A sanitary column position valve for biopharmaceutical applications

Abstract

This utility model discloses a sanitary column valve for biopharmaceutical applications, suitable for multi-process fluid control in the biopharmaceutical field. Its octagonal prism valve body has a working position at the top, and four ports and four other working positions are alternately arranged on its eight sides. The valve body has four straight internal flow channels that connect sequentially to the four working positions on the sides to form a passage. The four ports are designated A, P, B, and T. Ports A and B are connected to the two internal flow channels via port flow channels in a T-shape, while ports P and T are connected to the two internal flow channels via port flow channels in a cross-shape. Ports P and T are also connected via port flow channels, and their intersection is directly connected to the working position at the top. This design features a compact structure, replacing complex external piping connections with internal flow channel construction, saving installation space. The simplified straight flow channels and zero dead volume design effectively prevent contaminant accumulation.

Description

Technical Field

[0001] This utility model relates to a column position valve, and more particularly to a sanitary column position valve for use in biopharmaceuticals, belonging to the field of biopharmaceutical technology. Background Technology

[0002] Traditional multi-port column valves (such as multi-position valves) have complex and meandering internal flow channels. The path of the liquid from the inlet to the outlet is not a straight line, but needs to turn and detour multiple times in the valve body and valve core. Therefore, it is easy to form a "dead volume" that is difficult to be flushed by the liquid.

[0003] However, these stagnant areas often cannot be effectively flushed, exchanged, or emptied by the mainstream fluid, leading to many drawbacks. For example, when switching buffers or from one product to another, the previous batch of fluid (which may contain high concentrations of product or other impurities) stagnating in the dead volume will slowly diffuse into the next batch, causing contamination and reduced yield. In chromatographic purification, precise salt concentrations or pH gradients are crucial, but the old buffer in the dead volume will mix with and "contaminate" the new buffer, causing gradient curve distortion, peak tailing, or reduced resolution, severely affecting purification results. In addition, the dead volume is the area most difficult for washing fluid and sterilizing steam to reach and replace. Residual proteins or contaminants may become a nutrient source for microbial growth, and steam cannot completely penetrate it, increasing the risk to aseptic assurance.

[0004] Therefore, it is necessary to propose a hygienic column position valve for biopharmaceuticals to improve cleanability, reduce leakage risk, enhance the reliability of chromatography systems, and effectively shorten the cleaning validation cycle, thereby further promoting the development of biopharmaceuticals towards continuous production and higher compliance. Summary of the Invention

[0005] The purpose of this invention is to solve the above-mentioned problems and provide a sanitary column position valve for use in biopharmaceuticals.

[0006] The technical solution of this utility model is: a sanitary column valve for biopharmaceutical applications, comprising an octagonal prism valve body having a top surface, a bottom surface, and eight side surfaces, and further comprising a valve core adapted to and rotatably disposed within the valve body cavity. The key feature is that the top surface of the octagonal prism valve body is provided with a first working position, and four working positions and four ports are alternately arranged circumferentially on the eight side surfaces. The four working positions are sequentially defined as a second working position, a third working position, a fourth working position, and a fifth working position. The port between the second working position and the third working position... The port is defined as port A, the port between the third working position and the fourth working position is defined as port P, the port between the fourth working position and the fifth working position is defined as port B, and the port between the fifth working position and the first working position is defined as port T. The interior of the regular octagonal prism valve body forms a valve cavity and four independent internal flow channels are provided in the valve cavity. Each internal flow channel is a straight flow channel, and the two ends of each internal flow channel are respectively connected to two adjacent working positions on the side of the regular octagonal prism valve body. The four working positions are connected through the four internal flow channels to form a complete passage.

[0007] Furthermore, in the aforementioned sanitary column valve for biopharmaceutical applications: the A port is connected to the first inner flow channel via a first port flow channel, and the first port flow channel and the first inner flow channel form a T-shaped channel; the B port is connected to the third inner flow channel via a third port flow channel, and the third port flow channel and the third inner flow channel form a T-shaped channel.

[0008] Furthermore, in the aforementioned sanitary column valve for biopharmaceutical applications, the P port is connected to the second inner flow channel via a second port flow channel, forming a cross-shaped channel with the second inner flow channel; the T port is connected to the fourth inner flow channel via a fourth port flow channel, forming a cross-shaped channel with the fourth inner flow channel.

[0009] Furthermore, in the aforementioned sanitary column valve for biopharmaceutical applications, the second port flow channel and the fourth port flow channel are interconnected inside the octagonal prism valve body, and their connection point is directly connected to the first working position through the valve cavity.

