Connection structure between intermediates, buffer and chromatography system

Abstract

The present invention provides a connection structure of an intermediate, a buffer and a chromatography system, which belongs to the technical field of pharmaceutical equipment, and includes a first pipeline, a second pipeline, a buffer feed pipeline, an intermediate product feed pipeline, and a low-point discharge / sterilization drain pipeline; a first valve is provided between the first pipeline and the second pipeline, each buffer feed pipeline is provided with a second valve, and one end is connected to the first pipeline, one end of the intermediate product feed pipeline is connected to the second pipeline, and the low-point discharge / sterilization drain pipeline is connected to the first pipeline and the second pipeline respectively. The connection structure of the intermediate, the buffer and the chromatography system provided by the present invention, after the staff connects the first pipeline, the second pipeline, the buffer feed pipeline, the intermediate product feed pipeline and the low-point discharge / sterilization drain pipeline and docks with the chromatography system, the separation operation and the cleaning / sterilization operation can be realized only by opening or closing the corresponding valves, which greatly reduces the labor intensity and saves time and effort.

Description

Technical Field

[0001] The invention belongs to the technical field of pharmaceutical equipment, and more specifically, relates to a connection structure of an intermediate, a buffer solution and a chromatography system. Background Art

[0002] In the biological stock solution preparation system, the downstream process usually uses a chromatography system to separate the components of the intermediate product. Usually, the intermediate product pipeline and the buffer solution pipeline need to be connected to the chromatography system. The buffer solution generally uses a variety of buffer solutions, so there are multiple stainless steel pipelines that need to be connected to the chromatography system. In production, an adapter plate is usually designed, and the intermediate product and buffer solution pipelines are connected to the adapter plate. Then, the intermediate product or buffer solution pipeline is manually connected to the chromatography system through a hose. This operation method requires multiple installation and removal of the hose, which is labor-intensive, time-consuming and labor-intensive. Summary of the invention

[0003] The object of the present invention is to provide a connection structure of an intermediate, a buffer solution and a chromatography system, so as to solve the technical problems existing in the prior art that the multiple disassembly and assembly of the hose is labor-intensive, time-consuming and labor-intensive.

[0004] To achieve the above object, the technical solution adopted by the present invention is: to provide a connection structure of an intermediate, a buffer and a chromatography system, comprising:

[0005] First pipeline;

[0006] a second pipeline connected to the first pipeline; a first valve is provided between the first pipeline and the second pipeline; an end of the second pipeline away from the first pipeline is used to be connected to the chromatography system;

[0007] There are multiple buffer solution feed pipelines, each of which is provided with a second valve; one end of each of the buffer solution feed pipelines is connected to the first pipeline;

[0008] The intermediate product feed pipeline is provided with a third valve; one end of the intermediate product feed pipeline is connected to the second pipeline;

[0009] a fourth valve, disposed on a side of the second pipeline away from the intermediate product feed pipeline;

[0010] There are two low-point discharge / sterilization drain pipelines, which are connected to the first pipeline and the second pipeline respectively, and are used for low-point emptying / pipeline sterilization condensate discharge of each of the buffer feed pipelines and the intermediate product feed pipelines.

[0011] As another embodiment of the present application, the low-point discharge / sterilization drain pipeline includes:

[0012] A condensed water discharge pipe, provided with a switch valve, connected to the first pipeline or the second pipeline, and used for discharging condensed water from online sterilization of a buffer feed pipeline or an intermediate product pipeline;

[0013] The sewage pipe is provided with a switch valve and is connected to the first pipeline or the second pipeline, and is used to empty and clean the sewage generated by the buffer solution feed pipeline and the intermediate product feed pipeline.

[0014] As another embodiment of the present application, the low-point discharge / sterilization drain pipeline further includes:

[0015] The CIP reflux pipe is connected to the first pipeline or the second pipeline and is used for online cleaning reflux of the buffer feed pipeline or the intermediate product feed pipeline; the CIP reflux pipe is provided with a switch valve.

[0016] As another embodiment of the present application, a temperature sensor is provided on the condensate discharge pipe.

[0017] As another embodiment of the present application, a plurality of the buffer solution feed pipelines are arranged in parallel on one side of the first pipeline.

