Generating device for quantitative active microorganisms

Abstract

The utility model discloses a quantitative active microorganism generating device, which comprises a generating cavity assembly, a plurality of fixed-quantity active microorganism generating devices and a plurality of fixed-quantity active microorganism generating devices, and is characterized in that the generating cavity assembly comprises a first tank body and a second tank body, and the outlet end of the first tank body is detachably butted with the inlet end of the second tank body; the test piece comprises a supporting piece and a breathable film, the supporting piece is of a circular ring structure, the breathable film is a circular piece, the breathable film covers an inner hole of the supporting piece and is connected with the supporting piece to form an integrated structure, and a first surface of the breathable film is coated with a test bacterium layer; the test piece is arranged between the outlet end of the first tank body and the inlet end of the second tank body. According to the utility model, when compressed gas penetrates through the test piece during testing, microbial cells attached to the thin film are continuously separated from the test piece, then are taken out of the generation cavity by the compressed gas and are captured by the sampler. According to the design of the verification device, the state and distribution of the planktonic microorganisms in the compressed gas can be well simulated, and the normal sampling process and sampling conditions of the planktonic microorganisms in the compressed gas are reduced to the maximum extent.

Description

Technical Field

[0001] The utility model relates to the technical field of gas sampling devices, and more specifically, to a device for generating quantitative active microorganisms. Background Art

[0002] Compressed gas (air, nitrogen, carbon dioxide, etc.) is often used in the production process of drugs. Because it is in direct contact with the raw materials and inner packaging materials of drugs, it may become an important factor that directly affects the quality of drugs. On the one hand, the raw materials of compressed gas may carry a large number of microorganisms. For example, the main source of compressed air is the atmosphere. Each cubic meter of air in the environment contains about hundreds of millions of dust particles, and these particles often have a large number of microorganisms attached to them. On the other hand, compressed gas inevitably comes into contact with machine parts during compression and transportation. In this process, it may also be contaminated by various microorganisms. These microorganisms, if they contaminate the production environment and the final product, may cause various infections or allergic adverse reactions in the drug users. Therefore, the compressed gas used in the medical field must be clean, and pharmaceutical companies must use gas microbial samplers to monitor indicators such as the total number of microorganisms.

[0003] The existing technology for evaluating the effect of gas microbial sampling has the following technical problems:

[0004] 1. The current technology for evaluating the biological recovery efficiency of planktonic bacteria samplers can only give a relative value, and cannot accurately give the absolute recovery rate of active microorganisms in the sampled gas samples. For example, the "JJF 1826-2020 Air Microbial Sampler Calibration Specification" includes a microbiological determination method for sampling physical efficiency. It is to place the calibrated sampler and the reference device (membrane filtration sampler) in an aerosol containing a certain concentration of microorganisms for simultaneous sampling, and then culture and count the sampling plates and filter membranes. By comparing the sampling results with those of the reference device, the relative sampling efficiency of the calibrated sampler is obtained. Although this method can compare the performance differences of different types of samplers, it cannot truly reflect the ability of the sampler itself to capture and recover active microorganisms.

[0005] 2. The existing aerosol generating device used to evaluate the biological efficiency of the sampler can only work under low air pressure (less than 0.2MPa) and low air flow rate (28.3L / min or lower). Active microbial aerosols are generally carried by potassium iodide particles or droplet particles of different particle sizes. The aerosol containing active microorganisms is introduced into the sampler through the atomization chamber. Excessive working pressure or too fast air flow rate will lead to unevenness and loss of microorganisms in the aerosol, and even damage the atomization generating instrument. Utility Model Content

[0006] In view of the shortcomings of the prior art, the utility model innovatively provides a device for generating quantitative active microorganisms, which can solve the problem that the equipment for sampling planktonic bacteria in high-pressure gas cannot accurately evaluate its sampling efficiency.

[0007] In order to achieve the above technical objectives, the utility model discloses a device for generating quantitative active microorganisms, comprising:

[0008] The generating chamber assembly comprises a first tank body and a second tank body, wherein the outlet end of the first tank body and the inlet end of the second tank body are detachably connected;

[0009] A test sheet, comprising a support sheet and a breathable membrane, wherein the support sheet is a ring structure, the breathable membrane is a circular sheet, the breathable membrane covers the inner hole of the support sheet and is connected to the support sheet to form an integral structure, and the first surface of the breathable membrane is coated with a test bacteria layer;

[0010] The test piece is arranged between the outlet end of the first tank body and the inlet end of the second tank body.

[0011] Furthermore, a first chuck is disposed at the outlet end of the first tank body, a second chuck is disposed at the inlet end of the second tank body, and the test piece is clamped between the first chuck and the second chuck.

