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Sterility detection method for pipeline and container medical instruments

A technology for medical devices and detection methods, applied in the medical and health field, can solve the problems of false positives, false negatives, complicated operations, etc., and achieve the effects of high detection rate, improved detection rate, and simple operation method.

Pending Publication Date: 2021-11-12
山东省医疗器械和药品包装检验研究院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to solve the technical problems of false positives, false negatives and complex operation in the prior art for the sterility test of pipelines and containers, the present invention provides a method for detecting the sterility of pipelines and containers

Method used

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  • Sterility detection method for pipeline and container medical instruments
  • Sterility detection method for pipeline and container medical instruments
  • Sterility detection method for pipeline and container medical instruments

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The sterility testing method for tubing-type medical devices uses the culture medium flushing method to perform sterility testing on infusion sets, including the following steps:

[0032] (1) Insert the puncture needle of the infusion set (model specification: A 0.55×19RW LB) into the mouth of the bottle containing trypticase soytone liquid medium or thioglycolate fluid medium, so that the medium flows through the inner cavity of the tube , the flow rate is about 10mL / min, collect 100mL of washing liquid in a sterile culture bottle.

[0033] In order to facilitate the calculation of the detection rate, the infusion set in this step has been artificially polluted in advance, and the specific operation is as follows:

[0034] a. Preparation of test bacteria suspension

[0035] Use a pipette gun to take 0.1mL with a concentration of 1.9×10 8 / 0.1mL of ATCC9372 bacteria suspension was added to 9.9mL 40% alcohol solution to make 1.9×10 6 / 0.1mL of bacterial suspension, an...

Embodiment 2

[0046] The sterility test method for container medical devices uses the culture medium flushing method to test the sterility of blood bags, including the following steps:

[0047] (1) Use a disposable sterile syringe to add 100 mL of TSB medium or FTM medium into a disposable plastic blood bag, and then shake it manually for 2 minutes;

[0048] In order to facilitate the calculation of the detection rate, the blood bag in this step has been artificially polluted in advance, and the specific operation is as follows:

[0049] a. Preparation of test bacteria suspension

[0050] Use a pipette gun to take 0.1mL with a concentration of 1.9×10 8 / 0.1mL of ATCC9372 bacteria suspension was added to 9.9mL 40% alcohol solution to make 1.9×10 6 / 0.1mL of bacterial suspension, and serially diluted to 1.9×10 4 / 0.1mL, 1.9×10 2 / 0.1mL, the concentration will be 1.9×10 2 / 0.1mL of bacterial suspension is recorded as A (gradient 1'), take 5mL of bacterial suspension A and add it to 5mL of 4...

Embodiment 3

[0061] The sterility testing method for tubing-type medical devices uses the culture medium filling method to perform sterility testing on infusion sets, including the following steps:

[0062] (1) Pierce the puncture needle of the infusion set with the same model as in Example 1 into the mouth of the bottled TSB medium or FTM medium bottle, make the flushing liquid flow into and fill the inner cavity of the infusion tube, cover the puncture needle end with a protective cap, and the other end Use clips to prevent media from flowing out.

[0063] In order to facilitate the calculation of the detection rate, the infusion set in this step has been artificially polluted in advance, and the specific operation is the same as that in Example 1.

[0064] (2) The infusion set containing the culture medium was placed in an incubator and cultured for 14 days, the culture temperature of the TSB medium was 22.5°C, and the culture temperature of the FTM medium was 32.5°C.

[0065] (3) Visu...

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Abstract

The invention belongs to the field of sterility detection of medical instruments, and provides a sterility detection method for pipeline and container medical instruments. The method comprises the following steps: adding a sterility culture medium into the pipeline and container medical instruments, performing oscillating and flushing, transferring the culture medium into a sterility container, performing culturing, and checking bacterial colonies, namely a culture medium flushing method; or adding the sterility culture medium into the pipeline and container medical instruments for direct culture and bacterial colony inspection, namely a culture medium filling method. Compared with a membrane filtration method, the culture medium flushing method has the advantages that flushing liquid without nutritional ingredients is not needed for flushing, the culture medium with nutritional ingredients is directly adopted for flushing, the detection rate is higher, filtering operation is not needed, and the false positive probability is reduced. According to the culture medium filling method, the culture medium is directly filled into the inner cavity of a container for culture, and the product does not need to be eluted, so that the possibility of false negative is greatly reduced, and the detection rate is increased.

Description

technical field [0001] The invention belongs to the technical field of medical treatment and sanitation, in particular to a sterility testing method for pipeline-type and container-type medical instruments. Background technique [0002] Medical devices act on the human body directly or indirectly, and their extremely high degree of hygiene is of great significance for ensuring medical effects and patient health. Therefore, it is necessary to sterilize medical devices before they enter the market or be used, especially for large quantities of disposable medical devices. Sterility inspection to reduce the risk of infection to the human body during subsequent use. Sterility test refers to a method for checking whether medicines, dressings, sutures, sterile instruments and other varieties applicable to the sterility test required by the Pharmacopoeia are sterile. At present, the sterility test methods of medical device products commonly used in the medical device industry mainl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/22C12Q1/04
CPCC12Q1/22C12Q1/04
Inventor 张萌萌栾园园郝树彬王文庆黄经春栾同青
Owner 山东省医疗器械和药品包装检验研究院
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