CN217757511U - Biological reaction bag for cells or microorganisms - Google Patents
Biological reaction bag for cells or microorganisms Download PDFInfo
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- CN217757511U CN217757511U CN202220827827.XU CN202220827827U CN217757511U CN 217757511 U CN217757511 U CN 217757511U CN 202220827827 U CN202220827827 U CN 202220827827U CN 217757511 U CN217757511 U CN 217757511U
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Abstract
The utility model relates to a biological reaction bag for cell or microorganism, include: a plurality of bag buckles which are preset on the reaction bag and used for connecting the functional components; the breathable sheet is arranged on the reaction bag and is provided with large foam holes and/or micro foam holes; the functional components comprise at least one of a PH or dissolved oxygen interface component, a temperature measuring interface component, a pressure measuring interface component, a feeding component, a sampling component, a liquid inlet component, a harvesting component and a ventilating component, wherein the PH or dissolved oxygen interface component, the temperature measuring interface component and the pressure measuring interface component are positioned at the lower part in the reaction bag, the feeding component and the feeding component are positioned at the top of the reaction bag, the sampling component, the liquid inlet component and the harvesting component are positioned at the bottom of the reaction bag, and the ventilating component is positioned at the top and/or the bottom of the reaction bag. In the technical scheme of the utility model, the reaction bag is a disposable product sterilized in advance, and can meet the requirement of rapid multi-batch and large-scale switching production after being thrown after use; the air permeable sheet in the reaction bag is made of air permeable material and can be opened with millimeter-sized air holes, so that the combination of air inlet large bubbles and micro bubbles of a client can be realized, and the air inlet amount requirement of cell production can be met.
Description
Technical Field
The utility model relates to a bio-pharmaceuticals field especially relates to a biological reaction bag for cell or microorganism.
Background
In the field of biopharmaceuticals, disposable systems are rapidly accepted worldwide and gradually replace traditional stainless steel systems, which can save the repeated cleaning, sterilization and disinfection processes in the biopharmaceutical manufacturing process, save trial and error and production time for pharmaceutical enterprises, improve the success rate, shorten the drug marketing period the more production batches are, and the disposable biopharmaceutical process is increasingly favored by biopharmaceutical production enterprises. The demand for disposable reactors and consumables has grown at a rate of 13.5% per year and is expected to continue at this rate to 2026 years, where mammalian and bacterial cell cultures account for over 85% of the demand, which relates to product categories: monoclonal antibodies, vaccines, viruses, and the like.
In the using process of the disposable bioreactor, the sterility, the uniformity and the consistency of the environment in the bag are the primary consideration factors in the disposable biopharmaceutical process, the environment in the bag needs to be monitored at any time based on the factors, and supplementary measures such as supplementary feeding, acid supplementing, alkali supplementing and the like are taken according to the monitoring result to promote the culture environment in the culture bag to be met. The existing disposable reactors do not meet the above requirements well.
SUMMERY OF THE UTILITY MODEL
The present invention aims at least solving one of the technical problems existing in the prior art or the related art.
Therefore, the utility model aims to provide a biological reaction bag for cells or microorganisms, which can be sterilized in advance, has the characteristic of being thrown after being used up, and can meet the requirement of rapid multi-batch and large-scale switching production.
In order to achieve the above object, the present invention provides a bioreactor bag for cells or microorganisms, comprising a plurality of bag fasteners pre-arranged on the bioreactor bag for connecting functional components; the air permeable sheet is arranged on the reaction bag, and is provided with large foam holes and/or micro foam holes, the aperture of each large foam hole is 0.1-2 mm, and the aperture of each micro foam hole is 3-40 um; the functional components include at least one of the following components: the PH or dissolved oxygen interface component is positioned at the middle lower part of the reaction bag and is connected with an external PH detection device or dissolved oxygen detection device; the temperature measuring interface component is positioned at the middle lower part of the reaction bag and is connected with an external temperature detection device; the pressure measuring interface assembly is positioned at the middle lower part of the reaction bag and is connected with an external pressure detection device; the feeding assembly is positioned at the top of the reaction bag and is connected with an external feeding device; the material supplementing assembly is positioned at the top of the reaction bag and is connected with an external material supplementing device; the sampling assembly is positioned at the bottom of the reaction bag and is connected with an external cell or microorganism detection device; the liquid inlet component is positioned at the bottom of the reaction bag and is connected with an external liquid filling device; the harvesting component is positioned at the bottom of the reaction bag and is connected with an external harvesting device; a venting assembly located at the top and/or bottom of the reaction bag.
