阅读说明：本技术 纯化生产一次性制备系统 (Disposable preparation system for purification production ) 是由 李清楷 张敏学 邹兴军 何磊 邢宁 于 2019-10-15 设计创作，主要内容包括：本发明涉及生物制药技术领域,且公开了纯化生产一次性制备系统,包括XDM混合器、层析系统和储液车,所述XDM混合器的前表面固定有第一控制器,所述层析系统的上表面固定有第二控制器,所述XDM混合器通过配套管道与所述层析系统相连接,所述层析系统通过配套管道与所述储液车相连接；在使用的时候,运行参数适时监控,可随时调整运行参数,层析系统密封运行,无泄漏,保护操作人员健康,触摸屏PLC控制,一键式操作,工艺过程流程图直接明了,控制界面友好,易于操作,实验结果自动保存,生产报告,可保存多个运行方法以及结果,可进行手动控制或自动编程运行,全程自动在线实时检测重量并定容,设备无死角,易于清洗,便于操作。(The invention relates to the technical field of biological pharmacy, and discloses a purification production disposable preparation system which comprises an XDM mixer, a chromatography system and a liquid storage vehicle, wherein a first controller is fixed on the front surface of the XDM mixer, a second controller is fixed on the upper surface of the chromatography system, the XDM mixer is connected with the chromatography system through a matched pipeline, and the chromatography system is connected with the liquid storage vehicle through a matched pipeline; when the device is used, the operation parameters are monitored in time, the operation parameters can be adjusted at any time, the chromatography system runs in a sealed mode without leakage, the health of operators is protected, the PLC control is realized through a touch screen, the one-key operation is realized, the process flow diagram is directly clear, the control interface is friendly, the operation is easy, the experimental result is automatically stored, the production report can be stored, a plurality of operation methods and results can be stored, the manual control or automatic programming operation can be realized, the weight is automatically detected in real time in the whole process in an online mode, the volume is fixed, the device has no dead angle, the cleaning is easy.)

1. Purification production disposable preparation system, including XDM blender (4), chromatography system (8) and stock solution car (10), its characterized in that: a first controller (5) is fixed on the front surface of the XDM mixer (4), a second controller (8) is fixed on the upper surface of the chromatography system (9), the XDM mixer (4) is connected with the chromatography system (9) through a matched pipeline, and the chromatography system (9) is connected with the liquid storage vehicle (10) through a matched pipeline.

2. The purification production disposable preparation system according to claim 1, characterized in that: the support legs (2) are symmetrically welded and fixed on the front surface and the rear surface of the XDM mixer (4), the bottom ends of the four support legs (2) are welded and fixed with a bottom plate (1), the moving wheels (7) are fixed on four corners of the lower surface of the bottom plate (1) through screws, and the moving wheels (7) are fixed on four corners of the lower surfaces of the chromatographic system (9) and the liquid storage vehicle (10) through screws.

3. The purification production disposable preparation system according to claim 1, characterized in that: a disposable low-density polyethylene plastic bag (6) is fixed at the center of the inside of the XDM mixer (4), a disposable stirring paddle is anchored in the disposable low-density polyethylene plastic bag (6), and a motor (3) is fixed at the center of the bottom of the XDM mixer (4) through screws.

4. The purification production disposable preparation system according to claim 3, characterized in that: the motor (3) is in magnetic coupling connection with the disposable stirring paddle, and the disposable stirring paddle is in rotary connection with the XDM mixer (4) through a stainless steel bearing.

5. The purification production disposable preparation system according to claim 1, characterized in that: the chromatography system comprises three diaphragm pumps (12), four pressure sensors (16), two mass flow meters (15), a PH detector (18), fifty-six pneumatic diaphragm valves (11), two air sensors (14), an ultraviolet detector (17), two chromatography columns (19) and two conductivity detectors (13).

6. The purification production disposable preparation system according to claim 1, characterized in that: the XDM mixer (4), the chromatography system (9), and the stock solution cart (10) are all sealed environments.

Technical Field

The invention relates to the technical field of biological pharmacy, in particular to a purification production disposable preparation system.

Background

At present, in the separation and purification production of the biological pharmacy, the complete, continuous, one-stop, closed and aseptic control operation of the product from the processes of separation and purification, separation and purification and storage of the product after purification can not be completely ensured, which brings inconvenience to the production operation and can not effectively ensure the product quality.

Disclosure of Invention

Technical problem to be solved

Aiming at the defects of the prior art, the invention provides a disposable preparation system for purification production, which solves the problems of inconvenience brought to downstream production operation due to incomplete, discontinuous and non-closed operation forms and reduces the probability of product pollution risks.

(II) technical scheme

In order to achieve the purpose, the invention provides the following technical scheme: the disposable preparation system for purification production comprises an XDM mixer, a chromatography system and a liquid storage vehicle, wherein a first controller is fixed on the front surface of the XDM mixer, a second controller is fixed on the upper surface of the chromatography system, the XDM mixer is connected with the chromatography system through a matched pipeline, and the chromatography system is connected with the liquid storage vehicle through a matched pipeline.

Preferably, the front surface and the rear surface of the XDM mixer are symmetrically welded and fixed with supporting legs, the bottom ends of the four supporting legs are welded and fixed with a bottom plate, the four corners of the lower surface of the bottom plate are respectively fixed with moving wheels through screws, and the four corners of the lower surfaces of the chromatography system and the liquid storage vehicle are also respectively fixed with the moving wheels through screws.

