Tamper-evident plastic closure for a vial

Abstract

The present invention relates to a tamper-evident plastic closure for a medicine bottle for retaining a stopper in a mouth of the medicine bottle, comprising: a tubular locking body configured to be locked at a neck of the medicine bottle, and a cap coupled with the tubular locking body. The tubular locking body includes a retaining member to retain the stopper, and a central opening formed in the retaining member to provide access to an interior of the medicine bottle through the stopper. The cap includes a disc-shaped cover, and a coupling portion to couple the cap with the tubular locking body by a positive fit engagement. The coupling portion includes at least one frangible portion configured to be irreversibly broken by the annular frangible portion to provide access to the interior of the medicine bottle through the stopper, while at least one indicating member remains retained at an edge of the central opening of the tubular locking body as evidence of tampering after the cap is removed from a distal end of the tubular locking body.

Description

Technical Field

[0001] This invention relates to a tamper-evident plastic seal for medicine bottles used to store substances for medical or pharmaceutical applications, and to a method of using such a tamper-evident plastic seal, particularly for sealing medicine bottles having such a tamper-evident plastic seal, and for removing liquid from the medicine bottle or for reconstructing a drug inside the medicine bottle, the liquid comprising substances for medical or pharmaceutical applications. Background Technology

[0002] Bottles or vials made of glass or plastic materials are known from existing technology for storing pharmaceutical products (e.g., freeze-dried or liquid products for injection or perfusion). These vials are generally sealed with a rubber stopper that can be punctured by a needle. Typically, the rubber stopper is held in place at the neck of the vial by an aluminum capsule that completely covers the rubber stopper and has a tearable portion that allows access to the rubber stopper. However, this aluminum capsule cannot cover the stopper aseptically and without the presence of unwanted particles. Therefore, it is difficult for this aluminum capsule to minimize particulate contamination levels entering a controlled gas environment (e.g., a cleanroom).

[0003] To overcome these drawbacks, cap structures including a removable cap have been provided to provide access to a stopper via a central opening in a sleeve-like member attached to the distal end of the vial. Such cap structures are known, for example, from US3,193,128 or US 3,358,865.

[0004] To further reduce costs and facilitate the installation of this cap structure at the distal end of the vial, a plastic cap structure has been provided. This plastic cap structure includes a tubular locking body, which can be installed on the neck of the vial via a locking tab, etc., and includes a removable cap for providing access to the interior of the vial from the outside of the tubular locking body through a central opening and a stopper. Such a sealing cap is disclosed, for example, in EP 0 614 820 A1.

[0005] Another important feature of this cap structure is the provision of a tamper-evident feature. For this purpose, US 5,152,413 discloses a tamper-evident closure including a fragile bridge that remains visible after the cap is removed.

[0006] EP 3 326 932 A1 discloses a sealing system for a medicine bottle, including an inner capsule and an outer capsule. The inner capsule is configured to fit onto the neck of the medicine bottle and hold a stopper in a sealing configuration at the mouth of the bottle. The outer capsule can fit onto the inner capsule. The outer capsule is made of a single unit and includes an upper disc-shaped portion and a lower disc-shaped portion. The upper disc-shaped portion is configured to close the opening of the inner capsule, and the lower disc-shaped portion can fit around the inner capsule. The outer capsule includes a fragile portion, implemented as a break line between the upper and lower disc-shaped portions.

[0007] US 20120160850 A1 discloses a closure cap similar to EP 3 326 932 A1. To give the bead an L-shaped profile, this L-shape is curved around the edge of a central opening. The cap is snapped onto the ring by first inserting the bead, which is positioned on the bottom surface of the cap, into the central opening of the ring, and then heating it to deform the bead. The tubular body of the closure cap consists of two components: a cage that locks onto the neck of the vial and a cylindrical member that locks onto the cage.

[0008] US 20160200488 A1 discloses a tamper-evident plastic closure. The fragile portion is not located in the coupling portion of the cap, but rather in a ring, the lower portion of which is inwardly rolled so that the ring engages from below the lower surface of the bottle's edge. Specific locking tabs for securing the ring to the bottle's neck are not disclosed. When the user removes the cap from the ring, at least some of the bridging webs connecting the hub of the tamper-evident mechanism to the annular portion on the top surface of the ring are destroyed, as can be determined by the customer. Figures 8 and 9 of US 20160200488 A1 also disclose an embodiment where the edge of the central opening on the top surface of the ring can be relatively smooth after the cap is removed. Summary of the Invention

[0009] One object of the present invention is to provide a low-cost and reliable tamper-evident plastic seal for medicine bottles, which is easy to install and use to retain the stopper in the mouth of the medicine bottle in a sealed configuration. Another object of the present invention is to provide a method for sealing medicine bottles having such a tamper-evident plastic seal, and for removing liquids comprising substances for medical or pharmaceutical applications from the medicine bottle or for reconstructing medicines inside the medicine bottle.

[0010] According to the present invention, a tamper-evident plastic closure for storing substances for medical or pharmaceutical applications is provided. This tamper-evident plastic closure has a neck with a flange at its axial end for retaining a stopper in the mouth of the bottle. The plastic closure includes a tubular locking body and a cap. The tubular locking body has a distal end and a proximal end and is configured to be mounted on the neck of the bottle. The cap is coupled to the tubular locking body at its distal end. The tubular locking body includes a retaining member disposed at its distal end and configured to retain the stopper in the mouth of the bottle. The central opening... An opening is formed in the retaining member to provide access to the interior of the vial from the outside of the tubular locking body via a stopper, wherein the cap includes a disc-shaped cap and a coupling portion, the disc-shaped cap covering the distal end of the tubular locking body and closing the central opening of the locking body, the coupling portion being disposed at the center of the disc-shaped cap and protruding from the bottom surface of the disc-shaped cap for coupling the cap to the tubular locking body by positive engagement of the coupling portion with the central opening of the locking body, wherein the disc-shaped cap and the locking body are formed as separate components, and the tubular locking body is formed as a single piece and configured to cover the entire area of ​​the neck of the vial.

[0011] According to the invention, the coupling portion includes an annular fragile portion, a cylindrical protrusion, and an indicator ring. The annular fragile portion is integrally formed with the disc-shaped cap and protrudes from the bottom surface of the disc-shaped cap. The cylindrical protrusion protrudes from the bottom surface of the disc-shaped cap. The cylindrical protrusion and the indicator ring are connected to each other via the annular fragile portion and are configured such that, after irreversibly breaking the annular fragile portion to provide access to the interior of the vial via the stopper, and after removing the cap from the distal end of the tubular locking body, the indicator ring remains at the edge of the central opening of the tubular locking body as evidence of tampering. The indicator ring is clamped or held between the bottom of the retaining member and the upper surface of the stopper with an axial gap and protrudes radially inward beyond the edge of the central opening of the tubular locking body into the central opening.

[0012] Therefore, as a clearly visible tamper-proof indicator, the indicator ring remains clearly visible within the central opening of the locking body. Simultaneously, the indicator ring reliably prevents the plug from being closed or resealed by replacing the cap.

[0013] The coupling portion includes at least one fragile portion, each of which is configured such that, by irreversibly breaking at least one fragile portion, access to the interior of the vial is provided via a stopper, and after the cap is moved from the distal end of the locking body, at least one indicator member remains at the edge of the central opening of the locking body as evidence of tampering.

