CN213553763U - Closed cell preparation partial shipment device - Google Patents
Closed cell preparation partial shipment device Download PDFInfo
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- CN213553763U CN213553763U CN202120976569.7U CN202120976569U CN213553763U CN 213553763 U CN213553763 U CN 213553763U CN 202120976569 U CN202120976569 U CN 202120976569U CN 213553763 U CN213553763 U CN 213553763U
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- liquid storage
- cell preparation
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- 238000002360 preparation method Methods 0.000 title claims abstract description 37
- 239000007788 liquid Substances 0.000 claims abstract description 71
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- 238000003860 storage Methods 0.000 claims abstract description 33
- 238000001914 filtration Methods 0.000 claims abstract description 29
- 239000011148 porous material Substances 0.000 claims abstract description 4
- 239000006285 cell suspension Substances 0.000 claims description 30
- 238000005138 cryopreservation Methods 0.000 claims description 10
- 230000002209 hydrophobic effect Effects 0.000 claims description 9
- 241000894006 Bacteria Species 0.000 abstract description 11
- 239000000428 dust Substances 0.000 abstract description 11
- 238000000034 method Methods 0.000 abstract description 5
- 210000004027 cell Anatomy 0.000 description 23
- 239000011550 stock solution Substances 0.000 description 14
- 239000000243 solution Substances 0.000 description 8
- 238000007710 freezing Methods 0.000 description 7
- 230000008014 freezing Effects 0.000 description 7
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- 238000005070 sampling Methods 0.000 description 3
- 210000004881 tumor cell Anatomy 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 2
- 239000004743 Polypropylene Substances 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 239000003960 organic solvent Substances 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 229920000515 polycarbonate Polymers 0.000 description 2
- 239000004417 polycarbonate Substances 0.000 description 2
- 229920001155 polypropylene Polymers 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 239000004695 Polyether sulfone Substances 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000003213 activating effect Effects 0.000 description 1
- 238000000071 blow moulding Methods 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 230000010261 cell growth Effects 0.000 description 1
- 238000002659 cell therapy Methods 0.000 description 1
- 230000001413 cellular effect Effects 0.000 description 1
- 229920002301 cellulose acetate Polymers 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 238000012258 culturing Methods 0.000 description 1
- 238000000151 deposition Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000012239 gene modification Methods 0.000 description 1
- 238000010353 genetic engineering Methods 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
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Abstract
The utility model provides a closed cell preparation partial shipment device, closed cell preparation partial shipment device includes: the imbibing component comprises a liquid storage device, a filter and an injector, one end of the filter is connected with the first end of the liquid storage device, the other end of the filter is connected with the injector, the filter is provided with a filtering membrane, and the pore diameter of the filtering membrane is less than or equal to 0.45 mu m; the input assembly is connected with the second end of the liquid storage device and is used for inputting a sample to the liquid storage device; and the output assembly is connected with the second end of the liquid storage device and is used for outputting the sample to the outside. In the closed cell preparation subpackaging device of the utility model, the liquid storage device is connected with the injector through the filter, thus avoiding the possibility that external dust, bacteria and the like introduced by the injector in the operation process enter the liquid storage device; meanwhile, the air exhaust operation of the split charging container under the closed condition can be realized.
Description
Technical Field
The utility model relates to the technical field of medical equipment, more specifically relates to a closed cell preparation partial shipment device.
Background
Cell therapy is an emerging class of disease therapies. For the example of CAR-T therapy, the general treatment protocol is: (1) separating immune T cells from a cancer patient; (2) carrying out specific gene modification on the T cell by using a genetic engineering technology, so that a Chimeric Antibody (CAR) capable of recognizing the tumor cell and activating the T cell to kill the tumor cell is expressed on the surface of the T cell, and the T cell is converted into the CAR-T cell; (3) culturing and expanding CAR-T cells in vitro; (4) the expanded CAR-T cells are returned to the patient for targeted killing of tumor cells.
After CAR-T cell expansion is complete, it must be prepared as a stable formulation, transported to the hospital, and patient reinfused in a specific medical setting. In order to facilitate long-term storage and long-distance transportation of CAR-T cells, the preparations are generally packed in cryopreservation bags for cryopreservation and transportation after preparation is completed.
