WO2018187280A1 - Tamper evident seal for drug vial with frangible button - Google Patents

Abstract

A combination drug vial and tamper evident seal (10) includes a vial (12) having a vial neck (14) with a vial opening (16) therethrough to provide fluid communication with the inside of the vial. A ferrule (20) is coupled to the vial neck and includes a ferrule top portion (22) positioned over the vial opening with an aperture formed therein. A septum (18) is sealingly positioned in the vial opening and at least partially covered by the ferrule top portion. A cap (28) is detachably coupled to the ferrule and at least partially covers the ferrule top portion. The cap has an outer border (30) and a center (32) with a frangible tab (38) extending from the cap and being secured to the ferrule. A frangible score (34) line is formed in at least a portion of the cap, whereby the frangible score line and the frangible tab fracture as the cap is detached from the ferrule.

Description

TITLE OF THE INVENTION

[0001] Tamper Evident Seal For Drug Vial With Frangible Button

CROSS-REFERENCE TO RELATED APPLICATIONS [0002] This application claims priority from U.S. Provisional Patent Application No. 62/480,791, titled "Tamper Evident Seal for Drug Vial with Frangible Button," filed April 3, 2017, the entire contents of which are incorporated by reference herein.

BACKGROUND OF THE INVENTION

[0003] The present invention relates 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.

[0004] 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.

[0005] Alternatively, in many applications, whether medical or non-medical, a manufacturer may wish to instruct consumers 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 tampered with or opened. Likewise, it is often equally important for a place of business to be able to determine whether a container of product has been tampered with or opened, such as, for example, after purchase, because certain products sold in containers may no longer be returnable once opened.

[0006] 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.

[0007] The present 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 THE INVENTION

[0008] Briefly stated, one aspect of the present invention is directed to a combination drug vial and tamper evident seal comprising: a vial having a vial neck with a vial opening

therethrough; a ferrule coupled to the vial neck, the ferrule having a ferrule top-portion positioned over the vial opening and an aperture in the ferrule top-portion; a septum sealingly positioned in the vial opening and at least partially covered by the ferrule top-portion; a cap detachably coupled to the ferrule and at least partially covering the ferrule top-portion; the cap having an outer-border and a center; a frangible tab extending from the cap proximate the center, the frangible tab secured to the ferrule; and a frangible score-line formed in at least a portion of the cap extending from the outer-border toward the center, whereby the frangible score-line and the frangible tab fracture as the cap is detached from the ferrule by peeling the cap away from the ferrule.

[0009] Another aspect of the present invention is directed to a combination drug vial and tamper evident seal comprising: a vial having a vial neck with an vial opening therethrough; a ferrule coupled to the vial neck, the ferrule having a ferrule top-portion positioned over the vial opening and an aperture in the ferrule top-portion; a septum sealingly positioned in the vial opening and at least partially covered by the ferrule top-portion; a cap detachably coupled to the ferrule and at least partially covering the ferrule top-portion; and a frangible score-line in the cap, the frangible score-line enclosing a separable button, the separable button being fixed to the ferrule, such that upon the frangible score-line being fractured, the cap is detached and separated from the ferrule and the separable button so that the separable button is exposed and remains fixed to the ferrule.

[0010] Still another aspect of the present invention is directed to a combination drug vial and tamper evident seal comprising: a vial having a vial neck with a vial opening therethrough; a ferrule coupled to the vial neck and having a ferrule top-portion adjacent the vial neck; a septum sealingly positioned within the vial opening; a cap detachably coupled to the ferrule and covering the ferrule top-portion, the cap including a cap upper surface, a cap lower surface, and an outer border extending around the cap; and a plurality of frangible score-lines extending upwardly from the lower surface of the cap and extending spirally around at least a portion of the of the cap from the outer border toward a center of the cap, the frangible score-lines fracturing when the cap is detached from the ferrule.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] 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:

[0012] Fig. 1 is a top perspective view of a combination drug vial and tamper evident seal in accordance with a first preferred embodiment of the present invention;

[0013] Fig. 2 is a top perspective view of the combination drug vial and tamper evident seal of Fig. 1 with the tamper evident seal detached from the drug vial;