[0014] Therefore, the tamper-evident plastic closure according to the invention can be used to reliably cover or seal the stopper of a medicine bottle during storage and transportation, and provides easy access to the contents of the medicine bottle after the cap is removed by irreversibly breaking at least one fragile portion of the coupling protrusion. After breaking at least one fragile portion of the coupling protrusion, at least one indicator member (preferably shaped as an indicator ring) remains in the central opening of the locking piece as a clearly visible tamper-evident indicator, which also reliably prevents the stopper from being closed or resealed by replacing the cap. For this purpose, the tubular locking body can be formed as a kit covering the entire area of ​​the neck of the medicine bottle, and the cap is preferably configured to cover the entire area of ​​the stopper held in the mouth of the medicine bottle. Since the disc-shaped cap and the locking body are formed as separate components, the two components can be produced in separate manufacturing steps and then assembled onto the tamper-evident closure, for example, after the locking body is locked to the neck area of ​​the medicine bottle.

[0015] According to a further embodiment, a plurality of locking tabs or protrusions are integrally formed on the inner surface of the tubular locking body, wherein the locking tabs are configured to lock the tubular locking body to the neck of the vial.

[0016] According to a further embodiment, the retaining member is formed as an annular web, which is connected to the cylindrical sidewall of the tubular locking body via a plurality of radial webs spaced apart from each other along the periphery of the tubular locking body, and has a plurality of curved recesses formed between adjacent radial webs. A plurality of locking tabs are disposed near the proximal end of the locking body at positions corresponding to the plurality of curved recesses to lock the locking body in the neck of the vial, particularly through a positive engagement with the bottom surface of the vial's flange. Therefore, the locking body and locking tabs can be integrally molded together in a single injection molding process. Here, the annular web serves to prevent the stopper from being accidentally removed from the neck of the vial. However, neither the annular web nor at least one indicating member necessarily requires the stopper to be permanently pushed into the mouth of the vial. Instead, the stopper can be maintained in the mouth of the vial with a certain axial clearance.

[0017] According to a further embodiment, beveled surfaces are formed along the periphery of the central opening, each extending at an acute angle relative to a line perpendicular to the axial direction of the tubular locking body. The beveled surfaces surround at least one linear edge portion of at least one indicating member, the at least one linear edge portion extending in the axial direction of the tubular locking body. The length of the at least one linear edge portion can be used to suitably adjust the stiffness of the annular web, while the elasticity of the cap mounting to the locking piece can be adjusted by a suitable slope of the beveled surfaces. Because the edge of the central opening is beveled at least on the upper surface of the annular web, it facilitates the insertion of a swab for disinfecting the upper surface of the stopper before piercing the stopper with the distal tip of a needle or syringe.

[0018] According to a further embodiment, the annular fragile portion may have a notched profile, thus providing a region with reduced wall thickness near the free end of the coupling portion. Therefore, the force required to break the annular fragile portion can be easily adjusted.

[0019] According to a further embodiment, the upper surface of the indicator ring extends parallel to the bottom surface of the periphery of the central opening of the locking body.

[0020] According to a further embodiment, the bottom surface of the indicator ring is convex arc-shaped so that the indicator ring can abut against the upper surface of the plug along the annular contact line.

[0021] According to a further embodiment, the upper surface of the indicator member or ring is inclined at an acute angle toward the bottom surface of the cap, and this acute angle is the same as the acute angle formed between the bottom of the retaining member and a plane perpendicular to the axial direction of the plastic closure. This facilitates a positive engagement of the coupling portion with the central opening of the locking body and maximizes the contact area between the two components, which facilitates proper adjustment of the force required to actually break the fragile part.

[0022] According to a further embodiment, the peripheral edge of the cap protrudes radially outward beyond the outer surface of the tubular locking structure, and an annular concave recess is formed on the upper surface of the disc-shaped cap. This facilitates gripping the cap for handling and tearing the cap off the locking tab, thereby destroying the fragile portion.

[0023] According to a further embodiment, the coupling portion snaps into the central opening of the locking body for assembling a tamper-evident plastic closure. Alternatively, the coupling portion may include a front end that is irreversibly deformed by plastic deformation or by heating and plastic deformation, to establish a positive engagement between the coupling portion and the central opening of the tubular locking body during the assembly of the closure, when covering or sealing the stopper of the vial.

[0024] According to a further embodiment, the stopper is held inside the tubular locking body by a plurality of locking tabs or protrusions disposed on the inner surface of the tubular locking body. Therefore, the closure can be delivered to the customer while the stopper is already held inside the tubular locking body. To close the vial by inserting the stopper into the mouth of the vial, the tamper-evident plastic closure is simply placed on the axial end of the vial and pushed until the tubular locking body is sufficiently locked into the neck of the vial. When the tamper-evident plastic closure is pushed down onto the axial end of the vial, the stopper automatically inserts into the mouth of the vial.

[0025] According to a further related feature of the invention, a method for sealing a medicine bottle for storing a substance for medical or pharmaceutical use is provided, the medicine bottle having a neck with a flange at an axial end of the neck, the method comprising: providing the medicine bottle; filling the medicine bottle with a substance and closing the medicine bottle by inserting a stopper into the mouth of the medicine bottle; providing a tamper-evident plastic closure as described above; placing the tamper-evident plastic closure on the axial end of the medicine bottle; and locking a tubular locking body to the neck of the medicine bottle such that a retaining member holds the stopper on the enlarged upper edge of the medicine bottle, and an indicating member abuts against the bottom of the retaining member.

[0026] According to a further embodiment of this method, the step of placing the tamper-evident plastic seal on the axial end of the medicine bottle includes: snapping the coupling part into the central opening of the locking body, or irreversibly deforming the front end of the coupling part by plastic deformation or by heating and plastic deformation, so as to establish a positive engagement between the coupling part and the central opening of the locking body.

[0027] According to a further related feature of the invention, a method is provided for removing a liquid comprising a substance for medical or pharmaceutical application from a vial sealed with a stopper covered by a tamper-evident plastic closure as described in any of the foregoing embodiments. The method includes: pushing the peripheral edge of a disc-shaped cap away from a tubular locking body to remove the cap from a distal end of the locking body, such that at least one fragile portion is destroyed and at least one indicating member remains at the edge of a central opening in the locking body, thereby providing access to the interior of the vial via the stopper; piercing the central portion of the stopper by penetrating the central opening of the tubular locking body with the tip of a syringe; and drawing liquid from the vial by pulling the piston of the syringe.

[0028] According to a further embodiment, liquid is first injected into the inside of the vial by pushing the piston of the syringe through the stopper, and the substance stored inside the vial is mixed with the liquid injected into the vial before the liquid, which includes substances for medical or pharmaceutical use, is removed from the vial.

[0029] According to a further related feature of the present invention, a tamper-evident plastic closure for a medicine bottle is provided for storing a substance for medical or pharmaceutical use. This tamper-evident plastic closure has a neck with a flange at its axial end for retaining a stopper in the mouth of the medicine bottle. The plastic closure includes a tubular locking body and a cap. The tubular locking body has a distal end and a proximal end and is configured to be locked in the neck of the medicine bottle. The cap is coupled to the tubular locking body at its distal end. The tubular locking body includes a retaining member disposed at its distal end and configured to retain the stopper in the mouth of the medicine bottle. A central opening is formed in the retaining member for... A stopper is provided from the outside of a tubular locking body to the inside of a vial, and wherein the cap includes: a disc-shaped cap for covering the distal end of the locking body and closing the central opening of the locking body, wherein the disc-shaped cap is coupled to a retaining member by a positive engagement of a coupling portion with the central opening of the locking body, the coupling portion protruding from the bottom surface of the disc-shaped cap; wherein the coupling portion includes an annular fragile portion such that the cap can be removed from the locking body by irreversibly breaking the annular fragile portion to provide access to the inside of the vial through the stopper; wherein the central opening is configured such that after the cap is removed from the locking body by irreversibly breaking the annular fragile portion, the upper surface of the stopper can be disinfected with a swab.

