Patent Publication Number: US-2007108205-A1

Title: Protective outer enclosure for pharmaceutical 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&#39;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 in  FIG. 1  through the plane  2 - 2 .  
       FIG. 3  shows an exploded view of the container shown in  FIG. 1 .  
       FIG. 4  shows a partially assembled view of the container shown in  FIG. 1 .  
       FIG. 5  shows a plan view of the collar component of the container shown in  FIG. 1 .  
       FIG. 6  shows a cross section of the collar through the plane  6 - 6 .  
       FIG. 7  shows a cross section of the collar through the plane  7 - 7 .  
       FIG. 8  shows a plan view of the cap component of the outer enclosure shown in  FIG. 1 .  
       FIG. 9  shows a cross section of the cap through the plane  9 - 9 .  
       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.  
       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 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 .  
      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 .  
      According a further aspect of the invention, the pharmaceutical vial  50  is shipped from the factory fully enclosed by the protective outer container  10 , 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 .  
      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  30 , 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 .  
      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 .  
      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 .  
      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.  
      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 .  
      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 .  
      It will be seen in  FIGS. 1-4  that the diameter of the 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 sides of the vial  50 .  
      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.  
       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.  
      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 .  
      The flange  32  divides the outer wall  31  into a lower region  31   a  and an upper region  31   b.  The outer wall&#39;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 .  
      The wall&#39;s lower region  31   a  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&#39;s lower region further includes circumferential ridges  35  that serve to strengthen the attachment between the shell  20  and collar  30 .  
      The collar wall&#39;s upper region  31   b  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 .  
      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 .  
      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 .  
      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 .  
      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  50 , the fins  37  must deflect out of the way to allow the lip 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&#39;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 .  
       FIG. 8  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.  
      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  31   a  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 .  
      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 .  
      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.  
      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 U.S. Pat. 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 of the vial  50 .  
      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  10  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.  
      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 .  
      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 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.  
       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 lower the collar such that the neck of the vial passes through the collar&#39;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. In step  103 , 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.  
      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.  
      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.