[0010] Furthermore, in the aforementioned sanitary column valve for biopharmaceutical applications, the four internal flow channels are sequentially defined as a first internal flow channel, a second internal flow channel, a third internal flow channel, and a fourth internal flow channel. The first internal flow channel is connected between the second working position and the third working position; the second internal flow channel is connected between the third working position and the fourth working position; the third internal flow channel is connected between the fourth working position and the fifth working position; and the fourth internal flow channel is connected between the fifth working position and the first internal flow channel.

[0011] Furthermore, in the aforementioned sanitary column valve for biopharmaceutical applications, the openings of the A, P, B, and T ports on the octagonal prism valve body are configured to connect to quick-connect fittings, each of which is connected to its corresponding port via a gasket.

[0012] Furthermore, in the aforementioned sanitary column valve for biopharmaceutical applications, the second, third, fourth, and fifth working positions are configured to connect to a pneumatic diaphragm valve.

[0013] Compared with existing technologies, the column position valve has a compact overall structure after adopting the technical solution of this utility model. The internal flow channel structure replaces the complex external pipeline connection, which greatly saves installation space and makes the layout simpler. The simplified straight flow channel and zero dead volume design effectively clean and prevent the accumulation of contaminants, reduce the degradation of packing material, help maintain the loading and separation performance of the chromatography column, extend its service life, ensure batch consistency, and make it easier to be cleaned and validated. This results in fewer sampling points required, a simpler validation scheme, and a higher pass rate, saving a lot of time and resources. Attached Figure Description

[0014] Figure 1 This is a schematic diagram of the structure of the sanitary column valve of this utility model under test conditions;

[0015] Figure 2 This is an exploded view of the sanitary column valve of this utility model under test conditions;

[0016] Figure 3 for Figure 1 Top view of a sanitary column valve under test conditions;

[0017] Figure 4 This is a pipeline and instrumentation flow diagram of this utility model;

[0018] Figure 5 This is a schematic diagram of the structure of the regular octagonal prism valve body of this utility model;

[0019] Figure 6 for Figure 5 Top view of the octagonal valve body;

[0020] Figure 7 This is a cross-sectional schematic diagram of the regular octagonal prism valve body of this utility model.

[0021] The meanings of the labels in the figures are as follows: 1-Octagonal prism valve body, 10-Valve inner cavity, 11-First working position, 12-Second working position, 13-Third working position, 14-Fourth working position, 15-Fifth working position, 16-First inner flow channel, 17-Second inner flow channel, 18-Third inner flow channel, 19-Fourth inner flow channel, 20-Port A, 21-First port flow channel, 22-Port P, 23-Second port flow channel, 24-Port B, 25-Third port flow channel, 26-Port T, 27-Fourth port flow channel, 2-Pneumatic diaphragm valve, 3-Quick connector, 4-Gasket. Detailed Implementation

[0022] The technical solution of this utility model will be further described below with reference to the accompanying drawings to make it easier to understand and master. The pneumatic diaphragm valve 2, quick connector 3, and gasket 4 involved are all commonly used components that are generally recognized by those skilled in the art, and there are no special requirements for them in this application.

[0023] like Figures 1-3 As shown, this utility model provides a sanitary column valve for biopharmaceutical applications, including an octagonal prism valve body 1. The octagonal prism valve body 1 has a top surface, a bottom surface, and eight side surfaces. It also includes a valve core that is adapted to and assembled with the octagonal prism valve body 1 and rotatably disposed in its valve cavity 10. The valve core has a communication structure that cooperates with the inner flow channel. The five different rotation positions of the valve core correspond to the five different predefined flow path states, realizing the control function of the multi-way valve. By rotating the valve core, the communication relationship between each port through the working position and the inner flow channel is changed, thereby forming at least five different predefined flow path states.