[0030] According to a further embodiment, the edge of the central opening is formed by an angled surface that extends at an acute angle relative to a line perpendicular to the axial direction of the tubular locking body, such that before the annular fragile portion is broken, the virtual extension of the angled surface intersects the upper surface of the stopper at or near a radial position on the inner surface of the coupling portion. As an alternative or additional feature, the opening width and / or depth of the central opening are designed to allow a swab to be inserted into the central opening to disinfect the upper surface of the stopper.

[0031] According to a further related feature of the present invention, a tamper-evident plastic closure is provided for a medicine bottle for storing substances for medical or pharmaceutical applications. This tamper-evident plastic closure has a neck with a flange at an axial end for retaining a stopper in the mouth of the medicine bottle. The plastic closure includes a tubular locking body and a cap. The tubular locking body has a distal end and a proximal end and is configured to be locked in the neck of the medicine bottle. The cap is coupled to the tubular locking body at its distal end. The tubular locking body includes a retaining member disposed at its distal end and configured to retain the stopper in the mouth of the medicine bottle. A central opening is formed in the retaining member for providing access from the outside of the tubular locking body via the stopper. The cap includes: a disc-shaped cap for covering the distal end of the locking body and closing the central opening of the locking body; wherein the disc-shaped cap is coupled to a retaining member by a positive engagement of a coupling portion with the central opening of the locking body, the coupling portion protruding from the bottom surface of the disc-shaped cap; wherein the coupling portion includes an annular fragile portion such that the cap can be removed from the locking body by irreversibly breaking the annular fragile portion to provide access to the interior of the bottle via a stopper; wherein at least one window is formed in the sidewall of the tubular locking body, and when the tamper-evident plastic closure is locked in the neck of the bottle, a fluid path is formed between the surrounding environment and the upper surface of the stopper and / or the outer surface of the bottle in the area of ​​the neck and flange. Attached Figure Description

[0032] In the following, preferred embodiments of the invention will be described by way of example and with reference to the accompanying drawings, wherein:

[0033] Figure 1a as well as Figure 1b This invention displays a perspective top view and a perspective bottom view of the tamper-evident plastic sealant according to the present invention.

[0034] Figure 2a as well as Figure 2b This diagram shows a cross-sectional view and a partial three-dimensional cross-sectional view of a tamper-evident plastic sealant according to a first embodiment of the present invention.

[0035] Figure 3a This illustrates the state of the medicine bottle when the tamper-evident plastic seal is installed at the distal end according to a first embodiment of the invention.

[0036] Figure 3b This demonstrates the tamper-evident plastic sealant according to the first embodiment of the present invention. Figure 3a A cross-sectional view of the state.

[0037] Figure 3c This demonstrates the tamper-evident plastic sealant according to the first embodiment of the present invention. Figure 3a A cross-sectional view of the state in which the cap is removed from the tubular locking body.

[0038] Figure 3d The exploded view of the altered plastic closure according to the present invention shows the cap being removed from the tubular locking body.

[0039] Figure 4a as well as Figure 4b This invention displays a perspective top view and a perspective bottom view of the tubular locking body of the tamper-evident plastic closure according to the present invention.

[0040] Figure 5a as well as Figure 5b A perspective top view and a perspective bottom view of the cap of the tamper-evident plastic closure according to a first embodiment of the present invention are shown.

[0041] Figure 5c A schematic cross-sectional view of a cap for a tamper-evident plastic seal according to a first embodiment of the present invention is shown.

[0042] Figure 6a This shows the state of the tamper-evident plastic closure according to the second embodiment of the present invention before the cap is coupled to the tubular locking body.

[0043] Figure 6b This shows the tamper-evident plastic closure according to the second embodiment of the invention in a state where the coupling portion of the cap is inserted into the central opening of the annular retaining member of the tubular locking body, and before the front portion of the coupling portion is irreversibly deformed.

[0044] Figure 6c This shows the state of the tamper-evident plastic sealant after irreversible deformation at the front end of the coupling portion according to the second embodiment of the present invention.

[0045] Figure 6d Display at a larger scale Figure 6a Detail A.

[0046] Figure 6e Showing according to another embodiment Figure 6a A three-dimensional view of a partial cross-section of a tubular locking body.

[0047] Figure 7a as well as Figure 7b This invention displays a perspective top view and a perspective bottom view of a tamper-evident plastic sealant according to another embodiment of the invention.

[0048] Throughout the accompanying drawings, the same reference numerals denote equal or technically equivalent elements or groups of elements.

[0049] List of reference numerals

[0050] 1: Enclosure

[0051] 2: Cap

[0052] 4: Locked Body

[0053] 8: Medicine bottle

[0054] 20: Central body

[0055] 21: Cylindrical recess

[0056] 22: Outer Cover

[0057] 23: Surrounding edges

[0058] 24: Concave

[0059] 25: Top edge

[0060] 26: Bottom surface

[0061] 28: Cylindrical protrusion

[0062] 28a: Deformed portion of the cylindrical protrusion

[0063] 29: The inclined surface of the cylindrical protrusion 28

[0064] 30: Ring-shaped fragile part

[0065] 32: Indicator ring

[0066] 33: Visible portion of indicator ring 32

[0067] 34: Surrounding edges

[0068] 35: The beveled surface of the surrounding edge 34

[0069] 40: Sidewall

[0070] 40a: Inner surface of sidewall 40

[0071] 40b: Axial groove on inner surface 40a

[0072] 40c: Radial ridge on inner surface 40a

[0073] 41: Upper (far) end

[0074] 42: Bottom (near) end

[0075] 43: Annular web

[0076] 44: Radial web

[0077] 45: concave part

[0078] 46: Opening at the center

[0079] 47: Radial protrusions of the annular web 43

[0080] 47a: The inclined upper surface of the radial protrusion 47

[0081] 47b: Angled bottom surface of radial protrusion 47

[0082] 47c: The linear edge portion of the radial protrusion 47

[0083] 48: Bottom skirt

[0084] 49: Steps

[0085] 50: Bottom Container

[0086] 51: Upper Container

[0087] 52: Locking plate

[0088] 52a: Groove

[0089] 52b: The basis for locking plate 52

[0090] 53: Positioning components

[0091] 59: Window

[0092] 80: Sidewall

[0093] 81: Neck

[0094] 82: Flange

[0095] 83: Mouth

[0096] 84: Bottom

[0097] 85: Plug or stop

[0098] 86: Central body

[0099] A: Figure 6a Details Detailed Implementation

[0100] The invention relates to a tamper-evident plastic closure configuration for retaining a rubber stopper in the mouth of a necked container, particularly a medicine bottle. An example of such a medicine bottle is schematically shown. Figure 3a as well as Figure 3bThe medicine bottle 8 has a basic cylindrical shape, with cylindrical sidewalls 80, a fixed inner diameter and outer diameter, protruding upright from a flat bottom 84, converging in a relatively short (constricted) neck 81 near the upper opening end of the medicine bottle 8, and then converging into an enlarged flange 82 (upper edge) (so-called flared edge; hereinafter referred to as "flange"), which has an outer diameter greater than that of the associated neck 81 and surrounds the mouth 83 of the medicine bottle 8. As can be seen from... Figure 3b It is concluded that the lower side of the flange 82 (curled edge) is oblique and extends downward at an acute angle toward the constricted neck 81. The neck 81 may have a smooth wall without external threads, or it may have external threads for screwing into the closure member. The central cylinder 86 of the rubber stopper or stop 85 is inserted into the opening 83 of the neck 81, and the upper end of the rubber stopper rests against the flange 82 (upper edge) to seal the vial 8 in an airtight manner and prevent contaminants from entering the interior of the vial 8.

