Device and method for online detection of integrity of nuclear drug sterilization filter

Abstract

The invention relates to a device and a method for online detection of integrity of a nuclear medicine sterilization filter, which solve the problem of detection of the nuclear medicine sterilization filter, improve the detection efficiency and safety and guarantee the nuclear medicine quality. The device comprises a bubbling bottle, a pipeline, a valve, a wetting liquid container, a power injector, a gas buffer, a target bottle, a sterilization filter, a pressure monitoring device and the like, and is compact in structure and high in integration level. The method comprises the steps of liquid medicine sterilization, gas buffering, filter wetting and foaming point detection. The gas buffer firstly sucks the wetting liquid and then empties the pipeline gas, so that the wetting of the hydrophilic filter is ensured; bubbling point detection is carried out through sterile gas extraction and stepless pressurization, and accurate judgment is carried out according to pressure feedback. According to the nuclear medicine sterile detection device, full-online detection is achieved, manual operation of radiation risk and sterile destruction is avoided, wetting and detection functions are integrated, consumable disassembly and assembly, equipment adaptation to a hot chamber, buffer waste gas treatment and stepless pressurization of a filter membrane are operated with one hand, and the nuclear medicine sterile detection device is suitable for the nuclear medicine sterile production environment and has far-reaching significance in the nuclear medicine industry.

Description

Technical Field

[0001] The invention relates to the technical field of nuclear medicine production equipment, and in particular to an online device and method for detecting the integrity of a nuclear medicine sterilizing filter. Background Art

[0002] In the production process of nuclear medicine, sterilizing filters are the key barrier to the sterility index of nuclear medicine. The integrity of its terminal filter element is directly related to the qualification of batches of medicines, so testing the integrity of sterilizing filter elements has become a core process step. At present, the Good Manufacturing Practice (GMP) for pharmaceutical production clearly requires that after each filtration and sterilization operation, the filter integrity test must be performed immediately to ensure the sterility of the downstream filter.

[0003] The mainstream integrity testing modes in the industry today can be divided into two categories: offline and online testing. During offline testing, after the radioactive drug is filtered through a sterile filter membrane, technicians are required to manually remove the filter membrane and transfer it to a special testing instrument for bubble point verification. This process has significant disadvantages and is extremely time-consuming and labor-intensive, greatly increasing the radiation risk of technicians; the disassembly operation can easily damage the filter membrane, causing inaccurate test results; and it can easily destroy the overall sterile environment, posing a potential threat to drug quality. In addition, the complete test process covers a series of operations such as wetting the filter and bubble point detection. However, in the actual sterilization and filtration scenario of nuclear drugs, due to the constraints of process characteristics, when the drug solution is driven into the target bottle by gas positive pressure, the air retained in the pipeline will strongly hinder the wetting liquid from entering the hydrophilic filter, causing the filter to be unable to be effectively wetting, seriously interfering with the normal progress of the test process and the accuracy of the results.

[0004] At the same time, some existing patent technologies, such as "A sterile filtration and filter membrane integrity test system" with authorization announcement number CN215196355U, also have many limitations. First, the wetting function is missing. If the manual wetting process is supplemented, the operating efficiency will be greatly reduced; second, if the wetting effect is achieved with liquid medicine, the consistency of the measured bubble point value and the value measured by the standard solution wetting needs to be rigorously verified. After all, most filter membrane manufacturers regard distilled water for injection or saline as the wetting liquid, and use other liquid medicines for wetting at will. It is necessary to fully verify the wetting bubble points of various liquid medicines, which is cumbersome and high-risk; third, the gas supply equipment mentioned in this patent is a common idea for bubble point detection, but it makes the overall size of the instrument bloated, and the introduction of external gas may pollute the sterile environment in the nuclear medicine production hot room, which is difficult to meet the strict standards of the GMPA-level production environment.

[0005] To sum up, in order to effectively resolve the defects of the existing technology and fill the technical gaps in the industry, the present invention has carefully created a device and a method thereof with a superior degree of integration, which can solve the filter wetting problem online, is easy to operate, and is easy to place in the hot chamber, laying a solid foundation for the dual leap in the quality and efficiency of nuclear medicine production. Summary of the invention

[0006] The purpose of the present invention is to provide an on-line device and method for detecting the integrity of a nuclear medicine sterilizing filter in view of the above-mentioned problems existing in the prior art.