In the above technical solution, preferably, the ventilation assembly includes a plurality of ventilation pipes located at the top and/or the bottom of the reaction bag, each ventilation pipe is provided with an air filter, and any ventilation pipe is provided with a pressure detection device, and the air outlet end of the ventilation pipe is correspondingly arranged at the large pore and/or the micro pore.
In the above technical solution, preferably, the medical device further includes a sterile connector, and at least one of the functional components is provided with the sterile connector.
In the above technical scheme, preferably, an upper stirring assembly is arranged in the reaction bag, the upper stirring assembly comprises a connecting rod extending into the reaction bag from the top of the reaction bag and a paddle located at the end of the connecting rod, and the connecting rod is connected with an external stirring motor to drive the paddle.
In any of the above embodiments, preferably, the reaction bag has a stirring impeller provided at a bottom thereof and driven by an external magnetic coupling power unit, the stirring impeller has a magnet provided therein, and the external magnetic coupling power unit and the magnet form a magnetic motive force to drive the stirring impeller.
In any of the above technical solutions, preferably, the reaction bag is a disposable reaction bag.
Compared with the prior art, the utility model the advantage lie in: 1. the characteristic of pre-sterilization and throwing after use can meet the requirement of rapid multi-batch and large-scale switching production; 2. CIP and SIP cleaning and verification are not needed, so that the production cost is reduced; 3. the closed aseptic stirring is realized, and after the uniform stirring, the requirement of the growth of cells or microorganisms can be met; 4. the materials adopted by the reaction bag all meet the requirements related to United states pharmacopoeia and China GMP (good manufacturing practice) standards; 5. the reaction bag online culture parameter monitoring interface is convenient and fast to butt joint, can be used rapidly and aseptically, and can intervene and adjust the culture effect in time.
Drawings
The above and/or additional aspects and advantages of the present invention will become apparent and readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings of which:
FIG. 1 is a perspective view of a reactor according to an embodiment of the present invention;
FIG. 2 shows a front view of a reactor in accordance with an embodiment of the present invention;
FIG. 3 is a view showing a structure of a reaction bag according to example 2 of the present invention;
fig. 4 shows a connecting structure of the ventilation sheet and the ventilation pipe according to embodiment 2 of the present invention;
fig. 5 shows a structural view of a vent sheet according to an embodiment of the present invention;
FIG. 6 is a view showing a structure of a reaction bag according to example 1 of the present invention;
fig. 7 is a view showing a structure of a magnetic force generating mechanism according to an embodiment of the present invention;
fig. 8 is a structural view of a lifting mechanism according to embodiment 4 of the present invention;
fig. 9 is a structural view of a lifting mechanism according to embodiment 3 of the present invention;
fig. 10 is a structural view of an elevating mechanism according to embodiment 5 of the present invention;
wherein, the correspondence between the reference numbers and the part names in fig. 1 to 10 is:
100 reaction bags, 101 stirring impellers, 102 large-bubble holes and/or micro-bubble holes, 103 vent sheets, 104 vent pipes, 105 pump pipes, 106 silicone tubes, 107 air filters, 108 sterile connectors, 109 sampling components, 110 bag buckles, 111PH or dissolved oxygen interface components, 112 temperature measurement interface components, 113 pressure detection devices, 114 harvesting components, 115 liquid inlet components, 120 support frames, 130 cylinders, 131 guide grooves, 133 connecting plates, 140 motors, 150 magnetic force seats, 201 upper stirring components, 202 connecting rods, 203 blades, 211 guide columns, 213 fixing plates, 214 extending parts, 215 guide blocks, 300 reactors, 301 supports, 302 bases, 303 reaction tanks, 304 tank doors, 305 observation windows, 306 openings, 307 gravity sensors, 308 hinges, 309 door handle locks and 500 coupling rings.