[0101] Such medicine bottles 8 are used to store substances or reagents for cosmetic, medical, or pharmaceutical applications, which are stored in solid or liquid form as one or more components within the container. Particularly in the case of glass containers, the shelf life can be up to several years, depending primarily on the hydrolytic resistance of the type of glass used. Although cylindrical medicine bottles are disclosed below, it should be noted that, for the purposes of this invention, medicine bottles can also have different profiles, such as square, rectangular, or polygonal profiles.

[0102] These vials are made from transparent or colored glass or suitable plastic materials using blow molding or plastic injection molding techniques, and can be largely coated on the inside to minimize the release of impurities from the vial material to the reagent to be received.

[0103] If the rubber stopper 85 includes a valve member as disclosed in US 6,089,541, the central body 86 of the rubber stopper 85 may be pierced by the needle of a syringe (not shown) or by the front tip of a needleless syringe to remove liquid from a vial or inject liquid into a vial for drug reconstitution before removing liquid, including liquid for medical or pharmaceutical applications.

[0104] Figure 1a as well as Figure 1bThis is a schematic perspective view of a tamper-proof plastic seal 1 according to the present invention. The tamper-proof plastic seal 1 is used to retain a rubber stopper in the mouth of a medicine bottle in a sealed state, to maintain the upper surface of the rubber stopper under sterile conditions during storage, and is configured to provide access to the interior of the medicine bottle via the rubber stopper. The tamper-proof plastic seal 1 generally consists of a tubular locking body 4 and a cap 2, the cap 2 covering the distal end of the locking body 4 and coupled to or connected to the locking body 4.

[0105] Reference Figures 1b to 2b The locking body 4 is a hollow cylindrical member formed by a cylindrical sidewall 40 with a circular profile having a distal end 41 and a proximal end 42. A plurality of (elastic) locking tabs 52 are disposed on the inner surface 40a of the sidewall 40, the (elastic) locking tabs 52 being spaced apart from each other at equal angular intervals. The locking tabs 52 protrude radially inward at an acute angle toward the distal end 41 into the locking body. When the locking body 4 is inserted into the upper edge of the vial, the locking tabs 52 elastically flex outward toward the inner surface 40a of the sidewall 40. The locking tabs 52 conform to the shape of the neck of the vial so that the locking tabs 52 can be held behind the bottom surface of the flange 82 (widened upper edge) of the vial 8, as shown in... Figure 3b As shown in the figure, the tubular locking body 4 is used to lock the neck 81 of the medicine bottle 8.

[0106] Reference Figure 4a as well as Figure 4b The upper (distal) end of the locking body 4 is formed by an annular web 43, which is connected to the cylindrical sidewall 40 via a plurality of radial webs 44 spaced apart from each other along the periphery of the tubular locking body 4. Therefore, a plurality of curved recesses 45 are formed between adjacent radial webs 44. (Elastic) locking pieces 52 are respectively disposed at positions corresponding to the recesses 45 near the proximal end 42, facilitating the injection molding of (elastic) locking pieces 52 integrally formed with the tubular locking body 4. A circular central opening 46 is formed by the annular web 43.

[0107] As will be described in more detail below, when the locking body 4 is locked to the neck of the vial, the annular web 43 serves as a retaining member to hold the rubber stopper to be retained in the mouth of the vial. For this purpose, the annular web 43 does not need to push the rubber stopper onto the flange at the axial end of the vial. Instead, when the locking body 4 is locked to the neck of the vial, the stopper can be accommodated within the tubular locking body 4 with a certain axial clearance.

[0108] like Figure 2aAs shown, the bottom skirt 48 of the locking body 4 may have a greater wall thickness than the sidewall 40, so that the (elastic) locking piece 52 is supported on a radial step 49 on the inner surface 40a. The radial step 49 divides the contents of the locking body 4 into an upper container 51 and a bottom container 50. The height of the bottom container 50 approximately corresponds to the axial length of the neck 81 of the vial 8 (see...). Figure 3b This ensures that the area where the (elastic) locking piece 52 engages with the bottom side of the flange 82 (upper edge) of the vial 8 is reliably protected. On the other hand, the height of the upper container 51 formed between the upper end of the locking piece 52 and the bottom surface of the annular web 43 generally corresponds to or may be slightly less than the height of the flange 82 (upper edge) of the vial and the thickness of the periphery of the stopper 85 (see...). Figure 3b This allows the peripheral edge of the stopper 85 to be securely pressed against the flange 82 (upper edge) of the vial in an airtight manner if necessary, to seal the opening 83. Simultaneously, a portion of the upper surface of the stopper 85 inside the central opening 46 can be aseptically sealed in a manner as described in more detail below to prevent contaminants from entering this area, although such aseptic sealing of the stopper 85 is not a primary focus of the invention and may not be provided. In other words, when the locking body 4 is locked to the neck of the vial, there may be a certain axial gap between the bottom surface of the annular web 43 and the upper surface of the stopper located in the opening of the vial, and between the indicator ring 32 and the upper surface of the stopper, so that the upper surface of the stopper does not remain aseptic inside the tamper-evident plastic closure 1.

[0109] like Figure 1b as well as Figure 2a As shown, a plurality of block-shaped positioning members 53 may be formed at the center position on the bottom side of the radial web 44. The positioning members 53 are respectively curved along the inner surface 40a of the sidewall 40 and together surround a circular region of a diameter corresponding to or slightly larger than the outer diameter of the upper part of the disc shape of the plug 85, so that the plug 85 can also be accessed by the block-shaped positioning members 53 of the tubular locking body 4. Figure 3b The status shown is positioned in the radial direction.

[0110] like Figure 2a , Figure 4a as well as Figure 4b As shown, the annular web 43 may include radial protrusions 47, which are preferably annular, extending along the entire periphery of the central opening, projecting radially inward into the central opening, and having a thickness less than the corresponding annular web 43 when viewed in the axial direction. As summarized below, the radial protrusions are held at the rear by an indicator ring 32, which forms the bottom of the cap 2, and the cap 2 is coupled to the locking body by a positive engagement between the indicator ring 32 and the periphery of the central opening 46.

[0111] The cap 2 includes a disc-shaped central body 20 that covers the entire locking body 4 at its distal end 41. Preferably, the bottom of the peripheral edge 23 rests against the annular distal end 41 of the locking body 4, thereby preventing contaminants from entering the interior of the locking body 4. Figure 2a as well as Figure 5c As shown, a hollow cylindrical protrusion 28 is formed at the center of the bottom 26 of the cap 2. The hollow cylindrical protrusion 28 has an inner diameter that corresponds to the inner diameter of the central opening 46 of the locking body 4. To couple the cap 2 to the locking body 4, an indicator ring 32 protruding outward in a radial direction is provided at the bottom end of the cylindrical protrusion 28. The indicator ring 32 is connected to the cylindrical protrusion 28 via a concave, fragile portion 30 that is thinner than the cylindrical protrusion 28. Therefore, the fragile portion 30 is less stable than the cylindrical protrusion 28 and the indicator ring 32, and can therefore be destroyed by removing the cap 2 from the locking body 4, as described in more detail below.

[0112] like Figure 2a As shown, the bottom side of the indicator ring 32 may have a convex profile so that the indicator ring 32 can only abut against the upper surface of the stopper 85 along a narrow circular contact line, thereby aseptically sealing the upper surface of the stopper 85 in the area of ​​the central opening 46 and preventing contaminants from entering this area (see [reference]). Figure 3b However, according to the invention, such contact between the bottom side of the indicator ring 32 and the upper surface of the stopper 85 is not absolutely necessary. Rather, when the locking body 4 is locked to the neck 81 of the vial 8, a certain distance may still remain between the bottom side of the indicator ring 32 and the upper surface of the stopper 85. Since the entire area of ​​the axial end of the vial 8 is covered by the tubular locking body 4 and the cap 2, at least to a large extent preventing contaminants from penetrating the interior of the closure, this may be sufficient to reliably remove any contaminants remaining on the upper surface of the stopper 85 before use by disinfecting the upper surface of the stopper 85 with a swab and a disinfectant solution (e.g., alcohol).

