A hollow fiber column transmembrane pressure control system

Abstract

This invention discloses a hollow fiber column transmembrane pressure control system, comprising: a hollow fiber column having an inlet end, an outlet end, and a filter end; a first delivery pump connected to the inlet end of the hollow fiber column; a second delivery pump connected to the outlet end of the hollow fiber column; an ultrasonic flow meter connected to the filter end of the hollow fiber column; and a pressure monitoring unit for monitoring the pressure at the inlet end, outlet end, and filter end of the hollow fiber column. This invention addresses the need for dynamic adjustment of transmembrane pressure due to changes in membrane flux throughout the entire service life of the hollow fiber column, overcoming the shortcomings of existing solutions.

Description

Technical Field

[0001] This utility model relates to the field of biopharmaceutical technology, and in particular to a hollow fiber column transmembrane pressure control system. Background Technology

[0002] In biopharmaceuticals, transmembrane pressure (TMP, formula: TMP=(P1+P2) / 2-P3) is a core parameter in the operation of hollow fiber columns, directly affecting separation efficiency, membrane lifetime, and system stability. Transmembrane pressure (TMP) is defined as the pressure difference across the membrane, which is the primary driving force propelling fluid through the membrane. Its definition is as follows: Figure 1 As shown.

[0003] In continuous perfusion processes, it is crucial to strictly control the transmembrane pressure to ensure that mammalian cell membranes are not damaged. Simultaneously, by appropriately adjusting the transmembrane pressure (TMP), the filtration efficiency of hollow fiber columns can be significantly improved, membrane fouling reduced, membrane structure stabilized, system energy consumption lowered, product quality enhanced, and operational stability ensured.

[0004] Existing methods for controlling TMP primarily involve installing a control valve on the flexible hose connected to the outlet end of the hollow fiber column. This valve allows for adjustment of the hose's cross-sectional area, thereby regulating the TMP level within the hollow fiber column. The main principle is as follows: Figure 2 As shown, rotating the knob above the screw allows the pressure block above the hose to move up and down, changing the flow cross-section of the pipeline; when the pressure block moves downward, it increases the TMP; when the pressure block moves upward, it decreases the TMP.

[0005] This method has two main drawbacks:

[0006] 1. The up-and-down movement of the pressure block cannot cause a linear change in the cross-section of the pipeline, resulting in a non-linear change in TMP. In other words, this manual method makes it difficult to accurately control the size of TMP.

[0007] Second, as the service life of the hollow fiber column increases, its internal membrane flux changes. In the initial stage of use, the membrane flux is higher, requiring less transmembrane pressure; towards the end of use, the membrane flux is lower, requiring more transmembrane pressure. Therefore, this manual method cannot meet the process requirements of biopharmaceuticals, which necessitate dynamic adjustment of transmembrane flux (TMP), nor can it meet the needs of automated production. Summary of the Invention

[0008] According to an embodiment of the present invention, a hollow fiber column transmembrane pressure control system is provided, comprising:

[0009] Hollow fiber column, which has an inlet end, an outlet end and a filter end;

[0010] The first delivery pump is connected to the inlet end of the hollow fiber column;

[0011] The second delivery pump is connected to the outlet end of the hollow fiber column;

[0012] Ultrasonic flow meter, the ultrasonic flow meter is connected to the filter end of the hollow fiber column;

[0013] The pressure monitoring unit is used to monitor the pressure at the inlet, outlet, and filter outlet of the hollow fiber column.

[0014] Furthermore, the pressure monitoring unit includes:

[0015] The first pressure gauge is used to monitor the pressure at the inlet end of the hollow fiber column;

[0016] The second pressure gauge is used to monitor the pressure at the outlet end of the hollow fiber column;

[0017] The third pressure gauge is used to monitor the pressure at the filter end of the hollow fiber column.

[0018] Furthermore, it also includes:

[0019] The first connecting pipe is connected between the first delivery pump and the inlet end of the hollow fiber column, and the first connecting pipe is connected to the first pressure gauge.

[0020] The second connecting pipe is connected between the outlet end of the second delivery pump and the hollow fiber column, and is connected to the second pressure gauge.

