CN220090742U

CN220090742U - Filtration system

Info

Publication number: CN220090742U
Application number: CN202321647603.1U
Authority: CN
Inventors: 刘佳; 姬志峰; 王雨卓
Original assignee: Wuxi Yaoming Biotechnology Co ltd
Current assignee: Wuxi Yaoming Biotechnology Co ltd
Priority date: 2023-06-27
Filing date: 2023-06-27
Publication date: 2023-11-28
Anticipated expiration: 2033-06-27

Abstract

The utility model belongs to the technical field of medicine production, and discloses a filtering system. The filtration system comprises a main pipeline, at least one main filter, at least one auxiliary filter and a sterile breaker, wherein the at least one main filter is arranged on the main pipeline, and the auxiliary filter is connected to the upstream of the at least one main filter. An aseptic breaker is arranged between the main filter and the auxiliary filter, the filter system realizes the shutoff of the auxiliary filter and the main pipeline through the shutoff of the aseptic breaker, and two fractures of the aseptic breaker in the disconnected state are kept in aseptic closure. The filter system can realize the integrity detection of all the main filters and the auxiliary filters before use on the premise of not affecting the sterility of the filter system.

Description

Filtration system

Technical Field

The utility model relates to the technical field of medicine production, in particular to a filtering system.

Background

The final sterilization and filtration process of the drug production uses a sterilization filter, and the sterilization filter needs to be subjected to integrity test after sterilization, before use and after use.

The sterilization filter comprises a main filter and an auxiliary filter, the filtering system in the prior art can only realize the online integrity test of the main filter before the product is filtered, the auxiliary filter can not carry out the online integrity test before the product is filtered, and the damaged auxiliary filter can be put into the filtering work, so that the whole set of filtering system has leakage risk.

Accordingly, a filtration system is needed to address the above issues.

Disclosure of Invention

The utility model aims to provide a filtering system which can realize the integrity detection of all main filters and auxiliary filters before use on the premise of not influencing the sterility of the filtering system.

To achieve the purpose, the utility model adopts the following technical scheme:

a filtration system comprising:

a main pipeline;

at least one main filter, at least one of which is provided on the main pipeline;

at least one auxiliary filter connected upstream of at least one of the main filters;

the sterile breaker is arranged between the main filter and the auxiliary filter, the filter system is used for realizing the disconnection of the auxiliary filter and the main pipeline through the disconnection of the sterile breaker, and two fractures of the sterile breaker in the disconnection state are kept in sterile closure.

Alternatively, the main filter comprises a first main filter and a second main filter which are connected in series, the first main filter is arranged at the upstream of the second main filter, and the auxiliary filter is connected in series at the upstream of the first main filter and/or the second main filter.

Alternatively, the auxiliary filter comprises a first auxiliary filter and a second auxiliary filter connected in parallel, the first auxiliary filter and the second auxiliary filter are arranged upstream of the first main filter, the first auxiliary filter is used for filtering the gas flowing through, and the second auxiliary filter is used for filtering the liquid flowing through.

As an alternative, the auxiliary filter further comprises a third auxiliary filter connected to the main line between the first main filter and the second main filter, the third auxiliary filter being in communication with the main line through an auxiliary line, the auxiliary line being provided with the sterile disconnect.

Alternatively, the main filter is provided with a second collecting means into which the gas in the main filter can enter.

Alternatively, the outlet end of the second main filter is provided with a first sterile connector.

Alternatively, the filtration system further comprises:

and a first collection device connected downstream of the first main filter and the second main filter, the test liquid or gas being able to drain into the first collection device through the auxiliary filter and the main filter.

Alternatively, a first valve is provided between the first collecting device and the first sterile connector.

As an alternative, the first collecting device is connected to the main pipeline through a collecting pipeline, and a second valve is arranged on the collecting pipeline and used for adjusting the on-off state of the collecting pipeline.

Alternatively, the inlet end of the first main filter is provided with a second sterile connector.

The beneficial effects are that:

in the filtering system provided by the utility model, when the integrity test is carried out, the integrity test equipment is connected to the inlet end of the auxiliary filter, the test liquid or gas is introduced from the inlet end of the auxiliary filter, and the liquid or gas sequentially passes through the auxiliary filter and the main filter to carry out the integrity test of the main filter. Then, the auxiliary filter is detached through the sterile breaker, two fractures of the sterile breaker are kept sterile closed, and the auxiliary filter is connected to the integrity test equipment for integrity test. The integrity test of the main filter and the auxiliary filter in the whole set of filter system before use is realized by arranging the sterile breaker, so that the damaged main filter or auxiliary filter is prevented from being put into filtering work.

Drawings

FIG. 1 is a schematic diagram of a filtration system according to an embodiment of the present utility model;

fig. 2 is a schematic structural view of a connection state of a sterile breaker according to an embodiment of the present utility model;

fig. 3 is a schematic view of a disconnection state of a sterile disconnect provided by an embodiment of the present utility model.

