CN216639513U - GMP (good manufacturing practice) compliance high-flux intelligent biological medicine production system - Google Patents
GMP (good manufacturing practice) compliance high-flux intelligent biological medicine production system Download PDFInfo
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- CN216639513U CN216639513U CN202121942912.2U CN202121942912U CN216639513U CN 216639513 U CN216639513 U CN 216639513U CN 202121942912 U CN202121942912 U CN 202121942912U CN 216639513 U CN216639513 U CN 216639513U
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Abstract
The utility model relates to the technical field of biological medicine production, in particular to a GMP (good manufacturing practice) compliant high-flux intelligent biological medicine production system which comprises a detection cabin, a middle transferring discharging cabin, a feeding cabin, a culture cabin, a central cabin, a first liquid distribution cabin, a storage cabin, a second liquid distribution cabin, a laminar air return pipeline and a laminar air return cabin, wherein the middle transferring discharging cabin is arranged on the right side of the end part of the detection cabin, the culture cabin is arranged on the left side of the feeding cabin, the central cabin is arranged on the rear side of the culture cabin, the second liquid distribution cabin is arranged on the rear side of the central cabin, the storage cabin is arranged on the right side of the second liquid distribution cabin, the first liquid distribution cabin is arranged on the right side of the storage cabin, the system is reasonably arranged and isolated from different operation areas, and different process operations such as important material transfer, liquid operation and culture are carried out in a totally closed and airtight cabin body and is combined with an intelligent scheduling system, The operating system and the data acquisition system realize the full-automatic research and development and production of the biological medicines.
Description
Technical Field
The utility model relates to the technical field of biological medicine production, in particular to a GMP (good manufacturing practice) compliant high-throughput intelligent biological medicine production system.
Background
CAR-T, TCR-T, TIL novel biological medicines (immune cell medicines) are developed at a high speed, novel medicines are continuously sold on the market at home and in the whole world, and large-scale and personalized production is needed to meet the demand of personalized medicine application of patients. Novel biopharmaceuticals, such as customized protein drugs, nucleic acid drugs, gene virus drugs, are produced based on various types of carrier cells, requiring a highly safe, high throughput mode of production to meet individualized drug needs.
The method comprises the steps of sample introduction, consumable material transfer, culture medium feeding, isolated culture, daily detection and sampling, detection sample transfer, sample mixing, centrifugal liquid exchange, cell counting, flow operation and sample photographing in the complete process flow. The traditional manual operation is complex, a large number of personnel are required to be consumed, the personnel are easy to operate mistakenly, products or samples are scrapped, time is consumed, and waste is caused.
The traditional manual operation process needs a plurality of technical personnel with professional knowledge background to completely execute the whole process steps, and needs to have the capability of operating a plurality of detection devices, so that a production party needs to reserve a batch of technical personnel with professional training, a large amount of capital and manpower are consumed, and the cost of the existing product is always high.
In the traditional manual operation mode, the operation methods of different operators are difficult to keep consistent, and the quality consistency of the produced finished products cannot be ensured after the different operators operate the traditional manual operation mode. The same production process is handed over to different personnel for operation, and has serious risk of process repeatability.
The traditional manual operation mode is completed in an open laboratory, and pollution is easy to generate in the production process of products, so that the products are scrapped, and raw materials and time are wasted. Can not meet the requirement of sterility of the whole process of biological medicine production of a supervision institution. The traditional manual operation mode can not quickly and effectively electronize various environmental data and production process data in the production process, errors are very easy to occur in the manual recording process, data tracing and data analysis operations can not be carried out, and the process research and development and process updating speed is slow.
Due to the defects of the manual operation, even a successful biological medicine process flow cannot be rapidly deployed in other places, and the popularization and the use of the biological medicine are greatly hindered.
The existing semi-automatic desktop laboratory equipment partially solves the problem of a closed system. However, the device can only complete the operation of a single sample within a single time period, and cannot meet the requirement of large-scale multi-batch parallel production, and the personalized production requirement of a large number of patients cannot be effectively met. The existing semi-automatic desktop laboratory equipment mainly depends on import, binds process flows and matched consumables, limits the rapid iterative development of a new process, further increases the medicine cost, causes the difficulty of bearing novel biological medicines by an end user, and limits the rapid development of industry, so that a high-throughput intelligent biological medicine production system with GMP (good manufacturing practice) compliance is needed to improve the problems.
SUMMERY OF THE UTILITY MODEL
The present invention is directed to a GMP-compliant, high-throughput, intelligent biopharmaceutical production system to solve the above-mentioned problems of the background art.
In order to achieve the purpose, the utility model provides the following technical scheme:
a GMP-compliant high-flux intelligent biological medicine production system comprises a detection cabin, a transfer material outlet cabin, a material inlet cabin, a culture cabin, a central cabin, a first liquid distribution cabin, a storage cabin, a second liquid distribution cabin, a laminar flow air return pipeline and a laminar flow air return cabin, a middle rotating discharging cabin is arranged on the right side of the end part of the detection cabin, a feeding cabin is arranged on the left side of the middle rotating discharging cabin, a culture cabin is arranged on the left side of the feeding cabin, a central cabin is arranged on the rear side of the culture cabin, a second liquid distribution cabin is arranged on the rear side of the central cabin, a storage cabin is arranged on the right side of the second liquid distribution cabin, a first liquid distribution cabin is arranged on the right side of the storage cabin, the bottoms of the transfer discharging cabin, the feeding cabin, the central cabin, the first liquid distribution cabin, the storage cabin and the second liquid distribution cabin are all connected with a laminar air return pipeline, and the other end of the laminar air return pipeline is provided with a laminar air return cabin.
