Disposable system integrity tester

Abstract

The utility model relates to a disposable system integrity tester which comprises a base with the top in an opening shape and a top cover arranged on the base, the base and the top cover are mutually covered, one side of the base is provided with a short-edge opening penetrating through the top opening, and the side, away from the base, of the top cover is provided with a screen seat. A display is arranged on the screen seat, a PLC module group used for realizing logic control, signal input and output, data processing and other functions in the automatic control system is arranged in the base, a power interface is arranged on one side, far away from the short edge opening, of the base, is used for being connected with a power supply and is electrically connected with the PLC module group, and the PLC module group is electrically connected with the base. A power switch is arranged on the top cover in a penetrating mode and electrically connected with the PLC module set. The method has the effect of high measurement precision.

Description

Technical Field

[0001] The present application relates to the technical field of integrity testing, and in particular to a disposable system integrity tester. Background Art

[0002] Integrity testers are often used to test the performance of seals, sealing materials or sealing systems to ensure they have good sealing integrity under specific conditions.

[0003] Among them, a disposable bioprocess bag may be damaged during the manufacturing process, transportation or operation. Before use, the disposable bioprocess bag needs to be tested for integrity, which can achieve "early detection of problems" and reduce the risk of product scrapping. Before disposal after use, the disposable bioprocess bag is tested for integrity to confirm the integrity of the disposable bioprocess bag during the entire production process to support product release. Therefore, a tester is needed for integrity testing of flexible containers such as liquid storage bags and reaction bags (collectively referred to as disposable bioprocess bags) used in the fields of biomedicine and cell therapy.

[0004] Furthermore, temperature has an effect on the gas pressure value inside the single-use bioprocessing bag to be tested. According to the ideal gas state equation (PV = nRT), at a fixed mass and volume of the substance, an increase in temperature (T) will lead to an increase in pressure (P). This means that at higher temperatures, the gas pressure in the bag will increase, while at lower temperatures it will decrease.

[0005] The integrity tester in the related art, such as the invention patent with the authorization publication number CN101983324A, involves an apparatus and method for testing the integrity of a flexible container, including a flexible container to be tested, a second container, a second inner chamber for detecting gas, and a valve for controlling the flow of the detectable gas to the flexible container. During the test, the detectable gas is delivered to the second container, the second container is attached to the first flexible container, the valve is opened to deliver the detectable gas from the second container to the flexible container, and after waiting for a period of time, the bag is immersed in water to measure the volume difference, thereby checking the leakage of the flexible container and judging the integrity of the flexible container.

[0006] However, the integrity tester in the related art does not take into account the influence of temperature on the test results, and is unable to intuitively measure and observe the leakage, resulting in low detection accuracy. Utility Model Content

[0007] In order to improve the existing problem of not considering the impact of temperature on test results, being unable to intuitively measure and observe leakage conditions, and resulting in low detection accuracy, the present application provides a disposable system integrity tester that can measure temperature in real time, intuitively measure and observe leakage conditions, and achieve high detection accuracy.

[0008] The present application provides a one-time system integrity tester that adopts the following technical solution:

[0009] A disposable system integrity tester, comprising a base with an opening at the top and a top cover arranged on the base, wherein the base and the top cover cover each other, and characterized in that: a short side opening penetrating the top opening is opened on one side of the base, a screen holder is arranged on the side of the top cover away from the base, a display is arranged on the screen holder, a PLC module group for realizing logic control, signal input and output and data processing functions in an automatic control system is arranged in the base, a power interface is arranged on the side of the base away from the short side opening, the power interface is used to connect a power source, the power interface is electrically connected to the PLC module group, a power switch is passed through the top cover, and the power switch is electrically connected to the PLC module group;

[0010] An air access pipe is provided on one side of the base close to the power interface, and one end of the air access pipe extending into the base is connected to a shunt pipe, and the shunt pipe includes a shunt inlet and two shunt outlets, and the air access pipe is connected to the shunt inlet, and one end of the air access pipe located outside the base is connected to an external compressed air source, and a detection mechanism for boosting, stabilizing, reducing and measuring the pressure of the disposable bioprocess bag is provided in the base, and the detection mechanism includes a detection component for detecting the pressure in the disposable bioprocess bag and the ambient temperature;

[0011] The detection component includes a bracket arranged in the base, a pressure sensor arranged on the bracket, and a temperature sensor penetrated on the base. The pressure sensor is arranged on the bracket, the pressure sensor is electrically connected to the PLC module group, and a curve chart of the relationship between time and air pressure is formed on the display through the PLC module group. The base is provided with a pressure detection interface near the test interface, and the end of the pressure detection interface facing the inside of the base is connected to the monitoring end of the pressure sensor. The end of the pressure detection interface facing outward is provided with a pressure detection tube, and the end of the pressure detection tube away from the pressure detection interface extends into the disposable bioprocess bag, and the pressure detection tube is sealed and connected to the disposable bioprocess bag. The temperature sensor is used to detect the current ambient temperature in real time, the detection end of the temperature sensor faces outside the base, and the temperature sensor is electrically connected to the PLC module group.

[0012] By adopting the above technical solution, when preparing for detection, the power interface is connected to the power supply to power the PLC module group, and the PLC module group and the display can be started to work by turning on the power switch. The detection mechanism is sealed and connected to the disposable bioprocess bag, and the temperature sensor detects the preparation temperature of the environment.

