EP3333523A1 - Stopper for a container for use in freeze drying - Google Patents
Stopper for a container for use in freeze drying Download PDFInfo
- Publication number
- EP3333523A1 EP3333523A1 EP16202437.6A EP16202437A EP3333523A1 EP 3333523 A1 EP3333523 A1 EP 3333523A1 EP 16202437 A EP16202437 A EP 16202437A EP 3333523 A1 EP3333523 A1 EP 3333523A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- plug
- sealing body
- base body
- sealing
- container
- 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.)
- Granted
Links
- 238000004108 freeze drying Methods 0.000 title claims abstract description 25
- 238000007789 sealing Methods 0.000 claims abstract description 117
- 238000003780 insertion Methods 0.000 claims abstract description 41
- 230000037431 insertion Effects 0.000 claims abstract description 41
- 239000000463 material Substances 0.000 claims abstract description 35
- 230000004888 barrier function Effects 0.000 claims description 18
- 230000000903 blocking effect Effects 0.000 claims description 16
- 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
- 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 B65D39/0058Â -Â 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
Definitions
- the invention relates to a plug for a container for use in freeze-drying, also referred to as lyophilization.
- a solution with appropriate ingredients is first prepared and this solution then dried in a freeze dryer.
- the solution is an aqueous solution.
- the solution is first filled into a container, for example a glass cuvette or glass bottle.
- a plug is usually inserted into the container in order to completely close it for freeze-drying or after freeze-drying.
- the plug is designed such that the freeze-drying process, a gas exchange between the container interior and the environment is possible. This can be achieved, for example, in that the plug in the process of Freeze-drying is only partially inserted into the container, and thus the container is not yet sealed. In this way, during the freeze-drying process, the solvent may be removed from the solution to dry the ingredients of the solution. Following the freeze-drying process, the plug is typically pushed further into the container with the aid of a device formed in the lyophilizer, so that the bottle is then sealed tightly thereafter. Often, a fuse closure is then attached to the container to secure the plug. This securing closure may be, for example, a crimp cap or a screw cap.
- a plug for use in a freeze-drying process is known, for example, from the document DE 20 2011 050 413 U1 known.
- the piston plug has an upper side and a lower side, with the lower side facing the upper side in an axial direction.
- the piston plug has, in the area of the underside, at least one outwardly open, open cavity for gas exchange during freeze-drying, which is open in an axial direction downwards and in a radial direction.
- the stoppers currently used in the field of freeze-drying also referred to as lyophilization stoppers or freeze-drying stoppers, are generally produced from a butyl rubber, also referred to as butyl rubber, for example bromobutyl rubber or chlorobutyl rubber.
- a butyl rubber also referred to as butyl rubber
- bromobutyl rubber or chlorobutyl rubber for example bromobutyl rubber or chlorobutyl rubber.
- freeze-drying stoppers are known, which are formed in two parts, wherein the two parts of the plug are made of different materials.
- a plug having the features of the preamble of claim 1 is known from the document DE 1 942 347 A known.
- the plug has an insertable into the container insertable portion, wherein the insertion portion has a side surface and a bottom surface, wherein the bottom surface of a top surface the plug is formed opposite in an axial direction of the plug.
- the insertion section in turn has a sealing portion and a contact portion, wherein the abutment portion has a passage opening for a gas exchange, said passage opening extending from the side surface in the bottom surface.
- the stopper on a sealing body and a base body, which are interconnected.
- the sealing body is formed by an upper part of the plug and the base body is formed by a lower part of the plug, wherein the upper part consists of a different material than the lower part.
- the object of the present invention is to develop a plug having the features of the preamble of patent claim 1 in such a way that the plug nevertheless has a particularly good sealing property and / or barrier property and / or chemical resistance with lower material costs and lower production costs.
- the plug should be designed so that can be dispensed with a use of butyl rubber and thus on a vulcanization of the plug.
- the invention proposes a plug, which is formed according to the features of claim 1.
- the plug according to the invention is designed such that outer surfaces of the sealing body form the side surface and the bottom surface of the insertion section. Furthermore, the base body is formed in the region of the insertion section within the sealing body, wherein the base body consists of a material which has a higher hardness than a material of which the sealing body consists.
- a wall thickness of the sealing body and the base body relative to the total extent of the plug is reduced.
- the reduction of the wall thickness of the sealing body by the formation of the base body within the sealing body leads to a reduction of the material requirement for the sealing body, whereby the manufacturing costs are reduced, as for the base body can be used in comparison to the material of the sealing body more cost-effective material.
- the sealing body which comes into contact with the container and the contents of the container may be made of a material each having the desired material properties, for example the necessary elasticity, chemical resistance and / or barrier property to that in the substance stored in the container or the substances stored in the container and / or the solvent used in the solution. Also, contamination of the contents of the container by substances from the environment, such as oxygen, can be avoided or at least reduced by an appropriate choice of material.
- the base body can be made of a less expensive material, for example polypropylene (PP).
- PP polypropylene
- the plug is stiffened in the interior of the sealing portion, whereby the sealing effect of the plug despite reducing the wall thickness of the sealing body against a stopper which consists of a solid material in the region of the sealing portion, is approximately equal or even increased.
- the barrier property of the plug can be adjusted by adapting the material of the basic body.
- the formation of the plug with a formed inside the sealing body body made of a harder material also with regard to a manufacturing process of the plug to be considered advantageous.
- material of the sealing body and the base of the plug by means of a multi-component injection molding process, in particular by means of a two-component injection molding process can be produced by the harder against the sealing body a ejector during removal from an injection molding tool not exclusively in soft material which facilitates demolding and avoids damaging the plug in the demoulding process.
- the blocking effect of the plug to be stored in the container materials and / or the ambient atmosphere can be adjusted in a simple manner.
- the sealing body and the base body are connected directly to each other. It is therefore not intended to glue these together.
- the sealing body and the base body are connected to one another directly by material engagement.
- These direct, in particular direct cohesive connection between the sealing body and the main body these are inextricably linked, whereby the plug is quasi one piece. Due to the quasi-one-piece design of the plug, the use of the plug, in particular with regard to an automated freeze-drying method in which the mechanical insertion of the plug is automated, is facilitated.
- the sealing body from the body dissolves and example, the sealing body remains in the process of opening the container in the container or it during insertion of the Stopfens by a relative movement of the sealing body to the base body to a bead formation on the sealing body comes, which adversely affects the sealing effect of the plug.
- the cohesive connection preferably takes place without an additional method step in that the sealing body is injection-molded onto the base body or the base body is injection-molded onto the sealing body by means of an injection molding method.
- the sealing body has a circular cross-section in the region of the sealing section.
- a ratio of an outer radius of the annulus to an inner radius of the annulus is 1.1 to 2.5.
- the plug has a blocking body or a barrier layer.
- a blocking body or a barrier layer By means of the blocking body or the barrier layer, for example, a diffusion of oxygen through the stopper into the interior of the container can be prevented or at least reduced.
- the material of the blocking body or the barrier layer may be, for example, a plastic, for example vinyl alcohol copolymer (EVOH), or aluminum, in particular an aluminum foil.
- the barrier layer and / or the blocking body forms the top surface.
- the blocking body and / or the barrier layer is preferably formed between the main body and the sealing body. As a result, the barrier layer or the blocking body is particularly well protected against damage from external forces.
- the blocking body or the barrier layer is materially connected to the base body and / or materially connected to the sealing body.
- an outer surface of the base body forms the top surface of the plug, wherein the top surface covers the sealing body in the axial direction.
- the stopper has a cover section adjoining the insertion section in the axial direction, the cover section having the cover surface and wherein a radial dimension of the cover section is at least as great, in particular larger, than the radial dimension of the introductory section.
- the embodiment of the cover section with a larger radial dimension is to be regarded as advantageous in that is limited by the cover the insertion depth of the plug into the container.
- an outer surface of the sealing body forms a bearing surface of the cover section facing away from the cover surface. This bearing surface comes into contact with the outer surface of the container during insertion of the stopper into the container, whereby this bearing surface contributes to the sealing effect of the stopper.
- the base body in the region of the cover portion has a first projection formed in the radial direction, wherein the first projection is designed in particular as a circumferential first projection.
- This projection may serve to hold the plug in an additional closure attachable to the container.
- This closure may be, for example, a crimp cap or a screw cap.
- an additional closure is attached to the container following the freeze-drying process to secure the plug. It is quite conceivable that the complete insertion of the plug into the container takes place by attaching the closure to the container.
