US20040118802A1

Movatterモバイル変換

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.[0001]

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.[0002]

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.[0003]

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.[0004]

SUMMARY

In accordance with the present disclosure, the above and other problems are solved by the following:[0005]

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.[0006]

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.[0007]

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.[0008]

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. Thepharmaceutical container10 includes a pharmaceutical vial portion, or container,12 and asafety seal14. Thepharmaceutical container10 is not limited to vials; for example, thepharmaceutical container10 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 lines3-3. Thepharmaceutical container10 includes thepharmaceutical vial portion12. In general, thepharmaceutical vial portion12 includes apharmaceutical vial15 having afirst portion16 and asecond portion18. Thefirst portion16 is typically atop portion20 of thepharmaceutical vial15. Thetop portion20 includes atop22, aneck24, and atransition area26.

The[0021]

top

22 is typically circular and defines anopening28. Preferably, thetop22 has a first diameter D1 between 0.5 inches and 1.3 inches. Of course, any suitable diameter can be used. The opening28 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 theopening28. Theneck24 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 thethickness29, or neck wall, of theneck24.

The[0023]

top

22 further includes anunderside portion30 between theoutside circumference32 of thetop22 and theoutside circumference34 of theneck24. The top22 also includes a topside portion, or surface,35.

The[0024]

second portion

18 is typically abottom portion36 of thepharmaceutical vial15. Thebottom portion36 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. Thebottom portion36 defines aninner portion38. Theinner portion38 contains apharmaceutical product40. Theinner portion38 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. Thebottom portion36 includes avial wall42.

The[0025]

top portion

20 includes thetransition area26. Thetransition area26 is a transition between theneck24 and thebottom portion36. Thetransition area26 is generally configured of a series of reverse arcs as illustrated. Of course, thetransition area26 can have any suitable configuration.

The[0026]

pharmaceutical vial

15 can be constructed of any suitable material, and preferably, thepharmaceutical vial15 comprises glass. The pharmaceutical container might also comprise a polymer-type material or any other material. One skilled in the art will appreciate that thepharmaceutical vial15 can also be configured and arranged differently than that illustrated in FIGS. 1, 2, and3, for example, an ampoule, syringe, or cartridge.

The[0027]

pharmaceutical vial portion

12 further includes a sealingportion50. In general, the sealingportion50 is configured and arranged to substantially seal thepharmaceutical product40 in thepharmaceutical vial15. 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 astopper52 that is configured and arranged to fit within thefirst portion16 of thepharmaceutical vial15. Of course, other suitable sealing devices can be used, such as a disc of sealing material. Thestopper52 includes afirst stopper portion54 and asecond stopper portion56. Thesecond stopper portion56 is configured and arranged to fit into theopening28 of the top22 and into theopening28 of theneck24. As such, thesecond stopper portion56 has a sixth diameter D6 that is approximately equal to the second diameter D2. Preferably, thestopper52 is comprised of a material that is compressible, such as rubber, so that the sixth diameter D6 of thesecond stopper portion56 is slightly compressed when placed within theopening28. This compression helps to create the substantial seal that retains thepharmaceutical product40 within thebottom portion36 of thepharmaceutical vial15 when thestopper52 is properly seated.

The[0029]

second stopper portion

56 is inserted into theopening28 of the top22 and theneck24 until thefirst stopper portion54 comes to rest against thetopside surface35 of the top22. Of course, the sealingportion50 can be constructed of any suitable material, but is typically constructed of a compressible material and a material that substantially seals thepharmaceutical product40 within thepharmaceutical vial15.

The[0030]

pharmaceutical vial portion

12 further includes an over cap portion, or ring portion,70. The overcap portion70 is designed and configured to retain the sealingportion50 in thepharmaceutical vial15. The overcap portion70 includes an over cap, or ring,72. Of course, the overcap portion70 can be other types of devices designed to retain the sealingportion50 in thepharmaceutical vial15, for example, a line-seal, a screw-type cap, or a snap cap.

The over[0031]

cap

72 wraps around the sealingportion50 and theunderside surface30 of the top22 of thepharmaceutical vial15. The overcap72 sandwiches the sealingportion50 against thetopside surface35 of the top22 of thepharmaceutical vial15 and keeps the sealingportion50 slightly compressed against thetopside surface35 of the top22 of thepharmaceutical vial15. This slightly compressed state helps substantially seal thepharmaceutical product40 within thepharmaceutical vial15. The overcap72 clamps thestopper52 onto thepharmaceutical vial15 and prevents the sealingportion50 from dislodging from thepharmaceutical vial15. During manufacture, the overcap72 is typically crimped-on in a conventional manner.

Referring to FIG. 4, the over[0032]

cap

72 defines asecond opening74 having a seventh diameter D7. Preferably, the seventh diameter D7 is slightly smaller than the second diameter D2. Thesecond opening74 allows a needle to pass through and into thevial15 for removal of theproduct40. The overcap72 can comprise any suitable material, but typically comprises aluminum or a plastic material.

