EP3333523B1 - Bouchon de récipient destiné à être utilisé lors de la lyophilisation - Google Patents
Bouchon de récipient destiné à être utilisé lors de la lyophilisation Download PDFInfo
- Publication number
- EP3333523B1 EP3333523B1 EP16202437.6A EP16202437A EP3333523B1 EP 3333523 B1 EP3333523 B1 EP 3333523B1 EP 16202437 A EP16202437 A EP 16202437A EP 3333523 B1 EP3333523 B1 EP 3333523B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- stopper
- sealing body
- plug
- base body
- section
- 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.)
- Active
Links
- 238000004108 freeze drying Methods 0.000 title claims description 23
- 238000007789 sealing Methods 0.000 claims description 111
- 238000003780 insertion Methods 0.000 claims description 38
- 230000037431 insertion Effects 0.000 claims description 38
- 239000000463 material Substances 0.000 claims description 33
- 230000004888 barrier function Effects 0.000 claims description 21
- 238000001746 injection moulding Methods 0.000 claims description 14
- 239000004743 Polypropylene Substances 0.000 claims description 6
- 229920001155 polypropylene Polymers 0.000 claims description 6
- 229920001903 high density polyethylene Polymers 0.000 claims description 4
- 239000004700 high-density polyethylene Substances 0.000 claims description 4
- -1 polypropylene Polymers 0.000 claims description 4
- 229920002725 thermoplastic elastomer Polymers 0.000 claims description 4
- 230000000903 blocking effect Effects 0.000 description 14
- 238000000034 method Methods 0.000 description 13
- 239000000243 solution Substances 0.000 description 9
- 239000000126 substance Substances 0.000 description 8
- 239000007789 gas Substances 0.000 description 7
- 238000004519 manufacturing process Methods 0.000 description 7
- 230000000694 effects Effects 0.000 description 5
- 230000015572 biosynthetic process Effects 0.000 description 4
- 238000009792 diffusion process Methods 0.000 description 4
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 3
- 229910052782 aluminium Inorganic materials 0.000 description 3
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 3
- 229920005549 butyl rubber Polymers 0.000 description 3
- 238000011161 development Methods 0.000 description 3
- 230000018109 developmental process Effects 0.000 description 3
- 229920001971 elastomer Polymers 0.000 description 3
- 239000001301 oxygen Substances 0.000 description 3
- 229910052760 oxygen Inorganic materials 0.000 description 3
- 238000011109 contamination Methods 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 208000031872 Body Remains Diseases 0.000 description 1
- 229920000219 Ethylene vinyl alcohol Polymers 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 239000012080 ambient air Substances 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 239000011324 bead Substances 0.000 description 1
- 229920005557 bromobutyl Polymers 0.000 description 1
- 229920005556 chlorobutyl Polymers 0.000 description 1
- 239000012611 container material Substances 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000005265 energy consumption Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000004744 fabric Substances 0.000 description 1
- 239000011888 foil Substances 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000007779 soft material Substances 0.000 description 1
- 239000011343 solid material Substances 0.000 description 1
- 238000004073 vulcanization Methods 0.000 description 1
Images
Classifications
-
- 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
- B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
- B65D39/0052—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers made in more than one piece
- B65D39/0076—Plastic closures other than those covered by groups B65D39/0058 - B65D39/007
-
- 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
- B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
- B65D39/0052—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers made in more than one piece
- B65D39/0094—Glass, ceramic or metal stoppers for perfume bottles or the like
-
- 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
- B65D2539/00—Details relating to closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
- B65D2539/001—Details of closures arranged within necks or pouring opening or in discharge apertures, e.g. stoppers
- B65D2539/008—Details of closures arranged within necks or pouring opening or in discharge apertures, e.g. stoppers with coatings or coverings
-
- 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
- B65D51/00—Closures not otherwise provided for