In the field of medicine production, an automatic subpackaging device is generally adopted for filling medicines, but individual cell preparations represented by CAR-T are produced in a small number of batches and small in yield, and the average dose of each patient is less than 10, so that an expensive automatic subpackaging device is not needed, and the traditional manual subpackaging operation mode is more suitable for directly filling medicines through the manual subpackaging device under the grade A clean environment. The manual dispensing operation has the disadvantage of being prone to contamination, and the cell preparation product has a very high requirement for sterility to ensure the safety of the product for the patient. In addition, the gas in the split charging container (such as a freezing bag) needs to be discharged, but the gas cannot be discharged because any component cannot be taken off to discharge the gas in the split charging container in the prior art, the split charging container cannot be taken off, otherwise, external dust and bacteria can enter, and only one container can be independently arranged for containing the discharged gas.
Therefore, there is a need for development of a closed cell preparation dispensing device that can perform dispensing under closed conditions and allow the dispensing container to be vented.
SUMMERY OF THE UTILITY MODEL
The utility model aims at providing a closed cell preparation partial shipment device to solve or alleviate at least one shortcoming of the manual partial shipment device of prior art at least.
Therefore, the utility model provides a closed cell preparation partial shipment device, closed cell preparation partial shipment device includes:
the imbibing component comprises a liquid storage device, a filter and an injector, one end of the filter is connected with the first end of the liquid storage device, the other end of the filter is connected with the injector, a filtering membrane is arranged on the filter, and the pore diameter of the filtering membrane is less than or equal to 0.45 mu m;
an input assembly connected to the second end of the reservoir for inputting a cell preparation to the reservoir; and
and the output assembly is connected with the second end of the liquid storage device and is used for outputting the subpackaged cell preparation to the outside.
According to a preferred embodiment of the present invention, the liquid reservoir and the filter are fixedly connected or detachably connected.
According to a preferred embodiment of the present invention, the reservoir is provided with a scale.
According to a preferred embodiment of the present invention, the volume of the reservoir is set to 10ml to 100 ml, and the minimum scale can be set to 1ml, 2ml, 5ml, 10ml, etc.
According to a preferred embodiment of the present invention, the material of the liquid storage device may be a hard plastic material, such as polypropylene, polycarbonate, etc., preferably a transparent material. The components may be manufactured by methods known in the art, such as molding, blow molding, etc., or by other methods known in the art.
According to a preferred embodiment of the present invention, the filter is provided with a filtering membrane fixing mechanism detachably fixed in the filter so as to replace the filtering membrane.
According to a preferred embodiment of the present invention, the filtration membrane may be a hydrophilic filtration membrane or a hydrophobic filtration membrane, preferably a hydrophobic filtration membrane.
According to the utility model discloses a preferred embodiment sets up the extension pipe between filter and syringe, and the both ends of extension pipe are linked together with filter, syringe respectively, convenient operation.
According to the utility model discloses a preferred embodiment, the input subassembly includes cell suspension input tube, frozen stock solution input tube and feed liquor pipe, cell suspension input tube and frozen stock solution input tube through a tee bend shape pipe respectively with the one end of feed liquor pipe is connected, the other end of feed liquor pipe with the liquid ware second end of depositing is connected.
According to a preferred embodiment of the present invention, the output assembly comprises a liquid outlet pipe and an output pipe, wherein both ends of the liquid outlet pipe are respectively connected with the second end of the liquid storage device and the output pipe.
According to a preferred embodiment of the present invention, the shorter the liquid inlet pipe, the better. After the feed liquor pipe is short to a certain extent, the input module can only include cell suspension input tube, frozen stock liquid input tube, output module includes drain pipe and output tube, makes cell suspension input tube, frozen stock liquid input tube, stock liquid ware second end, output module's of input module drain pipe be connected through a cross shape pipe, the other end of drain pipe is connected with the output tube.
According to a preferred embodiment of the present invention, the cell suspension input tube and the cryopreservation liquid input tube are provided with flow stopping clips.
According to the utility model discloses a preferred embodiment, the number of output tube is 2 at least, for example 3, 4, 5, 6, 7, 8, 9, 10 etc. and each output tube parallel arrangement at the same stage also can be connected with the one end of drain pipe through tee bend shape or cross shape pipe to realize the function of a plurality of containers of partial shipment simultaneously.
According to a preferred embodiment of the present invention, the output tube is provided with a flow stopping clip.
The utility model discloses an among the closed cell preparation partial shipment device, store cell preparation the liquid storage ware through a filter with the syringe is connected, avoids with syringe direct contact, and like this, external dust, bacterium etc. that the syringe introduced in operation process are filtered by the filter, have avoided getting into the possibility of liquid storage ware. Meanwhile, due to the filter membrane in the filter, even if the injector is taken down from the filter in the air exhaust operation process of the subpackaging container, the filter membrane can block external dust, bacteria and the like, so that the air exhaust operation of the subpackaging container under a closed condition is realized actually.
