Abstract:
The present invention provides a radiation-shielding container for a radiopharmaceutical that may be magnetically picked and placed, assembled and dis-assembled.

Description:
FIELD OF THE INVENTION 
     The present invention relates to the field of containers. More specifically, the present invention is directed to a shielded container for a radiopharmaceutical. 
     BACKGROUND OF THE INVENTION 
     Radio-pharmaceuticals are typically packaged in a manner that reduces radiation exposure to the end-user of the product. Because most of these pharmaceuticals have short half-lives, radioactive content can be extremely high during manufacturing and handling of these products. Packaging containers consists of several components, with the main component being lead. Lead has a very high density and provides excellent shielding characteristics for both gamma and beta emitting radio-pharmaceuticals. Lead is also very heavy and thus contributes to ergonomically related strains during container assembly and handling. 
     A radio-pharmaceutical container typically consists of an outer shell, an inner shell, and a product container. The outer shell is typically formed from plastic that is bother durable and cleanable. The outer shell is durable to meet the requirements of the Department of Transportation (DOT). The outer shell must contain and protect the inner contents of the package during shipping and use of the product. The outer shell is cleanable so that any radioactive contamination can be washed off of the surface. Radioactive contamination is a possibility due to the nature of the contents and the environment where the containers are used. The outer shell typically has a label containing all of the product information such as; product name, manufacturing date, volume, specific activity, etc. The outer shell is usually and injection molded component that contains sub-parts that are assembled into a lower and upper assembly. 
     The inner shell, also known as the shield, fits within the outer shell. The inner shell is typically manufactured from lead with a small percentage of antimony. The inner shell is designed to provide shielding of the radioactive contents of the container. The inner shell is usually poured from molten lead into a negative void, or form. The inner shell typically includes subparts which correspond to the subparts of the outer shell. 
     The product container is the primary holder of the product. It can be made of plastic or glass and can be sterile or non-sterile. The product container may be kept in the shipping container during use to reduce exposure to the end-user. 
     The container may also include an absorbent material placed inside the inner shell to absorb fluid if the product container is breached during shipment or use. There may also be a cushioning material, such as a sponge, to protect the product container from shock during shipment or use. Additionally, there may also be an inner sleeve that can be positioned between the inner shell and the product container to segregate the product container from the lead. 
     Because the actual dose to be carried by the container may greatly vary from use to use, the lead shield is typically formed to be very thick so as to handle all doses it may encounter. The resulting weight of the container presents greater risks to the assemblers or handlers of the container of ergonomic or repetitive stress injuries. As lead is a non-ferrous metal, the shielding containers of the prior art do not lend themselves to handling machinery which employ magnets for transporting, and handling components. 
     There is therefore a need in the art for a shielded container for a radiopharmaceutical which reduces operator exposure to the radiopharmaceutical and to ergonomic and repetitive stresses relating to the manufacture, assembly, and handling of the container. 
     SUMMARY OF THE INVENTION 
     In view of the needs of the art, the present invention provides a radiation-shielding container for a radiopharmaceutical that may be magnetically picked and placed. 
     One embodiment of the present invention provides a radiation-shielding container for storing and transporting a radiopharmaceutical. The container includes a cap and a base. The container includes a first ferromagnetic plug positioned adjacent to an outer surface of the shield of one of the cap shield and the base shield. The container may also include a second ferromagnetic plug positioned adjacent the other of the cap shield and the base shield. A plug of the present invention may be provided between the outer plastic shell of the container and the lead shield. The plug may be incorporated into the outer plastic shell. Alternatively, the plug may be attached to the outer surface of the outer liner. In this manner, the plug of the present invention may be retrofitted to prior art containers. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  depicts a common product container for shipping radioactive pharmaceuticals, with the addition of a steel plug that is inset into the cap of the plastic container. 
         FIG. 2  shows the assembled product container of  FIG. 1  waiting for handling. 
         FIG. 3  shows a magnetic hoist/lift handling the product container of  FIG. 1 . 
         FIG. 4  depicts an alternate embodiment of a product container of the present invention. 
         FIG. 5  depicts another embodiment of a product container of the present invention. 
         FIG. 6  depicts yet another embodiment of a product container of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       FIG. 1  shows a shielded container  10  of the present invention for shipping radioactive pharmaceuticals. Container  10  includes a steel plug  12  that is inset into the cap  14  of the plastic outer shell  16 . Plug  12  can be made of any ferrous material, or material that can be attracted to a magnetic field.  FIG. 2  shows plug  10  as a component that is encapsulated within the cap  14  of the assembled container  10 . Plug  12  does not affect the inner shell  18 , or lead portion of the container so that the shielding ability of shielded container  10  is ensured. In addition, plug  12  does not affect the outer shell  16 , or durable and cleanable, plastic portion of container  10 . Outer shell  16  accommodates plug  12 , whether plug  12  is to its inside, outside, or incorporated therein. Desirably, plug  12  is incorporated into container  10  during vendor assembly of the container so that an assembled cap  14  and base  20  will be provided to the production department for product filling and final assembly for a product container  22 . Product container  22  is desirably a conventional container for a radioactive product such as a vial or a syringe or the like and is typically formed of plastic or glass and includes an elastomeric septum or piston. 