In the figure:

11. a first main filter; 12. a second main filter; 21. a first auxiliary filter; 22. a second auxiliary filter; 23. a third auxiliary filter; 3. a main pipeline; 4. a first collection device; 5. a sterile disconnect; 51. a first joint; 52. a second joint; 6. an auxiliary pipeline; 7. a second collection device; 8. a first sterile connector; 9. a first valve; 10. a second sterile connector; 20. a collecting pipeline; 30. and a second valve.

Detailed Description

The utility model is described in further detail below with reference to the drawings and examples. It is to be understood that the specific embodiments described herein are merely illustrative of the utility model and are not limiting thereof. It should be further noted that, for convenience of description, only some, but not all of the structures related to the present utility model are shown in the drawings.

In the description of the present utility model, unless explicitly stated and limited otherwise, the terms "connected," "connected," and "fixed" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. The specific meaning of the above terms in the present utility model will be understood in specific cases by those of ordinary skill in the art.

In the present utility model, unless expressly stated or limited otherwise, a first feature "above" or "below" a second feature may include both the first and second features being in direct contact, as well as the first and second features not being in direct contact but being in contact with each other through additional features therebetween. Moreover, a first feature being "above," "over" and "on" a second feature includes the first feature being directly above and obliquely above the second feature, or simply indicating that the first feature is higher in level than the second feature. The first feature being "under", "below" and "beneath" the second feature includes the first feature being directly under and obliquely below the second feature, or simply means that the first feature is less level than the second feature.

In the description of the present embodiment, the terms "upper", "lower", "left", "right", and the like are orientation or positional relationships based on those shown in the drawings, merely for convenience of description and simplicity of operation, and do not indicate or imply that the apparatus or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the utility model. Furthermore, the terms "first," "second," and the like, are used merely for distinguishing between descriptions and not for distinguishing between them.

As shown in fig. 1, the present embodiment provides a filtration system including a main line 3, at least one main filter provided on the main line 3, at least one auxiliary filter connected to an upstream of the at least one main filter, and a sterile breaker 5. An aseptic breaker 5 is arranged between the main filter and the auxiliary filter, the filter system realizes the shutoff of the auxiliary filter and the main pipeline 3 through the shutoff of the aseptic breaker 5, and two fractures of the aseptic breaker 5 in the disconnected state keep sterile closed.

When the integrity test is carried out, the integrity test equipment is connected to the inlet end of the auxiliary filter, the test liquid or gas is introduced from the inlet end of the auxiliary filter, and the liquid or gas sequentially passes through the auxiliary filter and the main filter to carry out the integrity test of the main filter. The auxiliary filter is then detached by means of the sterile breaker 5 and the two interruptions of the sterile breaker are kept sterile closed, the auxiliary filter being connected to the integrity test equipment for integrity testing. The integrity test of the main filter and the auxiliary filter in the whole set of filtering system before use is realized by arranging the sterile breaker 5, so that the damaged main filter or auxiliary filter is prevented from being put into filtering work. The integrity test of the filter by using the integrity test device is a mature technical means in the prior art, and specific test principles and connection modes are not described in detail herein.

Specifically, referring to fig. 2 and 3, the aseptic decoupler 5 includes a first joint 51 and a second joint 52, the first joint 51 and the second joint 52 may be connected by a snap fit or screw fit, and a seal is provided at the connection to achieve a sealed connection. The first joint 51 and the second joint 52 are each provided with a shutoff valve therein so as to be able to maintain sealing after the first joint 51 and the second joint 52 are disconnected. The sterile breaker 5 is only required to adopt a breaker structure existing in the prior art, and the specific structure and working principle thereof are not described in detail here.

Further, as shown in fig. 1, the main filter includes a first main filter 11 and a second main filter 12 connected in series, the first main filter 11 is disposed upstream of the second main filter 12, and an auxiliary filter is connected in series upstream of the first main filter 11 and/or the second main filter 12. That is, the auxiliary filters may be provided upstream of both the first main filter 11 and the second main filter 12, or may be provided upstream of either one of the first main filter 11 and the second main filter 12.

Specifically, as shown in fig. 1, the auxiliary filter includes a first auxiliary filter 21 and a second auxiliary filter 22 connected in parallel, the first auxiliary filter 21 being an air filter for filtering the gas flowing therethrough, and the second auxiliary filter 22 being a sterilizing filter for filtering the liquid flowing therethrough.

Optionally, the auxiliary filter further comprises a third auxiliary filter 23, the third auxiliary filter 23 being connected to the main line 3 between the first main filter 11 and the second main filter 12, the third auxiliary filter 23 being in communication with the main line 3 via an auxiliary line 6, the auxiliary line 6 being provided with a sterile breaker 5. The third auxiliary filter 23 is also an air filter, and the third auxiliary filter 23 can be detached by means of the above-mentioned sterile breaker 5 to enable an integrity test in connection with the integrity test equipment.

Further, the filtration system further comprises a first collecting device 4, the first collecting device 4 being connected downstream of the first main filter 11 and the second main filter 12, the test liquid or gas being able to drain into the first collecting device 4 via the auxiliary filter and the main filter.

