ETO Sterilizer

ETO Sterilizer Manufacturer

An ETO Sterilizer (Ethylene Oxide Sterilizer) is a medical and industrial device used to sterilize heat-sensitive and moisture-sensitive products using ethylene oxide (ETO) gas. This method of sterilization is essential for items that cannot endure high temperatures or moisture, such as plastics, electronic devices, medical equipment, and some pharmaceuticals.

The process begins by placing the items inside a sealed sterilization chamber, where the environment is controlled by adjusting factors such as temperature and humidity. Once the chamber is prepared, ethylene oxide gas is introduced under controlled conditions. The gas penetrates the materials and effectively destroys a wide range of microorganisms, including bacteria, viruses, fungi, and spores. This makes ETO sterilization particularly effective for ensuring the sterility of complex and delicate items that are difficult to sterilize with traditional methods, such as steam or dry heat.

After the sterilization cycle, the products undergo an aeration phase, where the chamber is ventilated to remove any residual ethylene oxide gas. This ensures that the items are safe to handle and free from toxic gas before being used or packaged for shipment.

Frequently Asked Questions About ETO Sterilizers

What is an ETO Sterilizer and how does it work? + An ETO sterilizer uses ethylene oxide gas to sterilize heat-sensitive medical devices and materials. The process involves introducing the gas into a sealed chamber, where it penetrates packaging and kills microorganisms. The gas is then removed in an aeration phase to ensure the items are safe to handle.
Is ETO sterilization safe? + While ethylene oxide is toxic and carcinogenic, proper safety measures such as controlled environments, gas leak detection systems, ventilation, and aeration are used to ensure the process is safe for both operators and patients. Strict guidelines and regulations govern its use to minimize risks.
What is the typical cycle time for an ETO sterilization process? +

ETO sterilization cycles generally take 4 to 12 hours. This includes phases such as pre-conditioning, sterilization, and aeration, during which the ethylene oxide gas is absorbed and then removed from the sterilized items.

What are the environmental and health concerns of ETO Sterilization?+ Ethylene oxide is a hazardous gas that poses risks to health and the environment. However, the proper use of ETO sterilizers with safety protocols (e.g., ventilation, aeration, and monitoring) significantly reduces these risks. Regulatory bodies ensure that the process complies with health and safety standards to protect operators and the environment.
Can ETO be used for re-sterilizing reusable medical devices?+ Yes, ETO sterilization is commonly used for reusable medical devices, especially when the devices are heat-sensitive or have intricate designs that make steam sterilization impractical.

Advantages of ETO Sterilizers:

Effective for Heat-Sensitive Items: ETO is ideal for sterilizing materials that cannot withstand high heat, such as plastics, electronics, and delicate medical devices.

Penetration Ability: The ethylene oxide gas can penetrate complex packaging and intricate designs, ensuring thorough sterilization of products with narrow passages or delicate structures.

Broad Spectrum of Microbial Activity: It is effective against a wide range of microorganisms, including bacteria, viruses, fungi, and bacterial spores, making it a reliable method for sterilization.

Low-Temperature Process: ETO sterilization operates at low temperatures (typically between 30°C to 60°C), reducing the risk of material degradation that could occur in other sterilization methods.

Versatility: It can be used to sterilize a wide variety of items, including medical devices, pharmaceutical products, packaging materials, and consumer goods.

Technical Specification of ETO Sterilizers

Specification Details
Sterilization Chamber Capacity Typically 10 to 500 liters; load capacity ranges from 10 kg to 200 kg.
Sterilization Temperature 30°C to 60°C (86°F to 140°F) for low-temperature sterilization.
Ethylene Oxide Gas Concentration 450 to 1200 mg/L (depends on load size and material type).
Cycle Time 1 to 4 hours (sterilization phase); total cycle time can vary with aeration.
Vacuum Pressure 50 to 750 mm Hg during pre-conditioning and aeration.
Aeration Time 8 to 12 hours (depends on the material and load size).
Aeration Temperature Generally ambient temperature, but can be elevated to speed up aeration.
Control System Programmable Logic Controller (PLC) with cycle programming and monitoring capabilities.
Data Logging and Monitoring Continuous logging of temperature, pressure, gas concentration, and cycle time.
Safety Features Gas leakage detection, alarms for temperature, pressure deviations, and system malfunctions.
Power Supply Typically 220V, 50/60Hz; depends on unit specifications.
Standards Compliance ISO 11135, FDA guidelines, and other local regulations.
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