[0013] During the detection, the detection mechanism uses compressed air to inflate and deflate the disposable bioprocess bag, thereby increasing, stabilizing and reducing the pressure of the disposable bioprocess bag. The pressure sensor detects the air pressure in the disposable bioprocess bag in real time, and forms a curve chart of the relationship between time and air pressure on the display through the PLC module group, so as to observe whether the disposable bioprocess bag is complete. When the pressure difference exceeds the preset range, it means that there is leakage in the bag. When the pressure difference is within the preset range, it means that the disposable bioprocess bag is complete. In this way, holes that cannot be observed by the naked eye can be measured, making the measurement accuracy high.

[0014] The depressurization temperature is detected by a temperature sensor. By judging whether the temperature change difference between the preparation temperature and the depressurization temperature exceeds the allowed range, it is determined whether the depressurization loss value obtained after the pressure increase, voltage stabilization and pressure reduction operations is credible, thereby preventing the temperature from affecting the air pressure value in the disposable bioprocess bag to be detected.

[0015] When the temperature change before and after the test exceeds the allowed change value, the pressure loss value is used to determine whether the disposable bioprocess bag is intact; when the temperature change before and after the test exceeds the allowed change value, the authenticity of the pressure loss value cannot be guaranteed. By extending the pressure stabilization time to ensure that the temperature change difference between the temperature during pressure reduction and the temperature during pressure stabilization is within the preset temperature difference range, the impact of temperature on the test results is reduced and the accuracy of the test results is improved. Thus, by measuring the temperature in real time, the leakage situation can be intuitively measured and observed, making the detection accuracy higher.

[0016] Preferably, the detection mechanism is provided in two groups, and the two diversion outlets are respectively connected to the two groups of detection mechanisms.

[0017] By adopting the above technical solution, the two diversion outlets are respectively connected to the two groups of detection mechanisms to provide compressed gas for the two groups of detection mechanisms, and the two groups of detection mechanisms are conducive to simultaneously detecting two disposable bioprocess bags, so that two or two different specifications of bioprocess bags can be detected at one time, thereby improving the detection efficiency.

[0018] Preferably, the pressure range / precision of the pressure sensor is 0.1% FS, the range of the temperature sensor is 0-200°C, and the measurement accuracy is Class A.

[0019] By adopting the above technical solution, a very accurate pressure measurement result can be provided with a range / accuracy of 0.1%FS, which is beneficial to application scenarios with high pressure measurement requirements. The temperature sensor with a range of 0-200°C and a measurement accuracy of Class A has the advantages of high accuracy, strong reliability, wide application range and helps to improve production efficiency, which is beneficial to application scenarios that require high-precision temperature measurement.

[0020] Preferably, the base is provided with convex wings on two opposite sides, the convex wings are inclined, and the convex wings are inclined upward from close to the short side opening to away from the short side opening. The screen seat is also inclined, and the inclination direction of the screen seat is consistent with that of the convex wings.

[0021] By adopting the above technical solution, the display end of the display is inclined to facilitate operation and observation by staff.

[0022] Preferably, the detection mechanism further comprises an inflation assembly for inflating the disposable bioprocess bag.

[0023] The inflation component includes an inflation pressure regulating valve arranged in the base, a pipeline solenoid valve connected to one end of the inflation pressure regulating valve, and an air replenishment solenoid valve connected to the other end of the inflation pressure regulating valve, the inflation pressure regulating valve includes an inflation inlet, an inflation outlet and an air replenishment outlet, the shunt outlet of the shunt pipe is connected to the inflation inlet of the inflation pressure regulating valve, an electromagnetic valve seat is arranged in the base, the pipeline solenoid valve is arranged on the electromagnetic valve seat, one end of the pipeline solenoid valve is connected to the inflation outlet of the inflation pressure regulating valve, the air replenishment solenoid valve is arranged in the electromagnetic valve seat, and the air replenishment solenoid valve and The pipeline solenoid valves are arranged along the height direction of the base, one end of the air supply solenoid valve is connected to the air supply outlet of the inflation pressure regulating valve, the other end of the pipeline solenoid valve is connected to a three-way pipe and connected to the first end of the three-way pipe, the second end of the three-way pipe is connected to the other end of the air supply solenoid valve, the base is provided with a test interface near the gas inlet, the third end of the three-way pipe is connected to the test interface, the other end of the test interface is connected to an air output pipe, the other end of the air output pipe extends into a disposable bioprocess bag, and the air output pipe is sealed and connected to the disposable bioprocess bag.

[0024] By adopting the above technical solution, during inflation, the compressed air is transported to the shunt pipe through the air access pipe, and enters the inflation pressure regulating valve through the shunt outlet of the shunt pipe. The pressure of the compressed air is adjusted by the inflation pressure regulating valve and transported to the pipeline solenoid valve and the air supply solenoid valve. The flow rate of compressed gas inflation is adjusted by the pipeline solenoid valve, and the inflation flow rate is adjusted by the air supply solenoid valve in cooperation with the pipeline solenoid valve. The air transported by the pipeline solenoid valve and the air supply solenoid valve is gathered in the air output pipe through the three-way pipe, and transported to the disposable bioprocess bag through the air output pipe, so as to achieve inflation. Then, the disposable bioprocess bag is pressure tested by the detection component.

[0025] Preferably, the inflation pressure regulating valve, pipeline solenoid valve and air supply solenoid valve are all electrically connected to the PLC module group.