[0018] As another embodiment of the present application, the first valve, the second valve, the third valve and the fourth valve are all pneumatic diaphragm valves.

[0019] As another embodiment of the present application, the connection structure between the intermediate, the buffer solution and the chromatography system also includes a control system, and the first valve, the second valve, the third valve and the fourth valve are all electrically connected to the control system.

[0020] The beneficial effects of the connection structure of the intermediate, buffer and chromatography system provided by the present invention are as follows: compared with the prior art, the connection structure of the intermediate, buffer and chromatography system of the present invention opens the second valve on the corresponding buffer feed pipeline, the third valve, the first valve and the fourth valve on the intermediate feed pipeline as needed, so that the buffer and the intermediate are connected to the chromatography system through the buffer feed pipeline, the intermediate feed pipeline, the first pipeline and the second pipeline and separated; after the separation operation is completed, the first valve and the fourth valve are closed to open the buffer feed pipeline and the intermediate feed pipeline, and the first pipeline and the buffer feed pipeline, the second pipeline and the intermediate feed pipeline are cleaned / sterilized by two low-point discharge / sterilization drain pipelines respectively connected to the first pipeline and the second pipeline. In this way, after the staff connects the first pipeline, the second pipeline, the buffer feed pipeline, the intermediate product feed pipeline and the low-point discharge / sterilization drain pipeline and docks them with the chromatography system, they only need to open or close the corresponding valves to perform separation operations and cleaning / sterilization operations, which greatly reduces labor intensity and saves time and effort. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0022] Figure 1 A schematic diagram of the structure of the connection structure of the intermediate, buffer and chromatography system provided in an embodiment of the present invention.

[0023] Among them, the reference numerals in the figure are:

[0024] 1. First pipeline; 2. Second pipeline; 21. First valve; 22. Fourth valve; 3. Buffer feed pipeline; 31. Second valve; 4. Intermediate product feed pipeline; 41. Third valve; 5. Low-point discharge / sterilization drain pipeline; 51. Condensate discharge pipe; 511. Temperature sensor; 52. Drain pipe; 53. Switch valve; 54. CIP reflux pipe; 6. Chromatography system. DETAILED DESCRIPTION

[0025] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0026] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or indirectly connected to the other element.

[0027] It should be understood that the orientation or position relationship indicated by terms such as "length", "width", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside" and "outside" are based on the orientation or position relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0028] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0029] See also Figure 1 Now, the connection structure of the intermediate, buffer and chromatography system provided by the present invention is described. A connection structure of an intermediate, a buffer and a chromatography system, comprising a first pipeline 1, a second pipeline 2, a buffer feed pipeline 3, an intermediate feed pipeline 4, a fourth valve 22 and a low-point discharge / sterilization drain pipeline 5; the second pipeline 2 is connected to the first pipeline 1; a first valve 21 is provided between the first pipeline 1 and the second pipeline 2; the end of the second pipeline 2 away from the first pipeline 1 is used to connect with the chromatography system 6; there are multiple buffer feed pipelines 3, all of which are provided with a second valve 31; one end of each buffer feed pipeline 3 is connected to the first pipeline 1; the intermediate feed pipeline 4 is provided with a third valve 41; one end of the intermediate feed pipeline 4 is connected to the second pipeline 2; the fourth valve 22 is provided on the side of the second pipeline 2 away from the intermediate feed pipeline 4; there are two low-point discharge / sterilization drain pipelines 5, which are respectively connected to the first pipeline 1 and the second pipeline 2, and are used for low-point emptying / pipeline sterilization condensate discharge of each buffer feed pipeline 3 and intermediate feed pipeline 4

[0030] Compared with the prior art, the connection structure of the intermediate, buffer and chromatography system provided by the present invention is as follows: the second valve 31 on the corresponding buffer feed pipeline 3, the third valve 41 on the intermediate feed pipeline 4, the first valve 21 and the fourth valve 22 are opened as needed, so that the buffer and the intermediate are connected to the chromatography system 6 through the buffer feed pipeline 3, the intermediate feed pipeline, the first pipeline 1 and the second pipeline 2 and separated; after the separation operation is completed, the first valve 21 and the fourth valve 22 are closed to open the buffer feed pipeline 3 and the intermediate feed pipeline 4, and the first pipeline 1 and the buffer feed pipeline 3, the second pipeline 2 and the intermediate feed pipeline 4 are cleaned / sterilized by two low-point discharge / sterilization drain pipelines 5 respectively connected to the first pipeline 1 and the second pipeline 2. In this way, after the staff connects the first pipeline 1, the second pipeline 2, the buffer feed pipeline 3, the intermediate product feed pipeline 4 and the low-point discharge / sterilization drain pipeline 5 and docks them with the chromatography system 6, they only need to open or close the corresponding valves to achieve separation operations and cleaning / sterilization operations, which greatly reduces labor intensity and saves time and effort.

