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Sterilization Methods

The methods of sterilizer: During the practice production, sterilization is to reduce the microorganism to the expected sterile level, that is to say, the sterile level should not be higher than 10-6.
The sterile of the products should not reply on the sterile test of the final products but should reply on the sterilization craft and strict GMP management and good sterile system. The sterilization craft should consider the characteristic of the items, effect and economy of sterilization methods, and the compatibility and stability of the items after sterilization.
Normal sterilization methods include moisture sterilization, dry sterilization, radiation sterilization, gas sterilization and filter sterilization. The sterilization method is chosen according to the characteristic of the items. If it permits, choose the final sterilization. If the final sterilization method is not suitable for the item, choose filter sterilization or sterile production. If it is possible, conduct final sterilization for the items, (for instance, steam sterilization).
1.Moisture sterilization
The moisture sterilization is conducted by putting the items into the chamber and sterilize by using the saturated steam or over-heat water to denature the protein of the microorganism. This method is the most effective and most widely used sterilization method. And could be used for the sterilization of high temperature and humidity resistance items, including the drugs, containers, culture, sterile clothes and rubs.
The high-temperature stability, heat penetration, microbial contamination degree should be considered before choosing moisture heat sterilization. Moisture sterilization normally uses the program 121℃ 15 min, 121℃ 30 min, or 116 ℃ 40 min. Other temperature and time parameter can also be adopted, but the sterile level should be SAL ≤10-6 after sterilization. F0 value means the sterilization time after the temperature reaches sterilization temperature 121℃. Besides validation of the program, microorganism should be monitored during production to prove that the microorganism level is lower than the set level. For the sterilization of stable items, excessive sterilization method could be adopted to ensure the sterilization effect. For the unstable items, its sterilization craft should be finished in certain time, the pollution level of an item before sterilization and its heat resistance level should be considered. As a result, the microbial contamination level should be monitored successively and strictly, to decrease the microbial pollution level, especially to prevent the contamination of heat resistance bacteria. Normally, items cannot bear high temperature, F0 value cannot be lower than 8 min.
The loading capacity cannot be too intensive during moisture sterilization, to ensure sterilization effect and evenness.
A Cold point may exist for moisture heat autoclave, a biological indicator should be placed in cold point to confirm the sterilization effect. The normal indicator is spores of Bacillus.

2.Dry heat sterilization method
This method sterilizes by putting the item to the dry sterilizer and using dry heat air to kill the microbial or eliminate heat source material. It is used for the sterilization of items which could bear high temperature but cannot be sterilized by moisture heat sterilizer, for instance, metal container, solid medicine, and liquid paraffin.
Dry heat sterilizer is normally operated under 160-170℃ longer than 120 min, 170-180 ℃ longer than 60min, 250 ℃ longer than 45 min. Other temperature and time parameter can also be adopted, but the sterile level should be SAL ≤10-6 after sterilization. The items sterilized by dry heat sterilizer normally do not need a microbial test before sterilization. Pyrogen on the package of sterile products can be killed under 250℃ 45min.
The loading method cannot be too intensive during dry heat sterilization to ensure sterilization effect.
The temperature distribution of dry heat sterilizer should meet the set standard and the cold point should be confirmed. a biological indicator should be placed in cold point to confirm the sterilization effect. The normal indicator is spores of Bacillus. Mycobacterium
Inactivation validation of bacteria is the effective validation method to check the pyrogen. Normally, adding bacteriocin less than 1000 units to the items after the removal of pyrogen, to certify the craft can reduce the mycobacterium by 3 log units.

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