US20040118802A1

US20040118802A1 - Safety seal for potent product

Info

Publication number: US20040118802A1
Application number: US10/324,658
Authority: US
Inventors: John Lysfjord; Alan Peterson; Stephen Bougie; Joseph Gierzynski
Original assignee: Robert Bosch Packaging Technology BV
Current assignee: Syntegon Packaging Solutions BV
Priority date: 2002-12-19
Filing date: 2002-12-19
Publication date: 2004-06-24

Abstract

A pharmaceutical container includes a vial, a sealing portion, an over cap portion, and a safety seal. The vial includes a first vial portion having a first surface. The vial is configured and arranged to hold a pharmaceutical product. The sealing portion includes a first stopper portion and a second stopper portion, the second stopper portion is positioned in the first vial portion and the first stopper portion rests against the first surface. The over cap portion surrounds the sealing portion and secures the first stopper portion against the first surface. The safety seal encapsulates at least the over cap portion to prevent accidental contact with any pharmaceutical product that might be present on the over cap portion. A method of manufacturing a pharmaceutical container includes filling a pharmaceutical vial with a pharmaceutical product; placing a sealing portion onto the pharmaceutical vial; placing an over cap portion around the sealing portion to secure the sealing portion in the pharmaceutical vial; and placing a safety seal around at least the over cap portion to prevent accidental contact with any pharmaceutical product that might be present on at least the over cap portion. A method of removing a pharmaceutical product from a container includes placing a needle through a safety seal and a stopper of the container; and removing the pharmaceutical product from the container through the needle.

Description

FIELD

The present disclosure relates to pharmaceutical containers and, in particular, to safety seals surrounding at least a portion of the pharmaceutical container.

BACKGROUND

A problem of growing concern among health care workers and pharmaceutical manufacturing personal is the risk of injury and disease resulting from the handling of pharmaceuticals or hazardous products, especially those having high levels of toxicity such as certain cancer chemotherapy drugs and other dangerous substances. The degree of risk to workers handling these toxic pharmaceuticals is dependent upon the drugs' inherent toxicity and the extent to which workers are exposed to the pharmaceuticals. For some pharmaceuticals, the degree of toxicity from accidental dosages is not well understood or known, and the effects of slight exposure over long time periods are unpredictable.

Exposure to toxic pharmaceuticals can be a result of inhalation of airborne dusts from recrystalized pharmaceuticals or of airborne droplets, absorption of pharmaceuticals through the skin, lungs, and mucous membranes from accidental contact, and ingestion of pharmaceuticals with food, beverages, and the like that have been contaminated through accidental contact with the pharmaceutical.

In particular, after manufacture of certain toxic pharmaceuticals, a small amount of pharmaceuticals might be left on the outside of the container containing the pharmaceutical. Accidental contact with this small amount can be harmful and even dangerous to a person. Therefore, improvements are desirable.

SUMMARY

In accordance with the present disclosure, the above and other problems are solved by the following:

In one aspect of the present disclosure, a pharmaceutical container includes a vial, a sealing portion, an over cap portion, and a safety seal. The vial includes a first vial portion having a first surface. The vial is configured and arranged to hold a pharmaceutical product. The sealing portion includes a first stopper portion and a second stopper portion, the second stopper portion is positioned in the first vial portion and the first stopper portion rests against the first surface. The over cap portion surrounds the sealing portion and secures the first stopper portion against the first surface. The safety seal encapsulates at least the over cap portion to prevent accidental contact with any pharmaceutical product that might be present on the over cap portion or the total package.

In another aspect of the present disclosure, a method of manufacturing a pharmaceutical container includes filling a pharmaceutical vial with a pharmaceutical product; placing a sealing portion into the pharmaceutical vial; placing an over cap portion around the sealing portion to secure the sealing portion in the pharmaceutical vial; and placing a safety seal around at least the over cap portion to prevent accidental contact with any pharmaceutical product that might be present on at least the over cap portion.

In another aspect of the present disclosure, a method of removing a pharmaceutical product from a container includes placing a needle through a safety seal and a stopper of the container; and removing the pharmaceutical product from the container through the needle.

