CN110745761A - Aseptic subpackaging method and subpackaging system for lentiviral vector liquid - Google Patents
Aseptic subpackaging method and subpackaging system for lentiviral vector liquid Download PDFInfo
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- CN110745761A CN110745761A CN201911077577.1A CN201911077577A CN110745761A CN 110745761 A CN110745761 A CN 110745761A CN 201911077577 A CN201911077577 A CN 201911077577A CN 110745761 A CN110745761 A CN 110745761A
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- aseptic
- isolator
- sterile
- subpackaging
- bottle
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B67—OPENING, CLOSING OR CLEANING BOTTLES, JARS OR SIMILAR CONTAINERS; LIQUID HANDLING
- B67C—CLEANING, FILLING WITH LIQUIDS OR SEMILIQUIDS, OR EMPTYING, OF BOTTLES, JARS, CANS, CASKS, BARRELS, OR SIMILAR CONTAINERS, NOT OTHERWISE PROVIDED FOR; FUNNELS
- B67C7/00—Concurrent cleaning, filling, and closing of bottles; Processes or devices for at least two of these operations
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B67—OPENING, CLOSING OR CLEANING BOTTLES, JARS OR SIMILAR CONTAINERS; LIQUID HANDLING
- B67C—CLEANING, FILLING WITH LIQUIDS OR SEMILIQUIDS, OR EMPTYING, OF BOTTLES, JARS, CANS, CASKS, BARRELS, OR SIMILAR CONTAINERS, NOT OTHERWISE PROVIDED FOR; FUNNELS
- B67C7/00—Concurrent cleaning, filling, and closing of bottles; Processes or devices for at least two of these operations
- B67C7/0073—Sterilising, aseptic filling and closing
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Abstract
The invention discloses a lentivirus vector liquid sterile subpackaging method and a subpackaging system, wherein the subpackaging method comprises the following steps: step 1: sterilizing the sterile isolator; step 2: introducing the lentivirus carrier fluid into a sterile isolator through an SART interface; and step 3: the lentivirus carrier fluid which enters an aseptic isolator and is filtered by a sterilizing filter is subpackaged into subpackage bottles by a subpackage tool; and 4, step 4: installing and sealing the split charging bottle by using a cap screwing tool; the subpackaging system comprises a sterile isolator, subpackaging bottles and a feeding assembly; the packaging method has the advantages that the lentivirus carrier fluid is introduced into the sterile isolator, then the packaging tool is used for carrying out sterile packaging, the lentivirus carrier fluid is packaged into the packaging bottle, the packaging bottle is uniformly sealed by the aid of the cap screwing tool, the whole process is carried out in a sterile environment, operation is simple, pollution is not prone to occurring, production efficiency is effectively increased, and product quality is guaranteed.
Description
Technical Field
The invention relates to the field of aseptic subpackaging methods, in particular to an aseptic subpackaging method and an aseptic subpackaging system for a lentiviral vector fluid.
Background
After the biological product is produced, the biological product is influenced by objective environment, will deteriorate gradually, and various external factors can be prevented by reasonably carrying out split charging and packaging: the effect of light, temperature, air, moisture and microorganisms on product quality; according to the characteristics of the lentiviral vector fluid production itself: the product production is little in batches, can't use the automatic partial shipment of production line, and storage temperature is low, and is high to the requirement of packing tube, consequently generally adopts the mode of traditional manual partial shipment, and used packing is manual spiral cover usually, and there is certain defect in the manual partial shipment mode of tradition: the operation is complex, the pollution is easy, the errors of neglected loading and repeated loading are easy to occur, the sealing performance is greatly influenced by individual operation difference, the traditional isolator needs to sterilize the container filled with the product together with all loading tools when the product is loaded, the sterilization time is long, and the sterilization gas can also influence the quality of the product, so that the sterile loading method which is simple and easy to operate, high in production efficiency, difficult to pollute, guaranteed in sterility and accurate in loading quantification is needed.
