CN114306659A - Full-automatic temperature control fixed tank type globulin inactivation device and use method - Google Patents
Full-automatic temperature control fixed tank type globulin inactivation device and use method Download PDFInfo
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- CN114306659A CN114306659A CN202210004958.2A CN202210004958A CN114306659A CN 114306659 A CN114306659 A CN 114306659A CN 202210004958 A CN202210004958 A CN 202210004958A CN 114306659 A CN114306659 A CN 114306659A
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Abstract
The invention discloses a full-automatic temperature control fixed pot type globulin inactivation device, belonging to the technical field of globulin product processing and comprising the following steps: biological product jar and temperature control unit, be used for depositing the globulin product in the biological product jar, just the outer wall cover of biological product jar is equipped with the cover that presss from both sides, press from both sides the cover with form the heat transfer cavity that is used for circulating heat-conducting medium between the biological product jar, temperature control unit includes: a first circulation line and a second circulation line. The invention also discloses a using method, which is applied to the full-automatic temperature control fixed tank type globulin inactivation device and comprises the following steps: cleaning the bioproduct tank; sterilizing the bioproduct tank; inputting a globulin product into the bioproduct tank; performing low-pH incubation virus inactivation on the globulin product; outputting the globulin product from the bioproduct tank.
Description
Technical Field
The invention relates to the technical field of globulin product processing, in particular to a full-automatic temperature control fixed tank type globulin inactivation device and a use method thereof.
Background
The starting raw material for blood product production is healthy human plasma, and before the raw material is put into use, production enterprises adopt various detection means to carry out strict detection and control on exogenous factor pollution, but because of the limitation of a plurality of factors such as the current cognitive degree, the detection method and the like, the potential risk of polluting exogenous viruses still exists in the actual production process of blood products, and the establishment of an effective virus inactivation/removal process in the production process is very important and is a key barrier for ensuring the safety of the blood products. The inactivation process of globulin products in blood products mostly adopts a low pH incubation method, namely the globulin products are placed for 21 days under the conditions of low pH and temperature control of 23-25 ℃.
The temperature control method required by the low-pH incubation method is to place the globulin products into a movable stainless steel tank or other movable containers and place the movable stainless steel tank or other movable containers into a constant-temperature room system (23-25 ℃) to implement temperature control.
The control method of the constant temperature room system has the following disadvantages: 1. the efficiency is low, the movable tank body or container usually has small volume, a plurality of tank bodies or containers are needed in mass production, and a product merging procedure is needed to be added before aseptic filling and sealing to enable the product to be uniform; 2. the temperature control precision is poor, the temperature is adjusted depending on the air temperature of a room, and the control precision is poor because the air heat conduction coefficient is small, the temperature lag coefficient is large during temperature control; 3. the energy consumption is high, after the globulin product finishes the low-pH incubation process, aseptic encapsulation can be carried out only after the product is qualified by verification, and the globulin product needs to be transferred to an independent high-energy-consumption cold storage at 2-8 ℃ for temporary storage to be subjected to aseptic encapsulation.
Disclosure of Invention
Aiming at the problems that the temperature control precision is poor and the temperature depends on the room air temperature to be adjusted in the prior art for treating globulin, the full-automatic temperature control fixed tank type globulin inactivation device and the use method are provided, the temperature in the tank can be accurately controlled, and the production quality of products is ensured.