Drawings
The advantages, features of the present invention will now be described in detail with reference to the accompanying drawings, in which the components are not necessarily drawn to scale, and wherein:
FIG. 1 illustrates a front view of a prior art manual racking device;
fig. 2 shows a front view of a closed Car-T cell preparation dispensing device according to a preferred embodiment of the present invention.
Fig. 3 shows a front view of the filter of fig. 2.
Wherein each number represents: 1-a wicking component; 11-liquid storage; 12-a filter; 13-a syringe; 2-an input component; 21-cell suspension input tube; 22-frozen stock solution input pipe; 23-a liquid inlet pipe; 3-an output component; 31-a liquid outlet pipe; 32-an output pipe; 4-a flow stopping clamp; 5-needle-free sampling port; 6-interface; 7-a linker; 8-three-way duct.
It is to be understood that the drawings are drawn for purposes of illustration only and are not to be construed as limiting the invention.
Detailed Description
Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to the same or similar elements or elements having the same or similar function throughout. It is to be understood that the following embodiments are illustrative only and are not limiting of the invention. It should also be understood that not all of the features of the embodiments described below need be included in the practice of the present invention, and that various combinations of these features are possible.
Furthermore, in the present invention, unless otherwise explicitly stated, the terms "first", "second", and the like should be understood to be used for distinguishing the same or similar parts, not to indicate a sequence; the terms "coupled" and the like are to be construed broadly and include both fixed and removable connections, as well as connections that may be made directly or indirectly through intervening elements.
Referring to fig. 1, a manual dispensing device for cellular products, which is commonly used in the prior art, includes:
an injector 13;
an input assembly 2, wherein the input assembly 2 is connected with the injector 13 and is used for inputting the cell preparation to the injector 13; and
and the output assembly 3, wherein the output assembly 3 is connected with the injector 13 and is used for outputting the cell preparation to the outside.
The input assembly 2 comprises a cell suspension input pipe 21, a freezing solution input pipe 22 and a liquid inlet pipe 23, the cell suspension input pipe 21 and the freezing solution input pipe 22 are respectively connected with the liquid inlet pipe 23 through a three-way guide pipe 8, and the other end of the liquid inlet pipe 23 is connected with the injector 13.
The output assembly 3 comprises a liquid outlet pipe 31 and an output pipe 32, and both ends of the liquid outlet pipe 31 are respectively connected with the injector 13 and the output pipe 32.
The inlet pipe 23, the outlet pipe 31 and the injector 13 may be integrally formed, or may be connected by a three-way pipe (not shown).
The cell suspension input tube 21 and the frozen stock solution input tube 22 are respectively connected with the cell suspension and the frozen stock solution, and the output tube 32 is connected with a subpackage container (such as a frozen stock bag). When the filling device is used, the flow stopping clamps 4 of all the output pipes 32 are closed, the flow stopping clamps 4 of the cell suspension input pipe 21 and the frozen stock solution input pipe 22 are opened, a solution to be filled is sucked by the injector 13, then the flow stopping clamps 4 of the cell suspension input pipe 21 and the frozen stock solution input pipe 22 are closed, the flow stopping clamp 4 of one of the output pipes 32 is opened, the subpackaged solution is pushed in, filling is completed for 1 time, and the operation is repeated to complete multiple subpackaging.
A significant disadvantage of this prior art device is that during repeated drawing and pushing operations of the syringe 13, external dust, bacteria, etc. may enter the chamber of the syringe 13 from the push rod, thereby contaminating the dispensed cell preparation. Further, the separate container has a gas to be discharged, but the gas cannot be discharged or a separate container for containing the discharged gas is required.
For solving the problem that exists among the prior art, the utility model provides a closed cell preparation partial shipment device, refer to fig. 2, it includes:
the liquid absorption assembly 1 comprises a liquid storage device 11, a filter 12 and an injector 13, wherein one end of the filter 12 is connected with the first end of the liquid storage device 11, the other end of the filter 12 is connected with the injector 13, a filter membrane is arranged on the filter 12, and the pore diameter of the filter membrane is less than or equal to 0.45 mu m;
the input assembly 2 is connected with the second end of the liquid storage device 11 and is used for inputting cell preparations to the liquid storage device 11; and
and the output assembly 3 is connected with the second end of the liquid storage device 11 and is used for outputting the subpackaged cell preparation to the outside.