Preferably, a disposable low density polyethylene plastic bag is fixed at the center of the inside of the XDM mixer, a disposable stirring paddle is anchored inside the disposable low density polyethylene plastic bag, and a motor is fixed at the center of the bottom of the XDM mixer through a screw.

Preferably, the motor is in magnetic coupling connection with the disposable stirring paddle, and the disposable stirring paddle is in rotary connection with the XDM mixer through a stainless steel bearing.

Preferably, the chromatography system comprises three diaphragm pumps, four pressure sensors, two mass flow meters, a PH detector, fifty-six pneumatic diaphragm valves, two air sensors, an ultraviolet detector, two chromatography columns and two conductivity detectors.

Preferably, the XDM mixer, the chromatography system and the stock solution cart are all sealed environments.

(III) advantageous effects

The invention provides a purification production disposable preparation system, which has the following beneficial effects:

when the device is used, the operation parameters are monitored in time, the operation parameters can be adjusted at any time, the chromatography system runs in a sealed mode without leakage, the health of operators is protected, the device is controlled by a touch screen PLC (programmable logic controller), the operation is carried out in a one-key mode, a process flow diagram is directly clear, a control interface is friendly, the device is easy to operate, experimental results are automatically stored, production reports can be stored, a plurality of operation methods and results can be stored, manual control or automatic programming operation can be carried out, the weight is automatically detected in real time in the whole process, the volume is fixed, the device has no dead angle, the device is easy to clean, the operation is convenient, the pollution risk is.

Drawings

FIG. 1 is a schematic structural view of the present invention;

FIG. 2 is a system diagram of a chromatography system according to the present invention.

In the figure: 1. a base plate; 2. supporting legs; 3. a motor; 4. an XDM mixer; 5. a first controller; 6. disposable low density polyethylene plastic bags; 7. a moving wheel; 8. a second controller; 9. a chromatography system; 10. a liquid storage vehicle; 11. a pneumatic diaphragm valve; 12. a diaphragm pump; 13. a conductivity detector; 14. an air sensor; 15. a mass flow meter; 16. a pressure sensor; 17. an ultraviolet detector; 18. a pH detector; 19. a chromatographic column.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

As shown in fig. 1-2, the present invention provides a technical solution: the disposable preparation system for purification production comprises an XDM mixer 4, a chromatography system 8 and a liquid storage vehicle 10, wherein a first controller 5 is fixed on the front surface of the XDM mixer 4, a second controller 8 is fixed on the upper surface of the chromatography system 9, the XDM mixer 4 is connected with the chromatography system 9 through a matched pipeline, the chromatography system 9 is connected with the liquid storage vehicle 10 through a matched pipeline, during work, a semi-finished product is stirred and mixed in the XDM mixer 4, then the stirred and mixed semi-finished product can be introduced into the chromatography system 9 through the matched pipeline to be separated, and the separated semi-finished product enters the liquid storage vehicle 10 to be collected under the action of the matched pipeline.

Further, the equal symmetrical welded fastening of front surface and the rear surface of XDM blender 4 has supporting leg 2, four supporting leg 2's bottom welded fastening have a bottom plate 1, four corners of the lower surface of bottom plate 1 all have removal wheel 7 through the screw fixation, four corners of the lower surface of chromatography system 9 and stock solution car 10 also all have removal wheel 7 through the screw fixation, make things convenient for the removal of XDM blender 4, chromatography system 9 and stock solution car 10 through removing wheel 7.

Further, a disposable low-density polyethylene plastic bag 6 is fixed at the center of the bottom of the XDM mixer 4, a disposable stirring paddle is anchored inside the disposable low-density polyethylene plastic bag 6, a motor 3 is fixed at the center of the bottom of the XDM mixer 4 through screws, and after the semi-finished product enters the XDM mixer 4, the motor 3 can drive the disposable stirring paddle to rotate, so that the inner semi-finished product can be stirred and mixed.

Further, the motor 3 is in magnetic coupling connection with the disposable stirring paddle, the disposable stirring paddle is in rotational connection with the XDM mixer 4 through a stainless steel bearing, and the motor 3 is in magnetic coupling connection with the disposable stirring paddle, so that higher torque can be provided for the whole system, and semi-finished products in the XDM mixer 4 can be quickly mixed.

Further, the chromatography system comprises three diaphragm pumps 12, four pressure sensors 16, two mass flow meters 15, one pH detector 18, fifty-six pneumatic diaphragm valves 11, two air sensors 14, one ultraviolet detector 17, two chromatography columns 19 and two conductivity detectors 13, and the stirred and mixed semi-finished product can be subjected to rapid air separation through elements in the chromatography system 9 and then guided into the liquid storage vehicle 10 for collection.

Furthermore, the XDM mixer 4, the chromatography system 9 and the liquid storage vehicle 10 are all sealed environments, the risk that the product is polluted by the external environment and personnel is reduced, and the quality of the product is guaranteed more.

In conclusion, the working process of the invention is as follows: when the rapid semi-finished product separation device is used, the motor 3 drives the disposable stirring paddle to rotate, so that a semi-finished product in the XDM mixer 4 can be rapidly stirred and mixed, then the stirred and mixed semi-finished product is guided into the chromatography system 9 through a matched pipeline, the semi-finished product can be separated through elements in the chromatography system 9, and the separated semi-finished product enters the liquid storage vehicle 10 to be collected under the action of the matched pipeline.

It is noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.