The specific technical scheme is as follows:
the utility model provides a fixed pot-type globulin inactivation device of full-automatic temperature control, includes:
the biological product tank is used for storing globulin products, a jacket is sleeved on the outer wall of the biological product tank, and a heat exchange cavity for circulating a heat-conducting medium is formed between the jacket and the biological product tank;
a temperature control unit, the temperature control unit comprising: a first circulation line and a second circulation line;
the first circulation pipeline comprises a first liquid inlet pipeline and a first liquid return pipeline, one end of the first liquid inlet pipeline and one end of the first liquid return pipeline are respectively communicated with the heat exchange cavity, a liquid inlet valve, a circulating pump, a heat exchanger, a heater, a water flow inductive switch and a liquid inlet temperature sensor are sequentially arranged on the first liquid inlet pipeline along the direction towards the biological product tank, the other end of the first liquid return pipeline is communicated with the first liquid inlet pipeline, a connector is positioned between the liquid inlet valve and the circulating pump, the first liquid return pipeline is provided with the liquid return temperature sensor, and the heat-conducting medium flows into the heat exchange cavity along the first liquid inlet pipeline and flows back to the first liquid inlet pipeline through the first liquid return pipeline;
the second circulation pipeline comprises a second liquid inlet pipeline and a second liquid return pipeline, the second liquid inlet pipeline and the second liquid return pipeline are respectively communicated with the heat exchanger, and a refrigerant liquid inlet adjustable valve and a refrigerant liquid return valve are respectively arranged on the second liquid inlet pipeline and the second liquid return pipeline.
Preferably, the heat-conducting medium is activated water, the heat exchanger is a plate heat exchanger, and the heater is an electric heater.
Preferably, the first liquid inlet pipeline is communicated with the bottom end of the biological product tank, and the first liquid return pipeline is communicated with one side of the top end of the biological product tank.
The full-automatic temperature control fixed tank type globulin inactivation device is characterized in that the first liquid return pipeline is further provided with a safety valve and a buffer section sight glass.
The full-automatic temperature control fixed tank type globulin inactivation device further comprises a pretreatment unit, wherein the pretreatment unit comprises a main input pipeline and a main output pipeline, and the main input pipeline and the main output pipeline are respectively communicated with the biological product tank.
Preferably, the main input pipeline is communicated with the top end of the biological product tank, and the main output pipeline is communicated with the bottom end of the biological product tank.
Above-mentioned fixed pot-type globulin inactivation device of full-automatic temperature control, wherein, the one end of main input pipeline connects in parallel respectively and is provided with saturated pure steam pipeline, water pipeline for injection, gaseous input pipeline, product input pipeline and cleaning ball pipeline, saturated pure steam pipeline water pipeline for injection gaseous input pipeline with be provided with pure steam stop valve, cleaning stop valve, gaseous stop valve, product stop valve and cleaning ball isolating valve on the product input pipeline respectively, the other end is provided with the feed liquor isolating valve, the cleaning ball pipeline still with the inside intercommunication of biological product jar.
Above-mentioned fixed pot-type globulin inactivation device of full-automatic temperature control, wherein, still be provided with air cleaner and sterilization filter on the gas input pipeline with the product input pipeline respectively.
The full-automatic temperature control fixed tank type globulin inactivation device is characterized in that the main output pipeline is also connected with an injection water loop and a product output pipeline in parallel, and the injection water loop and the product output pipeline are respectively provided with a liquid return valve and a product delivery valve.
Above-mentioned fixed pot-type globulin inactivation device of full-automatic temperature control, wherein, the preprocessing unit still includes the exhaust pipe, exhaust pipe with the inside intercommunication of biological product jar, air respirator and gaseous blow-off valve on the exhaust pipe.
Preferably, the gas discharge line is in communication with the top end of the bioproduct tank.
Above-mentioned fixed pot-type globulin inactivation device of full-automatic temperature control, wherein, still be provided with cleaning bulb, agitator, temperature sensor and pressure sensor in the biological product jar.
Preferably, the stirrer is a magnetic stirrer.
A using method is applied to the full-automatic temperature control fixed tank type globulin inactivation device, and comprises the following steps:
step S1: cleaning the bioproduct tank;
step S2: sterilizing the bioproduct tank;
step S3: inputting a globulin product into the bioproduct tank;
step S4: performing low-pH incubation virus inactivation on the globulin product;
step S5: outputting the globulin product from the bioproduct tank.