[0014] Fig. 3 is a top plan view of a tamper evident seal in accordance with a second preferred embodiment of the present invention;

[0015] Fig. 4 is a bottom plan view of the tamper evident seal of Fig. 3;

[0016] Fig. 5 is a bottom plan view of the tamper evident seal of Fig. 3 when the tamper evident seal is detached from the drug vial;

[0017] Fig. 6 is a top plan view of a tamper evident seal in accordance with a third preferred embodiment of the present invention;

[0018] Fig. 7 is a top perspective view of the tamper evident seal of Fig. 6 shown detached from and adjacent to the drug vial;

[0019] Fig. 8 is a top perspective view of a tamper evident seal in accordance with a fourth preferred embodiment of the present invention shown detached from and adjacent to the drug vial;

[0020] Fig. 9 is a top plan view of a tamper evident seal in accordance with a fifth preferred embodiment of the present invention; and

[0021] Fig. 10 is a bottom plan view of the tamper evident seal of Fig. 9 shown after detachment from the drug vial. DETAILED DESCRIPTION OF THE INVENTION

[0022] Reference will now be made in detail to embodiments of the invention, examples of which are illustrated in the accompanying drawings. The terminology used in the description of the invention herein is for the purpose of describing the particular embodiments only and is not intended to be limiting of the invention.

[0023] As used in the description of the invention, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The words "and/or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items. The words "comprises" and/or "comprising," when used in this specification, specify the presence of the stated features, integers, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

[0024] It should also be understood that the terms "about," "approximately," "generally," "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.

[0025] The words "right," left," "lower," "upper," "front," and "rear" designate directions in the drawings to which reference is made. The words "inwardly" and "outwardly" refer to directions toward and away from, respectively, the geometric center of the combination drug vial and tamper evident seal, and designated parts thereof. The terminology includes the words noted above, derivatives thereof and words of similar import.

[0026] Although the words first, second, etc., are used herein to describe various elements, these elements should not be limited by these words. These words are only used to distinguish one element from another. For example, a first frangible score-line could be termed a second frangible score-line without departing from the scope of the present invention.

[0027] Referring to the drawings in detail, where like numerals indicate like elements throughout, there is shown in Figs. 1-2, a first preferred embodiment of the combination drug vial and tamper evident seal, generally designated 10, and hereinafter referred to as the "tamper- evident sealed vial" 10 in accordance with the present invention.

[0028] The tamper-evident sealed vial 10 comprises a vial 12, such as a glass vial, for storing a material, for example, a medicament or liquid drug. The vial 12 has a vial neck 14 (shown in phantom) with a vial opening 16 (shown in phantom) therethrough to provide fluid

communication with the inside of the vial 12. A septum 18, adapted to be penetrated by a needle (not shown), is sealingly positioned in the vial opening 16.

[0029] A ferrule 20 is coupled to the vial neck 14 and has a ferrule top portion 22 positioned over the vial opening 16 such that the septum 18 is at least partially covered by the ferrule top- portion 22. An aperture 24 in the ferrule top portion 22 surrounds at least a portion of the septum 18, to expose a portion of the septum 18 (Fig. 2). The ferrule 20 includes a ferrule skirt 26 which extends downwardly from the ferrule top portion 22 and is preferably crimped to the vial 12 but may be secured by adhesive, weld, or any other method well known in the art. The aperture 24 extends through the top portion 22 of the ferrule 20, and the septum 18 seals the aperture 24 to prevent material from entering or exiting the vial opening 16. The septum 18 extends across the vial neck 14 to sealingly cover the entire vial opening 16. Alternatively, the septum 18 could be secured to the ferrule 20 such that the septum 18 covers the aperture 24 and only a portion of the vial opening 16 in the vial neck 14. In another preferred embodiment, the septum 18 and the ferrule 20 can be manufactured integrally, such that the septum 18 is within the aperture 24 and the aperture 24 surrounds at least a portion of the septum 18. The septum 18 is configured to be penetrable, such that the contents within the vial 12 can be removed via a needle which may be coupled to a syringe (not shown).

