require sterile packaging.

Advantages of HEDONE USA's Ethylene Oxide Sterilizers

Our EO sterilizers are designed to meet the rigorous demands of healthcare facilities and medical manufacturers. Key features include:

Precise Control Systems: Ensuring accurate monitoring of sterilization cycles to deliver consistent, high-quality results.
Versatile Applications: Suitable for a broad spectrum of medical products, from large, complex devices to small, intricate consumables.
Safe and Effective: Our sterilizers are designed with advanced safety features to protect both operators and the environment, while ensuring complete sterilization of all materials.
Compliance with Global Standards: We manufacture our sterilizers to comply with ISO standards and FDA regulations, ensuring that our clients receive equipment that meets the highest quality and safety requirements.

Contact with Us

We understand that the sterilization process is crucial for ensuring the safety and efficacy of medical devices and consumables. Our ethylene oxide gas sterilizers represent the pinnacle of sterilization technology, combining safety, efficiency, and compliance with the highest standards. Whether you are looking to enhance your existing facilities or are new to the industry, our expert team is here to provide comprehensive support and guidance. We invite you to connect with us to learn more about how our solutions can benefit your operations and ensure you meet the stringent demands of medical sterilization.

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