Device For Synthesis Of Radiopharmaceutical Products

Abstract

The invention concerns a device for synthesis of radiopharmaceutical products based on chemical reagents contained in bottles, said device comprising several reaction compartments, transfer means between said bottles and said reaction compartments as well as mechanical means acting on said transfer means and enabling to monitor and control mechanically the transfer of chemical reagents. The invention is characterized in that it comprises: a fixed module including at least the mechanical means; a removable and disposable module, essentially in the shape of a support, whereon are arranged the transfer means between said bottles and said reaction compartments, said removable and disposable module not including any mechanical means; and means for securing said removable and disposable module to said fixed module.

1 . A disposable module for use in a device for synthesis of radiopharmaceutical products from chemical reagents, the disposable module being essentially in the form of a support plate and furthermore comprising:
 means for transferring the chemical reagents;   bottles containing the chemical reagents;   the support plate being provided with positioning means for positioning the transfer means, and the disposable module wherein the bottles containing the chemical reagents are pre-metered bottles.   
     
     
         2 . The disposable module according to  claim 1 , wherein the disposable module does not have any mechanical means. 
     
     
         3 . The disposable module according to  claim 1 , wherein the positioning means are constituted by grooves in which the transfer means are placed. 
     
     
         4 . The disposable module according to  claim 1 , wherein the transfer means are flexible tubes. 
     
     
         5 . The disposable module according to  claim 1 , wherein it furthermore comprises reaction compartments. 
     
     
         6 . The disposable module according to  claim 1 , wherein the nature of the support plate and that of the transfer means are such that they allow washing of the disposable module by steam autoclaving and/or its sterilisation. 
     
     
         7 . The disposable module according to  claim 5 , wherein the support plate is made of ABS. 
     
     
         8 . The disposable module according to  claim 5 , wherein the transfer means are made of silicone. 
     
     
         9 . A device for synthesis of radiopharmaceutical products from chemical reagents contained in bottles, the device comprising a disposable module according to  claim 1  as well as a fixed module and means of securing the disposable module to the fixed module. 
     
     
         10 . The device according to  claim 9 , wherein the fixed module comprises at least mechanical means acting on the transfer means of the disposable module and enabling to monitor and control mechanically the transfer of the chemical reagents from the bottles of the disposable module. 
     
     
         11 . The device according to  claim 9 , wherein the mechanical means are pistons, the mechanical means, the transfer means and the positioning means being capable of co-operating so as to form valves. 
     
     
         12 . The device according to  claim 9 , wherein the securing means comprise at least one opening, shoulders and fasteners. 
     
     
         13 . The device according to  claim 12 , wherein the shoulders are located on the support plate, preferably at the four comers of the support plate, and are capable of fitting into fasteners located on the fixed module. 
     
     
         14 . The device according to  claim 12 , wherein the opening is likewise located on the support plate, preferably at the centre of the plate, and is capable of fitting into a fastener located on the fixed module. 
     
     
         15 . The device according to  claim 1 , wherein it includes means of actuating mechanical means of the fixed module. 
     
     
         16 . The device according to  claim 1 , wherein the actuating means are constituted by an automaton co-operating with a computer and forming part of the fixed module. 
     
     
         17 . A process for synthesising radiopharmaceutical products using the disposable module according to  claim 1  or the device for synthesis of radiopharmaceutical products from chemical reagents contained in bottles, the device comprising a disposable module according to  claim 1  as well as a fixed module and means of securing the disposable module to the fixed module, wherein it comprises the following stages:
 at the disposable module, the transfer means are arranged on the support plate, 
 at the disposable module, the bottles containing the chemical reagents are fixed to one of the ends of the transfer means, 
 the disposable module, that is to say the support plate with the transfer means, is attached to the fixed module with the aid of securing means, 
 the transfer means of the disposable module are connected to the various elements of the fixed module, 
 
       the various operations required for synthesis of the pharmaceutical products, including the actuation of the mechanical means of the fixed module are commanded via an automaton. 
     
     
         18 . The process according to  claim 17 , wherein before commanding the various operations required for synthesis of the pharmaceutical products, a test to verify the tightness of the device is carried out via the automaton. 
     
     
         19 . Use of the disposable module according to  claim 1  or of the device for synthesis of radiopharmaceutical products from chemical reagents contained in bottles, the device comprising a disposable module according to  claim 1  as well as a fixed module and means of securing the disposable module to the fixed module for synthesising radiopharmaceutical compounds containing radio-elements with a short half-life, preferably  11 C,  13 N,  15 O or  18 F.