
Sterilization Method:
Utilizes Ethylene Oxide (ETO) gas to sterilize heat-sensitive medical equipment, instruments, and devices.
Effective for sterilizing items that cannot withstand high temperatures such as plastics, electronics, and delicate materials.
Chamber Size:
Capacity: Varies based on model; can range from small (for limited quantities) to large chambers (for bulk sterilization).
Dimensions: Typically range from 1 cubic meter to over 10 cubic meters in capacity.
Sterilization Cycle Time:
Cycle Time: Can range from 2 to 6 hours, depending on the type of product and the level of sterilization required.
Temperature Range:
Typically 30C to 60C (86F to 140F), as Ethylene Oxide gas works effectively at lower temperatures compared to other sterilization methods.
Pressure:
Operating pressure in the chamber typically between 1 to 2 bar.
Gas Usage:
Uses Ethylene Oxide (ETO) gas, which is introduced into the sterilization chamber to penetrate the materials and sterilize them.
Control System:
Microprocessor-based or PLC-controlled systems with pre-programmed cycles.
Touch screen interface or remote access for monitoring and adjusting parameters.
Safety Features:
Gas leak detection systems.
Ventilation and exhaust systems for safe removal of the gas after sterilization.
Auto-decontamination systems to ensure that there is no residual ETO gas after the cycle is complete.
Power Requirements:
Typically requires 220V to 440V depending on the size and design.
Power consumption varies by model and cycle duration.
Compliance:
Conforms to international standards such as ISO 11135, ISO 14937, FDA, and CE.
Complies with safety regulations for handling and disposing of ethylene oxide gas.
ETO sterilizers are mainly used in the medical, pharmaceutical, and food industries for sterilizing items that cannot tolerate high temperatures, like plastic, electronics, and delicate instruments.
Ethylene oxide gas is introduced into a sealed chamber, where it penetrates the items to destroy microorganisms by disrupting their DNA. The process works effectively at lower temperatures, making it ideal for sensitive materials.
Ethylene oxide is a toxic, flammable, and potentially carcinogenic gas. Hence, ETO sterilizers are equipped with multiple safety measures like:
Gas leak detectors.
Proper ventilation systems.
Gas-neutralizing systems to ensure that no harmful gas is released into the environment.
The duration of a sterilization cycle typically ranges from 2 to 6 hours, depending on factors such as the material being sterilized and the specific sterilizer model.
ETO sterilization is efficient but has environmental concerns because of the toxic nature of the gas. Modern ETO sterilizers use systems to neutralize residual ethylene oxide after the sterilization process, minimizing environmental impact.
Sterilization cycles are generally monitored and controlled by a digital system that will alert you when the process is finished. Additionally, biological indicators (such as spores) are often used to verify the effectiveness of the sterilization.
Calibration is required periodically to ensure accurate and safe sterilization. Manufacturers generally recommend calibrating sterilizers at least once a year or after every major maintenance service.
No, ETO is only effective for certain materials, such as plastics and electronics, that cannot withstand high temperatures. Some materials may react negatively with ethylene oxide, so testing should be performed before full-scale sterilization.
The primary advantage is its ability to sterilize heat-sensitive materials without compromising their integrity. It also has the capability to penetrate porous materials, making it ideal for medical devices with complex geometries.
Yes, ETO sterilization must meet strict regulations and standards, such as ISO 11135 (Sterilization of health care products), ISO 14937 (General requirements for sterilization), and FDA and CE requirements. These standards ensure both the effectiveness of the process and the safety of operators.
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