WP8: Final set up of implemented micro device for actual production and process validation
WP leader: 
Siemens AG - Arno Steckenborn
This is the most critical part of the project. All the efforts made in parallel by each partner will be joined together, thus achieving the final target. WP8 will be organized into three main objectives because it aims to ensure that an efficient device for synthesis of no labelled molecules will be prepared before the final test with radioactive materials.
First of all some possibilities to fabricate a modular device will be exploited. Each module will be designed in such a way to facilitate the connection with another one and the insertion of radioactivity detectors. Once each module (pre-concentration, reaction, product purification, solvent evaporation) has been optimised and tested, it will be combined with the others to form an integrated system. The whole system will be projected and designed by CNR-INFM-NNL and Siemens, with the collaboration of all the groups, thus improving the efficiency of each part and ensuring a full electrical and fluidic compatibility of combination. Therefore this WP will start at the very beginning of the project to define the internal structure, thus granting the compatibility and pluggability of all modules and functions in the end phase for testing. The structure will be such that the individual modules will have autonomous controls (for sensors and actuators) to allow separate testing during development in WPs 3-6. In the final system, the productive cycle of FDG and other pharmaceuticals will be performed with non labelled fluorine.
The various setups to be proposed in the WP2-7 make no sense if they do not work properly together. To ensure this, a concept for integrating the system has to be developed (objective 2), which allows highest possible degree of freedom for module combinations, interoperatibility and safety. Safety in this context means internal shielding of the fluidic modules to avoid problems within the electronics and external shielding to guarantee a highest level of safety along with lowest requirements for additional precautions in the surrounding infrastructure. To accomplish this, objective 2 of WP8 starts at the very beginning of the whole project to develop a system structure in which all partners can implement their modules for special process steps, which allows intermediate tests of partial module combinations and as a final step the complete performance demonstration of the project outcome in WP9.
The various setups proposed in the first two objectives of WP8 will be tested for final application to the complete radiosynthesis of commonly used radiopharmaceuticals (objective 3). In this step, attention will be paid to the seamless interfacing of fluidic and electronic hardware, software and their application issues such as process validation, quality control and formulation issues, batch repeatability and final user interface optimization. This step will eventually lead to several chip prototypes each able to perform the complete synthesis of one injectable radiopharmaceutical starting from cyclotron H18F with great repeatability, increased operator safety and in shorter times.