- the holding of the plug in the closure can be effected, for example, by a partial region of the closure having the first projection on the container engages behind facing, for example, the first projection is disposed in an undercut of the closure.
- the connection between the closure and the plug ensures that the plug is pulled out of the container when the closure is removed from the container, for example when unscrewing a closure designed as a rotary closure.
- the base body in an advantageous embodiment of the plug covers the sealing body in the region of the cover radially outward at least partially.
- the base body in the area of the cover section, has a second projection formed radially on the outside, extending from the cover surface in the direction of the bottom surface, the second projection at least partially covering the sealing element radially outside in the region of the cover section.
- the sealing body is radially enclosed by the second projection.
- a partial region of the sealing body extending from the bottom surface in the direction of the top surface is radially enclosed by the base body.
- the base body has a through channel extending from the top surface in the direction of the bottom surface.
- This passage allows, for example, by means of a syringe or the like to remove contents from the container without removing the plug from the container.
- a needle or the like can be introduced into the through-channel, whereby the bottom surface of the sealing body is pierced in the region adjacent to the through-channel and thus the contents of the container become accessible.
- a partial region of the sealing body extending from the bottom surface in the direction of the top surface is formed in the through-channel.
- the design of the base body with a passage is also to be regarded as advantageous with respect to a production of the plug by injection molding.
- a main body can be injection-molded with a through-channel and subsequently the sealing body can be injection-molded from the side facing the top surface through the through-channel to the main body.
- the through-channel is formed centrally in the base body, whereby shape tolerances, in particular with regard to the roundness of the sealing body, can be reduced.
- the sealing body has a recess, wherein the recess forms the passage opening for the gas exchange.
- the sealing body consists of a material having a hardness of Shore A 40 to 80, preferably a hardness of Shore A 50 to 70, according to the standard DIN ISO 7619-1: 2010 and / or the sealing body of a thermoplastic elastomer (TPE) exists.
- TPE thermoplastic elastomer
- the base body consists of a material which has a hardness of Shore D 30 to 100, preferably a hardness of Shore D 40 to 85 according to DIN ISO 7619-1: 2010 and / / or the base body is made of polypropylene (PP) or high-density polyethylene (HDPE).
- PP polypropylene
- HDPE high-density polyethylene
- the base body and / or the sealing body and / or the plug is symmetrical, in particular radially symmetrical, to an axis of symmetry and / or plane of symmetry running in the axial direction.
- the plug is a plug made by a multi-component injection molding process, preferably by a two-component or a three-component injection molding process.
- Fig. 1 and 2 illustrate the upper end of a container 18 and a first embodiment of a plug 1 for use in a freeze-drying process.
- FIG. 1 an arrangement of the container 18 and the plug 1 is shown, in which an insertion portion 2 of the plug 1 is partially inserted in a neck 19 of the container 18.
- the Fig. 2 shows an arrangement of the container 18 and the plug 1, in which the insertion portion 2 of the plug 1 is fully inserted into the container neck 19 of the container 18 and a cover portion 10 of the plug 1 abuts an outer surface 20 of the container neck 19.
- the insertion section 2 has a side surface 3 and a bottom surface 4, the bottom surface 4 of a cover surface 5 formed in the region of the cover 10 of the plug 1 in an axial direction Z of the plug 1 is formed opposite.
- the insertion section 2 has a sealing section 16 and a contact section 17 on, wherein the abutment portion 17 has four passage openings 6 for a gas exchange, wherein the passage openings 6 are identical and each formed in the form of a recess 6.
- the respective recess 6 extends from the side surface 3 in the bottom surface 4 and thus allows in a state in which the insertion section 2 of the plug 1 is only partially inserted into the container 18, a gas exchange between the interior of the container 18 and the environment. This condition is in the Fig.
- abutment portion 17 of the plug 1 is partially formed outside the container neck 19, wherein the located outside of the container 18 portion of the abutment portion 17 has a in a radial direction Y open portion of the respective passage opening 6 and in this way a gas exchange between the container interior and the environment is possible. Consequently, in this, in the Fig. 1 state shown a freeze-drying of a stored in the container 18 solution possible.
- the plug 1 has a sealing portion 16 adjacent to the abutment portion 17 in the direction of the top surface 5, the sealing portion 16 abutting the inner surface 21 of the container neck 19 in a state in which the insertion portion 2 is fully inserted into the container 18 thus sealing the container 18 sealing.
- the plug 1 As in particular the sectional view of Fig. 6 can be seen, the plug 1, a sealing body 7 and a base body 8, wherein outer surfaces of the sealing body 7, the side surface 3 and the bottom surface 4 of the insertion section 2 form.
- the main body 8 is formed in the region of the insertion section 2 within the sealing body 7, whereby only the sealing body 7 comes into contact with the inner surface 21 of the container 18 and the interior of the container 18.
- the sealing body 7 and the base body 8 are materially connected to each other. Due to the cohesive connection of the sealing body 7 and the base body 8 are permanently connected to each other, so that the plug 1 is formed quasi one piece.
- the cohesive connection is preferably produced by a multi-component injection molding process, in particular a two-component injection molding process.
- the main body 8 and the sealing body 7 are made of different materials, wherein the base body 8 consists of a material which has a higher hardness than a material of which the sealing body 7 consists.
- the sealing body 7 has in the region of the sealing portion 16 has a circular cross-section, wherein an outer radius R of the annulus is approximately twice an inner radius r of the annulus.
- the sealing body 7 and the main body 8 are partially formed in the cover portion 10, wherein an outer surface of the base body 8 forms the top surface 5 and the top surface 5, the sealing body 7 in the axial direction Z covers.
- the cover portion 10 has a radial dimension which is greater than a radial dimension of the insertion section 2.
- support surface 11 of the cover 10 is located on the outer surface 20 of the container 18 at. This support surface 11 of the cover 10 is formed by an outer surface of the sealing body 7.
- Both the base body 8 and the sealing body 7 of the plug 1 are formed radially symmetrical to an axis of symmetry 18 of the plug 1 extending in the axial direction Z.
- the main body 8 is cylindrical both in the region of the insertion section 2 and substantially cylindrical in the region of the cover section 10, wherein the main body 8 in the region of the cover section 10 has a larger diameter than in the region of the insertion section 2.
- the main body 8 has a circumferential first projection 12 formed in the radial direction.
- This first projection 12 may, for example, serve to hold the plug 1 in an additional closure attachable to the container 18.
- the base body 8 covers in the in the 8 to 11 shown second embodiment of the plug 1, the sealing body 7 in the region of the cover portion 10 radially on the outside partially.
- the base body 8 in the region of the cover 10 has a radially outwardly extending, extending from the top surface 5 in the direction of the bottom surface 4 second projection 13, wherein the second projection 13, the sealing body 7 in the region of the cover 10 radially outward partially covering.
- the plug 1 differs from that in the Fig. 8 and 9 embodiment shown essentially in that the plug 1 has formed between the base body 8 and the sealing body 7 blocking body 9 in the form of a barrier layer 9 in order to improve the blocking effect of the plug 1, for example against oxygen diffusion.
- the barrier layer 9 and / or the blocking body 9 may for example consist of ethylene-vinyl alcohol copolymer (EVOH) or aluminum.
- EVOH ethylene-vinyl alcohol copolymer
- the locking body 9 and / or the barrier layer 9 is materially connected to the base body 8 and / or materially connected to the sealing body 7.
- Such a plug 1 can be produced for example by means of a three-component injection molding process. But it is also quite conceivable that the blocking body 9 and / or the barrier layer 9 between the base body 8 and the sealing body 7 is clamped or positively held.
- the base body 8 has a extending from the top surface 5 in the direction of the bottom surface 4, the central passageway 15, wherein a from the bottom surface 4 in the direction of the top surface 5 extending portion 14 of the sealing body 7 is formed in the passage 15, whereby the base 8 surrounds this portion 14 of the sealing body 7 radially.
- the passageway 15 allows removal of the contents of the container without removal of the plug 1 from the container 18, for example, by inserting a needle into the passage 15 and the sealing body 7 is pierced in the insertion of the needle.
- such an embodiment of the plug 1 is particularly simple and inexpensive to produce by first the main body 8, for example by means of an injection molding process is prepared and then the sealing body 7 is molded onto the base body 8, wherein the injection molding of the sealing body 7 through the passage 15 of the main body 8 takes place. Due to the centrally formed passage 15 and thus the central gating of the sealing body 7 to the main body 8 also shape tolerances of the plug 1 are reduced.
