Filter on-line integrity testing system and corresponding filling machine

Abstract

The utility model relates to a filter on-line integrity test system. The filter on-line integrity test system (1) is used for carrying out integrity detection on at least one filter (11) and comprises at least one vertical supporting structure (12) and at least one filter (11), and a piping system (13) for conveying a fluid; wherein the piping system (13) and the at least one filter (11) are held on the vertical support structure (12) such that at least a plurality of sub-segments (131) of the piping system (13) and the at least one filter (11) are arranged in an up-down positional relationship. According to some embodiments, the independent module design enables the pipeline design to be more flexible and the user layout to be simpler during testing; the cleaning device is positioned outside the isolator, so that the interior of the isolator is clean and the operation difficulty is reduced; online integrity testing can be carried out on the filter, the pollution risk is reduced, operation is reduced, and data can be stored in an equipment database; in the testing process, full-automatic control is achieved, and intervention of operators is not needed.

Description

Technical Field

[0001] The utility model relates to the field of medicine filling, in particular to an online filter integrity testing system and a corresponding filling machine. Background Art

[0002] With the promulgation of new regulations, pharmaceutical manufacturers are now required to verify the integrity of sterile filter assemblies through pre-use integrity testing (both pre-use and post-sterilization) to ensure product sterility. This testing is done to detect damage and integrity loss caused by filter preparation prior to use. Sterilizing-grade filters used to sterilize liquids should undergo non-destructive integrity testing before removal from the housing after use. This trend necessitates the design of more efficient and convenient online integrity testing systems.

[0003] However, many pharmaceutical companies currently rely on manual pre-use and post-sterilization testing to test product filter integrity before production. These methods involve numerous personnel and carry high risks. Furthermore, offline testing cannot integrate data with production batches, leading to high costs, lengthy testing processes, large space requirements, and operational difficulties.

[0004] Therefore, corresponding improvements are needed. Utility Model Content

[0005] In order to overcome at least one of the above disadvantages and / or other possible disadvantages in the prior art that may not be mentioned here, an object of the present invention is to provide an improved online filter integrity testing system and a corresponding filling machine.

[0006] According to a first aspect of the present invention, a filter online integrity testing system is provided, which is used to perform integrity testing on at least one filter and includes: at least one vertical support structure; and a pipeline system for conveying fluid; wherein the pipeline system and the at least one filter are maintained on the vertical support structure so that at least multiple sub-sections of the pipeline system and the at least one filter are arranged in an upper and lower positional relationship.

[0007] According to an optional embodiment of the present invention, the vertical support structure is configured to include a plate-like structure, and the at least multiple sub-segments and the at least one filter are arranged on a vertical side of the plate-like structure or distributed on both sides of the plate-like structure.

[0008] According to an optional embodiment of the present invention, the filter online integrity testing system also includes a waste liquid collection container for collecting waste liquid from the pipeline system. The waste liquid collection container is arranged on the side of the vertical support structure, and the lowest point of the collection area of ​​the waste liquid collection container is lower than the pipeline system and the filter.

[0009] According to an optional embodiment of the present invention, the filter is connected in series in the inclined subsection of the pipeline system, and the liquid inlet subsection of the pipeline system is connected to the upstream of the filter in an upwardly inclined manner.

[0010] According to an optional embodiment of the present invention, the filter online integrity testing system further includes an integrity detection device, and the integrity detection device is connected to the upstream of the filter.

[0011] According to an optional embodiment of the present invention, the filter online integrity testing system further comprises a first sampling container connected to the upstream of the filter and capable of sampling the influent.

[0012] According to an optional embodiment of the present invention, the filter online integrity testing system further includes a second sampling container connected to the downstream of the filter and capable of sampling the filtered liquid.

[0013] According to an optional embodiment of the present invention, the filter online integrity testing system further includes an exhaust container connected to the filter and capable of receiving exhaust gas from the filter.

[0014] According to an optional embodiment of the present invention, the filter online integrity testing system further includes a flow controller for controlling the flow of the pipeline system.

[0015] According to an optional embodiment of the present invention, the filter online integrity testing system further includes a clamp for holding the pipeline system and / or the filter.

[0016] According to an optional embodiment of the present invention, the integrity detection device is at least partially arranged on the back side of the vertical support structure.

[0017] According to an optional embodiment of the present invention, at least one of the filter, the piping system, the first sampling container, the second sampling container, the exhaust container, and the clamp is at least partially arranged on the operating side of the vertical support structure.

[0018] According to an optional embodiment of the present invention, at least one of the first sampling container, the second sampling container and the exhaust container is configured as a bag.

[0019] According to an optional embodiment of the present invention, the filter online integrity testing system further includes a separate controller for controlling the automatic execution of the online integrity test.

