Sterilization box sealing performance sterility tester and test method

Abstract

The invention provides a sterilization box sealing performance sterility tester and a test method, and relates to the technical field of sterilization box sealing performance test. The sterility tester comprises a case, a power supply assembly, a connecting assembly, a vacuum pump, an air exhaust electromagnetic valve, an air inlet electromagnetic valve, a double-voltage-stabilizing trigger, a pressure sensor and a timer are arranged in the case, and a negative-pressure vacuum chuck and an air filter are arranged outside the case. By arranging the bistable trigger, the negative pressure vacuum suction cup with the air filter element, the air filter and the like, a circuit structure and an air path structure are optimized; on the basis, the tester can be maintained in a stable working state, so that the accuracy of a test result can be ensured, and the damage to the sealing performance of the sterilization box is avoided; polluting bacteria possibly existing in air in an air path can be filtered, so that pollution to the sterilization box can be effectively avoided, and sterility of medical instruments in the sterilization box is guaranteed.

Description

Technical Field

[0001] The invention relates to the technical field of sealing performance testing of a sterilization box, in particular to a sealing performance sterility testing instrument and a testing method for a sterilization box. Background Art

[0002] In the medical field, many medical devices need to remain sterile until use, such as infusion sets, surgical sutures, etc. A sterilization box is a container used to load and protect medical devices in a sterile environment. It can ensure that the medical devices remain sterile during storage and transportation, and ensure that the medical devices meet the required sterility standards before clinical use, thereby effectively reducing the risk of infection and ensuring patient safety. Sealing performance is a decisive factor in the sterilization box's ability to function ideally, so it is very necessary to conduct sealing performance tests on the sterilization box.

[0003] However, the sealing performance tester and test method in the prior art have limitations in practical application. Specifically: First, the traditional pressure sensor and relay system are usually used to control the start and stop of the vacuum pump, and then control the air extraction inside the sterilization box; second, in the process of carrying out the sealing performance test, there is a lack of consideration for the sterile operating environment, and an effective sterile barrier is not established. For example, the patent with publication number CN113267302A provides a sealing tester and test method for a sterilization box. The tester includes a body and a pressure plate. The body is equipped with a switching power supply, a vacuum pump, a pressure sensor, a solenoid valve, a relay, a three-way valve, a one-way valve, a quick connector, a two-way switch, a timer and a power switch; in the test method, the relay disconnects the vacuum pump to stop working, and the relay attracts the vacuum pump to start working, and the vacuum pump draws negative pressure to test the sealing performance of the sterilization box.

[0004] In the first case, when using a pressure sensor and a relay system to control the start and stop of a vacuum pump, once the pressure value in the sterilization box exceeds the preset limit, the sensor will send a signal, and the relay will change its state after receiving the signal. On the contrary, when the sensor signal is interrupted, the relay will reset its state, thereby controlling the start and stop of the vacuum pump. Regardless of whether the pressure value is at the upper or lower limit, the goal of the test is always to detect whether the product is in a negative pressure state, rather than simply monitoring whether a leak occurs. However, in actual operation, due to the frequent small fluctuations in the pressure value, the traditional relay may cause the sensor to send a signal just when it exceeds the preset limit, and once the pressure value returns to the preset limit due to leakage, the signal will be interrupted immediately, which will cause the relay to switch states frequently, and thus fail to achieve continuous and stable control of the vacuum pump, making it difficult for the tester to maintain a stable working state. Therefore, the accuracy of the test results will be affected; and during the test, the sterilization box may be subjected to excessive negative pressure, which may damage its sealing performance.

[0005] Secondly, since a sterile barrier has not been established, the surface bacterial content of the components of the tester that need to be in direct contact with the sterilization box cannot be effectively controlled. Therefore, during the test process, there may be a potential risk of contamination to the sterilization box, which may in turn contaminate the medical devices in the sterilization box, thereby indirectly posing a threat to patient safety.

[0006] In summary, the present invention provides a sterilization box sealing performance sterility tester and a testing method. Summary of the invention

[0007] The purpose of the present invention is to provide a sterilization box sealing performance sterility tester and testing method to solve the problem mentioned in the above background technology that the sealing performance tester and testing method in the prior art have limitations in practical applications.