- the exemplary embodiments of the plug 1 illustrated in the figures have a conical outer contour in a region of the contact section 17 which has the bottom surface 4.
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- 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)
Abstract
Die Erfindung betrifft einen Stopfen (1) für einen Behälter zur Verwendung bei Gefriertrocknung, auch als Lyophilisation bezeichnet. Der Stopfen (1) weist einen in den Behälter einführbaren Einführabschnitt (2) auf, wobei der Einführabschnitt (2) eine Seitenfläche (3) und eine Bodenfläche (4) aufweist, wobei die Bodenfläche (4) einer Deckfläche (5) des Stopfens (1) in einer axialen Richtung (Z) des Stopfens (1) gegenüberliegend ausgebildet ist. Der Einführabschnitt (2) weist wiederum einen Dichtabschnitt (16) und einen Anlageabschnitt (17) auf, wobei der Anlageabschnitt (17) eine Durchlassöffnung (6) für einen Gasaustausch aufweist, wobei sich diese Durchlassöffnung (6) von der Seitenfläche (3) in die Bodenfläche (4) erstreckt. Der Stopfen (1) weist einen Dichtkörper (7) auf, wobei Außenflächen des Dichtkörpers (7) die Seitenfläche (3) und die Bodenfläche (4) des in den Behälter einführbaren Einführabschnitts (2) bilden. Des Weiteren weist der Stopfen (1) einen Grundkörper (8) auf, wobei der Grundkörper (8) im Bereich des Einführabschnitts (2) innerhalb des Dichtkörpers (7) ausgebildet ist. Der Grundkörper (8) und der Dichtkörper (7) sind miteinander verbunden. Der Grundkörper (8) besteht aus einem Material, das eine höhere Härte aufweist als ein Material, aus dem der Dichtkörper (7) besteht.The invention relates to a plug (1) for a container for use in freeze-drying, also referred to as lyophilization. The stopper (1) has an insertion section (2) insertable into the container, the insertion section (2) having a side surface (3) and a bottom surface (4), the bottom surface (4) being a top surface (5) of the stopper (5). 1) in an axial direction (Z) of the plug (1) is formed opposite. The insertion section (2) in turn has a sealing section (16) and a contact section (17), wherein the contact section (17) has a passage opening (6) for a gas exchange, said passage opening (6) from the side surface (3) the bottom surface (4) extends. The plug (1) has a sealing body (7), wherein outer surfaces of the sealing body (7) form the side surface (3) and the bottom surface (4) of the insertable into the container insertion section (2). Furthermore, the plug (1) has a base body (8), wherein the base body (8) is formed in the region of the insertion section (2) within the sealing body (7). The base body (8) and the sealing body (7) are interconnected. The base body (8) consists of a material which has a higher hardness than a material of which the sealing body (7) consists.
Description
Die Erfindung betrifft einen Stopfen für einen Behälter zur Verwendung bei Gefriertrocknung, auch als Lyophilisation bezeichnet.The invention relates to a plug for a container for use in freeze-drying, also referred to as lyophilization.
Bei einem Verfahren zur Herstellung eines gefriergetrockneten Produkts, wie es häufig im Bereich der medizinischen Diagnostik, chemischen Analytik, Lebensmittel- und/oder Pharmaindustrie eingesetzt wird, um beispielsweise Diagnostika und/oder Arzneimittel herzustellen, wird zunächst eine Lösung mit entsprechenden Inhaltsstoffen hergestellt und diese Lösung anschließend in einer Gefriertrocknungsanlage getrocknet. Typischerweise handelt es sich bei der Lösung um eine wässrige Lösung. Meist wird die Lösung zunächst in einen Behälter, zum Beispiel eine Glasküvette oder Glasflasche, abgefüllt. Um eine Kontamination der Lösung bzw. des Behälterinneren beim Vorgang der Gefriertrocknung und/oder im Anschluss an die Gefriertrocknung zu verhindern, wird in der Regel ein Stopfen in den Behälter eingesteckt, um diesen zwecks Gefriertrocknung teilweise oder im Anschluss an die Gefriertrocknung vollständig zu verschließen.In a method for producing a freeze-dried product, as is often used in the field of medical diagnostics, chemical analysis, food and / or pharmaceutical industry, for example, to produce diagnostics and / or drugs, a solution with appropriate ingredients is first prepared and this solution then dried in a freeze dryer. Typically, the solution is an aqueous solution. Usually, the solution is first filled into a container, for example a glass cuvette or glass bottle. In order to prevent contamination of the solution or of the container interior during the process of freeze-drying and / or following freeze-drying, a plug is usually inserted into the container in order to completely close it for freeze-drying or after freeze-drying.
Der Stopfen ist dabei derart gestaltet, dass beim Gefriertrocknungsvorgang ein Gasaustausch zwischen dem Behälterinneren und der Umgebung möglich ist. Dies kann beispielsweise dadurch erreicht werden, dass der Stopfen beim Vorgang des Gefriertrocknens lediglich teilweise in den Behälter eingesteckt ist, und somit der Behälter noch nicht dicht verschlossen ist. Auf diese Weise kann während des Gefriertrocknungsprozesses das Lösungsmittel der Lösung entzogen werden, um die Inhaltsstoffe der Lösung zu trocknen. Im Anschluss an den Gefriertrocknungsprozess wird der Stopfen typischerweise mit Hilfe einer in der Gefriertrocknungsanlage ausgebildeten Vorrichtung weiter in den Behälter hineingeschoben, sodass die Flasche im Anschluss daran dicht verschlossen ist. Häufig wird im Anschluss daran zur Sicherung des Stopfens ein Sicherungsverschluss an dem Behälter angebracht. Bei diesem Sicherungsverschluss kann es sich beispielsweise um eine Bördelkappe oder einen Schraubverschluss handeln.The plug is designed such that the freeze-drying process, a gas exchange between the container interior and the environment is possible. This can be achieved, for example, in that the plug in the process of Freeze-drying is only partially inserted into the container, and thus the container is not yet sealed. In this way, during the freeze-drying process, the solvent may be removed from the solution to dry the ingredients of the solution. Following the freeze-drying process, the plug is typically pushed further into the container with the aid of a device formed in the lyophilizer, so that the bottle is then sealed tightly thereafter. Often, a fuse closure is then attached to the container to secure the plug. This securing closure may be, for example, a crimp cap or a screw cap.
Ein Stopfen zur Verwendung bei einem Gefriertrocknungsverfahren ist beispielsweise aus der Druckschrift
Die derzeit im Bereich der Gefriertrocknung eingesetzten Stopfen, auch als Lyophilisationsstopfen oder Gefriertrocknungsstopfen bezeichnet, werden in der Regel aus einem Butylkautschuk, auch als Butylgummi bezeichnet, beispielsweise Brombutylkautschuk oder Chlorbutylkautschuk, hergestellt. Die Herstellung des Stopfens als Gummiformteil ist relativ kostenintensiv, da zum einen die Materialkosten relativ hoch sind und zudem die Gummimischung in einer beheizten Form ausvulkanisieren muss, wodurch die Zykluszeiten und der Energiebedarf bei der Herstellung relativ hoch sind.The stoppers currently used in the field of freeze-drying, also referred to as lyophilization stoppers or freeze-drying stoppers, are generally produced from a butyl rubber, also referred to as butyl rubber, for example bromobutyl rubber or chlorobutyl rubber. The production of the plug as a rubber molded part is relatively expensive, since on the one hand, the material costs are relatively high and also must vulcanize the rubber mixture in a heated mold, whereby the cycle times and the energy consumption during production are relatively high.
Es sind auch Gefriertrocknungstopfen bekannt, die zweiteilig ausgebildet sind, wobei die beiden Teile des Stopfens aus unterschiedlichen Materialien hergestellt sind. Ein derartiger Stopfen, der die Merkmale des Oberbegriffs des Patentanspruchs 1 aufweist, ist aus der Druckschrift
Bei dem Stopfen gemäß der vorgenannten Druckschrift ist der Dichtkörper durch einen oberen Teil des Stopfens und der Grundkörper ist durch einen unteren Teil des Stopfens gebildet, wobei der obere Teil aus einem anderen Material als der untere Teil besteht.In the plug according to the aforementioned document, the sealing body is formed by an upper part of the plug and the base body is formed by a lower part of the plug, wherein the upper part consists of a different material than the lower part.
