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How to Verify the Parameters of the Sterilizer?

Jan. 07, 2021
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Small sterilizers are widely used in departments such as dentistry, ophthalmology and operating rooms because of their small size and simple operation. Most hospital clinical departments do not understand the type of small pressure steam sterilizers being used and the impact of the sterilization cycle on the load, often mistaking them for fast sterilizers, overemphasizing convenience and speed, and neglecting the quality management of the sterilization process. So, do you know how to carry out quality control when using small  sterilizers on a daily basis? Sterilizer supplier will take you together to see how to verify the parameters of the sterilizer。

Validation

The sterilization parameters, sterilization effect and biological safety of the exhaust port of the small pressure steam sterilizer should be verified annually. For different types of sterilization cycles, the appropriate sterilization load type is selected for validation.

Type B sterilization cycles are validated with the corresponding tube cavity type PCD

N sterilization cycles are validated with bare entities

For Class S sterilization cycles, the corresponding load is selected for validation according to its sterilization load type

Result evaluation: If the validation result meets the requirements of sterilization parameters, sterilization effect and biological safety of the exhaust port, the sterilizer is qualified; if any one of the three items does not meet the requirements, the sterilizer is not qualified and should be re-validated or revalidated after overhauling the sterilizer.

Small Sterilizers

Sterilization parameters verification

Verification method: Place the temperature measuring instrument into the sterilizer, set 3 points per layer, and lay the points diagonally between each layer; place a pressure measuring instrument into the bottom center of the sterilizer; then place the simulated conventional processed items to full load. After one sterilization cycle, the temperature and pressure meters are removed and the measured values of temperature, pressure and time parameters are read.

Evaluation indicators.

1. the actual measured values of sterilization temperature range in the whole sterilization cycle shall not be lower than the set value and not higher than the set value by 3℃, and the difference between any 2 points in the sterilization chamber shall not exceed 2℃.

2. The measured pressure range should correspond to the measured temperature range.

3. The measured sterilization time is not lower than the set value and not more than 10% of the set value.

If the above 3 requirements are met, it is qualified; if any 1 of the 3 items does not meet the requirements, it is not qualified.

Verification of the biological safety of the exhaust port

In the following cases, it is necessary to check whether there are measures at the exhaust port of the small pressure steam sterilizer to prevent pathogenic microorganisms from being discharged into the environment, and to verify their effectiveness to ensure that there are no corresponding pathogenic microorganisms in the discharged air.

1、For biosafety level III laboratories (BSL-3).

2. Used in biosafety level IV laboratories (BSL-4).

3、The sterilized items may carry pathogenic microorganisms transmitted via respiratory tract.

 

Validation method: select the corresponding selective medium according to the characteristics of the pathogenic microorganisms to be detected, prepare the petri dish to be loaded into the Andersen six-stage sampler, the sampler is connected to the exhaust port, and the two are sealed with sealing film; load the sterilizer with the items to be sterilized, turn on the sterilizer, and turn on the sampler at the same time; after the cold air discharge stage of the sterilizer is over, remove the sampler and put the petri dish into the incubator.

 

Result evaluation: incubate until the specified time remove and observe whether there are corresponding pathogenic microorganisms on the culture medium.


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