[0008] The present invention is achieved by adopting the following technical solutions:

[0009] A sterilization box sealing performance sterility tester comprises a chassis, wherein a power supply component, a connection component, a vacuum pump, an exhaust solenoid valve, an air intake solenoid valve, a bistable trigger, a pressure sensor and a timer are arranged inside the chassis, and a negative pressure vacuum suction cup and an air filter are arranged outside the chassis; the signal output end of the pressure sensor is electrically connected to the signal input end of the bistable trigger and the timer respectively, and the signal output end of the bistable trigger is electrically connected to the signal input end of the vacuum pump and the exhaust solenoid valve respectively; the exhaust end of the vacuum pump is connected to the exhaust end of the exhaust solenoid valve, and the exhaust end of the exhaust solenoid valve is connected to a branch air path I and a branch air path II respectively; the branch air path I comprises a negative pressure vacuum suction cup with an air filter element, and the branch air path II comprises an air intake solenoid valve and an air filter.

[0010] In the above-mentioned sterility tester provided by the present invention, the circuit structure and the gas path structure are optimized. Specifically: in the circuit structure, a bistable trigger is set to control the start and stop of the vacuum pump; when the bistable trigger receives the K-end signal from the pressure sensor, it can accurately identify the rising edge of the signal and change its internal state accordingly, that is, when the K-end signal has a rising edge, the bistable trigger will switch its output state, so that the load end originally in the normally closed (NC) state is changed to the normally open (NO) state. This state change mode ensures that even if the K-end signal of the pressure sensor is interrupted, the controlled load device such as the vacuum pump can still maintain its output state unchanged. In the gas path structure, a branch gas path I for realizing negative pressure adsorption and a branch gas path II for realizing pressure exhaust and air intake are designed respectively, and a negative pressure vacuum suction cup with an air filter element is designed in the branch gas path I, and an air filter is designed in the branch gas path II, thereby filtering the contaminated bacteria that may exist in the air of the gas path.

[0011] Furthermore, the negative pressure vacuum suction cup includes a suction cup body and a quick-release interface, and an air filter element is provided at the center of the suction cup body. Although the filter paper in the sterilization box can block microbial contamination to a certain extent, the sterilization box needs to be repeatedly pumped and filled with gas during the sealing test, which is likely to cause the filter paper to deform, thereby affecting the anti-pollution effect; therefore, the sterility tester is provided with an air filter element at the center of the suction cup body, which can achieve effective filtration of bacteria.

[0012] Furthermore, two ampoule culture media are embedded in the air filter element, and the two ampoule culture media are thioglycollate fluid culture medium and tryptic soy liquid culture medium. By setting up two ampoule culture media, sterility verification can be performed, and bacteria on the valve port surface of the sterilization box and between the negative pressure vacuum suction cup and the valve port can be detected to further ensure the sterility during the test process, wherein the thioglycollate fluid culture medium is mainly used for the cultivation of anaerobic bacteria and aerobic bacteria, and the tryptic soy liquid culture medium is mainly used for the cultivation of fungi and aerobic bacteria.

[0013] Furthermore, a PWM signal generator is also provided inside the chassis, and a signal output end of the PWM signal generator is electrically connected to a signal input end of the bistable trigger.

[0014] Furthermore, the power supply assembly includes a power cord, a fuse, a power switch, a switching power supply and a circuit switch; the circuit switch is provided with an air extraction button, an air intake button and an off button.

[0015] Furthermore, the connection assembly includes a quick-screw joint, a quick-screw joint tee, a connecting rod and an air pipe.

[0016] A sterilization box sealing performance sterility test method, using the sterilization box sealing performance sterility tester described above, comprises the following steps:

[0017] Step 1: Prepare for the test;

[0018] Step 2: Perform sealing performance sterility test;

[0019] Step 3: Perform sterility test;

[0020] The step 2 includes the following sub-steps:

[0021] Step 2-1: Turn on the vacuum button on the circuit switch, start the vacuum pump and the vacuum solenoid valve, and extract air from the sterilization box;

[0022] Step 2-2: When the pressure sensor detects that the pressure value reaches the preset limit, the vacuum pump and the exhaust solenoid valve are linked to stop working through the bistable trigger, and the timer starts counting the set time;

[0023] Step 2-3: Monitor the pressure value during the timing process, and read the pressure value detected by the pressure sensor at the end of the timing; if the vacuum state cannot be maintained within the set time, the actual vacuum maintenance time is recorded according to the timer data;

[0024] Step 2-4: Switch the air intake button on the circuit switch, start the timer to start timing a specific time, the air intake solenoid valve is started, and the air enters the sterilization box after being processed by the air filter. After the timing ends, the air intake solenoid valve is closed.