[0007] In order to achieve the above application purpose, the present invention adopts the following technical solution: an online detection device for the integrity of a nuclear medicine sterilizing filter comprises:

[0008] Bubble bottle;

[0009] A pipeline, one end of which is connected to the bubbler bottle through the sixth valve, and the other end of which is used to pass gas and liquid medicine through the first valve;

[0010] a wetting liquid container connected to the pipeline via a second valve and used for providing the wetting liquid;

[0011] A power injector, connected to the pipeline through a third valve;

[0012] A gas buffer connected to the pipeline via a fifth valve;

[0013] a target bottle, connected to the pipeline via a sixth valve, for containing the sterilized liquid medicine;

[0014] A sterilizing filter is provided between the sixth valve and the fifth valve;

[0015] The pressure monitoring device is connected to the pipeline via the fourth valve and is used to monitor the changes in the pressure value of the pipeline in real time.

[0016] Furthermore, the pipeline is provided with a wetting liquid container, a power injector, a pressure monitoring device, a gas buffer, and a sterilizing filter in sequence from left to right or from right to left.

[0017] Furthermore, the first valve is provided with an air inlet end and a pipeline connecting end.

[0018] Furthermore, the pipeline, the wetting fluid container, the power injector, the gas buffer, the sterilizing filter and all valves on the pipeline constitute a replaceable consumable component.

[0019] Furthermore, it also includes a device body, on which a locking device and a consumable fixing device for fixing the consumable assembly are provided, and the consumable assembly is fixed by the cooperation of the consumable fixing device and the locking device.

[0020] Furthermore, a rotating structure corresponding to each valve on the pipeline is also provided on the device body, and the rotating structure is used to rotate the valve to achieve channel switching and opening and closing of the valve.

[0021] Furthermore, a power actuator is also provided on the device body, and the power actuator is used to drive the power injector and the gas buffer.

[0022] Furthermore, a bubble sensor is provided between the gas buffer and the fifth valve.

[0023] Furthermore, the wetting liquid is physiological saline or distilled water for injection.

[0024] The control method of the device for online detection of the integrity of the nuclear medicine sterilizing filter comprises the following steps:

[0025] S00, liquid sterilization:

[0026] Keep the pipeline from the first valve to the target bottle connected, close the other pipelines, pass the drug solution into the pipeline, and the drug solution enters the target bottle after passing through the sterilizing filter;

[0027] By passing gas through the pipeline, the gas is isolated by the sterilizing filter and cannot pass through the sterilizing filter;

[0028] S10, Gas Buffer:

[0029] Open the pipeline between the wetting fluid container and the power injector, close the other pipelines, and pump the gas in the pipeline and the wetting fluid in the wetting fluid container into the power injector through the power injector. At this time, the pipeline between the wetting fluid container and the power injector is filled with wetting fluid;

[0030] Open the pipeline between the power injector and the gas buffer, and draw the wetting fluid into the gas buffer through the gas buffer or push the wetting fluid into the gas buffer through the power injector, so that the gas between the wetting fluid container and the sterilizing filter is completely evacuated;

[0031] S20, Wetted Sterile Filter:

[0032] Open the pipeline between the wetting fluid container and the power injector, close the other pipelines, and pump the wetting fluid from the wetting fluid container into the power injector through the power injector again;

[0033] Open the pipeline between the power injector and the bubbler bottle, close the other pipelines, and allow the wetting liquid to pass through the sterilizing filter into the bubbler bottle through the power injector to achieve wetting of the sterilizing filter;

[0034] S30, bubble point detection:

[0035] Open the first valve, keep the pipeline from the first valve to the power injector connected through the third valve, close the remaining pipelines, and draw the sterile gas into the power injector;

[0036] Keep the pipeline from the power injector to the blister bottle connected, rotate the fourth valve to connect the pressure monitoring device to the pipeline, close the remaining pipelines, and perform stepless pressurization testing on the sterilizing filter;

[0037] Through real-time feedback from the pressure monitoring device, when the pressure drop value is greater than the threshold, it is determined that the bubble point has been reached and the bubble stable value is used as the bubble point.