     More fully, container  10  includes a cap  14  and a base  20 . Cap  14  includes a lead shield  18  and a plastic outer shell  16 . Cap  14  further defines an open cap cavity  24 . Base  20  includes a lead shield  26  and an outers shell  28 . Base  20  defines an open base cavity  30  in fluid communication with cap cavity  24  when cap  14  is mated to base  20 . An elastomeric gasket  32  may be supported at the interface between cap  14  and base  20 . It will be appreciated by those of ordinary skill in the art that container  10  may have other configurations for its cap and its base, such as including an inner plastic shell, lead shields fully encased within plastic, or a removable plastic sleeve insertable into cavity  30  and/or  24 . The present invention provides a ferromagnetic plug  12  which enables the container to be remotely handled, manipulated and transported. 
       FIG. 2  shows the assembled product container  10  waiting for handling. 
       FIG. 3  shows a magnetic hoist/lift  100  handling container  10 . 
     The purpose container  10  is to reduce the ergonomic and repetitive stress associated to the manufacture and handling of a radioactive product. Container  10  can weigh one pound or more, and a typical manufacturing lot may contain several hundred to several thousand product containers. The size of the container is such that single hand manipulation of the product container is common; however, the size may be up to several inches in diameter and/or length and thus ergonomically challenging when handling production volumes. The container  10  will minimize the operator whole body and extremity exposure incurred during manufacturing and handling of the product. In addition, container  10  will reduce the ergonomic and repetitive stress associated with the manufacturing and handling of the product. Finally, container  10  will offer these advantages to the end-user of these products as well as to those lading and assembling container  10 . 
     While plug  12  is desirably incorporated into container  10  during the container&#39;s manufacture, plug  12  may also be added to an already existing product package. Plug  10  will thus allow for a different set of handling capabilities than shielded containers of the prior art which would forego use of a ferromagnetic material since such material does not provide desirable radiation shielding properties. These handling capabilities can vary in complexity from a remote pick and place mechanical arm to a robotic arm programmed to assemble, pick up, and place the product container into a shipping container. The added weight of the plug is insignificant when compared to the overall weight of the lead portion of the inner shell. It is possible that the plug could provide additional top shielding of the product container, or the dimension of the lead insert may be reduced because of the added shielding by the top plug. 
     As shown in  FIG. 4 , the present invention further contemplates providing a container  110  having a ferrous plug  13  incorporated in base  20 . For this and the remaining embodiments (shown in  FIGS. 5 and 6 ) of the present invention, the identifying nomenclature of container  10  is retained as shown. Container  110  is shown as further providing plug  13  to the components of container  10 . Plug  13  allows for a sliding manipulation of either just the base  20  or the entire assembled and filled container  110 . As shown in  FIG. 5 , the present invention alternatively contemplates providing a container  210  having a ferrous cylinder  15  incorporated between the cylindrical walls of base  20  and lower shield  26 . Container  210  provides handling capabilities from the sides of container  210 . 
     The present invention contemplates that the plugs  12 ,  13 , and  15  of containers  10 ,  110 , and  210 , respectively may all be incorporated into a single container. Each of these containers provide a plastic outer surface when the containers are fully assembled, minimizing operator exposure to the lead shields while handling the container and providing an easily cleaned outer surface. While each of the shown containers show that the lead shield components provide an exposed lead surface on the interior, or container-receiving portion of the shields, the present invention is equally applicable to containers having an encapsulated or otherwise interiorly lined shield providing plastic on all of the surfaces to which an operator may be exposed. 
       FIG. 6  depicts a container  310  of the present invention. Container  310  is a conventional shielded container of the prior art which has a ferrous plug  17  attached to the outside of the container. Attachment of plug  17  to container  210  may be accomplished by known adhesives or by other conventional means. While plug  17  is shown attached to cap  14 , it is further contemplated that plug  17  may alternatively be attached to the exterior of base  20 . The provision of plug  17  provides a simple retrofit of existing lead-shielded containers. Plug  17  itself may further be covered or encapsulated in plastic so as to maintain the general appearance and cleanliness of the original container. 
     The present invention thus provides the ability to use an automated or remote pick and place machine/device with shielded containers for radiopharmaceuticals. Such machines can provide for a reduction in manufacturing time and time spent handling product containers, thereby reducing the ergonomic and repetitive stress risks to human operators. These machines also provide the ability to handle numerous product containers at the same time. The containers may be manufactured and handled in an ergonomically correct way. The present invention thus provides production personnel are provided with the best possible methods and tools for handling radioactive pharmaceuticals 
     While the particular embodiment of the present invention has been shown and described, it will be obvious to those skilled in the art that changes and modifications may be made without departing from the teachings of the invention. The matter set forth in the foregoing description and accompanying drawings is offered by way of illustration only and not as a limitation. The actual scope of the invention is intended to be defined in the following claims when viewed in their proper perspective based on the prior art.