[0026] By adopting the above technical solution, the inflation process can be controlled through the PLC module group, and the disposable bioprocess bag can be boosted, stabilized and reduced to obtain the pressure loss value, so as to judge whether the disposable bioprocess bag is complete. The pipeline solenoid valve and the air supply solenoid valve can achieve more flexible and accurate inflation control through the PLC module group to improve the accuracy, stability and controllability of inflation.

[0027] Preferably, the detection mechanism also includes a deflation component for deflation of the disposable bioprocess bag, the deflation component includes a deflation valve arranged in the base and a vacuum generator connected to the deflation valve, the deflation valve is used to control and release the pressure in the disposable bioprocess bag, one end of the deflation valve is connected to the vacuum generator, the base is provided with a deflation interface near the temperature sensor, the other end of the vacuum generator is connected to the deflation interface, the other end of the deflation interface is provided with a deflation pipe, the other end of the deflation pipe extends into the disposable bioprocess bag, and the deflation pipe is sealed and connected to the disposable bioprocess bag.

[0028] By adopting the above technical solution, when deflation occurs, the gas in the disposable bioprocess bag is extracted through the vacuum generator and discharged through the deflation valve, so that active exhaust can be performed to quickly discharge the residual gas in the bioprocess bag. By combining the deflation valve and the vacuum generator, the gas in the bag can be more effectively extracted, which is conducive to completing the deflation work more efficiently.

[0029] Preferably, a heat dissipation hole is opened on the long side of the base, and the heat dissipation hole passes through the base. There are multiple heat dissipation holes, and the multiple heat dissipation holes are divided into two groups. The two groups of heat dissipation holes are respectively opened on two opposite sides of the base, and the multiple heat dissipation holes in one group are arranged in an array.

[0030] By adopting the above technical solution, when the gas discharged from the air release valve enters the base, it undergoes heat exchange through the PLC module group, the inflation pressure regulating valve, the air replenishment battery valve, the pipeline solenoid valve and other equipment, and is discharged from the heat dissipation holes, thereby dissipating the heat of the equipment in the base and maintaining normal operation of the equipment.

[0031] Preferably, a barcode is provided on the disposable bioprocess bag, and the barcode is used to record the test formula of the disposable bioprocess bag of the current model and specification. The base is also provided with a barcode scanning gun interface for connecting a barcode scanning gun near the power interface, and the barcode scanning gun interface is electrically connected to the PLC module group.

[0032] By adopting the above technical solution, the barcode of the disposable bioprocess bag can be scanned by connecting the barcode scanner to the barcode scanner interface, so as to quickly obtain the required test formula and perform the test.

[0033] Preferably, a printer is also provided in the base, the discharge end of the printer extends out of the top cover, the printer is electrically connected to the PLC module group, and a USB interface is also provided on the base near the power interface, and the USB interface is electrically connected to the PLC module group.

[0034] By adopting the above technical solution, when the test is completed, the test report can be printed through a printer, or the storage device can be connected through a USB interface to export the corresponding test report, so as to mark the disposable bioprocess bag.

[0035] In summary, the present application includes at least one of the following beneficial technical effects:

[0036] 1. When the temperature change before and after the test exceeds the allowable change value, the integrity of the disposable bioprocess bag is judged by the pressure drop loss value; when the temperature change before and after the test exceeds the allowable change value, the authenticity of the pressure drop loss value cannot be guaranteed. By extending the pressure stabilization time to ensure that the temperature change difference between the temperature during pressure drop and the temperature during pressure stabilization is within the preset temperature difference range, the influence of temperature on the test results is reduced, and the accuracy of the test results is improved. Thus, by measuring the temperature in real time, the leakage situation can be intuitively measured and observed, making the detection accuracy higher;

[0037] 2. During the detection, the detection mechanism uses compressed air to inflate and deflate the disposable bioprocess bag, thereby increasing, stabilizing and reducing the pressure of the disposable bioprocess bag. The pressure sensor detects the air pressure in the disposable bioprocess bag in real time, and forms a curve chart of the relationship between time and air pressure on the display through the PLC module group, so as to observe whether the disposable bioprocess bag is complete. When the pressure difference exceeds the preset range, it means that there is leakage in the bag. When the pressure difference is within the preset range, it means that the disposable bioprocess bag is complete. In this way, holes that cannot be observed by the naked eye can be measured, making the measurement accuracy high. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 It is a schematic diagram of the overall structure of an embodiment of the present application.

[0039] Figure 2 It is a schematic diagram of the disposable bioprocess bag during testing in the embodiment of the present application.

[0040] Figure 3 It is a schematic diagram of the overall structure inside the bottom shell in the embodiment of the present application.

[0041] Figure 4 It is a schematic diagram of the structure of the inflatable component in the bottom shell in the embodiment of the present application.

[0042] Figure 5 yes Figure 4 Enlarged view of point A in the middle.

[0043] Figure 6 It is a rear view of the embodiment of the present application when the bottom shell and the top cover are covered.

[0044] Figure 7 yes Figure 4 Enlarged view of point B in the middle.

[0045] Explanation of the reference numerals: 1. base; 2. top cover; 3. display; 4. foot pad; 5. short side opening; 6. convex wing; 7. screen base; 8. PLC module group; 9. power interface; 10. power switch; 11. gas access port; 12. disposable bioprocess bag; 13. inflation pressure regulating valve; 14. pipeline solenoid valve; 15. air supply solenoid valve; 16. solenoid valve seat; 17. installation cavity; 18. test interface; 19. air output pipe; 20. bracket; 21. pressure sensor; 22. temperature sensor; 23. pressure detection interface; 24. pressure detection tube; 25. air relief valve; 26. vacuum generator; 27. air relief interface; 28. air relief pipe; 29. ​​heat dissipation hole; 30. barcode scanner interface; 31. printer. DETAILED DESCRIPTION

[0046] The following is combined with Figure 1-7 This application is described in further detail.

