Introduction
An ethylene oxide sterilizer is a large sterilization system that uses ethylene oxide (EO) gas to sterilize heat- and moisture-sensitive materials, and it is used in hospitals, medical device manufacturing, pharmaceutical, and other industries for sterilizing products and equipment that cannot withstand high-temperature steam sterilization. Ethylene oxide is a highly penetrating gas that kills microorganisms, including bacteria, spores, viruses, and fungi, by alkylating their proteins and nucleic acids; in operation, the items to be sterilized are placed in the sterilization chamber, the chamber is conditioned, and ethylene oxide gas is introduced, typically mixed with an inert gas such as carbon dioxide or nitrogen for safety, and the items are exposed to the gas at a controlled temperature, humidity, and concentration for a specified time; after the exposure, the chamber is aerated to remove the residual gas, and the sterilized items are further aerated to reduce the residual ethylene oxide to safe levels, and the process is monitored with biological and chemical indicators to ensure effectiveness. Ethylene oxide sterilizers are used for sterilizing medical devices, such as catheters, syringes, implants, and surgical instruments; for sterilizing pharmaceuticals and packaging; for sterilizing laboratory equipment and plastics; for sterilizing spices and other food products; and for many other applications, and they are available as large industrial systems and smaller units, with features such as process control, safety interlocks, and aeration. With their ability to sterilize heat-sensitive materials, ethylene oxide sterilizers are essential for sterilization in healthcare and industry.
Ethylene Oxide Sterilizer LEOS-T2014
Ethylene Oxide Sterilizer operates under a vacuum pressure of -60 kPa and maintains optimal humidity levels. With a spacious 300L chamber constructed from durable stainless steel or alu...
Ethylene Oxide Sterilizer LEOS-T2013
Ethylene Oxide Sterilizer offers a chamber capacity of 200L to efficiently sterilize a wide range of heat- and moisture-sensitive instruments. Operating under a working pressure of -60 ...
Ethylene Oxide Sterilizer LEOS-T2012
Ethylene Oxide Sterilizer is equipped with advanced 168L chamber, offering ample capacity for sterilizing a wide range of laboratory instruments. It supports a sterilization humidity ra...
Ethylene Oxide Sterilizer LEOS-T2011
Ethylene Oxide Sterilizer operates at a sterilization temperature of 50 °C ± 5 °C, creating optimal conditions for EO sterilization. With a 100-liter chamber capacity and a vertical ...
Ethylene Oxide Sterilizer LEOS-T2010
Ethylene Oxide Sterilizer operates at a sterilization temperature of 50 °C ± 5 °C, ensuring effective gas diffusion and sterilant penetration. With a 50-liter chamber capacity, it fe...
Ethylene Oxide Sterilizer LEOS-T2010
Ethylene Oxide Sterilizer has a generous capacity of 23 vacuum pump, offering high performance with minimal noise. Its chamber is made of corrosion-resistant SS304 stainless steel, and t...
Ethylene Oxide Sterilizer LEOS-T2013
Ethylene Oxide Sterilizer is a vertical type sterilizer that has a capacity of 294 L and a sterilization temperature range of 36℃ to 55℃. It uses saturated steam to introduce moisture ...
Ethylene Oxide Sterilizer LEOS-T2012
Ethylene Oxide Sterilizer has a capacity of 196 reliability. The sterilization cycle time typically ranges from 8 to 10 hours depending on the materials being sterilized. Also, to ensure...
Ethylene Oxide Sterilizer LEOS-T2011
Ethylene Oxide Sterilizer has a capacity of 103 chamber made of SS304 stainless steel. The sterilizer includes a control system and a 5-inch thermal printer and port facilitate data revi...
Ethylene Oxide Sterilizer LEOS-T2010
Ethylene Oxide Sterilizer has a capacity of 67 vacuum pump for high performance and low-noise operation. This sterilizer features an adjustable timing function for EO gas diffusion and r...
Ethylene Oxide Sterilizer LEOS-T2021
Ethylene Oxide Sterilizer features a capacity of 192 sterilization. The sterilizer has an oil-free vacuum pump for high-vacuum performance with minimal noise. Its sterilization chamber i...
Ethylene Oxide Sterilizer LEOS-T2020
Ethylene Oxide Sterilizer has a capacity of 126 humidity system. This sterilizer features a user-friendly keys, making operation intuitive and efficient. Users can select from preset ste...
Ethylene Oxide Sterilizer LEOS-T2014
Ethylene Oxide Sterilizer is a vertical, constant temperature heating box type sterilizer cabinet with manual door opening offers 460 kPa work pressure. Sterilization room material is ma...
Ethylene Oxide Sterilizer LEOS-T2013
Ethylene Oxide Sterilizer is a vertical , constant temperature heating box type sterilizer cabinet with manual door opening offers 360 kPa work pressure. Sterilization room material is m...
Ethylene Oxide Sterilizer LEOS-T2012
Ethylene Oxide Sterilizer is a vertical, constant temperature heating box type sterilizer cabinet with manual door opening offers 220 kPa work pressure. Sterilization room material is ma...
Ethylene Oxide Sterilizer LEOS-T2010
Ethylene Oxide Sterilizer is a floor-standing sterilization unit with a 67 sterilization of heat- and moisture-sensitive materials. It utilizes ethylene oxide gas to inactivate microorga...
Ethylene Oxide Sterilizer LEOS-T2011
Ethylene Oxide Sterilizer is a vertical, constant temperature heating box type sterilizer cabinet with manual door opening offers 120 kPa work pressure. Sterilization room material is ma...