As a preferable scheme of the utility model, a central cabin bottom cabin frame is arranged at the bottom of the central cabin, a central cabin middle cabin is arranged at the upper side of the central cabin bottom cabin frame, a cabin isolation door is arranged at the right side of the front surface of the central cabin middle cabin, a sterilization liquid path bottom unit is arranged at the left lower side inside the central cabin bottom cabin frame, a central cabin track laminar flow air inlet is arranged at the left upper side of the central cabin middle cabin, a central cabin laminar flow air inlet is arranged at the front side of the central cabin middle cabin at the central cabin track laminar flow air inlet, a central cabin mechanical arm is arranged on the central cabin track laminar flow air inlet, a metal bath module is arranged at the left front side of the central cabin middle cabin, a central cabin low-temperature refrigerator is arranged at the front side of the central cabin middle cabin, an automatic refrigerator door is arranged on the central cabin low-temperature refrigerator, and a low-temperature incubation refrigerator is arranged at the rear side of the central cabin middle cabin, an environment monitoring module is arranged on the right rear side of the central cabin middle cabin, and a static pressure cabin is arranged at the end part of the central cabin middle cabin.
As a preferable scheme of the utility model, a feeding cabin middle frame is arranged on the right side surface of the feeding cabin, a feeding cabin garbage can is arranged on the right rear side inside the feeding cabin, a feeding cabin DD motor assembly is arranged on the left lower side of the feeding cabin, a feeding cabin roller is arranged at the driving end of the feeding cabin DD motor assembly, a settlement bacteria collector is arranged on the right front side inside the feeding cabin, a settlement bacteria analyzer is arranged on the lower side of the feeding cabin, and a feeding cabin air velocity sensor is arranged on the front upper side inside the feeding cabin.
As a preferable scheme of the utility model, a temperature and humidity sensor is arranged on the right rear side inside the middle rotating discharging cabin, a middle cabin upturning door is arranged on the right front side at the bottom of the middle rotating discharging cabin, a middle transfer DD motor assembly is arranged on the left lower side of the middle rotating discharging cabin, a middle transfer roller is arranged at the driving end of the middle transfer DD motor assembly, a discharging cabin carrier frame is arranged on the rear side inside the middle rotating discharging cabin, a middle rotating discharging cabin middle frame is arranged on the right side surface of the middle rotating discharging cabin, and a middle transfer wind speed sensor is arranged on the front upper side inside the middle rotating discharging cabin.
As a preferable scheme of the utility model, the detection cabin is provided with a detection cabin frame, the left rear side inside the detection cabin frame is provided with a detection equipment controller, the right front side inside the detection cabin frame is provided with an automatic garbage transfer module, the lower side of the automatic garbage transfer module is provided with a garbage slide way, the right lower side inside the detection cabin frame is provided with a low-temperature storage refrigerator, the middle of the right side inside the detection cabin frame is provided with a liquid transfer unit, the left side of the bottom of the detection cabin frame is provided with a full-automatic centrifuge, the left side inside the detection cabin frame and positioned at the low-temperature storage refrigerator is provided with a mechanical arm, the left front side inside the detection cabin frame is provided with a flow cytometer, the right upper side of the front of the flow cytometer is provided with a cell counter, the left side of the front of the flow cytometer is provided with a manual feeding area, the right side of the end part of the flow cytometer is provided with a microscope, and the right upper side of the flow cytometer is provided with a full-automatic cover opener.
As a preferable scheme of the present invention, the storage cabin is provided with a storage cabin middle frame, a storage cabin DD motor assembly is arranged on a lower right side of the storage cabin middle frame, a storage cabin drum is arranged at a driving end of the storage cabin DD motor assembly, a storage cabin temperature and humidity sensor is arranged on a rear left side inside the storage cabin middle frame, and a storage cabin air velocity sensor is arranged on a rear upper side inside the storage cabin middle frame.
As a preferable scheme of the utility model, the first liquid distribution chamber and the second liquid distribution chamber are provided with a liquid distribution chamber bottom chamber frame, a liquid distribution chamber middle frame is arranged on the upper side of the liquid distribution chamber bottom chamber frame, a liquid distribution chamber full-automatic centrifuge is arranged on the left lower side inside the liquid distribution chamber bottom chamber frame, a refrigeration refrigerator assembly is arranged on the right side inside the liquid distribution chamber bottom chamber frame, a liquid distribution chamber roller is arranged on the left side inside the liquid distribution chamber middle frame, a liquid distribution chamber mechanical arm is arranged inside the liquid distribution chamber middle frame and on the right side of the liquid distribution chamber roller, and a liquid distribution chamber full-automatic cover opener is arranged on the right side inside the liquid distribution chamber middle frame.
As a preferable scheme of the utility model, the culture cabin is provided with a bottom cabin frame assembly, the upper side of the bottom cabin frame assembly is provided with a middle frame assembly, the left front side inside the bottom cabin frame assembly is provided with a culture unit control assembly, the right side inside the bottom cabin frame assembly is provided with a culture unit monitoring assembly, the end part of the middle frame assembly is provided with a sterile liquid circuit top assembly, the inside of the middle frame assembly is provided with an independent culture unit mounting rail, an independent culture unit is mounted on the independent culture unit mounting rail, the left rear side inside the bottom cabin frame assembly is provided with an independent culture unit air pipe and a water pipe, the left side surface of the middle frame assembly is provided with an independent culture unit cable, the independent culture unit is provided with a culture unit slide rail assembly, and the left side surface of the culture unit slide rail assembly is provided with a culture unit electrical wiring assembly, cultivate unit slide rail set's right flank and be provided with and cultivate unit water supply air feed subassembly, the right front side of cultivateing unit slide rail set is provided with cultivates unit aqueous vapor switching mouth, the front side of cultivateing unit slide rail set is provided with cultivates the unit emergency door, it is provided with cultivation unit locking support to the car from top to bottom to cultivate unit slide rail set's front side, the left rear side of cultivateing unit slide rail set is provided with cultivates unit slip table drive assembly, the left front side of cultivateing unit slide rail set is provided with cultivates unit electrical switching mouth, the tip of cultivateing unit slide rail set is provided with cultivates unit cabin body subassembly, the tip of cultivateing unit cabin body subassembly is provided with cultivates unit air duct subassembly, the inside of cultivateing unit slide rail set is provided with the blake bottle.
As a preferable scheme of the utility model, the detection cabin, the transfer discharging cabin, the feeding cabin, the culture cabin, the central cabin, the first liquid distribution cabin, the storage cabin and the second liquid distribution cabin are quickly aligned and installed through quick positioning pins and fastening bolts.
