US20070108205A1 - Protective outer enclosure for pharmaceutical vial - Google Patents

Abstract

A protective outer container for a pharmaceutical vial includes a shell, a collar, and a cap that fit together to form a secure enclosure. The collar includes an outer wall having a lower region that fits into the mouth of the shell, and an upper region that fits into the cap. A plurality of resiliently deformable fins extends radially inwardly from the upper region of the collar outer wall. Each fin includes a gripping edge. The gripping edges together define an opening for receiving and gripping an upper portion of the vial. According to a further aspect of the container, the collar includes a flange extending outwardly from the collar outer wall, defining its upper and lower regions. Also described is a method for packaging a pharmaceutical vial, in which a shell, a collar, and a cap are used to provide a secure enclosure around the vial.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present application claims the priority benefit of U.S. Provisional Application No. 60/733,225, filed Nov. 3, 2005, which is incorporated herein by reference in its entirety.
FIELD OF THE INVENTION
• The present invention relates to improvements in the field of product packaging, and more specifically to an improved protective outer enclosure for a pharmaceutical vial.
BACKGROUND OF THE INVENTION
• Certain pharmaceuticals, such as drugs used in chemotherapy, are manufactured in concentrated form, and are then sealed into individual vials for distribution to healthcare facilities. When a chemotherapy drug is used to treat a patient, a health worker must remove the concentrated drug from a vial and prepare a dilution for intravenous administration. In a typical hospital, chemotherapy drugs are handled by a relatively small number of people on the hospital's staff, who have received specific training in this area. Over the course of a year, it is not unusual for an individual staff member to handle hundreds of vials of concentrated chemotherapy drugs.
• Many chemotherapy drugs are cytotoxic materials that have medicinal value to patients. In their concentrated form, they typically require special methods to handle and formulate, in order to minimize or eliminate exposure to the drug by health workers, such as pharmacists. However, for a number of reasons, even when precautions are taken, a health worker may nonetheless be exposed to chemotherapy drugs. For example, because these drugs are typically packaged in glass vials, there is a possibility that a vial may crack or be otherwise damaged during the manufacturing process or in transit. A drug may leak out of a damaged vial onto other vials or onto packaging materials. Also, even though great care is taken during the manufacturing process, trace amounts of the drug are sometimes found on the outside of the vial.
• Protective outer containers have been developed for pharmaceutical vials. However, these containers suffer from a number of drawbacks. First, just as trace amounts of a chemotherapy drug may be found on the outer surface of a vial, trace amounts of the drug may also migrate onto the outer surface of the protective container. Second, a vial must typically be removed from the protective container in order to prepare a dilution.
SUMMARY OF THE INVENTION
• These and other issues are addressed by the present invention, one aspect of which provides a protective outer container for a pharmaceutical vial. The protective container includes a shell, a collar, and a cap that fit together to form a secure enclosure for a pharmaceutical vial. The shell is preferably fabricated from a material that allows a health worker to visually inspect the vial without removing it from the container. The collar includes an outer wall having a lower region that fits into the mouth of the shell, and an upper region that fits into the cap. A plurality of resiliently deformable fins extends radially inwardly from the upper region of the collar outer wall. Each fin includes a gripping edge. The gripping edges together define an opening for receiving and gripping an upper portion of the vial. According to a further aspect of the invention, the collar includes a flange extending outwardly from the collar outer wall, defining its upper and lower regions. Another aspect of the invention provides a method for providing a protective enclosure for a pharmaceutical vial.
• Additional features and advantages of the present invention will become apparent by reference to the following detailed description and accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 shows an isometric view of a protective outer container for a pharmaceutical vial, according to a first aspect of the invention.
• FIG. 2 shows a cross section of the container shown inFIG. 1 through the plane2-2.
• FIG. 3 shows an exploded view of the container shown inFIG. 1.
• FIG. 4 shows a partially assembled view of the container shown inFIG. 1.
• FIG. 5 shows a plan view of the collar component of the container shown inFIG. 1.
• FIG. 6 shows a cross section of the collar through the plane6-6.
• FIG. 7 shows a cross section of the collar through the plane7-7.
• FIG. 8 shows a plan view of the cap component of the outer enclosure shown inFIG. 1.
• FIG. 9 shows a cross section of the cap through the plane9-9.
• FIG. 10 shows an isometric view of the container shown inFIG. 1 with the cap removed, and with a dilution system fixture positioned above the container.
