Fractionation of radiopharmaceuticals: set-up and verification of an automatic system portable with integrated dose calibrator

Background-aim: The procedure of fractionation of the various radiopharmaceuticals (RP)—which include both those prepared inside the laboratory of Nuclear Medicine (NM) and the ones produced by the pharmaceutical industry and distributed as ready for use—has to be performed within the period of radiochemical stability of the preparation itself. In addition, all fractionation sessions have to be entirely carried out under aseptic conditions, taking into account those specific methods allowing to maintain the sterility and the apirogenicity of the RP and, at the same time, to comply with the basic principle of radiation protection, according to which it is mandatory to reduce, as much as possible, the radiation dose to the operator. According to National Regulations on the use radiopharmaceuticals (NBP-MN, GU n. 168 del 21 luglio 2005 and Farmacopea Ufficiale- current edition), the NM technician is responsible of the RP prepa- ration and fractionation into the single doses for each patient. Specifically, MN technician follows the specification of the MN physician regarding prescription and dosage of RP and takes care of the proper conservation of the RP until it is injected into the patient. Moreover, each syringe containing the RP has to be identified with a label in which all data allowing the traceability of the preparation are recorded. There is a diffuse consensus that the most performing modalities of RP fractionation are, at present, those based on auto- mated systems. The aim of the present work was to develop and test of a new automated fractionation instrument, integrated with a suitable RP activity calibrator. Methods: The first phase of our process consisted in the identification (and verification) of the best standard performance of a novel pro- totype instrument for automated RP fractionation (named FastDose and distributed by MecMurphyl) that was installed inside the clean room of our Nuclear Medicine Unit in November 2014. During a second phase of work, we focused on the detection of any cases of non-compliance linkable to the instrument work and, for conse- quence, we studied and introduced several technical ameliorations aimed to eliminate all those anomalies which prevented us to reach the best standard performance. A multidisciplinary team, including MecMurphyl Company’s specialists, NM physicians, technicians, and physicists of our Department, has consistently and synergistically contributed to the project for several months. Results: After the testing phase, the long process of qualification of the instrument, as well as required by the current National Regula- tions, has led to identify and resolve any functional non-compliance related to the new tool. In particular, it was decided to modify; the ionization chamber, the single-use kit for the RP dispensation into syringe, the instrument initialization software and: the specific sup- port that ensures the correct insertion of the syringe during the RP dispensation phase. Conclusions: In this project, the contribution of MN technician—who completely knows the methodological processes, in the light of the current National Regulations—was crucial for the final qualification of this prototype tool and its subsequent use in clinical practice. At present, the fractionator FastDose, suitably qualified as previously described, meets all the requirements in terms of efficiency and safety and is fully employed in the fractionation of all of the RP preparations.