Aufgabe der vorliegenden Erfindung ist es, einen Stopfen, der die Merkmale des Oberbegriffs des Patentanspruchs 1 aufweist, derart weiterzubilden, dass der Stopfen bei geringeren Materialkosten und geringerem Fertigungsaufwand dennoch eine besonders gute Dichteigenschaft und/oder Sperreigenschaft und/oder chemische Resistenz aufweist. Insbesondere soll gemäß Weiterbildungen der Stopfen derart gestaltet sein, dass auf eine Verwendung von Butylkautschuk und somit auf ein Ausvulkanisieren des Stopfens verzichtet werden kann.The object of the present invention is to develop a plug having the features of the preamble of
Zur Lösung der vorgenannten Aufgabe schlägt die Erfindung einen Stopfen vor, der gemäß den Merkmalen des Patentanspruchs 1 ausgebildet ist.To achieve the above object, the invention proposes a plug, which is formed according to the features of
Der erfindungsgemäßen Stopfen ist derart gestaltet, dass Außenflächen des Dichtkörpers die Seitenfläche und die Bodenfläche des Einführabschnitts bilden. Ferner ist der Grundkörper im Bereich des Einführabschnitts innerhalb des Dichtkörpers ausgebildet, wobei der Grundkörper aus einem Material besteht, das eine höhere Härte aufweist als ein Material, aus dem der Dichtkörper besteht.The plug according to the invention is designed such that outer surfaces of the sealing body form the side surface and the bottom surface of the insertion section. Furthermore, the base body is formed in the region of the insertion section within the sealing body, wherein the base body consists of a material which has a higher hardness than a material of which the sealing body consists.
Durch diese Gestaltung des Stopfens ist eine Wandstärke des Dichtkörpers und des Grundkörpers gegenüber der Gesamtausdehnung des Stopfens reduziert. Insbesondere die Reduzierung der Wandstärke des Dichtkörpers durch die Ausbildung des Grundkörpers innerhalb des Dichtkörpers, führt zu einer Reduzierung des Materialbedarfs für den Dichtkörper, wodurch die Fertigungskosten reduziert werden, da für den Grundkörper ein im Vergleich zu dem Material des Dichtkörpers kostengünstigeres Material verwendet werden kann.By this design of the plug, a wall thickness of the sealing body and the base body relative to the total extent of the plug is reduced. In particular, the reduction of the wall thickness of the sealing body by the formation of the base body within the sealing body, leads to a reduction of the material requirement for the sealing body, whereby the manufacturing costs are reduced, as for the base body can be used in comparison to the material of the sealing body more cost-effective material.
Bei einer solchen Ausbildung des Stopfens kann der Dichtkörper, der mit dem Behälter und dem Inhalt des Behälters in Kontakt kommt, aus einem Material gefertigt werden, das jeweils die gewünschten Materialeigenschaften, zum Beispiel die notwendige Elastizität, chemische Resistenz und/oder Sperreigenschaft gegenüber dem in dem Behälter aufbewahrten Stoff oder den in dem Behälter aufbewahrten Stoffen und/oder dem verwendeten Lösungsmittel der Lösung aufweist. Auch kann durch eine entsprechende Materialwahl eine Kontamination des Inhalts des Behälters durch Stoffe aus der Umgebung, beispielsweise Sauerstoff, vermieden oder zumindest reduziert werden.In such a plug formation, the sealing body which comes into contact with the container and the contents of the container may be made of a material each having the desired material properties, for example the necessary elasticity, chemical resistance and / or barrier property to that in the substance stored in the container or the substances stored in the container and / or the solvent used in the solution. Also, contamination of the contents of the container by substances from the environment, such as oxygen, can be avoided or at least reduced by an appropriate choice of material.
Demgegenüber kann der Grundkörper aus einem kostengünstigeren Material, beispielsweise Polypropylen (PP), hergestellt werden. Mittels des in den Dichtkörper angeordneten Grundkörpers wird der Stopfen im Bereich des Dichtabschnitts im Inneren versteift, wodurch die Dichtwirkung des Stopfens trotz Reduzierung der Wandstärke des Dichtkörpers gegenüber einem Stopfen, der im Bereich des Dichtabschnitts aus einem Vollmaterial besteht, annähernd gleich oder sogar erhöht ist. Zudem kann durch eine Anpassung des Materials des Grundkörpers die Sperreigenschaft des Stopfens angepasst werden.In contrast, the base body can be made of a less expensive material, for example polypropylene (PP). By means of the body arranged in the sealing body, the plug is stiffened in the interior of the sealing portion, whereby the sealing effect of the plug despite reducing the wall thickness of the sealing body against a stopper which consists of a solid material in the region of the sealing portion, is approximately equal or even increased. In addition, the barrier property of the plug can be adjusted by adapting the material of the basic body.
Des Weiteren ist die Ausbildung des Stopfens mit einem innerhalb des Dichtkörpers ausgebildeten Grundkörper aus einem härteren Material auch hinsichtlich eines Herstellungsverfahrens des Stopfens als vorteilhaft anzusehen. Bei entsprechender Materialwahl des Dichtkörpers und des Grundkörpers kann der Stopfen mittels eines Mehr-Komponenten-Spritzgussverfahrens, insbesondere mittels eines Zwei-Komponenten-Spritzgussverfahrens hergestellt werden, wobei durch den gegenüber dem Dichtkörper härteren Grundkörper ein Auswerfer beim Entformen aus einem Spritzgusswerkzeug nicht ausschließlich in weiches Material drückt, wodurch das Entformen erleichtert und eine Beschädigung des Stopfens beim Vorgang des Entformens vermieden wird.Furthermore, the formation of the plug with a formed inside the sealing body body made of a harder material, also with regard to a manufacturing process of the plug to be considered advantageous. With appropriate choice of material of the sealing body and the base of the plug by means of a multi-component injection molding process, in particular by means of a two-component injection molding process can be produced by the harder against the sealing body a ejector during removal from an injection molding tool not exclusively in soft material which facilitates demolding and avoids damaging the plug in the demoulding process.
Weiterhin kann durch eine geeignete Wahl der Materialkombination von Material des Dichtkörpers und Material des Grundkörpers die Sperrwirkung des Stopfens an die in dem Behälter aufzubewahrenden Stoffe und/oder der Umgebungsatmosphäre in einfacher Art und Weise angepasst werden.Furthermore, by a suitable choice of material combination of material of Sealing body and material of the body, the blocking effect of the plug to be stored in the container materials and / or the ambient atmosphere can be adjusted in a simple manner.
Vorzugsweise sind der Dichtkörper und der Grundkörper unmittelbar miteinander verbunden. Es ist somit nicht vorgesehen diese miteinander zu verkleben. Insbesondere sind der Dichtkörper und der Grundkörper unmittelbar stoffschlüssig miteinander verbunden. Durch diese unmittelbare, insbesondere unmittelbare stoffschlüssige Verbindung zwischen dem Dichtkörper und dem Grundkörper sind diese unlösbar miteinander verbunden, wodurch der Stopfen quasi einteilig ist. Durch die quasi einteilige Ausbildung des Stopfens ist die Verwendung des Stopfens, insbesondere hinsichtlich eines automatisierten Gefriertrocknungsverfahrens, bei dem das mechanische Einführen des Stopfens automatisiert erfolgt, erleichtert. Durch die quasi einteilige Ausbildung wird vermieden, dass bei einer mechanischen Belastung des Stopfens, beispielsweise zwecks Öffnen oder Schließen des Behälters, sich der Dichtkörper von dem Grundkörper löst und beispielsweise der Dichtkörper beim Vorgang des Öffnens des Behälters in dem Behälter verbleibt oder es beim Einführen des Stopfens durch eine Relativbewegung des Dichtkörpers zum Grundkörper zu einer Wulstbildung an dem Dichtkörper kommt, die sich nachteilig auf die Dichtwirkung des Stopfens auswirkt.Preferably, the sealing body and the base body are connected directly to each other. It is therefore not intended to glue these together. In particular, the sealing body and the base body are connected to one another directly by material engagement. These direct, in particular direct cohesive connection between the sealing body and the main body these are inextricably linked, whereby the plug is quasi one piece. Due to the quasi-one-piece design of the plug, the use of the plug, in particular with regard to an automated freeze-drying method in which the mechanical insertion of the plug is automated, is facilitated. Due to the quasi one-piece design prevents that under mechanical loading of the plug, for example, to open or close the container, the sealing body from the body dissolves and example, the sealing body remains in the process of opening the container in the container or it during insertion of the Stopfens by a relative movement of the sealing body to the base body to a bead formation on the sealing body comes, which adversely affects the sealing effect of the plug.
