Pressure maintaining testing device and integrity testing system

Abstract

According to the pressure maintaining testing device, multiple sets of filters are fixed through the fixing assembly, the plug assembly is driven by the driving assembly to move towards the filters, the exhaust ports and the liquid outlets of the filters are blocked, and the liquid inlets of the filters are connected, the automation degree of the pressure maintaining testing device is improved through electrical control, operation is easy, the sealing performance is improved, and the testing efficiency is improved. And the requirements of filter integrity testing are met. The integrity test system comprising the pressure maintaining test device is convenient to use, high in test efficiency and high in practical value.

Description

Technical Field

[0001] This utility model belongs to the field of biopharmaceutical process technology, specifically relating to a pressure holding test device and an integrity test system. Background Technology

[0002] Laboratory-scale depth filters are used for clarifying fermentation broths in small-scale laboratory settings, providing more options for clarification during the research and development phase. Pharmaceutical companies must perform integrity tests on the filters before each use. Current technology uses a one-to-one connection between a single filter and an integrity tester. Specifically, for laboratory-scale depth filter integrity testing, the filter under test is directly connected to the integrity tester. Each test requires blocking the filter's exhaust and outlet ports, injecting 3 kg of gas into the filter's interior through the inlet, and maintaining the pressure for 300 seconds to create a completely sealed space for integrity testing. Current technology has the following problems:

[0003] 1. Existing technology involves one-to-one testing of the deep filter under test and the integrity tester, which is inefficient and not conducive to the testing of large-volume products.

[0004] 2. Each test requires manual plugging of the exhaust port and liquid outlet, and manual connection of the air inlet pipe to the liquid inlet. During large-scale testing, the testers need to plug the pipe repeatedly, wasting a lot of time. Repeated plugging will cause arm fatigue for the operators.

[0005] 3. Manually blocking the vent and liquid outlet can easily lead to poor sealing, causing the test to fail. If the connector breaks during blocking, it needs to be re-blocked and the test repeated.

[0006] In summary, existing testing methods can only meet the needs of testing a small number of products, while they are too inefficient and cannot be carried out continuously for testing large batches of products. Summary of the Invention

[0007] To overcome the shortcomings of existing technologies, one objective of this utility model is to provide a pressure holding test device, and another objective is to provide an integrity test system. To achieve the above objectives, the technical solution adopted by this utility model is as follows:

[0008] One aspect of this utility model provides a pressure holding test device, including a driving component, a plug component, and a fixing component. A filter is fixed to the fixing component. The driving component drives the plug component to move toward the filter, blocking the filter's exhaust port and liquid outlet, and connecting to the filter's liquid inlet.

[0009] Optionally, the pressure holding test device further includes a control component for controlling the drive component to drive the plug assembly to move toward the filter.

[0010] Optionally, the pressure holding test device further includes a display component for displaying the status of the test device.

[0011] Optionally, the pressure holding test device further includes a frame assembly, the drive assembly and the fixing assembly are fixed to the frame assembly, and the plug assembly is movably connected to the frame assembly.

[0012] Optionally, the drive assembly includes an upper side plate and a cylinder fixed to the upper side plate. The cylinder drives the plug assembly to move along the frame assembly toward the filter, blocking the filter's exhaust port and liquid outlet, and connecting to the filter's liquid inlet.

[0013] Optionally, the plug assembly includes an intermediate plate and a sealing plug and an air inlet plug fixed to the intermediate plate. The sealing plug is used to block the exhaust port and liquid outlet of the filter, and the air inlet plug is used to connect to the liquid inlet of the filter.

[0014] Optionally, the fixing assembly includes a lower side plate and at least one contoured member fixed to the lower side plate, the contoured member being used to fix the filter.

[0015] Optionally, the frame assembly includes a guide post, the upper side plate and the lower side plate are fixed to the guide post, and the middle plate is movable along the guide post.

[0016] Another aspect of this utility model provides an integrity testing system, including an integrity tester, an air compressor, and a pressure holding test device as described above. The integrity tester controls the pressure holding test device to block the exhaust port and liquid outlet of the filter through the air compressor, and connects to the liquid inlet of the filter.

[0017] Optionally, the air compressor controls the pressure holding test device to block the exhaust port and liquid outlet of the filter via a solenoid valve, and connects to the liquid inlet of the filter; the integrity tester controls the gas to enter the liquid inlet of the filter via a gas path splitter connector.

