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CN-115303637-B - Tamper-evident plastic closure for a vial

CN115303637BCN 115303637 BCN115303637 BCN 115303637BCN-115303637-B

Abstract

The invention relates to a tamper-evident plastic closure for a vial for retaining a stopper in the mouth of the vial, comprising a tubular locking body configured to be locked to the neck of the vial and a cap coupled to the tubular locking body. The tubular locking body includes a retaining member for retaining the stopper and a central opening formed in the retaining member for providing access to the interior of the vial through the stopper. The cap includes a disc-shaped cover and a coupling portion for coupling the cap with the tubular locking body by a positive fit snap-fit. The coupling portions include at least one frangible portion, each configured such that by irreversibly breaking the annular frangible portion to provide access to the interior of the vial via the stopper, the at least one indicator member remains at the edge of the central opening of the tubular locking body after the cap is removed from the distal end of the tubular locking body as tamper evidence.

Inventors

  • Risad Kalos dadachangi
  • Keyol Kumar Alvinbai Patel

Assignees

  • 凯莎包装私人公司

Dates

Publication Date
20260508
Application Date
20220506
Priority Date
20210506

Claims (16)

  1. 1. A tamper-evident plastic closure for a vial (8) for storing a substance for medical or pharmaceutical applications, having a neck (81) with a flange (82) at an axial end thereof for retaining a stopper (85) in a mouth (83) of a vial, 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), and A cap (2) coupled at the distal end with the tubular locking body (4), wherein The tubular locking body (4) comprises: A retaining member provided at the distal end (41) and configured to retain the stopper (85) in the mouth (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 exterior of the tubular locking body (4) via the stopper (85), and wherein The cap (2) comprises: a disc-shaped cover (20) for covering the distal end (41) of the tubular locking body (4) and for covering the central opening (46) of the tubular locking body (4), and A coupling portion provided at a center of the disc-shaped cover (20) and protruding from a bottom surface (26) of the disc-shaped cover (20) for coupling the cap (2) with the tubular locking body (4) by positive engagement of the coupling portion with the central opening (46) of the tubular locking body (4), wherein The cap (2) and the tubular locking body (4) are formed in separate pieces in the shape of a disc, and The tubular locking body (4) is formed in a single piece and is configured to cover the entire area of the neck (81) of the vial (8), wherein The coupling portion includes: An annular frangible portion (30) integrally formed with the disc-shaped cover (20) and protruding from the bottom surface (26) of the disc-shaped cover (20), A cylindrical protrusion (28) protruding from the bottom surface (26) of the disc-shaped cover (20), and An indicator ring (32), wherein The cylindrical protrusion (28) and the indicator ring (32) are connected to each other via the annular frangible portion (30) such that after removal of the cap (2) from the distal end of the tubular locking body (4) by irreversibly destroying the annular frangible portion (30) to provide access to the interior of the vial (8) via the stopper (85), the indicator ring (32) remains maintained at an edge (34) of the central opening (46) of the tubular locking body (4) as tamper evidence, the indicator ring (32) being clamped or held with an axial gap between the bottom of the maintaining member and the upper surface of the stopper (85) and protruding radially inwardly beyond the edge (34) of the central opening (46) of the tubular locking body (4) into the central opening (46).
  2. 2. The tamper-evident plastic closure of 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) to the neck (81) of the vial.
  3. 3. The tamper-evident plastic closure of claim 2, wherein The retaining member is formed by an annular web (43), the annular web (43) being connected to a cylindrical side wall (40) of the tubular locking body (4) via a plurality of radial webs (44), the radial webs (44) being spaced apart from each other along the periphery of the tubular locking body (4), a plurality of recesses (45) being formed between adjacent radial webs (44), and wherein The plurality of locking pieces (52) are provided near the proximal end (42) of the tubular locking body (4), and the plurality of locking pieces (52) are respectively at positions corresponding to the plurality of recesses (45).