Es ist auch denkbar, den Dichtkörper mit dem Grundkörper zu verschweißen.It is also conceivable to weld the sealing body to the base body.
Bevorzugt erfolgt die stoffschlüssige Verbindung ohne einen zusätzlichen Verfahrensschritt, indem der Dichtkörper an den Grundkörper oder der Grundkörper an den Dichtkörper mittels eines Spritzgussverfahrens angespritzt wird.The cohesive connection preferably takes place without an additional method step in that the sealing body is injection-molded onto the base body or the base body is injection-molded onto the sealing body by means of an injection molding method.
Insbesondere hinsichtlich einer Reduzierung des Materials des Dichtkörpers bei dennoch guter Dichteigenschaft des Stopfens wird es als besonders vorteilhaft angesehen, wenn der Dichtkörper im Bereich des Dichtabschnitts einen kreisförmigen Querschnitt aufweist. Vorzugsweise beträgt ein Verhältnis von einem Außenradius des Kreisrings zu einem Innenradius des Kreisrings 1,1 bis 2,5.In particular with regard to a reduction of the material of the sealing body with nevertheless good sealing property of the plug, it is considered to be particularly advantageous if the sealing body has a circular cross-section in the region of the sealing section. Preferably, a ratio of an outer radius of the annulus to an inner radius of the annulus is 1.1 to 2.5.
Um die Sperrwirkung des Stopfens gegenüber den in dem Behälter zu lagernden Stoffen und/oder der außerhalb des Behälters befindlichen Atmosphäre zu verbessern, ist in einer bevorzugten Ausführungsform des Stopfens vorgesehen, dass der Stopfen einen Sperrkörper oder eine Sperrschicht aufweist. Mittels des Sperrkörpers bzw. der Sperrschicht kann beispielsweise eine Sauersstoffdiffusion durch den Stopfen in das Innere des Behälters verhindert oder zumindest reduziert werden. Bei dem Material des Sperrkörpers bzw. der Sperrschicht kann es sich beispielsweise um einen Kunststoff, beispielsweise Vinylalkohol-Copolymer (EVOH), oder um Aluminium, insbesondere um eine Aluminiumfolie handeln.To the blocking effect of the plug relative to the stored in the container To improve fabrics and / or located outside of the container atmosphere is provided in a preferred embodiment of the plug, that the plug has a blocking body or a barrier layer. By means of the blocking body or the barrier layer, for example, a diffusion of oxygen through the stopper into the interior of the container can be prevented or at least reduced. The material of the blocking body or the barrier layer may be, for example, a plastic, for example vinyl alcohol copolymer (EVOH), or aluminum, in particular an aluminum foil.
Es ist durchaus denkbar, dass die Sperrschicht und/oder der Sperrkörper die Deckfläche bildet. Bevorzugt ist der Sperrkörper und/oder die Sperrschicht allerdings zwischen dem Grundkörper und dem Dichtkörper ausgebildet. Dadurch ist die Sperrschicht bzw. der Sperrkörper gegen eine Beschädigung durch von außen einwirkende Kräfte besonders gut geschützt.It is quite conceivable that the barrier layer and / or the blocking body forms the top surface. However, the blocking body and / or the barrier layer is preferably formed between the main body and the sealing body. As a result, the barrier layer or the blocking body is particularly well protected against damage from external forces.
In diesem Zusammenhang wird es als besonders vorteilhaft angesehen, wenn der Sperrkörper bzw. die Sperrschicht stoffschlüssig mit dem Grundkörper und/oder stoffschlüssig mit dem Dichtkörper verbunden ist.In this context, it is considered to be particularly advantageous if the blocking body or the barrier layer is materially connected to the base body and / or materially connected to the sealing body.
In einer bevorzugten Ausführungsform des Stopfens bildet eine Außenfläche des Grundkörpers die Deckfläche des Stopfens, wobei die Deckfläche den Dichtkörper in der axialen Richtung abdeckt. Dadurch ist zum einen die Handhabung des Stopfens durch die gegenüber dem Dichtkörper härtere Deckfläche erleichtert und zum anderen die wirksame Außenfläche des Stopfens, reduziert, da die Fläche des Dichtkörpers, die mit der Umgebungsluft in Kontakt kommt, durch die Abdeckung mittels der Deckfläche des Grundkörpers reduziert ist, wodurch bei geeigneter Wahl des Materials des Grundkörpers in Kombination mit der Wahl des Materials des Dichtkörpers eine Diffusion von Stoffen aus der Umgebung in den Behälter und/oder eine Diffusion von Stoffen aus dem Behälter in die Umgebung zumindest verringert werden kann.In a preferred embodiment of the plug, an outer surface of the base body forms the top surface of the plug, wherein the top surface covers the sealing body in the axial direction. As a result, on the one hand, the handling of the plug is facilitated by the opposite to the sealing body harder top surface and the other the effective outer surface of the plug, reduced because the surface of the sealing body, which comes into contact with the ambient air, reduced by the cover by means of the top surface of the body is, whereby a suitable choice of the material of the base body in combination with the choice of the material of the sealing body, a diffusion of substances from the environment into the container and / or a diffusion of substances from the container into the environment can be at least reduced.
Als besonders vorteilhaft wird es angesehen, wenn der Stopfen einen in der axialen Richtung an den Einführabschnitt angrenzenden Abdeckabschnitt aufweist, wobei der Abdeckabschnitt die Deckfläche aufweist und wobei eine radiale Abmessung des Abdeckabschnitts mindestens so groß, insbesondere größer ist als radiale Abmessung des Einführabschnitts.It is considered to be particularly advantageous if the stopper has a cover section adjoining the insertion section in the axial direction, the cover section having the cover surface and wherein a radial dimension of the cover section is at least as great, in particular larger, than the radial dimension of the introductory section.
Insbesondere die Ausführungsform des Abdeckabschnitts mit einer größeren radialen Abmessung ist dahingehend als vorteilhaft anzusehen, dass durch den Abdeckabschnitt die Einführtiefe des Stopfens in den Behälter limitiert ist. Beim Einführen des Stopfens mit einem gegenüber dem Einführabschnitt größeren Abdeckabschnitts kommt der gegenüber dem Einführabschnitt hervorstehende Bereich des Abdeckabschnitts in Anlage mit einer dem Abdeckabschnitt zugewandten Außenfläche des Behälters, wodurch das weitere Einschieben des Stopfens in den Behälter verhindert ist.In particular, the embodiment of the cover section with a larger radial dimension is to be regarded as advantageous in that is limited by the cover the insertion depth of the plug into the container. During insertion of the plug with a cover section which is larger than the insertion section, the region of the cover section protruding from the insertion section comes into contact with an outer surface of the container facing the cover section, thereby preventing further insertion of the plug into the container.
Des Weiteren ist durch einen Abdeckabschnitt mit einer größeren radialen Abmessung ein Entnehmen des Stopfens aus dem Behälter erleichtert, da durch den Abdeckabschnitt eine gut zugängliche Angriffsfläche an dem Stopfen gebildet ist.Furthermore, removal of the plug from the container is facilitated by a cover section having a larger radial dimension, since the cover section forms an easily accessible engagement surface on the plug.
Es wird als vorteilhaft angesehen, wenn eine Außenfläche des Dichtkörpers eine der Deckfläche abgewandte Auflagefläche des Abdeckabschnitts bildet. Diese Auflagefläche kommt beim Einführen des Stopfens in den Behälter mit der Außenfläche des Behälters in Kontakt, wodurch diese Auflagefläche zur Dichtwirkung des Stopfens beiträgt.It is considered advantageous if an outer surface of the sealing body forms a bearing surface of the cover section facing away from the cover surface. This bearing surface comes into contact with the outer surface of the container during insertion of the stopper into the container, whereby this bearing surface contributes to the sealing effect of the stopper.