[0047] A disposable system integrity tester, referring to Figure 1 , including a base 1 with an opening at the top, a top cover 2 arranged on the base 1 and a display 3 arranged on the top cover 2.

[0048] Among them, refer to Figure 1 or Figure 2 The base 1 is arranged in a rectangular parallelepiped shape, and a foot pad 4 is arranged on the side of the base 1 away from the top opening. There are four foot pads 4, and the four foot pads 4 are respectively close to the four corners of the base 1. The foot pads 4 can increase the friction between the base 1 and the ground, which helps to prevent the base 1 from sliding or tilting during use, and maintain the balance and stability of the product.

[0049] Reference Figure 1 or Figure 3 One of the short sides of the base 1 is provided with a short side opening 5 that passes through the top opening. The top cover 2 is used to open or close the top opening and the short side opening 5 of the base 1. The top cover 2 and the base 1 cover each other, and the top cover 2 and the base 1 are connected by bolts. The two opposite long sides of the base 1 are provided with convex wings 6, which are inclined. The convex wings 6 are inclined upward from the direction close to the short side opening 5 to the direction away from the short side opening 5, so that when the top cover 2 is closed on the base 1, the top cover 2 is inclined.

[0050] Reference Figure 1 or Figure 2A screen holder 7 is provided on the side of the top cover 2 away from the base 1. The screen holder 7 is used to mount the display 3. The screen holder 7 is also tilted, and the tilt direction of the screen holder 7 is consistent with that of the convex wing 6. The display 3 is a 10-inch large industrial-grade color touch screen in the prior art, which makes the operation more comfortable and smooth. The display 3 is arranged in a rectangular shape, and the display 3 is distributed along the width direction of the base 1. The display 3 is arranged on the screen holder 7, so that the display end of the display 3 is tilted, so as to facilitate the operation and observation of the staff.

[0051] Reference Figure 2 or Figure 3 A PLC module group 8 is arranged in the base 1. The PLC module group 8 includes an input module, an output module and a central processing unit (CPU), etc., which are used to realize the functions of logic control, signal input and output and data processing in the automatic control system. The PLC module group 8 is a relatively mature technology in the prior art and will not be described in detail. The PLC module group 8 is electrically connected to the display 3. A power interface 9 is arranged on the side of the base 1 away from the short side opening 5. The power interface 9 is used to connect the power supply. The power interface 9 is electrically connected to the PLC module group 8 to power the PLC module group 8. A power switch 10 is provided on the top cover 2. The power switch 10 is electrically connected to the PLC module group 8, so that by starting the power switch 10, the PLC module group 8 and the display 3 can be started to work.

[0052] Reference Figure 3 or Figure 4 A gas access port 11 is provided on one side of the base 1 close to the power interface 9, and the gas access port 11 is close to the top side of the power interface 9. An air access pipe (not shown in the figure) is passed through the gas access port 11, and both ends of the air access pipe extend out of the gas access port 11, and the air access pipe is used to access compressed air. A shunt pipe (not shown in the figure) is connected to one end of the air access pipe extending into the base 1, and the shunt pipe includes a shunt inlet and two shunt outlets, and the air access pipe is connected to the shunt inlet. One end of the air access pipe located outside the base 1 is connected to an external compressed air source.

[0053] The base 1 is provided with a detection mechanism for boosting, stabilizing, reducing and measuring the pressure of the disposable bioprocess bag 12. Two groups of detection mechanisms are provided, and the two diversion outlets are respectively connected to the two groups of detection mechanisms to provide compressed gas for the two groups of detection mechanisms. The two groups of detection mechanisms are conducive to detecting two disposable bioprocess bags 12 at the same time, so that two or two different specifications of bioprocess bags can be detected at one time, thereby improving the detection efficiency.

[0054] Specifically, the detection mechanism includes an inflation component for inflating the disposable bioprocess bag 12, a detection component for detecting the pressure inside the disposable bioprocess bag 12 and the ambient temperature, and a deflation component for deflation of the disposable bioprocess bag 12. The inflation components in the two detection mechanisms are arranged side by side along the width direction of the base 1, and the detection components and deflation components in the two detection mechanisms are arranged side by side along the length direction of the base 1.

[0055] Reference Figure 3 or Figure 4 The inflation component includes an inflation pressure regulating valve 13 disposed in the base 1, a pipeline solenoid valve 14 connected to one end of the inflation pressure regulating valve 13, and an air replenishing solenoid valve 15 connected to the other end of the inflation pressure regulating valve 13. The inflation pressure regulating valve 13 is close to one long side of the base 1 and close to the short side opening 5. The inflation pressure regulating valve 13 is used to control the air pressure during the inflation process so that the air pressure during the inflation process remains stable. The inflation pressure regulating valve 13 includes an inflation inlet, an inflation outlet, and an air replenishing outlet. The shunt outlet of the shunt pipe is connected to the inflation inlet of the inflation pressure regulating valve 13. An electromagnetic valve seat 16 is disposed in the base 1, and the pipeline solenoid valve 14 is disposed on the top side of the electromagnetic valve seat 16. One end of the pipeline solenoid valve 14 is connected to the inflation outlet of the inflation pressure regulating valve 13. The pipeline solenoid valve 14 is used to turn on and off compressed gas or adjust the flow of compressed gas. A square installation cavity 17 is provided in the solenoid valve seat 16, and the installation cavity 17 penetrates the solenoid valve seat 16 along the length direction of the base 1. The air supply solenoid valve 15 is arranged in the installation cavity 17, and the air supply solenoid valve 15 and the pipeline solenoid valve 14 are arranged along the height direction of the base 1. One end of the air supply solenoid valve 15 is connected to the air supply outlet of the inflation pressure regulating valve 13, and the air supply solenoid valve 15 is used to cooperate with the pipeline solenoid valve 14 to adjust the inflation flow.