Disclosure of Invention
The technical problem to be solved by the invention is to provide a method for aseptically subpackaging the lentiviral vector liquid, wherein the lentiviral vector liquid is introduced into an aseptic isolator through an SART interface, then the subpackaging tool is used for aseptically subpackaging the lentiviral vector liquid into subpackaged bottles, and then the subpackaged bottles are uniformly capped by a capping tool, the whole process is carried out in an aseptic environment, the operation is simple, the pollution is not easy, the production efficiency is effectively increased, and the product quality is ensured;
the added SART interface is used for leading the product into the isolator, so that the articles in the isolator can be sterilized in advance, the product subpackaging time is reduced, the real-time subpackaging can be realized, the storage time of the virus vector at room temperature is reduced, and the product quality is effectively ensured;
the use of the aseptic degerming filter of SART interface connection avoids the product of not degerming to get into the contamination risk that the isolator brought, in addition, uses the peristaltic pump to carry out the degerming after leading-in product, avoids traditional manual filtration operation, uses manpower sparingly, improves production efficiency for solve the defect that prior art leads to.
In order to solve the technical problems, the invention provides the following technical scheme: a method for aseptically packaging a lentivirus vector fluid, which comprises the following steps:
step 1: sterilizing the sterile isolator;
step 2: introducing the lentivirus carrier fluid into a sterile isolator through an SART interface;
and step 3: the lentivirus carrier fluid which enters an aseptic isolator and is filtered by a sterilizing filter is subpackaged into subpackage bottles by a subpackage tool;
and 4, step 4: the bottle is capped using a screw-on cap tool.
In the above method for aseptically packaging the lentiviral vector liquid, the packaging environment of the lentiviral vector in the aseptic isolator in the step 3 is grade a under grade B.
The aseptic subpackaging method of the lentiviral vector fluid comprises the step 1, wherein the aseptic isolator is further used for sterilizing the subpackaging bottle, the subpackaging bottle is placed into the aseptic isolator for sterilization, the subpackaging bottle is torn off after sterilization, the subpackaging bottle is placed into a breathing bag, then the breathing bag is sealed, and self-purification is carried out.
The utility model provides an aseptic partial shipment system of lentiviral carrier liquid, wherein, includes aseptic isolator, partial bottling, feeding subassembly, the inside of aseptic isolator is equipped with partial shipment instrument, spiral cover instrument and places the sterilization support of partial bottling, the spiral cover instrument set up in the upside of sterilization support, feeding subassembly with SART interface intercommunication on the aseptic isolator, aseptic isolator inside be equipped with the aseptic filter of SART interface intercommunication, the other end of aseptic filter is connected with the square bottle, be connected with on the partial shipment instrument with the hose of square bottle intercommunication.
The above sterile subpackaging system for the lentiviral vector liquid is characterized in that the subpackaging tool is an electric dispenser.
The aseptic subpackaging system for the slow virus carrier liquid is characterized in that the cap screwing tool is an electric cap screwing device.
The above lentivirus carrier liquid aseptic split charging system, wherein, the split charging bottle is an aseptic sample tube.
The aseptic partial shipment system of foretell lentiviral vector liquid, wherein, feed assembly includes peristaltic pump, liquid reserve tank, the peristaltic pump pass through the pipeline respectively with the liquid reserve tank SART interface intercommunication.
In the above sterile subpackaging system for the lentiviral vector liquid, a plurality of rows of the sterile sample tubes are placed on the sterilization bracket, and each row is provided with a plurality of the sterile sample tubes.
The aseptic subpackaging system for the lentiviral vector liquid is characterized in that eight rows of the aseptic sample tubes are placed on the sterilization bracket, and each row is provided with eight aseptic sample tubes.
