CLOSURE FOR PHARMACEUTICAL CONTAINERS AND METHOD FOR SEALING A BOTTLE

Abstract

A closure for a pharmaceutical vial. The closure comprises an aluminum foil with an inductively meltable adhesive, an elastic seal, and a cap. The cap has an opening through which a perforating cannula can be inserted.

Claims

1. A closure for pharmaceutical packages, comprising: a cap made of a dielectric material and attachable on a vial; a metal foil which in its assembled state rests on a rim of said vial, wherein at least on a surface that rests on the rim the metal foil is provided with an adhesive which is meltable inductively through the metal foil; and an elastic seal inserted above the metal foil; wherein the cap has a base wall with at least one opening through which the elastic seal and the metal foil can be perforated; wherein the elastic seal is adapted so that once the cap has been applied on the vial the metal foil is already sealingly pressed onto the rim of the vial without the adhesive having been melted yet; and wherein the closure is embodies as a snap-on closure.

2. (canceled)

3. (canceled)

4. The closure as claimed in claim 1, wherein the snap-on closure is designed so that it cannot be removed without being destroyed.

5. The closure as claimed in claim 1, wherein the metal foil is an aluminum foil.

6. The closure as claimed in claim 1, wherein the elastic seal is rotatable relative to the metal foil.

7. The closure as claimed in claim 1, wherein the cap or the elastic seal is made of a transparent material.

8. The closure as claimed in claim 1, wherein the cap has claws for being latched on a collar of the vial, wherein the claws are distributed around the circumference of the cap covering a maximum of 180° in total.

9. The closure as claimed in claim 1, wherein the cap has claws for being latched on a collar of the vial, and wherein the cap has openings in its base wall above the claws.

10. The closure as claimed in claim 1, wherein the cap has claws for being latched on a collar of the vial, wherein the metal foil and the elastic seal are retained in the cap by the claws.

11. A package comprising a vial with a closure as claimed in claim 1.

12. The package as claimed in claim 11, wherein the package is filled with a bone cement monomer.

13. A mixing device for bone cement, comprising a package according to claim 12, which is filled with bone cement monomer.

14. A method for sealing a vial with a closure for pharmaceutical packages which comprises a cap made of a dielectric material and attachable on a vial; a metal foil which in its assembled state rests on a rim of said vial, wherein at least on a surface that rests on the rim the metal foil is provided with an adhesive which is meltable inductively through the metal foil; and an elastic seal inserted above the metal foil; wherein the cap has a base wall with at least one opening through which the elastic seal and the metal foil can be perforated; and wherein the method comprises the steps of: filling the vial; then applying the closure; and subsequently heating the metal foil by induction so that the adhesive melts thereby creating a material bond between the metal foil and a rim of the vial.

15. The method for sealing a vial as claimed in claim 14, wherein after the material bond has been created between the metal foil and the rim, the vial is sterilized externally using a gas.

16. The method for sealing a vial as claimed in claim 14, wherein the inductive heating of the metal foil is performed after leaving an aseptic filling area.

17. A closure for pharmaceutical packages which comprises: a cap made of a dielectric material and attachable on a vial; a metal foil which in its assembled state rests on a rim of said vial, wherein at least on the a surface that rests on the rim the metal foil is provided with an adhesive which is meltable inductively through the metal foil; and an elastic seal inserted above the metal foil; wherein the cap has a base wall with at least one opening through which the elastic seal and the metal foil can be perforated.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0059] FIG. 1 shows a perspective view of a cap which is intended for a closure.

[0060] FIG. 2 is a bottom view of the cap illustrated in FIG. 1.

[0061] FIG. 3 schematically illustrates an elastic seal.

[0062] FIG. 4 shows the elastic seal and an aluminum foil superimposed and covering both the rim of a vial onto which they are applied.

[0063] FIG. 5 shows a perspective view of a package for a liquid.

[0064] FIG. 6 shows the vial with the cap removed.

[0065] FIG. 7 shows a perspective view of a closure.

[0066] FIG. 8 shows an alternative embodiment of a closure.

[0067] FIG. 9 shows a perspective bottom view of the cap used for the closure illustrated in FIG. 8.

[0068] FIG. 10 is a flow chart for using the cap according to the invention for sealing a vial.

DETAILED DESCRIPTION

[0069] The invention will now be explained in more detail by way of exemplary embodiments and with reference to the drawings of FIGS. 1 to 10.

[0070] FIG. 1 shows a perspective view of a cap 1 which is intended for a closure according to the invention.

[0071] Cap 1 is designed as a snap-on closure and has a substantially circular cross section.

[0072] The base wall 2 of the cap has a central opening 3 through which for instance a hollow needle can be inserted into the closure.

[0073] However, the base wall 2 of the cap adjacent to the opening 3 should at least extend so as to cover the rim of the vial (not shown).

[0074] Cap 1 has a circular cylindrical basic shape.

[0075] The lateral wall 4 of cap 1 is provided with at least one slot 5 which has the effect that the individual segments of lateral wall 4 can deflect outwards more easily when the cap is applied.

[0076] The aluminum foil and the elastic seal are not inserted in this view.

[0077] FIG. 2 is a bottom view of the cap 1 illustrated in FIG. 1. Central opening 3 is visible. Moreover, three claws 6 can be seen in this view, which extend inwards from the lower end 7 of the lateral wall and which are latched below the collar of a vial in the assembled state.

[0078] Claws 6 extend over less than 180° of the circumference of cap 1 in total.

