3M wet heat sterilization biological indicator

Mrogi Quality Assurance3M wet heat sterilization biological indicator

Model: 1262-S

Strain: Thermophilic Bacillus subtilis spore ATCC7953

Number of spores: ≥ 10⁶

Packaging specification: 300 pieces/box

Cultivation time: 48 hours

Scope and purpose of use:

3M wet heat sterilization biological indicator300 units/box, used for exhaust pressure steam at 121 ℃ and 132℃Monitoring of pre vacuum pressure steam sterilization effect.

Product features:

1. Composed of thermophilic Bacillus subtilis spore ATCC7953, culture medium, and plastic shell integrated together

2. Self contained design; Prevent secondary pollution

Attention:

1. Positive controls should be established for each biological testing culture

2. Do not remove the rapid biological indicator until the machine has read the results

Instructions for using 3M1262-S biological indicator:

1. Place the pressure steam sterilization biological culture indicator in a standard test kit

2. According to national regulations, place the test kits in different positions inside the pot

3. Sterilization completed, remove the biological indicator

4. Squeeze the ampoule inside and place it together with a control tube in a 56 ℃ incubator

5. 48 hours later, read the results

How to read:

After cultivation, if the indicator tube does not change color (turns purple), it indicates that sterilization has passed; After cultivation, if the indicator tube changes color (yellow), it indicates that sterilization has not passed (the reason for sterilization failure must be promptly identified). The control tube cultured at the same time should be positive (yellow). If it is negative, the possible reasons are: the cultivation conditions do not meet the requirements; There is a problem with the biological indicator; (The negative cause should be identified in a timely manner) 1292 and 1492V can be quickly interpreted by displaying the results through a reader.

How to discard:

Positive indicators must be sterilized (at least 15 minutes at 121 ℃) and discarded

Validation principle of wet heat sterilization biological indicator:

According to the strong thermal lethal effect of sterilization process on microorganisms:

1. Usually, thermophilic fat loving Bacillus spores with a D value of not less than 1.53 minutes (the spore content of each indicator is usually between 105107) are selected as biological indicators to validate the heat sterilization process. When the F0 value of this type of biological indicator is lower than its survival time (D value * logarithm of spore -2), the interpretation results after cultivation should be able to show all positive results; When the F0 value is higher than its killing time (D value * logarithm of spores+4), all biological indicators after cultivation should show negative results.

2. For the sterilization process with an F0 value of 15 minutes (a commonly recommended sterilization process in pharmacopoeia), a microbial indicator with a D value of 1.5 minutes and a spore content of 106 or other heat-resistant microbial indicators can be selected to verify its sterilization effect.

3. Determine the sterilization biological indicator for different packaging methods based on the properties of the sterilized item. When using sterilization solutions, self-contained ampoules are often used as biological indicators; When sterilizing fabrics, spore strips are often used; When sterilizing pipelines, it may be necessary to use biological indicators with special packaging methods (such as steel wires or wires with spores attached) to verify the sterilization situation at dead corners (coldest points).

When choosing, the following principles should be followed:

Firstly, it is necessary to understand the status of contaminating bacteria in the product before sterilization, including the quantity of contaminating bacteria and their heat resistance;

Secondly, measure the heat resistance (D value and F value) of the biological agent in the product to be validated and the standard solution used for validation;

Finally, based on the productrequirementSterilization process conditions, requirements for controlling contaminating bacteria in the product before sterilization, and requirements for ensuring sterility of the final product.

5. Use relevant formulas to calculate the number of spores required for each biological indicator during validation.