As the preferable scheme of the utility model, static pressure cabins are arranged at the end parts of the transfer material outlet cabin, the material inlet cabin, the central cabin, the first liquid distribution cabin, the storage cabin and the second liquid distribution cabin.
Compared with the prior art, the utility model has the beneficial effects that:
according to the utility model, in addition to manual feeding, consumable material feeding and liquid preparation cabin culture medium replacement for manual operation at the beginning of production, the full process flow realizes full-automatic operation, including automatic material transfer, automatic consumable material transfer, automatic sample extraction, automatic sample detection, automatic isolation culture, automatic liquid operation, automatic sterilization and residue discharge, and automatic storage and processing of production data. High-flux intelligent production is realized; by the utility model, the research, development and production of the biological medicine can be rapidly carried out only by training a small amount of personnel with related professional backgrounds to operate the system skillfully. The method is suitable for production of different types of medicines to be replicated in multiple places; by the utility model, under the determined process flow, the results of all operators operating the utility model are highly consistent and have no difference; according to the utility model, all material transfer, consumable transfer, culture, liquid operation and product sampling are carried out in the sealed isolator, so that the sample and the product can be ensured not to be polluted; by the method, complete traceability of all material operation, consumable operation and process operation can be realized, and analysis and treatment can be rapidly carried out when a semi-finished product or a product has a problem; by the utility model, all production data, process data and product data can be automatically stored, analyzed and backed up; by the utility model, parallel production and development of biological medicines can be realized, data isolation is carried out in an equipment production information system, and further isolation of materials, semi-finished products and finished products in equipment is realized; by the method, the verified process flow can be rapidly deployed and implemented in different places, so that the application of the biological medicine is greatly improved; the utility model has the advantages of overall GMP compliance and capability of effectively ensuring the reliability and safety of the produced biological medicine. The online sterilization is carried out by controlling a sterilization system in the equipment, so that the cross contamination of multiple production batches is avoided.
Drawings
FIG. 1 is a top view of the basic structure of the system of the present invention;
FIG. 2 is a front view of the basic structure of the system of the present invention;
FIG. 3 is a block diagram of the modular cabin of the present invention for quick alignment and installation;
FIG. 4 is a right side view of a system in accordance with an embodiment of the present invention;
FIG. 5 is a front view of a system in accordance with an embodiment of the present invention;
FIG. 6 is an isometric view of a system in accordance with a specific embodiment of the present invention;
FIG. 7 is a system workflow of an embodiment of the present invention;
FIG. 8 is a front view of a heart chamber in an embodiment of the present invention;
FIG. 9 is a left side view of the heart chamber of an embodiment of the present invention;
FIG. 10 is a top view of a heart chamber in accordance with an embodiment of the present invention;
FIG. 11 is an isometric view of a heart capsule in an embodiment of the utility model;
FIG. 12 is a schematic view of a feeding chamber according to an embodiment of the present invention;
FIG. 13 is a composite view of a swing-out bin in an embodiment of the present invention;
FIG. 14 is a front view of a test chamber according to an embodiment of the present invention;
FIG. 15 is an isometric view of a test bay according to an embodiment of the present invention;
FIG. 16 is a composite view of a storage compartment according to an embodiment of the present invention;
FIG. 17 is a front view of a dispensing chamber according to an embodiment of the present invention;
FIG. 18 is a front view of a culture chamber according to an embodiment of the present invention;
FIG. 19 is an isometric view of a culture compartment according to an embodiment of the utility model;
FIG. 20 is an isometric view of an extension of a culture module slide according to an embodiment of the utility model;
FIG. 21 is an isometric view of a stand alone culture unit according to an embodiment of the present invention;
FIG. 22 is an isometric view of an isolated culture unit according to an embodiment of the utility model;
FIG. 23 is an automated control system architecture of the present invention;
FIG. 24 is an information system architecture of the present invention;
FIG. 25 is a system software architecture of the present invention;
FIG. 26 is a diagram illustrating the number and layout of adjustable system elements according to the present invention;
FIG. 27 is a star group extension topology of the present invention.
In the figure: 1. a detection cabin; 101. a detection chamber frame; 102. detecting a device controller; 103. An automatic garbage transferring module; 104. a refuse chute; 105. a low temperature storage refrigerator; 106. a pipetting unit; 107. a full-automatic centrifuge; 108. a mechanical arm; 109. a flow cytometer; 110. a cell counter; 111. a manual feeding area; 112. a microscope; 113. a full-automatic cover opener; 2. a middle-rotating discharging cabin; 201. a temperature and humidity sensor; 202. a transfer cabin tilt-up door; 203. A transfer DD motor assembly; 204. a transfer drum; 205. a discharging cabin carrier; 206. a middle frame of the middle transferring discharging cabin; 207. a transit wind speed sensor; 3. a feeding cabin; 301. a feeding cabin middle frame; 302. a feeding cabin garbage can; 303. a feeding compartment DD motor assembly; 304. a feeding cabin roller; 305. a sedimenting bacteria collector; 306. a sedimentary bacteria analyzer; 307. a feeding cabin air speed sensor; 4. a culture compartment; 401. a bottom bay frame assembly; 402. a middle frame assembly; 403. a culture unit control assembly; 404. a culture unit monitoring assembly; 405. a sterilizing liquid path top assembly; 406. installing a track on the independent culture unit; 407. an independent culture unit; 408. Independently culturing unit air pipe and water pipe; 409. an independent culture unit cable; 410. a culturing unit slide rail assembly; 411. an incubation unit electrical wiring assembly; 412. the culture unit supplies water and gas to the assembly; 413. a water-gas transfer port of the culture unit; 414. a culturing unit emergency door; 415. a culture unit locking bracket; 416. a culture unit slide table drive assembly; 417. an electrical transfer port of the culture unit; 418. a culture unit capsule body assembly; 419. a culture unit air duct assembly; 420. a culture bottle; 5. a central compartment; 501. a center bilge frame; 502. a center pod robot arm; 503. A center compartment intermediate compartment; 504. a cabin isolation door; 505. static pressure cabin; 506. a sterilizing fluid path bottom unit; 507. incubating the mixture in a refrigerator at a low temperature; 508. an environment monitoring module; 509. a metal bath module; 510. an automatic door of the refrigerator; 511. a center compartment cryogenic refrigerator; 512. a central cabin laminar flow air inlet; 513. a central cabin track laminar flow air inlet; 6. a first liquid distribution cabin; 601. a tank bottom frame of the liquid distribution tank; 602. a liquid distribution chamber middle frame; 603. a full-automatic centrifuge of the liquid distribution cabin; 604. A refrigerator component; 605. a liquid distribution chamber roller; 606. a liquid distribution chamber mechanical arm; 607. a full-automatic cover opener of the liquid distribution cabin; 7. a storage compartment; 701. a storage compartment mid-frame; 702. a storage compartment DD motor assembly; 703. a storage compartment drum; 704. a storage compartment temperature and humidity sensor; 705. A storage compartment anemometry sensor; 8. a second liquid distribution cabin; 9. a laminar flow return air duct; 10. laminar flow return air cabin.
