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Method for checking sealing performance of polypropylene ampoule bottle through biological method

An inspection method and ampoule technology, which is applied in the direction of fluid tightness testing, measuring devices, instruments, etc., and can solve problems such as unstable sealing of polypropylene ampoule bottles

Active Publication Date: 2021-07-09
HUBEI KELUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] The existing ampoule bottle testing adopts the vacuum decay method. The ampoule bottle is placed in a special test chamber, and the test chamber is evacuated. The pressure difference between the inside and outside of the ampoule bottle makes the gas inside the ampoule bottle leak into the test chamber through the leak hole. , the host pressure sensor monitors the pressure change, and compares the pressure change value with the reference value to determine whether the seal integrity of the ampoule is qualified. However, this method will cause broken bottles for plastic polypropylene ampoule bottles, resulting in polypropylene ampoule Vial tightness testing is unstable, and a new method is urgently needed to reliably measure the airtightness of polypropylene ampoules

Method used

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  • Method for checking sealing performance of polypropylene ampoule bottle through biological method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] A method for checking the airtightness of a biological polypropylene ampoule bottle comprises the following steps:

[0022] A. Select 20 polypropylene ampoules that have been confirmed as sterile, and after disinfecting the surface, clean the surface with sterile water for injection to prevent the disinfectant from immersing into the ampoule, and perform disinfection in a biological safety cabinet;

[0023] B. After heating the needle with an alcohol lamp, use a needle with a diameter of 30 μm to punch a hole in the polypropylene ampoule;

[0024] C. Insert capillaries with pore diameters of 5, 10, 15, 20, and 30 μm into the holes respectively, use an alcohol lamp to melt the polypropylene pellets, and then fill the periphery of the capillary with the melted polypropylene pellets. The material of the capillary is Titanium alloy;

[0025] D. Put 10 polypropylene ampoules that have been implanted into the capillary in the airtight container that Pseudomonas aeruginosa su...

Embodiment 2

[0030] A method for checking the airtightness of a biological polypropylene ampoule bottle comprises the following steps:

[0031] A. Select 10 polypropylene ampoules that have been confirmed as sterile, and after disinfecting the surface, clean the surface with sterile water for injection to prevent the disinfectant from immersing in the ampoule, and perform disinfection in a biological safety cabinet;

[0032] B. After heating the needle with an alcohol lamp, use a needle with a diameter of 30 μm to punch a hole in the polypropylene ampoule;

[0033] C. Insert capillaries with pore diameters of 5, 10, 15, 20, and 30 μm into the holes respectively, use an alcohol lamp to melt the polypropylene pellets, and then fill the periphery of the capillary with the melted polypropylene pellets. The material of the capillary is Titanium alloy;

[0034] D. Put 10 polypropylene ampoules that have been implanted into the capillary in the airtight container that Pseudomonas aeruginosa susp...

Embodiment 3

[0039] A method for checking the airtightness of a biological polypropylene ampoule bottle comprises the following steps:

[0040] A. Select 20 polypropylene ampoules that have been confirmed as sterile, and after disinfecting the surface, clean the surface with sterile water for injection to prevent the disinfectant from immersing into the ampoule, and perform disinfection in a biological safety cabinet;

[0041] B. After heating the needle with an alcohol lamp, use a needle with a diameter of 30 μm to punch a hole in the polypropylene ampoule;

[0042] C. Insert capillaries with pore diameters of 5, 10, 15, 20, and 30 μm into the holes respectively, use an alcohol lamp to melt the polypropylene pellets, and then fill the periphery of the capillary with the melted polypropylene pellets. The material of the capillary is Titanium alloy;

[0043] D. Put 10 polypropylene ampoules that have been implanted into the capillary in the airtight container that Pseudomonas aeruginosa su...

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Abstract

The invention relates to a method for checking the sealing performance of a polypropylene ampoule bottle by a biological method. The method comprises the following steps of implanting capillary tubes with different pore diameters into a bottle body of the polypropylene ampoule bottle, then putting the bottle body into a negative-pressure closed container filled with a pseudomonas aeruginosa suspension, and detecting whether pseudomonas aeruginosa enters the ampoule bottle or not so as to confirm the minimum pore diameter of air leakage of the polypropylene ampoule bottle, so whether the sealing performance of the polypropylene ampoule bottle is good is confirmed.

Description

technical field [0001] The invention relates to the field of a method for checking the airtightness of a polypropylene ampoule bottle, in particular to a method for checking the airtightness of a polypropylene ampoule bottle by a biological method. Background technique [0002] The existing ampoule bottle testing adopts the vacuum decay method, which is to place the ampoule bottle in a special test chamber, vacuumize the test chamber, and the pressure difference between the inside and outside of the ampoule bottle makes the gas inside the ampoule bottle leak into the test chamber through the leak hole , the host pressure sensor monitors the pressure change, and compares the pressure change value with the reference value to determine whether the seal integrity of the ampoule is qualified. However, this method will cause broken bottles for plastic polypropylene ampoule bottles, resulting in polypropylene ampoule The bottle tightness test is unstable, and a new method is urgent...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01M3/00
CPCG01M3/00
Inventor 高登银汤金婷熊启杰刘成友
Owner HUBEI KELUN PHARMA