Abstract:
A tamper evident safety seal includes a first band, a second band and first and second arms connecting the first band and the second band. The seal is positioned around a radiopharmaceutical container and further includes a connector assembly having a connector and a break away portion that, when separated, provides visual evidence that the seal has been broken.

Description:
BACKGROUND 
     The present disclosure relates to a safety sealing mechanism used in conjunction with radiopharmaceutical unit dose containers. In the field of nuclear medicine, radioactive materials (known as radiopharmaceuticals) are used in various applications. Typically, radiopharmaceuticals are delivered to a caregiver from an outside pharmacy “pre-loaded” into a syringe. Due to the radioactive nature of such radiopharmaceuticals, great care must be utilized in handling. It is common industry practice for the outside pharmacy to ship the syringe-loaded radiopharmaceutical (or other unit dose format) in a shielded container, referred to as a “radiopharmaceutical pig”. The radiopharmaceutical pig generally consists of a base and a cover that is threadably attachable to the base. For various reasons, it is important for caregivers and/or pharmacies to quickly recognize when a radiopharmaceutical pig has been opened (i.e., the cover unscrewed from the base). One current approach for providing this tamper evident safety feature is by applying a shrink wrap about the radiopharmaceutical pig. To effectuate disassembly of the cover from the base, the shrink wrap must be removed (or at least torn). While viable, this approach entails added manufacturing/handling costs, and caregivers may experience difficulties in removing and/or disposing of the shrink wrap. 
     SUMMARY 
     Aspects of the present disclosure relate to a tamper evident seal and method for sealing a radiopharmaceutical container. The seal includes a first band, a second band and a connector assembly adapted to be positioned around the container. First and second arms connect the first band to the second band. The connector assembly includes a connector connecting two ends of the seal together and a breakaway portion provided to separate two ends of the seal so as to provide visual evidence the seal has been broken. 
     In one embodiment, the first band forms an uninterrupted circle adapted to be positioned around an upper portion of the container and the second band includes the connector assembly and is adapted to be positioned around a lower portion of the container. In a further embodiment, the first arm connects the first band to a first leg of the connector assembly and the second arm connects the first band to a second leg of the connector assembly. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts. 
         FIG. 1  is a perspective view of an assembly including a safety seal partially assembled to a radiopharmaceutical container. 
         FIG. 2  is a perspective view of the safety seal of  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION 
     In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims. 
     It is to be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically noted otherwise. 
       FIG. 1  illustrates an assembly including a harness or safety seal  10  partially assembled to a radiopharmaceutical container or pig  12 . As a point of reference, the radiopharmaceutical pig  12  generally includes (upon final assembly) a tube  14  from which a flange  16  radially projects. The tube  14  includes upper and lower portions  18   a ,  18   b , with the flange  16  consisting of threadably secured halves  16   a ,  16   b  that are affixed with respect to a corresponding one of the tube portions  18   a ,  18   b.    
     As further illustrated in  FIG. 2 , the harness  10  is formed of a flexible, strong material, such as low density polyethylene (LDPE), and defines a first band or ring  20 , arms  22   a ,  22   b , and a second band or ring forming a connector assembly  24 . Other types of plastic can also be used, such as polypropylene, high density polyethylene (HDPE), etc. In the embodiment illustrated, the first band  20  is a continuous, uninterrupted circle (or similar shape) having a diameter greater than that of the tube  14 , but less than that of the flange  16 . The arms  22   a ,  22   b  interconnect the first band  20  with the connector assembly  24 . The connector assembly  24  includes opposing legs  26   a ,  26   b , and a connection tab  28 . Leg  26   a  extends between first and second ends  30   a ,  32   a , whereas leg  26   b  extends between first and second ends  30   b ,  32   b . Although illustrated wherein the second band forms the connector assembly  24 , the connector assembly can be formed in one or more of the other portions of seal  10 . For example, the connector assembly can be formed in first band  20 , arms  22   a ,  22   b  and/or combinations thereof. 
     As initially provided, the first ends  30   a ,  30   b  are interconnected by the connection tab  28 . The first end  30   a  is connected to a first portion of the tab  28  and spaced apart from the first end  30   b . The second ends  32   a ,  32   b  are free. In other words, the second ends  32   a ,  32   b  can be moved relative to one another, allowing a diameter collectively defined by the legs  26   a ,  26   b  to be increased or decreased as desired. In this regard, the first leg  26   a  forms a male plug  34 , and the second leg  26   b  forms a female receptacle  36  at the corresponding second end  32 . The plug  34 /receptacle  36  are configured such that the plug  34  can be captured within the receptacle  36 , and such that once captured, the plug  34  cannot be removed from the receptacle  36  without destroying the plug  34  (i.e., forming a non-removable connector). 
     During use, the seal  10  is applied over the radiopharmaceutical pig  12  by sliding the connector assembly  24  and the first band  20  over the tube  14 . Due to the extendable nature of the legs  26   a ,  26   b  relative to one another at the second ends  32   a ,  32   b , the collective diameter of the legs  26   a ,  26   b  can be expanded so as to slide over the flange  16 . The first band  20 , however, has a diameter less than that of the flange  16 , and thus cannot slide beyond the flange  16 . Once in the partial assembled position as shown in  FIG. 1 , the second ends  32   a ,  32   b  are compressed toward one another by a user, causing the plug  34  to be inserted within, and thus by captured by, the receptacle  36 . To this end, two grips  38 ,  40  extend from the second ends  32   a ,  32   b , respectively, which can be pressed together to secure plug  34  into receptacle  36 . In this secured state, an effective diameter of the connector assembly  24  is now less than that of the flange  16 . Thus, the harness  10  is “locked” about the flange  16 . In this position, the pharmaceutical pig  12  cannot be disassembled (i.e., the flange halves  16   a ,  16   b  cannot be disassembled from one another). 
     To access pig  12 , the seal  10  must first be removed; this is accomplished by breaking the connection tab  28  (e.g., the connection tab  28  is twisted relative to the legs  26   a ,  26   b ). Once broken, the first ends  30   a ,  30   b  can freely be moved relative to one another, allowing a user to displace the legs  26   a ,  26   b  to an effective diameter greater than that of the flange  16 . As a result, the user can now slide the seal  10  off of the pharmaceutical pig  12 . The removed seal  10  will clearly have the “broken” connection tab  28  (e.g., the connection tab  28  will no longer be connected to one or both of the legs  26   a ,  26   b ), whereas the second ends  32   a ,  32   b  will remain connected to one another. As a result, a visual indication that the pharmaceutical pig has been opened (or at least an attempt was made to open) will be quickly evident. 
     Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of the specific embodiments discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.