In a preferred embodiment, the input module 2 comprises a cell suspension input pipe 21, a cryopreservation liquid input pipe 22 and an inlet pipe 23, wherein the cell suspension input pipe 21 and the cryopreservation liquid input pipe 22 are respectively connected with one end of the inlet pipe 23 through a three-way conduit 8, and the other end of the inlet pipe 23 is connected with the second end of the liquid storage device 11. The output assembly 3 comprises a liquid outlet pipe 31 and an output pipe 32, and two ends of the liquid outlet pipe 31 are respectively connected with the second end of the liquid storage device 11 and the output pipe 32.
In a preferred embodiment, in order to homogenize the cell suspension and the freezing medium, the shorter the inlet pipe 23, the better, and the liquid in the inlet pipe 23 is prevented from being the cell suspension in one section and the freezing medium in one section. After feed liquor pipe 23 is short to a certain extent, input module 2 can only include cell suspension input tube 21, frozen stock solution input tube 22, output module 3 includes drain pipe 31 and output tube 32, makes cell suspension input tube 21, frozen stock solution input tube 22, the second end of liquid storage device 11, the drain pipe 31 of output module 3 of input module 2 be connected through a cross-shaped pipe, the other end of drain pipe 31 is connected with output tube 32.
When the solution is subpackaged, the cell suspension and the frozen stock solution respectively input from the cell suspension input tube 21 and the frozen stock solution input tube 22 enter the stock solution device 11, the filter 12 is arranged between the stock solution device 11 and the injector 13, the aperture of the filtering membrane of the filter 12 is less than or equal to 0.45 mu m, and the arrangement of the filter and the filtering membrane prevents external dust and bacteria from entering the stock solution device 11; meanwhile, in the prior art, the gas in the split charging container discharged by the injector 13 or any component cannot be taken off, and the split charging container cannot be taken off, otherwise, external dust and bacteria can enter. After the filter 12 and the filter membrane are added, air can pass through, but dust and bacteria cannot pass through, so that in the air exhaust operation of the dispensing container, the flow stopping clamp 4 of the cell suspension input tube 21 and the freezing solution input tube 22 is tightly closed, the air in the dispensing container such as a freezing bag can be exhausted from the filter 12 through the suction of the syringe 13, and after the syringe 13 is filled with the air, the syringe 13 can be taken down to exhaust the air, and then the syringe 13 is used for sucking the air again. After the syringe 13 is removed, the filter membrane can block dust, bacteria and the like from the outside, thereby actually realizing the air exhaust operation of the dispensing container under a closed condition (the closed condition refers to the condition that the dust, the bacteria and the like are closed, compared with the condition that the dust and the bacteria can enter in the prior art).
In a preferred embodiment, the cell suspension input tube and the freezing medium input tube are provided with flow stopping clips.
In a preferred embodiment, the number of the output pipes 32 is 4, each output pipe is connected with one end of the liquid outlet pipe 31 through three-way pipes 8, the models of the output pipes 32 can be the same or different, when the models of the output pipes 32 are the same, one of the output pipes 32 can be used as a working output pipe 32, and the rest of the output pipes 32 are used as spares, so that when one output pipe 32 is occupied or abnormal, the other output pipes 32 are used; when the output pipe 32 is different in model, the output pipe 32 can be selected according to the type of the subpackaging container during use, and the use is more convenient.
In a preferred embodiment, the outlet pipe 32 is a Male pipe (external threaded pipe) having a flow stopping clip 4, and during use, the flow stopping clip 4 is opened for dispensing.
In a preferred embodiment, the cell suspension input tube 21, the cryopreservation liquid input tube 22 and the output tube 32 are provided with connectors 7 at the ends, and the connectors 7 can be luer connectors, so that the operation is simple and convenient compared with the existing common pipe end socket. The cell suspension input tube 21 and the freezing solution input tube 22 are externally connected with a connector 6 through a connector 7, and the connector is connected with the liquid tank and is respectively used for inputting cell suspension and freezing solution.
In a preferred embodiment, a needle-free sampling port 5 is provided in the outlet pipe 31 to allow sampling.
In a preferred embodiment, reservoir 11 is graduated, and the volume of the filled formulation can be controlled by viewing the graduation of reservoir 11.
In a preferred embodiment, reservoir 11 may be made of a hard plastic material, such as polypropylene, polycarbonate, or the like.
Referring to fig. 3, the filter may be a filter known in the art, and a filtration membrane may be commercially available; for example, the filter housing may be formed of two parts that are snap-fit together with the filter membrane disposed within the housing. In a preferred embodiment, the filter is provided with a filter membrane fixing mechanism which is detachably fixed in the filter so as to replace the filter membrane.