- B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
-
- 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
- B65D51/00—Closures not otherwise provided for
- B65D51/24—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
- B65D51/241—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes provided with freeze-drying means
-
- 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)
- Mechanical Engineering (AREA)
- Chemical & Material Sciences (AREA)
- Ceramic Engineering (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- General Engineering & Computer Science (AREA)
- Closures For Containers (AREA)
Claims (15)
- Bouchon (1) pour un récipient (18) pour l'utilisation lors de la lyophilisation, le bouchon (1) présentant une partie d'insertion (2) pouvant être insérée dans le récipient (18), la partie d'insertion (2) présentant une surface latérale (3) et une surface de fond (4), la surface de fond (4) étant réalisée à l'opposé d'une surface de dessus (5) du bouchon (1) dans une direction axiale (Z) du bouchon (1), et la partie d'insertion (2) présentant une partie d'étanchéité (16) et une partie d'application (17), la partie d'application (17) présentant une ouverture de passage (6) pour un échange de gaz, l'ouverture de passage (6) s'étendant depuis la surface latérale (3) jusque dans la surface de fond (4) et le bouchon (1) présentant un corps d'étanchéité (7) et un corps de base (8) qui sont reliés l'un à l'autre, le corps de base (8) se composant d'un matériau présentant une dureté supérieure à un matériau constituant le corps d'étanchéité (7),
caractérisé en ce que des surfaces extérieures du corps d'étanchéité (7) forment la surface latérale (3) et la surface de fond (4) de la partie d'insertion (2), le corps de base (8) est réalisé dans la région de la partie d'insertion (2) à l'intérieur du corps d'étanchéité (7), le bouchon (1) présentant une partie de recouvrement (10) adjacente à la partie d'insertion (2) dans la direction axiale (7), la partie de recouvrement (10) présentant la surface de dessus (5) et une dimension radiale de la partie de recouvrement (10) étant au moins aussi grande qu'une dimension radiale de la partie d'insertion (2), le corps de base (8) présentant, dans la région de la partie de recouvrement (10), une saillie (13) réalisée radialement à l'extérieur, s'étendant depuis la surface de dessus (5) dans la direction de la surface de fond (4), la saillie (13) recouvrant au moins en partie radialement à l'extérieur le corps d'étanchéité (7) dans la région de la partie de recouvrement (10). - Bouchon (1) selon la revendication 1, caractérisé en ce que le corps d'étanchéité (7) et le corps de base (8) sont connectés directement l'un à l'autre, en particulier sont connectés directement l'un à l'autre par liaison de matière.
- Bouchon (1) selon la revendication 1 ou 2, caractérisé en ce que le bouchon (1) présente un corps de blocage (9) et/ou une couche de blocage (9), le corps de blocage (9) et/ou la couche de blocage (9) étant réalisés entre le corps de base (8) et le corps d'étanchéité (7), en particulier le corps de blocage (9) et/ou la couche de blocage (9) étant connectés par liaison de matière au corps de base (8) et/ou par liaison de matière au corps d'étanchéité (7).
- Bouchon (1) selon l'une quelconque des revendications 1 à 3, caractérisé en ce qu'une surface extérieure du corps de base (8) forme la surface de dessus (5) et la surface de dessus (5) recouvre le corps d'étanchéité (7) dans la direction axiale (Z).
- Bouchon (1) selon l'une quelconque des revendications 1 à 4, caractérisé en ce que la dimension radiale de la partie de recouvrement (10) est supérieure à la dimension radiale de la partie d'insertion (2).
- Bouchon (1) selon les revendications 1 à 5, caractérisé en ce qu'une surface extérieure du corps d'étanchéité (8) forme une surface d'appui (11) de la partie de recouvrement (10), opposée à la surface de dessus (5).
- Bouchon (1) selon les revendications 1 à 6, caractérisé en ce que le corps de base (8) présente, dans la région de la partie de recouvrement (10), une saillie supplémentaire (12) réalisée dans la direction radiale, en particulier le corps de base (8) présente, dans la région de la partie de recouvrement (10), une saillie supplémentaire périphérique (12).
- Bouchon (1) selon l'une quelconque des revendications 1 à 7, caractérisé en ce que le corps d'étanchéité (7) présente, dans la région de la partie d'étanchéité (16), une section transversale circulaire, de préférence un rapport d'un rayon extérieur (R) de l'anneau circulaire à un rayon intérieur (r) de l'anneau circulaire est de 1,1 à 2,5.