[0038] Compared with the prior art, the present invention has the following effects:

[0039] 1. Core detection performance optimization

[0040] Online detection innovation: This invention realizes full online detection of filter wetting and bubbling point, eliminates the radiation risk and sterility damage of manual operation, stabilizes the sterility of the production environment, and lays a solid foundation for the quality assurance of nuclear medicine. The unique gas buffer and wetting process overcomes the air obstruction problem of hydrophilic filters, ensures precise wetting, greatly improves the detection accuracy, avoids the defects of traditional offline and some online technologies, and has far-reaching significance for the sterile quality control of nuclear medicine.

[0041] Integrated functional efficiency enhancement: integrated wetting and bubble point detection functions, rewriting the traditional step-by-step operation mode. Highly integrated streamlined processes, compressed equipment physical space, significantly improved operational efficiency, and reduced overall costs. Under the demand for efficient production of nuclear medicines, it accelerates the product launch cycle, enhances the market resilience of enterprises, creates new advantages in industry competition, and leads the trend of integrated transformation of nuclear medicine detection technology.

[0042] 2. Operation and environmental adaptability upgrade

[0043] Convenient and space-friendly design: The consumables can be disassembled and assembled with one hand, which perfectly fits the narrow layout of nuclear medicine hot cells. Simplified operation process reduces manpower and operation difficulty, improves equipment usability and space utilization, avoids quality and safety risks caused by traditional complex operations in confined spaces, ensures production continuity and stability, optimizes the space value of hot cell facilities, and reshapes the micro-operation environment of nuclear medicine production.

[0044] Compact and environmentally friendly collaborative layout: The equipment is exquisite and does not require additional gas supply, which optimizes the resource allocation of the production site and avoids the land occupation and pollution risks of gas supply equipment. The gas buffer efficiently treats waste gas, curbs the spread of radioactive aerosols, reduces environmental protection costs and health risks, conforms to the green production concept and the sustainable development vision of the nuclear medicine industry, and promotes enterprises to move towards a new paradigm of environmentally friendly and efficient production.

[0045] 3. Long-lasting and stable testing quality

[0046] Stepless pressurization and intelligent feedback: The sterilization filter detection stepless pressurization is combined with real-time pressure feedback to accurately control and avoid damage to the filter membrane due to excessive speed, extend the service life, and reduce the frequency and cost of replacing consumables. Each test accurately assesses the integrity of the filter, ensures the consistency and stability of the quality of nuclear medicine batches, improves the depth and reliability of quality control technology, strengthens the core competitiveness of enterprise quality, and consolidates the long-term advantage of nuclear medicine product quality. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Figure 1 is a schematic structural diagram according to an embodiment of the present invention;

[0048] Figure 2 is a schematic diagram of introducing a liquid medicine into a liquid medicine sterilization process according to an embodiment of the present invention;

[0049] Figure 3 is a schematic diagram of introducing gas during the sterilization process of a liquid medicine according to an embodiment of the present invention;

[0050] Figure 4 is a schematic diagram of extracting wetting liquid during the gas buffering process of the sterilizing filter according to an embodiment of the present invention;

[0051] Figure 5 is a schematic diagram of discharging pipeline gas to a gas buffer during the wetting process of the sterilizing filter according to an embodiment of the present invention;

[0052] Figure 6 is a schematic diagram of extracting wetting liquid during the wetting process of the sterilizing filter according to an embodiment of the present invention;

[0053] Figure 7 is a schematic diagram of wetting a sterilizing filter during a wetting process of the sterilizing filter according to an embodiment of the present invention;

[0054] Figure 8 is a schematic diagram of extracting sterile gas from a hot chamber during a bubble point detection process according to an embodiment of the present invention;

[0055] Fig. 9 is a schematic diagram of a pressurization process during a bubble point detection process according to an embodiment of the present invention;

[0056] Fig.10 is a schematic structural diagram of a device body according to an embodiment of the present invention;

[0057] Fig.11 is a schematic diagram of a consumable component of a device body according to an embodiment of the present invention;

[0058] Fig.12 Schematic diagram of installing consumable components in a device main body according to an embodiment of the present invention.