In einer bevorzugten Ausführungsform des Stopfens weist der Grundkörper im Bereich des Abdeckabschnitts einen in radialer Richtung ausgebildeten ersten Vorsprung auf, wobei der erste Vorsprung insbesondere als umlaufender erster Vorsprung ausgebildet ist. Dieser Vorsprung kann dem Halten des Stopfens in einem an dem Behälter anbringbaren zusätzlichen Verschluss dienen. Bei diesem Verschluss kann es sich beispielsweise um eine Bördelkappe oder um einen Schraubverschluss handeln. Typischerweise wird ein solcher zusätzlicher Verschluss im Anschluss an das Gefriertrocknungsverfahren an dem Behälter angebracht, um den Stopfen zu sichern. Dabei ist es durchaus denkbar, dass das vollständige Einführen des Stopfens in den Behälter durch das Anbringen des Verschlusses an den Behälter erfolgt.In a preferred embodiment of the plug, the base body in the region of the cover portion has a first projection formed in the radial direction, wherein the first projection is designed in particular as a circumferential first projection. This projection may serve to hold the plug in an additional closure attachable to the container. This closure may be, for example, a crimp cap or a screw cap. Typically, such an additional closure is attached to the container following the freeze-drying process to secure the plug. It is quite conceivable that the complete insertion of the plug into the container takes place by attaching the closure to the container.
Das Halten des Stopfens in dem Verschluss kann beispielsweise dadurch erfolgen, dass ein Teilbereich des Verschlusses den ersten Vorsprung auf der dem Behälter zugewandten Seite hintergreift, beispielsweise der erste Vorsprung in einer Hinterschneidung des Verschlusses angeordnet ist. Durch die Verbindung zwischen dem Verschluss und dem Stopfen ist gewährleistet, dass der Stopfen beim Entfernen des Verschlusses von dem Behälter, beispielsweise beim Abschrauben eines als Drehverschluss ausgebildeten Verschlusses, aus dem Behälter herausgezogen wird.The holding of the plug in the closure can be effected, for example, by a partial region of the closure having the first projection on the container engages behind facing, for example, the first projection is disposed in an undercut of the closure. The connection between the closure and the plug ensures that the plug is pulled out of the container when the closure is removed from the container, for example when unscrewing a closure designed as a rotary closure.
Hinsichtlich der Verbindung zwischen dem Stopfen und dem Verschluss ist es durchaus denkbar, dass der Verschluss bereits vor dem Vorgang des Gefriertrocknens mit dem Stopfen verbunden wird.With regard to the connection between the plug and the closure, it is quite conceivable that the closure is already connected to the stopper before the process of freeze-drying.
Um die wirksame Außenfläche des Stopfens weiter zu reduzieren, deckt der Grundkörper in einer vorteilhaften Ausführungsform des Stopfens den Dichtkörper im Bereich des Abdeckabschnitts radial außen zumindest teilweise ab. Zu diesem Zweck weist der Grundkörper in einer bevorzugten Ausführungsform im Bereich des Abdeckabschnitts einen radial außen ausgebildeten, sich von der Deckfläche in Richtung der Bodenfläche erstreckenden zweiten Vorsprung auf, wobei der zweite Vorsprung den Dichtkörper im Bereich des Abdeckabschnitts radial außen zumindest teilweise abdeckt. Vorzugsweise wird der Dichtkörper von dem zweiten Vorsprung radial umschlossen.In order to further reduce the effective outer surface of the plug, the base body in an advantageous embodiment of the plug covers the sealing body in the region of the cover radially outward at least partially. For this purpose, in a preferred embodiment, in the area of the cover section, the base body has a second projection formed radially on the outside, extending from the cover surface in the direction of the bottom surface, the second projection at least partially covering the sealing element radially outside in the region of the cover section. Preferably, the sealing body is radially enclosed by the second projection.
In einer vorteilhaften Weiterbildung des Stopfens wird ein sich von der Bodenfläche in Richtung der Deckfläche erstreckender Teilbereich des Dichtkörpers von dem Grundkörper radial umschlossen. Dadurch wird die Kontaktfläche zwischen Dichtkörper und Grundkörper vergrößert, was sich vorteilhaft auf die Stabilität der Verbindung zwischen diesen auswirkt.In an advantageous development of the plug, a partial region of the sealing body extending from the bottom surface in the direction of the top surface is radially enclosed by the base body. As a result, the contact surface between the sealing body and the base body is increased, which has an advantageous effect on the stability of the connection between them.
Als besonders vorteilhaft wird es angesehen, wenn der Grundkörper einen sich von der Deckfläche in Richtung der Bodenfläche erstreckenden Durchgangskanal aufweist. Dieser Durchgangskanal ermöglicht es beispielsweise, mittels einer Spritze oder Ähnlichem, Inhalt aus dem Behälter zu entnehmen, ohne den Stopfen aus dem Behälter zu entfernen. Zu diesem Zweck kann eine Nadel oder Ähnliches in den Durchgangskanal eingeführt werden, wobei die Bodenfläche des Dichtkörpers im an den Durchgangskanal angrenzenden Bereich durchstochen und somit der Inhalt des Behälters zugänglich wird.It is considered to be particularly advantageous if the base body has a through channel extending from the top surface in the direction of the bottom surface. This passage allows, for example, by means of a syringe or the like to remove contents from the container without removing the plug from the container. For this purpose, a needle or the like can be introduced into the through-channel, whereby the bottom surface of the sealing body is pierced in the region adjacent to the through-channel and thus the contents of the container become accessible.
Es ist durchaus denkbar und bevorzugt, dass ein sich von der Bodenfläche in Richtung der Deckfläche erstreckender Teilbereich des Dichtkörpers in dem Durchgangskanal ausgebildet ist.It is entirely conceivable and preferred that a partial region of the sealing body extending from the bottom surface in the direction of the top surface is formed in the through-channel.
Die Ausbildung des Grundkörpers mit einem Durchgangskanal ist auch hinsichtlich einer Herstellung des Stopfens mittels Spritzgießens als vorteilhaft anzusehen. Beispielsweise kann zunächst ein Grundkörper mit einem Durchgangskanal spritzgegossen werden und im Anschluss daran der Dichtkörper von der der Deckfläche zugewandten Seite aus durch den Durchgangskanal hindurch an den Grundkörper angespritzt werden. Dadurch wird die erforderliche Werkzeugtechnik deutlich vereinfacht und das Werkzeug wird kostengünstiger, robuster und langlebiger. Dabei wird es als besonders vorteilhaft angesehen, wenn der Durchgangskanal zentral in dem Grundkörper ausgebildet ist, wodurch Formtoleranzen, insbesondere hinsichtlich der Rundheit des Dichtkörpers, reduziert werden können.The design of the base body with a passage is also to be regarded as advantageous with respect to a production of the plug by injection molding. For example, first of all a main body can be injection-molded with a through-channel and subsequently the sealing body can be injection-molded from the side facing the top surface through the through-channel to the main body. This significantly simplifies the required tooling technology and makes the tool less expensive, more robust and more durable. It is considered to be particularly advantageous if the through-channel is formed centrally in the base body, whereby shape tolerances, in particular with regard to the roundness of the sealing body, can be reduced.
Als besonders vorteilhaft wird es angesehen, wenn der Dichtkörper eine Ausnehmung aufweist, wobei die Ausnehmung die Durchlassöffnung für den Gasaustausch bildet.It is considered particularly advantageous if the sealing body has a recess, wherein the recess forms the passage opening for the gas exchange.
Vorzugsweise besteht der Dichtkörper aus einem Material, das eine Härte von Shore-A 40 bis 80, vorzugsweise eine Härte von Shore-A 50 bis 70, gemäß der Norm DIN ISO 7619-1: 2010 aufweist und/oder der Dichtkörper aus einem thermoplastischen Elastomer (TPE) besteht.Preferably, the sealing body consists of a material having a hardness of Shore A 40 to 80, preferably a hardness of Shore A 50 to 70, according to the standard DIN ISO 7619-1: 2010 and / or the sealing body of a thermoplastic elastomer (TPE) exists.
Hinsichtlich des Grundkörpers wird es als besonders vorteilhaft angesehen, wenn der Grundkörper aus einem Material besteht, das eine Härte von Shore-D 30 bis 100, vorzugsweise eine Härte von Shore-D 40 bis 85 gemäß DIN ISO 7619-1:2010 aufweist und/oder der Grundkörper aus Polypropylen (PP) oder High-Density-Polyethylen (HDPE) besteht.With regard to the main body, it is considered particularly advantageous if the base body consists of a material which has a hardness of Shore D 30 to 100, preferably a hardness of Shore D 40 to 85 according to DIN ISO 7619-1: 2010 and / / or the base body is made of polypropylene (PP) or high-density polyethylene (HDPE).
