A sample pretreatment device for liquid bacterial retention test of liquid filter

Abstract

The utility model provides a sample pretreatment device for liquid bacterial retention test of a liquid filter, including a suction filtration device, a mixing container and a stirring device. The suction filtration device is connected to the mixing container through a first pipe; after the sterile sodium chloride solution is filtered by the suction filtration device, it is transported to the mixing container through the first pipe to be mixed with the challenge bacteria stock solution; the stirring device is used to stir the sterile sodium chloride solution and the challenge bacteria stock solution in the mixing container, and the challenge bacteria suspension formed after sufficient mixing is transported to the liquid bacteria retention test equipment through the second pipe for testing. The utility model uses a suction filtration device to replace manual filtering of the sterile sodium chloride solution, and the filtered sterile sodium chloride solution is transported to the mixing container through the first pipe, without the need to pour the sample back and forth many times. On the one hand, the filtration efficiency is improved; on the other hand, the risk of secondary contamination of the sample is avoided; the stirring device is used to automatically stir the sample instead of manual stirring, thereby improving the sample mixing efficiency.

Description

Technical Field

[0001] The present application relates to the technical field of liquid bacteria retention testing, and in particular to a sample pre-treatment device for liquid bacteria retention testing of a liquid medicine filter. Background Art

[0002] The liquid bacteria retention test is used to evaluate the liquid bacteria retention capacity of 0.22μm sterilizing-grade filters. At present, liquid bacteria retention is a performance indicator that must be inspected during factory inspection and registration inspection of liquid medicine filters with a nominal pore size of 0.22μm. Failure of this indicator will directly lead to various infusion reactions in patients during the infusion process.

[0003] At present, manufacturers and testing institutions all use the method in YY / T 0929.3 "Drug Filters for Infusion Part 3: Liquid Bacteria Retention Test Method for Drug Filters with Nominal Pore Size 0.22μm" to conduct liquid bacteria retention tests. The sample pretreatment in this standard is manual, and the specific steps are as follows:

[0004] First, use 0.22μm filter paper to manually filter out particles and microorganisms larger than 0.22μm in the sterile sodium chloride solution, then open the upper cover of the mixing container, add a certain concentration of Pseudomonas diminuta challenge stock solution into the mixing container, and use a 500mL measuring cylinder to pour the filtered sterile sodium chloride solution into the mixing container to prepare a 7500mL challenge bacterial suspension, which is manually mixed. Finally, the prepared challenge bacterial suspension in the mixing container is introduced into the liquid bacterial retention test device through a pipeline to start the liquid bacterial retention test.

[0005] In actual operation, it was found that this method has the following disadvantages:

[0006] First, a single test requires filtering at least 9000mL of sterile sodium chloride solution, of which 1500mL is required for the negative control group, and 7500mL is required for the blank control group, positive control group and three sample test groups. Manual filtering of sterile sodium chloride solution requires multiple pouring back and forth, which is not only inefficient, but also the filtered sterile sodium chloride solution is prone to secondary contamination;

[0007] Secondly, since the amount of challenge bacteria suspension to be prepared is large, on the one hand, it is difficult to ensure the accuracy of the final configured challenge bacteria suspension volume; on the other hand, manually mixing the sterile sodium chloride solution and the challenge bacteria stock solution is inefficient and the mixing is insufficient, which can easily cause large test errors. Summary of the invention

[0008] The present application provides a sample pretreatment device for liquid bacteria retention testing of a liquid filter, which solves the problems of low efficiency, easy secondary contamination of samples, insufficient sample mixing, etc. in existing liquid bacteria retention tests, which are performed by manual sample pretreatment.

[0009] The present application provides a sample pretreatment device for liquid bacteria retention test of a drug liquid filter, comprising a suction filtration device, a mixing container and a stirring device, wherein the suction filtration device is connected to the mixing container through a first pipe; after the sterile sodium chloride solution is filtered by the suction filtration device, it is transported to the mixing container through the first pipe to be mixed with a challenge bacteria stock solution, and the stirring device is used to stir the sterile sodium chloride solution and the challenge bacteria stock solution in the mixing container, and the challenge bacteria suspension formed after sufficient mixing is transported to a liquid bacteria retention test device through a second pipe for testing.