[0059] In the figure, 1. first three-way valve; 2. wetting liquid container; 3. second three-way valve; 4. power injector; 5. third three-way valve; 6. pressure sensor; 7. fourth three-way valve; 8. gas buffer; 9. bubble sensor; 10. fifth three-way valve; 11. sterilizing filter; 12. sixth three-way valve; 13. target bottle; 14. foaming bottle; 15. device body; 16. consumable component; 17. first consumable fixing device; 18. second consumable fixing device; 19. power actuator; 20. rotating structure; 21. locking device. DETAILED DESCRIPTION

[0060] The following will be combined with the accompanying drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field belong to the scope of protection of the present invention.

[0061] Those skilled in the art should understand that, in the disclosure of the present invention, the orientation or position relationship indicated by terms such as "longitudinal", "lateral", "up", "down", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inside" and "outside" are based on the orientation or position relationship shown in the accompanying drawings, which are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, the above terms should not be understood as limiting the present invention.

[0062] Example 1

[0063] like Figure 1-12 As shown, the on-line nuclear medicine sterilizing filter integrity detection device includes:

[0064] Bubble bottle 14;

[0065] The pipeline has one end connected to the bubbling bottle 14 through the sixth valve, and the other end is used to pass gas and liquid medicine through the first valve; wherein the first valve is provided with an air inlet end (B port) and a pipeline connection end (A port);

[0066] The wetting liquid container 2 is connected to the pipeline through the second valve and is used to provide the wetting liquid; the wetting liquid is physiological saline or distilled water for injection;

[0067] The power injector 4 is connected to the pipeline through a third valve;

[0068] The gas buffer 8 is connected to the pipeline through the fifth valve; a bubble sensor 9 is provided between the gas buffer 8 and the fifth valve;

[0069] The target bottle 13 is connected to the pipeline through the sixth valve and is used to contain the sterilized liquid medicine;

[0070] A sterilizing filter 11 is provided between the sixth valve and the fifth valve;

[0071] The pressure monitoring device (pressure sensor 6, which may also be a pressure gauge or a pressure transmitter) is connected to the pipeline via the fourth valve and is used to monitor the pressure value change of the pipeline in real time.

[0072] In this embodiment, the pipeline is sequentially provided with a wetting fluid container 2, a power injector 4, a pressure sensor 6, a gas buffer 8, and a sterilizing filter 11 from left to right or from right to left. The pipeline, the wetting fluid container 2, the power injector 4, the gas buffer 8, the sterilizing filter 11, and all valves on the pipeline constitute a replaceable consumable component 16.

[0073] Preferably, the power injector 4 is connected to power and has a variable volume. The gas buffer 8 uses a syringe whose variable volume prevents the collected waste gas from being discharged and destroying the sterile environment, or a container with a fixed volume can be used, but a sterilizing filter membrane needs to be added.

[0074] In this embodiment, the first valve to the sixth valve are all three-way valves, that is, the first three-way valve 1 , the second three-way valve 3 , . . . , the sixth three-way valve 12 .

[0075] Example 2

[0076] On the basis of Example 1, the consumable component 16 of Example 1 is installed on the device body 15, as shown in FIG. Fig.10 and Fig.11 As shown, the device body 15 is provided with a locking device 21 and a consumable fixing device for fixing the consumable assembly 16 , and the consumable fixing device and the locking device 21 cooperate to fix the consumable assembly 16 .

[0077] In this embodiment, a rotating structure 20 corresponding to each valve on the pipeline is further provided on the device body 15, and the rotating structure 20 is used to rotate the valve to achieve channel switching and opening and closing of the valve.

[0078] Preferably, the device body 15 is also provided with a power actuator 19, which is used to drive the power injector 4 and the gas buffer 8. The power actuator 19 can be a cylinder, an electric cylinder or a motor, and the power source and the action form are not limited. Correspondingly, as long as the final power form is converted to drive the pressure change inside the power injector 4 and the gas buffer 8, it can be used.