  4. 4. A tamper-evident plastic closure as claimed in claim 3, wherein a radial projection (47) of a thickness smaller than a thickness of the annular web (43) projects radially inwardly from the annular web (43) into the central opening (46).
  5. 5. The tamper-evident plastic closure of claim 4, wherein the radial protrusion (47) comprises an inclined upper surface (47 a) and an inclined lower surface (47 b) formed along the periphery of the central opening (46), the inclined upper surface (47 a) and the inclined lower surface (47 b) each extending at an acute angle with respect to a line perpendicular to the axial direction of the tubular locking body (4), and wherein the inclined upper surface (47 a) and the inclined lower surface (47 b) enclose at least one linear edge portion (47 c), the at least one linear edge portion (47 c) extending in the axial direction of the tubular locking body (4).
  6. 6. Tamper-evident plastic closure according to claim 1, wherein an upper surface (35) of the indicator ring (32) extends parallel to a slanted lower surface (47 b) of a radial projection (47) of the tubular locking body (4).
  7. 7. The tamper-evident plastic closure of claim 6, wherein a bottom surface of the indicator ring (32) is convexly curved.
  8. 8. The tamper-evident plastic closure of claim 5, wherein an upper surface (35) of the indicator ring (32) is inclined towards the bottom surface (26) of the cap at an acute angle that 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 (1).
  9. 9. Tamper-evident plastic closure according to claim 1, wherein a peripheral edge (23) of the cap (2) protrudes radially outwards beyond an outer surface of the tubular locking body (4), and an annular shaped concave recess is formed on an upper surface of the disc-shaped cover (20).
  10. 10. The tamper-evident plastic closure of claim 1, wherein The coupling portion is snap-fitted into the central opening (46) of the tubular locking body (4) for establishing a positive-fit snap-fit engagement of the coupling portion with the central opening (46) of the tubular locking body (4).
  11. 11. Tamper-evident plastic closure according to claim 1, wherein a front end (28 a) of the coupling portion is irreversibly deformed by plastic deformation or by heating and plastic deformation for establishing a positive-fitting engagement of the coupling portion with the central opening (46) of the tubular locking body (4).
  12. 12. The tamper-evident plastic closure of claim 1, wherein A skirt (48) at the proximal end (42) of the tubular locking body (4) has a wall thickness that is greater than a cylindrical sidewall (40) at the distal end (41) of the tubular locking body (4); a circumferential radial step (49) provided on an inner surface of the skirt (48), and A plurality of locking tabs (52) supported on the circumferential radial step (49), wherein An axial groove (52 a) is formed between an inner surface of the cylindrical sidewall (40) and a plurality of bases or roots (52 b) of the locking pieces (52), respectively, for adjusting the elasticity of the plurality of locking pieces (52) by adjusting the radial width and/or axial depth of the axial groove (52 a).
  13. 13. The tamper-evident plastic closure of claim 1, wherein the central opening (46) is configured such that an upper surface of the plug (85) is sterilizable by a swab by irreversibly destroying the annular frangible portion (30) after removal of the cap (2) from the tubular locking body (4).
  14. 14. The tamper-evident plastic closure of claim 13, wherein an edge of the central opening (46) is formed by a beveled upper surface (47 a), the beveled upper surface (47 a) extending at an acute angle relative to a line perpendicular to the axial direction of the tubular locking body (4) such that a virtual extension of the beveled upper surface (47 a) intersects the upper surface of the plug (85) at a radial position or a radial position near an inner surface of the coupling portion prior to breaking the annular frangible portion (30).
  15. 15. The tamper-evident plastic closure of claim 13, wherein an opening width and/or depth of the central opening (46) is sized such that a swab may be inserted into the central opening (46) by a user's finger to disinfect the upper surface of the stopper (85).
  16. 16. The tamper-evident plastic closure of claim 1, wherein At least one window (59) is formed in a side wall (40) of the tubular locking body (4), and When the tamper-evident plastic closure (1) is held in the mouth (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).

