Process and device for preparing radiopharmaceutical products for injection

Abstract

Method for preparing, packaging and handling an individual dose of a radiopharmaceutical compound, comprising the following steps: filling a cartridge ( 1 ) with said dose of radiopharmaceutical compound via a first end, the second end being closed by means of a component serving as a piston ( 3 ); closing said cartridge ( 1 ) at said first end by means of a closure device ( 2 ); placing said cartridge ( 1 ) in a radiation shielding device ( 10 ), comprising an inner part ( 4 ) and an outer part ( 5 ), said inner part serving as radiation shielding for an operator and said outer part serving as a transportation shielding container; closing said container by means of an appropriate shielding lid ( 6 ); transporting said container up to the place at which an injection of said radiopharmaceutical compound will take place; removing the shielding lid ( 6 ) of the container; fixing a plunger ( 7 ) to the cartridge piston ( 3 ); extracting the cartridge and the inner part ( 4 ) of the radiation shielding device ( 10 ) from the outer part ( 5 ) serving as a container, and placing injection means ( 30 ) on the cartridge end which has the setting closure device ( 2 ).

1 . Device to be used in the automated preparation, packaging and further handling of a radiopharmaceutical compound individual dose, comprising the following set of elements 
 a cartridge intended to contain said individual dose, provided at a first end with a closing element ( 2 ) and at a second end by means of a component serving as a piston ( 3 );    a radiation-shielding container ( 10 ) comprising an inner cylinder-like part ( 4 ) capable to enclose said cartridge ( 1 ), and an outer cylinder-like part ( 5 ), serving as an additional shielding for transportation, said outer part being capable to enclose said inner part, said outer part being provided with a shielding lid ( 6 )    a plunger ( 7 ) to be fitted to the cartridge ( 1 ) at the time of an injection, while said cartridge is still inside said inner cylinder-like part ( 4 ) of the radiation shielding container ( 10 ), provided with a sliding rod ( 22 ) capable to contact said piston ( 3 ) of the cartridge ( 1 ), with a push button ( 23 ) and with support wings ( 25 ) for the fingers;    an injection means ( 30 ) to be fitted to the first end of the cartridge ( 1 ) at the time of an injection, while said cartridge is still inside said inner cylinder-like part ( 4 ) of the radiation shielding container ( 4 ), wherein: 
 the plunger is provided with fixing means ( 24 ) to said inner cylinder-like part ( 4 ) of the radiation shielding container ( 10 );  
 the closing element ( 2 ) is a septum, preferably an elastomeric stopper and the injection means ( 30 ) is capable to pierce the closing element ( 2 ) of the cartridge, ( 1 ) in a sterile manner and to enter in contact with said radiopharmaceutical compound.  
   
     
     
         2 . Device according to  claim 1 , wherein the fixing means ( 24 ) of the plunger comprise a rapid attachment device such as screwing or clipping means.  
     
     
         3 . Device according to  claim 1 , wherein said injection means ( 30 ) comprises inwardly a spike ( 31 ) and outwardly a needle ( 33 ) or a luer fitting ( 34 ) in connection to the spike ( 31 ), preferably of the VACUTAINER® type.  
     
     
         4 . Device according to  claim 1 , wherein said spike ( 31 ) is protected in a sterile manner by an elastomeric sleeve ( 32 ) until said closing element ( 2 ) of cartridge ( 1 ) has been pierced.  
     
     
         5 . Device according to  claim 3  or  4 , wherein the injection means elements ( 30 ) are covered by a protective cap ( 41 , 42 ) before use.  
     
     
         6 . Device according to  claim 1 , wherein the injection means ( 30 ) are designed for rapid attachment to the cartridge such as screwing or clipping.  
     
     
         7 . Device according to  claim 1 , wherein said cartridge is a standard cartridge of the type used for the packaging of insulin.  
     
     
         8 . Device according to  claim 1 , wherein it is suitable for using a short-lived Positron Emission Tomography (PET) compound.  
     
     
         9 . Device according to  claim 1 , wherein said inner cylinder-like part ( 4 ) is made of high density metal such as tungsten or a tungsten-based alloy.  
     
     
         10 . Device according to  claim 1 , wherein said outer cylinder-like part ( 5 ) and said shielding lid ( 6 ) are made of a high density metal such as lead, tungsten, a high lead content alloy or a high tungsten content alloy.  
     
     
         11 . Device according to  claim 1 , wherein a see-through window ( 20 ) is provided in the shielding ( 4 ).  
     
     
         12 . Use of the device, according to anyone of  claim 1  to  11 , for automatically preparing, packaging and handling an individual dose of a radiopharmaceutical compound, comprising the following steps: 
 filling the cartridge ( 1 ) with said dose of radiopharmaceutical compound via its first end, its second end remaining closed by means of the piston ( 3 );  
 closing said cartridge ( 1 ) at said first end by means of the closure device ( 2 );  
 placing said cartridge ( 1 ) in the radiation shielding device ( 10 ), comprising an inner part ( 4 ) and an outer part ( 5 ), said inner part serving as radiation shielding for an operator and said outer part serving as a transportation shielding container;  
 closing said shielding container ( 5 ) by means of the shielding lid ( 6 );  
 transporting said container up to the place at which an injection of said radiopharmaceutical compound will be carried out;  
 removing the shielding lid ( 6 ) of the container;  
 fixing the plunger ( 7 ) to the inner part ( 4 ) of the shielding device ( 10 );  
 extracting the inner part ( 4 ) of the radiation shielding device ( 10 ), enclosing the cartridge, from the outer part ( 5 ), and  
 placing injection means ( 30 ) on the cartridge end which is provided with the closing element, ( 2 ), said cartridge ( 1 ) being still enclosed in the inner part ( 4 ) of the shielding device ( 10 ).