[0079] like Fig.12 As shown, the installation process of the device body 15 is as follows:

[0080] 1) Open the first consumable fixing device 17;

[0081] 2) Insert the three-way valve handle in the consumable into the rotating structure 20 for positioning;

[0082] 3) Close the first consumable fixing device 17 and rotate the locking device 21;

[0083] 4) Clamp the remaining part of the consumable into the fixed position, and clamp the remaining part of the consumable with the second consumable fixing device 18, and rotate to lock.

[0084] Example 3

[0085] Based on the same concept, this embodiment provides a control method for an online device for detecting the integrity of a nuclear medicine sterilizing filter 11, characterized in that it includes the following steps:

[0086] S00, liquid sterilization:

[0087] like Figure 2 As shown, what this step means is that after the liquid medicine passes through, a section of air will enter. This is a description of the production conditions, which can be understood as the liquid medicine and air are in the same pipeline and the same inlet. The connection between this device and the external pipeline is the A port (pipeline connection end) of the first valve. The red mark is the pipeline flow direction, and the other directions are closed; the drug is transported in the pipeline, sterilized by the sterilizing filter 11, and then packaged into the target bottle 13. The power drive mechanism for packaging does not belong to the technical point to be protected by the present invention. When the packaging is completed, in order to transfer the nuclear medicine as completely as possible, the drug will be transferred to the target bottle 13 through gas in the pipeline, and the power mechanism for passing gas is not introduced in the present invention.

[0088] Since the nuclear medicine needs to be transferred as completely as possible, the medicine liquid is driven into the target bottle 13 by the positive pressure of the gas. The air in the pipeline will prevent the wetting liquid from entering the filter, making it impossible to wet the sterilizing filter 11. Figure 3 As shown, the pipeline indicated by the arrow → is open, and the other pipelines are closed; since the sterilizing filter 11 has been moistened with the drug solution, the gas will be isolated when it passes through, and the gas will not be allowed to pass unless the gas pressure reaches the bubble point value (of course, this is not allowed here, otherwise the integrity of the sterilizing filter 11 will be destroyed), so it is impossible to moisten the sterilizing filter 11 at this time, and the air in the pipeline needs to be cleared before moistening.

[0089] S10, Gas Buffer:

[0090] like Figure 4 As shown, during the process of pumping the wetting liquid, the second three-way valve 3 and the third three-way valve 5 rotate, so that the pipeline section 2-3-5-4 is open, that is, the pipeline indicated by the arrow → is open, and the other pipelines are closed. The wetting liquid is pumped into the power injector 4, and part of the gas in the pipeline exists above the power injector 4, and the pipeline section 2-3-5-4 is filled with the wetting liquid.

[0091] like Figure 5As shown, the pipeline gas is discharged into the gas buffer 8, and the third three-way valve 5 and the fifth three-way valve 10 are rotated to make the 4-5-7-10-8 section pipeline open, that is, the pipeline indicated by the arrow → is open, and the other pipelines are closed. The wetting liquid in the power injector 4 is pushed into the gas buffer 8. At this time, the wetting liquid in the power injector 4 will not be completely pushed out to prevent the gas in the power injector 4 from remaining in the pipeline. At this time, the 4-5-7-10-8 section pipeline is filled with wetting liquid. Since the sterilizing filter 11 and the fifth three-way valve 10 can be understood as directly connected, the gas between the wetting liquid container 2 and the sterilizing filter 11 is completely discharged, and the next wetting process can be carried out.

[0092] Among them, the gas is discharged into the gas buffer 8, and then the sterilizing filter 11 can be wetted, solving the problem that the hydrophilic sterilizing filter 11 cannot be wetted due to the presence of air in the front part of the sterilizing filter 11 pipeline; the gas buffer 8 can collect waste gas in the pipeline, reduce the generation of radioactive aerosols, and facilitate the collection and treatment of radioactive waste gas.

[0093] S20, moistening and sterilizing filter 11:

[0094] like Figure 6 As shown, during the process of pumping the wetting fluid, the third three-way valve 5 rotates to open the pipelines of sections 2-3-5-4, that is, the pipelines indicated by arrows → are open, and the other pipelines are closed. The wetting fluid is pumped into the power injector 4.

