WO2007056654A1

WO2007056654A1 - Protective outer enclosure for pharmaceutical vial

Info

Publication number: WO2007056654A1
Application number: PCT/US2006/060463
Authority: WO
Inventors: Jose A. Porras
Original assignee: Bristol-Myers Squibb Company
Priority date: 2005-11-03
Filing date: 2006-11-02
Publication date: 2007-05-18
Also published as: US20070108205A1

Abstract

The invention relates to a protective outer container (10) for a pharmaceutical vial (50) including a shell (20), a collar (30), and a cap (40) that fit together to form a secure enclosure. The collar includes an outer wall (31) having a lower region (31a) that fits into the mouth of the shell (25), and an upper region (31b) that fits into the cap. A plurality of resiliently deformable fins (37) extends radially inwardly from the upper region of the collar outer wall. Each fin includes a gripping edge. The gripping edges (38) together define an opening (39) for receiving and gripping an upper portion of the vial. According to a further aspect of the container, the collar includes a flange (32) extending outwardly from the collar outer wall, defining its upper and lower regions. The invention also relates to 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

PROTECTIVE OUTER ENCLOSURE FOR PHARMACEUTICAL VIAL

FIELD OF THE INVENTION

JOOOlJ 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 [0002] 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.

[0003] 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. [0004] Protective outer containers have been developed for pharmaceutical vials. However, these containers suffer from a numbei¹ 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 [0005] 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. Λ plurality of resϊlienlly 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. [0006] 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

[0007] Fig. 1 shows an isometric view of a protective outer container for a pharmaceutical vial, according to a first aspect of the invention.

[0008] Fig. 2 shows a cross section of the container shown in Fig. 1 through the plane 2-2.

[0009} Fig. 3 shows an exploded view of the container shown in Fig. 1.

[0010] Fig, 4 shows a partially assembled view of the container shown in Fig. 1. [0011] Fig. 5 shows a plan view of the collar component of the container shown in Fig. 1.

[0012] Fig. 6 shows a cross section of the collar through the plane 6-6.

- 7 - [0013] Fig. 7 shows a cross section of the collar through the plane 7-7. [0014] Fig. 8 shows a plan view of the cap component of the outer enclosure shown in Fig. 1.

[0015] Fig. 9 shows a cross section of the cap through, the plane 9-9. [0016] Fig. 10 shows an isometric view of the container shown in Fig. 1 with the cap removed, and with a dilution system fixture positioned above the container. [0017] 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

[0018] 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 [0019] Fig. 1 shows an isometric view of a protective outer container 10 according to a first aspect of the invention. Fig. 2 shows a cross section of the container 10 through the plane 2-2, Fig, 3 shows an exploded view of the container 10. and Fig. 4 shows a partially assembled view of the container 10.

[0020] As shown in Figs. 1 -4, the container 10 includes a shell 20, a collar 30, and a cap 40 that fit together to provide a protective enclosure for a vial 50 containing a pharmaceutical, or like product. As shown in Fig. 4, the shell 20 and the collar 30 are assembled together to form an enclosure for the body of the vial 50, with the neck of the vial 50 protruding upward through a central opening in the collar 30.

[0021] According a further aspect of the invention, the pharmaceutical vial 50 is shipped from the factory fully enclosed by the protective outer container 10₅ as shown in Fig. 1. When the outer container 10 is opened by a health worker, only the cap 40 is removed. The body of the vial 50 remains enclosed by the shell 20 and collar 30 during use and disposal of the vial 50.

[0022] The shell 20 is preferably fabricated from a material that allows a health worker to visually inspect the vial 50 without having to remove it from the container 10. As described in further detail below, the shell 20 may be fabricated from a suitable transparent plastic, or the like. It will be seen in Fig. 1 that the structural components of the shell 20, collar 3O₅ and cap 40 are shaped and positioned with respect to each other such that when a vial 50 is enclosed in the container 10, the body of the vial 50, including any label affixed thereto, is visible through the shell 20. [0023J Generally, the overall shape of the container 10 shown in Figs. 1-4 is cylindrical. However, it will be apparent that it would be possible to modify the overall shape of the container 10 without departing from the spirit of the invention. For example, the overall shape and size of the container 10 may be modified to accommodate a vial 50 different from the one shown in Figs. 1-4.

[0024] According to the present aspect of the invention, the shell 20, collar 30, and cap 40 are held together in the assembled container 10 through the use of interlocking structures, and without the use of an adhesive. However, an adhesive may be used, if desired, particularly between the shell 20 and the collar 30. Generally speaking, it is desirable for the shell 20, collar 30, and cap 40 to be attached to each other in such a way that a hospital worker can readily remove the cap 40 from the collar 30 without causing the collar 30 to become separated from the shell 20. [0025] In addition, an adhesive-backed plastic or paper tape (not shown) may be applied to the exterior of the container 10 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 loaded container 10 may be shrink-wrapped or otherwise encased. Further, it would be possible to modify some or all of the shell 20, collar 30, and cap 40 to include a breakaway strip or locking structure. [0026] According to the present aspect of the invention, the shell 20 comprises a cylindrical tube 21 to which there is attached a base 22 having a flat, circular portion that closes off the bottom of the tube. The base 22 includes a foot 23, which provides clearance between the flat portion of the base 22 and the bottom edge of the tube 21. The top edge of the tube 21 forms a brim 24 defining a mouth 25 for receiving the vial 50 and the bottom of the collar 30.