[0018] This utility model discloses a pressure-holding test device. Multiple filters are fixed by a fixing component, and a plug assembly is driven by a driving component to move towards the filters, blocking the exhaust port and liquid outlet of the filters and connecting to the liquid inlet of the filters. The pressure-holding test device improves automation through electrical control, is simple to operate, and improves sealing performance, meeting the requirements for filter integrity testing. This utility model's integrity testing system, including the pressure-holding test device, is convenient to use, highly efficient, and has significant practical value. Attached Figure Description

[0019] After reading the detailed embodiments of this utility model with reference to the accompanying drawings, the reader will gain a clearer understanding of all aspects of this utility model. Among them,

[0020] Figure 1 Figure 1 shows the existing technology.

[0021] Figure 2 Figure 2 shows the existing technology.

[0022] Figure 3 Figure 3 shows the existing technology.

[0023] Figure 4 This is a diagram of an integrity testing system according to an embodiment of the present invention;

[0024] Figure 5 This is a structural diagram of the upper side plate of one embodiment of the present utility model;

[0025] Figure 6 This is a cylinder structure diagram of one embodiment of the present invention;

[0026] Figure 7 This is a pneumatic circuit diagram of one embodiment of the present invention;

[0027] Figure 8 This is a structural diagram of the intermediate plate according to an embodiment of the present invention;

[0028] Figure 9 This is a structural diagram of a sealing plug according to an embodiment of the present invention;

[0029] Figure 10 This is a structural diagram of an air intake plug according to an embodiment of the present invention;

[0030] Figure 11 This is a structural diagram of the lower side plate of one embodiment of the present utility model;

[0031] Explanation of reference numerals in the attached figures:

[0032] 1: Pressure holding test device; 2: Deep filter; 3: Integrity tester; 4: Air compressor; 5: Solenoid valve; 6: Air circuit branch connector;

[0033] 11: Drive component; 12: End cap component; 13: Fixing component; 14: Control component; 15: Display component; 16: Frame component;

[0034] 111: Upper side plate; 112: Cylinder; 113: Upper guide post mounting hole; 134: Cylinder fixing screw hole;

[0035] 121: Intermediate plate; 122: Sealing plug; 123: Air inlet plug; 124: Intermediate guide post mounting hole; 125: Metal sleeve thread;

[0036] 131: Lower side plate; 132: Profile piece; 133: Lower guide post mounting hole;

[0037] 141: Power switch; 142: Start indicator light; 143: Emergency stop button; 144: Start button; 145: Power plug;

[0038] 161: Guide post;

[0039] 21: Vent; 22: Drain; 23: Inlet;

[0040] 51: First valve; 52: Second valve;

[0041] 61: Air inlet; 62: First product air outlet; 63: Second product air outlet; 64: Second product air outlet;

[0042] 1121: Cylinder intake port; 1122: Cylinder exhaust port; 1123: Piston diaphragm; 1124: Telescopic rod;

[0043] 1211: First through hole; 1212: Second through hole; 1213: Metal screw mounting hole;

[0044] 1221: First fixing screw; 1222: First metal sleeve; 1223: Contouring silicone sleeve;

[0045] 1231: O-ring seal; 1232: Second fixing screw; 1233: Second metal sleeve; 1234: Contouring silicone connector sleeve;

[0046] 1311: Third fixing screw. Detailed Implementation

[0047] To make the technical content disclosed in this application more detailed and complete, reference can be made to the accompanying drawings and the following specific embodiments of this utility model. However, those skilled in the art should understand that the embodiments provided below are not intended to limit the scope of this utility model. Furthermore, the drawings are for illustrative purposes only and are not drawn to their original dimensions.

[0048] The term "connection" in this specification includes both direct and indirect connections. The terms "several" and "more than" refer to two or more entities. The terms "first," "second," and "third" in the specification, claims, and accompanying drawings also apply.

[0049] The use of terms such as "fourth" (if present) is to distinguish similar objects and is not necessarily used to describe a specific order or sequence. It should be understood that such use of data can be interchanged where appropriate so that embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0050] The technical solution of this utility model will be described in detail below. The following embodiments can be combined with each other. The same or similar concepts or processes may not be described again in some embodiments.

