CN207605159U - Biopharmaceutical production processes continuous sterilization automatic control system - Google Patents

Biopharmaceutical production processes continuous sterilization automatic control system Download PDF

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CN207605159U
CN207605159U CN201720673676.6U CN201720673676U CN207605159U CN 207605159 U CN207605159 U CN 207605159U CN 201720673676 U CN201720673676 U CN 201720673676U CN 207605159 U CN207605159 U CN 207605159U
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valve
tank
compound tank
steam
pipeline
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李丽
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Beijing Zhongdinghengye Polytron Technologies Inc
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Beijing Zhongdinghengye Polytron Technologies Inc
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Abstract

The utility model discloses a kind of biopharmaceutical production processes continuous sterilization automatic control systems, including the first material-compound tank, the second material-compound tank, maintenance tank, steam jet ejector, first-class heat exchanger and secondary heat exchanger;Steam jet ejector maintains tank, first-class heat exchanger to pass sequentially through pipeline with secondary heat exchanger and connect, steam jet ejector, the first material-compound tank and the second material-compound tank are sequentially connected by pipeline, connection is there are two elevator pump between steam jet ejector and the second material-compound tank, is connected with valve after stop check valve, temperature sensor, material adjustable valve, mass flow meter and pump in turn between steam jet ejector and two elevator pumps.The application culture medium heated time is short, and nutritional ingredient destroys few, fermentation efficiency height.Steam 40%~60% can be saved, cycle water consumption can be also saved.High degree of automation reduces labor intensity, and the artificial factor that participates in is reduced, and is conducive to the consistency of each batch quality of production.By adjusting technical recipe, raw material can be saved and improve yield.

Description

Biopharmaceutical production processes continuous sterilization automatic control system
Technical field
The utility model belongs to biopharmaceutical technology, and it is continuous to particularly relate to a kind of biopharmaceutical production processes Sterilize automatic control system.
Background technology
China is the important big producer of bio-pharmaceuticals, and fermentation industry is the important industry in national economy, is that technology is close Collection type industry.Although China is biofermentation big producer, but the automatic control technology of the industry relatively falls behind, in production Many producers are still based on manual control, and Computer Control Technology is started late, and popularity rate is not high.With the development of fermentation industry With production-scale expansion, fermentation industry is faced with increasingly keen competition, also have increasing need for dependent on fermentation process from Dynamic detect improves competitiveness with the automatic control technology of computer optimization.Country's pharmaceuticals industry is in a great development at present In period, the development of pharmaceuticals industry, especially production of raw medicine enterprise is than very fast.The production scale of each manufacturer is also with one kind The speed of blowout increases, and each manufacturing enterprise in the conceived case, all works hard on a manufacturing scale.And with production work The progress and development of skill, demand of the manufacturing enterprise to production process is applied in production also have huge growth.Although China It is the important big producer of bio-pharmaceuticals, but the control means of fermentation process backwardness lead to a large amount of wastes of the energy, also make China Biofermentation industry become the product of a high energy consumption, the wherein sterilization process of culture medium consumes a large amount of steam, is biology One of most important energy consumption of fermentation industry.
The sterilizing methods of biological fermentation process culture medium mainly have discontinuous sterilization in fact to disappear with continuous sterilization even to disappear two methods. What country pharmaceutical factory was generally taken at present is discontinuous sterilization method, and discontinuous sterilization has the disadvantage that:1, culture medium heated time is long, battalion Foster component damage is big, and fermentation efficiency is low;2, steam consumption is big;3, labor intensity of operating staff is big, and labor cost is high;4、 Artificial participation factor is more simultaneously, it cannot be guaranteed that the consistency of each batch quality of production.Currently, automatically continuously sterilization process at For pharmaceutical factory biological fermentation process there is an urgent need for one of new technologies of research and development.Sterilizing master of country's biofermentation industry to culture medium at present If discontinuous sterilization mode, although there is sub-fraction manufacturing enterprise, although the company of taking disappears mode, all not to continuous sterilization Automatic control technology is furtherd investigate, and the production requirement of manufacturing enterprise can not be met.