[0030] A cap 28 is coupled to the ferrule 20, such that the cap 28 at least partially covers the ferrule top portion 22 and the septum 18, and preferably covers the entire ferrule top portion 22 and the septum 18. The cap 28 is preferably above the ferrule skirt 26, but may also extend downwardly such that a portion of the cap 28 is adjacent to the ferrule skirt 26. The cap 28 is preferably manufactured from a material that cannot be penetrated by a needle, such that the cap 28 prevents materials from being withdrawn or inserted into the vial 12 through the septum 18 (e.g. plastic, rubber, metal, foil). The cap 28 includes an outer border 30 surrounding the cap 28 and a center 32. A frangible score line 34 is formed in at least a portion of the cap 28 and extends from the outer border 30 spirally around and toward the center 32 of the cap 28 (see Fig. 1). The frangible score line 34 is a thinner portion of the cap 28 which fractures as a user removes the cap 28 from the vial 12 (see Fig. 2). Alternatively, the frangible score line 34 could be the same thickness as the rest of the cap 28 with perforation, chemical treatment, or a different material that makes it susceptible to fracturing before the rest of the cap 28. In other embodiments, the frangible score line 34 may not extend from the border and may be formed at any portion along the cap 28 in any desired pattern, such as, but not limited to, a square, triangle, or straight line. In further embodiments, more than one frangible score line 34 may be provided. In order to maintain an ample seal over the septum 18, the frangible score line 34 does not extend completely through the cap 28. However, a portion of the frangible score line 34 may extend completely through the cap 28 at the outer border 30 to enable a user to grasp a pull tab 36 at the outer border 30 of the cap 28 proximate to the ferrule skirt 26 and to remove the cap 28 as described in greater detail below. The pull tab 36 may extend beyond the perimeter of the outer border 30 to make it easier to grasp, if desired, and may also form a different shape, such as a ring, bar or any other shape well known in the art for facilitating gripping by a user. A frangible center tab 38 extends from the cap 28 proximate the cap center 32 and is secured to the ferrule 20 in order to secure the cap 28 to the ferrule 20 (see Fig. 2). The frangible tab 38 separates from the ferrule 20 when the cap 28 is detached from the ferrule 28. As can be seen in Fig. 2, the cap 28 unravels along the frangible score line 34 as the user pulls the pull tab 36 to prevent the cap 28 from being reattached to the vial 12 and providing a user with visual indication if the cap 28 and/or vial 12 has been tampered with.

[0031] In operation, the vial 12 is received by a user with a medicament or a liquid drug in the vial 12 and the ferrule 20, septum 18 and cap 28 secured to the vial 12. The user inspects the frangible score line 34 to ensure it is intact and has not been fractured, which would indicate tampering. If the inspection is satisfactory, the user grasps the pull tab 36 and the vial 12 and pulls upon the cap 28. The frangible score line 34 fractures as the user pulls on the pull tab 36, starting at the outer border 30 and moving toward the center 32. The frangible tab 38 is separated from the ferrule 20 as the fracturing makes its way toward the center 32 of the cap 28. The septum 18 is exposed when the frangible tab 38 is removed. The user can then insert a needle which may be connected to a syringe (not shown) through the septum 18 to insert or remove material from the vial 12. The fractured cap 28 is discarded or recycled as it is not configured to be re-attached to the ferrule 20. [0032] Referring now to Figs. 3-5, a second preferred embodiment of a tamper evident sealed vial, designated 110, is shown. Like reference numbers are utilized to identify like features of the tamper evident seal vial 110 when compared to the first preferred tamper evident sealed vial 10, with a "1" prefix utilized to distinguish the features of the second preferred vial 110 from the features of the first preferred vial 10. A cap 128 includes an upper surface 140 and a lower surface 142. A plurality of frangible score lines 134 are formed in one of the upper surface 140 and lower surface 142. Although the cap 128 is shown as having three frangible score lines 134, any number of score lines 134 may be utilized. An outer border 130 extends above the upper surface 140 and below the lower surface 142 to provide rigidity to the cap 128. A slit 144 is formed through the outer border 130 at the end of each frangible score line 134. In the present embodiment, a user pries off the cap 128 by placing a thumb, finger, or other implement below one or more areas of the outer border 130 and exerting an upward, prying force on the cap 128 away from the vial (not shown), as opposed to peeling the cap 128 away from the vial 12 and ferrule 20, as in the first embodiment. Reinforcing ridges 146 are positioned about a center 132 of the cap 128. The ridges 146 provide strength and rigidity to the cap 128, such that when an upward force is applied to the outer border 130, the frangible score lines 134 fracture (see Fig. 5). The ridges 146 contact the ferrule (not shown) as the cap 128 is pried to prevent a frangible tab 138 from puncturing the septum (not shown). The ridges 146 are shown as arcuate elements which extend downwardly from the lower surface 142, but ridges 146 may alternatively extend upwardly from the upper surface 140.

