CN111855082A - Packaging system leakproofness microorganism challenge test device - Google Patents

Abstract

A packaging system tightness microorganism challenge test device comprises a pressure container for containing bacteria liquid, wherein a sample containing a culture medium is immersed in the bacteria liquid in the pressure container, a grid for fixing the sample in the bacteria liquid is arranged in the pressure container, the upper part of the pressure container is communicated with the atmosphere through a vent hole, a first filter membrane capable of filtering microorganisms is arranged in the first vent hole, the side wall of the bottom of the pressure container is in threaded connection with a bottom cover, and a second filter membrane and a through hole capable of filtering the microorganisms are arranged on the bottom cover; the upper part of the pressure container is communicated with a first pipeline, a peristaltic pump is arranged on the first pipeline, the other end of the first pipeline is connected with one port of a tee joint, the other two ports of the tee joint are respectively connected with a second pipeline and a third pipeline, the second pipeline is connected with a sample injection needle through a first valve, a long needle of the sample injection needle is communicated with a breathing port with a filter membrane, and a short needle of the sample injection needle is communicated with the bacteria liquid in a bottle; and the third pipeline is sequentially provided with a second valve, a third filter membrane capable of filtering microorganisms, a pump interface and a pump.

Description

Packaging system leakproofness microorganism challenge test device

Technical Field

The invention relates to a detection device for detecting a microbiological challenge test for the tightness of a sealed product packaging system.

Background

With the development of the industry, the packaging tightness is more and more emphasized in a system for guaranteeing the product sterility, the existing packaging system tightness test needs to carry out deterministic leak test technical verification and probabilistic leak test technical verification, a microorganism challenge test is an important part of the probabilistic leak test technology, and other technologies mainly adopt physical technologies. Physical techniques are mature, and various methods and specific test schemes and parameters can be selected, but the microbial challenge test still lacks the corresponding specific test schemes and parameters.

According to research, most of pharmaceutical enterprises adopt a microorganism challenge test for package tightness by directly immersing a package containing a culture medium into a bacterium liquid, but the operation cannot guarantee complete immersion of a product, and the worst condition of the challenge test is simulated. Many regulations also indicate that the microbiological challenge test of package sealability tests requires sufficient immersion time and the creation of a pressure differential inside and outside the product package to simulate worst case conditions. There is a lack of a microbial challenge test device in the market that can be applied to create a pressure differential.

Disclosure of Invention

The present invention overcomes the above-mentioned shortcomings of the prior art and provides a packaging system hermeticity microbial challenge test device.

A packaging system leakproofness microorganism challenge test device which is characterized in that: the culture medium-containing pressure container comprises a pressure container 16 for containing bacteria liquid, a sample containing a culture medium is immersed in the bacteria liquid in the pressure container 16 in a sealed package, a grid 3 for fixing the sample in the bacteria liquid is arranged in the pressure container 16, the upper part of the pressure container 16 is communicated with the external atmosphere through a vent hole 1, a first filter membrane 2 capable of filtering microorganisms is arranged in the vent hole 1, the side wall of the bottom of the pressure container 16 is in threaded connection with a bottom cover 5, a second filter membrane 4 and a through hole 6 capable of filtering microorganisms are arranged on the bottom cover 5, and both the vent hole 1 and the through hole 6 are provided with switches;

the upper part of a pressure container 16 is communicated with a first pipeline, a peristaltic pump 7 is installed on the first pipeline, the other end of the first pipeline is connected with one port of a tee joint, the other two ports of the tee joint are respectively connected with a second pipeline and a third pipeline, the second pipeline is connected with a sample injection needle 14 through a first valve 8, a long needle of the sample injection needle 14 is communicated with a respiratory opening 15 with a filter membrane, and a short needle of the sample injection needle 14 is communicated with bacterial liquid in a bottle;

and the third pipeline is sequentially provided with a second valve 9, a third filter membrane 10 capable of filtering microorganisms, a pump interface 11 and a pump 13.

Preferably, the pump 13 is a pressure pump, or a vacuum pump.