The technical scheme provided by the aseptic subpackaging method and the subpackaging system for the lentiviral vector liquid has the following technical effects:
the method comprises the following steps of introducing the lentivirus carrier fluid into an aseptic isolator, then using a subpackaging tool to subpackage the lentivirus carrier fluid into subpackaging bottles in an aseptic way, and then using a cap screwing tool to seal the subpackaging bottles uniformly, wherein the whole process is carried out in an aseptic environment, the operation is simple, the pollution is not easy, the production efficiency is effectively increased, and the product quality is ensured;
the added SART interface is used for leading the product into the isolator, so that the articles in the isolator can be sterilized in advance, the product subpackaging time is reduced, the real-time subpackaging can be realized, the storage time of the virus vector at room temperature is reduced, and the product quality is effectively ensured;
the use of the aseptic degerming filter of SART interface connection avoids the product of not degerming to get into the contamination risk that the isolator brought, in addition, uses the peristaltic pump to carry out the degerming after leading-in product, avoids traditional manual filtration operation, uses manpower sparingly, improves production efficiency.
Drawings
FIG. 1 is a schematic diagram of a system for sterile packaging of lentiviral vector fluids.
Wherein the reference numbers are as follows: the device comprises a sterile isolator 101, a split charging bottle 102, a peristaltic pump 103, a liquid storage tank 104, a split charging tool 105, a cap screwing tool 106, a sterilization bracket 107, a pipeline 108, an SART interface 109, a sterilization filter 110, a square bottle 111 and a hose 112.
Detailed Description
The present invention is further described in order to make the technical means, inventive features, objectives and effects of the invention easy to understand.
It should be understood that the structures, ratios, sizes, and the like shown in the drawings and described in the specification are only used for matching with the disclosure of the specification, so as to be understood and read by those skilled in the art, and are not used to limit the conditions under which the present invention can be implemented, so that the present invention has no technical significance, and any structural modification, ratio relationship change, or size adjustment should still fall within the scope of the present invention without affecting the efficacy and the achievable purpose of the present invention.
In addition, the terms "upper", "lower", "left", "right", "middle" and "one" used in the present specification are for clarity of description, and are not intended to limit the scope of the present invention, and the relative relationship between the terms and the terms is not to be construed as a scope of the present invention.
The first embodiment of the invention provides a method for aseptically subpackaging lentiviral vector liquid, aiming at introducing the lentiviral vector liquid into an aseptic isolator through an SART interface, then using a subpackaging tool to subpackage the lentiviral vector liquid into subpackaged bottles in an aseptic way, then using a cap screwing tool to seal the subpackaged bottles uniformly, wherein the whole process is carried out in an aseptic environment, the operation is simple, the pollution is not easy, the production efficiency is effectively increased, and the product quality is ensured;
the added SART interface is used for leading the product into the isolator, so that the articles in the isolator can be sterilized in advance, the product subpackaging time is reduced, the real-time subpackaging can be realized, the storage time of the virus vector at room temperature is reduced, and the product quality is effectively ensured;
the use of the aseptic degerming filter of SART interface connection avoids the product of not degerming to get into the contamination risk that the isolator brought, in addition, uses the peristaltic pump to carry out the degerming after leading-in product, avoids traditional manual filtration operation, uses manpower sparingly, improves production efficiency.
A method for aseptically packaging a lentivirus vector fluid, which comprises the following steps:
step 1: sterilizing the sterile isolator 101;
step 2: introducing a lentiviral vector fluid into the sterile isolator 101 through the SART interface 109;
and step 3: the lentivirus carrier fluid which enters the sterile isolator 101 and is filtered by the sterilizing filter 110 is subpackaged into subpackage bottles 102 by a subpackage tool 105;
and 4, step 4: the bottle 102 is capped using a cap screwing tool 106.
In the aseptic subpackaging method of the lentiviral vector fluid provided by the embodiment, the subpackaging environment of the lentiviral vector in the step 3 in the aseptic isolator 101 is a clean grade A under a clean grade B.
In the method for aseptically subpackaging the lentiviral vector fluid, the adopted step 1 further comprises the steps of sterilizing the subpackaging bottle 102 by using the sterile isolator 101, putting the subpackaging bottle 102 into the sterile isolator 101 for sterilization, tearing off the subpackaging bottle 102 after sterilization, filling the torn subpackaging bottle 102 into a breathing bag, sealing the breathing bag, and self-cleaning.