In einer vorteilhaften Weiterbildung des Stopfens ist der Grundkörper und/oder der Dichtkörper und/oder der Stopfen symmetrisch, insbesondere radiärsymmetrisch, zu einer in der axialen Richtung verlaufenden Symmetrieachse und/oder Symmetrieebene.In an advantageous development of the plug, the base body and / or the sealing body and / or the plug is symmetrical, in particular radially symmetrical, to an axis of symmetry and / or plane of symmetry running in the axial direction.
Vorzugsweise handelt es sich bei dem Stopfen um einen mittels eines Mehr-Komponenten-Spritzgussverfahrens, vorzugsweise mittels eines Zwei-Komponenten- oder eines Drei-Komponenten-Spritzgussverfahrens hergestellten Stopfen.Preferably, the plug is a plug made by a multi-component injection molding process, preferably by a two-component or a three-component injection molding process.
Weitere Merkmale der Erfindung sind in den Unteransprüchen, der Beschreibung der Figuren und den Figuren selbst dargestellt, wobei bemerkt wird, dass alle Einzelmerkmale und alle Kombinationen von Einzelmerkmalen erfindungswesentlich sind.Further features of the invention are set forth in the subclaims, the description of the figures and the figures themselves, wherein it is noted that all individual features and all combinations of individual features are essential to the invention.
In den Figuren ist die Erfindung anhand von Ausführungsbeispielen dargestellt, ohne hierauf beschränkt zu sein.In the figures, the invention is illustrated by means of embodiments, without being limited thereto.
Es zeigt:
- Fig. 1
- eine erste Ausführungsform eines Stopfens und einen Behälter in einer Anordnung, in der der Stopfen teilweise in den Behälter eingeführt ist, in einer Seitenansicht,
- Fig. 2
- der Stopfen und der Behälter gemäß
Fig. 1 in einer Anordnung, in der der Stopfen maximal weit in den Behälter eingeführt ist, in einer Seitenansicht, - Fig. 3
- der Stopfen gemäß
Fig. 1 in einer Ansicht gemäß dem Pfeil III inFig. 6 , - Fig. 4
- der Stopfen in einer Ansicht gemäß dem Pfeil IV in
Fig. 3 , - Fig. 5
- der Stopfen in einer Ansicht gemäß dem Pfeil V in
Fig. 3 , - Fig. 6
- der Stopfen in einer Schnittansicht gemäß der Linie VI-VI in
Fig. 3 , - Fig. 7
- der Stopfen in einer Schnittansicht gemäß der Linie VII-VII in
Fig. 3 , - Fig. 8
- eine zweite Ausführungsform des Stopfens in einer Ansicht gemäß dem Pfeil VIII in
Fig. 9 , - Fig. 9
- der Stopfen in einer Schnittansicht gemäß der Linie IX-IX in
Fig. 8 , - Fig. 10
- eine dritte Ausführungsform des Stopfens in einer Ansicht gemäß dem Pfeil X in
Fig. 11 , - Fig. 11
- der Stopfen in einer Schnittansicht gemäß der Linie XI-XI in
Fig. 10 , - Fig. 12
- eine vierte Ausführungsform des Stopfens in einer Ansicht gemäß dem Pfeil XII in
Fig. 13 , - Fig. 13
- der Stopfen in einer Schnittansicht gemäß der Linie XIII-XIII in
Fig. 12 , - Fig. 14
- der Stopfen in einer Ansicht gemäß dem Pfeil XIV in
Fig. 13 .
- Fig. 1
- a first embodiment of a plug and a container in an arrangement in which the plug is partially inserted into the container, in a side view,
- Fig. 2
- the stopper and the container according to
Fig. 1 in an arrangement in which the stopper is inserted maximally far into the container, in a side view, - Fig. 3
- the plug according to
Fig. 1 in a view according to the arrow III inFig. 6 . - Fig. 4
- the plug in a view according to the arrow IV in
Fig. 3 . - Fig. 5
- the plug in a view according to the arrow V in
Fig. 3 . - Fig. 6
- the plug in a sectional view along the line VI-VI in
Fig. 3 . - Fig. 7
- the plug in a sectional view along the line VII-VII in
Fig. 3 . - Fig. 8
- a second embodiment of the plug in a view according to the arrow VIII in
Fig. 9 . - Fig. 9
- the stopper in a sectional view along the line IX-IX in
Fig. 8 . - Fig. 10
- a third embodiment of the plug in a view according to the arrow X in
Fig. 11 . - Fig. 11
- the plug in a sectional view along the line XI-XI in
Fig. 10 . - Fig. 12
- a fourth embodiment of the plug in a view according to the arrow XII in
Fig. 13 . - Fig. 13
- the plug in a sectional view along the line XIII-XIII in
Fig. 12 . - Fig. 14
- the stopper in a view according to the arrow XIV in
Fig. 13 ,
Die
In der
Die
Der Einführabschnitt 2 weist eine Seitenfläche 3 und eine Bodenfläche 4 auf, wobei die Bodenfläche 4 einer im Bereich des Abdeckabschnitts 10 ausgebildeten Deckfläche 5 des Stopfens 1 in einer axialen Richtung Z des Stopfens 1 gegenüberliegend ausgebildet ist.The
Der Einführabschnitt 2 weist einen Dichtabschnitt 16 und einen Anlageabschnitt 17 auf, wobei der Anlageabschnitt 17 vier Durchlassöffnungen 6 für einen Gasaustausch aufweist, wobei die Durchlassöffnungen 6 identisch und jeweils in Form einer Ausnehmung 6 ausgebildet sind. Die jeweilige Ausnehmung 6 erstreckt sich von der Seitenfläche 3 in die Bodenfläche 4 und ermöglicht somit in einem Zustand, in dem der Einführabschnitt 2 des Stopfens 1 nur teilweise in den Behälter 18 eingeführt ist, einen Gasaustausch zwischen dem Innenraum des Behälters 18 und der Umgebung. Dieser Zustand ist in der
In dem in der
Der Stopfen 1 weist einen in Richtung der Deckfläche 5 an den Anlageabschnitt 17 angrenzenden Dichtabschnitt 16 auf, wobei der Dichtabschnitt 16 in einem Zustand, in dem der Einführabschnitt 2 vollständig in den Behälter 18 eingeschoben ist, umfänglich an der Innenfläche 21 des Behälterhalses 19 anliegt und somit den Behälter 18 dichtend verschließt.The
Wie insbesondere der Schnittansicht der
Der Grundkörper 8 ist im Bereich des Einführabschnitts 2 innerhalb des Dichtkörpers 7 ausgebildet, wodurch lediglich der Dichtkörper 7 mit der Innenfläche 21 des Behälters 18 und dem Innenraum des Behälters 18 in Kontakt kommt. Der Dichtkörper 7 und der Grundkörper 8 sind stoffschlüssig miteinander verbunden. Aufgrund der stoffschlüssigen Verbindung sind der Dichtkörper 7 und der Grundkörper 8 unlösbar miteinander verbunden, sodass der Stopfen 1 quasi einteilig ausgebildet ist. Bevorzugt wird die stoffschlüssige Verbindung durch ein Mehr-Komponenten-Spritzgussverfahren, insbesondere ein Zwei-Komponenten-Spritzgussverfahren, hergestellt.The
Der Grundkörper 8 und der Dichtkörper 7 bestehen aus unterschiedlichen Materialien, wobei der Grundkörper 8 aus einem Material besteht, das eine höhere Härte aufweist als ein Material, aus dem der Dichtkörper 7 besteht.The
Der Dichtkörper 7 weist im Bereich des Dichtabschnitts 16 einen kreisförmigen Querschnitt auf, wobei ein Außenradius R des Kreisrings ungefähr das Zweifache eines Innenradius r des Kreisrings beträgt.The sealing
Der Dichtkörper 7 und der Grundkörper 8 sind teilweise in dem Abdeckabschnitt 10 ausgebildet, wobei eine Außenfläche des Grundkörpers 8 die Deckfläche 5 bildet und die Deckfläche 5 den Dichtkörper 7 in der axialen Richtung Z abdeckt.The sealing
Um die Einführtiefe des Stopfens 1 in der axialen Richtung Z zu begrenzen sowie die Dichtwirkung des Stopfens 1 zu verbessern und die Entnahme des Stopfens 1 aus dem Behälter 18 zu erleichtern, weist der Abdeckabschnitt 10 eine radiale Abmessung auf, die größer ist als eine radiale Abmessung des Einführabschnitts 2. Im vollständig in dem Behälter 18 eingeführten Zustand des Stopfens 1 liegt somit eine der Deckfläche 5 abgewandte Auflagefläche 11 des Abdeckabschnitts 10 an der Außenfläche 20 des Behälters 18 an. Diese Auflagefläche 11 des Abdeckabschnitts 10 ist dabei durch eine Außenfläche des Dichtkörpers 7 gebildet.In order to limit the insertion depth of the