[0031] See also Figure 1As a specific embodiment of the connection structure of the intermediate, buffer and chromatography system provided by the present invention, the low-point discharge / sterilization drain pipe 5 includes a condensed water discharge pipe 51 and a sewage pipe 52. The condensed water discharge pipe 51 is provided with a switch valve 53, which is connected to the first pipe 1 or the second pipe 2, and is used to feed water to the washing buffer feed pipe 3 and the intermediate feed pipe 4; the sewage pipe 52 is provided with a switch valve 53, which is connected to the first pipe 1 or the second pipe 2, and is used to discharge the sewage generated by the washing / sterilization buffer feed pipe 3 and the intermediate feed pipe 4. The switch valve 53 on the condensed water discharge pipe 51 is opened. , connecting the condensate discharge pipe 51 with the first pipeline 1 or the corresponding second pipeline 2, the water source passes through the condensate discharge pipe 51 and enters the first pipeline 1-buffer feed pipeline 3 or the second pipeline 2-intermediate product feed pipeline 4, so as to simultaneously and separately clean / sterilize the first pipeline 1-buffer feed pipeline 3 and the second pipeline 2-intermediate product feed pipeline 4. After the cleaning / sterilization is completed, close the switch valves 53 on the two condensate discharge pipes 51, open the switch valve 53 on the sewage pipe 52, so that the sewage generated after cleaning / sterilization enters the corresponding sewage pipe 52 and is discharged.

[0032] See also Figure 1 As a specific embodiment of the connection structure of the intermediate product, buffer solution and chromatography system provided by the present invention, the low-point discharge / sterilization drain pipe 5 also includes a CIP return pipe 54, which is connected to the first pipe 1 or the second pipe 2 and is used to recover the buffer solution or intermediate product in each buffer solution feed pipe 3 or the intermediate product feed pipe 4; a switch valve 53 is provided on the CIP return pipe 54, and after the operation between the intermediate product and the buffer solution and the chromatography system 6 is completed, the fourth valve 22 is closed, the second pipe 2 is connected to the chromatography system 6, and the intermediate product feed pipe 4 is connected to the second pipe 2. In order to reduce costs and avoid waste, two CIP return pipes 54 are respectively connected to the first pipe 1 and the second pipe 2. The switch valve 53 on the CIP return pipe 54 is opened, and the switch valves 53 on the condensate discharge pipe 51 and the sewage pipe 52 are closed, so that the intermediate product feed pipe 4, the buffer feed pipe 3, the first pipe 1 and the second pipe 2 can enter the corresponding CIP return pipe 54. The CIP return pipe 54 can be set below the first pipe 1 and the second pipe 2, and the residual intermediate product and buffer automatically flow into the CIP return pipe 54 under the action of gravity.

[0033] See also Figure 1As a specific embodiment of the connection structure of the intermediate product, buffer solution and chromatography system provided by the present invention, a temperature sensor 511 is provided on the condensed water discharge pipe 51. The temperature sensor 511 is provided to monitor the temperature in the condensed water discharge pipe 51, so that the water temperature of the intermediate product feed pipe 4 and the buffer solution feed pipe 3 for cleaning / sterilization is more suitable for cleaning / sterilization, and the cleaning / sterilization effect is better. The suitable water temperature will not cause energy waste.

[0034] See also Figure 1 As a specific embodiment of the connection structure of the intermediate product, buffer and chromatography system provided by the present invention, multiple buffer feed pipelines 3 are arranged in parallel on one side of the first pipeline 1. This parallel installation method occupies less space, and each buffer feed pipeline 3 can accurately add the corresponding buffer, and it is not easy to add the wrong buffer. At the same time, the operation of adding multiple buffers is also more convenient. The intermediate product feed pipeline 4 can be installed in parallel above the buffer feed pipeline 3.

