What is EtO sterilizer?
The full name of EtO sterilizer
is ethylene oxide sterilizer
, it is more advanced sterilization equipment. Under certain conditions, ethylene oxide gas is used to fumigate the items sealed in the sterilization chamber at low temperature to achieve sterilization; ethylene oxide can kill all kinds of microorganisms, including bacteria, Mycobacterium tuberculosis, fungi, bacilli and viruses. It has strong penetrating power and can penetrate microporous cotton and woolen fabrics, plastic films, cartons and other packaging items. The sterilization is reliable and easy for long-term storage. After sterilization, the articles are put in a well-ventilated room and volatilized to reach safe use.Ethylene oxide sterilization machine
is the key equipment for single-use sterile medical device manufacturers and is widely used in medical device production and laboratories.
Advantage of using EtO sterilizer
Ethylene oxide germicidal gas is a colorless and lucid liquid with the odor of ether. It is a highly effective disinfectant, which can kill bacterial propagules and germ cells, as well as fungi and viruses. It has strong penetrating power and does not damage most items.
Therefore, ethylene oxide sterilizers have the following advantages:
1. EtO sterilizer can kill all microorganisms, including bacillus, tubercle bacillus, bacteria, virus, fungus, etc.
2. Sterilized items can be wrapped and encapsulated as a whole, and can be kept in a sterile state before use.
3. Relatively speaking, ethylene oxide does not corrode plastics, metals and rubbers, and does not cause yellowing and brittleness of articles.
4. Ethylene oxide sterilization chamber can penetrate articles with an irregular shape, complicated structure and not easy to pass through (such as long and thin catheters) and sterilize them.
5. Ethylene oxide sterilization machine can be used for sterilization of articles that cannot be sterilized by disinfectant immersion, dry heat, pressure, steam and other chemical gases.
EtO sterilizer working principle
The sterilization mechanism of ethylene oxide is through its non-specific alkylation with microorganisms, which inhibits the normal function of microbial reactive groups and causes their metabolism to be impaired and die. These process parameters at appropriate values can shorten the sterilization time and achieve the best sterilization effect.
Therefore, the working process of EtO sterilizer firstly heats the sterilization chamber until the temperature reaches the predetermined sterilization temperature; then, the sterilization chamber is evacuated, and when the predetermined vacuum is reached, the sterilization chamber starts to be dosed; after the above process is finished, the fixed clock starts to work and the sterilization process begins; the constant temperature needs to be maintained throughout the sterilization process; when the sterilization time is up, the gas exchange of the sterilization chamber starts, that is, the residual ethylene oxide gas in the sterilization chamber is replaced with filtered The residual ethylene oxide gas in the sterilization chamber is replaced by clean air after filtration, and the residual gas is discharged; the residual gas is treated by the exhaust gas treatment system and then discharged. At this point, the whole sterilization process is finished.
Four elements of EtO sterilizer
In EtO sterilizers, there are four main factors that affect sterilization:
The conventional limit of temperature is usually in the range of 37°C to 63°C, and the appropriate temperature is 50±5°C. However, when the temperature is high enough to maximize the effectiveness of drugs, and then increase the temperature, the bactericidal effect is no longer enhanced.
The size of the pre-vacuum determines the amount of residual air, and the residual air can directly affect the amount of ethylene oxide gas, heat, and
moisture to reach the interior of the sterilized items, so the sterilization process, especially the pre-vacuum degree before humidification, has a great influence on the sterilization effect.
* on the sterilized article, and its packaging.
* negative versus positive pressure sterilization.
* The effect on humidity.
The water content of the sterilized items, the dryness of the microorganisms themselves, and the relative humidity of the sterilization environment have significant effects on the sterilization effect of EO sterilization effect.
The humidity in the sterilizer should be controlled within the range of 30%RH~80%RH.
4. Ethylene oxide concentration
300~1000mg/L is the common condition nowadays.
Types of EtO sterilizer
1. Specially customized ethylene oxide sterilizer
* 40--60 cubic meters
* Applications: mask factories, protective clothing, disposable disinfection products, etc.
2. Large ethylene oxide sterilizer
* 6--40 cubic meters
* Applications: mask factories, protective clothing, mask factories, pharmaceutical companies, disposable disinfection products, etc.
* Large ethylene oxide sterilizer is generally used for sterilization of a large number of processed items, with a dosage of 0.8kg/m³~1.2kg/m³, and a duration of action of 10 hours at 55℃~60℃, plus a resolution time of 8 hours.
3. Medium ethylene oxide sterilizer
* 1 to 6 cubic meters
* Applications: Band-Aids, implant manufacturers, disposable disinfection products.