Utility model content
The utility model in order to overcome the shortcomings of the prior art, provide a kind of high degree of automation, fermentation efficiency it is high, Raw material can effectively be saved and improve the biopharmaceutical production processes continuous sterilization automatic control system and its technique stream of yield Journey.
The utility model is achieved through the following technical solutions:A kind of biopharmaceutical production processes continuous sterilization is controlled automatically System processed comprising the first material-compound tank, maintains tank, steam jet ejector, first-class heat exchanger and secondary heat exchanger at the second material-compound tank; Steam jet ejector maintains tank, first-class heat exchanger to pass sequentially through pipeline with secondary heat exchanger and connect, steam jet ejector, the first dispensing Tank and the second material-compound tank are sequentially connected by pipeline, the elevator pump there are two connections between steam jet ejector and the second material-compound tank, It is connected with stop check valve, temperature sensor, material adjustable valve, material stream in turn between steam jet ejector and two elevator pumps Valve after gauge and pump.
It is connected separately with the first steam heating valve and the heating of the second steam in the bottom of the first material-compound tank and the second material-compound tank Valve, the first steam heating valve and the second steam heating valve are connect by pipeline with steam inlet;Match in the first material-compound tank and second The bottom of batch can is connected separately with the first inlet valve and the second inlet valve, and the first inlet valve and the second inlet valve are by pipeline and certainly Water is connected to.
It is connected with steam-flow meter, temperature sensor, pressure sensor in turn between steam inlet and steam jet ejector With steam check-valves;In steam jet ejector and maintain to be connected with temperature sensor and pressure sensor in turn between tank;It is maintaining It is connected with pressure-regulating valve and temperature sensor between tank and first-class heat exchanger in turn;First-class heat exchanger and secondary heat exchanger it Between be connected with temperature sensor;Be connected with a sterile material stop valve in the other end of secondary heat exchanger, sterile material stop valve it is another One end pipeline is connect with fermentation tank.
The first outlet valve and the second outlet valve, the first outlet valve are connected separately on the first material-compound tank and the second material-compound tank One total outlet valve is connected with by pipeline with the second outlet valve, there are two switching valves by pipeline connection for total outlet valve, and two are cut Valve is changed to connect by pipeline with two elevator pumps respectively;Pipeline is aseptic pipeline, on the first material-compound tank and the second material-compound tank It is connected with temperature sensor.
The utility model not only ensures to sterilize sterile but also reduces culture medium destruction to the maximum extent, overcomes artificial real tank disinfection labor The defects of fatigue resistance is high, control is inaccurate, arbitrariness is also big, fluctuation is big, implementation is precisely controlled, a key operation.It is given birth in fermentation In production, the flow of a most critical is exactly to sterilize, and includes the sterilizing to equipment and the sterilizing to material, and the quality of sterilization effect is straight The success or failure for being related to fermentation are connect, any careless omission all can cause current fermentation process to fall flat, and cause greatly to waste.Sterilizing Method has hot air sterilization, flame sterilization, electromagnetic wave, ray sterilizing, moist heat sterilization, chemical agent sterilizing, filtration sterilization etc. a variety of, In fermenting and producing, the general method for using moist heat sterilization.Into before fermentation tank, by continuous sterilization technique, make culture medium Reach the sterilisation temp of requirement, and maintain certain time, this disinfection way is to connect to disappear.Using even disappear technique when, it is right first Fermentation tank and pipeline carry out empty elimination bacterium, and then carrying out continuous sterilization, that is, so-called company to material disappears.
