Packaging systems for drugs and diagnostics are controlled by strict requirements under drugs legislation, both in terms of material compatibility and with regard to ability to sterilize. This applies in particular to injectable preparations and diagnostics. For example, no elements of the packaging used must be soluble in the solution to be packaged. Furthermore, the container must be such that it can be adequately sterilized before the contents are removed.
Consequently, it is standard practice to package injectable drug preparations either in solid glass vials closed by fused ends or glass vials which can be closed by means of a stopper and optionally a flanged cap. In the latter case, the contents are usually removed by piercing a septum or the actual stopper with the syringe and drawing the solution into the syringe with the stopper closed. In order to prevent any form of contamination, the cover region must therefore be sterilized beforehand. This is done by spraying and/or wiping with ethanol solutions.
In addition to these requirements intended to regulate the drug aspect, containers for radioactive materials, including radioactive solution, are subject to additional requirements with regard to containment of the emitted radiation. For transport purposes, therefore, radioactive materials are usually placed in a first packaging which is sealed. For containment purposes, this packaging is in turn placed in a lead container which acts as the actual shield. In the past, however, this type of packaging has proved to be impractical, specifically in the case of injectable drug preparations.
Vials of the type that are closed by fusion are totally unsuitable for packaging radioactive materials due to the risk of the syringe becoming contaminated when the vial end is broken off in order to open them. If glass vials sealed by stoppers are used, they usually have to be completely removed from the lead container, which means that the doctor handling them is exposed to what is usually a considerable amount of radiation, depending on the radiation emitted. The same risk of exposure exists, at least in the region of the tips of the fingers by which the vials are held, even in the case of (β-radiation, which is usually shielded by a few centimeters of air. This is also not acceptable for those who constantly handle radio-chemicals and radioactive drugs.
With the packaging systems used to date, therefore, it is not possible to provide shielding and permit removal of the contents with a visual control simultaneously. The sealed container has to be removed form the lead container so that the doctor can completely remove the entire solution from the vessel and visually check the removal process.
In order to get round this problem, a container has been used for radioactive solutions in the past, in which a vial or another container such as an Eppendorf container is placed in a casing of Plexiglass. The container is closed with a screw cap so that a rubber seal placed on the glass vial is pressed onto the glass vial by the screw cap and is sealed by it as a result. However, this system does not meet the requirements of current drug legislation. For one thing, impurities are able to get into the solution from the screw thread, simply by turning it. Secondly, there is no guarantee that the rubber seal will remain on the opening of the glass vial when the cap is unscrewed, thereby removing the contact pressure. More specifically, this type of packaging does not allow the container serving as the shield and the actual seal of the radioactive solution to be opened separately. In addition, the seal can not be adequately sterilized if left in place. The same applies to sterilization of the screw thread. Finally, radioactive contamination of the ambient environment can not be ruled out if the seal falls out.
The present invention is intended as a means of overcoming the problems of the prior art outlined above.
USPTO Backgrounds
USPTO Backgrounds