[0051] Example 1:

[0052] This embodiment provides a pressure holding test device 1. Please refer to [link / reference]. Figure 4-11 The pressure holding test device 1 is used to automatically block the exhaust port 21 and drain port 22 of the depth filter 2. Specifically, 3 kg of gas is injected into the interior of the depth filter 2 through the inlet port 23, and the pressure is maintained for 300 seconds to form a completely sealed space inside the depth filter 2, so as to facilitate subsequent integrity testing and ensure the accuracy of the test results. The pressure holding test device 1 includes a drive assembly 11, a plug assembly 12, a fixing assembly 13, a control assembly 14, a display assembly 15, and a frame assembly 16. The driving component 11 and the fixing component 13 are fixed to the frame component 16. The plug component 12 is movably connected to the frame component 16 and can move along the frame component 16. The fixing component 13 is used to fix the depth filter 2. The control component 14 controls the driving component 11 to drive the plug component 12 to move toward the depth filter 2, blocking the exhaust port 21 and the liquid outlet 22 of the depth filter 2. The plug component 12 is connected to the liquid inlet 23 of the depth filter 2. After the gas is injected into the interior of the depth filter 2 from the liquid inlet 23, an integrity test is performed.

[0053] In this embodiment, the drive assembly 11 includes an upper side plate 111 and a cylinder 112 fixed to the upper side plate 111. The cylinder 112 drives the plug assembly 12 to move along the frame assembly 16 toward the filter 2, blocking the exhaust port 21 and the liquid outlet 22 of the filter 2, and connecting to the liquid inlet 23 of the filter 2. Specifically, the frame assembly 16 includes four guide posts 161, and the edge of the upper side plate 111 is provided with four upper guide post mounting holes 113. The upper side plate 111 is fixed to the guide posts 161 through the upper guide post mounting holes 113. Specifically, the center of the upper side plate 111 is provided with a set of cylinder screw fixing holes 114. The cylinder 112 is fixed to the upper side plate 111 by screws cooperating with the cylinder screw fixing holes 114.

[0054] In this embodiment, the plug assembly 12 includes an intermediate plate 121 and a sealing plug 122 and an air inlet plug 123 fixed to the intermediate plate 121. The sealing plug 122 is used to block the exhaust port 21 and the liquid outlet 22 of the filter 2, and the air inlet plug 123 is used to connect to the liquid inlet 23 of the filter 2. Specifically, the edge of the intermediate plate 121 is provided with four intermediate guide post mounting holes 124. The intermediate plate 121 is movably connected to the guide post 161 through the intermediate guide post mounting holes 124. The driving assembly 11 can drive the intermediate plate 121 to move along the guide post 161 toward the deep filter 2. Specifically, the intermediate plate 121 further includes a first through hole 1211, a second through hole 1212, and a metal screw mounting hole 1213. The first through hole 1211 is used to connect the air intake plug 123. Specifically, the external air intake pipe is connected to the air intake plug 123 by a metal sleeve screw 125 cooperating with the metal screw mounting hole 1213. Specifically, the second through hole 1212 is used to connect and fix to the cylinder 112.

[0055] In this embodiment, the fixing assembly 13 includes a lower side plate 131 and at least one contoured member 132 fixed to the lower side plate 131. The contoured member 132 is used to fix the depth filter 2. Specifically, the lower side plate 131 has four lower guide post mounting holes 133 on its edge, and the lower side plate 131 is fixed to the guide post 161 through the lower guide post mounting holes 133. Specifically, the contoured member 132 is fixed to the lower side plate 131 by a third fixing screw 1311. During the integrity test, the depth filter 2 is placed in the contoured member 132 to ensure that the sealing plug 122 and the air inlet plug 123 can accurately position the exhaust port 21, the drain port 22 and the inlet port 23 of the depth filter 2, and also to prevent the position of the depth filter 2 from shifting during the test, thereby improving the accuracy of the test.

[0056] In this embodiment, the sealing plug 122 includes a first fixing screw 1221, a first metal sleeve 1222, and a conformal silicone sleeve 1223. The first metal sleeve 1222 is fixed to the intermediate plate 121 by the first fixing screw 1221, and the conformal silicone sleeve 1223 is fixed inside the first metal sleeve 1222. Specifically, the internal shape of the conformal silicone sleeve 1223 conforms to the shape of the exhaust port 21 and the drain port 22 of the depth filter 2, thereby achieving a blocking and sealing effect.