[0012] Furthermore, the generating chamber assembly also includes a connecting hoop, and a sealing ring is provided between the first chuck and the second chuck, and they are connected via the connecting hoop.

[0013] Furthermore, the generating chamber assembly includes a docking platform, the docking platform includes a base, and a sliding track is provided on the base.

[0014] At least one of the first tank body and the second tank body is slidably disposed on the sliding track.

[0015] Furthermore, the first tank body is fixed on the base, and the second tank body is slidably connected to the sliding track.

[0016] An elastic member is disposed on the base, and the elastic member provides an elastic force to the second tank body in a direction toward the first tank body.

[0017] Furthermore, the first tank body is connected to the first slider, the second tank body is connected to the second slider, and the first slider and the second slider are slidably connected to the sliding track.

[0018] The base is provided with a fixing pin, which is connected to the first sliding block and the base and is used to fix the first tank body on the base.

[0019] Furthermore, the inlet end of the first tank body and the outlet end of the second tank body are both provided with connectors.

[0020] The inlet end of the first tank is also provided with a pressure gauge.

[0021] Furthermore, an angle valve is provided on the connecting head.

[0022] Furthermore, the support sheet is made of PP material, and the support sheet and the breathable membrane are bonded into an integrated structure.

[0023] Furthermore, air holes are formed on the air permeable membrane, and the diameter of the air holes is 0.2 μm-0.3 μm.

[0024] The beneficial effects of the utility model are:

[0025] When the test piece containing active microorganisms in the utility model is used to verify the sampling efficiency, the compressed gas passes through the test piece, and the microbial cells attached to the film are continuously separated from the test piece, and then carried out of the generating cavity by the compressed gas and captured by the sampler. The design of this verification device can better simulate the state and distribution of planktonic microorganisms in compressed gas, and restore the normal sampling process and sampling conditions of compressed gas planktonic bacteria to the maximum extent. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 A schematic diagram showing the structure of a device for generating quantitative active microorganisms according to an embodiment of the utility model;

[0027] Figure 2 A schematic diagram showing the structure of the docking platform of an embodiment of the utility model is shown;

[0028] Figure 3 A schematic structural diagram of a test piece according to an embodiment of the utility model is shown.

[0029] In the figure,

[0030] 1. First tank body; 11. First chuck; 12. First slider; 2. Second tank body; 21. Second chuck; 22. Second slider; 3. Pressure gauge; 4. Angle valve; 5. Base; 51. Sliding rod; 52. Fixing pin; 53. Elastic member; 61. Support sheet; 62. Breathable membrane. DETAILED DESCRIPTION

[0031] The quantitative active microorganism generating device provided by the utility model is explained and illustrated in detail below in conjunction with the drawings of the specification.

[0032] At present, according to different working principles, gas microbial samplers can be divided into filtering type, impact type, centrifugal type, liquid absorption type, wet surface type, electrostatic type, etc. Among them, the impact type microbial sampler uses the inertia of the particles themselves to separate them from the main airflow. Aerosol particles containing active microorganisms directly impact on the culture medium, and the growth of microorganisms can be directly cultured and observed. Therefore, the impact type sampler has the advantages of high efficiency, sensitivity, and intuition. It is the most widely used microbial sampler and the most widely used and generally accepted sampler in the field of compressed gas detection in the pharmaceutical industry. However, this method requires special equipment to generate aerosol particles, and the structure of the generating device is relatively complex.

[0033] Generally speaking, compressed gas sampling can be divided into two types according to different control methods: pressure-maintaining type and normal pressure type. The sampling process of pressure-maintaining compressed gas is usually a passively controlled sampling principle. Because compressed gas itself has the characteristics of a power source, the sampling equipment only needs to control the gas flow and pressure to achieve the capture of active microorganisms, without the need for built-in power-driven sampling in the equipment itself. Some equipment manufacturers have also developed a normal pressure sampler, which is a compressed gas and air planktonic bacteria sampling compatible device. When collecting compressed gas, it is equipped with an adapter for adjusting pressure or flow. The active sampling principle is applied to actively extract gas through a built-in pump to achieve the capture of active microorganisms in the gas. In addition, there is also a liquid absorption sampling process: the compressed gas is directly passed into the liquid, the flow rate and sampling volume are controlled by a flowmeter, and then the number of microorganisms absorbed in the liquid is detected.

[0034] Since microbial samplers based on different principles have their own advantages and limitations, the need to verify the applicability and effectiveness of various sampling devices is growing. Compressed gas sampling has the advantages of large flow rate (usually 50-100L / min), large volume (usually collecting 1m 3 Therefore, the collection and recovery rate of active microorganisms are important indicators for evaluating the performance of microbial samplers.