[0010] In the technical solution provided by the present application, the sterile sodium chloride solution is automatically filtered by a suction filtration device instead of manual filtering, and the filtered sterile sodium chloride solution is directly transported to the mixing container through the first pipeline, without the need to pour the sample back and forth many times. On the one hand, the filtration efficiency is improved; on the other hand, the risk of secondary contamination of the sample is avoided; the sample is automatically stirred by a stirring device instead of manual stirring, thereby improving the sample mixing efficiency.

[0011] In some embodiments, the filtration device includes a filter cup, a fixing clamp, a sand core head and a liquid collecting bottle from top to bottom, and the side wall of the sand core head is provided with an exhaust port, and the exhaust port is connected to the vacuum pump through an exhaust pipe; the bottom side wall of the liquid collecting bottle is provided with a first liquid outlet, and the first liquid outlet is connected to the mixing container through a first pipe.

[0012] In certain embodiments, a peristaltic pump is provided on the first pipeline for quantitatively pumping the filtered sterile sodium chloride solution into the mixing container. By providing the peristaltic pump, the volume of the sterile sodium chloride solution can be precisely controlled to ensure the accuracy of the diluted challenge bacteria suspension and reduce experimental errors.

[0013] In certain embodiments, the mixing container includes a cylinder and a cover, which are sealed by flanges and bolts, making it convenient to open the cover and pour a certain amount of challenge bacteria stock solution into the cylinder. This ensures the sealing of the mixing container when preparing the challenge bacteria suspension, and minimizes the risk of contamination by other microorganisms.

[0014] In some embodiments, the cover body is provided with a liquid inlet for connecting to the first pipeline.

[0015] In certain embodiments, the cover body is further provided with a second liquid outlet, and the second liquid outlet is connected to a liquid bacteria retention test device through a second pipe, and the liquid bacteria retention test device introduces the challenge bacteria suspension into the mixing container through pressure.

[0016] In certain embodiments, the stirring device includes a magnetic stirring main unit and a stirring bar, wherein the stirring bar is placed in a mixing container, and the mixing container is placed on the magnetic stirring main unit; a rotating magnetic field is generated by the magnetic stirring main unit to drive the stirring bar in the mixing container to rotate at a high speed, thereby achieving contactless stirring, ensuring a closed environment in the mixing container, and reducing the risk of contamination.

[0017] In certain embodiments, the mixing container is made of stainless steel.

[0018] In certain embodiments, a vent hole (with a 0.22 μm filter membrane) is provided on the top of the mixing container to facilitate the filtered solution to flow smoothly into the mixing container.

[0019] The above description is only an overview of the technical solution of the present application. In order to more clearly understand the technical means of the present application, it can be implemented in accordance with the contents of the specification. In order to make the above and other purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are listed below. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The drawings in this application are used to illustrate preferred embodiments, so that those skilled in the art can clearly understand various other advantages and benefits, and should not be considered as limitations of this application. In addition, the same reference numerals are used throughout the drawings to represent the same or similar components.

[0021] Figure 1 This is a schematic structural diagram of a sample pretreatment device for liquid bacteria retention testing of a liquid filter in one embodiment of the present application;

[0022] Figure 2 This is a schematic diagram of the structure of a filtration device in one embodiment of the present application;

[0023] Figure 3 This is a schematic diagram of the structure of a mixing container in one embodiment of the present application;