[0056] The inflation pressure regulating valve 13, the pipeline solenoid valve 14 and the air supply solenoid valve 15 are all electrically connected to the PLC module group 8, so that the inflation process can be controlled by the PLC module group 8, and the disposable bioprocess bag 12 can be boosted and stabilized. The pipeline solenoid valve 14 and the air supply solenoid valve 15 can achieve more flexible and precise inflation control through the PLC module group 8 to improve the accuracy, stability and controllability of inflation.

[0057] The other end of the pipeline solenoid valve 14 is connected to a three-way pipe (not shown in the figure) and is connected to the first end of the three-way pipe, and the second end of the three-way pipe is connected to the other end of the gas replenishment solenoid valve 15. Figure 5 or Figure 6 The base 1 is provided with a test interface 18 near the gas inlet 11, and the third end of the three-way pipe is connected to the test interface 18. Figure 2The other end of the test interface 18 is connected to an air output tube 19, and the other end of the air output tube 19 extends into the disposable bioprocess bag 12. The air output tube 19 is sealed and connected to the disposable bioprocess bag 12 to prevent leakage of gas input into the disposable bioprocess bag 12.

[0058] During inflation, the compressed air is transported to the shunt pipe through the air access pipe, and enters the inflation pressure regulating valve 13 through the shunt outlet of the shunt pipe. The pressure of the compressed air is adjusted by the inflation pressure regulating valve 13 and the compressed air is transported to the pipeline solenoid valve 14 and the air supply solenoid valve 15. The flow rate of compressed gas inflation is adjusted by the pipeline solenoid valve 14, and the inflation flow rate is adjusted by cooperating with the pipeline solenoid valve 14 through the air supply solenoid valve 15. The air transported by the pipeline solenoid valve 14 and the air supply solenoid valve 15 is gathered in the air output pipe 19 through the three-way pipe, and is transported to the disposable bioprocess bag 12 through the air output pipe 19 to achieve inflation. Then, the disposable bioprocess bag 12 is pressure-tested by the detection component.

[0059] Specifically, refer to Figure 3 or Figure 4 The detection assembly includes a bracket 20 disposed in the base 1, a pressure sensor 21 disposed on the bracket 20, and a temperature sensor 22 disposed on the base 1. The bracket 20 is close to a long side of the base 1 and the PLC module group 8, and the bracket 20 is close to a short side of the base 1.

[0060] Reference Figure 3 or Figure 4 The pressure sensor 21 is arranged on the bracket 20. In this embodiment, the pressure range / precision of the pressure sensor 21 is 0.1% FS. The pressure sensor 21 is arranged in a long strip shape. The pressure sensor 21 is distributed along the width direction of the base 1. The pressure sensor 21 is electrically connected to the PLC module group 8, so that the PLC module group 8 receives the detection data of the pressure sensor 21, and forms a relationship curve graph between time and air pressure (pressure change curve graph) on the display 3 through the PLC module group 8, so as to observe whether the disposable bioprocess bag 12 has integrity. When the pressure difference exceeds the preset range, it indicates that there is leakage in the bag. When the pressure difference is within the preset range, it indicates that the disposable bioprocess bag is intact. In this way, holes that cannot be observed by the naked eye can be measured, so that the measurement accuracy is high.

[0061] Reference Figure 5 or Figure 6The base 1 is provided with a pressure detection interface 23 near the test interface 18, and one end of the pressure detection interface 23 facing the inside of the base 1 is connected to the monitoring end of the pressure sensor 21. A pressure detection tube 24 is provided at one end of the pressure detection interface 23 facing outward, and one end of the pressure detection tube 24 away from the pressure detection interface 23 extends into the disposable bioprocess bag 12, and the pressure detection tube 24 is sealed and connected to the disposable bioprocess bag 12, so that the pressure detection tube 24 serves as an extension of the pressure sensor 21, so as to realize the real-time monitoring of the gas pressure in the disposable bioprocess bag.

[0062] Reference Figure 6 or Figure 7 The temperature sensor 22 is arranged on a short side of the base 1. The temperature sensor 22 is used to detect the current ambient temperature in real time. The temperature sensor 22 in this embodiment has a range of 0-200°C and a measurement accuracy of Class A. The detection end of the temperature sensor 22 faces the outside of the base 1. The temperature sensor 22 is electrically connected to the PLC module group 8, so that the ambient temperature is measured by the temperature sensor 22, and the temperature information is received by the PLC module group 8, and the temperature information is displayed on the display 3 by the PLC module group 8.