[0113] like Figure 2aAs shown, the inclined upper surface 47a and bottom surface 47b of the radial protrusion 47 are respectively inclined at acute angles relative to a plane perpendicular to the axial direction of the locking body 4. However, preferably, the front end of the radial protrusion is C-shaped rather than V-shaped, having a linear edge portion 47c (small linear portion) extending in the axial direction, thus providing greater stability against tearing of the linear edge portion 47c (front end) of the radial protrusion, for example, when the cap 2 is removed from the locking body 4 by breaking the annular fragile portion 30. At the same time, the reduced material thickness of the radial protrusion 47 and its linear edge portion 47c extending in the axial direction give the radial protrusion a certain degree of elasticity. On the one hand, this helps to apply uniform pressure on the indicator ring 32 along its entire periphery, and on the other hand, it facilitates the insertion of the indicator ring 32 into the central opening 46 of the locking body 4. In addition, this elasticity of the radial protrusion 47 also helps to bias the bottom surface of the cap 2 against the annular distal end 41 of the locking body 4, for sealing the entire internal volume of the locking body 4 to the environment.

[0114] like Figure 2a As shown, the upper surface 35 of the indicator ring 32 is inclined at the same acute angle as the bottom surface 47b of the radial protrusion relative to the plane perpendicular to the axial direction of the locking body 4, thereby ensuring full surface contact between the two surfaces 35 and 47b when the indicator ring 32 is properly engaged with the central opening 46 of the locking body.

[0115] like Figure 2a as well as Figure 5c As shown, the bottom surface 26 of the cap 2 has a concave profile such that the linear edge portion 47c (front end) of the radial protrusion 47 and the notch-shaped fragile portion 30 are approximately at the same level as the bottom of the surrounding edge 23 and the annular edge at the distal end 41 of the sidewall 40. Figure 2a As shown, the peripheral edge 23 of the central body 20 extends beyond the outer periphery of the sidewall 40 of the locking body, allowing the cap 2 to be easily removed from the locking body 4 by pushing the peripheral edge 23 upward with the user's thumb. An annular recess 24 is formed on the upper surface of the cap 2, resulting in an annular upper edge 25 forming along the periphery of the cap 2. Therefore, the peripheral edge 23 of the cap 2 can also be easily actuated by the user by grasping the upper edge 25 with the index finger and the bottom of the peripheral edge 23 with the thumb to remove the cap 2.

[0116] like Figure 2a As shown, the shape of the upper surface of the annular web 43 can match the contour of the bottom surface 26 of the cap 2 to further enhance the sealing of the central recess 21 and the central opening 46 of the locking body 4.

[0117] Further details of the ring-shaped fragile part 30 are in Figure 5cAs shown in the image. The notched, fragile portion 30 can be formed by two inclined surfaces 39 and 35, which converge at an acute angle within the annular fragile portion 30, with the remaining material thickness being only a small fraction of the cylindrical protrusion 28. (See image for details.) Figure 2a As shown, when the indicator ring 32 of the cap 2 is engaged with the central opening 46 of the locking body 4, the upper end of the linear edge portion 47c of the radial protrusion 47 preferably does not contact the inclined surface of the bottom end of the cylindrical protrusion 28.

[0118] As will be apparent to those skilled in the art, although the indicator ring 32 has been disclosed above as an annular member, the cap 2 may instead be provided with a multi-piece indicator member consisting of a plurality of indicator portions having the same outline and function as those described above for the indicator ring 32, and may be arranged at equal angular intervals along the periphery of the bottom end of the cylindrical protrusion 28.

[0119] The following will refer to Figure 3a as well as Figure 3b The discussion focuses on the installation of a plastic closure 1, as outlined above according to a first embodiment of the invention, onto the distal end of a vial. First, the plastic closure 1 is assembled by coupling a cap 2 to a tubular locking body 4. The plastic closure 1 can be supplied separately from the vial 8 to a pharmaceutical filling company, for example, aseptically sealed in a plastic bag or container. Preferably, the plastic closure 1 is supplied to the pharmaceutical filling company together with the vial 8. For this purpose, a nested packaging solution can be used, in which a plurality of vials 8 are supported by a bracket (so-called "nesting") in a regular arrangement, each vial 8 being contained in a barrel-shaped container that provides an aseptic seal to the environment, for example, as disclosed in US 2015 / 0166212 A1. This nested packaging solution can also be used to correspondingly store and supply a plurality of plastic closures 1. Nests for holding multiple medicine bottles 8 in a regular arrangement and nests for holding multiple plastic seals 1 in the same regular arrangement can also be housed together in the same barrel-shaped container, which is sterile and sealed to the environment, for storing and supplying medicine bottles 8 together with plastic seals 1 to customers, such as pharmaceutical filling companies.

[0120] In order to obtain Figure 3a As shown in the diagram, once the stopper 85 is inserted into the opening 83 of the medicine bottle 8, the locking body 4 of the plastic closure 1 is positioned on the distal end of the medicine bottle 8, as... Figure 3bAs shown in the diagram. In this state, when the plastic closure 1 is placed on the distal end 41 of the vial 8, the flange 82 (upper edge) of the vial 8 will first insert into the tubular bottom container, which is formed by the bottom skirt 48 of the locking body 4, the inner diameter of which is approximately the same as the outer diameter of the flange 82 (upper edge) of the vial 8. As the locking body 4 is pushed further toward the vial 8, the locking piece 52 (elastic piece) begins to flex radially outward toward the inner surface of the sidewall 40, which is possible because of the radial gap between the inner surface of the sidewall 40 and the outer peripheral surface of the flange 82 (upper edge) of the vial 8. Finally, the front end of the elastic web will slide along the entire axial length of the flange 82 (upper edge) and will flex back toward the neck 81 again to engage behind the bottom surface of the flange 82 (upper edge) and lock onto the neck 81 of the vial 8. In this state, the bottom surface of the annular web 43 can contact the upper surface of the stopper 85; however, this is not necessary. Also in this state, the bottom surface of the indicator ring 32 can press against the upper surface of the stopper 85, thereby reliably pushing the central body 86 of the stopper 85 into the mouth 83 of the vial, and sealing the area of ​​the cylindrical recess 21 of the cap and the area of ​​the upper surface of the stopper 85 in the region of the central opening 46 (which is sterile to the environment).

[0121] However, according to the present invention, such aseptic sealing is not absolutely necessary. Therefore, according to other embodiments, there may also be a certain axial gap between the bottom surface of the annular web 43 and the upper surface of the plug 85, and between the bottom surface of the indicator ring 32 and the upper surface of the plug 85.

[0122] In this state, such as Figure 3a as well as Figure 3b As shown, the medicine bottle 8, sealed or covered by the plastic closure 1, can be delivered to the customer or end user.

[0123] As will become apparent to those with general knowledge in the field (especially from...) Figure 3b The plastic closure 1 can also be delivered to the customer with the stopper 85 already held or retained inside the tubular locking body 4. To hold the stopper 85 inside the tubular locking body 4, locking tabs 52 formed on the inner surface of the sidewall 40 can be used, requiring the outer diameter of the stopper 85 to correspond to or be slightly larger than the width of the circular space formed by the plurality of locking tabs 52. According to an alternative embodiment, additional protrusions (not shown in the figures) may be formed on the inner surface of the sidewall 40.