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 embodiments, and all other embodiments obtained by a person of ordinary skill in the art without creative efforts based on the embodiments of the present invention belong to the protection scope of the present invention.
In order to facilitate an understanding of the utility model, the utility model will now be described more fully hereinafter with reference to the accompanying drawings, in which several embodiments of the utility model are shown, but which can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.
It will be understood that when an element is referred to as being "secured to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the utility model herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the utility model. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
Referring to fig. 1-5, the present invention provides a technical solution:
a GMP (good manufacturing practice) compliant high-flux intelligent biological medicine production system, which comprises a detection cabin 1, a transfer discharging cabin 2, a feeding cabin 3, a culture cabin 4, a central cabin 5, a first liquid preparation cabin 6 and a storage cabin 7, no. two liquid distribution cabins 8, laminar flow return air pipeline 9 and laminar flow return air cabin 10, the tip right side that detects cabin 1 is provided with well transfer ejection of compact cabin 2, the left side of well transfer ejection of compact cabin 2 is provided with feeding cabin 3, the left side of feeding cabin 3 is provided with cultivates cabin 4, the rear side of cultivateing cabin 4 is provided with center cabin 5, the rear side of center cabin 5 is provided with No. two liquid distribution cabins 8, the right side of No. two liquid distribution cabins 8 is provided with storage cabin 7, the right side of storage cabin 7 is provided with one and joins in marriage liquid cabin 6, well transfer ejection of compact cabin 2, feeding cabin 3, center cabin 5, one liquid distribution cabin 6, storage cabin 7, the bottom of No. two liquid distribution cabins 8 all is connected with laminar flow return air pipeline 9, the other end of laminar flow return air pipeline 9 is provided with laminar flow return air cabin 10.
A central cabin bottom cabin frame 501 is arranged at the bottom of the central cabin 5, a central cabin middle cabin 503 is arranged at the upper side of the central cabin bottom cabin frame 501, a cabin isolation door 504 is arranged at the right side of the front surface of the central cabin middle cabin 503, a sterilization liquid path bottom unit 506 is arranged at the left lower side of the interior of the central cabin bottom cabin frame 501, a central cabin track laminar flow air inlet 513 is arranged at the left upper side of the central cabin middle cabin 503, a central cabin laminar flow air inlet 512 is arranged at the front side of the central cabin middle cabin 503 positioned at the central cabin track laminar flow air inlet 513, a central cabin mechanical arm 502 is arranged on the central cabin track laminar flow air inlet 513, a metal bath module 509 is arranged at the left front side of the central cabin middle cabin 503, a central cabin low-temperature refrigerator 511 is arranged at the front side of the central cabin middle cabin 503, a refrigerator automatic door 510 is arranged on the central cabin low-temperature refrigerator 511 is arranged at the rear side of the central cabin middle cabin 503, the right rear side of the center cabin middle compartment 503 is provided with an environmental monitoring module 508, and the end of the center cabin middle compartment 503 is provided with a static pressure compartment 505.
The right side face of the feeding cabin 3 is provided with a feeding cabin middle frame 301, the right rear side inside the feeding cabin 3 is provided with a feeding cabin garbage can 302, the left lower side of the feeding cabin 3 is provided with a feeding cabin DD motor assembly 303, the driving end of the feeding cabin DD motor assembly 303 is provided with a feeding cabin roller 304, the right front side inside the feeding cabin 3 is provided with a settlement bacterium collector 305, the lower side of the feeding cabin 3 is provided with a settlement bacterium analyzer 306, and the front upper side inside the feeding cabin 3 is provided with a feeding cabin air velocity sensor 307.
The inside right back side of well commentaries on classics ejection of compact cabin 2 is provided with temperature and humidity sensor 201, the right front side in bottom of well commentaries on classics ejection of compact cabin 2 is provided with well commentaries on classics cabin turn-over door 202, the left downside of well commentaries on classics ejection of compact cabin 2 is provided with well commentaries on classics DD motor element 203, the drive end of well commentaries on classics DD motor element 203 is provided with well transition cylinder 204, the inside rear side of well commentaries on classics ejection of compact cabin 2 is provided with ejection of compact cabin carrier 205, the right flank of well commentaries on classics ejection of compact cabin 2 is provided with well commentaries on classics ejection of compact cabin middle frame 206, the upside is provided with well commentaries on classics air velocity transducer 207 before the inside of well commentaries on classics ejection of compact cabin 2.
The detection chamber 1 is provided with a detection chamber frame 101, the left rear side inside the detection chamber frame 101 is provided with a detection device controller 102, the right front side inside the detection chamber frame 101 is provided with an automatic garbage transfer module 103, the lower side of the automatic garbage transfer module 103 is provided with a garbage chute 104, the right lower side inside the detection chamber frame 101 is provided with a low-temperature storage refrigerator 105, the middle of the right side inside the detection chamber frame 101 is provided with a liquid transfer unit 106, the left side of the bottom of the detection chamber frame 101 is provided with a full-automatic centrifuge 107, the left side inside the detection chamber frame 101 and positioned in the low-temperature storage refrigerator 105 is provided with a mechanical arm 108, the left front side inside the detection chamber frame 101 is provided with a flow cytometer 109, the right upper side of the front of the flow cytometer 109 is provided with a cell counter 110, the left side of the front of the flow cytometer 109 is provided with a manual feeding area 111, and the right side of the end of the flow cytometer 109 is provided with a microscope 112, the right upper side of the flow cytometer 109 is provided with a fully automatic lid opener 113.