[0020] According to an optional embodiment of the present invention, the back side of the vertical support structure is configured in a box shape.

[0021] According to an optional embodiment of the present invention, the filter online integrity testing system is applicable to a two-stage filter, and each stage of the filter corresponds to one of the vertical support structures.

[0022] According to an optional embodiment of the present invention, the filter online integrity testing system is configured as an independent module.

[0023] According to a second aspect of the present invention, a filling machine is provided, comprising an online filter integrity testing system according to any one of the above optional embodiments.

[0024] According to an optional embodiment of the present invention, the filling machine includes an isolator, and the filter online integrity testing system is arranged outside the isolator.

[0025] According to certain embodiments of the present invention, the independent module design makes the pipeline design during testing more flexible and the user layout simpler; it is located outside the isolator, ensuring the cleanliness of the isolator and reducing the difficulty of operation; the filter can be tested for integrity online, reducing the risk of contamination and reducing operations, and the data can be stored in the equipment database; during the test, it is fully automatically controlled and no operator intervention is required. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The present invention will be described in more detail below with reference to the accompanying drawings and exemplary embodiments, so that the principles, features and advantages of the present invention can be better understood. The accompanying drawings include:

[0027] Figure 1 The figure shows a front view of the operating side of an online filter integrity test system according to an exemplary embodiment of the present invention, wherein some dotted arrows are shown to indicate the flow direction of the fluid in a certain state.

[0028] Figure 2 and Figure 1 Similarly, some dotted arrows are shown to indicate the flow direction of the fluid in another state.

[0029] Figure 3 A perspective view of an online filter integrity testing system according to an exemplary embodiment of the present invention is shown. DETAILED DESCRIPTION

[0030] In order to make the technical problems, technical solutions and beneficial technical effects to be solved by the present invention more clearly understood, the present invention will be further described in detail below with reference to the accompanying drawings and multiple exemplary embodiments. It should be understood that the specific embodiments described herein are only intended to explain the present invention and are not intended to limit the scope of protection of the present invention.

[0031] Before officially beginning the description, it should be noted that due to viewing angles, space limitations for reference numerals in the drawings, or for the sake of brevity, some reference numerals are not included in all views. Therefore, when referring to the description, you may refer to multiple views simultaneously, if necessary, to facilitate understanding. However, this does not mean that all technical features must appear in all embodiments. On the contrary, whether various technical features can be varied or replaced, and whether they are essential, should be limited by whether the technical solution can be implemented.

[0032] Figure 1 The figure shows a front view of the operating side of an online filter integrity test system according to an exemplary embodiment of the present invention, wherein some dotted arrows are shown to indicate the flow direction of the fluid in a certain state.

[0033] Figure 2 and Figure 1 Similarly, some dotted arrows are shown to indicate the flow direction of the fluid in another state.

[0034] Figure 3 A perspective view of an online filter integrity test system according to an exemplary embodiment of the present invention is shown. However, in this perspective view, some components or structures are omitted so that the filter integrity test system shown in FIG. Figure 1-Figure 2 It is not a complete correspondence, and the figure is only intended to show the overall appearance of the filter online integrity testing system of the present invention.

[0035] According to one aspect of the present invention, a filter online integrity testing system is provided, wherein the filter online integrity testing system 1 is used to perform integrity detection on at least one filter 11, and comprises: at least one vertical support structure 12; and a piping system 13 for conveying fluid; wherein the piping system 13 and the at least one filter 11 are maintained on the vertical support structure 12 such that at least multiple sub-segments 131 of the piping system 13 and the at least one filter 11 are arranged in an upper and lower positional relationship.

[0036] Here, it should be pointed out that the term "upper and lower position relationship" refers to the direction relative to gravity, and corresponds to the distinction between high and low, so that gravity can be used to achieve some purposes, such as emptying certain waste liquids.

[0037] According to an exemplary embodiment of the present invention, Figure 1-Figure 3As shown, the vertical support structure 12 is configured to include a plate-like structure 121, and at least the plurality of sub-segments 131 and the at least one filter 11 are arranged on a vertical side of the plate-like structure 121 or distributed on both sides of the plate-like structure 121. In this way, space can be reasonably utilized and the entire structure looks neat.

[0038] According to an exemplary embodiment of the present invention, Figure 1 and Figure 2 As shown, the filter online integrity testing system 1 also includes a waste liquid collection container 14 for collecting waste liquid from the pipeline system 13. The waste liquid collection container 14 is arranged on the side of the vertical support structure 12, specifically on the side of the operating side of the plate-like structure 121, and the lowest point of the collection area of ​​the waste liquid collection container 14 is lower than the pipeline system 13 and the filter 11.