BRIEF DESCRIPTION OF THE DRAWINGS

The features and the advantages of the present disclosure are described more completely below in conjunction with the accompanying drawings in which like parts are identified by like numerals and wherein: [0009]
FIG. 1 is a perspective view of a pharmaceutical container having a safety seal in accordance with the present disclosure. [0010]
FIG. 2 is a front view of the pharmaceutical container of FIG. 1 in accordance with the present disclosure. [0011]
FIG. 3 is a cross-sectional view of the pharmaceutical container of FIG. 2, taken along lines [0012] 3-3, in accordance with the present disclosure.
FIG. 4 is a cross-sectional view of a pharmaceutical container without a safety seal, in accordance with the present disclosure. [0013]
FIG. 5 is a cross-sectional view of another embodiment of a pharmaceutical container having a safety seal in accordance with the present disclosure. [0014]
FIG. 6 is a front view of another embodiment of a pharmaceutical container having a safety seal in accordance with the present disclosure. [0015]
FIG. 7 is a front view of yet another embodiment of a pharmaceutical container having a safety seal in accordance with the present disclosure. [0016]
FIG. 8 is a perspective view of another embodiment of a pharmaceutical container having a safety seal in accordance with the present disclosure.[0017]

DETAILED DESCRIPTION

In general, the present disclosure relates to safety-seals for pharmaceutical containers. The safety seals are configured and arranged to protect a handler, or a person, of the pharmaceutical container from accidental contact with any pharmaceutical, or hazardous material, that might be left on the outside of the pharmaceutical container after filling. Such safety seals include vial prophylactics or condoms; sealing wax; dipped-on, paint-on, or spray-on rubbers, rubber-like materials, polymers, or polymer-like materials; shrink wrap; and other like devices. [0018]
Referring to FIGS. 1 and 2, a pharmaceutical container, or package, [0019] 10 is illustrated. The pharmaceutical container 10 includes a pharmaceutical vial portion, or container, 12 and a safety seal 14. The pharmaceutical container 10 is not limited to vials; for example, the pharmaceutical container 10 can be a syringe, ampoule, cartridge, or other container.
FIG. 3 is a cross-sectional view of the [0020] pharmaceutical container 10 of FIG. 2, taken along lines 3-3. The pharmaceutical container 10 includes the pharmaceutical vial portion 12. In general, the pharmaceutical vial portion 12 includes a pharmaceutical vial 15 having a first portion 16 and a second portion 18. The first portion 16 is typically a top portion 20 of the pharmaceutical vial 15. The top portion 20 includes a top 22, a neck 24, and a transition area 26.
The [0021] top 22 is typically circular and defines an opening 28. Preferably, the top 22 has a first diameter D1 between 0.5 inches and 1.3 inches. Of course, any suitable diameter can be used. The opening 28 has a second diameter D2 that is preferably less than D1. Preferably, the second diameter D2 is between 0.3 inches and 0.9 inches. Of course, any suitable diameter can be used.
The [0022] neck 24 is also typically circular and continues to define the opening 28. The neck 24 has a third diameter D3. The third diameter D3 is generally less than the first diameter D1 and greater than the second diameter D2. Preferably, the third diameter D3 is between 0.4 inches and 1.4 inches. Of course, any suitable diameter can be used. The difference between the third diameter D3 and the second diameter D2 is the thickness 29, or neck wall, of the neck 24.
The [0023] top 22 further includes an underside portion 30 between the outside circumference 32 of the top 22 and the outside circumference 34 of the neck 24. The top 22 also includes a topside portion, or surface, 35.
The [0024] second portion 18 is typically a bottom portion 36 of the pharmaceutical vial 15. The bottom portion 36 is generally circular having a fourth diameter D4. Preferably, the fourth diameter D4 is between 0.5 inches and 3.4 inches. Of course, any suitable diameter can be used. The bottom portion 36 defines an inner portion 38. The inner portion 38 contains a pharmaceutical product 40. The inner portion 38 has a fifth diameter D5 that is less than the fourth diameter D4. Preferably, the fifth diameter D5 is between 0.4 inches and 3.2 inches. Of course, any suitable diameter can be used. The bottom portion 36 includes a vial wall 42.
The [0025] top portion 20 includes the transition area 26. The transition area 26 is a transition between the neck 24 and the bottom portion 36. The transition area 26 is generally configured of a series of reverse arcs as illustrated. Of course, the transition area 26 can have any suitable configuration.
The [0026] pharmaceutical vial 15 can be constructed of any suitable material, and preferably, the pharmaceutical vial 15 comprises glass. The pharmaceutical container might also comprise a polymer-type material or any other material. One skilled in the art will appreciate that the pharmaceutical vial 15 can also be configured and arranged differently than that illustrated in FIGS. 1, 2, and 3, for example, an ampoule, syringe, or cartridge.