[0024] According to the technical solution of this utility model, such as Figures 5-7As shown, the top surface of the regular octagonal prism valve body 1 is provided with a first working position 11. Four working positions and four ports are also alternately arranged circumferentially on the eight sides. The four working positions are sequentially defined as the second working position 12, the third working position 13, the fourth working position 14, and the fifth working position 15. The port between the second working position 12 and the third working position 13 is defined as port A 20 (i.e., the first control output port). The port between the third working position 13 and the fourth working position 14 is defined as port P 22 (i.e., connected to a compressed air source (power source)). The fourth working position 14 and the fifth working position... The port in the middle of the fifth working position 15 is defined as port B 24 (i.e., the second control output port), and the port between the fifth working position 15 and the first working position 11 is defined as port T 26 (i.e., the exhaust port (to discharge used compressed air to the atmosphere)). The interior of the regular octagonal prism valve body 1 forms a valve cavity 10, and four independent internal flow channels are provided in this valve cavity 10. Each internal flow channel is a straight flow channel, and both ends of each internal flow channel are connected to two adjacent working positions on the side of the regular octagonal prism valve body 1. The four working positions are connected through the four internal flow channels to form a complete passage. Port A 20 is connected to the first internal flow channel 16 through the first port flow channel 21, and the first port flow channel 21 and the first internal flow channel 16 form a T-shaped channel. Port B 24 is connected to the third internal flow channel 18 through the third port flow channel 25, and the third port flow channel 25 and the third internal flow channel 18 form a T-shaped channel. The P-port 22 is connected to the second inner flow channel 17 via the second port flow channel 23, forming a cross-shaped channel. The T-port 26 is connected to the fourth inner flow channel 19 via the fourth port flow channel 27, forming a cross-shaped channel. The second port flow channel 23 and the fourth port flow channel 27 are interconnected inside the octagonal prism valve body 1. Their connection point is directly connected to the first working position 11 through the valve inner cavity 10, forming a pressure relief / balancing passage, reducing air pressure loss and response delay.

[0025] Preferably, in the above structure: the four inner flow channels are sequentially defined as a first inner flow channel 16, a second inner flow channel 17, a third inner flow channel 18, and a fourth inner flow channel 19. The first inner flow channel 16 is connected between the second working position 12 and the third working position 13. The second inner flow channel 17 is connected between the third working position 13 and the fourth working position 14. The third inner flow channel 18 is connected between the fourth working position 14 and the fifth working position 15. The fourth inner flow channel 19 is connected between the fifth working position 15 and the first inner flow channel 16.

[0026] Specifically, in the structure of the sanitary column valve for biopharmaceuticals described above, the openings of port A 20, port P 22, port B 24 and port T 26 on the octagonal prism valve body 1 are configured to connect to quick connectors 3. Each quick connector 3 is connected to the corresponding port through a gasket 4. Typically, the gasket 4 uses an O-ring seal, which provides good sealing while allowing for a certain amount of pipeline stress release and good vibration adaptability.

[0027] Specifically, in the structure of the above-mentioned sanitary column valve for biopharmaceuticals, the second working position 12, the third working position 13, the fourth working position 14 and the fifth working position 15 are configured to connect to the pneumatic diaphragm valve 2. The octagonal prism valve body 1 controls the flow direction of compressed air and uses compressed air as a power source to drive the pneumatic diaphragm valve 2 to perform operations, thereby opening or closing the pneumatic diaphragm valve 2 that is in contact with the drug liquid.

[0028] In this utility model's technical solution, a compact five-position four-way valve body with highly integrated multi-channel air passages is used. The internal flow channel structure of the valve body is simplified and changed to a straight flow channel and a zero dead volume design. The combination of these two aspects is the key technology of this case. Figure 7 The focus is on showcasing the specific structure of the internal components and flow channels of the regular octagonal prism valve body 1. For components such as the internal flow channels, port flow channels, and ports, those skilled in the art can perform conventional setups based on existing technology; this application does not have any special requirements regarding model selection or combination.

[0029] Thus, as Figure 4 As shown, using the technical solution of this utility model, a quick connector 3 is installed on the P port 22 to introduce compressed air (power source) into the interior of the octagonal prism valve body 1. The compressed air enters the second inner flow channel 17 through the second port flow channel 23, and is then diverted by the second port flow channel 23 to the pneumatic diaphragm valves 2 on the first working position 11, the third working position 13, and the fourth working position 14. The pneumatic diaphragm valve 2 on the first working position 11 discharges the compressed air through the quick connector 3 connected directly to the T port 26 (discharging the used compressed air to the atmosphere); the pneumatic diaphragm valve 2 on the third working position 13 discharges the compressed air through the quick connector 3 connected directly to the T port 26. The compressed air enters the pneumatic diaphragm valve 2 at the second working position 12 through the inner flow channel 16. The pneumatic diaphragm valve 2 at the second working position 12 then merges the compressed air through the fourth inner flow channel 19 to the T-port 26 to connect to the exhaust port (discharging the used compressed air to the atmosphere). The pneumatic diaphragm valve 2 at the fourth working position 14 then enters the pneumatic diaphragm valve 2 at the fifth working position 15 through the third inner flow channel 18. The pneumatic diaphragm valve 2 at the fifth working position 15 then merges the compressed air through the fourth inner flow channel 19 to the T-port 26 to connect to the exhaust port (discharging the used compressed air to the atmosphere), completing the gas flow of the valve body. This can be used to verify the pressure holding test of the entire valve.