[0039] As can be seen from the figure, the waste liquid collection container 14 can be placed on the support table, and the table top of the support table is arranged tilted, so that the waste liquid is more advantageously collected in the waste liquid collection container 14. The support table and the vertical support structure 12 can be placed together on another bracket.

[0040] According to an exemplary embodiment of the present invention, Figure 1 and Figure 2 As shown, the filter 11 is connected in series to the inclined sub-segment 131 of the pipeline system 13. The liquid inlet sub-segment 131 of the pipeline system 13 is connected to the upstream of the filter 11 at an upward inclination. In other words, the liquid received from the outside by the liquid inlet 132, such as the drug solution during production or the water for injection during testing, first flows along an ascending sub-segment 131, then moves to the descending sub-segment 131 and enters the filter 11. The filter 11 itself is also arranged at an inclination. After passing through the filter 11, the liquid flows along another descending sub-segment 131, as shown in FIG. Figure 1 As shown by the dotted arrow in . This path arrangement is very beneficial to the operation of the filter online integrity test system.

[0041] According to an exemplary embodiment of the present invention, Figure 1 and Figure 2 As shown, the filter online integrity testing system 1 further comprises an integrity detection device 15 , which is connected to the upstream of the filter 11 .

[0042] According to an exemplary embodiment of the present invention, Figure 1 and Figure 2 As shown, the filter online integrity test system 1 further includes an exhaust container 18 connected to the filter 11 and capable of receiving exhaust gas from the filter 11 .

[0043] exist Figure 1 and Figure 2In the figure, only a small part of the integrity detection device 15 (the connection port extending from the through hole extending from front to back) can be seen, because the integrity detection device 15 is mostly located on the back side of the plate-like structure 121. Figure 2 As shown, the integrity detection device 15 can generate gas, which is delivered to the wetted filter 11 for detection. When wet, the gas in the filter 11 can be squeezed into the exhaust container 18.

[0044] According to an exemplary embodiment of the present invention, Figure 1 and Figure 2 As shown, the filter online integrity testing system 1 further comprises a first sampling container 16 connected to the upstream of the filter 11 and capable of sampling the influent.

[0045] According to an exemplary embodiment of the present invention, Figure 1 and Figure 2 As shown, the filter online integrity testing system 1 further comprises a second sampling container 17 connected to the downstream of the filter 11 and capable of sampling the filtered liquid.

[0046] According to an exemplary embodiment of the present invention, at least one of the first sampling container 16 , the second sampling container 17 and the exhaust container 18 may be configured as a bag, and the bag may be hung on the vertical support structure 12 .

[0047] According to an exemplary embodiment of the present invention, Figure 1 and Figure 2 As shown, the in-line filter integrity testing system 1 further includes a flow controller 19 for controlling the flow of the piping system 13. Flow controller 19 can be a pinch valve. When the flow rate is controlled to zero, it is equivalent to shutting off the corresponding pipeline. Multiple flow controllers 19 can be provided, located at different pipe sections.

[0048] According to an exemplary embodiment of the present invention, Figure 1 and Figure 2 As shown, the filter online integrity testing system 1 further comprises a clamp 20 for holding the pipe system 13 and / or the filter 11. There may also be a plurality of clamps 20 so as to be able to hold the pipe system 13 and / or the filter 11 in a stable desired posture.

[0049] like Figure 1 and Figure 2 As shown, according to an exemplary embodiment of the present invention, at least one of the filter 11 , the pipe system 13 , the first sampling container 16 , the second sampling container 17 , the exhaust container 18 , and the clamp 20 is at least partially arranged on the operating side of the vertical support structure 12 .

[0050] According to an exemplary embodiment of the present invention, the filter online integrity test system 1 further comprises a separate controller (not shown) for controlling the automatic execution of the online integrity test. The controller can be independent of the host of the filling system or can communicate with the host.

[0051] According to an exemplary embodiment of the present invention, Figure 3 As shown, the back side of the vertical support structure 12 is configured in a box shape, ie, has a cavity so that certain components, such as the integrity detection device 15, can be placed therein.

[0052] like Figure 1-Figure 3 As shown, according to an exemplary embodiment of the present invention, an online filter integrity testing system 1 is suitable for use with a two-stage filter, with each filter stage corresponding to a vertical support structure 12. Each vertical support structure 12 has corresponding components described above, which will not be described in detail here. The two-stage filters are connected in series via a pipeline extending from one vertical support structure 12 to the other.

[0053] According to an exemplary embodiment of the present invention, the filter online integrity testing system 1 is configured as an independent module.

[0054] According to another aspect of the present invention, a filling machine is provided, comprising the online filter integrity testing system 1 according to any one of the above exemplary embodiments.