The utility model has the beneficial effects that:Continuous sterilizing system is the newest hair of current domestic fermentation industry medium sterilization Exhibition trend compares traditional discontinuous sterilization reality sterilizing system, and the automatic continuous sterilizing continuous sterilizing system in the utility model has as follows Advantage:Culture medium heated time is short, and nutritional ingredient destroys few, fermentation efficiency height.It is energy saving, steam consumption is especially saved, can be saved Steam 40%~60% saves steam consumption 1/3 or more, and in addition it can also save cycle water consumption.High degree of automation subtracts Light work personnel labor intensity saves human cost, saves labor cost, while the artificial factor that participates in is reduced, and is conducive to each The consistency of the batch quality of production.By adjusting technical recipe, raw material can be saved and improve yield.Automatic continuous sterilization technology Application in pharmaceutical factory can be that national energy conservation and emission reduction makes huge contribution, and production cost is reduced for pharmaceutical factory.The utility model energy It is enough energy saving to the maximum extent, it requires progress thermodynamics to account according to different process, such as hydrolysis temperature and sterilisation temp, uses The method of two-stage heat exchange is not only preheated to culture medium, moreover it is possible to provide hot water for dispensing.
The utility model single batch can save steam usage amount 20% or so, can be saved by 200 yuan of calculating of steam per ton 200*20%=40 members, enterprise are used for the steam consumption of culture medium continuous sterilization at 5000 tons every year, you can reduce cost 5000* 40=200000 members.The intelligent continuous sterilization group employee of disinfection can be reduced by 35 original people to 10 people, by everyone per labourer hired by the month 3000 yuan of calculating of money can reduce 7.5 ten thousand yuan of human cost, and whole year can reduce 900,000 yuan of cost.
The utility model also has the following advantages that:1, promote the innovation and application of bio-pharmaceuticals fermentation intelligent manufacturing equipment: By domesticizing, bio-pharmaceuticals fermentation intelligent observing and controlling system is implemented with device and its Applied D emonstration special project, will realize bio-pharmaceuticals hair The innovation and application of ferment intelligent manufacturing equipment are obviously improved the intelligent level of domestic designative species fermentation production process, Promote industrialization and information-based, information technology and manufacturing technology depth integration, improving production efficiency, technical merit and product matter Amount reduces the energy and resource consumption, realizes the intelligence and greenization of biofermentation production process.2, China's biofermentation is improved Technology level:Develop the technique control that bio-pharmaceuticals fermentation intelligent observing and controlling system is conducive to optimize microbial fermentation with device System improves the technical merit of zymotechnique control.3, the energy-saving environmental protection of biofermentation production process is realized:Bio-pharmaceuticals is sent out Ferment intelligent observing and controlling system and device are succeeded in developing, and are promoted and applied in biological industry, and Chinese pharmaceutical enterprises production process will be made Intelligent control, process intelligent optimization and the level of information system management reach advanced world standards, reduce cost, increase product Yield reduces the energy and resource consumption, reduces CO2 discharges, improves work and the living environment of pharmacy corporation, realizes energy-saving ring It protects.
Description of the drawings
Fig. 1 is the process pipeline flow diagram of the utility model fermentation medium continuous sterilization;
In figure:The first material-compound tanks of 1-;The second material-compound tanks of 2-;3- maintains tank;4- steam jet ejectors;5- first-class heat exchangers;6- Secondary heat exchanger;7- elevator pumps;8- stop check valves;9- material adjustable valves;10- mass flow meters;Valve after 11- pumps;12- first Steam heating valve;The second steam of 13- heating valve;The first inlet valves of 14-;The second inlet valves of 15-;16- tap water;17- steam streams Gauge;18- steam check-valves;19- pressure-regulating valves;The sterile material stop valves of 20-;The first outlet valves of 21-;The second outlet valves of 22-; The total outlet valves of 23-;24- switching valves.
Specific implementation mode
The utility model is described in detail below in conjunction with the drawings and specific embodiments.