Detailed Description
In order to make the aforementioned objects, features and advantages of the present invention more clearly understood, the present invention will be described in further detail with reference to the accompanying drawings and detailed description. It should be noted that the embodiments and features of the embodiments of the present application may be combined with each other without conflict.
In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention, however, the present invention may be practiced in other ways than those specifically described herein, and therefore the scope of the present invention is not limited to the specific embodiments disclosed below.
As shown in fig. 1 to 10, a bioreactor bag for cells or microorganisms according to an embodiment of the present invention is mounted on a support 301 of a reactor 300, and the bioreactor bag 100 includes: a plurality of bag buckles 110 for connecting functional components, which are preset on the reaction bag 100;
the air permeable sheet 103 is arranged on the reaction bag 100, the air permeable sheet 103 is provided with large foam holes and/or micro foam holes 102, the aperture of the large foam holes is 0.1 mm-2 mm, and the optional value is 0.8mm, 1mm and 1.5mm; the pore diameter of the micro-cells is 3um-40um, and the optional values are 8um, 20um and 30um;
the functional components include at least one of the following components:
a PH or dissolved oxygen interface assembly 111 located at the middle-lower portion of the reaction bag 100 and connected to an external PH detection device or dissolved oxygen detection device;
a temperature measuring interface assembly 112 located at the middle-lower part of the reaction bag 100 and connected with an external temperature detecting device;
the pressure measuring interface assembly is positioned at the middle lower part of the reaction bag and is connected with an external pressure detection device;
the feeding assembly is positioned at the top of the reaction bag and is connected with an external feeding device; the material supplementing assembly is positioned at the top of the reaction bag and is connected with an external material supplementing device;
a sampling assembly 109 located at the bottom of the reaction bag 100 and connected to an external cell or microorganism detection device;
the liquid inlet component 115 is positioned at the bottom of the reaction bag 100 and is connected with an external liquid filling device;
a harvesting assembly 114 located at the bottom of the reaction bag 100 and connected to an external harvesting device;
a vent assembly located at the top and/or bottom of the reaction bag;
a pump tube 105 and a silicone tube 106 are disposed at the top or bottom of the reaction bag 100.
In this embodiment, the reaction bag 100 is a disposable reaction bag sterilized in advance, and is disposable after use, so that the rapid multi-batch and large-scale switching production can be satisfied; the air permeability sheet 103 in the reaction bag 100 is made of air permeability material into micron-sized air permeability sheet 103, the air permeability sheet 103 can also be provided with millimeter-sized air holes, and the combination of large air bubbles and micro-bubbles for air inlet of customers can be realized so as to meet the air inlet amount requirement of cell production; a plurality of functional components on the reaction bag 100 can be selected according to the requirements of users, and the reaction bag 100 can be provided with a plurality of interfaces for monitoring on-line culture parameters, so that the rapid and sterile application can be realized through convenient butt joint, and the culture effect can be intervened and adjusted in time.
Example 1 (as shown in FIG. 6)
In this embodiment, an upper stirring assembly 201 is disposed in the reaction bag 100, the upper stirring assembly 201 includes a connecting rod 202 extending into the reaction bag 100 from the top of the reaction bag 100 and a paddle 203 located at an end of the connecting rod 202, an external stirring motor 140 for driving the paddle 203 through the connecting rod 202 is mounted on the external reactor 300, and the connecting rod 202 is connected to the stirring motor 140 for driving the paddle 203.
In this embodiment, the upper stirring component 201 is in an upper stirring form, and adopts the principle of hard connection of motor 140 drive and mechanical transmission seal, and the stirring motor 140 on the reactor 300 drives the paddle 203 to rotate through the connecting rod 202 to guide the solution in the bag to be uniformly mixed, so as to realize the stirring function.
Example 2 (as shown in FIGS. 3 to 5)
In this embodiment, the reaction bag 100 is provided at the bottom thereof with a stirring impeller 101 driven by an external magnetic coupling power unit, and magnets are provided in the stirring impeller 101, so that the magnetic coupling power unit and the magnets form a magnetic motive force to drive the stirring impeller 101.