[0055] According to an exemplary embodiment of the present invention, the filling machine comprises an isolator, and the filter online integrity testing system 1 is arranged outside the isolator.

[0056] Below, the working process is briefly described. After sterilization is completed, the filter 11 in the filter online integrity test system 1 is moistened with injection water through the liquid inlet 132, and the entire filter online integrity test system 1 is flushed, and the waste liquid is collected into the corresponding waste liquid collection container 14. Then, the two filters 11 are tested separately using the corresponding integrity testing equipment 15. After ensuring the integrity of the filter 11, the product is used to infiltrate and flush the complete main liquid inlet circuit, and then production is started. During production, the product passes through a pipeline different from the waste liquid collection pipeline ( Figure 1 The filtered liquid is then fed downstream (as indicated by the rightmost horizontal arrow in the figure). After production, the entire circuit is flushed again with water for injection, and the filter 11 undergoes another integrity test. The online filter integrity testing system 1 can be directly connected to the corresponding port of the filling machine as a module for online integrity testing, reducing contamination risks and transfer difficulties.

[0057] Although specific embodiments of the present invention are described in detail herein, they are provided for illustrative purposes only and should not be considered to limit the scope of the present invention. Various substitutions, changes, and modifications may be conceived without departing from the spirit and scope of the present invention.

Claims

1. A filter online integrity testing system, characterized in that: The filter online integrity testing system (1) is used to perform integrity testing on at least one filter (11), and comprises: at least one vertical support structure (12); and a piping system (13) for conveying fluid; The pipeline system (13) and the at least one filter (11) are held on the vertical support structure (12) such that at least a plurality of subsections (131) of the pipeline system (13) and the at least one filter (11) are arranged in an upper and lower positional relationship.

2. The filter online integrity testing system according to claim 1, characterized in that: The vertical support structure (12) is configured to include a plate-like structure (121), and the at least multiple sub-segments (131) and the at least one filter (11) are arranged on a vertical side of the plate-like structure (121) or distributed on both sides of the plate-like structure (121).

3. The filter online integrity testing system according to claim 2, characterized in that: The filter online integrity testing system (1) further comprises a waste liquid collection container (14) for collecting waste liquid from the pipeline system (13); the waste liquid collection container (14) is arranged beside the vertical support structure (12), and the lowest point of the collection area of ​​the waste liquid collection container (14) is lower than the pipeline system (13) and the filter (11).

4. The filter online integrity testing system according to claim 3, characterized in that: The filter (11) is connected in series to the inclined subsection (131) of the pipeline system (13), and the liquid-influent subsection (131) of the pipeline system (13) is connected upstream of the filter (11) in an upwardly inclined manner.

5. The filter online integrity testing system according to any one of claims 1 to 4, characterized in that: The filter online integrity testing system (1) further comprises an integrity detection device (15), wherein the integrity detection device (15) is connected to the upstream of the filter (11); and / or The filter online integrity testing system (1) further comprises a first sampling container (16) connected to the upstream of the filter (11) and capable of sampling the influent; and / or The filter online integrity testing system (1) further comprises a second sampling container (17) connected to the downstream of the filter (11) and capable of sampling the filtered liquid; and / or The filter online integrity test system (1) further comprises an exhaust container (18) connected to the filter (11) and capable of receiving exhaust gas from the filter (11); and / or The filter online integrity testing system (1) further comprises a flow controller (19) for controlling the flow of the pipeline system (13); and / or The filter online integrity testing system (1) further comprises a clamp (20) for holding the pipeline system (13) and / or the filter (11).

6. The filter online integrity testing system according to claim 5, characterized in that: The integrity detection device (15) is at least partially arranged on the back side of the vertical support structure (12); and / or At least one of the filter (11), the piping system (13), the first sampling container (16), the second sampling container (17), the exhaust container (18), and the clamp (20) is at least partially arranged on the operating side of the vertical support structure (12); and / or At least one of the first sampling container (16), the second sampling container (17), and the degassing container (18) is configured as a bag.

7. The filter online integrity testing system according to any one of claims 1-4 and 6, characterized in that: The filter online integrity testing system (1) further comprises a separate controller for controlling the automatic execution of the online integrity test.

8. The filter online integrity testing system according to any one of claims 1-4 and 6, characterized in that: The back side of the vertical support structure (12) is configured in a box shape; and / or The filter online integrity testing system (1) is applicable to a two-stage filter, each stage of the filter corresponding to one of the vertical support structures (12); and / or The filter online integrity testing system (1) is configured as an independent module.

9. A filling machine, characterized in that, The filling machine comprises an online filter integrity testing system (1) according to any one of claims 1-8.

10. The filling machine according to claim 9, characterized in that The filling machine comprises an isolator, and the filter online integrity testing system (1) is arranged outside the isolator.

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