• FIG. 11 shows a flowchart of a method, according to a further aspect of the invention, for packaging a pharmaceutical vial in a protective outer container.
DETAILED DESCRIPTION
• As used herein, the terms “vial” and “pharmaceutical vial” refer generally to all vials, and like containers, that are used to package pharmaceutical products, and the like. As will be apparent from the following discussion, the present invention is not limited to a particular type of vial. Also, although the present invention is suitable for use with chemotherapy drugs, it will be apparent that the present invention may be used to provide a protective outer enclosure for any product distributed in a vial.
• FIG. 1 shows an isometric view of a protectiveouter container10 according to a first aspect of the invention.FIG. 2 shows a cross section of thecontainer10 through the plane2-2,FIG. 3 shows an exploded view of thecontainer10, andFIG. 4 shows a partially assembled view of thecontainer10.
• As shown inFIGS. 1-4, thecontainer10 includes ashell20, acollar30, and acap40 that fit together to provide a protective enclosure for avial50 containing a pharmaceutical, or like product. As shown inFIG. 4, theshell20 and thecollar30 are assembled together to form an enclosure for the body of thevial50, with the neck of thevial50 protruding upward through a central opening in thecollar30.
• According a further aspect of the invention, thepharmaceutical vial50 is shipped from the factory fully enclosed by the protectiveouter container10, as shown inFIG. 1. When theouter container10 is opened by a health worker, only thecap40 is removed. The body of thevial50 remains enclosed by theshell20 andcollar30 during use and disposal of thevial50.
• Theshell20 is preferably fabricated from a material that allows a health worker to visually inspect thevial50 without having to remove it from thecontainer10. As described in further detail below, theshell20 may be fabricated from a suitable transparent plastic, or the like. It will be seen inFIG. 1 that the structural components of theshell20,collar30, andcap40 are shaped and positioned with respect to each other such that when avial50 is enclosed in thecontainer10, the body of thevial50, including any label affixed thereto, is visible through theshell20.
• Generally, the overall shape of thecontainer10 shown inFIGS. 1-4 is cylindrical. However, it will be apparent that it would be possible to modify the overall shape of thecontainer10 without departing from the spirit of the invention. For example, the overall shape and size of thecontainer10 may be modified to accommodate avial50 different from the one shown inFIGS. 1-4.
• According to the present aspect of the invention, theshell20,collar30, andcap40 are held together in the assembledcontainer10 through the use of interlocking structures, and without the use of an adhesive. However, an adhesive may be used, if desired, particularly between theshell20 and thecollar30. Generally speaking, it is desirable for theshell20,collar30, andcap40 to be attached to each other in such a way that a hospital worker can readily remove thecap40 from thecollar30 without causing thecollar30 to become separated from theshell20.
• In addition, an adhesive-backed plastic or paper tape (not shown) may be applied to the exterior of thecontainer10 to provide further security against accidental separation of the container components during shipping and handling, and to show evidence of tampering. Also, the assembled and loadedcontainer10 may be shrink-wrapped or otherwise encased. Further, it would be possible to modify some or all of theshell20,collar30, andcap40 to include a breakaway strip or locking structure.
• According to the present aspect of the invention, theshell20 comprises acylindrical tube21 to which there is attached abase22 having a flat, circular portion that closes off the bottom of the tube. Thebase22 includes afoot23, which provides clearance between the flat portion of thebase22 and the bottom edge of thetube21. The top edge of thetube21 forms abrim24 defining amouth25 for receiving thevial50 and the bottom of thecollar30.
• When thevial50 is packaged into thecontainer10, the base of thevial50 rests on the upper surface of theshell base22. The reason for this arrangement is to provide stability to thevial50 when it is used to prepare a dilution. Thus, it will be seen that thefoot23 provides protection to the base of thevial50.
• It will be seen inFIGS. 1-4 that the diameter of thetube21 is larger than the diameter of thevial50. Thus, there is some clearance between the outer circumference of thevial50 and the inner circumference of theshell tube21. This clearance provides protection to the sides of thevial50.
• A suitable material for theshell20 is polyethylene terepthalate (PET), with a thickness of 0.028 in. If PET is used, thebase22 may be attached to thetube21 using sonic welding or other suitable technique. However, it will be understood that theshell20 may be fabricated using other techniques and materials without departing from the spirit of the invention.
• FIG. 5 shows a plan view of thecollar30.FIGS. 6 and 7 show cross sections of the collar through the planes6-6 and7-7, respectively. According to the present aspect of the invention, thecollar30 is fabricated from low-density polyethylene, using an injection molding process. However, the material and technique used to fabricate thecollar30 may be modified without departing from the spirit of the invention.
