Aseptic terminal solution preparation system

Abstract

The application discloses a sterile terminal liquid preparation system, relates to the technical field of solution pipeline transportation, and comprises a main liquid supply pipeline, a liquid inlet of the main liquid supply pipeline is used for being connected with a liquid preparation tank, a distribution pipeline is connected to the main liquid supply pipeline, the distribution pipeline is used for being connected with a sterile terminal, a first control valve is arranged on the distribution pipeline, a sterilization pipeline is further connected to the distribution pipeline, the sterilization pipeline is used for being connected with a sterilization medium so as to sterilize the distribution pipeline, and a second control valve is arranged on the sterilization pipeline. The application can realize online sterilization of the distribution pipeline and valves arranged on the distribution pipeline, and improves the sterilization effect.

Description

Technical Field

[0001] This invention relates to the field of solution pipeline transportation technology, and in particular to a sterile terminal solution preparation system. Background Technology

[0002] In the production of biological products and vaccines, mobile tanks are often used for solution transportation. To improve the efficiency of material transfer, large tank preparation and pipeline transportation is receiving increasing attention. Large tank preparation and pipeline transportation involves preparing the solution in a large tank and then transporting it through pipelines to small containers in a sterile terminal.

[0003] Traditional aseptic terminals only have a distribution valve at the end of the circulation pipeline, with the pipeline connecting to the dispensed containers at the rear end. Sterilization is difficult to implement, online sterilization cannot be achieved, and there are certain risks associated with aseptic connection. Summary of the Invention

[0004] The purpose of this invention is to provide a sterile terminal liquid preparation system to solve the problems existing in the prior art, and to achieve online sterilization of the distribution pipeline and its valves, thereby improving the cleaning and sterilization effect.

[0005] To achieve the above objectives, the present invention provides the following solution:

[0006] This invention provides a sterile terminal liquid preparation system, including a main liquid supply pipeline, the inlet of which is connected to a liquid preparation tank, a distribution pipeline connected to the main liquid supply pipeline, the distribution pipeline being connected to a sterile terminal, and a first control valve provided on the distribution pipeline; a sterilization pipeline is also connected to the distribution pipeline, the sterilization pipeline being used to introduce a sterilization medium to sterilize the distribution pipeline, and a second control valve provided on the sterilization pipeline.

[0007] Preferably, the outlet of the main liquid supply pipeline is connected to the liquid distribution tank; and a fifth control valve is provided at one end of the main liquid supply pipeline near its inlet, and a first temperature sensor is provided at one end of the main liquid supply pipeline near its outlet. Both the fifth control valve and the first temperature sensor are electrically connected to the terminal controller.

[0008] Preferably, the main liquid supply pipeline includes multiple U-shaped pipelines arranged sequentially along the liquid flow direction. The bottom end of each U-shaped pipeline is connected to a distribution pipeline. The distribution pipeline is also provided with a drain port for discharging the condensate formed at the bottom end of the U-shaped pipeline. A drain valve is provided at the drain port, and a second temperature sensor is provided near the drain port on the distribution pipeline. The second temperature sensor is electrically connected to the terminal controller.

[0009] Preferably, the distribution pipeline is further provided with a control valve group, which is connected to the first control valve and the sterile terminal, and is also connected to the drain valve.

[0010] Preferably, the control valve assembly includes a third control valve and a fourth control valve, wherein the third control valve is a three-way valve, the A port of the three-way valve is connected to the first control valve, the B port of the three-way valve is connected to the drain valve, and the C port of the three-way valve is connected to the sterile terminal through the fourth control valve.

[0011] Preferably, the third control valve is a pneumatic three-way diaphragm valve or a pneumatic three-way ball valve, and the fourth control valve is a two-way manual diaphragm valve.

[0012] Preferably, the control valve assembly is detachably installed on the distribution pipeline.

[0013] Preferably, the first control valve is a two-way pneumatic diaphragm valve. The first control valve is electrically connected to a terminal programmable controller, and the first control valve is also electrically connected to a foot valve, through which the opening and closing of the first control valve can be controlled.

[0014] Preferably, multiple main liquid supply pipelines are provided.

[0015] Preferably, the terminal controller includes a controller, a touch screen, and a valve switch. The controller is electrically connected to the touch screen and the valve switch, and the controller is also electrically connected to a host computer.