[0025] Furthermore, the step 3 includes the following sub-steps:

[0026] Step 3-1: Take out the air filter element in the negative pressure vacuum suction cup and put it into a sterile homogenizing bag or a sterile culture dish;

[0027] Step 3-2: Press the two ampoules of culture medium in the air filter element to break the two ampoules of culture medium and wet the air filter element;

[0028] Step 3-3: Incubate the moistened air filter element at room temperature for 24 to 48 hours, and observe and record any bacterial growth during this period.

[0029] Furthermore, the step 1 includes the following sub-steps:

[0030] Step 1-1: Prepare the necessary equipment;

[0031] Step 1-2: Use an ultraviolet germicidal lamp to irradiate the sterilization box sealing performance sterility tester and the sterilization box for disinfection;

[0032] Step 1-3: After the disinfection is completed, connect the negative pressure vacuum suction cup to the air pipe of the sterilization box sealing performance sterility tester, and fit the negative pressure vacuum suction cup to the filter valve port of the sterilization box;

[0033] Step 1-4: Connect the sterilization box sealing performance sterility tester to the power supply.

[0034] Furthermore, if multiple sets of sealing performance sterility tests are required, after each set of tests is completed, first switch the off button on the circuit switch, then press the PWM signal generator to reset the bistable trigger, and then repeat step 2.

[0035] The beneficial effects achieved by the present invention are:

[0036] Provided is a sterilization box sealing performance sterility tester and test method, by setting a bistable trigger, a negative pressure vacuum suction cup with an air filter element, and an air filter, etc., the circuit structure and the air path structure are optimized. Based on this, compared with the existing tester, the present invention avoids the miscontrol of the vacuum pump due to the frequent fluctuation of the pressure value, thereby maintaining the tester in a stable working state, thereby ensuring the accuracy of the test results and avoiding damage to the sealing performance of the sterilization box; it can achieve the filtration of contaminating bacteria that may exist in the air of the air path, thereby effectively avoiding the contamination of the sterilization box, thereby ensuring the sterility of the medical devices in the sterilization box. In addition, the present invention simplifies the operation process through the optimized assembly of basic accessories, while ensuring high performance, it also has the advantages of simple structure, easy operation, and economical. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 Schematic diagram of the overall structure of the sterility tester described in Example 1 of the present invention;

[0038] Figure 2 Schematic diagram of the gas path structure of the sterility tester described in Example 1 of the present invention;

[0039] Figure 3 Schematic diagram of the circuit structure of the sterility tester described in Example 1 of the present invention;

[0040] Figure 4 1 is a schematic diagram of the structure of the negative pressure vacuum suction cup in the sterility tester described in Example 1 of the present invention;

[0041] In the figure: 1. power cord; 2. fuse; 3. power switch; 4. switching power supply; 5. circuit switch; 6. bistable trigger; 7. vacuum pump; 8. exhaust solenoid valve; 9. pressure sensor; 10. PWM signal generator; 11. timer; 12. air intake solenoid valve; 13. quick-twist connector tee; 14. quick-twist connector; 15. negative pressure vacuum suction cup; 16. air filter; 17. chassis; 15-1. suction cup body; 15-2. quick-release interface; 15-3. air filter element; 15-4. ampoule culture medium. DETAILED DESCRIPTION

[0042] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the accompanying drawings in the embodiments of the present invention.

[0043] Example 1

[0044] The first aspect of this embodiment provides a sterilization box sealing performance sterility tester, please refer to Figures 1 to 3The sterility tester includes a chassis 17, and the chassis 17 is provided with a power supply component, a connection component, a (micro) vacuum pump 7, an exhaust solenoid valve 8, an air intake solenoid valve 12, a dual-voltage trigger, a pressure sensor 9, a PWM signal generator 10 and a timer 11 inside, and a negative pressure vacuum suction cup 15 and an air filter 16 outside the chassis 17. Among them, the power supply component includes a power cord 1, a fuse 2, a power switch 3, a switching power supply 4 and a circuit switch 5, and the circuit switch 5 is provided with an exhaust button, an air intake button and a closing button; the connection component includes a quick-twist connector 14, a quick-twist connector tee 13, a connecting rod and an air circuit pipe. The above structure can be divided according to the circuit structure and the air circuit structure, and there are the following connection methods:

[0045] In the circuit structure, the power line 1 is connected to the fuse 2 and the power switch 3, the power switch 3 is connected to the switching power supply 4; the switching power supply 4 is connected to the circuit switch 5, and the circuit switch 5 is electrically connected to the bistable trigger 6, the timer 11 and the intake solenoid valve 12 respectively; the signal output end of the bistable trigger 6 is electrically connected to the signal input end of the vacuum pump 7 and the exhaust solenoid valve 8 respectively; the switching power supply 4 is electrically connected to the pressure sensor 9, the PWM signal generator 10 and the timer 11 respectively, and the signal output ends of the pressure sensor 9 and the PWM signal generator 10 are electrically connected to the signal input ends of the bistable trigger 6 and the timer 11 respectively.