[0095] like Figure 7 As shown, in the process of wetting the sterilizing filter 11, the third three-way valve 5, the fifth three-way valve 10, and the sixth three-way valve 12 rotate to make the 4-5-7-10-11-12-14 pipeline sections open, that is, the pipeline indicated by the arrow → is open, and the other pipelines are closed, so as to wet the sterilizing filter 11. The wetted liquid will be stored in the foaming bottle 14. At this time, the wetting liquid in the power injector 4 will not be completely pushed out, but it should be ensured that the sterilizing filter 11 is completely wetted.

[0096] S30, bubble point detection:

[0097] like Figure 8 As shown, when extracting sterile gas from the hot chamber, the first three-way valve 1 and the third three-way valve 5 rotate to make the B-1-3-5-4 pipeline open, that is, the pipeline indicated by the arrow → is open, and the other pipelines are closed. The sterile gas in the hot chamber is extracted into the power injector 4.

[0098] like Fig. 9As shown, during the pressurization process, the third three-way valve 5 rotates to open the pipeline sections 4-5-7-10-11-12-14, and the fourth three-way valve 7 rotates to connect the pressure sensor 6 to the pipeline, that is, the pipeline indicated by the arrow → is open, and the other pipelines are closed. The sterilizing filter 11 is subjected to a stepless pressurization detection process.

[0099] At this time, the pressure sensor 6 performs real-time pressure feedback, which can reduce the possibility of damage to the filter membrane due to excessive pressurization speed. By real-time monitoring of the pressure value changes during the pressurization process, when the pressure drop value is greater than the set value, it can be determined that the bubble point has been reached, and the bubble stable value is used as the bubble point. So far, wetting and bubble detection are fully online, which not only avoids manual operation to human radioactive radiation, but also avoids the destruction of the sterile state caused by manual disassembly of the sterilizing filter 11.

[0100] Among them, the principle of bubble point is as follows:

[0101] The bubble point refers to the minimum air pressure value for removing water or ethanol from the wet filter membrane, and is the basis for determining the pore size of the filter membrane. When measuring the bubble point, a small amount of bubbles will first occur, and then the bubbles will gradually increase and continue to bubble. When all the solution in the filter membrane is removed, the gas will instantly pass through the filter membrane, causing the pressure to drop. The bubble point value is not the pressure value when the bubbles are initially generated, but the pressure value when the bubble state is stable. When the measured bubble point value is greater than the standard minimum bubble point value, the sterilizing filter 11 integrity test is qualified.

[0102] The parts not described in detail in the present invention are prior art, so the present invention does not describe them in detail.

[0103] It is to be understood that the term "one" should be understood as "at least one" or "one or more", that is, in one embodiment, the number of an element may be one, while in another embodiment, the number of the element may be multiple, and the term "one" should not be understood as a limitation on the quantity.

[0104] Although the terms such as the first three-way valve 1, the wetting fluid container 2, the second three-way valve 3, the power injector 4, the third three-way valve 5, the pressure sensor 6, the fourth three-way valve 7, the gas buffer 8, the bubble sensor 9, the fifth three-way valve 10, the sterilizing filter 11, the sixth three-way valve 12, the target bottle 13, the foaming bottle 14, the device body 15, the consumable component 16, the consumable first fixing device 17, the consumable second fixing device 18, the power actuator 19, the rotating structure 20, the locking device 21 are used more frequently in this article, the possibility of using other terms is not excluded. The use of these terms is only for more convenient description and explanation of the essence of the present invention; interpreting them as any additional restrictions is contrary to the spirit of the present invention.

[0105] The present invention is not limited to the above-mentioned optimal implementation mode. Anyone can derive other various forms of products under the inspiration of the present invention. However, no matter what changes are made in the shape or structure, all technical solutions that are the same or similar to the present invention fall within the protection scope of the present invention.