[0035] See also Figure 1 As a specific embodiment of the connection structure of the intermediate, buffer and chromatography system provided by the present invention, the first valve 21, the second valve 31, the third valve 41 and the fourth valve 22 are all pneumatic diaphragm valves. The pneumatic diaphragm valves have good sealing performance. When the intermediate and buffer are added, there will be no leakage when the corresponding valve is opened or closed. The flow path is simple and the intermediate and buffer are subject to little resistance.

[0036] See also Figure 1 As a specific embodiment of the connection structure of the intermediate, buffer and chromatography system provided by the present invention, the connection structure of the intermediate, buffer and chromatography system also includes a control system, and the first valve 21, the second valve 31, the third valve 41 and the fourth valve 22 are all electrically connected to the control system, and the first valve 21, the second valve 31, the third valve 41 and the fourth valve 22 can be quickly and accurately controlled to open or close through the control system. A DP interface is set on the chromatography system 6, and the control system is connected to the chromatography system 6 through the DP interface for process interactive control to achieve full automatic operation of the system.

[0037] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A connection structure of an intermediate, a buffer and a chromatography system, characterized in that: include: First pipeline; a second pipeline connected to the first pipeline; A first valve is provided between the first pipeline and the second pipeline; an end of the second pipeline away from the first pipeline is used to connect to the chromatography system; There are multiple buffer solution feed pipelines, each of which is provided with a second valve; one end of each of the buffer solution feed pipelines is connected to the first pipeline; The intermediate product feed pipeline is provided with a third valve; one end of the intermediate product feed pipeline is connected to the second pipeline; a fourth valve, disposed on a side of the second pipeline away from the intermediate product feed pipeline; Two low-point discharge / sterilization drain pipelines are respectively connected to the first pipeline and the second pipeline, and are used for low-point emptying / pipeline sterilization condensate discharge of each of the buffer feed pipeline and the intermediate product feed pipeline; The buffer and the intermediate are connected to the chromatography system through the buffer feed pipeline, the intermediate feed pipeline, the first pipeline and the second pipeline and separated; After the separation operation is completed, the first valve and the fourth valve are closed to disconnect the buffer feed pipeline and the intermediate product feed pipeline, and the first pipeline and the buffer feed pipeline, the second pipeline and the intermediate product feed pipeline are cleaned / sterilized by two low-point discharge / sterilization drain pipelines respectively connected to the first pipeline and the second pipeline; A plurality of buffer solution feed pipelines are arranged in parallel on one side of the first pipeline; and the intermediate product feed pipelines are installed in parallel above the buffer solution feed pipelines.

2. The connection structure of the intermediate, buffer and chromatography system according to claim 1, characterized in that: The low point discharge / sterilization drain pipeline includes: A condensed water discharge pipe, provided with a switch valve, connected to the first pipeline or the second pipeline, and used for discharging condensed water from online sterilization of a buffer feed pipeline or an intermediate product pipeline; The sewage pipe is provided with a switch valve and is connected to the first pipeline or the second pipeline, and is used to empty and clean the sewage generated by the buffer solution feed pipeline and the intermediate product feed pipeline.

3. The connection structure of the intermediate, buffer and chromatography system according to claim 2, characterized in that: The low point discharge / sterilization drain line also includes: The CIP reflux pipe is connected to the first pipeline or the second pipeline and is used for online cleaning reflux of the buffer feed pipeline or the intermediate product feed pipeline; the CIP reflux pipe is provided with a switch valve.

4. The connection structure of the intermediate, buffer and chromatography system according to claim 2, characterized in that: The condensed water discharge pipe is provided with a temperature sensor.

5. The connection structure of the intermediate, buffer and chromatography system according to claim 1, characterized in that: The first valve, the second valve, the third valve and the fourth valve are all pneumatic diaphragm valves.

6. The connection structure of the intermediate, buffer and chromatography system according to claim 1, characterized in that: The connection structure of the intermediate, the buffer and the chromatography system also includes a control system, and the first valve, the second valve, the third valve and the fourth valve are all electrically connected to the control system.

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