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In-house cyclotron production of high-purity Tc-99m and Tc-99m radiopharmaceuticals. 2018

Petra Martini, and Alessandra Boschi, and Gianfranco Cicoria, and Federico Zagni, and Andrea Corazza, and Licia Uccelli, and Micòl Pasquali, and Gaia Pupillo, and Mario Marengo, and Massimo Loriggiola, and Hanna Skliarova, and Liliana Mou, and Sara Cisternino, and Sara Carturan, and Laura Melendez-Alafort, and Nikolay M Uzunov, and Michele Bello, and Carlos Rossi Alvarez, and Juan Esposito, and Adriano Duatti
Legnaro Laboratories, Italian National Institute for Nuclear Physics (INFN), Legnaro, Padua, Italy; Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy. Electronic address: petra.martini@unife.it.

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.

UI MeSH Term Description Entries
D009684 Nuclear Medicine Department, Hospital Hospital department responsible for the administration and management of nuclear medicine services. Hospital Nuclear Medicine Department,Hospital Nuclear Medicine Departments,Nuclear Medicine Departments, Hospital
D010607 Pharmacy Service, Hospital Hospital department responsible for the receiving, storing, and distribution of pharmaceutical supplies. Clinical Pharmacy Service,Hospital Pharmacy Service,Pharmacy Service, Clinical,Hospital Pharmaceutic Service,Hospital Pharmaceutical Service,Hospital Pharmacy Services,Pharmaceutic Service, Hospital,Pharmaceutical Service, Hospital,Service, Clinical Pharmacy,Service, Hospital Pharmaceutic,Service, Hospital Pharmaceutical,Service, Hospital Pharmacy,Clinical Pharmacy Services,Hospital Pharmaceutic Services,Hospital Pharmaceutical Services,Pharmaceutic Services, Hospital,Pharmaceutical Services, Hospital,Pharmacy Services, Clinical,Pharmacy Services, Hospital,Services, Clinical Pharmacy,Services, Hospital Pharmaceutic,Services, Hospital Pharmaceutical,Services, Hospital Pharmacy
D011786 Quality Control A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed) Control, Quality,Controls, Quality,Quality Controls
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D013667 Technetium The first artificially produced element and a radioactive fission product of URANIUM. Technetium has the atomic symbol Tc, and atomic number 43. All technetium isotopes are radioactive. Technetium 99m (m Technetium 99m,99m, Technetium
D013679 Technology, Radiologic The application of scientific knowledge or technology to the field of radiology. The applications center mostly around x-ray or radioisotopes for diagnostic and therapeutic purposes but the technological applications of any radiation or radiologic procedure is within the scope of radiologic technology. Radiologic Technology,Technology, Radiological,Radiological Technology
D017357 Cyclotrons Devices for accelerating charged particles in a spiral path by a constant-frequency alternating electric field. This electric field is synchronized with the movement of the particles in a constant magnetic field. Synchrocyclotrons,Cyclotron,Synchrocyclotron
D019047 Phantoms, Imaging Devices or objects in various imaging techniques used to visualize or enhance visualization by simulating conditions encountered in the procedure. Phantoms are used very often in procedures employing or measuring x-irradiation or radioactive material to evaluate performance. Phantoms often have properties similar to human tissue. Water demonstrates absorbing properties similar to normal tissue, hence water-filled phantoms are used to map radiation levels. Phantoms are used also as teaching aids to simulate real conditions with x-ray or ultrasonic machines. (From Iturralde, Dictionary and Handbook of Nuclear Medicine and Clinical Imaging, 1990) Phantoms, Radiographic,Phantoms, Radiologic,Radiographic Phantoms,Radiologic Phantoms,Phantom, Radiographic,Phantom, Radiologic,Radiographic Phantom,Radiologic Phantom,Imaging Phantom,Imaging Phantoms,Phantom, Imaging
D019275 Radiopharmaceuticals Compounds that are used in medicine as sources of radiation for radiotherapy and for diagnostic purposes. They have numerous uses in research and industry. (Martindale, The Extra Pharmacopoeia, 30th ed, p1161) Radiopharmaceutical

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