[0063] When preparing for detection, the temperature sensor 22 detects the preparation temperature of the environment. During detection, the gas in the disposable bioprocess bag 12 is transmitted to the pressure sensor 21 through the pressure detection tube 24, so that the air pressure in the disposable bioprocess bag 12 is detected in real time. The design is conducive to avoiding the direct placement of the sensor in the bag, thereby reducing the occupation of the space in the bag, and also facilitating the installation and maintenance of the sensor. The disposable bioprocess bag 12 is boosted and stabilized through the air output tube 19, and the gas in the disposable bioprocess bag 12 is deflated (depressurized) through the deflation component. The temperature sensor 22 detects the depressurization temperature. By judging whether the temperature change difference between the preparation temperature and the depressurization temperature exceeds the allowed range, it is determined whether the depressurization loss value obtained after the boost, stabilization and depressurization operations is credible, so as to prevent the temperature from affecting the air pressure value in the disposable bioprocess bag 12 to be detected.

[0064] When the temperature change before and after the detection work exceeds the allowable change value, the integrity of the disposable bioprocess bag 12 is judged by the pressure drop loss value; when the temperature change before and after the detection work exceeds the allowable change value, the authenticity of the pressure drop loss value cannot be guaranteed. By extending the pressure stabilization time to ensure that the temperature change difference between the temperature during pressure drop and the temperature during pressure stabilization is within the preset temperature difference range, the influence of temperature on the detection result is reduced, and the accuracy of the detection result is improved.

[0065] Specifically, refer to Figure 3 or Figure 4The degassing assembly includes a degassing valve 25 disposed in the base 1 and a vacuum generator 26 connected to the degassing valve 25. The degassing valve 25 is used to control and release the pressure in the disposable bioprocessing bag 12, and one end of the degassing valve 25 is connected to the vacuum generator 26. The base 1 is provided with a degassing interface 27 near the temperature sensor 22, and the other end of the vacuum generator 26 is connected to the degassing interface 27. A degassing pipe 28 is provided at the other end of the degassing interface 27, and the other end of the degassing pipe 28 extends into the disposable bioprocessing bag 12, and the degassing pipe 28 is sealed and connected to the disposable bioprocessing bag 12. The degassing valve 25 and the vacuum generator 26 are both electrically connected to the PLC module group 8, so that when the test is completed, the degassing valve 25 and the vacuum generator 26 are controlled by the PLC module group 8 to degas.

[0066] Reference Figure 3 or Figure 4 , a heat dissipation hole 29 is provided on the long side of the base 1. The heat dissipation hole 29 is in the shape of a long strip and is distributed along the length direction of the base 1. The heat dissipation hole 29 runs through the base 1. There are multiple heat dissipation holes 29, and the multiple heat dissipation holes 29 are divided into two groups. The two groups of heat dissipation holes 29 are respectively provided on the two long sides of the base 1 and are arranged opposite to each other. The multiple heat dissipation holes 29 in one group are arranged in an array to form an elliptical shape. When the gas discharged from the air release valve 25 enters the base 1, it is heat exchanged through the PLC module group 8, the inflation pressure regulating valve 13, the air replenishment battery valve, and the pipeline solenoid valve 14, and is discharged from the heat dissipation hole 29, so as to dissipate the heat of the equipment in the base 1 and maintain the normal operation of the equipment. Therefore, the multiple heat dissipation holes 29 help to dissipate the heat for the equipment in the base 1 and help the equipment to work normally.

[0067] During deflation, the gas in the disposable bioprocess bag 12 is extracted through the vacuum generator 26 and discharged through the deflation valve 25, so that active exhaust can be performed to quickly discharge the residual gas in the bioprocess bag. By combining the deflation valve 25 and the vacuum generator 26, the gas in the bag can be more effectively extracted, which is conducive to more efficient deflation work and prevention of contamination in the bag.

[0068] In addition, in this embodiment, a barcode is provided on the disposable bioprocess bag 12, and the barcode is used to record the test formula of the disposable bioprocess bag 12 of the current model specification. Figure 5 or Figure 6The base 1 is also provided with a barcode scanning gun interface 30 for connecting a barcode scanning gun near the power interface 9. The barcode scanning gun interface 30 is electrically connected to the PLC module group 8, so that the barcode of the disposable bioprocess bag 12 is scanned by connecting the barcode scanning gun through the barcode scanning gun interface 30, and the required test formula is quickly obtained and tested. When the two groups of detection mechanisms are synchronously detected, by selecting the disposable bioprocess bag 12 of the corresponding interface in the display 3 and scanning it, two disposable bioprocess bags 12 of different specifications can be tested synchronously.

[0069] Reference Figure 1 or Figure 3 The base 1 is also provided with a printer 31, which is a dot matrix printer 31. The dot matrix printer 31 has a longer print shelf life. The discharge end of the printer 31 extends out of the top cover 2. The printer 31 is electrically connected to the PLC module group 8. When the test is completed, the test report is printed by the printer 31. The test report includes the temperature and pressure change curves of the entire test cycle. The base 1 is also provided with a USB interface near the barcode scanner interface 30. The USB interface is electrically connected to the PLC module group 8, so that the storage device is connected through the USB interface. The storage device includes a U disk, and the electronic test report in PDF format can be exported.

[0070] The implementation principle of the present application is: when preparing for detection, connect the power interface 9 to the power supply to power the PLC module group 8, start the power switch 10, start the PLC module group 8 and the display 3 to work, connect the barcode scanner to the barcode scanner interface 30, and scan the barcode on the disposable bioprocess bag 12 with the barcode scanner to quickly obtain the test formula required for the current specifications of the disposable bioprocess bag 12, and seal the air output pipe 19, the pressure detection pipe 24 and the air release pipe 28 with the disposable bioprocess bag 12, and the temperature sensor 22 detects the preparation temperature of the environment.