[0046] In the air circuit structure, the air extraction end of the vacuum pump 7 is connected to the air outlet end of the air extraction solenoid valve 8, and the air inlet end of the air extraction solenoid valve 8 is respectively connected to the pressure sensor 9, the branch air circuit I and the branch air circuit II through the quick-tightening joint tee 13; the branch air circuit I includes a negative pressure vacuum suction cup 15. In the present embodiment, two negative pressure vacuum suction cups 15 are provided (the number can be set according to actual conditions and can be adapted to the model structure of the sterilization box), and the two negative pressure vacuum suction cups 15 are respectively connected to the air extraction solenoid valve 8 through the quick-tightening joint 14, the quick-tightening joint tee 13, the connecting rod and the air circuit pipe; the branch air circuit II includes an air intake solenoid valve 12 and an air filter 16, and the air intake solenoid valve 12 and the air filter 16 are connected to the air circuit pipe through the quick-tightening joint 14.

[0047] Please refer to Figure 4 The negative pressure vacuum suction cup 15 includes a suction cup body 15-1 and a quick-release interface 15-2 located above the suction cup body 15-1. An air filter element 15-3 is provided at the center of the suction cup body 15-1. The air filter element 15-3 in this embodiment has a 0.45μm PTFE filter membrane; two ampoules of culture medium 15-4 are embedded in the air filter element 15-3, and the two ampoules of culture medium 15-4 are thioglycollate fluid culture medium and tryptic soy liquid culture medium respectively.

[0048] A second aspect of the present embodiment provides a sterilization box sealing performance sterility test method, using the sterilization box sealing performance sterility tester described above, comprising the following steps:

[0049] Step 1: Perform preparation work before testing.

[0050] The specific steps include the following:

[0051] Step 1-1: Prepare the necessary equipment, including power supply, sterilization box (containing medical devices), sterilization box sealing performance sterility tester, ultraviolet sterilization lamp, sterile homogenization bag (or other sterile portable culture dish), etc.

[0052] Step 1-2: Use an ultraviolet germicidal lamp with a radiation intensity value ≥ 70μW / cm2, place it 25cm to 60cm away from the surface of the sterilization box and the sterilization box sealing performance sterility tester, and irradiate for at least 20 minutes to disinfect the surface of the items.

[0053] Step 1-3: After disinfection is completed, remove the tube cap and plug at the tracheal tip end of the sterilization box sealing performance sterility tester, and open the negative pressure vacuum suction cup 15 under the sterile packaging (PETG blister box or dialysis bag), connect the quick-release interface 15-2 on the negative pressure vacuum suction cup 15 to the trachea of ​​the sterilization box sealing performance sterility tester, and fit the negative pressure vacuum suction cup 15 to the filter valve port of the sterilization box.

[0054] Among them, the commonly used sterilization boxes on the market are 1 / 1 model, 1 / 2 model and 3 / 4 model. For 1 / 2 model and 3 / 4 model, it is only necessary to completely cover one filter valve port of the sterilization box with the negative pressure vacuum suction cup 15, and then press downward lightly to make the negative pressure vacuum suction cup 15 fit completely with the edge of the filter valve port; for 1 / 1 model, two negative pressure vacuum suction cups 15 are required to cover the two filter valve ports of the sterilization box respectively.

[0055] Step 1-4: Connect the sterilization box sealing performance sterility tester to the power supply.

[0056] Step 2: Perform a seal performance sterility test.

[0057] The specific steps include the following:

[0058] Step 2-1: Turn on the vacuum button on the circuit switch 5, start the vacuum pump 7 and the vacuum solenoid valve 8, and extract air from the sterilization box.

[0059] Step 2-2: When the pressure sensor 9 detects that the pressure value reaches the preset limit, the vacuum pump 7 and the exhaust solenoid valve 8 are stopped through the bistable trigger 6, and the timer 11 starts timing the set time; in this embodiment, the preset limit is set to -6kpa and the set time is set to 10min.

