Stopper for a container for use in freeze-drying processes, and assembly of a stopper and a container

Abstract

A stopper for a container and an assembly of a stopper and a container wherein the stopper has an insertion section configured for insertion into the container. The insertion section has a sealing section for closing the container in a sealing position of the stopper and a contact section for holding the stopper in a drying position of the stopper. The contact section has at least one passage opening for a gas exchange between an interior of the container and the surroundings of the container. The stopper has a sealing body and a main body connected together, wherein the main body has a higher degree of hardness than the sealing body. Regions of a lateral surface of the insertion section in contact with an inner surface of a container wall are formed by outer surfaces of the sealing body in the region of the contact section.

Claims

1. A stopper for a container for use in freeze-drying processes, wherein the stopper has an insertion section configured for insertion into the container, and the insertion section has a lateral surface and a bottom surface, wherein the bottom surface of the insertion section is configured opposite a top surface of the stopper in an axial direction of the stopper, and the insertion section has a sealing section for closing the container in a fluid-tight manner in a sealing position of the stopper and a contact section which adjoins the sealing section axially in the direction of the bottom surface of the insertion section for holding the stopper in a drying position of the stopper, wherein the contact section has at least one passage opening for a gas exchange between an interior of the container and the surroundings of the container, wherein the at least one passage opening extends from the lateral surface of the insertion section into the bottom surface of the insertion section and the stopper has a sealing body and a main body connected together, wherein outer surfaces of the sealing body in the region of the sealing section form the lateral surface of the insertion section and the main body is configured within the sealing body in the region of the sealing section, wherein the outer surfaces of the sealing body form the lateral surface of the insertion section and the bottom surface of the insertion section, wherein the bottom surface of the insertion section forms a continuous closed surface that encloses the main body such that the main body is sealed from the interior of the container, wherein the main body consists of a material which has a higher degree of hardness than a material which makes up the sealing body, wherein regions of the lateral surface of the insertion section in contact with an inner surface of a container wall of the container in the drying position and/or the sealing position are formed by the outer surfaces of the sealing body in the region of the contact section, and wherein the main body is configured within the sealing body in the region of the contact section.

2. The stopper as claimed in claim 1, wherein the outer surfaces of the sealing body form the lateral surface of the insertion section in the region of the contact section.

3. The stopper as claimed in claim 1, wherein the main body has an outer surface, wherein at least a partial region of the outer surface of the main body is not covered by the sealing body in the axial direction of the stopper.

4. The stopper as claimed in claim 3, wherein the outer surface of the main body forms at least a partial region of the top surface of the stopper.

5. The stopper as claimed in claim 1, wherein the sealing body and the main body are directly connected together by a material connection.

6. The stopper as claimed in claim 1, wherein an outer surface of the main body forms the top surface of the stopper and the top surface of the stopper covers the sealing body in the axial direction.

7. The stopper as claimed in claim 1, wherein the stopper has a cover section adjoining the insertion section in the axial direction, and wherein a radial dimension of the cover section is larger than a radial dimension of the insertion section.

8. The stopper as claimed in claim 7, wherein an outer surface of the sealing body forms a bearing surface of the cover section remote from the top surface of the stopper.

9. The stopper as claimed in claim 1, wherein the sealing body in the region of the sealing section has a circular cross section perpendicular to the axial direction of the stopper, and wherein a ratio of an external radius of the sealing body and an internal radius of the sealing body is from about 1.1 to about 2.5.

10. The stopper as claimed in claim 1, wherein the insertion section comprises at least one recess, and wherein the recess forms the at least one passage opening.

11. The stopper as claimed in claim 1, wherein the sealing body consists of a material which has a Shore A hardness of about 40 to about 80 according to DIN ISO 7619-1:2010 and/or the sealing body consists of a thermoplastic elastomer (TPE).

