Rapid sterility inspection method

A rapid technology for sterility inspection, applied in the determination/inspection of microorganisms, biochemical equipment and methods, measuring devices, etc., can solve the problems of expensive equipment and reagents, interference from other particles, complicated operation, etc., and achieve short inspection time , easy operation and high sensitivity

Inactive Publication Date: 2020-12-15
STEMIRNA THERAPEUTICS CO LTD
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  • Application Information

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Problems solved by technology

The above methods have improved the ability to detect microbial contamination, but due to the size of microorganisms, interference from other particles, complex operations, expensive equipment and reagents, or the lack of universality of the method (only for a certain microorganism, the detection area is narrow), etc. The restriction of factors affects its popularization and application, so it is necessary to try to establish a new, more convenient, accurate and rapid sterility inspection method based on the life and growth characteristics of microorganisms

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Experimental program
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Embodiment 2

[0039] The comparison of the earliest observation time of embodiment 2

[0040] This embodiment is tested according to the method of Example 1, and detects the earliest observation time of different bacterial species by the traditional sterility test method (STD) and the rapid sterility test method (AMT) provided by the present invention.

[0041] Among them, after cultivating for 8 hours, under the traditional method (STD) and this method (AMT) culture, different concentrations of Staphylococcus aureus (S.aerues), Escherichia coli (E.coli), Pseudomonas aeruginosa The color changes of P.aeruginosa and C.sporogensis are as follows: figure 1 shown. Depend on figure 1 It can be seen that, adopting the traditional method (STD) and the present method (AMT) after culturing for 8 hours, the color has no obvious change, and it is difficult to accurately distinguish whether there are bacteria with the naked eye.

[0042] A spectrometer was used to detect the different concentrations...

Embodiment 3

[0048] The comparison of embodiment 3 accuracy and limit of detection

[0049] This embodiment compares the accuracy and sensitivity of the traditional sterility testing method and the rapid sterility testing method provided by the present invention through experiments. Traditional sterility testing method wherein and the fast sterility testing method provided by the present invention are tested according to the method of embodiment 1, and two kinds of methods are tested in parallel 5 times respectively, traditional sterility testing method and the fast sterility testing method provided by the present invention The test results are shown in Table 3.

[0050] Table 3 traditional sterility testing method and rapid sterility testing method detection result comparison of the present invention

[0051]

[0052] As can be seen from Table 3, the inventive method has no difference with traditional pharmacopoeia method accuracy and detection limit.

[0053] Embodiment 4 method dur...

Embodiment 5

[0056] Embodiment 5 two kinds of indicator interaction test

[0057] This embodiment adopts the rapid sterility testing method provided by the present invention according to Example 2, wherein the indicators are divided into three situations, the first one has only TTC, which is used to detect the large intestine with concentrations of 10, 100, and 1000 CFU / ml Bacteria, Pseudomonas aeruginosa, Staphylococcus aureus, Clostridium sporogenes, Bacillus subtilis and Candida albicans, investigate the earliest observation time (time point of first positive reaction); the second only CWM, used for Aspergillus niger with a detection concentration of 10, 100, and 1000 CFU / ml, to investigate the earliest observation time; the third type contains TTC+CWM, which is used to detect Escherichia coli and Pseudomonas aeruginosa at a concentration of 10, 100, and 1000 CFU / ml bacteria, Staphylococcus aureus, Clostridium sporogenes, Bacillus subtilis, Candida albicans and Aspergillus niger. Throu...

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Abstract

The invention provides a rapid sterility test method, which comprises the following steps: respectively adding an indicator 2, 3, 5-triphenyltetrazolium chloride (TTC) and/or Calcofluor White M2R (CWM) into a traditional sterility test culture medium soya-bean caseincligest liquid culture medium and a thioglycollate culture medium in pharmacopeia, and continuously detecting the change value of light intensity in the culture process to judge the presence or absence of bacteria, thereby rapidly completing the sterility check of the sample within 3-5 days. The sterility inspection method has theadvantages of short inspection time, high sensitivity, simplicity and convenience in operation and low cost, and can be used for more quickly and accurately qualitatively analyzing the microbial pollution condition.

Description

technical field [0001] The invention relates to the field of inspection of aseptic products such as medicines, food, biological products, medical devices, etc., and specifically relates to a rapid sterility inspection method. Background technique [0002] Sterility inspection is a necessary inspection item to ensure the safety of sterile products, and it is also one of the important links in determining the production cycle of sterile products. For example, in the field of pharmaceuticals, the pharmacopoeias of various countries have strict requirements on the sterility inspection of injections, and basically formed internationally consistent inspection standards and operating procedures, effectively improving the sterility assurance level of preparations. [0003] However, the current sterility testing methods have certain limitations. First of all, the cycle of sterility inspection is long, which restricts the improvement of production efficiency of enterprises: the pharm...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/22C12Q1/04G01N21/64
CPCC12Q1/045C12Q1/22C12Q2304/24G01N21/6428
Inventor 龚枝田丽娜李航文
Owner STEMIRNA THERAPEUTICS CO LTD
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