[0033] In operation, the vial is received by a user with a medicament or a liquid drug in the vial and the ferrule, septum and cap 128 secured to the vial. The user inspects the frangible score lines 134 to ensure they are intact and have not been fractured, which would indicate tampering. If the inspection is satisfactory, the user places a finger, thumb or other device along the outer border 130 and exerts an upward, prying force away from the vial. The frangible score lines 134 fracture as the cap 128 moves away from the vial. The frangible tab 138 is separated from the ferrule and the septum is exposed, when the frangible score lines 134 have fractured and the cap 128 has been pulled away from the vial. The user can then insert a needle which may be connected to a syringe (not shown) through the septum to insert or remove material from the vial. The fractured cap 128 is discarded or recycled as it is not configured to be re-attached to the ferrule. [0034] Referring now to Figs. 6-7, a third preferred embodiment of a tamper evident sealed vial, designated 210, is shown. The tamper evident sealed vial 210 has a similar configuration and structure to the first and second preferred tamper evident sealed vials 10, 110. Like reference numbers are utilized to identify like features of the third preferred tamper evident sealed vial 210 when compared to the first preferred tamper evident sealed vial 10 and the second preferred tamper evident sealed vial 110, with a "2" prefix utilized to distinguish the features of the third preferred tamper evident sealed vial 210 from the features of the first and second preferred tamper evident sealed vials 10, 110. A cap 228 includes a generally curved frangible score line 234 with a first end 248, a middle portion 250, and a second end 252. The first end 248 is adjacent an outer border 230 and forms a slit 244 in the outer border 230. The middle portion 250 is generally circular and extends around at least a portion of a center 232 and therefore at least a portion of a septum 218. The second end 252 is generally circular and overlays a separable button 254. A hole 256, extending through the cap 228 at the second end 252, is formed when the cap 228 is removed from the separable button 254. As can be seen in Fig. 7, the cap 228 preferably has a single frangible score line 234 and a single separable button 254; but the cap 228 may have any number of score lines 234 and separable buttons 254. In an alternative embodiment, the cap 228 may have multiple score lines 234 which converge at the separable button 254. In another alternative embodiment, the cap 228 may have a single frangible score line 234 which connects several separable buttons 254. In a further embodiment, the separable button 254 need not be formed at the second end 252 of the frangible score line 234, but instead could be formed at the first end 248 or middle portion 250. In Figs. 6-7, the separable button 254 is shown as a circular element which is fixed to a post 258 on a ferrule 220 via adhesive, welding, etc. The post 258 can be manufactured from the same material as the ferrule 220 or the cap 228, provided that the post 258 remains fixed to the ferrule 220 when the cap 228 is removed. Alternatively, the ferrule 220 may have an indentation or receiver 260 and the separable button 254 may extend below a lower surface 242 and into the receiver 260 when the cap 228 is secured to the ferrule 220.

[0035] In operation, the cap 228 operates similarly to the cap 10 of the first preferred embodiment, in that the frangible score line 234 fractures as the cap 228 is forced away from a vial 212. However, the frangible score line 234 encloses the separable button 254, such that as the score line 234 is fractured, the cap 228 is detached and separated from the ferrule 220 and the separable button 254, so that the separable button 254 is exposed and remains fixed to the ferrule 220. The septum 218 is exposed when the cap 228 is removed. The user can then insert a needle which may be connected to a syringe (not shown) through the septum 218 to insert or remove material from the vial 212. The fractured cap 228 is discarded or recycled as it is not configured to be re-attached to the ferrule 220. As can be seen in Fig. 6, the frangible score line 234 fractures as the user exerts and upward, prying force on the cap 228 and removes the cap 228, thereby providing the user with visual indication if the cap 228 and/or vial 212 has been tampered with.