The storage cabin 7 is provided with a storage cabin middle frame 701, a storage cabin DD motor assembly 702 is arranged on the right lower side of the storage cabin middle frame 701, a storage cabin roller 703 is arranged at the driving end of the storage cabin DD motor assembly 702, a storage cabin temperature and humidity sensor 704 is arranged on the left rear side inside the storage cabin middle frame 701, and a storage cabin air velocity sensor 705 is arranged on the rear upper side inside the storage cabin middle frame 701.
The first liquid distribution tank 6 and the second liquid distribution tank 8 are provided with a liquid distribution tank bottom tank frame 601, the upper side of the liquid distribution tank bottom tank frame 601 is provided with a liquid distribution tank middle frame 602, the left lower side inside the liquid distribution tank bottom tank frame 601 is provided with a liquid distribution tank full-automatic centrifuge 603, the right side inside the liquid distribution tank bottom tank frame 601 is provided with a refrigeration refrigerator assembly 604, the left side inside the liquid distribution tank middle frame 602 is provided with a liquid distribution tank roller 605, the right side inside the liquid distribution tank middle frame 602 and located on the liquid distribution tank roller 605 is provided with a liquid distribution tank mechanical arm 606, and the right side inside the liquid distribution tank middle frame 602 is provided with a liquid distribution tank full-automatic cover opener 607.
The culture cabin 4 is provided with a bottom cabin frame assembly 401, the upper side of the bottom cabin frame assembly 401 is provided with a middle frame assembly 402, the left front side inside the bottom cabin frame assembly 401 is provided with a culture unit control assembly 403, the right side inside the bottom cabin frame assembly 401 is provided with a culture unit monitoring assembly 404, the end part of the middle frame assembly 402 is provided with a sterile liquid road top assembly 405, the inside of the middle frame assembly 402 is provided with an independent culture unit installation track 406, the independent culture unit installation track 406 is provided with an independent culture unit 407, the left rear side inside the bottom cabin frame assembly 401 is provided with an independent culture unit air pipe and water pipe 408, the left side surface of the middle frame assembly 402 is provided with an independent culture unit cable 409, the independent culture unit 407 is provided with a culture unit slide rail assembly 410, and the left side surface of the culture unit slide rail assembly 410 is provided with a culture unit electrical wiring assembly 411, the right side of the cultivation unit slide rail assembly 410 is provided with a cultivation unit water and gas supply assembly 412, the right front side of the cultivation unit slide rail assembly 410 is provided with a cultivation unit water and gas transfer port 413, the front side of the cultivation unit slide rail assembly 410 is provided with a cultivation unit emergency door 414, the front side of the cultivation unit slide rail assembly 410 is provided with a cultivation unit locking support 415 for up and down opposite to the vehicle, the left rear side of the cultivation unit slide rail assembly 410 is provided with a cultivation unit sliding table driving assembly 416, the left front side of the cultivation unit slide rail assembly 410 is provided with a cultivation unit electric transfer port 417, the end of the cultivation unit slide rail assembly 410 is provided with a cultivation unit cabin assembly 418, the end of the cultivation unit cabin assembly 418 is provided with a cultivation unit air duct assembly 419, and the inside of the cultivation unit slide rail assembly 410 is provided with a cultivation bottle 420.
The detection cabin 1, the transfer discharging cabin 2, the feeding cabin 3, the culture cabin 4, the central cabin 5, the first liquid distribution cabin 6, the storage cabin 7 and the second liquid distribution cabin 8 are installed in a quick aligning mode through quick positioning pins and fastening bolts.
Example (b): to meet higher throughput production, different numbers of process chambers can be configured based on actual process requirements, and the specific chamber layout can be adjusted according to actual process requirements, as shown in fig. 26; the system units can adopt a star-shaped layout, the installation and maintenance of modules are further optimized, meanwhile, the star-shaped layout can be spliced at multiple ends, and more flexible function configuration and flux adjustment are realized, as shown in fig. 27;
the feeding chamber 3 performs the following operations accordingly:
1) manually scanning the code and tearing off the package, and placing the material or the consumable material on the corresponding position of the feeding cabin roller 304;
2) replacing culture dishes for environment monitoring manually and periodically;
3) the outer package in the feeding cabin garbage can 302 is manually and periodically removed;
4) the environment monitoring system operates in real time and uploads the data to the system for analysis and storage;
5) the feeding cabin roller 304 rotates to rotate the corresponding material or consumable material to the butt joint direction of the central cabin 5;
6) performing VHP sterilization and residue removal operation regularly to ensure the cleanliness of the 3A-level environment of the feeding cabin;
the middle-rotating discharging cabin 2 correspondingly performs the following operations:
1) the transfer roller 204 rotates to the position of butt joint with the central cabin 5, and used consumables or samples to be detected are received from the central cabin 5;
2) opening an upward turnover door 202 of the transfer cabin, opening a material transfer channel of the detection cabin 1, and transferring garbage or transferring samples in the cabin to be detected;
3) the discharge bin carrier 205 receives the product to be received transferred from the central bin 5;
4) the environment monitoring system operates in real time and uploads the data to the system for analysis and storage;
performing VHP sterilization and residue discharge operation regularly to ensure the cleanliness of the 2A-level environment of the transfer discharge cabin;
the central cabin 5 performs the following operations accordingly:
1) the consumables are grabbed from the feeding cabin 3 and transferred to the liquid preparation cabin or the storage cabin 7;
2) the cell carrying disc is grabbed from the feeding cabin 3 and transferred to the liquid preparation cabin;
3) the materials are grabbed from the feeding cabin 3 and transferred to the low-temperature refrigerator 511 of the central cabin;
4) the culture bottle 420 filled with the cells after the liquid preparation cabin treatment is sent into the culture cabin 4 for culture;
5) periodically grabbing the culture bottles 420 from the culture cabin 5 and transferring the culture bottles to the liquid preparation cabin for liquid supplementing, liquid changing and sampling;
6) the sampled sample is transferred to a detection cabin 1 through a transfer discharging cabin 2 for detection;
7) taking out the materials from the low-temperature storage refrigerator 105 and transferring the materials to a liquid preparation cabin for related operation;
8) the consumables are grabbed from the storage cabin 7 and transferred to the liquid preparation cabin;
9) the consumables used by the liquid preparation cabin are transferred to a garbage slide 104 of the detection cabin 1 through the transfer discharge cabin 2 for collection;
10) performing VHP sterilization and residue removal operation regularly to ensure the cleanliness of a 5A-level environment of the central cabin;
11) when the process is finished, the harvested materials are transferred to a transfer discharging cabin 2;
the detection cabin 1 performs the following operations accordingly:
1) the automatic garbage transfer module grabs the sample disc to be detected from the transfer roller 204 and places the sample disc to the transfer position;
2) the mechanical arm 108 places the sample disc to be detected from the middle to the storage position in an indexing way;
3) the automatic garbage transferring module grabs the garbage from the transferring roller 204 and transfers the garbage to the garbage chute 104;
4) the mechanical arm 108 sends the sample tube and the centrifuge tube into the full-automatic cap opener 113 to open and close the cap;
5) the robotic arm 108 places the manual feed material into the low temperature storage refrigerator 105;
6) the robotic arm 108 sends the sample tube to the pipetting unit 106 for liquid handling;
7) according to the process, the pipetting unit performs corresponding liquid suction and pumping operation;
8) the mechanical arm 108 sends the sample tube to the full-automatic centrifuge 107 for centrifugal operation;
9) the mechanical arm 108 sends the sample tube to the flow cytometer 10, the cell counter 110 and the microscope 112 for corresponding detection operation;
10) the robotic arm 108 discards the detected sample tube into the refuse chute 104;
the storage bay 7 performs the following operations accordingly:
1) the storage compartment drum 703 is rotated to an orientation to dock with the central compartment 5, receiving spare consumables from the central compartment 5;
2) according to the process arrangement, the center chamber mechanical arm 502 grabs the consumables from the storage chamber roller 703 to the liquid distribution chamber;
3) the environment monitoring system operates in real time and uploads data to the system for analysis and storage;
4) performing VHP sterilization and residue removal operation regularly to ensure the cleanliness of the 7A-level environment of the storage cabin;
the liquid distribution cabin correspondingly performs the following operations:
1) the liquid distribution chamber roller 605 receives materials and consumables from the central chamber 5;
2) the liquid preparation cabin mechanical arm 606 clamps and places materials and consumables on corresponding magnetic suspension rotors;
3) the magnetic suspension stator controls the magnetic suspension rotor to move to a corresponding uncovering and liquid pumping station;
4) the liquid distribution cabin mechanical arm 606 sends the injector into a liquid distribution cabin full-automatic cover opener 607 to open and close the cover;
5) the solution dispensing bay robotic arm 606 delivers the syringe into the corresponding automatic syringe operating assembly;
6) opening an upturning door of the centrifuge, and conveying the centrifuge bottles to a full-automatic centrifuge 603 of the liquid distribution cabin by a liquid distribution cabin mechanical arm 606 for centrifugal operation;
7) according to the process, the automatic liquid pumping module performs corresponding liquid pumping operation on the centrifugal bottle and the culture bottle 420;
8) the liquid preparation cabin full-automatic cap opener 607 performs cap opening and closing operations on the syringe, the centrifugal bottle, the culture bottle 420, the waste liquid bottle, the cryopreservation tube and the centrifuge tube;
9) the solution preparation cabin mechanical arm 606 stores the culture bottles and the sample plate materials to be detected on the solution preparation cabin roller 605;
10) the environment monitoring system operates in real time and uploads the data to the system for analysis and storage;
11) and the VHP sterilization and residue removal operation is performed regularly, so that the cleanliness of the A-level environment of the liquid distribution tank is ensured.
12) The solution distribution chamber mechanical arm 606 automatically changes the culture dish for environment monitoring;
the culture chamber 4 performs the following operations accordingly:
1) the interior of the independent culture unit is clean, and the system is sterilized and residue is discharged;
2) the culture unit slide rail assembly 410 slides out, and the center compartment mechanical arm 502 puts the culture bottle 420 into the culture bottle storage position in the sliding table;
3) the culture unit sliding table assembly slides in, and the door plate is automatically sealed;
4) feeding air, CO2 and water according to the process requirements, and monitoring the temperature, humidity and gas solubility in the cabin in real time;
5) periodically taking out the culture bottle 420 for liquid changing operation and cell growth condition detection operation;
6) after the culture is finished, taking out the culture flask for treatment, and harvesting finished cells;
7) the interior of the individual culture units is cleaned and ready for the next batch of culture.
