In-house cyclotron production of high-purity Tc-99m and Tc-99m radiopharmaceuticals

• Published in: Applied radiation and isotopes Vol. 139; pp. 325 - 331
• Main Authors: Martini, Petra, Boschi, Alessandra, Cicoria, Gianfranco, Zagni, Federico, Corazza, Andrea, Uccelli, Licia, Pasquali, Micòl, Pupillo, Gaia, Marengo, Mario, Loriggiola, Massimo, Skliarova, Hanna, Mou, Liliana, Cisternino, Sara, Carturan, Sara, Melendez-Alafort, Laura, Uzunov, Nikolay M., Bello, Michele, Alvarez, Carlos Rossi, Esposito, Juan, Duatti, Adriano
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.09.2018
• Subjects: 99mTc-radiopharmaceuticals; Cyclotron; European Pharmacopoeia; Generator; Hospital radiopharmacy; Molybdenum-100; SPECT; Technetium-99m; Cyclotron; 99mTc-radiopharmaceuticals; European Pharmacopoeia; Hospital radiopharmacy; Technetium-99m; Molybdenum-100; SPECT; Generator; (99m)Tc-radiopharmaceuticals
• ISSN: 0969-8043; 1872-9800
• DOI: 10.1016/j.apradiso.2018.05.033

In the last years, the technology for producing the important medical radionuclide technetium-99m by cyclotrons has become sufficiently mature to justify its introduction as an alternative source of the starting precursor [99mTc][TcO4]- ubiquitously employed for the production of 99mTc-radiopharmaceuticals in hospitals. These technologies make use almost exclusively of the nuclear reaction 100Mo(p,2n)99mTc that allows direct production of Tc-99m. In this study, it is conjectured that this alternative production route will not replace the current supply chain based on the distribution of 99Mo/99mTc generators, but could become a convenient emergency source of Tc-99m only for in-house hospitals equipped with a conventional, low-energy, medical cyclotron. On this ground, an outline of the essential steps that should be implemented for setting up a hospital radiopharmacy aimed at the occasional production of Tc-99m by a small cyclotron is discussed. These include (1) target production, (2) irradiation conditions, (3) separation/purification procedures, (4) terminal sterilization, (5) quality control, and (6) Mo-100 recovery. To address these issues, a comprehensive technology for cyclotron-production of Tc-99m, developed at the Legnaro National Laboratories of the Italian National Institute of Nuclear Physics (LNL-INFN), will be used as a reference example. •Direct production of Tc-99m by cyclotrons.•Requisites for Mo-100 target production.•Requisites for separation/purification of accelerator-produced [99mTc][TcO4]-.•Quality requirements for cyclotron-produced [99mTc][TcO4]- suitable for clinical use.