As shown in Figure 1, a kind of biopharmaceutical production processes continuous sterilization automatic control system comprising the first material-compound tank 1, Second material-compound tank 2 maintains tank 3, steam jet ejector 4, first-class heat exchanger 5 and secondary heat exchanger 6;Steam jet ejector 4, maintain tank 3, First-class heat exchanger 5 passes sequentially through pipeline with secondary heat exchanger 6 and connects, steam jet ejector 4, the first material-compound tank 1 and the second material-compound tank 2 It is sequentially connected by pipeline, there are two elevator pumps 7 for connection between steam jet ejector 4 and the second material-compound tank 2, in steam jet ejector It is connected with stop check valve 8, temperature sensor, material adjustable valve 9,10 and of mass flow meter between 4 and two elevator pumps 7 in turn Valve 11 after pump.
It is connected separately with the first steam heating valve 12 and the second steam in the bottom of the first material-compound tank 1 and the second material-compound tank 2 Heat up valve 13, and the first steam heating valve 12 and the second steam heating valve 13 are connect by pipeline with steam inlet;In the first dispensing The bottom of tank 1 and the second material-compound tank 2 is connected separately with the first inlet valve 14 and the second inlet valve 15, the first inlet valve 14 and second Inlet valve 15 is connected to by pipeline with tap water 16.
It is connected with steam-flow meter 17, temperature sensor, pressure sensing in turn between steam inlet and steam jet ejector 4 Device and steam check-valves 18;In steam jet ejector 4 and maintain to be connected with temperature sensor and pressure sensor in turn between tank 3; It is maintaining to be connected with pressure-regulating valve 19 and temperature sensor in turn between tank 3 and first-class heat exchanger 5;In 5 He of first-class heat exchanger It is connected with temperature sensor between secondary heat exchanger 6;It is connected with a sterile material stop valve 20 in the other end of secondary heat exchanger 6, The other end pipeline of sterile material stop valve 20 is connect with fermentation tank.
It is connected separately with the first outlet valve 21 and the second outlet valve 22 on the first material-compound tank 1 and the second material-compound tank 2, first Outlet valve 21 and the second outlet valve 22 are connected with a total outlet valve 23 by pipeline, there are two total outlet valve 23 is connected by pipeline Switching valve 24, two switching valves 24 are connect with two elevator pumps 7 by pipeline respectively;Pipeline is aseptic pipeline, in the first dispensing It is respectively connected with temperature sensor on tank 1 and the second material-compound tank 2.
A kind of technological process of biopharmaceutical production processes continuous sterilization automatic control system, culture medium automatically continuously sterilize Technological process be followed successively by cleaning, pipeline sterilizing, sky disappears, culture medium preheat, level-one heat exchange heating, spray heat exchange, insulated sterilizing, Level-one heat exchange cooling, goes fermentation tank, sterilizing to terminate at secondary heat exchange cooling;First with steam to related in entire technological process Equipment carries out disinfection, and is then continuously pumped into culture medium and disappears device and maintain tank 3, and steam is mixed with culture medium in the device that even disappears, And the temperature of material is improved to sterilisation temp, controlling the flow velocity of culture medium makes them in the stop disinfection for maintaining to have certain in tank 3 Time, to reach the disinfection to culture medium, substrate or culture medium after disinfection are re-fed into required fermentation tank or kind Sub- tank.
The technological process of the utility model biopharmaceutical production processes continuous sterilization automatic control system specifically includes as follows Step:A, during continuous sterilization, culture medium is preheating to 65 DEG C~70 DEG C first;B, it by level-one heat-exchanger rig, realizes High-temperature material both heat exchanges between the material after insulated sterilizing and the low-temperature material after preheating for the first time, low-temperature material is warming up to 90℃;C, it in jet mixing device, carries out 130 DEG C of saturated vapor and 90 DEG C of material to be mixed heat exchange, material exists It is brought rapidly up to 125 DEG C in several seconds;D, it is maintaining tank 3 or is maintaining in pipe, material keeps 125 DEG C of 8~12min of temperature, realizes Complete sterilizing;E, 125 DEG C of high-temperature materials after sterilizing are cooled to 80 DEG C, then pass through secondary heat exchange by level-one heat-exchanger rig Device cools to 60 DEG C, while 30 DEG C of tap water at normal temperature 16 is heated to 50 DEG C, enters material-compound tank and carries out dispensing.