12. The stopper as claimed in claim 1, wherein the main body consists of a material which has a Shore D hardness of about 30 to about 100 according to DIN ISO 7619-1:2010 and/or the main body consists of polypropylene (PP) or high density polyethylene (HDPE).

13. The stopper as claimed in claim 1, wherein the contact section is free of regions protruding outwardly relative to the sealing section in a radial direction.

14. An assembly of a container and a stopper for use during freeze-drying processes, wherein the stopper is inserted into an opening of the container, the stopper has an insertion section configured to be inserted into the container, and the insertion section has a lateral surface and a bottom surface, wherein the bottom surface is configured opposite a top surface of the stopper in an axial direction of the stopper, and the insertion section has a sealing section for closing the container in a fluid-tight manner from the surroundings of the container in a sealing position of the stopper and a contact section which adjoins the sealing section axially in the direction of the bottom surface of the insertion section for holding the stopper in a drying position of the stopper during the freeze-drying processes, wherein the contact section has at least one passage opening for a gas exchange between an interior of the container and the surroundings of the container during the freeze-drying processes, wherein the at least one passage opening extends from the lateral surface of the insertion section into the bottom surface of the insertion section, and the stopper has a sealing body and a main body which are connected together, wherein outer surfaces of the sealing body in the region of the sealing section form the lateral surface of the insertion section and the main body is configured within the sealing body in the region of the sealing section, wherein the outer surfaces of the sealing body form the lateral surface of the insertion section and the bottom surface of the insertion section, wherein the bottom surface of the insertion section forms a continuous closed surface that encloses the main body such that the main body is sealed from the interior of the container, wherein the main body consists of a material which has a higher degree of hardness than a material which makes up the sealing body, wherein in the drying position of the stopper the sealing section is arranged outside the container, the contact section is in contact with an inner surface of a container wall of the container and the at least one passage opening opens into the interior of the container and into the surroundings, and wherein in the sealing position of the stopper the sealing section is arranged within the container and the sealing section is in contact in a peripheral manner with the inner surface of the container wall of the container, wherein regions of the lateral surface of the insertion section, which are in contact with the inner surface of the container wall of the container in the drying position and/or the sealing position, are formed by the outer surfaces of the sealing body in the region of the contact section, and wherein the main body is configured within the sealing body in the region of the contact section.

Description

BRIEF DESCRIPTION OF THE DRAWING FIGURES

(1) The invention is shown with reference to exemplary embodiments in the accompanying drawing figures, without being limited thereto.

(2) FIG. 1 shows a first embodiment of a stopper and a container in an assembly in which the stopper is partially inserted into the container, in a side view.

(3) FIG. 2 shows the stopper and the container according to FIG. 1 in an assembly in which the stopper is inserted to a maximum extent into the container, in a side view.

(4) FIG. 3 shows the stopper according to FIG. 1 in a view according to the arrow III in FIG. 6.

(5) FIG. 4 shows the stopper in a view according to the arrow IV in FIG. 3.

(6) FIG. 5 shows the stopper in a view according to the arrow V in FIG. 3.

(7) FIG. 6 shows the stopper in a sectional view according to the line VI-VI in FIG. 3.

(8) FIG. 7 shows the stopper in a sectional view according to the line VII-VII in FIG. 3.

(9) FIG. 8 shows a second embodiment of the stopper in a view according to the arrow VIII in FIG. 9

(10) FIG. 9 shows the stopper in a sectional view according to the line IX-IX in FIG. 8.

(11) FIG. 10 shows a third embodiment of the stopper in a view according to the arrow X in FIG. 11.

(12) FIG. 11 shows the stopper in a sectional view according to the line XI-XI in FIG. 10.

(13) FIG. 12 shows a fourth embodiment of the stopper in a view according to the arrow XII in FIG. 13.

(14) FIG. 13 shows the stopper in a sectional view according to the line XIII-XIII in FIG. 12.

(15) FIG. 14 shows the stopper in a view according to the arrow XIV in FIG. 13.