Sowohl der Grundkörper 8 als auch der Dichtkörper 7 des Stopfens 1 sind radiärsymmetrisch zu einer in der axialen Richtung Z verlaufenden Symmetrieachse 18 des Stopfens 1 ausgebildet.Both the
Der Grundkörper 8 ist sowohl im Bereich des Einführabschnitts 2 zylinderförmig und im Bereich des Abdeckabschnitts 10 im wesentlichen zylinderförmig ausgebildet, wobei der Grundkörper 8 im Bereich des Abdeckabschnitts 10 einen größeren Durchmesser aufweist als im Bereich des Einführabschnitts 2.The
Der Grundkörper 8 weist des Weiteren im Bereich des Abdeckabschnitts 10 einen in radialer Richtung ausgebildeten, umlaufenden ersten Vorsprung 12 auf. Dieser erste Vorsprung 12 kann beispielsweise dem Halten des Stopfens 1 in einem an dem Behälter 18 anbringbaren zusätzlichen Verschluss dienen.Furthermore, in the region of the
Um die wirksame Außenfläche des Stopfens 1 weiter zu reduzieren, deckt der Grundkörper 8 bei dem in den
Das in den
Das in den
Weiterhin ist eine derartige Ausführungsform des Stopfens 1 besonders einfach und kostengünstig herstellbar, indem zunächst der Grundkörper 8, beispielsweise mittels eines Spritzgussverfahrens, hergestellt wird und im Anschluss daran der Dichtkörper 7 an den Grundkörper 8 angespritzt wird, wobei das Anspritzen des Dichtkörpers 7 durch den Durchgangskanal 15 des Grundkörpers 8 erfolgt. Durch den zentral ausgebildeten Durchgangskanal 15 und die folglich zentrale Anspritzung des Dichtkörpers 7 an den Grundkörper 8 werden zudem Formtoleranzen des Stopfens 1 reduziert.Furthermore, such an embodiment of the
Um ein Einführen des Stopfens 1 zu erleichtern, weisen die in den Figuren dargestellten Ausführungsbeispiele des Stopfens 1 in einem die Bodenfläche 4 aufweisenden Bereich des Anlageabschnitts 17 eine konische Außenkontur auf.In order to facilitate insertion of the
- 11
- StopfenPlug
- 22
- Einführabschnittinsertion
- 33
- Seitenflächeside surface
- 44
- Bodenflächefloor area
- 55
- Deckflächecover surface
- 66
- DurchlassöffnungPort
- 77
- Dichtkörpersealing body
- 88th
- Grundkörperbody
- 99
- Sperrkörper/SperrschichtBlocking body / barrier
- 1010
- Abdeckabschnittcover
- 1111
- Anlageflächecontact surface
- 1212
- erster Vorsprungfirst advantage
- 1313
- zweiter Vorsprungsecond lead
- 1414
- Teilbereichsubregion
- 1515
- DurchgangskanalThrough channel
- 1616
- Dichtabschnittsealing portion
- 1717
- Anlageabschnittcontact section
- 1818
- Behältercontainer
- 1919
- Behälterhalscontainer neck
- 2020
- Außenflächeouter surface
- 2121
- Innenflächepalm
- YY
- radiale Richtungradial direction
- ZZ
- axiale Richtungaxial direction
Claims (15)
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP16202437.6A EP3333523B1 (en) | 2016-12-06 | 2016-12-06 | Stopper for a container for use in freeze drying |
EP17769107.8A EP3384219B1 (en) | 2016-12-06 | 2017-09-26 | Stopper for a container for use in freeze-drying |
PCT/EP2017/074314 WO2018103906A1 (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 |
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 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP16202437.6A EP3333523B1 (en) | 2016-12-06 | 2016-12-06 | Stopper for a container for use in freeze drying |
Publications (2)
Publication Number | Publication Date |
---|---|
EP3333523A1 true EP3333523A1 (en) | 2018-06-13 |
EP3333523B1 EP3333523B1 (en) | 2019-09-04 |
Family
ID=57530510
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP16202437.6A Active EP3333523B1 (en) | 2016-12-06 | 2016-12-06 | Stopper for a container for use in freeze drying |
EP17769107.8A Active EP3384219B1 (en) | 2016-12-06 | 2017-09-26 | Stopper for a container for use in freeze-drying |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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EP17769107.8A Active EP3384219B1 (en) | 2016-12-06 | 2017-09-26 | Stopper for a container for use in freeze-drying |
Country Status (3)
Country | Link |
---|---|
US (1) | US11434050B2 (en) |
EP (2) | EP3333523B1 (en) |
WO (1) | WO2018103906A1 (en) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
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EP3333523B1 (en) | 2016-12-06 | 2019-09-04 | KISIKO Kirchner, Simon & Co. GmbH | Stopper for a container for use in freeze drying |
US11345505B2 (en) * | 2020-08-19 | 2022-05-31 | Innovative Distilling Technologies, Inc. | Capped barrel system and methods |
US11957790B1 (en) | 2022-01-31 | 2024-04-16 | Thomas John Harkins, JR. | Combination lyophilization and dispensing syringe assembly and methods of using same |
US20240083645A1 (en) * | 2023-08-02 | 2024-03-14 | Huacheng Li | Container sealing plug and container |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR1479255A (en) * | 1965-11-25 | 1967-05-05 | Stopper for containers such as flasks or the like | |
DE1942347A1 (en) | 1969-08-20 | 1971-03-04 | Wimmer Pharma Gummi Gmbh | Stopper for bottles that are freeze-drying |
US4306357A (en) * | 1978-06-05 | 1981-12-22 | Merck & Co., Inc. | Tamperproof container |
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 |
DE202011050413U1 (en) | 2011-06-10 | 2012-09-11 | Helvoet Pharma Belgium N.V. | Piston stopper for a lyophilization unit |
Family Cites Families (11)
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 |
US4040421A (en) * | 1975-04-04 | 1977-08-09 | Becton, Dickinson And Company | Hypodermic syringe and attached needle assembly |
DE3736343C2 (en) * | 1987-10-27 | 1996-07-18 | Wasserburger Arzneimittelwerk | Hypodermic syringe |
CA2006584C (en) * | 1988-12-27 | 1998-11-10 | Gabriel Meyer | Storage and transfer bottle for storing a component of a medicinal substance |
US5377854A (en) * | 1993-04-16 | 1995-01-03 | International Technidyne Corp. | Stopper apparatus for a test tube or similar article |
JPH1147234A (en) * | 1997-07-29 | 1999-02-23 | Naniwa Rubber Kogyo Kk | Medical rubber cock |
US9199768B1 (en) * | 2015-02-11 | 2015-12-01 | Ryan M. Casey | Two-piece stopper |
EP3333523B1 (en) | 2016-12-06 | 2019-09-04 | KISIKO Kirchner, Simon & Co. GmbH | Stopper for a container for use in freeze drying |
-
2016
- 2016-12-06 EP EP16202437.6A patent/EP3333523B1/en active Active
-
2017
- 2017-09-26 US US16/466,466 patent/US11434050B2/en active Active
- 2017-09-26 EP EP17769107.8A patent/EP3384219B1/en active Active
- 2017-09-26 WO PCT/EP2017/074314 patent/WO2018103906A1/en active Application Filing
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR1479255A (en) * | 1965-11-25 | 1967-05-05 | Stopper for containers such as flasks or the like | |
DE1942347A1 (en) | 1969-08-20 | 1971-03-04 | Wimmer Pharma Gummi Gmbh | Stopper for bottles that are freeze-drying |
US4306357A (en) * | 1978-06-05 | 1981-12-22 | Merck & Co., Inc. | Tamperproof container |
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 |
DE202011050413U1 (en) | 2011-06-10 | 2012-09-11 | Helvoet Pharma Belgium N.V. | Piston stopper for a lyophilization unit |
Also Published As
Publication number | Publication date |
---|---|
US20190389630A1 (en) | 2019-12-26 |
WO2018103906A1 (en) | 2018-06-14 |
EP3333523B1 (en) | 2019-09-04 |
EP3384219B1 (en) | 2020-11-18 |
EP3384219A1 (en) | 2018-10-10 |
US11434050B2 (en) | 2022-09-06 |
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