[0016] The present invention achieves the following beneficial technical effects compared to the prior art:

[0017] The present invention also includes a sterilization pipeline connected to the distribution pipeline. By introducing a sterilization medium through the sterilization pipeline, the distribution pipeline and its valves can be sterilized, achieving online sterilization and effectively improving the sterilization effect. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 This is a schematic diagram of the aseptic terminal solution preparation system in an embodiment of the present invention;

[0020] Figure 2 This is a schematic diagram of the aseptic terminal connection in an embodiment of the present invention;

[0021] Figure 3 This is a schematic diagram of offline cleaning and sterilization of the control valve assembly in an embodiment of the present invention;

[0022] Among them, 1 is the main liquid supply line, 2 is the distribution line, 3 is the first control valve, 4 is the second control valve, 5 is the fifth control valve, 6 is the first temperature sensor, 7 is the drain valve, 8 is the laminar flow dispensing hood, 9 is the dispensing container, 10 is the second temperature sensor, 11 is the third control valve, 12 is the fourth control valve, 13 is the first respirator, and 14 is the second respirator. Detailed Implementation

[0023] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0024] The purpose of this invention is to provide a sterile terminal liquid preparation system to solve the problems existing in the prior art, and to achieve online sterilization of the distribution pipeline and its valves, thereby improving the cleaning and sterilization effect.

[0025] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0026] Example 1

[0027] like Figures 1-3 As shown, this embodiment provides a sterile terminal liquid preparation system, including a main liquid supply pipeline 1. The inlet of the main liquid supply pipeline 1 is used to connect to a liquid preparation tank. A distribution pipeline 2 is connected to the main liquid supply pipeline 1. The distribution pipeline 2 is used to connect to a sterile terminal, and a first control valve 3 is provided on the distribution pipeline 2 at the connection position between the distribution pipeline 2 and the main liquid supply pipeline 1. A sterilization pipeline is also connected to the distribution pipeline 2. The sterilization pipeline is connected downstream of the first control valve 3 and is used to introduce a sterilization medium to sterilize the distribution pipeline 2. A second control valve 4 is provided on the sterilization pipeline. The second control valve 4 is preferably a two-way pneumatic diaphragm valve, and the sterilization medium is preferably pure steam.

[0028] In this embodiment, sterilization medium is introduced through a sterilization pipeline to sterilize the distribution pipeline 2 and its valves, achieving online sterilization and effectively improving the sterilization effect.

[0029] In this embodiment, the outlet of the main liquid supply pipeline 1 is connected to the liquid preparation tank, enabling the solution to flow back to the liquid preparation tank; and a fifth control valve 5 is provided at one end of the main liquid supply pipeline 1 near its inlet, and a first temperature sensor 6 is provided at one end near its outlet. Both the fifth control valve 5 and the first temperature sensor 6 are electrically connected to the terminal controller; wherein, the fifth control valve 5 is preferably a two-way pneumatic diaphragm valve, and the first sensor is preferably a TIC temperature sensor.

[0030] In this embodiment, the main liquid supply line 1 includes multiple U-shaped pipes arranged sequentially along the liquid flow direction. The bottom end of each U-shaped pipe is connected to a distribution line 2, that is, the main liquid supply line 1 is connected to multiple distribution lines 2, and each distribution line 2 can be connected to a sterile terminal. Further, the distribution line 2 is also provided with a drain port for discharging the condensate formed at the bottom end of the U-shaped pipe. A drain valve 7 is provided at the drain port to control the liquid discharge. A second temperature sensor 10 is provided near the drain port of the distribution line 2. The second temperature sensor 10 is electrically connected to the terminal controller. The second temperature sensor 10 is preferably a TRC temperature sensor.

[0031] In this embodiment, a control valve assembly is also provided on the distribution pipeline 2. The control valve assembly is connected to the first control valve 3 and the sterile terminal, and is also connected to the steam trap 7. Specifically, the control valve assembly includes a third control valve 11 and a fourth control valve 12. The third control valve 11 is a three-way valve. Port A of the three-way valve is connected to the first control valve 3, port B of the three-way valve is connected to the steam trap 7, and port C of the three-way valve is connected to the sterile terminal through the fourth control valve 12.

[0032] The third control valve 11 is a pneumatic three-way diaphragm valve or a pneumatic three-way ball valve, preferably a pneumatic three-way diaphragm valve. The fourth control valve 12 is preferably a two-way manual diaphragm valve. The pneumatic three-way diaphragm valve with the smallest cleaning dead corner residue is closely connected to the two-way manual diaphragm valve to form a control valve group.

[0033] In this embodiment, the control valve assembly is detachably installed on the distribution pipeline 2 so that the control valve assembly can be disassembled for offline cleaning and sterilization; wherein, the A port and B port of the pneumatic three-way diaphragm valve (third control valve 11) are detachably connected to the distribution pipeline via quick-connect couplings, and the fourth control valve 12 is detachably connected to the connection pipeline of the sterile terminal via quick-connect couplings, or other detachable connection methods may also be used.