[0024] Icons: 1. Filtration device; 11. Filter cup; 12. Fixing clamp; 13. Sand core head; 14. Liquid collecting bottle; 15. Vacuum port; 16. Vacuum pipe; 17. Vacuum pump; 18. First liquid outlet; 2. Mixing container; 21. Cylinder; 22. Cover; 23. Flange; 24. Bolt; 25. Liquid inlet; 26. Second liquid outlet; 3. Stirring device; 31. Magnetic stirring main unit; 32. Stirring bar; 4. First pipeline; 5. Second pipeline; 6. Liquid bacteria retention test equipment; 7. Peristaltic pump. DETAILED DESCRIPTION

[0025] The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with specific embodiments. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0026] Reference to "embodiments" herein means that a particular feature, structure, or characteristic described in conjunction with the embodiments may be included in at least one embodiment of the present application. The appearance of the phrase in various locations in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0027] In the description of the embodiments of the present application, the technical terms "first", "second", etc. are only used to distinguish different objects, and cannot be understood as indicating or implying relative importance or implicitly indicating the number, specific order or primary and secondary relationship of the indicated technical features. In the description of the embodiments of the present application, the meaning of "multiple" is more than two (including two), unless otherwise clearly and specifically defined.

[0028] In the description of the embodiments of the present application, the term "and / or" is only a description of the association relationship of the associated objects, indicating that there may be three relationships. For example, A and / or B can represent: A exists alone, A and B exist at the same time, and B exists alone. In addition, the character " / " in this article generally indicates that the associated objects before and after are in an "or" relationship.

[0029] In the description of the embodiments of the present application, the technical terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, which are only for the convenience of describing the embodiments of the present application and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the embodiments of the present application.

[0030] In the description of the embodiments of the present application, unless otherwise clearly specified and limited, technical terms such as "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the embodiments of the present application can be understood according to the specific circumstances.

[0031] See also Figure 1-Figure 3 The embodiment of the present application provides a sample pretreatment device for liquid bacterial retention test of a liquid filter, comprising a suction filtration device 1, a mixing container 2 and a stirring device 3, wherein the suction filtration device 1 is connected to the mixing container 2 through a first pipe 4; after the sterile sodium chloride solution is filtered by the suction filtration device 1, it is transported to the mixing container 2 through the first pipe 4 to be mixed with a challenge bacteria stock solution, and the stirring device 3 is used to stir the sterile sodium chloride solution and the challenge bacteria stock solution in the mixing container 2, and the challenge bacteria suspension formed after sufficient mixing is transported to the liquid bacteria retention test equipment 6 through the second pipe 5 for testing.

[0032] In the technical solution provided by the present application, the sterile sodium chloride solution is automatically filtered by the filtration device 1 instead of manual filtering, and the filtered sterile sodium chloride solution is directly transported to the mixing container 2 through the first pipe 4, without the need to pour the sample back and forth many times. On the one hand, the filtration efficiency is improved; on the other hand, the risk of secondary contamination of the sample is avoided; the sample is automatically stirred by the stirring device 3 instead of manual stirring, thereby improving the sample mixing efficiency.

[0033] Please continue reading Figure 2 In some embodiments, the filtration device 1 includes a filter cup 11, a fixing clamp 12, a sand core head 13 and a liquid collecting bottle 14 from top to bottom, and the side wall of the sand core head 13 is provided with an air suction port 15, and the air suction port 15 is connected to a vacuum pump 17 through an air suction pipe 16; the bottom side wall of the liquid collecting bottle 14 is provided with a first liquid outlet 18, and the first liquid outlet 18 is connected to the mixing container 2 through a first pipe 4.

[0034] The suction filtration device 1 in this embodiment can directly utilize an existing suction filtration device (such as a suction filtration device of model JOANLAB VP-10), and only needs to open a first liquid outlet 18 on the bottom side wall of the liquid collecting bottle 14 .

[0035] Please continue reading Figure 1In some embodiments, a peristaltic pump 7 is provided on the first pipeline 4 for quantitatively pumping the filtered sterile sodium chloride solution into the mixing container 2. By setting the peristaltic pump 7, the volume of the sterile sodium chloride solution can be accurately controlled to ensure the accuracy of the diluted challenge bacterial suspension and reduce experimental errors.