[0021] The third connecting pipe is connected between the ultrasonic flow meter and the filter end of the hollow fiber column, and is connected to the third pressure gauge.

[0022] Furthermore, both the first and second transfer pumps are centrifugal pumps.

[0023] According to an embodiment of the present invention, a transmembrane pressure control system for hollow fiber columns can meet the need for dynamic adjustment of transmembrane pressure caused by changes in membrane flux throughout the entire service life of the hollow fiber column, thus solving the shortcomings of existing solutions.

[0024] It should be understood that both the foregoing general description and the following detailed description are exemplary and intended to provide further illustration of the claimed technology. Attached Figure Description

[0025] Figure 1 Indicator diagram defined for TPM.

[0026] Figure 2A structural diagram of the control TMP in the prior art.

[0027] Figure 3 This is a structural diagram of a hollow fiber column transmembrane pressure control system according to an embodiment of the present invention. Detailed Implementation

[0028] The preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings, further illustrating the present invention.

[0029] First, combine Figure 3 This invention describes a hollow fiber column transmembrane pressure control system according to an embodiment of the present invention, which is used to dynamically adjust the transmembrane pressure and has a wide range of applications.

[0030] like Figure 3 As shown, an embodiment of the present invention provides a hollow fiber column transmembrane pressure control system, comprising a hollow fiber column 100, a first delivery pump 200, a second delivery pump 300, an ultrasonic flow meter 400, and a pressure monitoring unit.

[0031] Specifically, such as Figure 3 As shown, the hollow fiber column 100 has an inlet end, an outlet end, and a filter end. The hollow fiber column 100 is composed of several fibers. It blocks cells through a filter medium with a pore size smaller than the cell diameter, allowing cell debris, metabolic waste, and target products (such as antibodies and viruses) to pass through.

[0032] Specifically, such as Figure 3 As shown, the first delivery pump 200 is connected to the inlet end of the hollow fiber column 100. The first delivery pump 200 is a centrifugal pump, which can be used to increase the initial pressure of cell fluid entering the hollow fiber column 100 in the perfusion process.

[0033] Specifically, such as Figure 3 As shown, the second delivery pump 300 is connected to the outlet end of the hollow fiber column 100. The second delivery pump 300 is a centrifugal pump used to increase the outlet pressure of the hollow fiber column 100.

[0034] Specifically, such as Figure 3 As shown, the ultrasonic flow meter 400 is connected to the filter end of the hollow fiber column 100 and is used to monitor the flow rate at the filter end of the hollow fiber column 100.

[0035] Specifically, such as Figure 3As shown, the pressure monitoring unit is used to monitor the pressure at the inlet, outlet, and filter end of the hollow fiber column 100. The pressure monitoring unit includes a first pressure gauge 501, a second pressure gauge 502, and a third pressure gauge 503. The first pressure gauge 501 monitors the pressure at the inlet of the hollow fiber column 100 (i.e., P1). The pressure value of the cell fluid is fed back in real time by the first pressure gauge 501 to adjust the impeller speed of the first delivery pump 200, thereby ensuring that a constant pressure of cell fluid enters the hollow fiber column 100. The second pressure gauge 502 monitors the pressure at the outlet of the hollow fiber column 100 (i.e., P2). The third pressure gauge 503 monitors the pressure at the filter end of the hollow fiber column 100 (i.e., P3).

[0036] Furthermore, such as Figure 3 As shown, a hollow fiber column transmembrane pressure control system according to an embodiment of the present invention further includes: a first connecting pipe 601, a second connecting pipe 602, and a third connecting pipe 603. The first connecting pipe 601 is connected between the first delivery pump 200 and the inlet end of the hollow fiber column 100, and is connected to the first pressure gauge 501; the second connecting pipe 602 is connected between the second delivery pump 300 and the outlet end of the hollow fiber column 100, and is connected to the second pressure gauge 502; the third connecting pipe 603 is connected between the ultrasonic flow meter 400 and the filter end of the hollow fiber column 100, and is connected to the third pressure gauge 503.