[0034] In this embodiment, the first control valve 3 is a two-way pneumatic diaphragm valve. The first control valve 3 is electrically connected to a terminal controller, and the terminal controller is also electrically connected to a foot valve. The foot valve can control the opening and closing of the first control valve 3. This allows operators next to the clean bench to control the opening and closing of the first control valve 3 by using the foot valve under the clean bench.

[0035] In this embodiment, multiple main liquid supply lines 1 are provided, and multiple main liquid supply lines 1 are controlled by a terminal programmable controller; wherein, the number of main liquid supply lines 1 can be selected according to specific working needs.

[0036] In this embodiment, the cleaning and sterilization process of the main liquid supply line 1 is as follows:

[0037] The main liquid supply line 1 and the liquid preparation tank (not shown in the figure) are cleaned and sterilized separately by an online cleaning (CIP) and online sterilization (SIP) workstation (not shown in the figure) connected to them.

[0038] When the main liquid supply line 1 and the liquid preparation tank are being cleaned, the fifth control valve 5 is opened to facilitate the circulation of the CIP / SIP workstation cleaning solution, cleaning purified water, and water for injection.

[0039] During the sterilization of the main supply line 1, the fifth control valve 5 is opened to facilitate the flow of steam from the CIP / SIP workstation in the main supply line. The A and B ends of the first control valve 3 and the third control valve 11 at all sterile terminals in the supply loop are opened to allow condensate at the lowest point of the U-bend of the main supply line 1 to be discharged through the lower drain valve 7, thereby improving the sterilization efficiency of the main supply line. Once the temperature rises until the temperature at the first temperature sensor 6 at the end of the loop reaches 121 degrees Celsius and is maintained for more than 15 minutes, the first control valve 3 is closed after the main supply line 1 has been sterilized.

[0040] The offline cleaning and sterilization process of the control valve assembly in this embodiment is as follows:

[0041] The three-way pneumatic diaphragm valve (third control valve 11) is normally open at the AC end and normally closed at the AB and BC ends when pneumatic power is lost. Therefore, remove the control valve assembly and open the fourth control valve 12 to perform soaking and rinsing cleaning operations on the AC passage for dispensing liquid. After cleaning, connect the first respirator 13 to the A end and the dispensing hose and second respirator 14 or aseptic docking device (e.g., Figure 3 As shown in the image, place the sample in a moist heat sterilizer for offline sterilization.

[0042] The online sterilization process of the control valve assembly in this embodiment is as follows:

[0043] After the control valve assembly is sterilized offline, the fourth control valve 12 is closed to ensure that the distribution tubing after end C is sterile. The first respirator 13 at end A is disconnected. The control valve assembly is then snapped into the system. The third control valve 11 is connected to the pneumatic power supply. After obtaining the gas, the third control valve 11 is switched to AB end conduction. The second control valve 4 is opened to introduce pure steam to sterilize the third control valve 11 and the pipeline connecting it to the first control valve 3. The condensate is discharged through the lower drain valve 7 until the temperature of the second temperature sensor 10 reaches 121 degrees and is maintained for more than 15 minutes.

[0044] After sterilization is completed, close the second control valve 4 to disconnect the pure steam, close the pneumatic power of the third control valve 11 to switch it to AC conduction (AB and BC closed), and manually open the fourth control valve 12 to put the entire sterilized distribution pipeline 2 into standby mode.

[0045] The aseptic connection process of the dispensing container 9 in this embodiment is as follows:

[0046] Under the Class A clean bench or laminar flow dispensing hood 8 in the Class C background operating room, the second respirator 14 (or aseptic connector) is aseptically connected to the dispensing container 9, thus completing the aseptic connection of the entire pipeline.

[0047] The solution delivery process in this embodiment is as follows:

[0048] During liquid delivery, the fifth control valve 5 is closed, and 0.2MPa constant clean compressed air is introduced into the liquid preparation tank to maintain a pressure of 0.2MPa in the liquid preparation tank and the main liquid supply pipeline 1. The first control valve 3 is opened, and the solution in the liquid preparation tank flows into the dispensing container 9 along the distribution pipeline 2. Once the material, length, and diameter of the main liquid supply pipeline 1 are fixed, the pressure is constant, and the flow rate is also basically fixed. As long as the opening time of the first control valve 3 is set and controlled, the volume dispensed into the dispensing container 9 each time can be controlled to achieve quantitative dispensing.