- Bouchon (1) selon l'une quelconque des revendications 1 à 8, caractérisé en ce que le corps de base (8) entoure radialement une région partielle (14) du corps d'étanchéité (7) s'étendant depuis la surface de fond (4) dans la direction de la surface de dessus (5).
- Bouchon (1) selon l'une quelconque des revendications 1 à 9, caractérisé en ce que le corps de base (8) présente un canal de passage (15) s'étendant depuis la surface de dessus (5) dans la direction de la surface de fond (4), en particulier la région partielle (14) du corps d'étanchéité (7) s'étendant depuis la surface de fond (4) dans la direction de la surface de dessus (5) est réalisée dans le canal de passage (15).
- Bouchon (1) selon l'une quelconque des revendications 1 à 10, caractérisé en ce que le corps d'étanchéité (7) présente un évidement (6), l'évidement (6) formant l'ouverture de passage (6).
- Bouchon (1) selon l'une quelconque des revendications 1 à 11, caractérisé en ce que le corps d'étanchéité (7) se compose d'un matériau qui présente une dureté Shore A de 40 à 80, de préférence une dureté Shore A de 50 à 70 selon DIN ISO 7619-1:2010, et/ou le corps d'étanchéité (7) se compose d'un élastomère thermoplastique (TPE).
- Bouchon (1) selon l'une quelconque des revendications 1 à 12, caractérisé en ce que le corps de base (8) se compose d'un matériau qui présente une dureté Shore D de 30 à 100, de préférence une dureté Shore D de 40 à 85 selon DIN ISO 7619-1:2010, et/ou le corps de base (8) se compose de polypropylène (PP) ou de polyéthylène haute densité (HDPE).
- Bouchon (1) selon l'une quelconque des revendications 1 à 13, caractérisé en ce que le corps de base (8) et/ou le corps d'étanchéité (7) et/ou le bouchon (1) sont symétriques par rapport à un axe de symétrie (18) et/ou un plan de symétrie s'étendant dans la direction axiale (Z).
- Bouchon (1) selon l'une quelconque des revendications 1 à 14, caractérisé en ce qu'il s'agit d'un bouchon (1) fabriqué au moyen d'un procédé de moulage par injection à plusieurs composants, en particulier d'un procédé de moulage par injection à deux composants ou à trois composants.
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP16202437.6A EP3333523B1 (fr) | 2016-12-06 | 2016-12-06 | Bouchon de récipient destiné à être utilisé lors de la lyophilisation |
US16/466,466 US11434050B2 (en) | 2016-12-06 | 2017-09-26 | Stopper for a container for use in freeze-drying processes, and assembly of a stopper and a container |
PCT/EP2017/074314 WO2018103906A1 (fr) | 2016-12-06 | 2017-09-26 | Bouchon pour un récipient destiné à être utilisé lors de la cryodessiccation et arrangement d'un bouchon et d'un récipient |
EP17769107.8A EP3384219B1 (fr) | 2016-12-06 | 2017-09-26 | Bouchon de récipient destiné à être utilisé lors de la lyophilisation |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP16202437.6A EP3333523B1 (fr) | 2016-12-06 | 2016-12-06 | Bouchon de récipient destiné à être utilisé lors de la lyophilisation |
Publications (2)
Publication Number | Publication Date |
---|---|
EP3333523A1 EP3333523A1 (fr) | 2018-06-13 |
EP3333523B1 true EP3333523B1 (fr) | 2019-09-04 |
Family
ID=57530510
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP16202437.6A Active EP3333523B1 (fr) | 2016-12-06 | 2016-12-06 | Bouchon de récipient destiné à être utilisé lors de la lyophilisation |
EP17769107.8A Active EP3384219B1 (fr) | 2016-12-06 | 2017-09-26 | Bouchon de récipient destiné à être utilisé lors de la lyophilisation |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP17769107.8A Active EP3384219B1 (fr) | 2016-12-06 | 2017-09-26 | Bouchon de récipient destiné à être utilisé lors de la lyophilisation |