The process pipeline flow of the utility model fermentation medium continuous sterilization includes that sky disappears and process and even disappears process:
1, sky disappears process:
The sky process that disappears mainly carries out disinfection to fermentation tank and equipment pipeline.During sky disappears, steam from steam jet ejector 4 into Enter, along pipeline to tank 3 is maintained, enter back into level-one, secondary heat exchanger 6, sky disappears beginnings, and steam enters the sterile tube that needs sterilize Line.Control system detects several key points in real time:Injector outlet temperature maintains 3 outlet temperature of tank and 6 hot material of secondary heat exchanger These three disinfection key temperatures of outlet temperature.When three key temperatures all reach 121 DEG C of sterilisation temp, meet conditions for sterilization, Control system starts sky and disappears timing.In sky disappears timing course, any one in three key temperatures is less than sterilisation temp, and sky disappears Elapsed time clock is reset, and waits for meet conditions for sterilization to sterilize timing again next time.When sky disappear timing reach disinfecting time when, generally For 30min, the sky process of disappearing terminates, and steam off injector 4 is transferred to continuous sterilization or wait state.
2, even disappear process:
Company, which disappears, mainly carries out disinfection to material.When company disappears, it is first turned on the first outlet valve 21, total outlet valve 23, switching valve 24 and pump after the equal valves of valve 11, open the steam control valve of steam jet ejector 4 to certain aperture.Steam control valve postpones after opening After 5s, steam pressure is higher than certain value, and minimum 0.2MPa starts to gradually pass through metering pump adjusting mass flow to final setting Value.The final setting value of flow-rate adjustment is limited to steam pressure and mass flow setting value, corresponding according to different steam pressures Different maximum processing mass flows.
During continuous sterilization, injector outlet temperature control range is sterilisation temp ± 1.5 DEG C, while passing through adjusting 3 pressure 0.24MPa of tank is maintained, ensures that 3 outlet temperature of tank is maintained to be more than sterilisation temp.When steam pressure or injector outlet temperature When being unsatisfactory for imposing a condition, control system will alarm and stop the process that even disappears.During continuous sterilization, early period is needed due to material It fills pipeline and maintains tank 3, in first-class heat exchanger 5 and do not set up thermal cycle, therefore the first tank material needs are warming up to 65 in advance DEG C or so.When maintaining pipe filling to complete, the high-temperature material after sterilizing enters first-class heat exchanger 5, and high-temperature material is opened with low-temperature material Establish vertical thermal cycle when, injector material inlet temperature there are one the short time dramatic temperature uphill process.This process disappears to company System brings a larger interference, and at this moment control system needs to be controlled to avoid injector outlet temperature by algorithm It drastically increases, to avoid the oscillation on large scale of destruction and entire continuous sterilizing system to material.
After the completion of the first tank material is substantially sterile, need to be switched to the second material-compound tank 2.Due to the of the first material-compound tank 1 One tank material is pre- heating material, and main cause is not establish heat exchange early period, and the material of the second material-compound tank 2 is room temperature object Material when two tank materials switch, since there are larger temperature differences for two tank materials, will bring a step interference, control to continuous sterilizing system Algorithm processed needs to carry out interpretation and adjusting to this situation.Meanwhile the first material-compound tank 1 and the second material-compound tank 2 will frequencies during even disappearing It is numerous to switch over, interference when needing to consider in control algolithm the switching of two tanks to mass flow, when specific to realizing, need by First outlet valve 21 and the second outlet valve 22 open 3~5s to ensure that valve fully opens simultaneously, are then shut off the first outlet valve 21 or second outlet valve 22.After the completion of company disappears, respective valves and Beng Deng executing agencies are closed, is discharged into salvage stores using steam To fermentation tank.