[0079] This has the advantage, inter alia, that when the cap 1 is manufactured by injection molding, it can be demolded by rotating the cap.

[0080] Claws 6 are distributed uniformly around the circumference, and a slot 5 is provided between each pair of adjacent claws. In the present exemplary embodiment, the slot extends over at least half of the height of the lateral wall (4 in FIG. 1).

[0081] FIG. 3 schematically illustrates an elastic seal 8, for example made of silicone, and an aluminum foil 9, which are intended to be inserted into the cap.

[0082] Elastic seal 8 and aluminum foil 9 are not tightly connected, for example not glued together.

[0083] As can be seen in FIG. 4, the elastic seal 8 and the aluminum foil 9 are superimposed and cover both the rim of a vial onto which they are applied as well as the entire mouth opening of the vial.

[0084] Aluminum foil 9 is provided with an adhesive (not shown) on its lower surface.

[0085] In this manner, the aluminum foil provides an inductively applicable seal insofar as the aluminum foil is heated inductively so that the adhesive melts and a material bond is produced between the rim of the vial and the aluminum foil.

[0086] FIG. 5 shows a perspective view of a package 14 for a liquid (not shown).

[0087] In this exemplary embodiment, package 14 consists of a circular cylindrical vial 11 and of the closure 10 which comprises the cap 1 as shown in FIGS. 1 and 2 and an aluminum foil and an elastic seal 8.

[0088] FIG. 6 shows the vial 11 with the cap removed.

[0089] It can be seen that the vial has a collar 12.

[0090] The upper end of collar 12 defines the rim on which the aluminum foil rests in its applied state.

[0091] The claws of the cap latch below the underside of collar 12.

[0092] FIG. 7 is a perspective view of a closure.

[0093] It comprises the cap as illustrated in FIGS. 1 and 2, which has slots 5 provided in the lateral wall and claws adjacent to the lower end 15, which are intended for being latched below the collar of a vial.

[0094] The elastic seal and the aluminum foil 9 are now inserted here. The aluminum foil can be seen.

[0095] Once inserted, the aluminum foil 9 and the elastic seal (not shown) are retained in the cap by the claws 6.

[0096] The closure of the invention can thus be introduced into a machine as a preassembled component and can be applied automatically in a single processing step.

[0097] This view clearly shows that the claws 6 are in the form of wedges projecting inwardly from the circular circumferential shape of the cap.

[0098] Furthermore, the wedge-shaped claws 6 are beveled at their lower end so as to slide over the collar of a vial when being applied. In this case the lateral wall is able to slightly deflect due to the slots 5.

[0099] On their upper end, by contrast, the claws extend substantially horizontally in the present exemplary embodiment.

[0100] This configuration has the consequence that the cap will be destroyed if it is forcible withdrawn.

[0101] FIG. 8 shows an alternative embodiment of a closure.

[0102] It essentially corresponds to the previously illustrated closure, with the difference that openings 13 are provided in the base wall, which are located above the claws.

[0103] The openings follow the circular extension of the cap.

[0104] Furthermore, this embodiment variant has no slots in the lateral wall.

[0105] For this embodiment, a suitable material with increased yield strength has to be selected.

[0106] The elastic seal 8 can be seen through the opening of the cap.

[0107] However, it will be understood that it is conceivable to provide further layers above the elastic seal without thereby impairing the function of the closure.

[0108] FIG. 9 shows a perspective bottom view of the cap 1 used for the closure illustrated in FIG. 8.

[0109] The central opening can be seen. Furthermore, claws 6 can be seen, which are similar to those of the embodiment variant illustrated before and which occupy only part of the circumference of the cap.

[0110] In addition to their function for demolding the cap, claws which do not extend along the entire circumference have the advantage of reducing the risk for inclusion of gas. Thus, during sterilization the gas can enter unhindered between the cap and the vial and then re-escape. The gas barrier is alone formed by the aluminum seal.

[0111] It can furthermore be seen here that the openings 13 which are provided above the claws 6 essentially correspond to the claws 6 in terms of their shape and location.

[0112] Now referring to the flow chart of FIG. 10, the use of the cap according to the invention for sealing a vial will be explained by way of example.

[0113] First, a glass vial is filled with a bone cement monomer in an aseptic filling machine, and the closure according to the invention, for example the closure illustrated above, is applied by snap-fitting within the aseptic filling machine.

[0114] The snap-fitting process is automated.

[0115] Then, the glass vial is transferred, for example on a conveyor, into a sealing machine for the purpose of inductively sealing the aluminum seal. This sealing machine need not necessarily be arranged in the aseptic area, since after snap-fitting of the closure the vial is already closed in liquid-tight manner and largely provides a sterile barrier.

[0116] Then, the aluminum foil is sealed by inductive melting of the adhesive layer and then forms a gas barrier which prevents the penetration of gas and ensures that highly volatile substances can be stored over elongated periods of time.

[0117] Subsequently, the package is sterilized using ethylene oxide, prior to packaging.

[0118] The invention permits for the first time to provide a package with a septum for a perforating cannula in which even highly volatile substances can be stored over elongated periods of time.

LIST OF REFERENCE NUMERALS

[0119] 1 Cap [0120] 2 Base wall [0121] 3 Opening [0122] 4 Lateral wall [0123] 5 Slot [0124] 6 Claw [0125] 7 Lower end [0126] 8 Elastic seal [0127] 9 Aluminum foil [0128] 10 Closure [0129] 11 Vial [0130] 12 Collar [0131] 13 Opening [0132] 14 Package [0133] 15 Lower end [0134] 16 Rim