In this embodiment, the stirring impeller 101 at the bottom of the reaction bag 100 and the external magnetic coupling power assembly form a lower stirring device in a lower stirring form, and by adopting the principle of magnetic coupling, the stirring impeller 101 and the magnet thereon are attracted by the magnetic coupling power assembly on the reactor 300, and the magnet drives the stirring impeller 101 to rotate in a non-contact manner under the rotation of the electrode, so as to realize the stirring function
In the foregoing embodiment 2, preferably, the magnetic coupling power assembly includes a support frame 120, a magnetic force generating mechanism mounted on the support frame 120, and a lifting mechanism for driving the magnetic force generating mechanism to lift, and the lifting mechanism controls the lifting of the magnetic force generating mechanism to enable the magnetic base of the reaction tank and the magnet in the reaction bag to enter or leave the magnetic coupling position.
In the embodiment, the lifting mechanism can automatically and accurately control the magnetic force generating mechanism to move to a required position according to the requirement, and the lifting mechanism can keep higher stability and guidance in the lifting process; in the running process of the magnetic force generating mechanism, the continuous stability is better; after the magnetic coupling power assembly stops operating, the disposable product can be disassembled and replaced more conveniently.
In any of the above embodiments, as shown in fig. 7, the magnetic force generating mechanism preferably includes a coupling ring 500 supported on the support frame 120 and a magnetic base 150 connected to the coupling ring 500, and the magnetic base 150 generates a magnetic force with the magnet through the coupling ring 500.
In any of the above embodiments, preferably, the lifting mechanism includes a guide rail, a guide block 215 sliding on the guide rail, a flange plate for fixing the magnetic force generating mechanism, and a motor 140 or a cylinder 130 for driving the flange plate to lift.
The arrangement of the lifting mechanism comprises but is not limited to the following technical scheme:
example 3 (as shown in FIG. 9)
The guide rail is a guide post 211, the guide post 211 is fixed on the support frame 120, the flange plate includes a fixing plate 213 and extending portions 214 formed at both sides of the fixing plate 213, the guide post 211 penetrates the extending portions 214 and the guide block 215, and the guide block 215 is fixed on the extending portions 214.
Example 4 (as shown in FIG. 8)
The guide rail is a guide groove 131, the guide groove 131 is formed on the support frame 120, the flange plate comprises a main plate and a connecting plate 133 fixed on the main plate, and the connecting plate 133 is fixedly connected with the guide block 215.
Example 5 (as shown in FIG. 10)
The guide rails are guide posts 211 and guide grooves 131, the guide posts 211 are fixed on the support frame 120, the guide grooves 131 are formed on the support frame 120, the flange plate comprises a fixing plate 213 (main plate) and extending parts 214 formed on two sides of the fixing plate 213 (main plate), the guide posts 211 penetrate through the extending parts 214 and the guide blocks 215, and the guide blocks 215 are fixed on the extending parts 214; the flange plate further includes a main plate (fixing plate 213) and a connecting plate 133 fixed to the main plate (fixing plate 213), and the connecting plate 133 is fixedly connected to the guide block 215.
In any of the above embodiments, preferably, as shown in fig. 1, the reactor 300 includes a movable base 302 and a reaction tank 303 supported on the base 302, the reaction tank 303 is hinged to a tank door 304 through a hinge 308, the tank door 304 is provided with an observation window 305 and a door handle lock 309, the reaction tank 303 is provided with an opening 306, and the base 302 is provided with a gravity sensor 307 for sensing the reaction tank 303.
Compared with the prior art, the utility model the advantage lie in: 1. the method has the characteristics of pre-sterilization and disposal after use, and can meet the requirement of rapid multi-batch and large-scale switching production; 2. CIP and SIP cleaning and verification are not needed, so that the production cost is reduced; 3. the closed aseptic stirring is realized, and after the stirring is uniform, the requirement of cell or microorganism growth can be met; 4. the materials adopted by the reaction bag 100 all meet the requirements related to United states pharmacopoeia and China GMP (good manufacturing practice) regulations; 5. the reaction bag 100 is connected with an online culture parameter monitoring interface, is convenient to butt joint, can be rapidly applied in a sterile manner, and can intervene and adjust the culture effect in time; 6. the stability and the guidance performance of the magnetic head of the motor 140 are higher in the lifting process; 7. the continuous stability is better in the running process of the motor 140 equipment; 8. the accuracy of the motor 140 magnetic head to move to a relative position; 9. the magnetic force anastomosis equipment is detachable and convenient for replacing the disposable article after stopping operation; 10. the lifting motion can be automatically controlled.