The [0027] pharmaceutical vial portion 12 further includes a sealing portion 50. In general, the sealing portion 50 is configured and arranged to substantially seal the pharmaceutical product 40 in the pharmaceutical vial 15. By the term “substantially seal,” it is meant, if the process is in control, that leakage past the seal of any container is a rare event.
The sealing [0028] portion 50 includes a stopper 52 that is configured and arranged to fit within the first portion 16 of the pharmaceutical vial 15. Of course, other suitable sealing devices can be used, such as a disc of sealing material. The stopper 52 includes a first stopper portion 54 and a second stopper portion 56. The second stopper portion 56 is configured and arranged to fit into the opening 28 of the top 22 and into the opening 28 of the neck 24. As such, the second stopper portion 56 has a sixth diameter D6 that is approximately equal to the second diameter D2. Preferably, the stopper 52 is comprised of a material that is compressible, such as rubber, so that the sixth diameter D6 of the second stopper portion 56 is slightly compressed when placed within the opening 28. This compression helps to create the substantial seal that retains the pharmaceutical product 40 within the bottom portion 36 of the pharmaceutical vial 15 when the stopper 52 is properly seated.
The [0029] second stopper portion 56 is inserted into the opening 28 of the top 22 and the neck 24 until the first stopper portion 54 comes to rest against the topside surface 35 of the top 22. Of course, the sealing portion 50 can be constructed of any suitable material, but is typically constructed of a compressible material and a material that substantially seals the pharmaceutical product 40 within the pharmaceutical vial 15.
The [0030] pharmaceutical vial portion 12 further includes an over cap portion, or ring portion, 70. The over cap portion 70 is designed and configured to retain the sealing portion 50 in the pharmaceutical vial 15. The over cap portion 70 includes an over cap, or ring, 72. Of course, the over cap portion 70 can be other types of devices designed to retain the sealing portion 50 in the pharmaceutical vial 15, for example, a line-seal, a screw-type cap, or a snap cap.
The over [0031] cap 72 wraps around the sealing portion 50 and the underside surface 30 of the top 22 of the pharmaceutical vial 15. The over cap 72 sandwiches the sealing portion 50 against the topside surface 35 of the top 22 of the pharmaceutical vial 15 and keeps the sealing portion 50 slightly compressed against the topside surface 35 of the top 22 of the pharmaceutical vial 15. This slightly compressed state helps substantially seal the pharmaceutical product 40 within the pharmaceutical vial 15. The over cap 72 clamps the stopper 52 onto the pharmaceutical vial 15 and prevents the sealing portion 50 from dislodging from the pharmaceutical vial 15. During manufacture, the over cap 72 is typically crimped-on in a conventional manner.
Referring to FIG. 4, the over [0032] cap 72 defines a second opening 74 having a seventh diameter D7. Preferably, the seventh diameter D7 is slightly smaller than the second diameter D2. The second opening 74 allows a needle to pass through and into the vial 15 for removal of the product 40. The over cap 72 can comprise any suitable material, but typically comprises aluminum or a plastic material.
The [0033] pharmaceutical container 10 further includes the safety seal 14. The safety seal 14 is configured and arranged to protect a handler, or a person, of the pharmaceutical container 10 from accidental contact with any pharmaceutical, or hazardous material, that might be left on the outside of the pharmaceutical container 10 after filling.
Preferably, the [0034] safety seal 14 is configured and arranged to surround or encapsulate the over cap portion 70, and a part of neck 24 of the pharmaceutical vial 15. In general, the safety seal 14 is designed to enclose any particles that might be present on the outside surfaces of the over cap portion 70 and the part of the neck 24 of the pharmaceutical vial 15 after filling of the pharmaceutical product 40 into the pharmaceutical vial 15. In general, the safety seal 14 protects a person, such as operators, handlers, inspectors, nurses, doctors, and the like, from accidental contact with a pharmaceutical product, such as a harmful or toxic pharmaceutical product. The safety seal 14 can comprise any suitable material, but preferably is a latex-type material. The safety seal 14 can be other materials as well, such as a sealing wax, paint-on rubber, or a shrink-wrap cap.
The [0035] safety seal 14 can have other configurations as well, in addition to that illustrated in FIGS. 1, 2, and 3. Referring to FIG. 5, an entire pharmaceutical vial portion 112 can be completely encased with a safety seal 114.
Referring to FIG. 6, another example embodiment of a [0036] pharmaceutical container 210 is illustrated. In this example embodiment, the pharmaceutical container 210 includes a safety seal 214 and a pharmaceutical vial 215. The pharmaceutical container 210 is packaged in a blister package 220. The blister package 220 serves to keep people from coming into contact with toxic product directly or indirectly. Of course, the blister package 220 itself can be the safety seal 214 instead of a separate safety seal 214 and blister package 220.