[0027] When the vial 50 is packaged into the container 10, the base of the vial 50 rests on the upper surface of the shell base 22. The reason for this arrangement is to provide stability to the vial 50 when it is used to prepare a dilution. Thus, it will be seen that the foot 23 provides protection to the base of the vial 50. [0028] It will be seen in Figs. 1-4 that the diameter of Hie tube 21 is larger than the diameter of the vial 50. Thus, there is some clearance between the outer circumference of the vial 50 and the inner circumference of the shell tube 21. This clearance provides protection to the aides of the vial 50.

[0029] A suitable material for the shell 20 is polyethylene terepthalate (PET), with a thickness of 0.028 in. If PET is used, the base 22 may be attached to the tube 21 using sonic welding or other suitable technique. However, it will be understood that the shell 20 may be fabricated using other techniques and materials without departing from the spirit of the invention.

|0030J Fig. 5 shows a plan view of the collar 30. Figs. 6 and 7 show cross sections of the collar through the planes 6-6 and 7-7, respectively. According to the present aspect of the invention, the collar 30 is fabricated from low-density polyethylene, using an injection molding process. However, the material and technique used to fabricate the collar 30 may be modified without departing from the spirit of the invention.

JO031] The collar includes a circumferential outer wall 31 , and a flange 32 that protrudes outwardly from the outer wall 31. The collar flange 32 serves a number of purposes, including providing a gripping surface that is useful both for loading the vial 50 into the container 10 and also for subsequently separating the cap 40 from the collar 30,

[0032] The flange 32 divides the outer wall 31 into a lower region 31a and an upper region 31b. The outer wall's lower region 31 a is shaped to snugly fit within the shell mouth 25. When the collar 30 is mounted onto the shell 20, the shell brim 24 butts up against the lower surface of the collar flange 32. In addition, there is formed in the bottom surface of the flange 32 a circumferential channel 33. When the collar 30 is mounted onto the shell 20, the shell brim 24 seats firmly within the channel 33, helping to create a firm attachment between the shell 20 and collar 30. [0033] The wall's lower region 31a includes a pair of substantially rectangular cutout regions 34, which help provide visibility of the body of a vial 50 packaged in the assembled container 10. The wall's lower region further includes circumferential ridges 35 that serve to strengthen the attachment between the shell 20 and collar 30. [0034] The collar wall's upper region 3 Ib is shaped to snugly fit within the cap opening 44 (Fig. 9). When the cap 40 is mounted onto the collar 30, the cap brim 43 (Fig. 9) butts up against the upper surface of the collar flange 32. A bevel 36 is provided at the top of the collar outer wall 31 to facilitate the mounting of the cap 40 onto the collar 30.

