Qualification of design (dq) and installation (iq) of cyclotrons for radiopharmaceuticals production
International Journal of Development Research
Qualification of design (dq) and installation (iq) of cyclotrons for radiopharmaceuticals production
Received 10th December, 2019; Received in revised form 20th January, 2020; Accepted 06th February, 2020; Published online 30th March, 2020
Copyright © 2020, Heber Simões Videira et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
The rapid increase of radiopharmaceutical units in Brazil after the monopoly flexibilization in 2006, together with the requirements of the National Nuclear Energy Commission (CNEN) and the National Agency of Sanitary Surveillance (ANVISA), have raised the need for a proposal of Design (DQ) and Installation (IQ) Qualification for Cyclotrons by applicable national standards, manufacturer’s guide and international literature recommendations. The objective of this study was to present a proposal for the DQ and IQ for low and medium energy cyclotrons according to national standards and international recommendations. Our proposal was evaluated for two facilities that underwent the referred qualification requirements. We showed that our methodology fits the needs of national regulations and international recommendations for the evaluated cyclotrons in these qualifications. Indeed, our proposal will support new facilities in Brazil and worldwide to evaluate their cyclotron during the design and installation process.