The use method according to claim 9, wherein the step S4 further comprises:
step S4.1: aerating the bioproduct tank;
step S4.2: supplementing water to the jacket;
step S4.3: incubating the globulin product in an environment with a low pH value;
step S4.4: and reducing the temperature in the biological product tank, and temporarily storing the globulin product at low temperature.
Compared with the prior art, the technical scheme has the positive effects that:
(1) the invention adopts the large-capacity biological product tank to replace a movable stainless steel tank body or other movable containers, one tank is a batch, the merging process of the globulin products after low pH incubation is reduced, and the products can be uniform by stirring in situ before aseptic filling and sealing, so that the production efficiency is improved;
(2) compared with a constant temperature room system, the air is adopted as a medium for heat conduction, in order to achieve the temperature condition required by a low pH incubation method, the temperature of products in a movable stainless steel tank body or other movable containers is influenced depending on the air temperature of a room, the temperature hysteresis coefficient of the control method is large, and the control precision is poor;
(3) according to the invention, a full-automatic temperature control fixed tank type globulin product inactivation device is adopted, after the globulin product is incubated at a low pH value, the storage at 2-8 ℃ can be realized in situ, and the globulin product does not need to be transferred to an independent high-energy-consumption cold storage at 2-8 ℃ for temporary storage to be subjected to aseptic encapsulation;
(4) the high-capacity biological product tank used in the invention is sterilized in Situ (SIP), so that the high-capacity biological product tank is ensured to reach an aseptic state, a product enters the biological product tank after being sterilized and filtered by a sterilizing filter element (the membrane aperture is less than or equal to 0.22 mu m), the product is ensured to reach the aseptic state, and during the low-pH incubation period of the product, the biological product tank is filled with aseptic gas, so that the pressure in the tank is greater than the atmospheric pressure, so that the invasion of microorganisms is prevented, the tank is ensured to be always in the aseptic state, and the aseptic degree level of the globulin product is ensured.
Drawings
FIG. 1 is a system diagram of a full-automatic temperature control fixed tank type globulin inactivation device of the present invention.
In the drawings: 1. a bioproduct tank; 2. a temperature control unit; 2-1, a first liquid inlet pipeline; 2-2, a first liquid return pipeline; 2-3, a second liquid inlet pipeline; 2-4, a second liquid return pipeline; 3. an electronic control cabinet; 4-1, a main input pipeline; 4-2, a main output pipeline; 4-3, a saturated pure steam pipeline; 4-4, a water pipeline for injection; 4-5, a gas input pipeline; 4-6, a product input pipeline; 4-7, cleaning a ball pipeline; 4-8, an injection water loop; 4-9, a product output pipeline; 4-10 parts of an exhaust pipeline; 5. a stirrer; 6. an air filter; 7. an air respirator; 8. a sterilizing filter; 9. a temperature sensor; 10. a pressure sensor; 11. a product stop valve; 12. a gas shutoff valve; 13. cleaning the stop valve; 14. a pure steam stop valve; 15. a liquid inlet closing valve; 16. a cleaning ball block valve; 17. cleaning the ball; 18. a gas discharge valve; 19. a tank bottom valve; 20. a liquid return valve; 21. a product delivery valve; 22. a safety valve; 23. a liquid inlet valve; 24. a circulation pump; 25. the refrigerant liquid inlet adjustable valve; 26. a refrigerant return valve; 27. a heat exchanger; 28. a heater; 29. a liquid inlet temperature sensor; 30. a return liquid temperature sensor; 31. a water flow inductive switch; 32. buffer section sight glass.
Detailed Description
The invention is further described with reference to the following drawings and specific examples, which are not intended to be limiting.
As shown in fig. 1, the full-automatic temperature control fixed tank type globulin inactivation device of the present application comprises: the area is used for the biological product jar 1 of the large capacity of the cover that presss from both sides of control by temperature change regulation, temperature control unit 2, electronic control cabinet 3 etc. is used for depositing the globulin product in the biological product jar 1, and presss from both sides the cover to establish on the outer wall of biological product jar 1, presss from both sides the cover and forms the heat transfer cavity that is used for circulating activated water between the biological product jar 1, and temperature control unit 2 includes: a first circulation line and a second circulation line.