[0057] In this embodiment, the air inlet plug 123 includes an O-ring seal 1231, a second fixing screw 1232, a second metal sleeve 1233, and a conformal silicone connector sleeve 1234. The middle portions of the second metal sleeve 1233 and the conformal silicone connector sleeve 1234 are both through holes. The second metal sleeve 1233 is fixed to the intermediate plate 121 by the second fixing screw 1232. Furthermore, an O-ring seal 1231 is provided between the second metal sleeve 1233 and the intermediate plate 121 to ensure the sealing of the connection. The conformal silicone connector sleeve 1234 is fixed inside the second metal sleeve 1233. The internal shape of the conformal silicone connector sleeve 1234 conforms to the shape of the liquid inlet 23 of the depth filter 2. Under the pressure of the intermediate plate 121, the conformal silicone connector sleeve 1234 can tightly adhere to the liquid inlet 23, ensuring that no gas leakage occurs between the conformal silicone connector sleeve 1234 and the liquid inlet 23.

[0058] In this embodiment, the control component 14 includes a power switch 141, a start indicator light 142, an emergency stop button 143, a start button 144, and a power plug 145. After connecting to a power source via the power plug 145, pressing the power switch 141 starts the pressure holding test device 1. When the pressure holding test device 1 is operating normally, the start indicator light 142 remains constantly lit. In case of an emergency, pressing the emergency stop button 143 will stop the pressure holding test device 1 from operating.

[0059] In this embodiment, the display component 15 is used to display the status of the pressure holding test device 1.

[0060] Example 2:

[0061] This embodiment provides an integrity testing system; please refer to [link / reference]. Figure 4-11 The integrity testing system includes the pressure holding test device 1, integrity tester 3, and air compressor 4 described in Embodiment 1. The integrity tester 3 controls the pressure holding test device 1 to block the exhaust port 21 and liquid outlet 22 of the depth filter 2 through the air compressor 4, and connects to the liquid inlet 23 of the depth filter 2.

[0062] In this embodiment, the plug assembly 12 of the pressure holding test device 1 includes three sets of sealing plugs 122 and air inlet plugs 123, and the fixing assembly 13 includes three sets of contour parts 132, which can fix the three deep filters 2.

[0063] In this embodiment, the air compressor 4 controls the pressure holding test device 1 to block the exhaust port 21 and liquid outlet 22 of the depth filter 2 through the solenoid valve 5, and connects to the liquid inlet 23 of the depth filter 2; the integrity tester 3 controls the gas to enter the liquid inlet 23 of the depth filter 2 through the gas path splitter 6.

[0064] In this embodiment, the solenoid valve 5 includes a first valve 51 and a second valve 52; the cylinder 112 includes a cylinder inlet 1121, a cylinder exhaust port 1122, a piston diaphragm 1123, and a telescopic rod 1124. Specifically, the solenoid valve 5 needs to be connected to an actuating air source. The control component 14 opens the first valve 51, and compressed air enters the cylinder inlet 1121 through the pipeline. As the pressure increases, it pushes the piston diaphragm 1123 forward, and the telescopic rod 1124 extends and retracts forward, thereby pushing the intermediate plate 121 towards the depth filter 2, so that the sealing plug 122 and the inlet plug 123 align with the exhaust port 21, drain port 22, and inlet port 23 of the depth filter 2. After the test is completed, the second valve 52 is opened by the control component 14, and compressed air enters the cylinder exhaust port 1122, pushing the piston diaphragm 1123 away from the deep filter 2. The telescopic rod 1124 extends and retracts backward to release the deep filter 2, making it convenient for the operator to remove the deep filter 2 for the next round of testing.

[0065] In this embodiment, the gas path connector 6 includes four interfaces, one of which is an air inlet 61, used to connect to the air outlet of the integrity tester 3. The other three are air outlets, namely the first product air outlet 62, the second product air outlet 63, and the third product air outlet 64. After the gas enters from the air inlet 61, it enters through the first product air outlet 62, the second product air outlet 63, and the third product air outlet 64 respectively and connects to the three air inlet plugs of the intermediate plate 121, which are respectively connected to the three liquid inlets 23 of the depth filter 2. That is, compressed air enters the depth filter 2 through the pipeline for integrity testing.

[0066] Example 3:

[0067] This embodiment provides the usage process of the integrity testing system to further illustrate the technical solution of this utility model. The operating conditions for this test are: the equipment needs to be connected to one compressed air supply, one 220V power supply, and an integrity tester. The integrity testing steps are as follows:

[0068] (1) Connect the power supply through the power plug 145, press the power switch 141 to start the pressure holding test device 1, and the display component 15 and the start indicator light 142 will light up.