(16) FIG. 15 shows a fifth embodiment of the stopper in a view according to the arrow XV in FIG. 16.

(17) FIG. 16 shows the stopper in a sectional view according to the line XVI-XVI in FIG. 15.

(18) FIG. 17 shows a sixth embodiment of the stopper in a view according to the arrow XVII in FIG. 18.

(19) FIG. 18 shows the stopper in a sectional view according to the line XVIII-XVIII in FIG. 17.

(20) FIG. 19 shows a seventh embodiment of the stopper in a view according to the arrow XIX in FIG. 20.

(21) FIG. 20 shows the stopper in a sectional view according to the line XX-XX in FIG. 19.

(22) FIG. 21 shows the container according to FIG. 1 in a sectional view according to the line XXI-XXI in FIG. 22.

(23) FIG. 22 shows the container in a view according to the arrow XXII in FIG. 21.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS OF THE INVENTION

(24) FIGS. 1 and 2 illustrate the upper end of a container 18 and a first embodiment of a stopper 1 for use in a freeze-drying method, wherein the stopper is inserted into an opening 23 of the container 18, which is configured in the region of a container neck 19.

(25) In FIGS. 1 and 2, the container 18 is shown in each case in section and the stopper 1 in each case not in section.

(26) In FIG. 1 an assembly of the container 18 and the stopper 1 is shown in which an insertion section 2 of the stopper 1 is partially inserted into the neck 19 of the container 18. This position of the stopper 1 corresponds to a drying position of the stopper 1.

(27) FIG. 2 shows an assembly of the container 18 and of the stopper 1 in which the insertion section 2 of the stopper 1 is fully inserted into the container neck 19 of the container 18 and in an axial direction Z of the stopper 1 a cover section 10 of the stopper 1 adjoining the insertion section 2 bears against an outer surface 20 of the container neck 19. This position of the stopper 1 corresponds to a sealing position of the stopper 1.

(28) The insertion section 2 has a lateral surface 3 and a bottom surface 4, wherein the bottom surface 4 is configured opposite a top surface 5 of the stopper 1 which is configured in the region of the cover section 10 in the axial direction Z of the stopper 1.

(29) The insertion section 2 has a sealing section 16 for closing the container 18 in a fluid-tight manner relative to the surroundings of the container 18 in the sealing position of the stopper 1 and a contact section 17 adjoining the sealing section 16 axially from the top surface 5 in the direction of the bottom surface 4 for holding the stopper 1 in the drying position of the stopper 1 during the freeze-drying process, wherein the contact section 17 has four passage openings 6, wherein the passage openings 6 are configured identically and in each case in the form of a recess 6. The respective recess 6 extends from the lateral surface 3 into the bottom surface 4 and in the drying position of the stopper, thus in a state in which the insertion section 2 of the stopper 1 is only partially inserted into the container 18, permits a gas exchange between an interior 22 of the container 18 and the surroundings. This state is shown in FIG. 1, wherein the contact section 17 of the stopper 1 is partially configured outside the container neck 19, wherein the partial region of the contact section 17 which is located outside the container 18 has a partial region of the respective passage opening 6 which is open in a radial direction X, Y, and in this manner a gas exchange is permitted between the container interior 22 and the surroundings. As a result, in the drying position of the stopper 1 shown in FIG. 1, a solution stored in the container 18 is able to be freeze-dried.

(30) In the drying position of the stopper 1 only a partial region of the inner surface 21 adjoining the contact section 17 is in contact with the sealing body 7. In the present case, the tangential expansion of the respective recess is approximately 45°. As a result, the proportion of the partial region in contact with the region of the inner surface of the container, which adjoins the contact section, is approximately 50%.

(31) The insertion section 2 has a substantially circular cylindrical external contour, wherein the contact section 17 is free of regions which protrude relative to the sealing section 16 in the radial direction X, Y.