Further, the first circulation pipeline comprises a first liquid inlet pipeline 2-1 and a first liquid return pipeline 2-2, one end of the first liquid inlet pipeline 2-2 and one end of the first liquid return pipeline 2-2 are respectively communicated with the heat exchange cavity, a liquid inlet valve 23, a circulation pump 24, a heat exchanger 27, a heater 28, a water flow inductive switch 31 and a liquid inlet temperature sensor 29 are sequentially arranged on the first liquid inlet pipeline 2-1 along the direction towards the biological product tank 1, the other end of the first liquid return pipeline 2-2 is communicated with the first liquid inlet pipeline 2-1, a connector is positioned between the liquid inlet valve 23 and the circulation pump 24, a liquid return temperature sensor 30 is arranged on the first liquid return pipeline 2-2, activated water flows into the heat exchange cavity along the first liquid inlet pipeline 2-1 and flows back to the first liquid inlet pipeline 2-1 from the first liquid return pipeline 2-2, thereby realizing the recycling of the activated water.
Further, the second circulation pipeline comprises a second liquid inlet pipeline 2-3 and a second liquid return pipeline 2-4, the second liquid inlet pipeline 2-3 and the second liquid return pipeline 2-4 are respectively communicated with the heat exchanger 27, and the second liquid inlet pipeline 2-3 and the second liquid return pipeline 2-4 are respectively provided with a refrigerant liquid inlet adjustable valve 25 and a refrigerant liquid return valve 26.
Furthermore, a safety valve 22 and a buffering section sight glass 32 are further arranged on the first liquid return pipeline 2-2, the water flow sensing switch 31, the safety valve 22 and the buffering section sight glass 32 provide safety guarantee, if the activated water in the sensing jacket is insufficient, the water flow sensing switch 31 stops working of the circulating pump 24 and the electric heater 28 to prevent the electric heater 28 from being damaged due to overheating, and in addition, if the activated water in the jacket is too high, the safety valve 22 bounces to prevent the biological product tank 1 from deforming due to the fact that the activated water in the jacket is too high, and the buffering section sight glass 32 provides an escape channel for observing whether the softened water of the jacket is sufficient or not and for the activated water in the circulating system during maintenance.
Further, the full-automatic temperature control fixed tank type globulin inactivation device further comprises a pretreatment unit, the pretreatment unit comprises a main input pipeline 4-1 and a main output pipeline 4-2, the main input pipeline 4-1 and the main output pipeline 4-2 are respectively communicated with the biological product tank 1, one end of the main input pipeline 4-1 is respectively provided with a saturated pure steam pipeline 4-3, an injection water pipeline 4-4, a gas input pipeline 4-5, a product input pipeline 4-6 and a cleaning ball pipeline 4-7 in parallel, the saturated pure steam pipeline 4-3, the injection water pipeline 4-4, the gas input pipeline 4-5 and the product input pipeline 4-6 are respectively provided with a pure steam stop valve 14, a cleaning stop valve 13, a gas stop valve 12, a product stop valve 11 and a cleaning ball isolating valve 16, the other end is provided with a liquid inlet isolating valve 15, a cleaning ball pipeline 4-7 is also communicated with the interior of the biological product tank 1, an air filter 6 and a sterilizing filter 8 are respectively arranged on a gas input pipeline 4-5 and a product input pipeline 4-6, an injection water loop 4-8 and a product output pipeline 4-9 are also connected in parallel on the main output pipeline 4-1, a liquid return valve 20 and a product delivery valve 21 are respectively arranged on the injection water loop 4-8 and the product output pipeline 4-9, the pretreatment unit also comprises an exhaust pipeline 4-10, the exhaust pipeline 4-10 is communicated with the interior of the biological product tank 1, an air respirator 7 and a gas discharge valve 18 are arranged on the exhaust pipeline 4-10, a liquid sterilizing filter core (the aperture of a membrane is less than or equal to 0.22 mu m) is arranged in the filter 8, air filter 6 and air respirator 7 are provided with air degerming filter core (membrane pore size is less than or equal to 0.22 μm).