[0036] The peristaltic pump 7 in this embodiment can directly utilize existing products, such as a peristaltic pump of model YZ1515X, the maximum flow rate of which can be adjusted to 1249 ml / min, which can meet the experimental requirements.

[0037] Please continue reading Figure 3 In some embodiments, the mixing container 2 includes a cylinder 21 and a cover 22, and the cylinder 21 and the cover 22 are sealed by a flange 23 and a bolt 24 (a sealing rubber ring is provided between the two flanges 23), so that it is convenient to open the cover 22 and pour a certain amount of challenge bacteria stock solution into the cylinder 21. When preparing the challenge bacteria suspension, the sealing of the mixing container 2 can be ensured, and the risk of contamination by other microorganisms can be minimized.

[0038] Please continue reading Figure 3 In some embodiments, the cover body 22 is provided with a liquid inlet 25 for connecting the first pipeline 4.

[0039] Please continue reading Figure 3 In some embodiments, the cover body 22 is further provided with a second liquid outlet 26, and the second liquid outlet 26 is connected to the liquid bacteria retention test device through the second pipe 5, and the liquid bacteria retention test device introduces the challenge bacteria suspension into the mixing container 2 through pressure.

[0040] Please continue reading Figure 1 In some embodiments, the stirring device 3 includes a magnetic stirring host 31 and a stirrer 32, the stirrer 32 is placed in the mixing container 2, and the mixing container 2 is placed on the magnetic stirring host 31; the magnetic stirring host 31 generates a rotating magnetic field to drive the stirrer 32 in the mixing container 2 to rotate at a high speed, thereby achieving contactless stirring, ensuring a closed environment in the mixing container 2, and reducing the risk of contamination.

[0041] The magnetic stirrer in this embodiment can directly use existing products, such as a magnetic stirrer of model HMS-901B, with an adjustable speed range of 0 to 1250 rpm and a maximum stirring volume of 2000 ml.

[0042] In some embodiments, the mixing container 2 is made of stainless steel, can be repeatedly cleaned and sterilized, and has a capacity of not less than 8000 mL.

[0043] In some embodiments, an exhaust hole is provided on the top of the mixing container 2 (with a 0.22 μm filter membrane to prevent microorganisms in the outside air from entering the mixing container 2) to facilitate the filtered solution to flow smoothly into the mixing container 2 (the exhaust hole can balance the pressure inside and outside the mixing container to prevent the internal air pressure from being too high and causing the solution to be unable to flow smoothly into the mixing container 2).

[0044] The working process of the sample pretreatment device in this embodiment is as follows:

[0045] First, the stirring bar 32 is placed in the mixing container 2 for sterilization, and then the challenge bacteria stock solution of the specified concentration and volume is poured into the mixing container 2, and the cover 22 is covered to ensure the sealing of the mixing container 2; then the mixing container 2 is placed on the magnetic stirring host 31; because there are various microorganisms and particles in the 0.9% sterile sodium chloride solution and the air, these microorganisms and particles will cause the filter membrane in the 0.22μm liquid filter to be blocked, thereby causing the experiment to fail; therefore, this embodiment uses the suction filtration device 1 to filter the microorganisms in the 0.9% sterile sodium chloride solution and particles, and then the filtered 0.9% sterile sodium chloride solution is quantitatively introduced into the mixing container 2 through the peristaltic pump 7; then the magnetic stirrer is turned on, and the 0.9% sterile sodium chloride solution is introduced while stirring. When the peristaltic pump 7 introduces the specified volume of 0.9% sterile sodium chloride solution, it automatically stops, and the filtration device 1 is closed. After the challenge bacteria suspension in the mixing container 2 is fully mixed, the magnetic stirrer is turned off, and the valve at the second liquid outlet 26 is opened, and the fully mixed challenge bacteria suspension is introduced into the liquid bacteria retention test equipment 6 to automatically perform a liquid bacteria retention experiment.