(32) In the state shown in FIG. 1, the partial regions of the lateral surface 3 of the contact section 17 bear against an inner surface 21 of the container neck 19, whereby the stopper 1 is held in its partially inserted position, and for further insertion of the stopper 1 an action of force is required on the stopper 1 in the axial direction Z, in the direction of the container 18.

(33) The stopper 1 has a sealing section 16 adjoining the contact section 17 in the direction of the top surface 5, wherein in a state in which the insertion section 2 is fully inserted into the container 18, the sealing section 16 bears in a peripheral manner against the inner surface 21 of the container neck 19, and thus sealingly closes the container 18.

(34) As may be derived, in particular, from the sectional view of FIG. 6, the stopper 1 has a sealing body 7 and a main body 8, wherein the outer surfaces of the sealing body 7 in the region of the sealing section 16 and the contact section 17 form the lateral surface 3 of the insertion section 2 and the bottom surface 4 of the insertion section 2.

(35) In the present case, the sealing body 8 is configured to be substantially pot-shaped.

(36) The main body 8 is configured 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 main body 8 are connected together by a material connection. Due to the material connection, the sealing body 7 and the main body 8 are unreleasably connected together so that the stopper 1 is configured approximately in one piece. Preferably, the material connection is produced by a multi-component injection-molding method, in particular a two-component injection-molding method.

(37) The main body 8 and the sealing body 7 consist of different materials, wherein the main body 8 consists of a material which has a higher degree of hardness than a material which makes up the sealing body 7.

(38) The sealing body 7 has a circular cross section in the region of the sealing section 16, wherein an external radius R of the annulus is approximately double an internal radius r of the annulus.

(39) The sealing body 7 and the main body 8 are partially configured in the cover section 10, wherein an outer surface of the main body 8 forms the top surface 5 and the top surface 5 covers the sealing body 7 in the axial direction Z.

(40) In order to define the insertion depth of the stopper 1 in the axial direction Z and to improve the sealing action of the stopper 1 and to facilitate the removal of the stopper 1 from the container 18, the cover section 10 has a radial dimension which is larger than a radial dimension of the insertion section 2. In the state fully inserted into the container 18 of the stopper 1, therefore, a bearing surface 11 of the cover section 10 remote from the top surface 5 bears against the outer surface 20 of the container 18. In this case, this bearing surface 11 of the cover section 10 is formed by an outer surface of the sealing body 7.

(41) Both the main body 8 and the sealing body 7 of the stopper 1 are radially symmetrical to an axis of symmetry of the stopper 1 extending in the axial direction Z.

(42) The main body 8 is configured both in the region of the insertion section 2 in a substantially circular cylindrical manner and in the region of the cover section 10 in a substantially circular cylindrical manner, wherein the main body 8 has a larger diameter in the region of the cover section 10 than in the region of the insertion section 2.

(43) In the region of the cover section 10 the main body 8 also has a peripheral first projection 12 which is configured in the radial direction X, Y. This first projection 12, for example, may serve for holding the stopper 1 in an additional closure which may be attached to the container 18.

(44) In order to reduce further the effective outer surface of the stopper 1, in the second exemplary embodiment of the stopper 1 shown in FIGS. 8 to 11, the main body 8 partially covers the sealing body 7 radially outwardly in the region of the cover section 10. To this end, in the region of the cover section 10 the main body 8 has a peripheral second projection 13 which is configured radially outwardly and which extends from the top surface 5 in the direction of the bottom surface 4, wherein the second projection 13 at least partially covers the sealing body 7 radially outwardly in the region of the cover section 10.

