Analysis of the Production Routine of Iodine123 at IEN and an Adaptation Proposal for a New Radiopharmaceuticals Production Facility

Abstract

The Brazilian Nuclear Energy Commission (CNEN) is the main manufacturer of radiopharmaceuticals in Brazil. The Nuclear Engineering Institute (IEN), located at Rio de Janeiro, is one of its main research and production centers, supplying public and private hospitals in the country. This radiopharmaceutical production is used in diagnostic and therapy procedures and allows one and a half million nuclear medicine procedures annually. However, IEN facilities were designed in the 60's and today its structure is inadequate in relation to the good manufacturing practices established by sanitary regulator (ANVISA) for the production of radiopharmaceuticals, leading to the need for a new project. In order to adapt and increase production in the country, a new plant will be built and integrated to the existing facilities with a new 30 MeV Cyclotron. Thus, it is proposed an analysis of the productive capacity of this plant in accordance with the principles of good manufacturing practices in order to define daily production and propose an optimized routine. As a result, the IEN / CNEN will in the future have a well-defined and standardized production process, with the flexibility to produce several radioisotopes required in nuclear medicine, obtaining a greater efficiency in its operation.