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Microbial integrity test device and test method for closed sterile barrier system

A sterile barrier and test device technology, applied in enzymology/microbiology devices, methods of supporting/immobilizing microorganisms, biochemical cleaning devices, etc., can solve the problem of unreasonable control of the production quality and cost of packaged products Incapable of quantitative determination, over-design of the seal, etc., to achieve the effect of controlling manufacturing costs, avoiding over-design, and ensuring quality inspection

Pending Publication Date: 2021-11-05
山东省医疗器械和药品包装检验研究院
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In addition, in order to ensure the airtightness of medical device packaging in the current production process, only the corresponding requirements for the width of the packaging edge sealing are made. Due to the variety of sealing boundary styles and different sealing methods of different packaging products, whether the packaging products meet the microbial barrier performance requirements Quantitative judgment cannot be made at present, resulting in the failure to control the production quality and cost of finished packaging products reasonably, and there are risks of unstable quality and excessive sealing design

Method used

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  • Microbial integrity test device and test method for closed sterile barrier system
  • Microbial integrity test device and test method for closed sterile barrier system
  • Microbial integrity test device and test method for closed sterile barrier system

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Such as figure 1 As shown, a closed sterile barrier system microbial integrity test device, including a test box 1, an aerosol generating system and a vacuum pump 6, the right side of the test box 1 is provided with an exhaust pipeline 1-1, the exhaust The pipeline 1-1 is connected with the vacuum pump 6 through the valve 21; the aerosol generating system is connected with an air filter 2, a compressor 3 and a nebulizer 4 sequentially from left to right, and the nebulizer 4 is connected with the test chamber 1, so The sprayer 4 is provided with a flow control valve 5; the test device is also provided with a microbial integrity detection system, and the microbial integrity detection system includes a test environment detection device and a packaging detection device.

[0059] The package detection device includes a package connector 9, a first colony collector 7 positioned on the right side of the test box 1 and a first flow regulating valve 8 positioned on the right sid...

Embodiment 2

[0069] Such as Figure 4 with Figure 5 As shown, different from Embodiment 1, the packaging connector 9 includes a bowl-shaped cover 12 , a vacuum suction cup 14 and a sealing ring 15 .

[0070] Described vacuum chuck 14 comprises adsorption ring 14-1, vacuum suction pipe 14-2 and vacuum generator 14-3, and described adsorption ring 14-1 is arranged on the lower end surface of bowl-shaped cover 12, and the adsorption of described adsorption ring 14-1 The cavity is connected to a vacuum generator 14-3 through a vacuum suction pipe 14-2, and the vacuum generator 14-3 is fixedly arranged on the bowl-shaped cover 12. The sealing ring 15 cooperates with the lower end surface of the adsorption ring 14-1.

[0071] In this embodiment, it is necessary to fix the sealing ring 15 and the packaging sample to be tested together, and then cut out an opening in the sealing ring 15, so that the adsorption ring 14-1 and the sealing ring 15 are adsorbed together, so as to ensure that the ins...

Embodiment 3

[0073] Such as Image 6 As shown, on the basis of Embodiment 1, the packaging connector 9 is also provided with an opener 16, and the opener 16 includes a lifting pipe 16-1, a lifting motor 16-2, an electric push rod 16-3, a rotary Motor 16-4 and cutting tool 16-5, vertically arranged in the lifting pipeline 16-1 in the test chamber 1 is connected with the bowl-shaped cover 12, and the described lifting motor 16-2 is fixedly arranged in the lifting pipeline 16-1, so The lifting motor 16-2 is connected with an electric push rod 16-3, the lower end of the electric push rod 16-3 is fixed with a rotating motor 16-4, and the motor shaft of the rotating motor 16-4 is fixedly provided with a cutting tool 16-5 .

[0074] In this embodiment, double-sided sealant is used to seal the packaged sample to be tested with the bowl-shaped cover 12, and then the opener 16 is used to cut out the opening of the packaged sample to be tested in the bowl-shaped cover 12, so that the inside of the p...

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Abstract

The invention relates to the technical field of medical instrument detection, in particular to a closed sterile barrier system microorganism integrity test device and method, the test device is provided with a microorganism integrity detection system, and the microorganism integrity detection system comprises a test environment detection device and a medical instrument package detection device. The test environment detection device is used for determining whether an aerosol environment in the test box meets test requirements or not, and the package detection device is used for detecting the integrity of a to-be-detected package sample, namely, the barrier performance of the whole medical instrument package to microorganisms, so that the quantitative test on the integrity of the medical instrument package is realized; quality detection of medical instrument packaging is achieved, and safety of medical instruments in the transportation process is guaranteed. And test support is provided for the overall sealing design of the package, so that the manufacturing cost of the medical instrument package is favorably controlled, and the excessive design of the package sealing is avoided.

Description

technical field [0001] The invention relates to the technical field of medical device detection, in particular to a microbial integrity test device and a test method for a closed sterile barrier system. Background technique [0002] The goal of medical device packaging is to be able to sterilize, provide physical protection for medical devices, and maintain the sterile state of medical devices before use. There are many factors that affect the performance of medical device packaging, such as the performance of the packaging material itself, the design of the packaging system, the packaging Adaptability to sterilization process and sealing process, etc. Gas-permeable packaging materials used in medical packaging are used to provide an environmental and biological barrier while allowing sufficient airflow during gas sterilization (eg, ethylene oxide, steam, gas plasma). [0003] The reference standard of Chinese patent document CN203858187U is YY / T 0681.10—2011. The measureme...

Claims

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Application Information

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IPC IPC(8): C12M1/34C12M1/26C12M1/12C12M1/04C12M1/00C12Q1/22C12Q1/06
CPCC12M29/04C12M29/06C12M33/00C12M41/36C12Q1/22C12Q1/06
Inventor 王文庆郝建新张静郝树彬栾同青
Owner 山东省医疗器械和药品包装检验研究院
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