Further, a cleaning ball 17, a stirrer 5, a temperature sensor 9 and a pressure sensor 10 are arranged in the biological product tank 1.
Further, the electronic control cabinet 3 includes a PLC (programmable logic controller), a touch panel, and an electric line.
The above are merely preferred embodiments of the present invention, and the embodiments and the protection scope of the present invention are not limited thereby.
The present invention also has the following embodiments in addition to the above:
in a further embodiment of the present invention, please refer to fig. 1 with continued reference, the present application further discloses a method for using a full-automatic temperature-controlled fixed-tank type globin inactivation device, wherein a cleaning program, a sterilization program, a liquid feeding program, a low pH incubation program, and a liquid discharging program of a biological product tank 1 are set in a PLC of an electronic control cabinet 3, so as to realize automatic control of tank feeding, low pH incubation and product removal after cleaning, sterilization, product sterilization and filtration, and the specific steps are as follows:
step S1: cleaning the bioproduct tank 1;
clicking a 'cleaning program' on a touch screen on the electronic control cabinet 3, opening a cleaning stop valve 13, a liquid inlet closing valve 15, a cleaning ball closing valve 16, a gas discharge valve 18, a tank bottom valve 19 and a liquid return valve 20, supplying injection water under pressure to an external cleaning station, cleaning a biological product tank 1 by a cleaning ball 17 through a pipeline opened by the valves, pumping out the cleaned injection water from the external cleaning station for discharge, stopping water supply in the external cleaning station after the set cleaning qualified standard is reached, closing the cleaning stop valve 13, the liquid inlet closing valve 15, the cleaning ball closing valve 16, the tank bottom valve 19, the gas discharge valve 18 and the liquid return valve 20 after the cleaning injection water is pumped out, and finishing the cleaning program.
Step S2: sterilizing the bioproduct tank 1;
"sterilization procedure" is clicked on the touch-sensitive screen on electronic control cabinet 3, pure steam stop valve 14, feed liquor block valve 15, cleaning ball block valve 16, tank bottom valve 19, return liquid valve 20 opens, outside pure steam generator provides saturated pure steam, the pipeline of opening through above-mentioned valve, saturated pure steam gets into in the biological product jar 1, after reaching the qualified standard of setting for sterilization, outside pure steam generator stops the steam supply, treat that pure steam is about to the evacuation, when biological product jar 1 still keeps the malleation, pure steam stop valve 14, feed liquor block valve 15, cleaning ball block valve 16, tank bottom valve 19, return liquid valve 20 closes, the sterilization procedure ends, this time biological product jar reaches sterile condition.
Step S3: inputting a globulin product into the bioproduct tank 1;
clicking a liquid inlet program on a touch screen on the electronic control cabinet 3, opening the product stop valve 11, the liquid inlet closing valve 15 and the gas discharge valve 18, providing a pressurized product for the external raw liquid tank, passing through a sterilizing filter element (the membrane pore size is less than or equal to 0.22 mu m) of the sterilizing filter 8 to obtain a sterile product, enabling the sterile product to enter the biological product tank 1, closing the product stop valve 11, the liquid inlet closing valve 15 and the gas discharge valve 18 after the whole batch of products enter the biological product tank 1, and ending the liquid inlet program.
Step S4: incubating the globulin product at low pH and inactivating the virus;
the touch screen on the electronic control cabinet 3 clicks the 'low pH incubation program', and the device automatically operates according to the set program (inflation → water supplement by the jacket → low pH incubation → low temperature temporary storage).