[0037] Working principle explanation:

[0038] 1. In the initial stage of the perfusion process, there is no blockage in the fiber membrane of the hollow fiber column 100, the membrane permeability is good, and the membrane flux is large. At this time, the first delivery pump 200 below the hollow fiber column 100 is started as the power source for the cell fluid to cross the hollow fiber membrane, while the second delivery pump 300 above the hollow fiber column 100 is not started.

[0039] 2. Adjust the first delivery pump 200 below the hollow fiber column 100, use the ultrasonic flow meter 400 to monitor the flow rate at the filter end of the hollow fiber column 100, and at the same time calculate the TMP value by using the readings of the first pressure gauge 501, the second pressure gauge 502, and the third pressure gauge 503 to ensure that the TMP is within a controllable range.

[0040] 3. As the perfusion process time increases, the fiber membrane inside the hollow fiber column 100 becomes blocked, reducing membrane permeability and membrane flux. The values ​​of the second pressure gauge 502 and the third pressure gauge 503 decrease, and the TMP decreases simultaneously to the point that it can no longer meet the requirements of the perfusion process. At this time, the speed of the first delivery pump 200 below the hollow fiber column 100 is increased to improve the value of the first pressure gauge 501, and the second delivery pump 300 located above the hollow fiber column 100 is started to improve the value of the second pressure gauge 502. This method can eliminate the process risk caused by the reduced permeability of the fiber membrane.

[0041] 4. The impeller speeds of the second delivery pump 300 and the first delivery pump 200, located above and below the hollow fiber column 100, are dynamically adjusted, and the impeller speeds can be linearly changed to ensure that the TMP is within a reasonable working range and to achieve a constant reading of the ultrasonic flow meter 400 at the filter end of the hollow fiber column 100. This method meets the process requirements of dynamically adjusting TMP in biopharmaceuticals and also meets the requirements of automated production.

[0042] Above, refer to Figure 3 This invention describes a hollow fiber column transmembrane pressure control system according to an embodiment of the present invention, which can meet the need for dynamic adjustment of transmembrane pressure caused by changes in membrane flux throughout the entire service life of the hollow fiber column, and solves the shortcomings of existing solutions.

[0043] It should be noted that, in this specification, the terms "comprising," "including," or any other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0044] Although the present invention has been described in detail through the above preferred embodiments, it should be understood that the above description should not be considered as a limitation of the present invention. Various modifications and substitutions to the present invention will be apparent to those skilled in the art after reading the above content. Therefore, the scope of protection of the present invention should be defined by the appended claims.

Claims

1. A hollow fiber column transmembrane pressure control system, characterized by, Include: A hollow fiber column having an inlet end, an outlet end, and a filter end; A first delivery pump is connected to the inlet end of the hollow fiber column; A second delivery pump is connected to the outlet end of the hollow fiber column; An ultrasonic flow meter, wherein the ultrasonic flow meter is connected to the filter end of the hollow fiber column; A pressure monitoring unit is used to monitor the pressure at the inlet, outlet, and filter outlet of the hollow fiber column.

2. The hollow fiber column transmembrane pressure control system as described in claim 1, characterized in that, The pressure monitoring unit includes: The first pressure gauge is used to monitor the pressure at the inlet end of the hollow fiber column; The second pressure gauge is used to monitor the pressure at the outlet end of the hollow fiber column; The third pressure gauge is used to monitor the pressure at the filter end of the hollow fiber column.

3. The hollow fiber column transmembrane pressure control system as described in claim 2, characterized in that, Also includes: The first connecting pipe is connected between the first delivery pump and the inlet end of the hollow fiber column, and the first connecting pipe is connected to the first pressure gauge; The second connecting pipe is connected between the second delivery pump and the outlet end of the hollow fiber column, and the second connecting pipe is connected to the second pressure gauge; The third connecting pipe is connected between the ultrasonic flow meter and the filter end of the hollow fiber column, and the third connecting pipe is connected to the third pressure gauge.

4. The hollow fiber column transmembrane pressure control system as described in claim 1, characterized in that, Both the first delivery pump and the second delivery pump are centrifugal pumps.

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