[0124] In this embodiment, in order to obtain Figure 3aThe sealed medicine bottle 8 shown in the diagram has the locking body 4 of the plastic closure 1 and the stopper 85 held inside the tubular locking body 4 placed at the distal end of the medicine bottle 8. As the plastic closure 1 with the stopper 85 approaches the medicine bottle 8, the stopper 85 will finally be inserted into the mouth 83 of the medicine bottle 8 to seal the medicine bottle 8. At this stage, the locking tab 52 (elastic tab) may have already been engaged behind the bottom surface of the flange 82 (upper edge) to lock the medicine bottle 8 to the neck 81 of the medicine bottle 8. Alternatively, at this stage, there may still be a certain axial gap between the upper end of the locking tab 52 (elastic tab) and the bottom surface of the flange 82 (upper edge). When the plastic closure 1 is further pushed onto the distal end 41 of the bottle 8 in this state, the locking tab 52 (elastic tab) will finally flex outward toward the inner surface of the side wall 40 in the radial direction and finally be secured behind the bottom surface of the flange 82 (upper edge) to lock the bottle 8 to the neck 81 of the bottle 8.

[0125] To provide access to the stopper 85 for drug delivery, the user must first remove the cap 2 from the locking body 4 by breaking the fragile part 30 of the cap 2. Figure 3c As shown, after the cap is removed, the annular indicator ring 32 (or annular indicator rings 32 of multiple individual indicator members) will still maintain clamping or containment within the axial gap between the inclined bottom surface 35 of the radial protrusion 47 and the upper surface of the plug 85. In this state, a portion 33 of the annular indicator ring 32 (or annular indicator rings 32 of multiple individual indicator members) will protrude radially into the central opening 46 of the locking body 4 and will be clearly visible to the user, as the visible evidence of tampering clearly indicates that the cap has been removed by breaking the fragile part of the cap. At the same time, since the annular indicator ring 32 (or annular indicator rings 32 of multiple individual indicator members) still maintains clamping or containment with the axial gap along the periphery of the central opening 46 and cannot be removed without damaging other parts of the locking body 4, such as the annular web 43, it is no longer possible to reseal the central opening 46 and the plug 5 by re-coupled another (new, unused) cap to the locking body. To further enhance the tamper-proof indication effect, the annular indicator ring 32 (or annular indicator ring 32 of multiple individual indicator components) may have a different color from other parts of the locking body 4, especially a different color from the annular web 43 and the radial protrusions 47.

[0126] It should be noted that after the fragile part 30 is broken, the annular indicator ring 32 (or the annular indicator ring 32 of a plurality of individual indicator elements) is not necessarily held between the inclined bottom surface 35 of the radial protrusion 47 and the upper surface of the plug 85. The only important thing is that the annular indicator ring 32 (or the annular indicator ring 32 of a plurality of individual indicator elements) is not mistakenly lost or peeled off by the user from the central opening 46. Of course, the annular indicator ring 32 (or the annular indicator ring 32 of a plurality of individual indicator elements) can move to a certain extent within the central opening 46.

[0127] exist Figure 3c In this state, the user can use the needle of a syringe that penetrates the central opening 46 of the tubular locking body 4 to pierce the central portion of the stopper 85, and then pull the plunger of the syringe to extract the liquid from the vial for administration. Although the central portion of the stopper inside the central opening 46 is sterile and sealed to the environment, the user usually cleans this central portion first with a sterile swab through the central opening.

[0128] If it is necessary to reconstitute the medication inside the vial first, the user will first inject the liquid stored in the syringe into the vial 8 through the stopper 85 by pushing the plunger of the syringe. The substance stored inside the vial 8 can then be mixed with the injected liquid to reconstitute the medication. Finally, by pulling the plunger of the syringe, the liquid containing the substance for medical or pharmaceutical application is removed again from the vial 8.

[0129] As will become apparent to those skilled in the art upon studying the above, the stopper 85 may also be punctured using the tip of a needleless injector, for example, if the stopper includes a valve component, such as that disclosed in US 6,089,541, for removing liquid from a vial or injecting liquid into a vial for drug reconstitution before removing liquid comprising a medicine for medical or pharmaceutical use.

[0130] In order to Figure 3b When removing the cap 2 from the locking body 4, the user will grasp or actuate the peripheral edge 23 of the cap, as described above, to push or tear the cap 2 upwards, preferably at an acute angle relative to the axial direction of the locking body 4. However, the outer cap portion 22, the cylindrical protrusion 28, the fragile portion 30, the indicator ring 32, and the radial protrusion 47 of the annular web 43 provide a degree of elasticity in the plastic closure to prevent accidental tearing of the fragile portion 30 when only a small force is applied to the cap 2 for removal. Therefore, accidental opening of the plastic closure 1 can be reliably prevented.

[0131] Cap 2 can only be removed from locking body 4 when the force applied to it exceeds a minimum threshold, which is primarily defined by the characteristics of the fragile part 30 and the material used. Here, the peripheral edge 23 and the portion of cap 2 positioned radially outside the annular web 43 serve as an actuating rod, which is pivotally supported on the upper surface of the annular web, which can be bent according to the contour of the bottom surface 26 of cap 2, as outlined above. This actuating rod causes a corresponding pivot of a much shorter rod formed by the cylindrical protrusion 28, which then begins to tear upwards at the indicator ring 32. Because the indicator ring 32 is held or accommodated by an axial clearance formed in the notch-shaped annular region between the upper surface of plug 35 and the bottom surface 47b of the radial protrusion 47, the resulting force will eventually cause the fragile part 30 to break along the entire periphery of the central opening 46. Finally, cap 2 can be removed from locking body 4, which will result in Figure 3c As shown in Figure 4, the locking body 4 is provided with an access to the plug 85 from the outside.

[0132] Of course, the cap can also be coupled to the locking body in a step after these two components are manufactured. For example... Figure 2a As shown, for this purpose, the cap 2 can be pushed onto the locking member 4, thereby snapping the indicator ring 32 into the central opening 46 of the locking body 4 and establishing a positive engagement. This assembly is facilitated by providing the radial protrusion 47 with an acute-angled inclined upper surface 47a facing the distal end 42, and by having a convex arcuate profile on the bottom surface of the indicator ring 32. Figure 2a As shown in the diagram, when the cap 2 is pushed onto the locking body 4, the bottom surface of the indicator ring 32 will first contact the inclined upper surface 47a of the radial protrusion 47. Then, the indicator ring 32 will flex towards the bottom of the cap 2 and slide over the inclined upper surface 47a of the radial protrusion 47. Finally, the radial ring 32 will flex back radially and engage behind the radial protrusion 47, resulting in mechanical coupling between the cap 2 and the locking member 4, as shown in the diagram. Figure 2a As shown in the image.

[0133] Reference Figures 6a to 6c A second embodiment of the tamper-evident plastic sealant according to the present invention will be described. Figure 6a In the diagram, the two components of the closure, namely the cap 2 and the locking body 4, are shown in their state before the cap 2 is coupled to the tubular locking body 4. Unlike the first embodiment, the front end 28a of the cylindrical protrusion 28 formed in front of the fragile portion 30 has an outer diameter that fits into the central opening of the annular web 43. Therefore, the cylindrical protrusion 28 can be inserted unimpeded into the central opening of the annular web 43 using its front end 28a, as... Figure 6b As shown, this is used to attach the cap 2 to the locking body 4. Figure 6b In this state, the front end 28a of the cylindrical protrusion 28 is irreversibly deformed by means of a rivet to establish a positive engagement between the cylindrical protrusion 28 (coupling portion) and the central opening provided in the annular web 43 of the locking body 4. For this purpose, a cylindrical counter-member can be inserted from the bottom end 42 of the locking body 4 into the interior of the locking body 4 until the cylindrical counter-member is in the... Figure 6b The front end 28a of the cylindrical protrusion 28 is abutted in the state shown. Applying appropriate pressure between the anti-component and the cap 2 while pressing the cap 2 against the locking body 4 is sufficient to induce irreversible plastic deformation of the front end 28a, ultimately achieving... Figure 6c In the final state shown, the deformed front end of the cylindrical protrusion forms an indicator ring 32, which is fastened to the back of the bottom surface 47b of the radial protrusion 47 of the annular web 43 by means of a rivet, thereby establishing a positive engagement between the cylindrical protrusion 28 (coupling portion) and the central opening provided in the annular web 43 of the locking body 4.