Step S4.1: the biological product tank 1 is aerated;
the gas stop valve 12 and the liquid inlet closing valve 15 are opened, the gas is filled into the biological product tank 1 through the air filter 6 (namely, the sterile gas), the gas stop valve 12 and the liquid inlet closing valve 15 are closed after the set positive pressure is reached, and the program jumps to the next step. And sterile gas is filled to keep the positive pressure in the biological product tank 1, so that the invasion of microorganisms is prevented, and the sterile environment in the biological product tank 1 is ensured all the time.
Step S4.2: supplementing water to the jacket;
the softened water inlet valve 23 is opened, the external softened water system provides softened water to enter the jacket, after the set value is reached, the softened water inlet valve 23 is closed, and the program jumps to the next step.
Step S4.3: incubating the globulin product in an environment with a low pH value;
the circulating pump 24, the electric heater 28, the liquid inlet temperature sensor 29, the liquid return temperature sensor 30, the water flow inductive switch 31 and the magnetic stirring 5 are started, the electric heater 28 heats softened water in the circulating system, the temperature of the softened water in the jacket is raised to a set temperature, the temperature of a globulin product in the biological product tank 1 reaches 23-25 ℃ through heat exchange, the refrigerant liquid inlet adjustable valve 25 and the refrigerant liquid return valve 26 are controllably adjusted and started by the PLC during the period, cooling capacity is provided, the temperature of the softened water in the jacket is further adjusted, the condition that the temperature of the globulin product in the biological product tank 1 exceeds the required temperature to cause the inactivation of the globulin is prevented, and the program automatically jumps to the next step after the temperature of the globulin product in the biological product tank 1 is kept within the range of 23-25 ℃ for 21 days.
Step S4.4: reducing the temperature in the biological product tank, and temporarily storing the globulin product at a low temperature;
when the low pH incubation jumps to low temperature for temporary storage, the electric heater 28 is closed, the circulating pump 24, the electric heater 28, the liquid inlet temperature sensor 29, the liquid return temperature sensor 30 and the water flow sense reduce the temperature of softened water in the jacket, so that the purpose of storing the globulin product at low temperature is realized, the temperature of the product in the biological product tank 1 is reduced to 2-8 ℃ through heat exchange, and the program is kept running to wait for aseptic encapsulation. During the running of the low pH incubation program, the water flow inductive switch 31, the safety valve 22 and the buffer section sight glass 32 provide safety guarantee, if the water flow inductive switch 31 senses that the activated water in the jacket is insufficient, the circulating pump 24 and the electric heater 28 stop working, and the electric heater 28 is prevented from being damaged due to overheating. The safety valve 22 is opened when the pressure of the activation water in the jacket is too high, so as to prevent the biological product tank 1 from deforming because of the too high pressure of the activation water in the jacket, and the buffer section sight glass 32 provides an escape channel for observing whether the softened water of the jacket is sufficient and for the activated water in the circulating system during maintenance.
Step S5: outputting a globulin product from said bioproduct tank;
after the verification of the globulin product is qualified, the gas stop valve 12, the liquid inlet closing valve 15, the tank bottom valve 19 and the product delivery valve 21 are opened, the aseptic gas provides pressure for the biological product tank 1, the product is conveyed to external equipment through the pipeline opened by the valve for aseptic encapsulation, and after the whole batch of the product is conveyed, the gas stop valve 12, the liquid inlet closing valve 15, the tank bottom valve 19 and the product delivery valve 21 are closed.
While the invention has been described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention.