• The collar includes a circumferentialouter wall31, and aflange32 that protrudes outwardly from theouter wall31. Thecollar flange32 serves a number of purposes, including providing a gripping surface that is useful both for loading thevial50 into thecontainer10 and also for subsequently separating thecap40 from thecollar30.
• Theflange32 divides theouter wall31 into alower region31aand an upper region31b.The outer wall'slower region31 a is shaped to snugly fit within theshell mouth25. When thecollar30 is mounted onto theshell20, theshell brim24 butts up against the lower surface of thecollar flange32. In addition, there is formed in the bottom surface of the flange32 acircumferential channel33. When thecollar30 is mounted onto theshell20, the shell brim24 seats firmly within thechannel33, helping to create a firm attachment between theshell20 andcollar30.
• The wall'slower region31aincludes a pair of substantiallyrectangular cutout regions34, which help provide visibility of the body of avial50 packaged in the assembledcontainer10. The wall's lower region further includescircumferential ridges35 that serve to strengthen the attachment between theshell20 andcollar30.
• The collar wall's upper region31bis shaped to snugly fit within the cap opening44 (FIG. 9). When thecap40 is mounted onto thecollar30, the cap brim43 (FIG. 9) butts up against the upper surface of thecollar flange32. Abevel36 is provided at the top of the collarouter wall31 to facilitate the mounting of thecap40 onto thecollar30.
• Extending radially inwardly from the upper edge of thecollar wall31 is a plurality of resilientlydeflectable fins37. Eachfin37 includes an arcuate, concave grippingedge38. The respectivegripping edges38 of all of thefins37 combine to define a substantiallycircular opening39 for receiving the neck of thevial50. It will further be seen inFIG. 5, that thefins37 are arranged such thatopen spaces310 are provided betweenadjacent fins37. At least part of eachopen space310 remains unobstructed, even after thecollar40 has been mounted onto avial50.
• Thefins37 are sloped to generally follow the contour of the shoulder region of thevial50. The sloping of thefins37 creates a funnel-like shape that facilitates the installation of thecollar30 onto thevial50. In addition, the sloping of thefins37 allows thecollar30 to hold thevial50 more securely, and also tends to prevent thecollar30 from being pulled free of thevial50.
• Thecollar30 further includes a plurality ofvertical ribs311 that are extend along the interior surface of the collarouter wall31. The structure of theribs311 is illustrated inFIG. 7, which is a cross section of thecollar30 through the plane7-7. Theribs311 add rigidity to the collarouter wall31, which tends to enhance the strength of the attachment of thecollar30 to theshell20. It should be noted, however, that it has been found that it is possible to fabricate a collarouter wall31 having sufficient rigidity without the use of thevertical ribs311.
• As shown inFIGS. 1-4, the lip of thevial50 has a larger diameter than the neck of thevial50. Thus, it will be seen that when thecollar30 is installed onto thevial50, thefins37 must deflect out of the way to allow the lip of thevial50 to pass through thecollar opening39. The resilience of thefins37 causes them to tend to return to their original angle, thereby allowing the fin'sgripping edges38 to grip the neck of thevial50. In order to improve the grip between thecollar30 and thevial50, it is desirable for the diameter of theopening39 to be somewhat smaller than the diameter of the neck of thevial50. Thus, in the assembled package, thefins37 are in a slightly deflected condition, causing them to pinch the neck of thevial50.
• FIG. 8 shows a plan view of thecap40, andFIG. 9 shows a cross section of thecap40 through plane9-9. According to the present aspect of the invention, thecap40 is fabricated from low-density polyethylene, using an injection molding process. However, the material and technique used to fabricate thecap40 may be modified without departing from the spirit of the invention.
• The cap includes a top41 and acircumferential wall42. The bottom edge of the wall forms abrim43 defining anopening44 that fits snugly around theupper region31aof the collarouter wall31. When thecap40 is mounted to thecollar30, thecap brim43 butts up against the upper surface of thecollar flange32. Because thecap40 is fabricated using an injection molding technique, a small gate well45 is formed on the lower surface of the top41.
• Thecap40 further includes aflange46 proximate to the top41. In the assembledcontainer10, thecap flange46 is substantially parallel to thecollar flange32. One purpose served by the twoflanges32 and46 is to provide handy gripping surfaces that allow a hospital worker to easily remove thecap40 from thecontainer30, without accidentally causing thecollar30 to separate from theshell20.
• According to a further aspect of the invention, thecollar flange32 and thecap flange46 are provided with rounded edges, to lessen the possibility that hospital workers may accidentally damage their gloves when gripping theflanges32 and46 to open thecontainer10. According to this aspect of the invention, the vertex formed by the upper and circumferential surfaces of thecollar flange32, and the vertex formed by the lower and circumferential surfaces of thecap flange46, are each provided with a radius (not shown), such that the vertices are rounded.
