CN112762661A - 用于对产品进行冻干的方法 - Google Patents
用于对产品进行冻干的方法 Download PDFInfo
- Publication number
- CN112762661A CN112762661A CN202110017619.3A CN202110017619A CN112762661A CN 112762661 A CN112762661 A CN 112762661A CN 202110017619 A CN202110017619 A CN 202110017619A CN 112762661 A CN112762661 A CN 112762661A
- Authority
- CN
- China
- Prior art keywords
- bag
- product
- interior
- lyophilization
- filling
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000000034 method Methods 0.000 title claims abstract description 75
- 238000004108 freeze drying Methods 0.000 title claims abstract description 74
- 238000011049 filling Methods 0.000 claims abstract description 44
- 238000011068 loading method Methods 0.000 claims abstract description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 21
- 230000001580 bacterial effect Effects 0.000 claims description 13
- 229910052751 metal Inorganic materials 0.000 claims description 5
- 239000002184 metal Substances 0.000 claims description 5
- 229910052782 aluminium Inorganic materials 0.000 claims description 3
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical group [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 3
- 239000002775 capsule Substances 0.000 claims description 3
- 239000000047 product Substances 0.000 description 99
- 239000010410 layer Substances 0.000 description 24
- 239000000463 material Substances 0.000 description 21
- 238000001035 drying Methods 0.000 description 10
- 230000035899 viability Effects 0.000 description 9
- 238000000859 sublimation Methods 0.000 description 7
- 230000008022 sublimation Effects 0.000 description 7
- 238000012546 transfer Methods 0.000 description 7
- 238000010276 construction Methods 0.000 description 6
- 238000007789 sealing Methods 0.000 description 6
- 230000004888 barrier function Effects 0.000 description 5
- 238000011109 contamination Methods 0.000 description 5
- 238000003795 desorption Methods 0.000 description 5
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- 238000001704 evaporation Methods 0.000 description 5
- -1 polyethylene Polymers 0.000 description 5
- 230000008569 process Effects 0.000 description 5
- 238000007710 freezing Methods 0.000 description 4
- 230000008014 freezing Effects 0.000 description 4
- 239000012528 membrane Substances 0.000 description 4
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- 230000035699 permeability Effects 0.000 description 4
- 239000000825 pharmaceutical preparation Substances 0.000 description 4
- 229940127557 pharmaceutical product Drugs 0.000 description 4
- 238000003860 storage Methods 0.000 description 4
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 3
- 239000000356 contaminant Substances 0.000 description 3
- 238000012792 lyophilization process Methods 0.000 description 3
- 238000003466 welding Methods 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 241000831652 Salinivibrio sharmensis Species 0.000 description 2
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- 239000002552 dosage form Substances 0.000 description 2
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- 238000010438 heat treatment Methods 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
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- 239000005020 polyethylene terephthalate Substances 0.000 description 2
- 229920000139 polyethylene terephthalate Polymers 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- BLDFSDCBQJUWFG-UHFFFAOYSA-N 2-(methylamino)-1,2-diphenylethanol Chemical compound C=1C=CC=CC=1C(NC)C(O)C1=CC=CC=C1 BLDFSDCBQJUWFG-UHFFFAOYSA-N 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 241000186012 Bifidobacterium breve Species 0.000 description 1
- 241000194030 Enterococcus gallinarum Species 0.000 description 1
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 description 1
- 241000233866 Fungi Species 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
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- 241000206220 Roseobacter Species 0.000 description 1
- 229910000831 Steel Inorganic materials 0.000 description 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 239000004708 Very-low-density polyethylene Substances 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 238000007664 blowing Methods 0.000 description 1
- 239000004067 bulking agent Substances 0.000 description 1
- 230000001332 colony forming effect Effects 0.000 description 1
- 238000009833 condensation Methods 0.000 description 1
- 230000005494 condensation Effects 0.000 description 1
- XUJNEKJLAYXESH-UHFFFAOYSA-N cysteine Natural products SCC(N)C(O)=O XUJNEKJLAYXESH-UHFFFAOYSA-N 0.000 description 1
- 235000018417 cysteine Nutrition 0.000 description 1