[0134] As will become apparent to those skilled in the art, this irreversible deformation of the front end 28a of the cylindrical protrusion 28 can be further aided by heating and simultaneously deforming the front end 28a. For this purpose, the aforementioned cylindrical anti-protrusion member can be equipped with a heater capable of heating the front end 28a of the cylindrical protrusion 28 to a softened state, thereby mitigating the deformation of the front end 28a and ultimately obtaining… Figure 6c The mushroom-shaped rivet structure shown in the figure couples the cap 2 to the locking body 4.

[0135] Figure 6d Display at a larger scale Figure 6a Detail A. This feature can be applied to all embodiments of the tamper-evident plastic closure for medicine bottles according to the present invention. As in the previous embodiments, the bottom skirt 48 of the locking body may be provided with a greater wall thickness than the sidewall 40, so that the (elastic) locking piece 52 is supported on a radially inwardly projecting circumferential step 49, which divides the contents of the locking body into an upper container and a bottom container 50. To provide greater elasticity to the locking piece 52, axial grooves 52a are provided between the sidewall 40 and the base or root 52b of the locking piece 52. Therefore, the elasticity of the locking piece 52 can be adjusted as needed by adjusting the radial width and / or axial depth of the axial groove 52a, and further by adjusting the width of the base or root 52b of the locking piece 52.

[0136] like Figure 6eAs shown, the axial groove 52a corresponds to the bottom portion of the axial recess 40b formed on the inner surface 40a of the sidewall 40. The depth of this axial recess 40b can be a constant along the axial direction; if the slight tilt angle typically caused by injection molding is ignored, a small deformation angle is required to release the finished product from the injection mold. The circumferential width of the axial recess 40b corresponds to the width of the corresponding recess 45 on the upper surface of the tubular locking body 4. Therefore, the slider of the injection mold can be inserted from above until the bottom portion of the groove 52a, forming the axial recess 40b together with the corresponding recess 45 on the upper surface of the tubular locking body 4. Preferably, when viewed from above, the front ends 52c of the locking piece 52 do not protrude beyond the outer edge of the annular web 43 in the radial direction. Therefore, the locking piece 52 can also be easily formed by injection molding using the same mold. Figure 6e As shown, the front end 52c of the locking tab 52 can be formed as a generally flat surface extending in the horizontal direction, or at a slightly acute angle relative to the horizontal reference plane, so as to be within the enlarged flange 82 (upper edge) of the vial (see...). Figure 3b It can be securely fastened.

[0137] like Figure 6e As shown, radial ridges 40c may be formed on portions of the inner surface 40a of the sidewall 40 formed below the radial web 44, for further stiffening of the tubular locking body 4. These radial ridges 40c are interrupted only by the aforementioned axial recesses 40b.

[0138] The height of the bottom container 50 roughly corresponds to the axial length of the neck 81 of the medicine bottle 8 (see...). Figure 3b This ensures reliable protection of the area where the (elastic) locking piece 52 engages with the bottom side of the flange 82 (upper edge) of the vial 8. On the other hand, the height of the upper container 51 formed between the upper end of the locking piece 52 and the bottom surface of the annular web 43 generally corresponds to or may be slightly less than the height of the flange 82 (upper edge) of the vial and the thickness of the periphery of the stopper 85 (see...). Figure 3bThis allows the peripheral edge of the stopper 85 to be firmly pressed against the flange 82 (upper edge) of the vial, if necessary, to airtightly seal the opening 83. Simultaneously, a portion of the upper surface of the stopper 85 inside the central opening 46 can be aseptically sealed in a manner as described in more detail below to prevent contaminants from entering this area, although such aseptic sealing of the stopper 85 is not essential according to the invention and may not be provided. In other words, when the locking body 4 is locked in the neck of the vial, there may be a certain axial gap between the bottom surface of the annular web 43 and the upper surface of the stopper located in the opening of the vial, and between the indicator ring 32 and the upper surface of the stopper, so that the upper surface of the stopper may not maintain aseptic conditions inside the tamper-evident plastic closure 1.

[0139] refer to Figure 7a as well as Figure 7b Additional features applicable to all embodiments of the tamper-evident plastic sealant according to the present invention will be described. For example... Figure 7a as well as Figure 7b As shown, at least one window 59 is formed in the sidewall 40 of the tubular locking body 4, which can be used as a vent to allow a fluid path between the internal volume of the enclosure 1 and the surrounding environment. More specifically, at least one window 59 is disposed in the upper container 51 of the locking body (see...). Figure 2a At the same level. Preferably, at least one pair of such windows 59 (vents) are located at diametrically opposite positions on the sidewalls 40 at the same level. When the tamper-evident plastic closure 1 is locked in the neck of the vial, at least one window 59 (vent) functions to establish a fluid path between the surrounding environment and the upper surface of the stopper, and / or the outer surface of the vial in the neck and flange areas. Such windows 59 (vents) facilitate the removal of moisture and residual material during the production of the closure 1 or during subsequent further processing (e.g., sterilization or use during lyophilization of the vial contents). For this purpose, it is important that the corresponding area from which moisture and residual material are removed from the vial or stopper is in fluid communication with at least one window 59 (vent), which can be ensured by the appropriate design of the closure 1 and its installation on the vial.

[0140] refer to Figure 3cAdditional features applicable to all embodiments of the tamper-evident plastic closure according to the invention will be described. As outlined above, the tamper-evident plastic closure according to the invention does not necessarily seal the area of ​​the stopper 85 that may be pierced at a later stage under aseptic conditions by the distal tip of a needle or syringe. Therefore, in the tamper-evident plastic closure according to the invention, the central opening 46 of the locking body 4 is preferably configured such that the upper surface of the stopper 85 of the vial 8 can be easily disinfected by a swab after the cap has been removed from the locking body 4 by irreversibly breaking the annular fragile portion. For this purpose, the depth and diameter of the central opening 46 of the locking body 4 are sized such that the user can easily disinfect the upper surface of the stopper 85 by a swab soaked in a disinfectant (e.g., alcohol) before actually piercing the stopper 85 with the distal tip of a needle or syringe. In other words, the depth and diameter of the central opening 46 of the locking body 4 are such that a swab can be easily inserted into the central opening 46 by, for example, a user's index finger, and essentially the entire area of ​​the central opening 46 on the upper surface of the plug 85 can be cleaned and disinfected by the swab.

[0141] To further facilitate the insertion of the swab into the central opening and to essentially disinfect the entire area of ​​the central opening 46 on the upper surface of the stopper 85, the edge of the central opening 46 is formed by an inclined upper surface 47a, which extends at an acute angle relative to a line perpendicular to the axial direction of the tubular locking body 4, such that before breaking the annular fragile portion 30, the virtual extension line (not shown) of the inclined upper surface 47a intersects the upper surface of the stopper 85 at or near the radial position of the edge of the indicator ring 32, wherein the indicator ring 32 corresponds to the inner surface of the cylindrical protrusion 28, as can be seen from... Figure 3b The conclusions drawn.

