TWI771451B - 凍乾產品之方法 - Google Patents
凍乾產品之方法 Download PDFInfo
- Publication number
- TWI771451B TWI771451B TW107124264A TW107124264A TWI771451B TW I771451 B TWI771451 B TW I771451B TW 107124264 A TW107124264 A TW 107124264A TW 107124264 A TW107124264 A TW 107124264A TW I771451 B TWI771451 B TW I771451B
- Authority
- TW
- Taiwan
- Prior art keywords
- bag
- product
- interior
- filling
- lyophilization
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims abstract description 56
- 238000004108 freeze drying Methods 0.000 claims abstract description 60
- 238000011068 loading method Methods 0.000 claims abstract description 15
- 238000011049 filling Methods 0.000 claims description 47
- 230000001580 bacterial effect Effects 0.000 claims description 8
- 230000035899 viability Effects 0.000 claims description 6
- 229910052751 metal Inorganic materials 0.000 claims description 3
- 239000002184 metal Substances 0.000 claims description 3
- 229910052782 aluminium Inorganic materials 0.000 claims description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical group [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 2
- 239000002775 capsule Substances 0.000 claims description 2
- 239000002552 dosage form Substances 0.000 claims 2
- 238000011109 contamination Methods 0.000 abstract description 6
- 239000000047 product Substances 0.000 description 85
- 239000010410 layer Substances 0.000 description 24
- 239000000463 material Substances 0.000 description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 12
- 239000012528 membrane Substances 0.000 description 8
- 238000007789 sealing Methods 0.000 description 7
- 238000000859 sublimation Methods 0.000 description 7
- 230000008022 sublimation Effects 0.000 description 7
- 238000012546 transfer Methods 0.000 description 7
- 230000004888 barrier function Effects 0.000 description 6
- 238000010276 construction Methods 0.000 description 6
- 238000003860 storage Methods 0.000 description 6
- 238000003795 desorption Methods 0.000 description 5
- 238000001035 drying Methods 0.000 description 5
- 238000001704 evaporation Methods 0.000 description 5
- 230000008020 evaporation Effects 0.000 description 5
- 238000007710 freezing Methods 0.000 description 4
- 230000008014 freezing Effects 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- -1 polyethylene Polymers 0.000 description 4
- 239000000356 contaminant Substances 0.000 description 3
- 230000035699 permeability Effects 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
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 238000004026 adhesive bonding Methods 0.000 description 2
- 238000004140 cleaning Methods 0.000 description 2
- 230000008878 coupling Effects 0.000 description 2
- 238000010168 coupling process Methods 0.000 description 2
- 238000005859 coupling reaction Methods 0.000 description 2
- 238000012864 cross contamination Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 229940126601 medicinal product Drugs 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 229920003023 plastic Polymers 0.000 description 2
- 239000005020 polyethylene terephthalate Substances 0.000 description 2
- 229920000139 polyethylene terephthalate Polymers 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 230000005855 radiation Effects 0.000 description 2
- 239000002356 single layer Substances 0.000 description 2
- 230000001954 sterilising effect Effects 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
- 239000004743 Polypropylene Substances 0.000 description 1
- 241000872832 Roseburia hominis Species 0.000 description 1
- 241000831652 Salinivibrio sharmensis 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
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 238000000071 blow moulding Methods 0.000 description 1
- 238000009833 condensation Methods 0.000 description 1
- 230000005494 condensation Effects 0.000 description 1
- 238000001816 cooling Methods 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
- 125000000151 cysteine group Chemical group N[C@@H](CS)C(=O)* 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000000945 filler Substances 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
- 238000010438 heat treatment 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
- 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
- 238000012792 lyophilization process Methods 0.000 description 1
- 238000004519 manufacturing process Methods 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
- 239000002245 particle Substances 0.000 description 1
- 238000011020 pilot scale process Methods 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
- 238000012545 processing Methods 0.000 description 1
- 230000035945 sensitivity Effects 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
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
- 238000007669 thermal treatment Methods 0.000 description 1
- 238000009827 uniform distribution Methods 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
- 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
- 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
- A61K9/48—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 |
|---|---|---|---|
| GB1711359.8 | 2017-07-14 | ||
| ??1711359.8 | 2017-07-14 | ||
| GB1711359.8A GB2564481B (en) | 2017-07-14 | 2017-07-14 | Process |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| TW201934945A TW201934945A (zh) | 2019-09-01 |
| TWI771451B true TWI771451B (zh) | 2022-07-21 |
Family
ID=59713621
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TW107124264A TWI771451B (zh) | 2017-07-14 | 2018-07-13 | 凍乾產品之方法 |
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 |
|---|---|---|---|---|
| US10729616B2 (en) * | 2014-08-04 | 2020-08-04 | Genentech, Inc. | Apparatus and methods for sealing a medicament within a medical delivery device |
| 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 |
| CN113597532B (zh) | 2019-03-14 | 2023-02-17 | 泰尔茂比司特生物技术有限公司 | 冻干容器填充固定装置、系统及使用方法 |
| EP3839039A1 (en) | 2019-12-16 | 2021-06-23 | 4D Pharma Research Limited | Providing bacterial biomass with improved storage stability |
| KR20220118413A (ko) | 2019-12-20 | 2022-08-25 | 4디 파마 레온, 에스.엘.유. | 동결건조 방법 |
| 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 |
| CN119698536B (zh) * | 2022-06-28 | 2026-01-09 | 合规咨询与策划服务有限公司 | 用于控制具有板堆系统的冻干机的冻干过程的系统和生成设计空间的方法 |
| 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 (6)
| 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 |
| CN105163704A (zh) * | 2013-02-22 | 2015-12-16 | 莱福奈特海尔斯公司 | 用于储存组织和细胞材料的包装组件 |
| US20170000738A1 (en) * | 2015-07-02 | 2017-01-05 | Astex Pharmaceuticals, Inc. | 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 |
| EP0742888B1 (en) * | 1994-02-09 | 1998-04-22 | Kinerton Limited | Process for drying a material from solution |
| PL179210B1 (pl) * | 1994-08-05 | 2000-08-31 | Smithkline Beecham Plc | Pojemnik z substancja wrazliwa na wilgoc PL PL PL PL |
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| JP2014043280A (ja) | 2013-11-20 | 2014-03-13 | Sumitomo Bakelite Co Ltd | 凍結真空乾燥用包装袋及び凍結真空乾燥用包装袋を用いた凍結真空乾燥方法 |
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