[0035] When the test piece containing active microorganisms in the utility model is used to verify the sampling efficiency, while the compressed gas passes through the test piece, the microbial cells attached to the film are continuously separated from the test piece, and then carried out of the generating cavity by the compressed gas and captured by the sampler. The design of this verification device can better simulate the state and distribution of planktonic microorganisms in compressed gas, and restore the normal sampling process and sampling conditions of compressed gas planktonic bacteria to the maximum extent. In addition, the utility model can be applied to the verification of pressure-maintaining samplers and normal pressure samplers. The utility model is described in detail below in conjunction with specific embodiments:

[0036] In one embodiment, the utility model provides a device for generating quantitative active microorganisms, including a generating chamber assembly and a test piece, on which a test bacteria layer is arranged. The test piece is clamped in the generating chamber assembly and is located on a gas flow channel. The test bacteria layer cells on the test piece are blown off by the airflow and are carried out by the airflow to be captured by a sampler.

[0037] In one embodiment, Figure 1 As shown, the generating chamber assembly includes a first tank body 1 and a second tank body 2, the first tank body 1 and the second tank body 2 are made of stainless steel, and the outlet end of the first tank body 1 and the inlet end of the second tank body 2 are detachably connected. Optionally, a first chuck 11 is provided at the outlet end of the first tank body 1, and a second chuck 21 is provided at the inlet end of the second tank body 2, and the test piece is clamped between the first chuck 11 and the second chuck 21. In the present embodiment, the first chuck 11 and the second chuck 21 are both disc structures with a central opening, and optionally, the diameter size of the first chuck 11 and the second chuck 21 is 50mm-51mm, and the aperture of the central opening is 8mm-10mm, and the test piece is clamped between the first chuck 11 and the second chuck 21 and is located at the central opening. The generating chamber assembly also includes a connecting hoop, which wraps the edges of the first chuck 11 and the second chuck 21, and presses the two to achieve a fixed connection. Optionally, a sealing ring is further provided between the first chuck 11 and the second chuck 21 . The sealing ring is located on the outside of the test piece and seals the connection between the first chuck 11 and the second chuck 21 .

[0038] In one embodiment, the chamber assembly includes a docking platform, such as Figure 1 , Figure 2 As shown, the docking platform includes a base 5, on which a sliding track is provided, and at least one of the first tank body 1 and the second tank body 2 is slidably provided on the sliding track, and the first tank body 1 or the second tank body 2 is slidably guided by the sliding track to ensure that there is no deviation when the first tank body 1 and the second tank body 2 are docked. Optionally, the sliding track includes two sliding rods 51 arranged in parallel, and the axes of the first tank body 1 and the second tank body 2 are parallel to the two sliding rods 51.

[0039] In one embodiment, the first tank body 1 is fixed on the base 5, the second tank body 2 is slidably connected to the sliding track, and an elastic member 53 is provided on the base 5. The elastic member 53 provides an elastic force to the second tank body 2 in the direction of the first tank body 1, and can clamp the test piece between the first chuck 11 and the second chuck 21, so as to facilitate the installation of the connecting clamp. Optionally, the first tank body 1 is connected to the first slider 12, and the second tank body 2 is connected to the second slider 22. The first slider 12 and the second slider 22 are slidably connected to the sliding track. A fixing pin 52 is provided on the base 5, and the fixing pin 52 is connected to the first slider 12 and the base 5, and is used to fix the first tank body 1 on the base 5. When the generating chamber assembly needs to be maintained, it is convenient to remove the first tank body 1 and the second tank body 2 from the base 5.

[0040] In other embodiments, the first tank body 1 and the second tank body 2 may be slidably connected to the sliding track at the same time, so that the range of adjusting the distance between the first chuck 11 and the second chuck 21 can be increased.

[0041] In one embodiment, the inlet end of the first tank body 1 and the outlet end of the second tank body 2 are both provided with connectors, the inlet end of the first tank body 1 is used to connect to the gas source, and the outlet end of the second tank body 2 is used to connect to the sampler. Optionally, the inlet end of the first tank body 1 is also provided with a pressure gauge 3 to indicate the pressure condition inside the first tank body 1. Furthermore, both connectors are provided with angle valves 4, which can control the opening and closing of the inlet end of the first tank body 1 and the outlet end of the second tank body 2, thereby controlling the gas supply and gas flow direction, and preventing backflow and misoperation of the cavity caused by opening in a pressurized state.