[0069] (2) Place the three deep filters 2 to be tested into the contour part 132.

[0070] (3) Connect the air source in the air compressor 4 to the solenoid valve 5.

[0071] (4) Press the start button 144, the cylinder 112 drives the intermediate plate 121 to move toward the deep filter 2, the sealing plug 122 blocks the exhaust port 21 and the drain port 22 of the deep filter 2, and the air inlet plug 123 connects to the liquid inlet 23 of the deep filter 2.

[0072] (5) Operate the integrity tester 3 to set the test conditions, connect the test gas source in the integrity tester 3 to the deep filter 2 through the gas path branch connector 6, and perform the integrity test.

[0073] (6) After the integrity test is completed, press the start button 144 again. The cylinder 112 drives the intermediate plate 121 away from the deep filter 2, thereby releasing the deep filter 2.

[0074] (7) Take out the deep filter 2, put in a new deep filter, and conduct the next round of testing.

[0075] This utility model discloses a pressure-holding test device. Multiple filters are fixed by a fixing component, and a plug assembly is driven by a driving component to move towards the filters, blocking the exhaust port and liquid outlet of the filters and connecting to the liquid inlet of the filters. The pressure-holding test device improves automation through electrical control, is simple to operate, and improves sealing performance, meeting the requirements for filter integrity testing. This utility model's integrity testing system, including the pressure-holding test device, is convenient to use, highly efficient, and has significant practical value.

[0076] Obviously, the above embodiments of this utility model are merely examples for clearly illustrating this utility model, and are not intended to limit the implementation of this utility model. Those skilled in the art can make other variations or modifications based on the above description. The embodiments listed in this utility model cannot exhaustively describe all implementation methods. All obvious variations or modifications derived from the technical solutions of this utility model are still within the protection scope of this utility model. All documents mentioned in this utility model are incorporated herein by reference as if they were individually incorporated by reference.

Claims

1. A pressure holding test device, characterized in that, The testing device includes a driving component, a plug component, and a fixing component. The filter is fixed to the fixing component. The driving component drives the plug component to move toward the filter, blocking the filter's exhaust port and liquid outlet, and connecting to the filter's liquid inlet.

2. The pressure holding test device according to claim 1, characterized in that, The pressure holding test device also includes a control component for controlling the drive component to drive the plug assembly to move toward the filter.

3. The pressure holding test device according to claim 1, characterized in that, The pressure holding test device also includes a display component for displaying the status of the test device.

4. The pressure holding test device according to claim 1, characterized in that, The pressure holding test device also includes a frame assembly, the drive assembly and the fixing assembly are fixed to the frame assembly, and the plug assembly is movably connected to the frame assembly.

5. The pressure holding test device according to claim 4, characterized in that, The drive assembly includes an upper side plate and a cylinder fixed to the upper side plate. The cylinder drives the plug assembly to move along the frame assembly toward the filter, blocking the filter's exhaust port and liquid outlet, and connecting to the filter's liquid inlet.

6. The pressure holding test device according to claim 5, characterized in that, The plug assembly includes an intermediate plate and a sealing plug and an air inlet plug fixed to the intermediate plate. The sealing plug is used to block the exhaust port and liquid outlet of the filter, and the air inlet plug is used to connect to the liquid inlet of the filter.

7. The pressure holding test device according to claim 6, characterized in that, The fixing assembly includes a lower side plate and at least one contoured member fixed to the lower side plate, the contoured member being used to fix the filter.

8. The pressure holding test device according to claim 7, characterized in that, The frame assembly includes a guide post, the upper side plate and the lower side plate are fixed to the guide post, and the middle plate is movable along the guide post.

9. An integrity testing system, characterized in that, The device includes an integrity tester, an air compressor, and a pressure holding test device as described in any one of claims 1-8. The integrity tester controls the pressure holding test device to block the exhaust port and liquid outlet of the filter through the air compressor, and connects to the liquid inlet of the filter.

10. The integrity testing system according to claim 9, characterized in that, The air compressor controls the pressure holding test device to block the exhaust port and liquid outlet of the filter via a solenoid valve, and connects to the liquid inlet of the filter; the integrity tester controls the gas to enter the liquid inlet of the filter via a gas path splitter connector.

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