The[0033]

pharmaceutical container

10 further includes thesafety seal14. Thesafety seal14 is configured and arranged to protect a handler, or a person, of thepharmaceutical container10 from accidental contact with any pharmaceutical, or hazardous material, that might be left on the outside of thepharmaceutical container10 after filling.

Preferably, the[0034]

safety seal

14 is configured and arranged to surround or encapsulate the overcap portion70, and a part ofneck24 of thepharmaceutical vial15. In general, thesafety seal14 is designed to enclose any particles that might be present on the outside surfaces of the overcap portion70 and the part of theneck24 of thepharmaceutical vial15 after filling of thepharmaceutical product40 into thepharmaceutical vial15. In general, thesafety seal14 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. Thesafety seal14 can comprise any suitable material, but preferably is a latex-type material. Thesafety seal14 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, and3. Referring to FIG. 5, an entirepharmaceutical vial portion112 can be completely encased with asafety seal114.

Referring to FIG. 6, another example embodiment of a[0036]

pharmaceutical container

210 is illustrated. In this example embodiment, thepharmaceutical container210 includes asafety seal214 and apharmaceutical vial215. Thepharmaceutical container210 is packaged in ablister package220. Theblister package220 serves to keep people from coming into contact with toxic product directly or indirectly. Of course, theblister package220 itself can be thesafety seal214 instead of aseparate safety seal214 andblister package220.

The[0037]

blister package

220 is conventional and includes a backing, Lidding foil, orLidding material222 and an overlay, forming film, or formingmaterial224. Typically, thebacking222 comprises a foil or cardboard like substance, and theoverlay224 comprises a polymer, such as plastic. Of course, any suitable material, insert, or lamination combination can be used for both thebacking222 and theoverlay224.

Referring to FIG. 7, another example embodiment of a[0038]

pharmaceutical container

310 is illustrated. In this example embodiment, thepharmaceutical container310 includes asafety seal314 and apharmaceutical vial315. Thepharmaceutical container310 is packaged in a form, fill, andseal package320. Of course, the form, fill, andseal package320 itself can be thesafety seal314 instead of aseparate safety seal314 and form, fill, andseal package320. The form, fill, andseal package320 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, andseal package320 is flexible. Of course, any suitable material or combination of laminations can be used for form, fill, andseal package320.

In this embodiment, the[0040]

pharmaceutical container

310 might also include a conventional plastic flip cap that can be removed from thepharmaceutical vial315 before use through the form, fill, andseal package320 without opening the form, fill, andseal package320.

During manufacture, the[0041]

pharmaceutical vial

15 is filled with apharmaceutical product40. Thesecond portion56 of thestopper52 is press fitted into theopening28 of the top22 and theneck24 of thepharmaceutical vial15 until thefirst portion54 of thestopper52 rests against, or comes in contact with, thetopside surface35 of the top22 of thepharmaceutical vial15. The overcap72 is crimped-on over thestopper52 to hold it in place and substantially seal thepharmaceutical product40 within thepharmaceutical vial15. Thesafety seal14 is then placed around the overcap72 and a portion of theneck24 to prevent accidental contact with any particles of thepharmaceutical product40 that might be on the outside of the overcap72 and a portion of theneck24 or the total package. Thepharmaceutical container10 with thesafety seal14 is then thoroughly washed to remove any trace of toxic pharmaceutical or hazardous substance left outside thesafety seal14. 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 thesecond opening74 in the overcap72 and through thestopper52. Thepharmaceutical product40 is withdrawn from thepharmaceutical vial15 via a needle, typically into a syringe. When a blister package, such as theblister package220 of FIG. 6, the needle can be poked through theblister package220. Then the above-described method can be used to remove the product from thepharmaceutical vial215. Similarly, when a form, fill, and seal package, such as the form, fill, andseal package320 of FIG. 7, is used, the needle can be poked through the form, fill, andseal package320. Then the above-described method can be used to remove the product from thepharmaceutical vial315.

Referring to FIG. 8, another example embodiment of a[0043]

pharmaceutical container

410 is illustrated. In this example embodiment, thepharmaceutical container410 includes asafety seal414 and apharmaceutical vial415. In this embodiment thepharmaceutical container10 includes aconvention flip cap420. After manufacture, theflip cap420 is generally integral with an overcap422. In this embodiment, thesafety seal414 is loose at the top portion of thepharmaceutical container410.

During use, a person flips off the[0044]

flip cap

420 by placing a finger on theflip cap420 and flipping it off. Thesafety seal414 is loose enough to although theflip cap420 to be removed without penetrating thesafety seal414. A needle can then be poked through thesafety seal414, and astopper424, now exposed by removal of theflip cap420, and into thepharmaceutical vial415 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 toclaim 1, wherein the safety seal comprises a latex-type material.

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

4. A pharmaceutical container according toclaim 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 toclaim 1, wherein the safety seal comprises a shrink wrap.

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

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

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

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

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

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

12. A pharmaceutical container according toclaim 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 toclaim 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 toclaim 15, wherein placing a safety seal includes placing a blister package around the pharmaceutical container.

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

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

22. A method according toclaim 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 toclaim 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.