[0060] Step 2-3: Monitor the pressure value during the timing process and read the pressure value detected by the pressure sensor 9 at the end of the timing; if the negative pressure state cannot be maintained within the set time, the actual vacuum maintenance time is recorded according to the data of the timer 11.

[0061] Among them, the main purpose of the sealing performance sterility test is to determine the function of the sterilization box to maintain the negative pressure state; in the actual test process, the negative pressure may be maintained or weakened due to leakage. If it is maintained, it means that the sealing performance of the sterilization box is good, and if it is weakened, it means that the sealing performance of the sterilization box does not meet the standard; if the negative pressure is maintained, the pressure value read at the end of the timing is the preset limit (or within the allowable fluctuation range). If it weakens, the pressure value will gradually increase to approach the atmospheric pressure value, and the pressure value read at the end of the timing is significantly different from the preset limit. If the sealing performance of the sterilization box does not meet the standard, the possible source of leakage is analyzed based on the actual vacuum maintenance time recorded, combined with other relevant factors such as the degree of consumption of spare parts, and timely countermeasures are taken after finding the potential source of leakage (on-site repair or return to the factory for repair, etc.).

[0062] Step 2-4: Switch the air intake button on the circuit switch 5, start the timer 11 to start timing a specific time, start the air intake solenoid valve 12, and the air enters the sterilization box after being processed by the air filter 16 to balance the pressure. After the timing ends, the air intake solenoid valve 12 is closed; in this embodiment, the specific time is set to 10s.

[0063] If multiple sets of sealing performance sterility tests are required, after each set of tests is completed, the off button on the circuit switch 5 is first switched, and then the PWM signal generator 10 is pressed to reset the bistable trigger 6, and then step 2 is repeated.

[0064] Step 2-5: Turn off the power supply, separate the negative pressure vacuum suction cup 15 from the filter valve port of the sterilization box, and use a pipe cap and a pipe plug to seal the tracheal head end on the sterilization box sealing performance sterility tester.

[0065] Step 3: Perform sterility test.

[0066] The specific steps include the following:

[0067] Step 3-1: Take out the air filter element 15-3 in the negative pressure vacuum suction cup 15 and put it into a sterile homogenizing bag (or other sterile portable culture dish).

[0068] Step 3-2: Press the two ampoules of culture medium 15-4 in the air filter element 15-3 to break the two ampoules of culture medium 15-4 and wet the PTFE filter membrane on the air filter element 15-3.

[0069] Step 3-3: Incubate the moistened air filter element 15-3 at room temperature for 24 to 48 hours, and observe and record whether there is bacterial growth during this period.

[0070] In summary, the sterilization box sealing performance sterility tester and test method provided in this embodiment have optimized the circuit structure and the air path structure, and provided a sterility testing method. Compared with the prior art, on the one hand, it avoids the miscontrol of the vacuum pump 7 due to the frequent fluctuations in the pressure value, thereby maintaining the tester in a stable working state, thereby ensuring the accuracy of the test results and avoiding damage to the sealing performance of the sterilization box; on the other hand, it can realize the filtration of contaminated bacteria that may exist in the air in the air path, thereby effectively avoiding contamination of the sterilization box, thereby ensuring the sterility of the medical devices in the sterilization box.

[0071] It should be noted that the parts not described in detail or expanded in the above scheme are all existing technologies, which do not belong to the improvements made by the present invention on the existing technologies, nor do they belong to the protection scope of the technical scheme of the present invention. Therefore, they will not be described in detail in this article.

[0072] Of course, the above contents are only preferred embodiments of the present invention and cannot be considered to limit the scope of the embodiments of the present invention. The present invention is not limited to the above examples, and equal changes and improvements made by ordinary technicians in the technical field within the essential scope of the present invention should all fall within the scope of the patent coverage of the present invention.

Claims

1. A sterilization box sealing performance sterility tester, characterized by: The invention comprises a case (17), wherein the case (17) is provided with a power supply component, a connection component, a vacuum pump (7), an exhaust solenoid valve (8), an air intake solenoid valve (12), a bistable trigger, a pressure sensor (9) and a timer (11), and the case (17) is provided with a negative pressure vacuum suction cup (15) and an air filter (16) outside; the signal output end of the pressure sensor (9) is electrically connected to the signal input end of the bistable trigger (6) and the timer (11), respectively, and the signal output end of the bistable trigger (6) is electrically connected to the signal input end of the vacuum pump (7) and the exhaust solenoid valve (8), respectively; the exhaust end of the vacuum pump (7) is connected to the exhaust end of the exhaust solenoid valve (8), and the exhaust end of the exhaust solenoid valve (8) is connected to the branch air path I and the branch air path II; the branch air path I comprises a negative pressure vacuum suction cup (15) with an air filter element (15-3), and the branch air path II comprises the air intake solenoid valve (12) and the air filter (16).

