CA1337974C - Processus et contenant utilises pour la lyophilisation dans des conditions steriles - Google Patents
Processus et contenant utilises pour la lyophilisation dans des conditions sterilesInfo
- Publication number
- CA1337974C CA1337974C CA000600212A CA600212A CA1337974C CA 1337974 C CA1337974 C CA 1337974C CA 000600212 A CA000600212 A CA 000600212A CA 600212 A CA600212 A CA 600212A CA 1337974 C CA1337974 C CA 1337974C
- Authority
- CA
- Canada
- Prior art keywords
- container
- process according
- membrane
- biological
- pharmaceutical
- 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.)
- Expired - Lifetime
Links
- 238000000034 method Methods 0.000 title claims abstract description 68
- 238000004108 freeze drying Methods 0.000 title claims abstract description 20
- 239000000463 material Substances 0.000 claims abstract description 57
- 239000012528 membrane Substances 0.000 claims abstract description 53
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 13
- 230000002209 hydrophobic effect Effects 0.000 claims abstract description 7
- 239000001913 cellulose Substances 0.000 claims description 10
- 229920000642 polymer Polymers 0.000 claims description 9
- -1 polytetrafluoroethylene Polymers 0.000 claims description 9
- 229920002678 cellulose Polymers 0.000 claims description 8
- 239000011148 porous material Substances 0.000 claims description 8
- 239000004743 Polypropylene Substances 0.000 claims description 5
- 229920002301 cellulose acetate Polymers 0.000 claims description 5
- 229920001155 polypropylene Polymers 0.000 claims description 5
- 210000004379 membrane Anatomy 0.000 claims 36
- 235000010980 cellulose Nutrition 0.000 claims 8
- 150000001875 compounds Chemical class 0.000 claims 8
- 239000003708 ampul Substances 0.000 claims 6
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims 4
- 239000004810 polytetrafluoroethylene Substances 0.000 claims 4
- 229940106135 cellulose Drugs 0.000 claims 2
- 238000001035 drying Methods 0.000 description 18
- 244000005700 microbiome Species 0.000 description 14
- 238000012360 testing method Methods 0.000 description 9
- 235000015097 nutrients Nutrition 0.000 description 4
- 229920001817 Agar Polymers 0.000 description 3
- 239000008272 agar Substances 0.000 description 3
- 229910052751 metal Inorganic materials 0.000 description 3
- 239000002184 metal Substances 0.000 description 3
- 238000004659 sterilization and disinfection Methods 0.000 description 3
- 238000000859 sublimation Methods 0.000 description 3
- 230000008022 sublimation Effects 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 238000003466 welding Methods 0.000 description 3
- 230000001580 bacterial effect Effects 0.000 description 2
- 238000011109 contamination Methods 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 239000008223 sterile water Substances 0.000 description 2
- 241000861718 Chloris <Aves> Species 0.000 description 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 239000001888 Peptone Substances 0.000 description 1
- 108010080698 Peptones Proteins 0.000 description 1
- 238000006887 Ullmann reaction Methods 0.000 description 1
- 239000004411 aluminium Substances 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 239000006161 blood agar Substances 0.000 description 1
- 239000000356 contaminant Substances 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-M dihydrogenphosphate Chemical compound OP(O)([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-M 0.000 description 1
- KDQPSPMLNJTZAL-UHFFFAOYSA-L disodium hydrogenphosphate dihydrate Chemical compound O.O.[Na+].[Na+].OP([O-])([O-])=O KDQPSPMLNJTZAL-UHFFFAOYSA-L 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 239000011261 inert gas Substances 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000010297 mechanical methods and process Methods 0.000 description 1