The process software executes and realizes: as in fig. 23, 24 and 25:
after a user edits a process on an operation interface, a new batch is created by starting a batch process, the user selects a production process used by the batch, and after the production process is put into a container with cells, the user operation interface interacts with a process operation service established in dispatching software through a communication service layer to finish automatic sterilization after feeding and inspection and confirmation of materials fed into a cabin;
after the batch starting process is completed successfully, the warehousing management system allocates proper positions for the batched materials, the transfer management system transfers the materials to a target position for storage, and meanwhile, a newly created batch is submitted to the batch management system for processing, and the batch management system allocates proper resources for the new batch according to the processes used by the new batch and the execution states of other batches, so as to execute the operations in the processes in sequence;
when liquid operation needs to be executed in batches, the dispatcher distributes idle liquid distribution cabins for the batches according to system resources and submits the idle liquid distribution cabins to a corresponding liquid distribution cabin management system for processing, the liquid distribution cabin system calculates the consumption of various consumables and liquid needed by execution according to an operation list in a batch process and submits material application to a storage management system, after the material application is successful, a transfer system transfers the used consumables and containers containing batch cells into the liquid distribution cabins, and then the liquid distribution cabins are automatically sterilized according to the configuration. The liquid distribution cabin management system optimizes the execution sequence of various liquid operations of batch processes, generates a liquid adding, liquid transferring, blowing, sampling, bottle separating and centrifuging operation list, submits the liquid adding, liquid transferring, bottle separating and centrifuging operation list to a corresponding equipment subsystem through an equipment operation execution library to control equipment to complete operation, and during execution, the event management and MES data system records various operation and production data and stores the operation and production data in a database;
when the batch needs to be cultured, the incubator management system distributes incubator resources for the batch, the culture bottles containing the batch cells are conveyed into the incubator by the transfer system, and the incubator management system controls proper culture parameters to complete the culture operation. The period environmental control system records each item of environmental control data in the incubator into a database;
the garbage generated in the batch production process is submitted to a garbage material system to finish the delivery of the garbage and the sterilization and cleaning of a transfer cabin;
the test tubes generated by the batch sampling operation are submitted to a quality inspection system to finish the pretreatment of the test tubes and the control operation of the detection equipment, and the test results are stored in a database after being processed for display and subsequent tracking;
during production, the material management system detects the use and stock of each consumable part, generates a feeding list to prompt a user to supplement the consumable parts, and the environment control system also continuously monitors and records the data of each sensor in the whole machine and prompts the user to intervene in treatment when abnormal;
after the production indexes of the batches are achieved, the user interface prompts the user to carry out harvesting operation, the user informs the dispatcher to harvest the designated batches by executing the harvesting process, and as above, the dispatcher operates each management system to complete the execution of the harvesting process, transfers the final products of the batches into the discharging cabin and informs the user to take out the final products.
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 utility model, the scope of which is defined in the appended claims and their equivalents.
Claims (10)
1. The utility model provides a GMP compliance's intelligent biological medicine production system of high flux, includes detection cabin (1), transfer ejection of compact cabin (2), pan feeding cabin (3), cultivates cabin (4), center compartment (5), join in marriage liquid cabin (6), storage cabin (7), join in marriage liquid cabin (8), laminar flow return air pipeline (9) and laminar flow return air cabin (10), its characterized in that: the utility model discloses a liquid distribution cabinet, including detection cabin (1), cultivation cabin (4), liquid distribution cabin (6), well commentaries on classics material cabin (2), the tip right side of detection cabin (1) is provided with well commentaries on classics material cabin (2), the left side of well commentaries on classics material cabin (2) is provided with feeding cabin (3), the left side of feeding cabin (3) is provided with cultivates cabin (4), the rear side of cultivateing cabin (4) is provided with central cabin (5), the rear side of central cabin (5) is provided with No. two and joins in marriage liquid cabin (8), the right side of No. two liquid cabin (8) is provided with one and joins in marriage liquid cabin (6), well commentaries on classics material cabin (2), feeding cabin (3), central cabin (5), one join in marriage liquid cabin (6), storage cabin (7), the bottom of No. two liquid cabin (8) and all be connected with laminar flow return air duct (9), the other end of laminar flow return air duct (9) is provided with laminar flow return air cabin (10).
2. The GMP-compliant high-throughput intelligent biopharmaceutical production system according to claim 1, wherein: a central cabin bottom cabin frame (501) is arranged at the bottom of the central cabin (5), a central cabin middle cabin (503) is arranged on the upper side of the central cabin bottom cabin frame (501), a cabin isolation door (504) is arranged on the right side of the front face of the central cabin middle cabin (503), a sterilization liquid path bottom unit (506) is arranged on the left lower side of the inside of the central cabin bottom cabin frame (501), a central cabin track laminar flow air inlet (513) is arranged on the left upper side of the central cabin middle cabin (503), a central cabin laminar flow air inlet (512) is arranged on the front side, located on the central cabin track laminar flow air inlet (513), of the central cabin middle cabin (503), a central cabin mechanical arm (502) is installed on the central cabin track laminar flow air inlet (513), a metal bath module (509) is arranged on the left front side of the central cabin middle cabin (503), and a central cabin low-temperature refrigerator (511) is arranged on the front side of the central cabin middle cabin (503), the refrigerator is characterized in that an automatic refrigerator door (510) is arranged on the central cabin low-temperature refrigerator (511), a low-temperature incubation refrigerator (507) is arranged on the rear side of the central cabin middle cabin (503), an environment monitoring module (508) is arranged on the right rear side of the central cabin middle cabin (503), and a static pressure cabin (505) is arranged at the end part of the central cabin middle cabin (503).
3. The GMP-compliant high-throughput intelligent biopharmaceutical production system according to claim 1, wherein: the right flank of income material cabin (3) is provided with into material cabin middle frame (301), the inside right rear side of income material cabin (3) is provided with into material cabin garbage bin (302), the left downside of income material cabin (3) is provided with into material cabin DD motor element (303), the drive end of income material cabin DD motor element (303) is provided with into material cabin cylinder (304), the inside right front side of income material cabin (3) is provided with subsides fungus collector (305), the downside of income material cabin (3) is provided with subsides fungus analysis appearance (306), the upside is provided with into material cabin air velocity transducer (307) before the inside of income material cabin (3).
4. The GMP-compliant high-throughput intelligent biopharmaceutical production system according to claim 1, wherein: the inside right rear side of well commentaries on classics material cabin (2) is provided with temperature and humidity sensor (201), the bottom right front side of well commentaries on classics material cabin (2) is provided with transfer cabin tilt-up door (202), the left downside of well commentaries on classics material cabin (2) is provided with transfer DD motor element (203), the drive end of transfer DD motor element (203) is provided with transfer cylinder (204), the inside rear side of well commentaries on classics material cabin (2) is provided with out material cabin carrier frame (205), the right flank of well commentaries on classics material cabin (2) is provided with well commentaries on classics material cabin intermediate frame (206), upside is provided with transfer air velocity transducer (207) before the inside of well commentaries on classics material cabin (2).