[0142] Therefore, the tamper-evident plastic closure according to the invention can be used to reliably cover or seal the stopper of a medicine bottle during storage and transportation, and provides easy access to the contents of the bottle after the cap is removed by irreversibly breaking at least one fragile portion of the coupling protrusion. After breaking at least one fragile portion of the coupling protrusion, at least one indicator member (preferably shaped as an indicator ring) remains in the central opening of the locking tab as a clearly visible tamper-evident indicator, which also reliably prevents the stopper from being closed or resealed by replacing the cap.

Claims

1. A tamper-evident plastic closure for a medicine bottle (8) for storing a substance for medical or pharmaceutical use, having a neck (81) and a flange (82) at an axial end of the neck, the tamper-evident plastic closure for holding a stopper (85) in the mouth (83) of the medicine bottle, the tamper-evident plastic closure (1) comprising: A tubular locking body (4) having a distal end (41) and a proximal end (42) and configured to be mounted on the neck (81) of the vial (8); as well as A cap (2) is coupled to the tubular locking body (4) at the distal end; in The tubular locking body (4) includes: A retaining member, disposed at the distal end (41), is configured to retain the stopper (85) in the opening (83) of the vial (8), wherein a central opening (46) is formed in the retaining member for providing access to the interior of the vial (8) from the outside of the tubular locking body (4) via the stopper (85); and wherein The cap (2) includes: A disc-shaped cap (20) is provided to cover the distal end (41) of the tubular locking body (4) and the central opening (46) of the tubular locking body (4); and A coupling portion is disposed at a center of the disc-shaped cover (20) and protrudes from a bottom surface (26) of the disc-shaped cover (20) for engaging with the central opening (46) of the tubular locking body (4) through a positive fit; wherein The disc-shaped cap (2) and the tubular locking body (4) are formed as separate components; and The tubular locking body (4) is formed as a single piece and is configured to cover the entire area of ​​the neck (81) of the vial (8); wherein The coupling portion includes: A ring-shaped fragile portion (30) is integrally formed with the disc-shaped cover (20) and protrudes from the bottom surface (26) of the disc-shaped cover (20). A cylindrical protrusion (28) protrudes from the bottom surface (26) of the disc-shaped cover (20); and One indicator ring (32); wherein The cylindrical protrusion (28) and the indicator ring (32) are connected to each other via the annular fragile portion (30) so that, after irreversibly breaking the annular fragile portion (30) to provide access to the interior of the vial (8) via the stopper (85) and removing the cap (2) from the distal end of the tubular locking body (4), the indicator ring (32) remains at an edge (34) of the central opening (46) of the tubular locking body (4) as evidence of tampering. The indicator ring (32) is clamped or held between the bottom of the retaining member and the upper surface of the stopper (85) with an axial gap and protrudes radially inward beyond the edge (34) of the central opening (46) of the tubular locking body (4) into the central opening (46).

2. The tamper-evident plastic closure as claimed in claim 1, wherein a plurality of locking tabs (52) or protrusions are integrally formed on an inner surface of the tubular locking body (4), wherein the locking tabs (52) are configured to lock the tubular locking body (4) at the neck (81) of the vial.

3. The tamper-evident plastic sealant as described in claim 2, wherein... The retaining member is formed of an annular web (43), which is connected to a cylindrical sidewall (40) of the tubular locking body (4) via a plurality of radial webs (44). The radial webs (44) are spaced apart from each other along the periphery of the tubular locking body (4), and a plurality of recesses (45) are formed between adjacent radial webs (44). The plurality of locking pieces (52) are disposed near the proximal end (42) of the tubular locking body (4), and the plurality of locking pieces (52) are respectively located at positions corresponding to the plurality of recesses (45).

4. The tamper-evident plastic seal as claimed in claim 3, wherein a radial protrusion (47) with a thickness less than that of the annular web (43) protrudes radially inward from the annular web (43) into the central opening (46).

5. The tamper-evident plastic closure as claimed in claim 4, wherein the radial protrusion (47) includes an inclined upper surface (47a) and an inclined lower surface (47b) formed along the periphery of the central opening (46), the inclined upper surface (47a) and the inclined lower surface (47b) extending at an acute angle relative to a line perpendicular to the axial direction of the tubular locking body (4), and wherein the inclined upper surface (47a) and the inclined lower surface (47b) surround at least one linear edge portion (47c) extending in the axial direction of the tubular locking body (4).

6. The tamper-evident plastic closure as claimed in claim 1, wherein an upper surface (35) of the indicator ring (32) extends parallel to an oblique lower surface (47b) of a radial protrusion (47) of the tubular locking body (4).

7. The tamper-evident plastic closure as claimed in claim 6, wherein a bottom surface of the indicator ring (32) is convex.

8. The tamper-evident plastic closure as claimed in claim 5, wherein an upper surface (35) of the indicator ring (32) is inclined at an acute angle toward the bottom surface (26) of the cap, the acute angle being the same as the acute angle formed between the bottom of the retaining member and a plane perpendicular to the axial direction of the plastic closure (1).

9. The tamper-evident plastic closure as claimed in claim 1, wherein a peripheral edge (23) of the cap (2) protrudes outward in the radial direction beyond an outer surface of the tubular locking body (4), and an annular concave recess is formed on an upper surface of the disc-shaped cap (20).

10. The tamper-evident plastic sealant as described in claim 1, wherein... The coupling part snaps into the central opening (46) of the tubular locking body (4) to establish a positive engagement between the coupling part and the central opening (46) of the tubular locking body (4).

11. The tamper-evident plastic closure as claimed in claim 1, wherein a front end (28a) of the coupling portion is irreversibly deformed by plastic deformation or by heating and plastic deformation to establish a positive engagement between the coupling portion and the central opening (46) of the tubular locking body (4).

12. The tamper-evident plastic sealant as described in claim 1, wherein... A skirt (48) at the proximal end (42) of the tubular locking body (4) has a wall thickness greater than that of a cylindrical sidewall (40) at the distal end (41) of the tubular locking body (4). A circumferential radial step (49) is provided on an inner surface of the skirt (48); and A plurality of locking tabs (52) are supported on the circumferential radial step (49); wherein An axial groove (52a) is formed between an inner surface of the cylindrical sidewall (40) and several bases or roots (52b) of the locking piece (52) to adjust the elasticity of the plurality of locking pieces (52) by adjusting the radial width and / or axial depth of the axial groove (52a).

13. The tamper-evident plastic closure as claimed in claim 1, wherein the central opening (46) is configured such that, after the cap (2) is removed from the tubular locking body (4), an upper surface of the plug (85) can be disinfected by a swab by irreversibly breaking the annular fragile portion (30).

14. The tamper-evident plastic closure as claimed in claim 13, wherein one edge of the central opening (46) is formed by an inclined upper surface (47a) that extends at an acute angle relative to a line perpendicular to the axial direction of the tubular locking body (4), such that before the annular fragile portion (30) is destroyed, a virtual extension of the inclined upper surface (47a) intersects the upper surface of the plug (85) in a radial position or in a radial position near an inner surface of the coupling portion.

15. The tamper-evident plastic closure as claimed in claim 13, wherein the width and / or depth of the central opening (46) are designed such that a swab can be inserted into the central opening (46) by a user's finger to disinfect the upper surface of the plug (85).

16. The tamper-evident plastic sealant as described in claim 1, wherein... At least one window (59) is formed in one side wall (40) of the tubular locking body (4); and When the tamper-evident plastic closure (1) is held in the opening (83) of the vial (8), a fluid path is formed between the surrounding environment and the upper surface of the stopper (85) and / or an outer surface of the vial in the region of the neck (81) and the flange (82).

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