[0030] As can be seen from the above description, compared with the prior art, after adopting the technical solution of this utility model, the column position valve has a compact overall structure and highly integrated multi-channel gas path. The internal flow channel structure replaces the complex external pipeline connection, which greatly saves installation space and makes the layout simpler and more compact. The simplified straight flow channel and zero dead volume design effectively clean and prevent the accumulation of contaminants, reduce the degradation of packing material, help maintain the loading and separation performance of the chromatography column, extend its service life, ensure batch-to-batch consistency, and make it easier to be cleaned and verified. This results in fewer sampling points required, a simpler verification scheme, and a higher pass rate, saving a lot of time and resources.

[0031] The technical solution, working process and implementation effect of this utility model have been described in detail above. It should be noted that the described example is only a typical example of this utility model. In addition, this utility model may have many other specific implementation methods. All technical solutions formed by equivalent substitution or equivalent transformation fall within the scope of protection claimed by this utility model.

Claims

1. A sanitary column position valve for biopharmaceutical applications, comprising an octagonal prism valve body (1) having a top surface, a bottom surface, and eight side surfaces, characterized in that: The top surface of the regular octagonal prism valve body (1) is provided with a first working position (11), and four working positions and four ports are alternately arranged along the circumference on the eight sides. The four working positions are defined as the second working position (12), the third working position (13), the fourth working position (14), and the fifth working position (15) in sequence. The port between the second working position (12) and the third working position (13) is defined as port A (20), and the port between the third working position (13) and the fourth working position (14) is defined as port P (22). The fourth working position (14) The port between the fifth working position (15) and the first working position (11) is defined as port B (24), and the port between the fifth working position (15) and the first working position (11) is defined as port T (26). The interior of the regular octagonal prism valve body (1) forms a valve cavity (10) and four independent internal flow channels are provided in the valve cavity (10). Each internal flow channel is a straight flow channel, and the two ends of each internal flow channel are respectively connected to two adjacent working positions on the side of the regular octagonal prism valve body (1). The four working positions are connected through the four internal flow channels to form a complete passage.

2. The sanitary column position valve for biopharmaceutical applications according to claim 1, characterized in that: The four internal flow channels are defined sequentially as a first internal flow channel (16), a second internal flow channel (17), a third internal flow channel (18), and a fourth internal flow channel (19). The first internal flow channel (16) is connected between the second working position (12) and the third working position (13). The second internal flow channel (17) is connected between the third working position (13) and the fourth working position (14). The third internal flow channel (18) is connected between the fourth working position (14) and the fifth working position (15). The fourth internal flow channel (19) is connected between the fifth working position (15) and the first internal flow channel (16).

3. A sanitary column position valve for biopharmaceutical applications according to claim 2, characterized in that: The A port (20) is connected to the first inner channel (16) through the first port flow channel (21), and the first port flow channel (21) and the first inner channel (16) form a T-shaped channel; the B port (24) is connected to the third inner channel (18) through the third port flow channel (25), and the third port flow channel (25) and the third inner channel (18) form a T-shaped channel.

4. A sanitary column position valve for biopharmaceutical applications according to claim 2, characterized in that: The P port (22) is connected to the second inner channel (17) through the second port flow channel (23), and the second port flow channel (23) and the second inner channel (17) form a cross-shaped channel; the T port (26) is connected to the fourth inner channel (19) through the fourth port flow channel (27), and the fourth port flow channel (27) and the fourth inner channel (19) form a cross-shaped channel.

5. A sanitary column position valve for biopharmaceutical applications according to claim 4, characterized in that: The second port flow channel (23) and the fourth port flow channel (27) are interconnected inside the regular octagonal prism valve body (1), and their connection position is directly connected to the first working position (11) through the valve cavity (10).

6. A sanitary column position valve for biopharmaceutical applications according to claim 1, characterized in that: The openings of the A port (20), P port (22), B port (24) and T port (26) on the octagonal prism valve body (1) are configured to connect to quick connectors (3), and each quick connector (3) is connected to the corresponding port one by one through a gasket (4).

7. A sanitary column position valve for biopharmaceutical applications according to claim 1, characterized in that: The second working position (12), the third working position (13), the fourth working position (14) and the fifth working position (15) are configured to connect to the pneumatic diaphragm valve (2).

8. A sanitary column position valve for biopharmaceutical applications according to claim 1, characterized in that: It also includes a valve core that is adapted to be assembled with the regular octagonal prism valve body (1) and rotatably disposed in the valve cavity (10).

Images