[0049] In this embodiment, the terminal controller includes a controller, a touch screen, and valve switches. The controller is electrically connected to the touch screen and the valve switches. The valve switches are selected according to the control valves. Since all control valves (except manual valves) in this embodiment are pneumatic valves, the valve switches are preferably pneumatic switches used to control the opening and closing of the pneumatic valves. The controller is also electrically connected to the main computer. Specifically, the touch screen is a Siemens 7-inch color touch screen, and the controller is a Siemens S7-200 PLC controller. The controller is connected to the main computer of the liquid preparation system via a network cable and can monitor the solution status of the liquid preparation system, such as temperature, weight volume, pH, pressure, and other parameters. The flow rate or time for each dispensing can be set through the touch screen, as well as the method of opening the first control valve 3. The touch screen also allows for a direct view of the temperature sensor and the status of each valve at each sterile terminal.

[0050] In this embodiment, two main liquid supply lines 1 are preferably provided. The two independent main liquid supply lines 1 from different liquid preparation tanks can be controlled simultaneously by the terminal controller, and each line can be supplied to two independent terminal distributors at the same time, so as to deliver two different solutions to one or two sterile terminal dispensing containers 9 at the same time, or one can be used as a backup for flexible use.

[0051] This invention applies a sterile terminal solution preparation system to the pipeline delivery of vaccines, such as the preparation and delivery of solutions for cell culture, viral and bacterial culture, and the formulation and delivery of semi-finished buffer solutions, protectants, and stabilizers. The design of the sterile terminal solution preparation system conforms to the scientific principles of sterile dispensing and takes into account the characteristics of the work, greatly improving work efficiency.

[0052] It should be noted that, for those skilled in the art, it is obvious that the present invention is not limited to the details of the above exemplary embodiments, and that the present invention can be implemented in other specific forms without departing from the spirit or essential characteristics of the invention. Therefore, the embodiments should be considered exemplary and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention, and no reference numerals in the claims should be construed as limiting the scope of the claims.

[0053] Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this invention. Furthermore, those skilled in the art will recognize that, based on the ideas of this invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of this invention.

Claims

1. A sterile terminal solution preparation system, characterized in that: The system includes a main liquid supply pipeline, the inlet of which is connected to a mixing tank. A distribution pipeline is connected to the main liquid supply pipeline, which is connected to a sterile terminal and is equipped with a first control valve. A sterilization pipeline is also connected to the distribution pipeline, which is used to introduce a sterilization medium to sterilize the distribution pipeline. A second control valve is installed on the sterilization pipeline. The main liquid supply pipeline includes multiple U-shaped pipelines arranged sequentially along the liquid flow direction. Each U-shaped pipeline is connected to a distribution pipeline at its bottom end. The distribution pipeline is also provided with a drain port for discharging the condensate formed at the bottom end of the U-shaped pipeline. A drain valve is provided at the drain port. The distribution pipeline is also equipped with a control valve assembly, which can be connected to the first control valve and the sterile terminal, and is also connected to the steam trap. The control valve assembly includes a third control valve and a fourth control valve, wherein the third control valve is a three-way valve, the A port of the three-way valve is connected to the first control valve, the B port of the three-way valve is connected to the steam trap, and the C port of the three-way valve can be connected to the sterile terminal through the fourth control valve. The control valve assembly is detachably installed on the distribution pipeline.

2. The aseptic terminal solution preparation system according to claim 1, characterized in that: The outlet of the main liquid supply pipeline is connected to the liquid distribution tank; and a fifth control valve is provided at one end of the main liquid supply pipeline near its inlet, and a first temperature sensor is provided at one end of the main liquid supply pipeline near its outlet. Both the fifth control valve and the first temperature sensor are electrically connected to the terminal controller.

3. The aseptic terminal solution preparation system according to claim 1, characterized in that: A second temperature sensor is installed near the drain outlet in the distribution pipeline, and the second temperature sensor is electrically connected to the terminal controller.

4. The aseptic terminal solution preparation system according to claim 3, characterized in that: The third control valve is a pneumatic three-way diaphragm valve or a pneumatic three-way ball valve, and the fourth control valve is a two-way manual diaphragm valve.

5. The aseptic terminal solution preparation system according to claim 1, characterized in that: The first control valve is a two-way pneumatic diaphragm valve. The first control valve is electrically connected to a terminal programmable controller, and the first control valve is also electrically connected to a foot valve, which can control the opening and closing of the first control valve.

6. The aseptic terminal solution preparation system according to any one of claims 1-5, characterized in that: The main liquid supply pipeline is provided in multiple ways.

7. The aseptic terminal solution preparation system according to claim 2, characterized in that: The terminal controller includes a controller, a touch screen, and a valve switch. The controller is electrically connected to the touch screen and the valve switch, and the controller is also electrically connected to the host computer.

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