The [0037] blister package 220 is conventional and includes a backing, Lidding foil, or Lidding material 222 and an overlay, forming film, or forming material 224. Typically, the backing 222 comprises a foil or cardboard like substance, and the overlay 224 comprises a polymer, such as plastic. Of course, any suitable material, insert, or lamination combination can be used for both the backing 222 and the overlay 224.
Referring to FIG. 7, another example embodiment of a [0038] pharmaceutical container 310 is illustrated. In this example embodiment, the pharmaceutical container 310 includes a safety seal 314 and a pharmaceutical vial 315. The pharmaceutical container 310 is packaged in a form, fill, and seal package 320. Of course, the form, fill, and seal package 320 itself can be the safety seal 314 instead of a separate safety seal 314 and form, fill, and seal package 320. The form, fill, and seal package 320 serves to keep people from coming into contact with toxic product directly or indirectly.
The form, fill, and [0039] seal package 320 is conventional and typically comprises a polymer, such as plastic. Typically, the form, fill, and seal package 320 is flexible. Of course, any suitable material or combination of laminations can be used for form, fill, and seal package 320.
In this embodiment, the [0040] pharmaceutical container 310 might also include a conventional plastic flip cap that can be removed from the pharmaceutical vial 315 before use through the form, fill, and seal package 320 without opening the form, fill, and seal package 320.
During manufacture, the [0041] pharmaceutical vial 15 is filled with a pharmaceutical product 40. The second portion 56 of the stopper 52 is press fitted into the opening 28 of the top 22 and the neck 24 of the pharmaceutical vial 15 until the first portion 54 of the stopper 52 rests against, or comes in contact with, the topside surface 35 of the top 22 of the pharmaceutical vial 15. The over cap 72 is crimped-on over the stopper 52 to hold it in place and substantially seal the pharmaceutical product 40 within the pharmaceutical vial 15. The safety seal 14 is then placed around the over cap 72 and a portion of the neck 24 to prevent accidental contact with any particles of the pharmaceutical product 40 that might be on the outside of the over cap 72 and a portion of the neck 24 or the total package. The pharmaceutical container 10 with the safety seal 14 is then thoroughly washed to remove any trace of toxic pharmaceutical or hazardous substance left outside the safety seal 14. Of course, other methods of manufacture can be used without deviating from the scope of the present disclosure.
During use, a needle is poked through the [0042] safety seal 14 and through the second opening 74 in the over cap 72 and through the stopper 52. The pharmaceutical product 40 is withdrawn from the pharmaceutical vial 15 via a needle, typically into a syringe. When a blister package, such as the blister package 220 of FIG. 6, the needle can be poked through the blister package 220. Then the above-described method can be used to remove the product from the pharmaceutical vial 215. Similarly, when a form, fill, and seal package, such as the form, fill, and seal package 320 of FIG. 7, is used, the needle can be poked through the form, fill, and seal package 320. Then the above-described method can be used to remove the product from the pharmaceutical vial 315.
Referring to FIG. 8, another example embodiment of a [0043] pharmaceutical container 410 is illustrated. In this example embodiment, the pharmaceutical container 410 includes a safety seal 414 and a pharmaceutical vial 415. In this embodiment the pharmaceutical container 10 includes a convention flip cap 420. After manufacture, the flip cap 420 is generally integral with an over cap 422. In this embodiment, the safety seal 414 is loose at the top portion of the pharmaceutical container 410.
During use, a person flips off the [0044] flip cap 420 by placing a finger on the flip cap 420 and flipping it off. The safety seal 414 is loose enough to although the flip cap 420 to be removed without penetrating the safety seal 414. A needle can then be poked through the safety seal 414, and a stopper 424, now exposed by removal of the flip cap 420, and into the pharmaceutical vial 415 to remove a product.
It is noted that while the above ideas regarding a safety-seal are generally described with regard to pharmaceutical containers, the invention can be applied to any suitable container for which accidental contact with a product might be of concern. [0045]
Although specific embodiments of the present invention have been described and illustrated, it will be appreciated by those skilled in the art that many variations of the designs described can be practiced within the scope of the present disclosure, and that all such variations are contemplated within the teaching of the present disclosure. Accordingly, the scope of the disclosure is not limited to the specific embodiments shown, but is limited only by the scope of the following claims. [0046]