- 230000005226 mechanical processes and functions Effects 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 235000019319 peptone Nutrition 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 229920003002 synthetic resin Polymers 0.000 description 1
- 239000000057 synthetic resin Substances 0.000 description 1
Classifications
-
- 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
Landscapes
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- Mechanical Engineering (AREA)
- General Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Drying Of Solid Materials (AREA)
- Freezing, Cooling And Drying Of Foods (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DEP3817906.7 | 1988-05-26 | ||
| DE3817906A DE3817906A1 (de) | 1988-05-26 | 1988-05-26 | Verfahren und behaeltnis zum gefriertrocknen unter sterilen bedingungen |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1337974C true CA1337974C (fr) | 1996-01-23 |
Family
ID=6355171
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000600212A Expired - Lifetime CA1337974C (fr) | 1988-05-26 | 1989-05-19 | Processus et contenant utilises pour la lyophilisation dans des conditions steriles |
Country Status (13)
| Country | Link |
|---|---|
| EP (1) | EP0343596B1 (fr) |
| JP (1) | JPH0229256A (fr) |
| AT (1) | ATE73226T1 (fr) |
| CA (1) | CA1337974C (fr) |
| DD (1) | DD283864A5 (fr) |
| DE (2) | DE3817906A1 (fr) |
| DK (1) | DK173643B1 (fr) |
| ES (1) | ES2030556T3 (fr) |
| FI (1) | FI91442C (fr) |
| GR (1) | GR3004584T3 (fr) |
| HU (1) | HU204126B (fr) |
| IE (1) | IE61012B1 (fr) |
| PL (1) | PL159938B1 (fr) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL90188A0 (en) * | 1988-05-18 | 1989-12-15 | Cryopharm Corp | Process and medium for the lyophilization of erythrocytes |
| US5045446A (en) * | 1988-08-26 | 1991-09-03 | Cryopharm Corporation | Lyophilization of cells |
| US5257983A (en) * | 1991-04-12 | 1993-11-02 | Cryopharm Corporation | Blood bag for lyophilization |
| WO1995027180A1 (fr) * | 1994-04-04 | 1995-10-12 | W.L. Gore & Associates, Inc. | Procede ameliore pour minimiser la contamination de produits lyophilises |
| WO1996006018A1 (fr) * | 1994-08-19 | 1996-02-29 | W. L. Gore & Associates, Inc. | Flacon a event pour lyophilisation et procede permettant de minimiser la contamination de produits lyophilises |
| FR2738057B1 (fr) * | 1995-08-22 | 1997-11-07 | Lab Francais Du Fractionnement | Emballage etanche pour sechage, notamment lyophilisation, et procede de sechage, notamment de lyophilisation, a l'aide d'un tel emballage |
| FR2740108B1 (fr) * | 1995-08-22 | 1998-03-27 | Lab Francais Du Fractionnement | Emballage etanche pour sechage, notamment lyophilisation, et procede de sechage, notamment de lyophilisation, a l'aide d'un tel emballage |
| EP0854911B1 (fr) | 1995-09-22 | 2004-11-24 | GOVERNMENT OF THE UNITED STATES OF AMERICA, as represented by THE SECRETARY OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES | Recipient pour secher des echantillons biologiques, procede de fabrication et mode d'utilisation dudit recipient |
| US5596814A (en) * | 1995-11-06 | 1997-01-28 | W. L. Gore & Associates, Inc. | Vented vial stopper for processing freeze-dried products |
| AT1399U1 (de) | 1995-11-29 | 1997-04-25 | Immuno Ag | Verfahren und einrichtung zum lyophilisieren |
| DE19751031A1 (de) * | 1997-11-19 | 1999-06-24 | Ingo Dipl Ing Heschel | Verfahren zur Herstellung poröser Strukturen |
| US6312648B1 (en) | 1998-01-12 | 2001-11-06 | The United States Of America As Represented By The Department Of Health And Human Services | Applicator system |