[0035] Extending radially inwardly from the upper edge of the collar wall 31 is a plurality of resiliently deflectable fins 37. Each fin 37 includes an arcuate, concave gripping edge 38. The respective gripping edges 38 of all of the fins 37 combine to define a substantially circular opening 39 for receiving the neck of the vial 50. It will further be seen in Fig. 5, that the fins 37 are arranged such that open spaces 310 are provided between adjacent fins 37. At least part of each open space 310 remains unobstructed, even after the collar 40 has been mounted onto a vial 50. [0036] The fins 37 are sloped to generally follow the contour of the shoulder region of the vial 50, The sloping of the fins 37 creates a funnel-like shape that facilitates the installation of the collar 30 onto the vial 50. In addition, the sloping of the fins 37 allows the collar 30 to hold the vial 50 more securely, and also tends to prevent the collar 30 from being pulled free of the vial 50. [0037] The collar 30 further includes a plurality of vertical ribs 311 that are extend along the interior surface of the collar outer wall 31. The structure of the ribs 311 is illustrated in Fig. 7, which is a cross section of the collar 30 through the plane 7-7. The ribs 311 add rigidity to the collar outer wall 31 , which tends to enhance the strength of the attachment of the collar 30 to the shell 20. It should be noted, however, that it has been found that it is possible to fabricate a collar outer wall 31 having sufficient rigidity without the use of the vertical ribs 311. [0038] As shown in Figs. 1-4, the lip of the vial 50 has a larger diameter than the neck of the vial 50. Thus, it will be seen that when the collar 30 is installed onto the vial 5O₅ the fins 37 must deflect out of the way to allow the Hp of the vial 50 to pass through the collar opening 39. The resilience of the fins 37 causes them to tend to return to their original angle, thereby allowing the fin's gripping edges 38 to grip the neck of the vial 50. In order to improve the grip between the collar 30 and the vial 50, it is desirable for the diameter of the opening 39 to be somewhat smaller than the diameter of the neck of the vial 50. Thus, in the assembled package, the fins 37 are in a slightly deflected condition, causing them to pinch the neck of the vial 50. [0039] Fig. S shows a plan view of the cap 40, and Fig. 9 shows a cross section of the cap 40 through plane 9-9. According to the present aspect of the invention, the cap 40 is fabricated from low-density polyethylene, using an injection molding process. However, the material and technique used to fabricate the cap 40 may be modified without departing from the spirit of the invention. 10040] The cap includes a top 41 and a circumferential wall 42. The bottom edge of the wall forms a brim 43 defining an opening 44 that fits snugly around the upper region 31a of the collar outer wall 31. When the cap 40 is mounted to the collar 30, the cap brim 43 butts up against the upper surface of the collar flange 32. Because the cap 40 is fabricated using an injection molding technique, a small gate well 45 is formed on the lower surface of the top 41. [0041] The cap 40 further includes a flange 46 proximate to the top 41. In the assembled container 10, the cap flange 46 is substantially parallel to the collar flange 32. One purpose served by the two flanges 32 and 46 is to provide handy gripping surfaces that allow a hospital worker to easily remove the cap 40 from the container 30, without accidentally causing the collar 30 to separate from the shell 20. [0042] According to a further aspect of the invention, the collar flange 32 and the cap flange 46 are provided with rounded edges, to lessen the possibility that hospital workers may accidentally damage their gloves when gripping the flanges 32 and 46 to open the container 10. According to this aspect of the invention, the vertex formed by the upper and circumferential surfaces of the collar flange 32, and the vertex formed by the lower and circumferential surfaces of the cap flange 46, are each provided with a radius (not shown), such that the vertices are rounded.

[0043] Once the cap 40 has been removed, a hospital worker may then use the vial 50 to prepare a dilution. Fig. 10 shows an isometric view of the container 10, in which the cap 40 has been removed, and in which the top of the vial 50 includes an exposed, pierceable membrane 51. Also shown in Fig. 10, positioned over the container 10, is a fixture 60 used in a dilution system known as the PhaSeal system, manufactured by Carmel Pharma AB, and described in United States Patent No. 6,343.629. The bottom of the PhaSeal fixture 60 is shaped to fit over the top of the vial 50, and includes a hollow needle 61 that is inserted through the membrane 51 to extract the contents of the vial 50. The fixture 60 includes a plurality of long projections 62 and short projections 63 that extend downward around the lip and neck ofthe vial SO.

[0044] As shown in Fig. 10, the open spaces 310 between the fins 37 correspond in position to the long projections 62 of the fixture 60. Thus, by suitably rotating the container IO relative to the fixture 60, it is possible to install the fixture 60 onto the vial 50 without having to remove the vial 50 from the shell 20 and collar 30. 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 the collar 30 may be modified to accommodate other type of fixtures, without departing from the spirit of the invention. (0045) The container 10 provides protection to the vial 50 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. The transparent shell 20 of the container 10 described herein allows a health worker to visually inspect the vial 50 for cracks and leaks without directly handling the vial 50. In addition, a health worker may detect a leak by noticing an accumulation of pharmaceutical product at the base of the shell 22.

[0046] 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.

(0047] 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.

{0048] Using a container according to the present invention, it is possible for a manufacturer to load and seal a vial 50 into the container 10, and for a hospital worker to prepare a dilution from the container 10. without ever directly touching the vial 50. Thus, using the container 10, is possible to eliminate most, if not all, contamination pathways.

[0049] Fig. 11 shows a flowchart of a method 100 according to the present invention for packaging a pharmaceutical vial into a protective outer enclosure. In step 101 , a collar is provided, such as the collar 30 illustrated in Figs. 5-7, discussed above. In step 102, 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 Sower the collar such that the neck of the vial passes through the collar's central opening.

[0050] Once the collar has been installed, the pinching action of the resiliently defbrmable fins then allows the vial to be lifted from the work surface, again only touching an exterior surface of the collar. In step 103, the collar is used in this manner to load the vial into a shell, talcing care to make sure that no exposed surface of the vial makes contact with the exterior of the shell.

[0051] In step 104, 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. In step 105, 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. [0052] 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. [0053] 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

CLAIMSWhat is claimed is:

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 resiliency 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 of claim I₅ 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 of claim I , 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 of claim 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 of claim 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 of claim 1 , wherein the fins are sloped to follow a contour of the pharmaceutical vial.

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

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

10. The container of claim 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 of claim 9, wherein the shell comprises a tube with a welded base.

12. The container of claim 1 _; wherein the lower region of the outer wall includes at least one cutout section.

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

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

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

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

17. The container of claim 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 resϊliently 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 of claim 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 of claim 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.