In a second embodiment, as shown in fig. 1, the system for aseptic packaging of a lentiviral vector liquid comprises an aseptic isolator 101, a packaging bottle 102, and a feeding assembly, wherein a packaging tool 105, a cap screwing tool 106, and a sterilization support 107 for placing the packaging bottle 102 are disposed inside the aseptic isolator 101, the cap screwing tool 106 is disposed on the upper side of the sterilization support 107, the feeding assembly is communicated with an SART interface 109 on the aseptic isolator 101, a sterilizing filter 110 communicated with the SART interface 109 is disposed inside the aseptic isolator 101, a square bottle 111 is connected to the other end of the sterilizing filter 110, and a hose 112 communicated with the square bottle 111 is connected to the packaging tool 105.
In the aseptic dispensing system for lentiviral vector liquid provided in this embodiment, the dispensing tool 105 is an electric dispenser.
In the aseptic packaging system for lentiviral vector liquid provided in this embodiment, the cap screwing tool 106 is an electric cap screwing device.
The electric cap screwing device is high in sealing performance of screwing the cap relative to a manual cap screwing device, and the following cap screwing sealing performance experiment is carried out on the manual cap screwing device and the electric cap screwing device:
the operator respectively rotates the cover by hand and the electric cover rotating device according to the simulated production conditions;
putting the filled sample tube into a container containing a methylene blue solution to completely immerse the sample tube;
placing the container in a sterilizing cabinet, vacuumizing to below-25 kPa, maintaining for at least 30min, recovering to normal pressure, and continuously maintaining for 30 min;
taking out the sample tube, washing the outer wall of the sample tube with water, and visually inspecting to prevent the methylene blue solution from permeating into the sample tube;
cleaning the sample tube, placing the sealed sample tube into a refrigerator at-80 ℃ and standing for not less than 24 hours;
taking the sample tube out of the refrigerator, and putting the sample tube into a container containing a methylene blue solution to be completely immersed;
placing the container in a sterilizing cabinet, vacuumizing to below-25 kPa, maintaining for at least 30min, recovering to normal pressure, and continuously maintaining for 30 min;
taking out the sample tube, washing the outer wall of the sample tube with water, and visually inspecting to prevent the methylene blue solution from permeating into the sample tube;
observing test results of the two modes, wherein the tightness test of the manual screw cap is not passed, the methylene blue does not permeate into the sample tube which is visually inspected by the electric screw cap mode, and the test results are shown in the following table 1:
table 1:
in the system for aseptically packaging a lentiviral vector liquid provided in this embodiment, the packaging bottle 102 is an aseptic sample tube.
The aseptic partial shipment system of lentiviral vector liquid that this embodiment provided, the feed assembly who adopts includes peristaltic pump 103, liquid reserve tank 104, and peristaltic pump 103 communicates with liquid reserve tank 104, SART interface 109 respectively through pipeline 108, and liquid reserve tank 104 is used for placing lentiviral vector liquid.
In the aseptic subpackaging system for the lentiviral vector liquid provided by the embodiment, multiple rows of aseptic sample tubes are placed on the adopted sterilization bracket 107, and each row is provided with multiple aseptic sample tubes.
The aseptic partial shipment system of lentiviral carrier liquid that this embodiment provided has placed eight rows of aseptic sample tubes on the sterilization support 107 of adoption, and every row is equipped with eight aseptic sample tubes, carries out one row of liquid and spiral cover of irritating when concrete partial shipment, can guarantee the quality of product when increasing production efficiency, is difficult for polluting.