| DE19815993C2 (de) * | 1998-04-09 | 2003-03-06 | Schott Glas | Behälter zur Gefriertrocknung und Aufbewahrung medizinischer Produkte |
| EP1958618A1 (fr) | 2007-02-15 | 2008-08-20 | Octapharma AG | Procédé destiné à la lyophilisation par reconstitution optimisée de biopolymères |
| JP2010124931A (ja) * | 2008-11-26 | 2010-06-10 | Kanae Co Ltd | 凍結乾燥製剤の包装体の製造方法 |
| EP2386399B8 (fr) * | 2010-04-23 | 2015-08-05 | MC Beteiligungs-GmbH | Procédé pour faire des trous dans un revêtement étanche et corps de base avec un tel revêtement |
| WO2015162273A1 (fr) | 2014-04-25 | 2015-10-29 | Merck Sharp & Dohme Bv | Procédé pour assécher de multiples corps individuels congelés et système permettant d'appliquer ce procédé |
| EP3694322B1 (fr) | 2017-10-09 | 2024-07-03 | Terumo BCT Biotechnologies, LLC | Récipient de lyophilisation et son procédé d'utilisation |
| JP2019090596A (ja) * | 2017-11-10 | 2019-06-13 | エイブル株式会社 | 凍結乾燥生成物の製造方法、及び、凍結乾燥用袋、並びに、凍結乾燥装置 |
| EP3938741B1 (fr) | 2019-03-14 | 2024-05-01 | Terumo BCT Biotechnologies, LLC | Agencement de remplissage de contenant de lyophilisation, système et procédé d'utilisation |
| DE102023118662B3 (de) * | 2023-07-13 | 2024-07-11 | Jürgen Kögel | Gefriertrocknungsbehälter |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BE620147A (fr) * | 1961-07-17 | |||
| BE622411A (fr) * | 1961-11-28 | |||
| GB1154320A (en) * | 1965-09-24 | 1969-06-04 | Unilever Ltd | Freeze Drying |
| FR2284842A1 (fr) * | 1974-09-11 | 1976-04-09 | Nestle Sa | Perfectionnement apporte la lyophilisation des produits solides, liquides ou pateux |
| JPS60168464A (ja) * | 1983-11-18 | 1985-08-31 | 新技術事業団 | 血液保存方法及びその保存用容器 |
| JPS6136942A (ja) * | 1984-07-28 | 1986-02-21 | Sony Corp | 電子部品装置 |
-
1988
- 1988-05-26 DE DE3817906A patent/DE3817906A1/de not_active Withdrawn
-
1989
- 1989-05-11 IE IE154189A patent/IE61012B1/en not_active IP Right Cessation
- 1989-05-19 CA CA000600212A patent/CA1337974C/fr not_active Expired - Lifetime
- 1989-05-23 DE DE8989109246T patent/DE58900902D1/de not_active Expired - Lifetime
- 1989-05-23 EP EP89109246A patent/EP0343596B1/fr not_active Expired - Lifetime
- 1989-05-23 ES ES198989109246T patent/ES2030556T3/es not_active Expired - Lifetime
- 1989-05-23 AT AT89109246T patent/ATE73226T1/de not_active IP Right Cessation
- 1989-05-24 DD DD89328870A patent/DD283864A5/de not_active IP Right Cessation
- 1989-05-24 DK DK198902525A patent/DK173643B1/da not_active IP Right Cessation
- 1989-05-24 PL PL1989279609A patent/PL159938B1/pl unknown
- 1989-05-25 FI FI892563A patent/FI91442C/fi not_active IP Right Cessation
- 1989-05-25 HU HU892683A patent/HU204126B/hu unknown
- 1989-05-26 JP JP1131693A patent/JPH0229256A/ja active Granted
-
1992
- 1992-05-13 GR GR920400224T patent/GR3004584T3/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| GR3004584T3 (fr) | 1993-04-28 |
| FI91442B (fi) | 1994-03-15 |
| HU204126B (en) | 1991-11-28 |
| DK173643B1 (da) | 2001-05-14 |
| JPH0450830B2 (fr) | 1992-08-17 |
| EP0343596B1 (fr) | 1992-03-04 |
| DE58900902D1 (de) | 1992-04-09 |
| IE61012B1 (en) | 1994-09-07 |
| DE3817906A1 (de) | 1989-11-30 |
| FI892563A0 (fi) | 1989-05-25 |
| EP0343596A3 (en) | 1990-02-28 |
| DD283864A5 (de) | 1990-10-24 |
| JPH0229256A (ja) | 1990-01-31 |
| PL159938B1 (pl) | 1993-01-29 |
| IE891541L (en) | 1989-11-26 |
| EP0343596A2 (fr) | 1989-11-29 |
| PL279609A1 (en) | 1990-01-22 |
| DK252589A (da) | 1989-11-27 |
| ES2030556T3 (es) | 1992-11-01 |
| HUT52617A (en) | 1990-07-28 |
| ATE73226T1 (de) | 1992-03-15 |
| FI892563L (fi) | 1989-11-27 |
| DK252589D0 (da) | 1989-05-24 |
| FI91442C (fi) | 1994-06-27 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKEX | Expiry |
Effective date: 20130123 |