Claims (10)
1. The utility model provides a fixed pot-type globulin inactivation device of full-automatic temperature control which characterized in that includes:
the biological product tank is used for storing globulin products, a jacket is sleeved on the outer wall of the biological product tank, and a heat exchange cavity for circulating a heat-conducting medium is formed between the jacket and the biological product tank;
a temperature control unit, the temperature control unit comprising: a first circulation line and a second circulation line;
the first circulation pipeline comprises a first liquid inlet pipeline and a first liquid return pipeline, one end of the first liquid inlet pipeline and one end of the first liquid return pipeline are respectively communicated with the heat exchange cavity, a liquid inlet valve, a circulating pump, a heat exchanger, a heater, a water flow inductive switch and a liquid inlet temperature sensor are sequentially arranged on the first liquid inlet pipeline along the direction towards the biological product tank, the other end of the first liquid return pipeline is communicated with the first liquid inlet pipeline, a connector is positioned between the liquid inlet valve and the circulating pump, the first liquid return pipeline is provided with the liquid return temperature sensor, and the heat-conducting medium flows into the heat exchange cavity along the first liquid inlet pipeline and flows back to the first liquid inlet pipeline through the first liquid return pipeline;
the second circulation pipeline comprises a second liquid inlet pipeline and a second liquid return pipeline, the second liquid inlet pipeline and the second liquid return pipeline are respectively communicated with the heat exchanger, and a refrigerant liquid inlet adjustable valve and a refrigerant liquid return valve are respectively arranged on the second liquid inlet pipeline and the second liquid return pipeline.
2. The fully automatic temperature controlled fixed tank type globin inactivation device according to claim 1, wherein said first liquid return line is further provided with a safety valve and a buffer section view mirror.
3. The fully automated temperature controlled fixed-tank globin inactivation device of claim 2, further comprising a pre-treatment unit comprising a main input line and a main output line, said main input line and said main output line being in communication with said bioproduct tank, respectively.
4. The automatic temperature-controlled fixed-tank type globulin inactivation device according to claim 3, wherein a saturated pure steam pipeline, an injection water pipeline, a gas input pipeline, a product input pipeline and a cleaning ball pipeline are respectively arranged in parallel at one end of the main input pipeline, a pure steam stop valve, a cleaning stop valve, a gas stop valve, a product stop valve and a cleaning ball block valve are respectively arranged on the saturated pure steam pipeline, the injection water pipeline, the gas input pipeline and the product input pipeline, a liquid inlet block valve is arranged at the other end of the saturated pure steam pipeline, the cleaning stop valve, the gas stop valve, the product stop valve and the cleaning ball block valve, and the cleaning ball pipeline is further communicated with the interior of the biological product tank.
5. The fully automatic temperature controlled fixed tank type globulin inactivation device according to claim 4, wherein said gas input line and said product input line are further provided with an air filter and a sterilization filter, respectively.
6. The automatic temperature-controlled fixed-tank type globulin inactivation device according to claim 5, wherein the main output pipeline is further connected in parallel with an injection water circuit and a product output pipeline, and the injection water circuit and the product output pipeline are respectively provided with a liquid return valve and a product delivery valve.
7. The fully automated temperature controlled fixed-tank globin inactivation device of claim 6, wherein said pre-treatment unit further comprises an exhaust line in communication with the interior of said bioproduct tank, said exhaust line having an air breather and a gas exhaust valve.
8. The fully automatic temperature controlled fixed tank type globin inactivation device of claim 7, wherein said biological product tank is further provided with a cleaning ball, a stirrer, a temperature sensor and a pressure sensor.
9. A method for using the fully automatic temperature control fixed tank type globulin inactivation device of claim 8, comprising the following steps:
step S1: cleaning the bioproduct tank;
step S2: sterilizing the bioproduct tank;
step S3: inputting a globulin product into the bioproduct tank;
step S4: performing low-pH incubation virus inactivation on the globulin product;
step S5: outputting the globulin product from the bioproduct tank.
10. The use method according to claim 9, wherein the step S4 further comprises:
step S4.1: aerating the bioproduct tank;
step S4.2: supplementing water to the jacket;
step S4.3: incubating the globulin product in an environment with a low pH value;
step S4.4: and reducing the temperature in the biological product tank, and temporarily storing the globulin product at low temperature.
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