[0071] During the detection, compressed air is connected through the air access pipe, and the compressed air is respectively input into the inflation pressure regulating valve 13 of the two detection mechanisms through the two shunt outlets of the shunt pipe. The compressed air is pressure-regulated by the inflation pressure regulating valve 13 and transported to the pipeline solenoid valve 14 and the air supply solenoid valve 15. The flow rate of compressed gas inflation is regulated by the pipeline solenoid valve 14, and the inflation flow rate is adjusted by the air supply solenoid valve 15 in cooperation with the pipeline solenoid valve 14. The air transported by the pipeline solenoid valve 14 and the air supply solenoid valve 15 is gathered in the air output pipe 19 through the three-way pipe, and transported to the disposable bioprocess bag 12 through the air output pipe 19. The inflation process can be controlled by the PLC module group 8, and the disposable bioprocess bag 12 is boosted and stabilized. The pipeline solenoid valve 14 and the air supply solenoid valve 15 can achieve more flexible and accurate inflation control through the PLC module group 8 to improve the accuracy, stability and controllability of inflation.

[0072] After the inflation test of the disposable bioprocess bag 12 is completed, the gas in the disposable bioprocess bag 12 is extracted from the deflation pipe 28 through the vacuum generator 26 and discharged through the deflation valve 25, so that active exhaust can be performed to quickly discharge the residual gas in the bioprocess bag. By combining the deflation valve 25 and the vacuum generator 26, the gas in the bag can be more effectively extracted, so that compressed air can be used for inflation and deflation, which is conducive to completing the deflation work more efficiently and preventing contamination in the bag.

[0073] When the gas discharged from the air release valve 25 enters the base 1, it undergoes heat exchange through the PLC module group 8, the gas charging pressure regulating valve 13, the gas replenishing battery valve, and the pipeline solenoid valve 14, and is discharged from the heat dissipation hole 29, thereby dissipating the heat of the equipment in the base 1 and maintaining the normal operation of the equipment. Therefore, the multiple heat dissipation holes 29 help to dissipate the heat of the equipment in the base 1 and help the equipment to operate normally.

[0074] The pressure sensor 21 detects the air pressure in the disposable bioprocess bag 12 in real time, and forms a time-pressure relationship curve (pressure change curve) on the display 3 through the PLC module group 8, so as to observe whether the disposable bioprocess bag 12 has integrity. When the pressure difference exceeds the preset range, it indicates that there is leakage in the bag. When the pressure difference is within the preset range, it indicates that the disposable bioprocess bag is intact. In this way, holes that cannot be observed by the naked eye can be measured, so that the measurement accuracy is high.

[0075] The depressurization temperature is detected by the temperature sensor 22. By judging whether the temperature change difference between the preparation temperature and the depressurization temperature exceeds the allowed range, it is determined whether the depressurization loss value obtained after the pressure increase, pressure stabilization and pressure reduction operations is credible, thereby preventing the temperature from affecting the air pressure value in the disposable bioprocess bag 12 to be detected.

[0076] When the temperature change before and after the detection work exceeds the allowable change value, the integrity of the disposable bioprocess bag 12 is judged by the pressure drop loss value; when the temperature change before and after the detection work exceeds the allowable change value, the authenticity of the pressure drop loss value cannot be guaranteed. By extending the pressure stabilization time to ensure that the temperature change difference between the temperature during pressure drop and the temperature during pressure stabilization is within the preset temperature difference range, the influence of temperature on the detection result is reduced, and the accuracy of the detection result is improved.

[0077] After the test is completed, the test report can be printed by the printer 31 or the electronic test report can be obtained by connecting the storage device to the USB interface. Thus, by measuring the temperature in real time, the leakage situation can be intuitively measured and observed, making the test accuracy higher.

[0078] The above are all preferred embodiments of the present application, and the protection scope of the present application is not limited thereto. Therefore, any equivalent changes made according to the structure, shape, and principle of the present application should be included in the protection scope of the present application.

Claims

1. A disposable system integrity tester, comprising a base (1) with an open top and a top cover (2) arranged on the base (1), wherein the base (1) and the top cover (2) cover each other, characterized in that: A short side opening (5) penetrating the top opening is provided on one side of the base (1); a screen seat (7) is provided on the side of the top cover (2) away from the base (1); a display (3) is provided on the screen seat (7); a PLC module group (8) for realizing logic control, signal input and output, and data processing functions in an automatic control system is provided in the base (1); a power interface (9) is provided on the side of the base (1) away from the short side opening (5); the power interface (9) is used to connect a power source; the power interface (9) is electrically connected to the PLC module group (8); a power switch (10) is provided on the top cover (2); the power switch (10) is electrically connected to the PLC module group (8); An air inlet pipe is provided on one side of the base (1) near the power interface (9); one end of the air inlet pipe extending into the base (1) is connected to a shunt pipe, the shunt pipe comprises a shunt inlet and two shunt outlets, the air inlet pipe is connected to the shunt inlet, one end of the air inlet pipe located outside the base (1) is connected to an external compressed air source, and a detection mechanism for boosting, stabilizing, reducing and measuring the pressure of the disposable bioprocess bag (12) is provided inside the base (1), the detection mechanism comprises a detection component for detecting the pressure inside the disposable bioprocess bag (12) and the ambient temperature; The detection assembly comprises a bracket (20) arranged in the base (1), a pressure sensor (21) arranged on the bracket (20), and a temperature sensor (22) penetrating the base (1); the pressure sensor (21) is arranged on the bracket (20); the pressure sensor (21) is electrically connected to the PLC module group (8), and a curve diagram of the relationship between time and air pressure is formed on the display (3) through the PLC module group (8); the base (1) is provided with a pressure detection interface (23) near the test interface (18), and the pressure detection interface (23) faces the base (1). ) is connected to the monitoring end of the pressure sensor (21); the end of the pressure detection interface (23) facing outward is provided with a pressure detection tube (24); the end of the pressure detection tube (24) away from the pressure detection interface (23) extends into the disposable bioprocess bag (12), and the pressure detection tube (24) is sealed and connected to the disposable bioprocess bag (12); the temperature sensor (22) is used to detect the current ambient temperature in real time; the detection end of the temperature sensor (22) faces outside the base (1); and the temperature sensor (22) is electrically connected to the PLC module group (8).