[0036] Referring now to Fig. 8, a fourth preferred embodiment of a tamper evident sealed vial, designated 310, is shown. The tamper evident sealed vial 310 has a similar configuration and structure to the first, second, and third preferred tamper evident sealed vials 10, 110, 210. Like reference numbers are utilized to identify like features of the fourth preferred tamper evident sealed vial 310 when compared to the first, second, and third preferred tamper evident sealed vials 10, 110, 210 with a "3" prefix utilized to distinguish the features of the fourth preferred tamper evident sealed vial 310 from the features of the first, second, and third preferred tamper evident sealed vials 10, 110, 210. At least one and preferably three separable buttons 354 are formed on a ferrule 320 with one or more frangible score lines 334 that do not extend to an outer border 330 of a cap 338. Instead, one of the frangible score lines 334 surrounds each of the separable buttons 354. In an alternative embodiment, the frangible score lines 334 could also extend between the separable buttons 354 without extending to the outer border 330. Holes 356, extending through the cap 328, are formed when the cap 328 is removed from the separable buttons 354. In operation, the user places a finger, thumb, or other device along the outer border 330 and exerts a force away from the vial 312, similar to the operation of the second preferred embodiment. As each frangible line 334 fractures, the cap 328 is detached and separated from the ferrule 320 and each separable button 354, so that each separable button 354 is exposed and remains fixed to the ferrule 320. As can be seen in Fig. 8, each of the frangible score lines 334 fractures as the user exerts and upward, prying force on the cap 328 and removes the cap 328, thereby providing the user with visual indication if the cap 328 and/or vial 312 has been tampered with.

[0037] Referring now to Figs. 9-10, a fifth preferred embodiment of a tamper evident sealed vial, designated 410, is shown. The tamper evident sealed vial 410 has a similar configuration and structure to the first, second, third, and fourth preferred tamper evident sealed vials 10, 110, 210, 310. Like reference numbers are utilized to identify like features of the fifth preferred tamper evident sealed vial 410 when compared to the first, second, third, and fourth preferred tamper evident sealed vials 10, 110, 210, 310 with a "4" prefix utilized to distinguish the features of the fifth preferred tamper evident sealed vial 410 from the features of the first, second, third, and fourth preferred tamper evident sealed vials 10, 110, 210, 310. A separable button 454 may have any desired shape, such as, for example, an elongated arcuate element that extends around a portion of the ferrule (not shown). A post (not shown) may have the same shape as the separable button 454, but may have a different shape, if desired. As in the fourth preferred embodiment, a frangible score line 434 of a cap 428 surrounds the separable button 454 without extending to an outer border 430. In operation, the user places a finger, thumb, or other device along the outer border 430 and exerts an upward, prying force away from the vial (not shown), similar to the operation of the second, third, and fourth preferred embodiments. The frangible score line 434 fractures as the cap 428 moves away from the vial and the at least one separable button 454 detaches from the cap 428 and remains fixed to a ferrule 420. As can be seen in Fig. 10, the frangible score line 434 fractures as the user exerts an upward, prying force on the cap 428 and removes the cap 428, thereby providing the user with visual indication if the cap 428 and/or vial has been tampered with.

[0038] 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

CLAIMS We claim:

1. A combination drug vial and tamper evident seal comprising:

a vial having a vial neck with a vial opening therethrough;

a ferrule coupled to the vial neck, the ferrule having a ferrule top-portion positioned over the vial opening and an aperture in the ferrule top-portion;

a septum sealingly positioned in the vial opening and at least partially covered by the ferrule top-portion;

a cap detachably coupled to the ferrule and at least partially covering the ferrule top- portion, the cap having an outer-border and a center;

a frangible tab extending from the cap proximate the center, the frangible tab secured to the ferrule; and

a frangible score-line formed in at least a portion of the cap extending from the outer- border toward the center, whereby the frangible score-line and the frangible tab fracture as the cap is detached from the ferrule by peeling the cap away from the ferrule.

2. The combination drug vial and tamper evident seal of claim 1, wherein the ferrule includes a ferrule skirt extending away from the ferrule top-portion in a direction opposite of the cap, the ferrule skirt being secured to the drug-vial neck.