• Once thecap40 has been removed, a hospital worker may then use thevial50 to prepare a dilution.FIG. 10 shows an isometric view of thecontainer10, in which thecap40 has been removed, and in which the top of thevial50 includes an exposed,pierceable membrane51. Also shown inFIG. 10, positioned over thecontainer10, is afixture60 used in a dilution system known as the PhaSeal system, manufactured by Carmel Pharma AB, and described in U.S. Pat. No. 6,343,629. The bottom of thePhaSeal fixture60 is shaped to fit over the top of thevial50, and includes ahollow needle61 that is inserted through themembrane51 to extract the contents of thevial50. Thefixture60 includes a plurality oflong projections62 and short projections63 that extend downward around the lip and neck of thevial50.
• As shown inFIG. 10, theopen spaces310 between thefins37 correspond in position to thelong projections62 of thefixture60. Thus, by suitably rotating thecontainer10 relative to thefixture60, it is possible to install thefixture60 onto thevial50 without having to remove thevial50 from theshell20 andcollar30. It should be noted that although the present aspect of the invention is described with respect to the PhaSeal fixture, it will be apparent that thecollar30 may be modified to accommodate other type of fixtures, without departing from the spirit of the invention.
• Thecontainer10 provides protection to thevial50 against impacts during shipping and handling, and also serves a number of other purposes. As discussed above, health workers should have minimal or no direct contact with certain pharmaceutical products, such as chemotherapy drugs, particularly in their undiluted form. It is possible for a vial to crack or otherwise develop a leak that may not be apparent to a health worker until the worker has already begun to handle the vial. Thetransparent shell20 of thecontainer10 described herein allows a health worker to visually inspect thevial50 for cracks and leaks without directly handling thevial50. In addition, a health worker may detect a leak by noticing an accumulation of pharmaceutical product at the base of theshell22.
• Beyond the issue of leakage, there is another significant issue to be addressed. Even when great care is taken during manufacturing, packaging, shipping, and handling, and even when there is no readily detectible leak in a vial, it is nonetheless possible for trace amounts of a drug to contaminate the outer surface of the vial. Trace amounts of the drug may also migrate to packaging materials, countertops, etc. It is desirable to minimize or eliminate exposure to the drug by health workers, for example, minimizing repeated exposure to trace amounts of the drug residing on the outer surface of the vial.
• To address this issue, there have been developed protective outer containers for pharmaceutical vials. However, even when using one of these outer containers, there is a risk that some of the pharmaceutical product may contaminate the exterior surfaces of the protective outer container.
• Using a container according to the present invention, it is possible for a manufacturer to load and seal avial50 into thecontainer10, and for a hospital worker to prepare a dilution from thecontainer10, without ever directly touching thevial50. Thus, using thecontainer10, is possible to eliminate most, if not all, contamination pathways.
• FIG. 11 shows a flowchart of amethod100 according to the present invention for packaging a pharmaceutical vial into a protective outer enclosure. Instep101, a collar is provided, such as thecollar30 illustrated inFIGS. 5-7, discussed above. Instep102, the collar is mounted onto a vial, holding only an exterior surface of the collar. For example, the vial could be placed onto a conveyor belt, countertop, or other suitable work surface. A worker, or an automated machine, could then manipulate the collar, touching only an exterior surface thereof, and lower the collar such that the neck of the vial passes through the collar's central opening.
• Once the collar has been installed, the pinching action of the resiliently deformable fins then allows the vial to be lifted from the work surface, again only touching an exterior surface of the collar. Instep103, the collar is used in this manner to load the vial into a shell, taking care to make sure that no exposed surface of the vial makes contact with the exterior of the shell.
• Instep104, once the vial has been loaded into the shell, the collar can then be sealed to the shell by fitting it into the shell mouth, and seating the shell brim into a receiving channel in the collar. Instep105, once the collar has been sealed to the shell, the cap may then be mounted onto the collar, thereby securely enclosing the vial. Once the vial has been safely loaded into the protective outer container, the vial and container can be further packaged, as described above.
• As noted above, while the present invention has been described with respect to pharmaceutical vials containing chemotherapy drugs, it will be apparent that the present invention is not limited to this particular context. The described system may be used to provide a protective outer enclosure for other types of containers and substances without departing from the spirit of the invention.
• While the foregoing description includes details that will enable those skilled in the art to practice the invention, it should be recognized that the description is illustrative in nature and that many modifications and variations thereof will be apparent to those skilled in the art having the benefit of these teachings. It is accordingly intended that the invention herein be defined solely by the claims appended hereto and that the claims be interpreted as broadly as permitted by the prior art.