[0042] In one embodiment, Figure 3 As shown, the test piece includes a support piece 61 and a breathable membrane 62. The support piece 61 is a circular ring structure with a circular inner hole formed in the middle. The breathable membrane 62 is a circular piece. The breathable membrane 62 covers the inner hole of the support piece 61 and is connected to the support piece 61 to form an integral structure. Optionally, the breathable membrane 62 is concentrically arranged with the support piece 61. The outer diameter of the support piece 61 is 50mm-55mm, and the inner diameter is 25mm-28mm. The pore size of the breathable membrane 62 is 0.2μm-0.3μm, and the diameter of the breathable membrane 62 is 29mm-32mm.

[0043] The first surface of the air permeable membrane 62 is coated with a test bacteria layer, and the microorganisms in the test bacteria layer can be blown off by the airflow and flow out through the second tank body 2 with the airflow. The test piece is arranged between the outlet end of the first tank body 1 and the inlet end of the second tank body 2. In this embodiment, the test bacteria layer is formed by applying a certain amount of fresh test bacteria liquid to the surface of the sterilized test piece air permeable membrane 62, drying at room temperature, and fixing active microorganisms on the surface of the air permeable membrane 62.

[0044] Optionally, the support sheet 61 is made of PP material, the breathable membrane 62 is made of a composite material of PET and PTFE, and the support sheet 61 and the breathable membrane 62 are bonded into an integral structure, for example, by hot-melt bonding.

[0045] The quantitative active microorganism generating device provided by the utility model is suitable for a pressure-maintaining type sampler and a normal pressure type sampler.

[0046] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention 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 present invention.

[0047] In the present invention, unless otherwise clearly specified and limited, the terms "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, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0048] In the description of this specification, the description with reference to the terms "this embodiment", "one embodiment", "some embodiments", "example", "specific example", or "some examples" means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the utility model. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in a suitable manner in any at least one embodiment or example. In addition, those skilled in the art may combine and combine the different embodiments or examples described in this specification and the features of the different embodiments or examples, without contradiction.

[0049] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In the description of the present utility model, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0050] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions and simple improvements made to the essential contents of the present invention shall be included in the protection scope of the present invention.

Claims

1. A device for generating quantitative active microorganisms, characterized in that: include: The generating chamber assembly comprises a first tank body and a second tank body, wherein the outlet end of the first tank body and the inlet end of the second tank body are detachably connected; A test sheet, comprising a support sheet and a breathable membrane, wherein the support sheet is a ring structure, the breathable membrane is a circular sheet, the breathable membrane covers the inner hole of the support sheet and is connected to the support sheet to form an integral structure, and the first surface of the breathable membrane is coated with a test bacteria layer; The test piece is arranged between the outlet end of the first tank body and the inlet end of the second tank body.

2. The device for generating quantitative active microorganisms according to claim 1, characterized in that: A first chuck is disposed at the outlet end of the first tank body, a second chuck is disposed at the inlet end of the second tank body, and the test piece is clamped between the first chuck and the second chuck.

3. The device for generating quantitative active microorganisms according to claim 2, characterized in that: The generating chamber assembly further comprises a connecting hoop, and a sealing ring is further arranged between the first chuck and the second chuck, and the first chuck and the second chuck are connected via the connecting hoop.

4. The device for generating quantitative active microorganisms according to claim 1, characterized in that: The generating chamber assembly comprises a docking platform, the docking platform comprises a base, and a sliding track is arranged on the base. At least one of the first tank body and the second tank body is slidably disposed on the sliding track.

5. The device for generating quantitative active microorganisms according to claim 4, characterized in that: The first tank body is fixed on the base, and the second tank body is slidably connected to the sliding track. An elastic member is disposed on the base, and the elastic member provides an elastic force to the second tank body in a direction toward the first tank body.

6. The device for generating quantitative active microorganisms according to claim 5, characterized in that: The first tank body is connected to the first slider, the second tank body is connected to the second slider, and the first slider and the second slider are slidably connected to the sliding track. The base is provided with a fixing pin, which is connected to the first sliding block and the base and is used to fix the first tank body on the base.

7. The device for generating quantitative active microorganisms according to claim 1, characterized in that: The inlet end of the first tank body and the outlet end of the second tank body are both provided with connectors. The inlet end of the first tank is also provided with a pressure gauge.

8. The device for generating quantitative active microorganisms according to claim 7, characterized in that: An angle valve is arranged on the connecting head.

9. The device for generating quantitative active microorganisms according to claim 1, characterized in that: The support sheet is made of PP material, and the support sheet and the breathable membrane are bonded into an integrated structure.

10. The device for generating quantitative active microorganisms according to claim 9, characterized in that: The breathable membrane is formed with breathable holes, and the aperture of the breathable holes is 0.2 μm-0.3 μm.

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