2. The sterilization box sealing performance sterility tester according to claim 1, characterized in that: The negative pressure vacuum suction cup (15) comprises a suction cup body (15-1) and a quick-install interface (15-2), and an air filter element (15-3) is provided at the center of the suction cup body (15-1).

3. The sterilization box sealing performance sterility tester according to claim 2, characterized in that: Two ampoule culture media (15-4) are embedded in the air filter element (15-3), and the two ampoule culture media (15-4) are thioglycollate fluid culture medium and trypticase soytone liquid culture medium respectively.

4. The sterilization box sealing performance sterility tester according to claim 1, characterized in that: A PWM signal generator (10) is also provided inside the chassis (17), and a signal output end of the PWM signal generator (10) is electrically connected to a signal input end of the bistable trigger (6).

5. The sterilization box sealing performance sterility tester according to claim 1, characterized in that: The power supply assembly comprises a power line (v1), a fuse (2), a power switch (3), a switching power supply (4) and a circuit switch (5); the circuit switch (5) is provided with an air extraction button, an air intake button and an off button.

6. The sterilization box sealing performance sterility tester according to claim 1, characterized in that: The connection assembly comprises a quick-twist joint (14), a quick-twist joint tee (13), a connecting rod and an air pipe.

7. A sterilization box sealing performance sterility test method, using the sterilization box sealing performance sterility tester according to any one of claims 1 to 6, characterized in that: The steps include: Step 1: Prepare for the test; Step 2: Perform sealing performance sterility test; Step 3: Perform sterility test; The step 2 includes the following sub-steps: Step 2-1: Turn on the vacuum button on the circuit switch (5), start the vacuum pump (7) and the vacuum solenoid valve (8), and extract air from the sterilization box; Step 2-2: When the pressure sensor (9) detects that the pressure value reaches a preset limit, the vacuum pump (7) and the exhaust solenoid valve (8) are linked to stop working through the bistable trigger (6), and the timer (11) starts counting the set time; Step 2-3: monitor the pressure value during the timing process, and read the pressure value detected by the pressure sensor (9) at the end of the timing; if the negative pressure state cannot be maintained within the set time of the timing, record the actual time of maintaining the vacuum according to the data of the timer (11); Step 2-4: Switch the air intake button on the circuit switch (5), start the timer (11) to start timing, start the air intake solenoid valve (12), and the air enters the sterilization box after being processed by the air filter (16). After the timing ends, the air intake solenoid valve (12) is closed.

8. The method for testing the sealing performance of a sterilization box according to claim 7, characterized in that: The step 3 includes the following sub-steps: Step 3-1: Take out the air filter element (15-3) in the negative pressure vacuum suction cup (15), and put it into a sterile homogenizing bag or a sterile culture dish; Step 3-2: Press the two ampoules of culture medium (15-4) in the air filter element (15-3) to break the two ampoules of culture medium (15-4) and wet the air filter element (15-3); Step 3-3: Incubate the moistened air filter element (15-3) at room temperature for 24 to 48 hours, and observe and record whether there is bacterial growth during this period.

9. The sterilization box sealing performance sterility test method according to claim 7, characterized in that: The step 1 includes the following sub-steps: Step 1-1: Prepare the necessary equipment; Step 1-2: Use an ultraviolet germicidal lamp to irradiate the sterilization box sealing performance sterility tester and the sterilization box for disinfection; Step 1-3: After the disinfection is completed, the negative pressure vacuum suction cup (15) is connected to the air pipe of the sterilization box sealing performance sterility tester, and the negative pressure vacuum suction cup (15) is attached to the filter valve port of the sterilization box; Step 1-4: Connect the sterilization box sealing performance sterility tester to the power supply.

10. The method for testing the sealing performance of a sterilization box according to claim 7, characterized in that: If multiple sets of sealing performance sterility tests are required, after each set of tests is completed, first switch the off button on the circuit switch (5), then press the PWM signal generator (10) to reset the bistable trigger (6), and then repeat step 2.

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