(45) The third exemplary embodiment of the stopper 1 shown in FIGS. 10 and 11 substantially differs from the exemplary embodiment shown in FIGS. 8 and 9 in that the stopper 1 has a blocking body 9 in the form of a blocking layer 9 which is configured between the main body 8 and the sealing body 7, in order to improve the blocking action of the stopper 1, for example against the diffusion of oxygen. The blocking layer 9 and/or the blocking body 9, for example, may consist of ethylene vinyl alcohol copolymer (EVOH) or aluminum. Preferably the blocking body 9 and/or the blocking layer 9 is connected by a material connection to the main body 8 and/or by a material connection to the sealing body 7. Such a stopper 1 may be produced, for example, by means of a three-component injection-molding method. However, it is also perfectly conceivable that the blocking body 9 and/or the blocking layer 9 is held between the main body 8 and the sealing body 7 in a clamped or positive manner.

(46) The fourth exemplary embodiment of the stopper 1 shown in FIGS. 12 to 14 substantially differs from the first exemplary embodiment in that the main body 8 has a central through-channel 15 extending from the top surface 5 in the direction of the bottom surface 4, wherein a partial region 14 of the sealing body 7 extending from the bottom surface 4 in the direction of the top surface 5 is configured in the through-channel 15, whereby the main body 8 radially encloses this partial region 14 of the sealing body 7. The through-channel 15 permits a removal of the container contents without removing the stopper 1 from the container 18 by, for example, a needle being inserted into the through-channel 15 and the sealing body 7 being punctured in the insertion region of the needle.

(47) Moreover, such an embodiment of the stopper 1 is able to be produced in a particularly simple and cost-effective manner, by the main body 8 being initially produced, for example, by an injection-molding method and subsequently thereto the sealing body 7 being injection-molded onto the main body 8, wherein the injection-molding of the sealing body 7 takes place through the through-channel 15 of the main body 8. By the centrally configured through-channel 15 and the resulting central injection-molding of the sealing body 7 on the main body 8, shape tolerances of the stopper 1 are additionally reduced.

(48) The fifth exemplary embodiment of the stopper 1 shown in FIGS. 15 and 16 substantially differs from the first exemplary embodiment in that the main body 8 has an outer surface, wherein a partial region of this outer surface in the axial direction Z of the stopper 1 is not covered by the sealing body 7. In the present case, this outer surface of the main body 8 forms a partial region of the bottom surface 4, wherein the corresponding outer surface of the sealing body 7, which also forms a partial region of the bottom surface 4, terminates in a planar manner with this outer surface of the main body 8 in the axial direction Z. Moreover, in contrast to the first exemplary embodiment of the stopper 1 the top surface 5 is formed by the sealing body 7.

(49) The sixth exemplary embodiment of the stopper 1 shown in FIGS. 17 and 18 substantially differs from the first exemplary embodiment in that the main body 8 has an outer surface, wherein a partial region of this outer surface in the axial direction Z of the stopper 1 is not covered by the sealing body 7. In the present case, this outer surface of the main body 8 forms a partial region of the top surface 5, wherein the corresponding outer surface of the sealing body 7, which also forms a partial region of the top surface 5, terminates in a planar manner with this outer surface of the main body 8 in the axial direction Z.

(50) The seventh exemplary embodiment of the stopper 1 shown in FIGS. 19 and 20 substantially differs from the fifth exemplary embodiment in that the lateral surface 3 of the insertion section 2 is not exclusively formed by the outer surfaces of the sealing body 7 but merely the regions of the lateral surface 3 of the insertion section 2, which are in contact with the inner surface 21 of the container wall 24 in the drying position and/or the sealing position, are formed by the outer surfaces of the sealing body 7. Accordingly, in the region of the insertion section 2 only the outer surfaces of the more flexible sealing body 7 come into contact with inner surfaces 21 of the container wall 24 in the drying position and/or the sealing position. Partial regions of the lateral surface 3 of the insertion section 2, in the present case a partial region of the lateral surface 3 adjoining the respective recess 6, are formed by the outer surfaces of the main body 8.

(51) FIGS. 21 and 22 show the container 18 without a stopper 1.

(52) In order to facilitate an insertion of the stopper 1, the exemplary embodiments of the stopper 1, which are shown in the drawing figures in a region of the contact section 17 comprising the bottom surface 4, have a conical external contour.