Claims

1. A pharmaceutical package comprising:

a container including a first container portion having a first surface, the container being configured and arranged to hold a pharmaceutical product;

a sealing portion having a first sealing portion and a second sealing portion, the second sealing portion being positioned in the first container portion and the first sealing portion being in contact with the first surface; and

a safety seal encapsulating at least a portion of the container to prevent accidental contact with any pharmaceutical product that might be present on the portion of the container.

2. A pharmaceutical container according to claim 1, wherein the safety seal comprises a latex-type material.

3. A pharmaceutical container according to claim 1, wherein the safety seal comprises a sealing wax.

4. A pharmaceutical container according to claim 1, wherein the safety seal comprises a paint-on, spray-on, dipped rubber, rubber-like material, polymer, or polymer-like material.

5. A pharmaceutical container according to claim 1, wherein the safety seal comprises a shrink wrap.

6. A pharmaceutical container according to claim 1, wherein the safety-seal encapsulates the entire container.

7. A pharmaceutical container according to claim 1, wherein the safety seal is a blister package.

8. A pharmaceutical container according to claim 1, wherein the safety seal is a form, fill, and seal package.

9. A pharmaceutical container according to claim 8, wherein the form, fill, and seal package is a flexible bag.

10. A pharmaceutical container according to claim 1, wherein the sealing portion is a stopper.

11. A pharmaceutical container according to claim 1, wherein the sealing portion is a disc of sealing material.

12. A pharmaceutical container according to claim 1, further comprising an over cap portion around the sealing portion to secure the first sealing portion against the first surface.

13. A pharmaceutical container according to claim 12, further including a flip cap integral with the over cap.

14. A pharmaceutical container wherein the container is a vial, ampoule, syringe, or cartridge.

15. A method of manufacturing a pharmaceutical package, the method comprising:

filling a pharmaceutical container with a pharmaceutical product;

placing a sealing portion onto the pharmaceutical container; and

placing a safety seal around at least a portion of the pharmaceutical container to prevent accidental contact with any pharmaceutical product that might be present on the portion of the pharmaceutical container.

16. A method according to claim 15, wherein placing a safety seal includes placing a blister package around the pharmaceutical container.

17. A method according to claim 15, wherein placing a safety seal includes placing a form, fill, and seal package around the pharmaceutical container.

18. A method according to claim 15, wherein placing a safety seal includes placing a safety seal around the entire container to prevent accidental contact with any pharmaceutical product that might be present on the container.

19. A method according to claim 15, wherein placing a safety seal includes placing a paint-on, spray-on, or dipped rubber, rubber-like material, polymer, or polymer-like material; shrink wrap; sealing wax; or latex-type material around at least a portion of the container to prevent accidental contact with any pharmaceutical product that might be present on the container.

20. A method of removing a pharmaceutical product from a container having a safety seal, the method comprising:

placing a needle through the safety seal; and

removing the pharmaceutical product from the container through the needle.

21. A method according to claim 20, wherein placing a needle includes placing a needle through a blister package and a sealing device of the container.

22. A method according to claim 20, wherein placing a needle includes placing a needle through a form, fill, and seal package and a sealing device of the container.

23. A method according to claim 20, further comprising removing a flip-cap prior to placing the needle.

24. A package comprising:

a container including a first container portion having a first surface, the container being configured and arranged to hold a hazardous product;

a safety seal encapsulating at least a portion of the product container to prevent accidental contact with any hazardous product that might be present on the portion of the container.