3. The combination drug vial and tamper evident seal of claim 1, wherein a portion of the outer-border comprises a pull-tab, the pull-tab extending beyond the perimeter of the outer border to facilitate gripping by a user.

4. The combination drug vial and tamper evident seal of claim 1, wherein the frangible score-line extends spirally around at least a portion of the center of the cap.

5. A combination drug vial and tamper evident seal comprising:

a vial having a vial neck with a vial opening therethrough;

a ferrule coupled to the vial neck, the ferrule having a ferrule top-portion positioned over the vial opening and an aperture in the ferrule top-portion; a septum sealingly positioned in the vial opening and at least partially covered by the ferrule top-portion;

a cap detachably coupled to the ferrule and at least partially covering the ferrule top- portion; and

a frangible score-line in the cap, the frangible score-line enclosing a separable button, the separable button being fixed to the ferrule, such that upon the frangible score-line being fractured, the cap is detached and separated from the ferrule and the separable button so that the separable button is exposed and remains fixed to the ferrule.

6. The combination drug vial and tamper evident seal of claim 5, further comprising: a receiver formed in the ferrule, a portion of the separable button extending away from the cap and positioned within the receiver when the cap is coupled to the ferrule.

7. The combination drug vial and tamper evident seal of claim 5, wherein the separable button is elongated and extends around at least a portion of a border of the cap.

8. The combination drug vial and tamper evident seal of claim 5, further comprising a second frangible score-line in the cap, the second frangible score-line enclosing a second separable button in the cap, the second separable button being fixed to the ferrule such that upon the second frangible score-line being fractured, the cap is detached and separated from the ferrule and the second separable button so that the second separable button is exposed and remains fixed to the ferrule.

9. The combination drug vial and tamper evident seal of claim 5, wherein the cap includes a cap upper surface opposite a cap lower surface and the frangible score-line extends upwardly from the cap lower surface toward the cap upper surface.

10. The combination drug vial and tamper evident seal of claim 5, wherein the frangible score-line comprises a first end, a middle portion, and a second end; wherein the first end is adjacent to an outer edge of the cap, the middle portion extends around at least a portion of the septum when the cap is coupled to the ferrule, and the second end forms the separable button; and

wherein the frangible score-line is fractured when the cap is detached from the ferrule.

11. The combination drug vial and tamper evident seal of claim 5, wherein a hole extends completely through the cap after the cap is detached from the ferrule.

12. The combination drug vial and tamper evident seal of claim 5, wherein the ferrule is constructed of metal and the cap is constructed of one of plastic and rubber.

13. The combination drug vial and tamper evident seal of claim 5, wherein the combination drug vial and tamper evident seal comprises a plurality of frangible lines, each of the plurality of frangible score-lines separately enclosing a separable button in the cap, each separable button being fixed to the ferrule such that as the plurality of frangible score-lines are fractured, the cap is detached and separated from the ferrule and each separable button, so that each separable button is exposed and remains fixed to the ferrule.

14. The combination drug vial and tamper evident seal of claim 13, wherein a plurality of holes extend through the cap after the cap is detached from the ferrule.

15. A combination drug vial and tamper evident seal comprising:

a vial having a vial neck with a vial opening therethrough;

a ferrule coupled to the vial neck and having a ferrule top-portion adjacent the vial neck; a septum sealingly positioned within the vial opening;

a cap detachably coupled to the ferrule and covering the ferrule top-portion, the cap including a cap upper surface, a cap lower surface, and an outer border extending around the cap; and

a plurality of frangible score-lines extending upwardly from the lower surface of the cap and extending spirally around at least a portion of the of the cap from the outer border toward a center of the cap, the frangible score-lines fracturing when the cap is detached from the ferrule.

16. The combination drug vial and tamper evident seal of claim 15, further comprising a reinforcing ridge extending downward from the cap lower surface and positioned about the septum.

17. The combination drug vial and tamper evident seal of claim 15, wherein the outer border extends upwardly from the cap upper surface and downwardly from the cap lower surface.

18. The combination drug vial and tamper evident seal of claim 15, further comprising a slit in the outer border at an end of each of the plurality of frangible score-lines.