WO2017188949A1

WO2017188949A1 - Tamper evident seal for drug vial

Info

Publication number: WO2017188949A1
Application number: PCT/US2016/029675
Authority: WO
Inventors: Phil HUMPHREY; Markus Vor Dem Esche; Xia Zhao
Original assignee: West Pharmaceutical Services Inc
Current assignee: West Pharmaceutical Services Inc
Priority date: 2016-04-28
Filing date: 2016-04-28
Publication date: 2017-11-02
Anticipated expiration: 2018-10-28

Abstract

A combination drug vial and tamper evident seal includes an internal chamber (12) for storing a material and has a neck with an opening therethrough in fluid communication with the internal chamber. A cap (18) is detachably and sealingly coupled to the vial and includes a top covering the opening. A skirt (22) extends around the perimeter and away from the top while surrounding at least a portion of the neck (16). The skirt has a proximal end adjacent the top and a distal end opposite the proximal end. At least one frangible score line (28) extends from the proximal end of the skirt toward, but terminates prior to, the distal end of the skirt. The at least one frangible score line is configured to break when the cap is detached from the vial.

Description

TITLE OF THE INVENTION

Tamper Evident Seal For Drug Vial

BACKGROUND OF THE INVENTION

[0001] The present invention relates generally to a closure for containers, for example, pharmaceutical vials, and more particularly to a closure for containers that indicates whether the closure has been tampered with or previously opened or accessed.

[0002] Containers, such as, for example, pharmaceutical vials, often contain contents that may be compromised once exposed to the environment, or even if merely unsealed. Such contents, for example, may be intended for single use consumption only. In such applications, it is important for a user, such as, for example, a health care worker, to be able to determine whether the contents within a container have been previously exposed and are therefore no longer suitable for use, or dispensing, or whether the contents have not been previously accessed or exposed and are suitable for use.

[0003] Alternatively, in many applications, whether medical or non-medical a manufacturer may wish to instruct consumer and/or end users to not purchase or use product within a container that has been tampered with or opened prior to purchase. Similarly, it is often preferred by an end-user and/or consumer to be able to determine whether a particular container of product to be purchased has been previously opened or tampered with. Likewise, it is often equally important for a place of business to be able to determine whether a container of product has been opened or tampered with, such as, for example, after purchase because certain products sold in containers are no longer returnable once opened.

[0004] Therefore, it would be advantageous to have a closure for containers that can indicate whether or not the closure has been opened or accessed. Such a closure, usable with different existing container designs in the market, would minimize the costs associated with designing and manufacturing new containers that indicate whether or not the container has been previously opened, accessed or tampered with.

[0005] The invention provides tamper evident closures for containers, particularly, tamper evident closures for containers having an open end for assembling with a closure. BRIEF SUMMARY OF TFIE INVENTION

[0006] Briefly stated, one aspect of the present invention is directed to a combination drug vial and tamper evident seal. The vial includes an internal chamber for storing a material and has a neck with an opening therethrough in fluid communication with the internal chamber. A cap is detachably and sealingly coupled to the vial and includes a top covering the opening. A skirt extends around the perimeter and away from the top while surrounding at least a portion of the neck. The skirt has a proximal end adjacent the top and a distal end opposite the proximal end. At least one frangible score line extends from the proximal end of the skirt toward, but terminating prior to, the distal end of the skirt. The at least one frangible score line is configured to break when the cap is detached from the vial.

[0007] Another aspect of the present invention is directed to a combination drug vial and tamper evident seal. The vial includes an internal chamber for storing a material and has a neck with an opening therethrough in fluid communication with the internal chamber. A cap is detachably and sealingly coupled to the vial and includes a top covering the opening. A skirt having a first section and a second section extends around the perimeter of the cap. The skirt extends away from the top and surrounds at least a portion of the neck. The skirt has a proximal end adjacent the top and a distal end opposite the proximal end. A frangible score line extends circumferentially around at least a portion of the skirt between the first section and the second sections.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The foregoing summary, as well as the following detailed description of preferred embodiments of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown. In the drawings:

[0009] Fig. 1 is a side perspective view of a vial and tamper evident seal in accordance with one embodiment of the present invention;

[0010] Fig. 2 is an isolated side perspective view of the tamper evident seal of Fig. 1 ; [0011] Fig. 3 is a side perspective view of a vial and tamper evident seal in accordance with another embodiment of the present invention;

[0012] Fig. 4 is a side perspective view of the vial and tamper evident seal of Fig. 3 with a different score line.