2. A disposable system integrity tester according to claim 1, characterized in that: The detection mechanism is provided with two groups, and the two diversion outlets are respectively connected to the two groups of detection mechanisms.

3. A disposable system integrity tester according to claim 1, characterized in that: The pressure range / accuracy of the pressure sensor (21) is 0.1% FS, the range of the temperature sensor (22) is 0-200° C., and the measurement accuracy is Class A.

4. A disposable system integrity tester according to claim 1, characterized in that: The base (1) is provided with convex wings (6) on two opposite sides. The convex wings (6) are arranged in an inclined manner. The convex wings (6) are inclined upward from the direction close to the short side opening (5) to the direction away from the short side opening (5). The screen seat (7) is also arranged in an inclined manner. The inclination direction of the screen seat (7) and the convex wings (6) are consistent.

5. A disposable system integrity tester according to claim 1, characterized in that: The detection mechanism also includes an inflation component for inflating the disposable bioprocess bag (12), the inflation component including an inflation pressure regulating valve (13) arranged in the base (1), a pipeline solenoid valve (14) connected to one end of the inflation pressure regulating valve (13), and an air replenishment solenoid valve (15) connected to the other end of the inflation pressure regulating valve (13), the inflation pressure regulating valve (13) including an inflation inlet, an inflation outlet and an air replenishment outlet, the shunt outlet of the shunt pipe is connected to the inflation inlet of the inflation pressure regulating valve (13), an electromagnetic valve seat (16) is arranged in the base (1), the pipeline electromagnetic valve (14) is arranged on the electromagnetic valve seat (16), one end of the pipeline electromagnetic valve (14) is connected to the inflation outlet of the inflation pressure regulating valve (13), and the air replenishment solenoid valve (15) is arranged on the electromagnetic valve seat (16), the gas replenishment solenoid valve (15) and the pipeline solenoid valve (14) are arranged along the height direction of the base (1), one end of the gas replenishment solenoid valve (15) is connected to the gas replenishment outlet of the inflation pressure regulating valve (13), the other end of the pipeline solenoid valve (14) is connected to a three-way pipe and connected to the first end of the three-way pipe, the second end of the three-way pipe is connected to the other end of the gas replenishment solenoid valve (15), the base (1) is provided with a test interface (18) near the gas inlet (11), the third end of the three-way pipe is connected to the test interface (18), the other end of the test interface (18) is connected to an air output pipe (19), the other end of the air output pipe (19) extends into the disposable bioprocess bag (12), and the air output pipe (19) is sealed and connected to the disposable bioprocess bag (12).

6. A disposable system integrity tester according to claim 5, characterized in that: The inflation pressure regulating valve (13), the pipeline solenoid valve (14) and the air supply solenoid valve (15) are all electrically connected to the PLC module group (8).

7. A disposable system integrity tester according to claim 1, characterized in that: The detection mechanism further comprises a deflation component for deflation of the disposable bioprocess bag (12), the deflation component comprising a deflation valve (25) arranged in the base (1) and a vacuum generator (26) connected to the deflation valve (25), the deflation valve (25) being used to control and release the pressure in the disposable bioprocess bag (12), one end of the deflation valve (25) being connected to the vacuum generator (26), the base (1) being provided with a deflation interface (27) near the temperature sensor (22), the other end of the vacuum generator (26) being connected to the deflation interface (27), the other end of the deflation interface (27) being provided with a deflation pipe (28), the other end of the deflation pipe (28) extending into the disposable bioprocess bag (12), the deflation pipe (28) being sealedly connected to the disposable bioprocess bag (12).

8. A disposable system integrity tester according to claim 7, characterized in that: A heat dissipation hole (29) is provided on the long side of the base (1), the heat dissipation hole (29) passes through the base (1), a plurality of the heat dissipation holes (29) are provided, and the plurality of the heat dissipation holes (29) are divided into two groups, the two groups of heat dissipation holes (29) are respectively provided on two opposite sides of the base (1), and the plurality of heat dissipation holes (29) in one group are arranged in an array.

9. A disposable system integrity tester according to claim 1, characterized in that: A barcode is provided on the disposable bioprocess bag (12), and the barcode is used to record the test formula of the disposable bioprocess bag (12) of the current model and specification. The base (1) is also provided with a barcode scanning gun interface (30) for connecting a barcode scanning gun near the power interface (9), and the barcode scanning gun interface (30) is electrically connected to the PLC module group (8).

10. A disposable system integrity tester according to claim 1, characterized in that: A printer (31) is also provided in the base (1), the discharge end of the printer (31) protruding from the top cover (2), the printer (31) being electrically connected to the PLC module group (8), and a USB interface is also provided near the power interface (9) of the base (1), the USB interface being electrically connected to the PLC module group (8).

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