Preferably, pressure pump 13 is provided with a pressure gauge 12 to indicate the output air pressure.

Preferably, a gasket is provided between the bottom cap 5 and the pressure vessel 16 for sealing.

As shown in the figure, the pump interface 11 is connected to the pump 13, wherein the pump interface 11 is an interface on a plastic pipe, the pump 13 is a pressure pump or a vacuum pump with a pressure gauge, pressure can be conveyed outwards or vacuum can be extracted, the value of the output pressure or vacuum degree can be displayed, and the pump interface 11 and the pump 13 are in a nested mode, so that air tightness can be ensured.

The bottom cover 5 and the pressure vessel 16 can be separated in a unscrewing mode, the bottom cover 5 is unscrewed, and a sample to be detected is put into the pressure vessel 16 and then screwed tightly.

The sample injection needle 14 is provided with a long needle and a short needle, the long needle is communicated with a breathing port 15 with a filter membrane and can be used for maintaining the pressure inside and outside a bottle containing bacteria liquid, the sample injection needle 14 is inserted into the bottle containing the bacteria liquid, the switch through hole 6 and the second valve 9 are closed, the peristaltic pump 7 is opened after the first valve 8 is opened, negative pressure is generated by the first pipeline and the second pipeline under the action of the peristaltic pump, the bottle containing the bacteria liquid is inverted, the bacteria liquid enters the pressure container 16 from the bottle through the sample injection needle 14, the first valve 8, the tee joint 17 and the peristaltic pump 7, and gas in the pressure container 16 is discharged from the vent hole 1 through the first filter membrane 2 due to the fact that the through hole 6 at the bottom of the pressure container 16 is closed, so that the bacteria liquid smoothly enters the pressure container 16 and. Wherein, the grid 3 in the pressure container 16 is a grid with large aperture, which can effectively prevent the sample from floating in the bacteria liquid.

After the bacteria liquid submerges the sample, the bottle containing the bacteria liquid is arranged, so that air can enter the pressure container 16 through the pipeline along the breathing port 15, the sample injection needle 14, the first valve 8 and the tee joint 17 in sequence, and the air entering the pipeline drives the bacteria liquid in the pipeline to completely enter the pressure container 16.

And stopping the peristaltic pump 7 after the bacteria liquid completely enters the pressure container 1, closing the vent hole 1 and the first valve 8, opening the second valve 9, starting the pump 13, and pressurizing or vacuumizing the pressure container 16 by the pump 13 through the third filter membrane 10, so that the pressure outside the sample is increased or reduced, and the pressure difference between the inside and the outside of the sample is generated. When the pressurization mode is adopted, if the sealed package of the sample is damaged, the bacteria liquid is pressed into the sample and contacts with the culture medium in the sample; when the vacuum pumping is adopted, if the package of the sample is damaged, part of the culture medium in the sample can be partially pressed out due to negative pressure so as to achieve the pressure balance between the inside and the outside of the sample.

After the pressure indicated by the pressure gauge 12 reaches a specified value, the pump 13 is closed, the second valve 9 is closed, and the positive pressure or negative pressure state in the whole device is maintained to be a standard specified time

The process of releasing pressure or vacuum is a process of slowly opening the vent hole 1 to slowly return the pressure in the pressure container 16 to normal pressure. When the vacuum-pumping method is adopted, if the package of the sample is damaged, a relative negative pressure is generated inside the sample relative to the outside, so that the external bacterium solution is pressed into the sample and contacts the internal culture medium.

Open through-hole 6, open peristaltic pump 7 behind the first valve 8 after closing air vent 1, the direction of air is for turning right from a left side in the pipeline, and liquid in the pressure vessel 16 can be because the increase of upper portion pressure and flow out through-hole 6 completely through second filter membrane 4, waits that liquid in the pressure vessel 16 flows out completely in 6, unscrews bottom 5, takes out the sample, accomplishes the experiment.

The invention has the advantages that: pressure difference can be generated for testing, and meanwhile, the biological safety of the whole experiment is ensured through a plurality of filter membranes, so that microbial pollution is effectively prevented; the operation is simple, and the operation can be basically realized after simple training.