DETAILED DESCRIPTION OF THE INVENTION

[0013] Certain terminology is used in the following description for convenience only and is not limiting. The words "right," "left," "lower," and "upper" designate directions in the drawings to which reference is made. The words "inwardly" or "distally" and "outwardly" or "proximally" refer to directions toward and away from, respectively, the geometric center or orientation of the device and related parts thereof. Unless specifically set forth herein, the terms "a", "an" and "the" are not limited to one element but instead should be read as meaning "at least one". The terminology includes the above-listed words, derivatives thereof and words of similar import.

[0014] It should also be understood that the terms "about," "approximately," "substantially" and like terms, used herein when referring to a dimension or characteristic of a component of the invention, indicate that the described dimension/characteristic is not a strict boundary or parameter and does not exclude minor variations therefrom that are functionally similar. At a minimum, such references that include a numerical parameter would include variations that, using mathematical and industrial principles accepted in the art (e.g. , rounding, measurement or other systematic errors, manufacturing tolerances, etc.), would not vary the least significant digit.

[0015] The present invention relates to a tamper evident seal for a container generally designated 10 as shown in Figs. 1-2. The seal 10 is coupled to a vial 12 or other container to provide a closure for the container 12. The vial 12 includes a body 14 and a neck 16. The body 14 includes an internal chamber 12a for storing material such as liquid drugs or medicament. An opening 12b, shown in phantom on Fig. 1 , extends through the neck to establish fluid communication with the internal chamber 12a.

[0016] A cap 18 is detachably coupled to the vial 12 and seals the vial opening 12b to provide a hermetic seal on the vial 12. The cap 18 includes an upper portion or top 20 and a skirt 22. The upper portion 20 has an outer diameter at least slightly larger than the diameter of the skirt 22. The skirt 22 extends around the perimeter of the upper portion 20 or top of the cap 18 and surrounds at least a portion of the vial neck 16. The skirt 22 has a proximal end 22a adjacent the top 20 of the cap 18 and a lower or distal end 22b opposite the proximal end 22a. A shoulder 24 is formed where the upper portion 20 meets the skirt 22. Alternatively, the upper portion 20 and skirt 22 can have the same diameter and no shoulder is needed (not shown). In yet another alternative (not shown), the skirt 24 can have a larger diameter than the upper portion 20.

[0017] The skirt 22 is preferably manufactured from a thin rigid material (e.g. metal) that can retain its shape when the skirt 22 is crimped around the neck 16 of the container 12 such that a lower edge 26 of the skirt 22 is secured below a lip (not shown) on the neck 16. One or more and preferably five spaced apart score lines 28 are formed on the skirt 22 which are frangible and designed to fracture as the skirt 22 is pulled away from the neck 18 and the cap 18 is removed or partially removed from the vial 12. Each score line 28 can be a segment having a reduced thickness compared to the rest of the skirt 22 with an indentation formed on an outer surface of the skirt 22 and extending toward, but terminating prior to, an inner surface of the skirt 22. Alternatively, the score lines 28 may be a different material than the rest of the skirt 22 with a lower yield strength such that one or more of the score lines 28 are fractured before the rest of the skirt 22 as explained in greater detail below. Alternatively, the score lines 28 may be the same material and/or thickness as the rest of the skirt 22 but may be chemically or physically treated such that the score lines 28 fracture before the rest of the skirt 22. The score lines 28 extend generally vertically in the embodiment of Figs. 1 -2 and generally horizontally in the embodiment shown in Figs. 3-4. Alternatively, the score lines 28 could extend at an angle and may not extend completely around the skirt 22. The score lines 28 of Figs. 1 -2 terminate at least 0.5 millimeters from the distal end of the skirt 22.

[0018] The skirt 22 is transitionable between an expanded pre-crimped state and a crimped state as shown in Fig. 1. The score lines 28 may be formed prior to crimping or may be scored during or after crimping the skirt 22 to the vial 12. Although the score lines 28 of Fig. 1 are shown as generally having the same length, one or more score lines 28 may have different lengths. A seal line 30 is created toward the distal end of the skirt 22 which forms the hermetic seal between the skirt 22 and the vial 12. The score lines 28 extend above and beyond the seal line 30 in Fig. 1. Although five score lines are shown in Figs. 1 -2. any number of score lines 28 could be used.

