Radiopharmaceutical unit dose container tamper evident safety seal

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.

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.

DETAILED DESCRIPTION

FIG. 1illustrates an assembly including a harness or safety seal10partially assembled to a radiopharmaceutical container or pig12. As a point of reference, the radiopharmaceutical pig12generally includes (upon final assembly) a tube14from which a flange16radially projects. The tube14includes upper and lower portions18a,18b, with the flange16consisting of threadably secured halves16a,16bthat are affixed with respect to a corresponding one of the tube portions18a,18b.

As further illustrated inFIG. 2, the harness10is formed of a flexible, strong material, such as low density polyethylene (LDPE), and defines a first band or ring20, arms22a,22b, and a second band or ring forming a connector assembly24. Other types of plastic can also be used, such as polypropylene, high density polyethylene (HDPE), etc. In the embodiment illustrated, the first band20is a continuous, uninterrupted circle (or similar shape) having a diameter greater than that of the tube14, but less than that of the flange16. The arms22a,22binterconnect the first band20with the connector assembly24. The connector assembly24includes opposing legs26a,26b, and a connection tab28. Leg26aextends between first and second ends30a,32a, whereas leg26bextends between first and second ends30b,32b. Although illustrated wherein the second band forms the connector assembly24, the connector assembly can be formed in one or more of the other portions of seal10. For example, the connector assembly can be formed in first band20, arms22a,22band/or combinations thereof.

As initially provided, the first ends30a,30bare interconnected by the connection tab28. The first end30ais connected to a first portion of the tab28and spaced apart from the first end30b. The second ends32a,32bare free. In other words, the second ends32a,32bcan be moved relative to one another, allowing a diameter collectively defined by the legs26a,26bto be increased or decreased as desired. In this regard, the first leg26aforms a male plug34, and the second leg26bforms a female receptacle36at the corresponding second end32. The plug34/receptacle36are configured such that the plug34can be captured within the receptacle36, and such that once captured, the plug34cannot be removed from the receptacle36without destroying the plug34(i.e., forming a non-removable connector).

During use, the seal10is applied over the radiopharmaceutical pig12by sliding the connector assembly24and the first band20over the tube14. Due to the extendable nature of the legs26a,26brelative to one another at the second ends32a,32b, the collective diameter of the legs26a,26bcan be expanded so as to slide over the flange16. The first band20, however, has a diameter less than that of the flange16, and thus cannot slide beyond the flange16. Once in the partial assembled position as shown inFIG. 1, the second ends32a,32bare compressed toward one another by a user, causing the plug34to be inserted within, and thus by captured by, the receptacle36. To this end, two grips38,40extend from the second ends32a,32b, respectively, which can be pressed together to secure plug34into receptacle36. In this secured state, an effective diameter of the connector assembly24is now less than that of the flange16. Thus, the harness10is “locked” about the flange16. In this position, the pharmaceutical pig12cannot be disassembled (i.e., the flange halves16a,16bcannot be disassembled from one another).

To access pig12, the seal10must first be removed; this is accomplished by breaking the connection tab28(e.g., the connection tab28is twisted relative to the legs26a,26b). Once broken, the first ends30a,30bcan freely be moved relative to one another, allowing a user to displace the legs26a,26bto an effective diameter greater than that of the flange16. As a result, the user can now slide the seal10off of the pharmaceutical pig12. The removed seal10will clearly have the “broken” connection tab28(e.g., the connection tab28will no longer be connected to one or both of the legs26a,26b), whereas the second ends32a,32bwill 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.