Standards
IEC 61010-2-040:2020-Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
ISO 17665-1:2006-Sterilization of health-care products-Moist heat-Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Complies with the above standards, but is not limited to them.
Features
1. Ethylene oxide (EO) sterilizer for low-temperature sterilization of heat-sensitive items.
2. EO gas sterilization for materials incompatible with steam or heat.
3. Suitable for hospitals, medical device manufacturing, pharmaceutical and research.
4. Includes sterilization chamber, EO supply, aeration, controller and operation manual.
5. Supports sterilization of plastics, electronics, optical and heat-sensitive equipment.
FAQ
Q1: What testing scenarios is this sterilizer mainly applied to?
A: The ethylene oxide sterilizer is used in hospitals, medical device manufacturing, pharmaceutical production, research institutions and healthcare facilities to sterilize heat- and moisture-sensitive medical devices, equipment and materials using ethylene oxide gas at low temperature. It supports hospital sterilization of heat-sensitive instruments (endoscopes, plastic devices), medical device manufacturing sterilization of single-use products, pharmaceutical component sterilization, electronic and optical equipment sterilization, and research laboratory sterilization of sensitive materials. EO sterilization is effective at low temperatures (30-60 degrees C), making it suitable for plastics, electronics, optics and other materials damaged by steam or heat sterilization, though it requires proper aeration to remove EO residue. It is essential for hospitals, medical device manufacturing, pharmaceutical and research facilities requiring low-temperature EO sterilization for heat- and moisture-sensitive medical devices, electronics, optics and plastics, where ethylene oxide gas provides effective sterilization at low temperature, supporting hospital instrument sterilization, medical device manufacturing, pharmaceutical production and research in healthcare and industrial environments requiring reliable sterilization of heat-sensitive materials with proper aeration and safety controls.
Q2: What standards does the sterilizer comply with?
A: The ethylene oxide sterilizer complies with relevant ISO 11135 for EO sterilization, applicable medical device regulations (FDA, CE, NMPA), IEC 61010 safety standards, and relevant GB/T standards for sterilization equipment. EO exposure limits follow occupational safety regulations (OSHA, GBZ 2.1). Sterilization efficacy should be verified with biological indicators (Bacillus atrophaeus) per ISO 11138. Users should comply with all EO safety and environmental regulations.
Q3: What is the warranty period for the whole machine and key components?
A: The whole EO sterilizer is covered by a 12-month warranty. The chamber, EO delivery system, controller, aeration system and housing are covered, while gaskets, filters, biological indicators and fuses are consumables or accessories. Damage from improper use, EO leakage or unauthorized repair is excluded. Extended service contracts are standard for this critical sterilization equipment.
Q4: Is this device difficult to operate? Is professional training required?
A: Operation requires specially trained personnel familiar with EO sterilization, gas safety and regulatory requirements. We provide comprehensive training, operation manuals and application support. Proper cycle programming, EO handling, aeration, biological indicator testing, safety procedures and regulatory compliance are critical for safe, effective EO sterilization.
Q5: What is the typical lead-time for order delivery?
A: Standard models require 7-30 working days. In-stock units can ship within 3-7 working days. Custom configurations or large built-to-order systems may require additional time, and we confirm the exact schedule before order confirmation.
Q6: Is regular calibration required? What is the recommended calibration cycle?
A: Temperature, humidity and EO concentration calibration recommended every 6-12 months. Biological indicator testing (Bacillus atrophaeus) per cycle or per schedule for validation. Leak testing of chamber and EO system regularly. Safety system (alarms, ventilation) verification per schedule. Full system revalidation annually or after major changes. Gasket and seal inspection regularly.
Q7: Are supporting consumables universal?
A: EO gas cartridges/cylinders, biological indicators, chemical indicators, gaskets and filters are available from specialized suppliers, though instrument-specific parts should be verified. Long-term consumable cost is moderate to high depending on usage and EO supply.
Q8: Can I customize parameters or supporting accessories?
A: Customization includes chamber capacity, EO delivery method (cartridge, cylinder), aeration capability, cycle programs, safety features, data logging and accessories. Additional consumables and accessories can be ordered separately. Custom orders extend delivery lead-time.
Q9: Does the purchase include on-site installation and commissioning service?
A: Yes, ethylene oxide sterilizers include on-site installation, commissioning, validation (IQ/OQ/PQ), safety system testing and operator training by certified sterilization specialists. Site preparation guidance is provided before delivery to ensure ventilation, EO storage and safety requirements are met.
Q10: What types of items are compatible with this equipment?
A: The ethylene oxide sterilizer sterilizes heat- and moisture-sensitive items including plastics, electronics, optics, electrical devices, complex instruments and other materials within the chamber capacity and EO compatibility specification. Items must be compatible with EO exposure and able to withstand the sterilization temperature and humidity. EO can penetrate packaging but requires proper aeration to remove residue. Liquid items, powders and certain materials may not be suitable. Users should follow validated sterilization cycles per ISO 11135, use proper packaging that allows EO penetration, include biological indicators for efficacy verification, ensure proper aeration to reduce EO residue below safe limits, maintain EO safety systems (ventilation, alarms, monitoring), and comply with all occupational and environmental regulations for EO use. The sterilizer should be installed in a properly ventilated area with EO detection and emergency systems. For medical device manufacturing, the sterilization process should be validated and maintained per applicable regulatory requirements (FDA, CE, NMPA). EO is a toxic, flammable and carcinogenic gas, so strict safety procedures must be followed at all times.
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