In the present application, the term "plurality" means two or more unless expressly defined otherwise. The terms "mounted," "connected," "fixed," and the like are to be construed broadly, and for example, "connected" may be a fixed connection, a removable connection, or an integral connection; "connected" may be directly connected or indirectly connected through an intermediate. The specific meaning of the above terms in the present invention can be understood according to specific situations by those skilled in the art.
In the description of the present invention, it should be understood that the terms "upper", "lower", "left", "right", "front", "back", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the device or unit indicated must have a specific direction, be constructed and operated in a specific orientation, and therefore, should not be construed as limiting the present invention.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (6)
1. A bioreactor bag for cells or microorganisms, comprising:
a plurality of bag buckles which are preset on the reaction bag and used for connecting the functional components;
the breathable sheet is arranged on the reaction bag, and is provided with large cells and/or micro-bubble cells, the pore diameter of the large cells is 0.1-2 mm, and the pore diameter of the micro-bubble cells is 3-40 um;
the functional components include at least one of the following components:
the PH or dissolved oxygen interface component is positioned at the middle lower part of the reaction bag and is connected with an external PH detection device or dissolved oxygen detection device;
the temperature measuring interface component is positioned at the middle lower part of the reaction bag and is connected with an external temperature detection device;
the pressure measuring interface component is positioned at the middle lower part of the reaction bag and is connected with an external pressure detection device;
the feeding assembly is positioned at the top of the reaction bag and is connected with an external feeding device;
the material supplementing assembly is positioned at the top of the reaction bag and is connected with an external material supplementing device;
the sampling assembly is positioned at the bottom of the reaction bag and is connected with an external cell or microorganism detection device;
the liquid inlet assembly is positioned at the bottom of the reaction bag and is connected with an external liquid filling device;
the harvesting component is positioned at the bottom of the reaction bag and is connected with an external harvesting device;
a venting assembly located at the top and/or bottom of the reaction bag.
2. The bioreactor bag for cells or microorganisms according to claim 1, characterized in that: the aeration component comprises a plurality of aeration pipes positioned at the top and/or the bottom of the reaction bag, each aeration pipe is provided with an air filter, any one of the aeration pipes is provided with a pressure detection device, and the air outlet end of each aeration pipe is correspondingly arranged at the large bubble hole and/or the micro bubble hole;
wherein at least one of the vent pipes is connected with an external exhaust gas collecting device; at least one of the snorkels is connected to an external air intake assembly.
3. The bioreactor bag for cells or microorganisms according to claim 1 or 2, characterized in that: the multifunctional component assembly is characterized by further comprising a sterile connector, wherein the sterile connector is arranged on at least one of the functional components.
4. The bioreactor bag for cells or microorganisms according to claim 1 or 2, characterized in that: the reaction bag is internally provided with an upper stirring assembly, the upper stirring assembly comprises a connecting rod and a paddle, the connecting rod extends into the reaction bag from the top of the reaction bag, the paddle is positioned at the end of the connecting rod, and the connecting rod is connected with an external stirring motor to drive the paddle.
5. The bioreactor bag for cells or microorganisms according to claim 1 or 2, characterized in that: the bottom of the reaction bag is provided with a stirring impeller driven by an external magnetic coupling power component, a magnet is arranged in the stirring impeller, and the external magnetic coupling power component and the magnet form magnetic power to drive the stirring impeller.
6. The bioreactor bag for cells or microorganisms according to claim 1 or 2, characterized in that: the reaction bag is a disposable reaction bag.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202220827827.XU CN217757511U (en) | 2022-04-02 | 2022-04-02 | Biological reaction bag for cells or microorganisms |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202220827827.XU CN217757511U (en) | 2022-04-02 | 2022-04-02 | Biological reaction bag for cells or microorganisms |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN217757511U true CN217757511U (en) | 2022-11-08 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202220827827.XU Active CN217757511U (en) | 2022-04-02 | 2022-04-02 | Biological reaction bag for cells or microorganisms |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN217757511U (en) |
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- 2022-04-02 CN CN202220827827.XU patent/CN217757511U/en active Active
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