Description

Tamper-evident plastic closure for a vial Technical Field The present invention relates to a tamper-evident plastic closure for a vial for storing a substance for medical or pharmaceutical applications, and to a method of using such a tamper-evident plastic closure, in particular for sealing a vial having such a tamper-evident plastic closure, and for removing a liquid from the vial or for reconstituting a drug within the vial, such liquid comprising a substance for medical or pharmaceutical applications. Background Bottles or vials of glass or plastic material for storing pharmaceutical products (e.g. freeze-dried or liquid products for injection or infusion) are known from the prior art. Such vials are generally closed by a rubber stopper that can be pierced by a needle. Typically, the rubber stopper is held on the neck of the vial by an aluminum capsule that completely covers the rubber stopper, and has a portion that can be removed by tearing, which allows access to the rubber stopper. However, such aluminium capsules cannot cover the plug in a sterile manner and in the absence of undesirable particles. Thus, such aluminum capsules have difficulty minimizing the level of particulate contamination into a controlled gas environment (e.g., clean room). To overcome these drawbacks, cap structures have been provided that include a cap that can be removed to provide access to the stopper via a central opening of a sleeve-like member mounted to the distal end of the vial. Such cap structures are known, for example from US 3,193,128 or US 3,358,865. In order to further reduce costs and facilitate the mounting of such a cap structure at the distal end of a drug vial, plastic cap structures have been provided that include a tubular locking body that is mountable on the neck of the drug vial by a locking tab or the like and that includes a cover that can be torn off to provide access to the interior of the drug vial from the exterior of the tubular locking body via a central opening of the tubular locking body and a stopper. Such a closure is disclosed, for example, in EP 0 614 A1. Providing tamper evident means in such cap structures is another important feature. For this purpose, US 5,152,413 discloses a tamper evident closure comprising frangible bridges which remain visible after removal of the cap. EP 3 326,932 A1 discloses a closure system for a vial comprising an inner capsule configured to fit over the neck of the vial and to retain a stopper in a sealed closure configuration of the mouth of the vial, and an outer capsule capable of fitting over the inner capsule. The outer capsule is made in one piece and comprises an upper disc-shaped portion configured to close the opening of the inner capsule and a lower disc-shaped portion capable of fitting around the inner capsule, wherein the outer capsule comprises frangible portions embodied as breaking lines between the upper disc-shaped portion and the lower disc-shaped portion. US 20160550 A1 discloses a closure cap similar to EP 3 326 932 A1. To give the bead an L-shaped profile which is bent around the edge of the central opening, the cap is snap-fastened to the ring by first inserting the bead provided on the bottom surface of the cap into the central opening of the ring and then deforming the bead by heating. The tubular body of the closure cap consists of two members, namely a cage which can be locked onto the neck of the vial and a cylindrical member which is locked to the cage. US 2016010488 A1 discloses a tamper-evident plastic closure. The frangible portion is not provided in the coupling portion of the cap, but is provided in the collar, the lower portion of the skirt of the collar being curled inwardly so that the collar engages the lower surface of the rim of the vial from below. Specific locking tabs for locking the collar to the neck of the vial are not disclosed. When the user removes the cap from the collar, at least some of the bridging webs that connect the hub of the tamper evident mechanism to the annular portion on the top surface of the collar are broken, which can be determined by the customer. Fig. 8 and 9 of US 2016010488 A1 also disclose an embodiment wherein the edge of the central opening on the top surface of the collar may be relatively smooth after removal of the cap cover. Disclosure of Invention It is an object of the present invention to provide a low cost and reliable tamper-evident plastic closure for a vial that can be easily installed and used conveniently to retain a stopper in the mouth of the vial in a sealed configuration. It is a further object of the present invention to provide a method for sealing a vial having such a tamper-evident plastic closure, and for withdrawing a liquid comprising a substance for medical or pharmaceutical applications from the vial or for reconstituting a drug within the vial. According to the present invention there is provided a tamper-evident plastic closure for a vial for storing a subs