Finally it should be noted that the above content is only to illustrate the technical solution of the utility model, rather than to this practicality The limitation of novel protected range, those skilled in the art to the technical solution of the utility model carry out it is simple modification or Person's equivalent replacement, all without departing from the spirit and scope of technical solutions of the utility model.

Claims (4)

1. a kind of biopharmaceutical production processes continuous sterilization automatic control system, it is characterised in that:The bio-pharmaceuticals produced Journey continuous sterilization automatic control system includes the first material-compound tank, the second material-compound tank, maintains tank, steam jet ejector, first-class heat exchanger And secondary heat exchanger;The steam jet ejector maintains tank, first-class heat exchanger to pass sequentially through pipeline with secondary heat exchanger and connect, institute It states steam jet ejector, the first material-compound tank and the second material-compound tank to be sequentially connected by pipeline, in steam jet ejector and the second material-compound tank Between connection there are two elevator pump, be connected with stop check valve in turn between steam jet ejector and two elevator pumps, temperature passes Valve after sensor, material adjustable valve, mass flow meter and pump.
2. biopharmaceutical production processes continuous sterilization automatic control system according to claim 1, it is characterised in that: The bottom of one material-compound tank and the second material-compound tank is connected separately with the first steam heating valve and the second steam heating valve, and described first steams Vapour heating valve and the second steam heating valve are connect by pipeline with steam inlet;In first material-compound tank and the second material-compound tank Bottom is connected separately with the first inlet valve and the second inlet valve, and first inlet valve and the second inlet valve are by pipeline and originally Water is connected to.
3. biopharmaceutical production processes continuous sterilization automatic control system according to claim 1, it is characterised in that:It is steaming It is connected with steam-flow meter, temperature sensor, pressure sensor and steam check-valves between vapor inlet and steam jet ejector in turn; In steam jet ejector and maintain to be connected with temperature sensor and pressure sensor in turn between tank;Maintaining tank and first-class heat exchanger Between be connected with pressure-regulating valve and temperature sensor in turn;Temperature biography is connected between first-class heat exchanger and secondary heat exchanger Sensor;It is connected with a sterile material stop valve, other end pipeline and the fermentation of sterile material stop valve in the other end of secondary heat exchanger Tank connects.
4. biopharmaceutical production processes continuous sterilization automatic control system according to claim 1, it is characterised in that: The first outlet valve and the second outlet valve are connected separately on one material-compound tank and the second material-compound tank, first outlet valve and second go out Material valve is connected with a total outlet valve by pipeline, and there are two switching valve, two switching valves by pipeline connection for total outlet valve It is connect respectively by pipeline with described two elevator pumps;The pipeline is aseptic pipeline, in the first material-compound tank and the second material-compound tank On be respectively connected with temperature sensor.
CN201720673676.6U 2017-06-12 2017-06-12 Biopharmaceutical production processes continuous sterilization automatic control system Active CN207605159U (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111450271A (en) * 2020-04-24 2020-07-28 连云港佑源医药设备制造有限公司 Chinese patent medicine intermediate sterilization equipment
CN117228819A (en) * 2023-11-15 2023-12-15 江苏今石环境有限责任公司 Heterotrophic nitrification and aerobic denitrification strain in-situ expansion culture system and method
CN117228819B (en) * 2023-11-15 2024-05-10 江苏今石环境有限责任公司 Heterotrophic nitrification and aerobic denitrification strain in-situ expansion culture system and method

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111450271A (en) * 2020-04-24 2020-07-28 连云港佑源医药设备制造有限公司 Chinese patent medicine intermediate sterilization equipment
CN117228819A (en) * 2023-11-15 2023-12-15 江苏今石环境有限责任公司 Heterotrophic nitrification and aerobic denitrification strain in-situ expansion culture system and method
CN117228819B (en) * 2023-11-15 2024-05-10 江苏今石环境有限责任公司 Heterotrophic nitrification and aerobic denitrification strain in-situ expansion culture system and method

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