Fully-enclosed membrane filter for aseptic packaging interlayer sterility inspection and its detection method

Abstract

The invention relates to the field of sterile detection, in particular to a fully closed membrane filter for sterile examination of a sterile packaging interlayer and a detection method of the fully closed membrane filter. The fully closed membrane filter comprises two bacterium collecting incubators and an air filter device, wherein the two bacterium collecting incubators and the air filter device are connected to one end of a three-phase circulator by virtue of a conduit; the other end of the three-phase circulator is connected to a sterile sampling needle by virtue of a detection tube; and an intercepting clip is arranged on the part, close to the three-phase circulation valve (the three-phase circulator), of the conduit. By virtue of the fully closed membrane filter disclosed by the invention, secondary pollution on leaching liquor during operating is reduced, a microorganism detection rate is improved and an experimental result is better guaranteed. The circulation of medicine liquid in a sealed space is achieved and the medicine liquid is prevented from getting into contact with external side, so that the fully closed membrane filter plays a great role in the prevention of microbial pollution. Meanwhile, as for operation time, the experimental operation time is shortened by half, the detection efficiency of test article sterile examination is greatly improved, and a detection pollution rate is reduced to be less than 5% from original 20-25%.

Description

technical field [0001] The invention relates to the field of sterility detection, in particular to a fully-enclosed membrane filter for aseptic inspection of aseptic packaging interlayers and a detection method thereof. Background technique [0002] The soft bag double-layer aseptic packaging infusion bag mainly includes an inner bag, medicine filled in the inner bag, and an outer bag covered with an outer layer of the inner bag. The interlayer between the inner packaging bag and the outer packaging bag is a vacuum negative pressure structure. Because it can be placed in the outer packaging bag and then sterilized, this ensures that the inner packaging is sterile. For some medical places that require strict hygiene levels, the use of double-layer aseptic outer packaging can ensure the aseptic state. After removing the outer packaging bag Afterwards, the inner packaging of the infusion solution does not need to be sterilized again by the medical staff and can be used directl...

AI Technical Summary

Problems solved by technology

However, there is a problem that when the sterile sodium chloride solution is injected, the solution is not easy to infiltrate the surface of the entire inner bag due to the negative pressure of the vacuum packaging, and it is also prone to liquid overflow.

If the test solution is leaked during the experiment, it will cause secondary pollution and affect the accuracy of the experiment results.

However, due to the limitations of the experimental items and the large number of test items, the test time is too long, which leads to false positive results in the experimental results, which interferes with the judgment of the experimental results.

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