Factors Affecting the EO Gas Sterilization Process

There are many Factors Affecting in the EO Gas Sterilization Process, pls view the following:

1. Gas Concentration

• Within a certain range of gas concentration, the higher the concentration, the better theEO Gas Sterilization effect; beyond 1000 mg/L, the improvement in sterilization effect is not significant.

2. Relative Humidity

• When relative humidity is between 40%-80%, there is no significant difference in sterilization effect; below 40%, the sterilization effect decreases significantly; above 90%, there is no noticeable improvement, and it can easily cause water droplets, which adversely affects sterilization.

3. Temperature

• At temperatures between 30-65°C, for every increase of 10°C, the EO Gas Sterilization effect doubles; above 65°C, there is no significant improvement in sterilization effect.

Time

• Higher ETO concentration requires a shorter action time; lower ETO concentration requires a longer action time.

Survival Probability

• The longer the EO Gas Sterilization time, the lower the survival probability of microorganisms in the product (better sterilization effect).
• The EO Gas Sterilization time has a linear relationship with the logarithm of the number of surviving microorganisms (this is the most important theoretical support for determining mortality rate).

Other Influencing Factors

Product Characteristics

1. Product Materials and Structure:
   • The structure affects gas ingress and egress; some materials are unsuitable for ethylene oxide sterilization, and certain materials need to absorb more moisture/heat.
2. Packaging Materials.
3. Initial Contamination:
   • Initial quantity and types of contaminating bacteria in the product (methods such as residual probability and direct counting have requirements for initial contamination levels; some products have endotoxin requirements; some microorganisms exhibit resistance to ethylene oxide).

Process Operations

1. Vacuum Level:
   • Affects gas diffusion and penetration, impacts the concentration of gas acting on the product; affects packaging safety and product safety; influences displacement effectiveness and residue.
2. Loading Conditions:
   • Affects heat/wet penetration and distribution; influences gas circulation.

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