5. The GMP compliant high throughput intelligent biopharmaceutical production system according to claim 1, wherein: the detection chamber (1) is provided with a detection chamber frame (101), the left rear side of the inside of the detection chamber frame (101) is provided with a detection device controller (102), the right front side of the inside of the detection chamber frame (101) is provided with an automatic garbage transfer module (103), the lower side of the automatic garbage transfer module (103) is provided with a garbage chute (104), the right lower side of the inside of the detection chamber frame (101) is provided with a low-temperature storage refrigerator (105), the middle part of the right side of the inside of the detection chamber frame (101) is provided with a liquid transfer unit (106), the left side of the bottom of the detection chamber frame (101) is provided with a full-automatic centrifuge (107), the left side of the inside of the detection chamber frame (101) and the left side of the low-temperature storage refrigerator (105) is provided with a mechanical arm (108), the left front side of the inside of the detection chamber frame (101) is provided with a flow cytometer (109), a cell counter (110) is arranged on the right upper side of the front face of the flow cytometer (109), a manual feeding area (111) is arranged on the left side of the front face of the flow cytometer (109), a microscope (112) is arranged on the right side of the end portion of the flow cytometer (109), and a full-automatic cover opener (113) is arranged on the right upper side of the flow cytometer (109).
6. The GMP compliant high throughput intelligent biopharmaceutical production system according to claim 1, wherein: storage compartment (7) are provided with storage compartment middle frame (701), the right downside of storage compartment middle frame (701) is provided with storage compartment DD motor element (702), the drive end of storage compartment DD motor element (702) is provided with storage compartment cylinder (703), the inside left rear side of storage compartment middle frame (701) is provided with storage compartment temperature and humidity sensor (704), the inside back upside of storage compartment middle frame (701) is provided with storage compartment air velocity transducer (705).
7. The GMP compliant high throughput intelligent biopharmaceutical production system according to claim 1, wherein: first join in marriage liquid cabin (6) and No. two and join in marriage liquid cabin (8) and be provided with and join in marriage liquid cabin bottom bay frame (601), the upside of joining in marriage liquid cabin bottom bay frame (601) is provided with joins in marriage liquid cabin middle frame (602), the inside left side downside of joining in marriage liquid cabin bottom bay frame (601) is provided with joins in marriage liquid cabin full-automatic centrifuge (603), the inside right side of joining in marriage liquid cabin bottom bay frame (601) is provided with cold-stored refrigerator subassembly (604), the inside left side of joining in marriage liquid cabin middle frame (602) is provided with joins in marriage liquid cabin cylinder (605), the inside of joining in marriage liquid cabin middle frame (602) and the right side that is located joins in marriage liquid cabin cylinder (605) is provided with joins in marriage liquid cabin arm (606), the inside right side of joining in marriage liquid cabin middle frame (602) is provided with and joins in marriage liquid cabin full-automatic uncapping machine (607).
8. The GMP-compliant high-throughput intelligent biopharmaceutical production system according to claim 1, wherein: the cultivation cabin (4) is provided with a bottom cabin frame assembly (401), the upper side of the bottom cabin frame assembly (401) is provided with a middle frame assembly (402), the left front side inside the bottom cabin frame assembly (401) is provided with a cultivation unit control assembly (403), the right side inside the bottom cabin frame assembly (401) is provided with a cultivation unit monitoring assembly (404), the end part of the middle frame assembly (402) is provided with a sterilization liquid top assembly (405), an independent cultivation unit installation track (406) is arranged inside the middle frame assembly (402), an independent cultivation unit (407) is installed on the independent cultivation unit installation track (406), an independent cultivation unit air pipe and an independent cultivation unit water pipe (408) are arranged on the left rear side inside the bottom cabin frame assembly (401), and an independent cultivation unit cable (409) is arranged on the left side face of the middle frame assembly (402), independently cultivate unit (407) and be provided with and cultivate unit slide rail set spare (410), the left surface of cultivateing unit slide rail set spare (410) is provided with cultivates unit electric wiring subassembly (411), the right flank of cultivateing unit slide rail set spare (410) is provided with cultivates unit water supply air feed subassembly (412), the right front side of cultivateing unit slide rail set spare (410) is provided with cultivates unit aqueous vapor switching mouth (413), the front side of cultivateing unit slide rail set spare (410) is provided with cultivates unit emergency door (414), the front side of cultivateing unit slide rail set spare (410) is provided with cultivation unit locking support (415) to the car from top to bottom, the left rear side of cultivateing unit slide rail set spare (410) is provided with cultivates unit slip table drive assembly (416), the left front side of cultivateing unit slide rail set spare (410) is provided with cultivates unit electric switching mouth (417), the end part of the culture unit slide rail assembly (410) is provided with a culture unit cabin body assembly (418), the end part of the culture unit cabin body assembly (418) is provided with a culture unit air duct assembly (419), and a culture bottle (420) is arranged inside the culture unit slide rail assembly (410).
9. The GMP-compliant high-throughput intelligent biopharmaceutical production system according to claim 1, wherein: the device is characterized in that the detection cabin (1), the transfer discharging cabin (2), the feeding cabin (3), the culture cabin (4), the central cabin (5), the first liquid distribution cabin (6), the storage cabin (7) and the second liquid distribution cabin (8) are quickly aligned and installed through quick positioning pins and fastening bolts.
10. The GMP-compliant high-throughput intelligent biopharmaceutical production system according to claim 1, wherein: the end parts of the transfer discharging cabin (2), the feeding cabin (3), the central cabin (5), the first liquid distribution cabin (6), the storage cabin (7) and the second liquid distribution cabin (8) are all provided with static pressure cabins (505).
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116855380A (en) * | 2023-07-06 | 2023-10-10 | 广州沙艾生物科技有限公司 | Stem cell expansion culture system and expansion culture method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116855380A (en) * | 2023-07-06 | 2023-10-10 | 广州沙艾生物科技有限公司 | Stem cell expansion culture system and expansion culture method |
| CN116855380B (en) * | 2023-07-06 | 2024-03-29 | 广州沙艾生物科技有限公司 | Stem cell expansion culture system and expansion culture method |
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