The specific operation process is as follows:
placing articles required by subpackaging the lentivirus carrier fluid on a sterilization bracket 107 in a sterilization isolator according to a loading mode, opening the sterile isolator 101 for starting sterilization, and after the sterilization is finished, carrying out self-cleaning;
after sterilization, putting the lentiviral vector liquid to be subpackaged into a liquid storage box 104, introducing the lentiviral vector liquid into an aseptic isolator 101 for filtering by using a peristaltic pump 103, connecting a pipeline interface of a pipeline 108 on the peristaltic pump 103 with an SART interface 109 of the aseptic isolator 101, internally connecting a sterilization pipeline 108 with a sterilization filter 110 through the SART interface 109, and filtering the lentiviral vector liquid into a square bottle 111 in the aseptic isolator 101 through the SART interface 109;
first operating personnel uses electronic knockout to absorb lentivirus carrier liquid, and second operating personnel gets rid of the lid of a row of aseptic sample tube with electronic spiral cover ware simultaneously: placing the electric cap screwing device above the sample tube to be uncapped, ensuring that an ejection plate of the electric cap screwing device is aligned with the cap of the sterile sample tube, slightly pressing the electric cap screwing device to ensure that all the caps are correctly entered into a driver of the electric cap screwing device, and starting the electric cap screwing device after all the caps are in place until the caps in a row are screwed up;
first operating personnel carries out the partial shipment, and second operating personnel carries out the spiral cover operation after the partial shipment is accomplished: aligning an ejection plate on an electric cap screwing device with a cover with the sterile sample tube, opening the electric cap screwing device, starting the electric cap screwing device to screw the cover onto the sterile sample tube until the cover is firmly fixed at the top of the sterile sample tube, pressing an ejection trigger to eject the cover from the electric cap screwing device, and separating the cover from the electric cap screwing device to finish cap screwing work;
and (4) subpackaging the rest products according to the process.
In conclusion, according to the aseptic subpackaging method and the subpackaging system for the lentiviral vector liquid, the lentiviral vector liquid is introduced into the aseptic isolator through the SART interface, then aseptic subpackaging is carried out by using the subpackaging tool to subpackage the lentiviral vector liquid into the subpackaging bottles, then the subpackaging bottles are uniformly capped by using the capping tool, the whole process is carried out in an aseptic environment, the operation is simple, the pollution is not easy, the production efficiency is effectively increased, and the product quality is ensured;
the added SART interface is used for leading the product into the isolator, so that the articles in the isolator can be sterilized in advance, the product subpackaging time is reduced, the real-time subpackaging can be realized, the storage time of the virus vector at room temperature is reduced, and the product quality is effectively ensured;
the use of the aseptic degerming filter of SART interface connection avoids the product of not degerming to get into the contamination risk that the isolator brought, in addition, uses the peristaltic pump to carry out the degerming after leading-in product, avoids traditional manual filtration operation, uses manpower sparingly, improves production efficiency.
Specific embodiments of the invention have been described above. It is to be understood that the invention is not limited to the particular embodiments described above, in that devices and structures not described in detail are understood to be implemented in a manner common in the art; various changes or modifications may be made by one skilled in the art within the scope of the claims without departing from the spirit of the invention, and without affecting the spirit of the invention.
Claims (10)
1. A method for aseptically subpackaging a lentivirus vector fluid is characterized by comprising the following steps:
step 1: sterilizing the sterile isolator;
step 2: introducing the lentivirus carrier fluid into a sterile isolator through an SART interface;
and step 3: the lentivirus carrier fluid which enters an aseptic isolator and is filtered by a sterilizing filter is subpackaged into subpackage bottles by a subpackage tool;
and 4, step 4: the bottle is capped using a screw-on cap tool.
2. The method for aseptically packaging a lentiviral vector fluid according to claim 1, wherein the packaging environment of the lentiviral vector in the aseptic isolator in the step 3 is clean grade A under clean grade B.
3. The method according to claim 2, wherein the step 1 further comprises sterilizing the sub-packaging bottle with the sterile isolator, tearing off the sub-packaging bottle after sterilization, packaging the sub-packaging bottle into a breathing bag, sealing the breathing bag, and performing self-cleaning.