Drawings

Fig. 1 is a schematic structural view of the present invention.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are only some embodiments, but not all embodiments, of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the description of the present invention, it should be noted that the orientations or positional relationships indicated as the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., appear based on the orientations or positional relationships shown in the drawings only for the convenience of describing the present invention and simplifying the description, but not for indicating or implying that the referred devices or elements must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" as appearing herein are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless otherwise explicitly stated or limited, the terms "mounted," "connected," and "connected" should be interpreted broadly, e.g., as being fixed or detachable or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

A packaging system leakproofness microorganism challenge test device comprises a pressure container 16 used for containing bacterial liquid, a sample containing culture medium in sealed package is immersed in the bacterial liquid in the pressure container 16, a grid 3 for fixing the sample in the bacterial liquid is arranged in the pressure container 16, the upper portion of the pressure container 16 is communicated with the outside atmosphere through a vent hole 1, a first filter membrane 2 capable of filtering microorganisms is arranged in the vent hole 1, a bottom cover 5 is screwed on the side wall of the bottom of the pressure container 16, a second filter membrane 4 and a through hole 6 capable of filtering microorganisms are arranged on the bottom cover 5, and both the vent hole 1 and the through hole 6 are provided with switches;

The upper part of a pressure container 16 is communicated with a first pipeline, a peristaltic pump 7 is arranged on the first pipeline, the other end of the first pipeline is connected with one port of a tee joint, the other two ports of the tee joint are respectively connected with a second pipeline and a third pipeline, the second pipeline is connected with a sample injection needle 14 through a first valve 8, a long needle of the sample injection needle 14 is communicated with a respiratory opening 15 with a filter membrane, and a short needle of the sample injection needle 14 is communicated with bacterial liquid in a bottle;

and the third pipeline is sequentially provided with a second valve 9, a third filter membrane 10 capable of filtering microorganisms, a pump interface 11 and a pump 13. The pump 13 is a pressure pump or a vacuum pump.

The pump 13 is provided with a pressure gauge 12 to indicate the output air pressure or vacuum. A gasket for sealing is arranged between the bottom cover 5 and the pressure container 16.

Claims (4)

1. A packaging system leakproofness microorganism challenge test device which is characterized in that: the culture medium-containing pressure container comprises a pressure container (16) for containing bacteria liquid, a sample containing a culture medium is immersed in the bacteria liquid in the pressure container (16) in sealed package, a grid (3) for fixing the sample in the bacteria liquid is arranged in the pressure container (16), the upper part of the pressure container (16) is communicated with the external atmosphere through a vent hole (1), a first filter membrane capable of filtering microorganisms is arranged in the first vent hole (1), a bottom cover (5) is screwed on the side wall of the bottom of the pressure container (16), a second filter membrane (4) and a through hole (6) capable of filtering microorganisms are arranged on the bottom cover (5), and both the vent hole (1) and the through hole (6) are provided with switches;

The upper part of a pressure container (16) is communicated with a first pipeline, a peristaltic pump (7) is arranged on the first pipeline, the other end of the first pipeline is connected with one port of a tee joint, the other two ports of the tee joint are respectively connected with a second pipeline and a third pipeline, the second pipeline is connected with a sample injection needle (14) through a first valve (8), a long needle of the sample injection needle (14) is communicated with a breathing port (15) with a filter membrane, and a short needle of the sample injection needle (14) is communicated with bacteria liquid in a bottle;

and a second valve (9), a third filter membrane (10) capable of filtering microorganisms, a pump interface (11) and a pump (13) are sequentially arranged on the third pipeline.

2. A packaging system containment microbial challenge test device as claimed in claim 1 wherein: the pump (13) is provided with a pressure gauge (12) to display the output air pressure or vacuum degree.

3. A packaging system containment microbial challenge test device as claimed in claim 1 wherein: a gasket for sealing is arranged between the bottom cover (5) and the pressure container (16).

4. A packaging system containment microbial challenge test device as claimed in claim 1 wherein: the pump (13) is a pressure pump or a vacuum pump.

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