* Medium ethylene oxide sterilizer is generally used for sterilization of single-use medical supplies. This sterilization equipment is perfect and highly automated, and pure ethylene oxide or mixed gas of ethylene oxide and carbon dioxide is available. Vacuuming is required after sterilization. Sterilized items are often packaged in airtight plastic films that are permeable to ethylene oxide. The sterilization effect is better if there is a filter membrane on the small package that can filter air.
4. Small ethylene oxide sterilizer
* 50 - 1000L
* Applications: Hospital suppliers, operating rooms, research institutes, laboratories, disposable disinfection supplies.
* Small ethylene oxide sterilizer is mostly used in the medical and health sector to process small amounts of medical devices and supplies, and are currently available in 100% pure ethylene oxide or a mixed gas of ethylene oxide and carbon dioxide. These sterilizers are more automatic, can automatically pump vacuum, automatically add drugs, automatically adjust the temperature and relative humidity, and can automatically control the sterilization time.
EtO sterilizer specifications
Large EtO sterilizer
|Effective volume||6 cubic meters
|Product form|| automatic door cabinet type
|Sterilization chamber material||304 stainless steel
Large EtO sterilizer is well designed and crafted, mainly composed of microcomputer control system, residual gas treatment device, sterilization studio and other parts.
Vertical EtO sterilizer
|Power supply||AC 220V 50Hz
Type: Medium ethylene oxide sterilizer
Vertical ethylene oxide sterilizer set a variety of protection functions, can be over-voltage, leakage, over-temperature and other situations to protect, more safe, and reliable.
Tabletop EtO sterilizer
|Power supply||AC 220V 50Hz
Type: Small ethylene oxide sterilizer
Tabletop EtO sterilizer adopts an explosion-proof electric heating device to make the temperature of the sterilization room more uniform and accurate, in addition to the installation of the independent temperature control device, the temperature control is more.
How to use EtO sterilizer?
The operation procedure of the EtO sterilizer is as follows
1. The procedure of ethylene oxide sterilization needs to include preheating, pre-wetting, vacuuming, passing into the gasified ethylene oxide to reach a predetermined concentration, maintaining the sterilization time, removing the ethylene oxide gas in the sterilization cabinet, and analyzing to remove the residual ethylene oxide in the sterilized articles.
2 .For ethylene oxide sterilization, 100% pure ethylene oxide or a mixture of ethylene oxide and carbon dioxide can be used. The use of Freon is prohibited.
3. The analysis can be continued in the ethylene oxide sterilization cabinet or placed in a special fume hood, and the natural ventilation method should not be used. The repeatedly input air should be filtered with high efficiency, which can filter out ≥0.3um particles above 99.6%.
4. Ethylene oxide residue mainly refers to ethylene oxide and its two by-products ethanol ethane and ethylene glycol ethane left in articles and packaging materials after ethylene oxide sterilization. The amount of ethylene oxide residue is related to the material of sterilized articles, parameters of sterilization, packaging materials and package size, loading volume, and resolution parameters. Polyvinyl chloride catheters are resolved for 8 h at 60°C and 12 h at 50°C. Some materials can be resolved for shorter periods, such as metal and glass, which can be used immediately, while others require longer resolution times, such as built-in pacemakers.
Precautions for using EtO sterilizer
1. Ensure that the ethylene oxide sterilizer and gas cylinders or tanks are away from fire and static electricity.
2. The storage place of ethylene oxide should be free from fire, no rotating motor, no sunlight, good ventilation, and temperature below 40℃, but it should not be put in the refrigerator. It should be handled in strict accordance with the national storage requirements for flammable and explosive substances.
3. Do not use too much force to avoid the spraying of the drug when putting in and opening the bottle.
4. Monitor the air concentration of ethylene oxide working environment every year.
5. Temperature and relative humidity have a greater impact on the sterilization effect of ethylene oxide gas, so the relevant conditions in the test should be strictly controlled.
6. Ethylene oxide liquid can dissolve polyethylene, polyvinyl chloride, etc., and its liquid should not be dripped on such items.
7. Ethylene oxide is flammable and explosive, the operation site should take fire and explosion-proof measures, and there should be no open fire operations and electric sparks.
8. Inhaling too much ethylene oxide gas can cause headache, vomiting and other symptoms of poisoning, and in serious cases, pulmonary edema. There should be good ventilation in the working environment. The concentration of ethylene oxide should not exceed 1.82mg/m3 (1ppm) in 8h work per day, and the exposure concentration should not exceed 9.1mg/m3 (5.0ppm) in 15min work. If symptoms of poisoning appear, you need to leave the site quickly. The lighter ones should breathe fresh air until the symptoms are eliminated; the heavier ones should be sent to the hospital for treatment.
How to buy EtO sterilizer?
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