[0019] In the embodiment shown in Figs. 3-4, at least one score line 28 is located above the seal line 30. The score line 28 of Fig. 3 is a generally horizontal dashed line which extends circumferentially around at least a portion of the skirt 22 and may extend completely around. Furthermore, more than one score line (not shown) could be used or one score line 28 could extend spirally around the skirt 22 completing more than one revolution. The score line of Fig. 4 is a generally horizontal line with a scalloped pattern with peaks 32 and troughs 34 and the troughs are proximate to the distal end 22b of the skirt 22. Alternatively, a zigzag pattern or any other desired pattern (not shown) could be adopted for the score line 28 provided that the score line is adapted to fracture prior to the rest of the skirt 22. The horizontal score line 28 is proximal to the seal line 30 such that the hermetic seal is destroyed when the score line 28 fractures.

[0020] In use, a user receives the vial 12 with liquid medicament within the internal chamber. The user visually inspects the skirt 22 to determine if a score line 28 is fractured which would indicate that the contents of the internal chamber may have been tampered with. If none of the score lines 28 is fractured, the user knows the vial 10 has not been tampered with or previously opened so the user removes the cap 18 and skirt 22 from the vial 12. As the skirt 22 is removed one or more of the score lines 28 fracture as shown in Fig. 2. At least one of the score lines 28 fractures when the cap 18 is removed but not all the score lines 28 are required to fracture. Similarly, it is not required that the entire horizontal score line 28 fractures when the skirt 22 of the embodiment of Figs. 3 and 4 is removed.

[0021] It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiment disclosed, but is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.

Claims

1. A combination vial and tamper evident seal comprising:

a vial having an internal chamber for storing a material, the vial having a neck with an opening extending through the neck in fluid communication with the internal chamber; and

a cap detachably sealingly coupled to the vial and including a top covering the opening and a skirt extending around the perimeter and away from the top and surrounding at least a portion of the neck, the skirt having a proximal end adjacent the top and a distal end opposite the proximal end, at least one frangible score line extending from the proximal end of the skirt toward, but terminating prior to, the distal end of the skirt, the at least one frangible score line being configured to break when the cap is detached from the vial.

2. The combination vial and tamper evident seal of claim 1, wherein the skirt comprises an outer surface and an inner surface, the plurality of score lines being formed on the outer surface of the skirt but not extending through the skirt.

3. The combination vial and tamper evident seal of claim 1, wherein the skirt includes at least five score lines.

4. The combination vial and tamper evident seal of claim 1, wherein the at least one frangible score line comprises a plurality of frangible score lines.

5. The combination vial and tamper evident seal of claim 1 , wherein the at least one score line terminates 0.5 millimeters from the distal end of the skirt.

6. The combination vial and tamper evident seal of claim 1 , wherein the skirt is transitionable between an expanded, pre-crimped state and a contracted, crimped state, the cap is positioned on the vial when the skirt is in the expanded, pre-crimped state and the cap is secured to the vial when the skirt is transitioned to the contracted, crimped state, and the at least one frangible score line breaks after the skirt is in the crimped state and the cap is detached from the vial.

7. The combination vial and tamper evident seal of claim 1, wherein the at least one score line extends perpendicularly away from the proximal end of the skirt.

8. The combination vial and tamper evident seal of claim 1, wherein the skirt includes a seal line creating a hermetic seal between the skirt and the neck and a portion of the at least one score line is proximal to the seal line.

9. A combination vial and tamper evident seal comprising:

a cap detachably sealingly coupled to the vial and including an top covering the opening and a skirt having a first section and a second section, the skirt extending around the perimeter and away from the top and surrounding at least a portion of the neck, the skirt having a proximal end adjacent the top and a distal end opposite the proximal end, with a frangible score line extending circumferentially around at least a portion of the skirt between the first section and second section.

10. The combination vial and tamper evident seal of claim 9, wherein the frangible score line comprises a scalloped pattern.

11. The combination vial and tamper evident seal of claim 10, wherein the scalloped pattern includes peaks and troughs and the troughs are proximate to the distal end of the skirt.

12. The combination vial and tamper evident seal of claim 9, wherein the score line comprises a horizontal line.

13. The combination vial and tamper evident seal of claim 9, wherein the skirt is transitionable between an expanded, pre-crimped state and a contracted, crimped state, the cap is positioned on the vial when the skirt is in the expanded, pre-crimped state and the cap is secured to the vial when the skirt is transitioned to the contracted, crimped state, and the frangible score line breaks after the skirt is in the crimped state and the cap is detached from the vial.

14. The combination vial and tamper evident seal of claim 9, wherein the score line extends from an outer surface of the skirt toward an inner surface of the skirt.

15. The combination vial and tamper evident seal of claim 9, further comprising a seal line on the skirt, the seal line providing a hermetic seal between the skirt and the neck, wherein the score line is at or below the seal line.

16. The combination vial and tamper evident seal of claim 9, wherein a most distal end of the frangible score line does not extend to the distal end of the skirt.