4. The utility model provides an aseptic partial shipment system of lentiviral carrier liquid, its characterized in that, includes aseptic isolator, partial shipment bottle, feeding subassembly, the inside of aseptic isolator is equipped with partial shipment instrument, spiral cover instrument and places the sterilization support of partial shipment bottle, the spiral cover instrument set up in the upside of sterilization support, feeding subassembly with SART interface intercommunication on the aseptic isolator, aseptic isolator inside be equipped with the aseptic filter of SART interface intercommunication, the other end of aseptic filter is connected with the square bottle, be connected with on the partial shipment instrument with the hose of square bottle intercommunication.
5. The system of claim 4, wherein the dispensing means is an electric dispenser.
6. The system for sterile dispensing of a lentiviral vector liquid according to claim 4 or claim 5, wherein the capping tool is a motorized cap screw.
7. The system according to claim 4 or 5, wherein the packaging bottle is a sterile sample tube.
8. The system of claim 4 or 5, wherein the feeding assembly comprises a peristaltic pump and a liquid storage tank, and the peristaltic pump is respectively communicated with the liquid storage tank and the SART interface through pipelines.
9. The system of claim 4 or 5, wherein a plurality of rows of said sterile sample tubes are disposed on said sterilization rack, each row comprising a plurality of said sterile sample tubes.
10. The system of claim 9, wherein eight rows of said sterile sample tubes are disposed on said sterilization rack, each row having eight of said sterile sample tubes.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201911077577.1A CN110745761A (en) | 2019-11-06 | 2019-11-06 | Aseptic subpackaging method and subpackaging system for lentiviral vector liquid |
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| CN201911077577.1A CN110745761A (en) | 2019-11-06 | 2019-11-06 | Aseptic subpackaging method and subpackaging system for lentiviral vector liquid |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2024017323A1 (en) * | 2022-07-20 | 2024-01-25 | 浙江健新原力制药有限公司 | Vector liquid aseptic dispensing system and application thereof |
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| WO2000045862A1 (en) * | 1999-02-02 | 2000-08-10 | Steuben Foods, Inc. | Method and apparatus for aseptic packaging |
| US20020029543A1 (en) * | 1999-02-02 | 2002-03-14 | Taggart Thomas D. | Method and apparatus for aseptic packaging |
| CN105129706A (en) * | 2015-08-11 | 2015-12-09 | 江苏大红鹰恒顺药业有限公司 | Production technology of sterile oxygen humidification bottles |
| US10166686B1 (en) * | 2017-11-30 | 2019-01-01 | Jasbir Dhanjal | Portable, self-contained, ready-to-use, sterile enclosure for filling sterile products |
| CN211393828U (en) * | 2019-11-06 | 2020-09-01 | 无锡生基医药科技有限公司 | Aseptic partial shipment system of lentiviral vector |
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2019
- 2019-11-06 CN CN201911077577.1A patent/CN110745761A/en active Pending
Patent Citations (5)
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| WO2000045862A1 (en) * | 1999-02-02 | 2000-08-10 | Steuben Foods, Inc. | Method and apparatus for aseptic packaging |
| US20020029543A1 (en) * | 1999-02-02 | 2002-03-14 | Taggart Thomas D. | Method and apparatus for aseptic packaging |
| CN105129706A (en) * | 2015-08-11 | 2015-12-09 | 江苏大红鹰恒顺药业有限公司 | Production technology of sterile oxygen humidification bottles |
| US10166686B1 (en) * | 2017-11-30 | 2019-01-01 | Jasbir Dhanjal | Portable, self-contained, ready-to-use, sterile enclosure for filling sterile products |
| CN211393828U (en) * | 2019-11-06 | 2020-09-01 | 无锡生基医药科技有限公司 | Aseptic partial shipment system of lentiviral vector |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2024017323A1 (en) * | 2022-07-20 | 2024-01-25 | 浙江健新原力制药有限公司 | Vector liquid aseptic dispensing system and application thereof |
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