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Method for measuring number of initial spores of bacillus stearothermophilus in biological indicator

A thermophilic fat spore and biological indicator technology, which is applied in the field of initial spore quantity determination, can solve the problem of inability to apply demand for independent determination, and achieves the effect of facilitating popularization and application

Inactive Publication Date: 2014-12-17
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Bacillus stearothermophilus is a part of the biological indicator. So far, there is no effective method for determining the initial spore count of Bacillus stearothermophilus. Users can only know the number of spores marked on the products they leave the factory, and cannot independently measure it according to application requirements. , especially for biological indicators with unknown number of spores of Bacillus stearothermophilus

Method used

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  • Method for measuring number of initial spores of bacillus stearothermophilus in biological indicator
  • Method for measuring number of initial spores of bacillus stearothermophilus in biological indicator
  • Method for measuring number of initial spores of bacillus stearothermophilus in biological indicator

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Experiment with the following steps:

[0019] (1) Take 15 biological indicators of German Merck with the production batch number "VM328674", each 2ml, and mix them with a vortex mixer for 5 minutes, then place the 15 biological indicators in a sterile blue cap bottle, and use a glass Crush all the ampoules of the indicator, add 120ml of sterile water to make a dilution, the volume ratio between the biological indicator and sterile water in the dilution is 1:4, add sterile water while Rinse the glass rod; after the washing is completed, mix the primary dilution in the sterile blue cap bottle with a vortex mixer for 5 minutes, take 13 sterile test tubes, and transfer 10ml of the primary dilution in the sterile blue cap bottle to 12 sterile test tubes, respectively marked as A1-A12, to obtain the test product A; another sterile test tube (generally referred to as "blank control tube"), take 10ml of sterile water and transfer it, marked as I-0, to make It is used for tempe...

Embodiment 2

[0027] Experiment with the following steps:

[0028] (1) Take 15 biological indicators of German Merck with the production batch number "VM373174", each 2ml, and mix them with a vortex mixer for 5 minutes, then place the 15 biological indicators in a sterile blue cap bottle, and use a glass Crush all the ampoules of the indicator, add 120ml of sterile water to make a dilution, the volume ratio between the biological indicator and sterile water in the dilution is 1:3, add sterile water while Rinse the glass rod; after the washing is completed, mix the primary dilution in the sterile blue cap bottle with a vortex mixer for 5 minutes, take 13 sterile test tubes, and transfer 10ml of the primary dilution in the sterile blue cap bottle to 12 sterile test tubes, respectively marked as B1-B12, to obtain the test product B; another sterile test tube (generally called "blank control tube"), transfer 10ml of sterile water, marked as I-0, do It is used for temperature rise timer during ...

Embodiment 3

[0036] Experiment with the following steps:

[0037](1) Take 15 biological indicators of German Merck with the production batch number "VM373274", each 2ml, and mix them with a vortex mixer for 5 minutes, then place the 15 biological indicators in a sterile blue cap bottle, and use a glass Crush all the ampoules of the indicator, add 120ml of sterile water to make a dilution, the volume ratio between the biological indicator and sterile water in the dilution is 1:5, add sterile water while Rinse the glass rod; after the washing is completed, mix the primary dilution in the sterile blue cap bottle with a vortex mixer for 5 minutes, take 13 sterile test tubes, and transfer 10ml of the primary dilution in the sterile blue cap bottle to 12 sterile test tubes, respectively marked as C1-C12, to obtain the test product C; another sterile test tube (generally called "blank control tube") was transferred with 10ml of sterile water, marked as I-0, and made It is used for temperature ri...

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Abstract

The invention discloses a method for measuring the number of initial spores of bacillus stearothermophilus in a biological indicator. The method comprises the following steps: adding aseptic water into the biological indicator to obtain a primary diluted liquid, and respectively adding the primary diluted liquid to a plurality of aseptic test tubes; performing thermal shock in a water bath; taking out the aseptic test tubes, quickly cooling to the room temperature, and performing operations on each aseptic test tube as follows: diluting the primary diluted liquid until the primary diluted liquid is in the proper gradient stage by stage by adopting a tenfold increasing dilution method to obtain a secondary diluted liquid, injecting two parts of the secondary diluted liquids into two aseptic plates respectively, injecting soybean casein agar mediums respectively, solidifying, and culturing; counting the numbers of the initial spores of the bacillus stearothermophilus in all the aseptic plates, averagely calculating all counting results, and dividing by the dilution level corresponding to the proper gradient to obtain an initial spore number so as to finish the measurement. The method is stable and feasible through verification, solves the problem of incapability of measuring the number of initial spores of bacillus stearothermophilus in a biological indicator in the past, and is convenient to popularize and apply.

Description

technical field [0001] The invention relates to a method for determining the initial spore number of Bacillus stearothermophilus in a biological indicator. Background technique [0002] Biological indicators are a special kind of live microbial products, usually bacterial spores, because of their definite resistance to specific sterilization treatments, they can be used to confirm the performance of sterilization equipment, the verification of sterilization processes, and the sterilization effect of production processes monitoring, etc. The use of biological indicators makes the disinfection and sterilization monitoring methods more perfect, the sterilization effect is more intuitive, effective, and safer. It has been widely used in medical care products, health quarantine, pharmaceutical companies, hospital preparation production, food production, etc. Industry, evaluation and verification of sterilization effects of various aseptic production processes, aseptic products, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/06
Inventor 邓茂林伍丹谭鸿波吴小愚刘文军罗成鑫刘思川程志鹏万阳浴葛均友
Owner SICHUAN KELUN PHARMA CO LTD
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