Claims

1. An online device for detecting the integrity of a nuclear medicine sterilizing filter, characterized in that: include: Bubble bottle; A pipeline, one end of which is connected to the bubbling bottle through the sixth valve, and the other end of which is used to pass gas and liquid medicine through the first valve; a wetting liquid container, connected to the pipeline via a second valve, for providing the wetting liquid; a power injector connected to the pipeline via a third valve; A gas buffer connected to the pipeline via a fifth valve; a target bottle, connected to the pipeline via a sixth valve, for containing the sterilized liquid medicine; a sterilizing filter, disposed between the sixth valve and the fifth valve; The pressure monitoring device is connected to the pipeline via the fourth valve and is used to monitor the pressure value changes of the pipeline in real time.

2. The device for detecting the integrity of a nuclear medicine sterilizing filter online according to claim 1 is characterized in that: The pipeline is provided with a wetting liquid container, a power injector, a pressure monitoring device, a gas buffer, and a sterilizing filter in sequence from left to right or from right to left.

3. The device for detecting the integrity of a nuclear medicine sterilizing filter online according to claim 1 is characterized in that: The first valve is provided with an air inlet end and a pipeline connecting end.

4. The device for detecting the integrity of a nuclear medicine sterilizing filter online according to any one of claims 1 to 3, characterized in that: The pipeline, the wetting liquid container, the power injector, the gas buffer, the sterilizing filter and all the valves on the pipeline constitute a replaceable consumable component.

5. The device for online detection of the integrity of a nuclear medicine sterilizing filter according to claim 4 is characterized in that: It also includes a device body, on which a locking device and a consumable fixing device for fixing the consumable assembly are provided, and the consumable assembly is fixed by the cooperation of the consumable fixing device and the locking device.

6. The device for detecting the integrity of a nuclear medicine sterilizing filter online according to claim 5 is characterized in that: The device body is also provided with a rotating structure corresponding to each valve on the pipeline, and the rotating structure is used to rotate the valve to achieve channel switching and opening and closing of the valve.

7. The device for detecting the integrity of a nuclear medicine sterilizing filter online according to claim 5 is characterized in that: The device body is also provided with a power actuator, which is used to drive the power injector and the gas buffer.

8. The device for detecting the integrity of a nuclear medicine sterilizing filter online according to claim 1 is characterized in that: A bubble sensor is provided between the gas buffer and the fifth valve.

9. The device for online detection of the integrity of a nuclear medicine sterilizing filter according to claim 1 is characterized in that: The wetting liquid is physiological saline or distilled water for injection.

10. The control method for an online detection device for detecting the integrity of a nuclear medicine sterilizing filter according to any one of claims 1 to 9, characterized in that: The following steps are involved: S00, liquid sterilization: Keep the pipeline from the first valve to the target bottle connected, close the other pipelines, pass the drug solution into the pipeline, and the drug solution enters the target bottle after passing through the sterilizing filter; By passing gas through the pipeline, the gas is isolated by the sterilizing filter and cannot pass through the sterilizing filter; S10, Gas Buffer: Open the pipeline between the wetting fluid container and the power injector, close the other pipelines, and pump the gas in the pipeline and the wetting fluid in the wetting fluid container into the power injector through the power injector. At this time, the pipeline between the wetting fluid container and the power injector is filled with wetting fluid; Open the pipeline between the power injector and the gas buffer, and draw the wetting fluid into the gas buffer through the gas buffer or push the wetting fluid into the gas buffer through the power injector, so that the gas between the wetting fluid container and the sterilizing filter is completely evacuated; S20, Wetted Sterile Filter: Open the pipeline between the wetting fluid container and the power injector, close the other pipelines, and pump the wetting fluid from the wetting fluid container into the power injector through the power injector again; Open the pipeline between the power injector and the bubbler bottle, close the other pipelines, and allow the wetting liquid to pass through the sterilizing filter into the bubbler bottle through the power injector to achieve wetting of the sterilizing filter; S30, bubble point detection: Open the first valve, keep the pipeline from the first valve to the power injector through the third valve connected, close the remaining pipelines, and draw sterile gas into the power injector; Keep the pipeline from the power injector to the blister bottle connected, rotate the fourth valve to connect the pressure monitoring device to the pipeline, close the remaining pipelines, and perform stepless pressurization testing on the sterilizing filter; Through real-time feedback from the pressure monitoring device, when the pressure drop value is greater than the threshold, it is determined that the bubble point has been reached and the bubble stable value is used as the bubble point.

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