In a preferred embodiment, the filter may be a hydrophilic filtration membrane or a hydrophobic filtration membrane, preferably a hydrophobic filtration membrane. The difference between hydrophilic and hydrophobic filtration membranes is: the degree of easiness of wetting by water is different, a hydrophilic filtering membrane is easy to wet by water, a hydrophobic filtering membrane is difficult to wet by water and is easy to wet by organic solvents such as alcohol, isopropanol and the like; the application fields are different, the hydrophilic filtering membrane is mainly used for liquid filtration, the hydrophobic filtering membrane is commonly used for gas filtration, and organic solvents can also be filtered; the material is different, the hydrophilic filtering membrane material is cellulose acetate, polyethersulfone, nylon and the like, and the hydrophobic filtering membrane material is polytetrafluoroethylene.
In a preferred embodiment, an extension tube (not shown) is disposed between the filter 12 and the syringe 13, and both ends of the extension tube are respectively communicated with the filter and the syringe for convenient operation.
The foregoing has described the general principles and exemplary embodiments of the present invention. It will be appreciated by those skilled in the art that the present invention is not limited by the above-described embodiments. The above description is for the purpose of illustrating the invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and modifications, which fall within the scope of the claims of the present invention.
Claims (10)
1. A closed cell preparation subpackaging device is characterized by comprising:
the imbibing component comprises a liquid storage device, a filter and an injector, one end of the filter is connected with the first end of the liquid storage device, the other end of the filter is connected with the injector, the filter is provided with a filtering membrane, and the pore diameter of the filtering membrane is less than or equal to 0.45 mu m;
the input assembly is connected with the second end of the liquid storage device and is used for inputting cell preparations into the liquid storage device; and
and the output assembly is connected with the second end of the liquid storage device and is used for outputting the subpackaged cell preparation to the outside.
2. The closed cell preparation dispensing device of claim 1, wherein the reservoir is fixedly or removably connected to the filter.
3. The closed cell preparation dispensing device according to claim 1 or 2, wherein the reservoir is provided with a scale;
and/or the volume of the liquid storage device is set to be 10ml to 100 ml.
4. The closed cell preparation dispensing device of claim 1 or 2 wherein the filter is provided with a filter membrane fixing mechanism, the filter membrane fixing mechanism being detachably fixed in the filter.
5. The closed cell preparation dispensing apparatus according to claim 1 or 2, wherein the filtration membrane is a hydrophobic filtration membrane;
and/or an extension tube is arranged between the filter and the injector, and two ends of the extension tube are respectively communicated with the filter and the injector.
6. The closed cell preparation subpackaging device according to claim 1, wherein the input assembly comprises a cell suspension input pipe, a cryopreservation liquid input pipe and a liquid inlet pipe, the cell suspension input pipe and the cryopreservation liquid input pipe are respectively connected with one end of the liquid inlet pipe through a three-way conduit, and the other end of the liquid inlet pipe is connected with the second end of the liquid storage device; the output assembly comprises a liquid outlet pipe and an output pipe, and two ends of the liquid outlet pipe are respectively connected with the second end of the liquid storage device and the output pipe.
7. The closed cell preparation subpackaging device according to claim 1, wherein the input assembly comprises a cell suspension input pipe and a cryopreservation liquid input pipe, the output assembly comprises a liquid outlet pipe and an output pipe, the cell suspension input pipe, the cryopreservation liquid input pipe, the second end of the liquid storage device and one end of the liquid outlet pipe of the output assembly are connected through a four-way conduit, and the other end of the liquid outlet pipe is connected with the output pipe.
8. The closed cell preparation dispensing device according to claim 6 or 7, wherein the cell suspension input tube is provided with a flow stopping clip.
9. A closed cell preparation dispensing device as claimed in claim 8, wherein the number of the output tubes is at least 2, and each output tube is arranged in parallel in the same stage or connected to one end of the liquid outlet tube through one or more tee-shaped or cross-shaped tubes.
10. The closed cell preparation dispensing apparatus of claim 9 wherein the delivery tube is provided with a flow stop clip.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202120976569.7U CN213553763U (en) | 2021-05-10 | 2021-05-10 | Closed cell preparation partial shipment device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202120976569.7U CN213553763U (en) | 2021-05-10 | 2021-05-10 | Closed cell preparation partial shipment device |
Publications (1)
| Publication Number | Publication Date |
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| CN213553763U true CN213553763U (en) | 2021-06-29 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202120976569.7U Active CN213553763U (en) | 2021-05-10 | 2021-05-10 | Closed cell preparation partial shipment device |
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| CN (1) | CN213553763U (en) |
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- 2021-05-10 CN CN202120976569.7U patent/CN213553763U/en active Active
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