[0046] The sample pretreatment equipment of this embodiment can complete the fully automatic pretreatment process of 0.9% sterile sodium chloride solution and challenge bacteria suspension, thereby improving the sample pretreatment efficiency. Moreover, the entire sample pretreatment process is completed in a closed environment, which can minimize the risk of sample contamination. By equipping with a calibrated peristaltic pump 7, the amount of 0.9% sterile sodium chloride solution added can be accurately controlled to ensure the accuracy of sample dilution. By using a magnetic stirrer to stir the sample in the container, the challenge bacteria suspension can be fully mixed, thereby effectively controlling the experimental error.

[0047] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present application, rather than to limit them. Although the present application has been described in detail with reference to the aforementioned embodiments, a person of ordinary skill in the art should understand that the technical solutions described in the aforementioned embodiments can still be modified, or some or all of the technical features therein can be replaced by equivalents; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present application, and they should all be included in the scope of the claims and specification of the present application. In particular, as long as there is no contradiction or conflict, the various technical features mentioned in the embodiments can be combined in any way. The present application is not limited to the specific embodiments disclosed herein, but includes all technical solutions that fall within the scope of the claims.

Claims

1. A sample pretreatment device for liquid bacterial retention test of a liquid filter, characterized in that: The invention comprises a suction filtration device (1), a mixing container (2) and a stirring device (3), wherein the suction filtration device (1) is connected to the mixing container (2) via a first pipeline (4); after the sterile sodium chloride solution is filtered by the suction filtration device (1), it is transported to the mixing container (2) via the first pipeline (4) to be mixed with a challenge bacteria stock solution; the stirring device (3) is used to stir the sterile sodium chloride solution and the challenge bacteria stock solution in the mixing container (2); and the challenge bacteria suspension formed after sufficient mixing is transported to a liquid bacteria retention test device (6) via a second pipeline (5) for testing; The suction filtration device (1) comprises, from top to bottom, a filter cup (11), a fixing clamp (12), a sand core head (13) and a liquid collecting bottle (14); a side wall of the sand core head (13) is provided with an air suction port (15), and the air suction port (15) is connected to a vacuum pump (17) through an air suction pipe (16); a bottom side wall of the liquid collecting bottle (14) is provided with a first liquid outlet (18), and the first liquid outlet (18) is connected to a mixing container (2) through a first pipeline (4).

2. A sample pretreatment device for liquid bacterial retention test of a liquid filter according to claim 1, characterized in that: The first pipeline (4) is provided with a peristaltic pump (7) for quantitatively pumping the filtered 0.9% sterile sodium chloride solution into the mixing container (2).

3. A sample pretreatment device for liquid bacterial retention test of a liquid filter according to claim 1, characterized in that: The mixing container (2) comprises a cylinder (21) and a cover (22), and the cylinder (21) and the cover (22) are sealed and connected via a flange (23) and bolts (24).

4. A sample pretreatment device for liquid bacterial retention test of a liquid filter according to claim 3, characterized in that: The cover body (22) is provided with a liquid inlet (25) for connecting to the first pipeline (4).

5. A sample pretreatment device for liquid bacterial retention test of a liquid filter according to claim 3, characterized in that: The cover body (22) is also provided with a second liquid outlet (26), and the second liquid outlet (26) is connected to the liquid bacteria retention test device (6) through a second pipeline (5).

6. A sample pretreatment device for liquid bacterial retention test of a liquid filter according to claim 1, characterized in that: The stirring device (3) comprises a magnetic stirring main unit (31) and a stirring bar (32), wherein the stirring bar (32) is placed in a mixing container (2), and the mixing container (2) is placed on the magnetic stirring main unit (31).

7. A sample pretreatment device for liquid bacterial retention test of a liquid filter according to claim 1, characterized in that: The mixing container (2) is made of stainless steel.

8. A sample pretreatment device for liquid bacterial retention test of a liquid filter according to claim 1, characterized in that: The top of the mixing container (2) is provided with an exhaust hole.

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