Claims (20)

1. A container for a pharmaceutical vial, comprising:

a shell having a mouth for receiving a lower portion of the vial; a collar including an outer wall, a lower region of which fits snugly into the mouth of the shell, the collar further including a plurality of resiliently deformable fins extending radially inwardly from an upper region of the collar outer wall, each fin including a gripping edge, the gripping edges together defining an opening for receiving and gripping an upper portion of the vial; and a cap including an opening that fits snugly over the upper region of the collar outer wall, the shell, collar, and cap together forming a sealed enclosure around the vial.

2. The container ofclaim 1, wherein the shell is fabricated from a material allowing a health worker to visually inspect the vial without removing it from the container.

3. The container ofclaim 1, wherein the opening defined by the gripping edges of the undeflected fins is smaller than the upper portion of the vial, such that when the vial is enclosed in the container, the deflection and resilience of the fins causes them to pinch the upper portion of the vial.

4. The container ofclaim 1, wherein the collar further comprises:

a flange extending outwardly from the collar outer wall, the flange defining the upper and lower regions of the collar outer wall and including a lower surface that butts up against the mouth of the shell when the shell is mounted to the collar, and an upper surface that butts up against the cap opening when the cap is mounted to the collar.

5. The container ofclaim 4, wherein the lower surface of the circumferential flange includes a channel that is shaped to closely receive the mouth of the shell.

6. The container ofclaim 1, wherein the fins are sloped to follow a contour of the pharmaceutical vial.

7. The container ofclaim 6, wherein the opening defined by the fins is shaped to receive and grip a neck region of the vial, and wherein the fins are sloped to follow the contour of a shoulder region of the vial.

8. The container ofclaim 7, wherein the collar includes a plurality of interior vertical ribs.

9. The container ofclaim 1, wherein the shell includes a substantially flat base.

10. The container ofclaim 9, wherein a base region of the vial rests on the base of the shell when the vial is enclosed in the container.

11. The container ofclaim 9, wherein the shell comprises a tube with a welded base.

12. The container ofclaim 1, wherein the lower region of the outer wall includes at least one cutout section.

13. The container ofclaim 12, wherein the cutout section has a substantially rectangular shape.

14. The container ofclaim 4, wherein the cap includes a flange extending outwardly from an upper region of the cap.

15. The container ofclaim 1, wherein the sealed enclosure is substantially cylindrical in shape.

16. The container ofclaim 1, wherein the fins are spaced apart from each other to define there between a plurality of open spaces.

17. The container ofclaim 16, wherein the plurality of open spaces between the fins corresponds in position to a plurality of projections extending from a fixture, thereby allowing the fixture to be installed onto the vial without removing the collar therefrom.

18. A method for providing a protective enclosure for a pharmaceutical vial, comprising:

providing a collar having an outer wall and a plurality of resiliently deformable fins extending inwardly from the collar outer wall, each fin including a gripping edge, the gripping edges together defining an opening for receiving and gripping an upper portion of the vial; mounting the collar onto the vial, while holding an exterior surface of the collar, whereby only the fins of the collar make direct contact with the vial; using the collar to load the vial into a shell through a mouth thereof, the collar including a lower region that fits snugly into the mouth of the shell; mounting the collar to the shell by fitting the lower region of the collar into the mouth of the shell; and mounting a cap to the collar.

19. The method ofclaim 18, wherein the collar includes a flange that extends outwardly from the collar outer wall, and wherein the step of mounting the collar to the shell includes butting the mouth of the shell up against a lower surface of the flange; and the step of mounting a cap to the collar includes butting the cap up against an upper surface of the flange.

20. The method ofclaim 19, wherein the lower surface of the flange includes a channel shaped to closely receive the mouth of the shell, and wherein the step of mounting the collar to the shell includes fitting the mouth of the shell into the receiving channel in the collar flange.

Images