From March 27-31, 2017, Rick Muñoz of AdSTM participated in a RSRP mission to Paraguay’s Radiological and Nuclear Regulatory Authority (ARRN) in Asuncion to provide technical support for the evaluation and operation of a Siemens Eclipse™ Cyclotron and Positron Emission Tomography (PET) pharmaceuticals. The 11 MeV self-shielded cyclotron is used to produce fluorine-18 (F-18) dedicated to FDG production for PET imaging studies. This is the first, and the only cyclotron authorized in Paraguay. The AdSTM expert provided technical training on licensing and inspection of self-shielded type cyclotrons used for F-18 radionuclide production and radiopharmaceutical licenses.
At the time of the site visit, ARRN had authorized the construction for the cyclotron facility as a result of a previous AdSTM visit by the same expert in November 2015. At that time, the operational license and the radiopharmacy license applications were discussed. Since the AdSTM consultation of 2015, ARRN has issued both an operating license for the cyclotron and a radiopharmaceutical license for the production of FDG to be used at customer sites for PET imaging; both licenses were issued on March 9, 2016. The AdSTM expert completed additional training on inspection procedures and protocols for both types of licenses.
The Paraguay Authority had also requested on-site inspection assistance for both the self-shielded cyclotron and the radiopharmaceutical license. On March 28 and March 30, the AdSTM representative provided assistance and oversite during the performance of formal inspections of the operating PET production facility using the 11 MeV Siemens Eclipse™ Cyclotron and the radiopharmacy license authorized for the synthesis of FDG for PET diagnostic imaging. ARRN had designated a lead inspector and support staff to conduct the inspection. An on-site exit briefing was conducted with licensee management and staff personnel at the conclusion of each inspection. Formal written reports will be issued by ARRN.