What are the main factors affecting the sterilization effect of ethylene oxide in medical devices?

Mondo Health Updated on 2024-02-01

First, if the four elements of ethylene oxide sterilization are analogized:

Ethylene oxide sterilization: The use of ethylene oxide to replace unstable hydrogen atoms by alkyl groups makes the active groups in the protein such as hydroxyl group, sulfhydryl group, amino group, and carboxyl group form an irreversible alkylation reaction, thereby hindering the metabolism of the protein and making it inactive to achieve the sterilization effect. Ethylene chloroethylene reaction must have water vapor, which can lead to the four major elements of ethylene oxide sterilization: temperature, humidity, concentration, time, and secondary factors: vacuum, product material, product packaging, product structure, microbial load, and loading.

In order to make you grasp the four elements more vividly and memorably, we compare ethylene oxide sterilization to a commonly used spell skill in online games, then: concentration is spell strength; Temperature and humidity are spell penetration; Time is cast time; Vacuum, product packaging, product structure, and loading are spell resistance; The microbial load is the object of spelling. The most important factor in this magic is the temperature at which the spell penetrates.

2. The influence of temperature on the sterilization effect:

1. The sterilization speed is proportional to the temperature;

2. For spores: for every 10 increases, the mortality rate is doubled;

3. The common temperature range of ethylene oxide sterilization: 38 -60. More than 60, ethylene oxide will polymerize;

3. The influence of humidity on the sterilization effect.

1. It is worth noting that the humidity refers to the relative humidity;

2. The dryness of the microorganisms themselves and the relative humidity of the sterilization environment have an impact on the effect of ethylene oxide;

3. The relative humidity is too low or too high will affect the sterilization effect, which is generally controlled within 30%-80%RH;

Fourth, the influence of sterilization time on the sterilization effect:

Time is related to the evaluation of sterilization effect, with the probability of microbial survival in the product after sterilization to evaluate, under the same conditions (gas concentration, temperature, relative humidity), the longer the sterilization time, the smaller the probability of microbial survival in the product, the better the sterilization effect. However, the sterilization time should not be arbitrarily extended in pursuit of sterilization effect, because too long the sterilization time will affect the resolution and residue.

5. Conventional methods of concentration control:

1. Pressure control: relatively more accurate;

2. Weight control: relatively simpler;

In practice, pressure control and weight control are used for review.

6. The influence of secondary factors on the sterilization effect:

1. Vacuum: conducive to sterilization;

2. Product material: related to analysis and residue;

3. Product packaging: related to the effect, analysis and residue of sterilization;

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