Country Status (3)
Country | Link |
---|---|
US (1) | US11434050B2 (fr) |
EP (2) | EP3333523B1 (fr) |
WO (1) | WO2018103906A1 (fr) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11957790B1 (en) | 2022-01-31 | 2024-04-16 | Thomas John Harkins, JR. | Combination lyophilization and dispensing syringe assembly and methods of using same |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP3333523B1 (fr) | 2016-12-06 | 2019-09-04 | KISIKO Kirchner, Simon & Co. GmbH | Bouchon de récipient destiné à être utilisé lors de la lyophilisation |
US11345505B2 (en) * | 2020-08-19 | 2022-05-31 | Innovative Distilling Technologies, Inc. | Capped barrel system and methods |
US20240083645A1 (en) * | 2023-08-02 | 2024-03-14 | Huacheng Li | Container sealing plug and container |
Family Cites Families (17)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US2889951A (en) * | 1954-10-22 | 1959-06-09 | Bunder Glas G M B H | Bottle closures |
US2820564A (en) * | 1956-06-11 | 1958-01-21 | Coty Inc | Bottle neck stoppers |
US2927709A (en) * | 1959-07-07 | 1960-03-08 | Faultless Rubber Co | Bottle stopple |
US3292342A (en) * | 1964-01-16 | 1966-12-20 | Copiague Res And Dev Company | Device for vacuum sealing |
FR1479255A (fr) * | 1965-11-25 | 1967-05-05 | Bouchon pour récipients tels que flacons ou analogues | |
DE1942347A1 (de) | 1969-08-20 | 1971-03-04 | Wimmer Pharma Gummi Gmbh | Stopfen fuer Flaschen,bei denen eine Gefriertrocknung vorgenommen wird |
US4040421A (en) * | 1975-04-04 | 1977-08-09 | Becton, Dickinson And Company | Hypodermic syringe and attached needle assembly |
US4306357A (en) * | 1978-06-05 | 1981-12-22 | Merck & Co., Inc. | Tamperproof container |
DE3736343C2 (de) | 1987-10-27 | 1996-07-18 | Wasserburger Arzneimittelwerk | Injektionsspritze |
CA2006584C (fr) * | 1988-12-27 | 1998-11-10 | Gabriel Meyer | Flacon de stockage et de transfert pour stocker un composant d'une substance medicamenteuse |
US5377854A (en) * | 1993-04-16 | 1995-01-03 | International Technidyne Corp. | Stopper apparatus for a test tube or similar article |
US5596814A (en) * | 1995-11-06 | 1997-01-28 | W. L. Gore & Associates, Inc. | Vented vial stopper for processing freeze-dried products |
US5689895A (en) * | 1996-10-31 | 1997-11-25 | S.P. Industries, Inc., The Virtis Division | Probe positioning device for a flask freeze drying |
JPH1147234A (ja) | 1997-07-29 | 1999-02-23 | Naniwa Rubber Kogyo Kk | 医療用ゴム栓 |
DE202011050413U1 (de) | 2011-06-10 | 2012-09-11 | Helvoet Pharma Belgium N.V. | Kolbenstopfen für eine Lyophilisations-Einheit |
US9199768B1 (en) | 2015-02-11 | 2015-12-01 | Ryan M. Casey | Two-piece stopper |
EP3333523B1 (fr) | 2016-12-06 | 2019-09-04 | KISIKO Kirchner, Simon & Co. GmbH | Bouchon de récipient destiné à être utilisé lors de la lyophilisation |
-
2016
- 2016-12-06 EP EP16202437.6A patent/EP3333523B1/fr active Active
-
2017
- 2017-09-26 EP EP17769107.8A patent/EP3384219B1/fr active Active
- 2017-09-26 WO PCT/EP2017/074314 patent/WO2018103906A1/fr active Application Filing
- 2017-09-26 US US16/466,466 patent/US11434050B2/en active Active
Non-Patent Citations (1)
Title |
---|
None * |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11957790B1 (en) | 2022-01-31 | 2024-04-16 | Thomas John Harkins, JR. | Combination lyophilization and dispensing syringe assembly and methods of using same |
Also Published As
Publication number | Publication date |
---|---|
EP3333523A1 (fr) | 2018-06-13 |
US11434050B2 (en) | 2022-09-06 |
EP3384219B1 (fr) | 2020-11-18 |
WO2018103906A1 (fr) | 2018-06-14 |
US20190389630A1 (en) | 2019-12-26 |
EP3384219A1 (fr) | 2018-10-10 |
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