- 230000000249 desinfective effect Effects 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 238000011143 downstream manufacturing Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 229920002457 flexible plastic Polymers 0.000 description 1
- 238000011010 flushing procedure Methods 0.000 description 1
- 230000002538 fungal effect Effects 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 229920001903 high density polyethylene Polymers 0.000 description 1
- 239000004700 high-density polyethylene Substances 0.000 description 1
- 239000011261 inert gas Substances 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 229920001684 low density polyethylene Polymers 0.000 description 1
- 239000004702 low-density polyethylene Substances 0.000 description 1
- 229920001179 medium density polyethylene Polymers 0.000 description 1
- 239000004701 medium-density polyethylene Substances 0.000 description 1
- 150000002739 metals Chemical class 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920005644 polyethylene terephthalate glycol copolymer Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 239000002356 single layer Substances 0.000 description 1
- 239000012265 solid product Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 239000010959 steel Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 229920001866 very low density polyethylene Polymers 0.000 description 1
Images
Classifications
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D33/00—Details of, or accessories for, sacks or bags
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B25/00—Details of general application not covered by group F26B21/00 or F26B23/00
- F26B25/001—Handling, e.g. loading or unloading arrangements
- F26B25/002—Handling, e.g. loading or unloading arrangements for bulk goods
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B25/00—Details of general application not covered by group F26B21/00 or F26B23/00
- F26B25/06—Chambers, containers, or receptacles
- F26B25/063—Movable containers or receptacles, e.g. carts, trolleys, pallet-boxes
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B25/00—Details of general application not covered by group F26B21/00 or F26B23/00
- F26B25/06—Chambers, containers, or receptacles
- F26B25/14—Chambers, containers, receptacles of simple construction
- F26B25/16—Chambers, containers, receptacles of simple construction mainly closed, e.g. drum
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/044—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum for drying materials in a batch operation in an enclosure having a plurality of shelves which may be heated
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/08—Drying solid materials or objects by processes not involving the application of heat by centrifugal treatment
- F26B5/10—Drying solid materials or objects by processes not involving the application of heat by centrifugal treatment the process involving freezing
Landscapes
- Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Mechanical Engineering (AREA)
- General Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Packages (AREA)
- Drying Of Solid Materials (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB1711359.8A GB2564481B (en) | 2017-07-14 | 2017-07-14 | Process |
| GB1711359.8 | 2017-07-14 | ||
| CN201880046566.4A CN110892220B (zh) | 2017-07-14 | 2018-07-16 | 用于对产品进行冻干的方法 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201880046566.4A Division CN110892220B (zh) | 2017-07-14 | 2018-07-16 | 用于对产品进行冻干的方法 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN112762661A true CN112762661A (zh) | 2021-05-07 |
Family
ID=59713621
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110017619.3A Pending CN112762661A (zh) | 2017-07-14 | 2018-07-16 | 用于对产品进行冻干的方法 |
| CN201880046566.4A Expired - Fee Related CN110892220B (zh) | 2017-07-14 | 2018-07-16 | 用于对产品进行冻干的方法 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201880046566.4A Expired - Fee Related CN110892220B (zh) | 2017-07-14 | 2018-07-16 | 用于对产品进行冻干的方法 |
Country Status (25)
| Country | Link |
|---|---|
| US (2) | US11135168B2 (https=) |
| EP (2) | EP3978852A1 (https=) |
| JP (2) | JP7049373B2 (https=) |
| KR (1) | KR20200029497A (https=) |
| CN (2) | CN112762661A (https=) |
| AU (3) | AU2018300358B2 (https=) |
| CA (1) | CA3068394A1 (https=) |
| CY (1) | CY1124780T1 (https=) |
| DK (1) | DK3652491T3 (https=) |
| ES (1) | ES2878136T3 (https=) |
| GB (1) | GB2564481B (https=) |
| HR (1) | HRP20211227T1 (https=) |
| HU (1) | HUE055005T2 (https=) |
| IL (3) | IL271979B (https=) |
| LT (1) | LT3652491T (https=) |
| MA (1) | MA49569B1 (https=) |
| MD (1) | MD3652491T2 (https=) |
| PL (1) | PL3652491T3 (https=) |