Optionally, a first aseptic connector 8 is provided at the outlet end of the second main filter 12, and a second aseptic connector 10 is provided at the inlet end of the first main filter 11, the first aseptic connector 8 and the second aseptic connector 10 being respectively for aseptic connection with external equipment. Wherein, a first valve 9 is arranged between the first collecting device 4 and the first sterile connector 8 to control the on-off of the main pipeline 3 between the first collecting device 4 and the first sterile connector 8.

Alternatively, as shown in fig. 1, the outlet ends of the first main filter 11 and the second main filter 12 are each connected to the first collecting device 4, so that the liquid or gas discharged from the first main filter 11 and the second main filter 12 can be collected in the first collecting device 4. Specifically, the first collecting device 4 is connected to the main pipeline 3 through a collecting pipeline 20, a second valve 30 is arranged on the collecting pipeline 20, and the second valve 30 is used for adjusting the on-off state of the collecting pipeline 20.

Further, as shown in fig. 1, the main filter is provided with a second collecting means 7, and the gas in the main filter can enter the second collecting means 7. The first main filter 11 and the second main filter 12 are both connected with the second collecting device 7, and when liquid is injected into the main filter, gas in the main filter can be extruded into the second collecting device 7, so that the rapid injection of the liquid is facilitated.

The testing steps are as follows:

s1: before the whole set of the filtering system is put into production, liquid is introduced from the second auxiliary filter 22 to wet the first main filter 11 and the second main filter 12, the first main filter 11 and the second main filter 12 are exhausted into the second collecting device 7, and flushing waste gas and flushing waste liquid enter the first collecting device 4;

s2: connecting the inlet end of the first auxiliary filter 21 with an integrity test device, and introducing test gas to perform integrity test on the first main filter 11 and the second main filter 12;

s3: after the first main filter 11 and the second main filter 12 are tested, the whole first auxiliary filter 21, the whole second auxiliary filter 22 and the whole third auxiliary filter 23 are respectively detached and respectively connected with an integrity test device for integrity test under the premise of guaranteeing the sterility of the system through the sterile breaker 5;

s4: and after all the main filters and the auxiliary filters pass through the integrity test, the whole set of filter system is used for sterilizing and filtering in medicine production.

It is to be understood that the above examples of the present utility model are provided for clarity of illustration only and are not limiting of the embodiments of the present utility model. Various obvious changes, rearrangements and substitutions can be made by those skilled in the art without departing from the scope of the utility model. It is not necessary here nor is it exhaustive of all embodiments. Any modification, equivalent replacement, improvement, etc. which come within the spirit and principles of the utility model are desired to be protected by the following claims.

Claims

1. A filtration system, comprising:

a main pipeline (3);

at least one main filter, at least one of which is arranged on the main line (3);

the sterile breaker (5) is arranged between the main filter and the auxiliary filter, the filter system achieves the closing of the auxiliary filter and the main pipeline (3) through the closing of the sterile breaker (5), and two fractures of the sterile breaker (5) in the opened state are kept sterile closed.

2. The filtration system according to claim 1, characterized in that the main filter comprises a first main filter (11) and a second main filter (12) connected in series, the first main filter (11) being arranged upstream of the second main filter (12), the first main filter (11) and/or the second main filter (12) being connected in series with the auxiliary filter.

3. The filtration system according to claim 2, characterized in that the auxiliary filter comprises a first auxiliary filter (21) and a second auxiliary filter (22) connected in parallel, the first auxiliary filter (21) and the second auxiliary filter (22) being arranged upstream of the first main filter (11), the first auxiliary filter (21) being intended to filter the gas flowing therethrough and the second auxiliary filter (22) being intended to filter the liquid flowing therethrough.

4. The filtration system according to claim 2, characterized in that the auxiliary filter further comprises a third auxiliary filter (23), the third auxiliary filter (23) being connected to the main line (3) between the first main filter (11) and the second main filter (12), the third auxiliary filter (23) being in communication with the main line (3) through an auxiliary line (6), the auxiliary line (6) being provided with the aseptic decoupler (5).

5. A filter system according to any one of claims 1-4, characterized in that the main filter is provided with a second collecting device (7), the gas in the main filter being able to enter the second collecting device (7).

6. A filter system according to any of claims 2-4, characterized in that the outlet end of the second main filter (12) is provided with a first sterile connector (8).

7. The filtration system of claim 6, wherein the filtration system further comprises:

-a first collecting device (4) connected downstream of said first main filter (11) and said second main filter (12), through which test liquid or gas can be discharged into said first collecting device (4).

8. The filtration system according to claim 7, wherein a first valve (9) is arranged between the first collecting means (4) and the first aseptic connector (8).

9. The filtering system according to claim 7, characterized in that the first collecting device (4) is connected to the main pipeline (3) through a collecting pipeline (20), a second valve (30) is arranged on the collecting pipeline (20), and the second valve (30) is used for adjusting the on-off state of the collecting pipeline (20).

10. A filter system according to any of claims 2-4, characterized in that the inlet end of the first main filter (11) is provided with a second aseptic connector (10).