| PT (1) | PT3652491T (https=) |
| RS (1) | RS62104B1 (https=) |
| SG (1) | SG11202000223UA (https=) |
| SI (1) | SI3652491T1 (https=) |
| SM (1) | SMT202100446T1 (https=) |
| TW (1) | TWI771451B (https=) |
| WO (1) | WO2019012512A1 (https=) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL3177359T3 (pl) * | 2014-08-04 | 2020-09-21 | F. Hoffmann-La Roche Ag | Urządzenie i sposoby do uszczelniania lekarstwa w obrębie medycznego urządzenia dostarczającego |
| GB2564481B (en) * | 2017-07-14 | 2019-10-23 | 4D Pharma Leon S L U | Process |
| JP7110360B2 (ja) | 2017-10-09 | 2022-08-01 | テルモ ビーシーティー バイオテクノロジーズ，エルエルシー | 凍結乾燥方法 |
| CN113614477B (zh) | 2019-03-14 | 2023-04-28 | 泰尔茂比司特生物技术有限公司 | 冷冻干燥装载托盘组件及系统 |
| EP3839039A1 (en) | 2019-12-16 | 2021-06-23 | 4D Pharma Research Limited | Providing bacterial biomass with improved storage stability |
| EP4077633A1 (en) | 2019-12-20 | 2022-10-26 | 4D Pharma León, S.L.U. | Lyophilisation process |
| TW202304415A (zh) * | 2021-04-08 | 2023-02-01 | 美商艾弗洛生物科技股份有限公司 | 含有細菌的藥物製劑 |
| CN113357880B (zh) * | 2021-05-17 | 2022-11-11 | 云南易门丛山食用菌有限责任公司 | 一种半冻干松茸的处理工艺 |
| JP2025521429A (ja) * | 2022-06-28 | 2025-07-10 | コンプライアンス コンサルティング アンド エンジニアリング サーヴィシーズ， ソシエダ リミターダ | プレートスタックシステムを備えた凍結乾燥機における凍結乾燥プロセスを制御するためのシステムおよび設計空間を生成するための方法 |
| EP4357709A1 (en) | 2022-10-19 | 2024-04-24 | EAD Sàrl | Lyophilization stopper comprising a membrane |
| CN117367040A (zh) | 2023-11-03 | 2024-01-09 | 甘肃省药品检验研究院 | 一种中药材冷冻干燥的加工装置 |
| WO2025099273A1 (en) | 2023-11-08 | 2025-05-15 | Bachem Holding Ag | Drying bag and drying system |
| EP4553432B1 (en) | 2023-11-08 | 2026-04-29 | Bachem Holding AG | Drying bag and drying system |
Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4035924A (en) * | 1974-09-11 | 1977-07-19 | Societe D'assistance Technique Pour Produits Nestle S.A. | Freeze-drying of solid, liquid or paste-like products |
| US4973327A (en) * | 1989-11-01 | 1990-11-27 | Cryopharm | Blood bag for lyophilization |
| EP0914813A2 (en) * | 1997-11-04 | 1999-05-12 | Material Engineering Technology Laboratory, Inc. | Container for therapeutic use |
| US20080229609A1 (en) * | 2004-06-02 | 2008-09-25 | Victor Bronshtein | Preservation by Vaporization |
| CN202153093U (zh) * | 2011-06-12 | 2012-02-29 | 陈长清 | 一种真空冷冻干燥机搁板上使用的托盘 |
| CN103169741A (zh) * | 2013-01-10 | 2013-06-26 | 济南康众医药科技开发有限公司 | 冻干马齿苋在制备抗疲劳药物中的应用 |
| CN103211871A (zh) * | 2012-01-24 | 2013-07-24 | 贺文军 | 肉苁蓉的冷冻干燥保鲜加工工艺 |
| CN106461327A (zh) * | 2014-06-09 | 2017-02-22 | 泰尔茂比司特公司 | 冻干法 |
| US10485764B2 (en) * | 2015-07-02 | 2019-11-26 | Otsuka Pharmaceutical Co., Ltd. | Lyophilized pharmaceutical compositions |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US1053936A (en) | 1911-10-31 | 1913-02-18 | Burt R Van Valkenburg | Control-valve. |
| US4022206A (en) * | 1975-08-01 | 1977-05-10 | Merck & Co., Inc. | Vaccine delivery system |
| US4132848A (en) * | 1977-11-03 | 1979-01-02 | Eli Lilly And Company | Method of preparing a rapidly dissolving powder of crystalline cephalothin sodium for parenteral administration |
| CA1232549A (en) * | 1983-04-21 | 1988-02-09 | Annie Bedout | Container in the form of a flexible bag for liquids to be lyophilized and a method of utilization of said container |
| KR930001382B1 (ko) * | 1990-09-05 | 1993-02-27 | 보령신약 주식회사 | 경구용 장티프스 생균백신 및 그의 제조방법 |
| US5257983A (en) * | 1991-04-12 | 1993-11-02 | Cryopharm Corporation | Blood bag for lyophilization |
| JP3121632B2 (ja) * | 1991-04-30 | 2001-01-09 | 株式会社アズウェル | 凍結乾燥製剤の製造方法及び凍結真空乾燥装置 |
| WO1995022036A1 (en) * | 1994-02-09 | 1995-08-17 | Kinerton Limited | Process for drying a material from solution |
| ATE208333T1 (de) * | 1994-08-05 | 2001-11-15 | West Pharm Serv Cornall Ltd | Behälter für feuchtickeitsempfindliche stoffe und entsprechendes verfahren zum trocknen und zur reduktion |
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| FR2793767B1 (fr) * | 1999-05-17 | 2001-09-21 | Aerospatiale Airbus | Dispositif d'accrochage d'un moteur d'aeronef |
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| EP1541158B1 (de) * | 2003-12-04 | 2008-03-05 | Cognis IP Management GmbH | Antioxidantzubereitung für die orale und/oder topische Anwendung |
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2017
- 2017-07-14 GB GB1711359.8A patent/GB2564481B/en not_active Expired - Fee Related
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2018
- 2018-07-13 TW TW107124264A patent/TWI771451B/zh not_active IP Right Cessation
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- 2018-07-16 EP EP21172900.9A patent/EP3978852A1/en not_active Withdrawn
- 2018-07-16 KR KR1020207002713A patent/KR20200029497A/ko not_active Ceased
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