Classification of areas of a new installation of radioisotopes and radiopharmaceuticals in the IEN

The National Nuclear Energy Commission (CNEN) is the main radiopharmaceuticals producer in Brazil, and the Institute of Nuclear Engineering (IEN) is one of its main research and production centers. These radiopharmaceuticals are used in nuclear medicine for diagnosis and therapy of diseases and about one and a half million procedures per year are performed in the country. In this scenario, IEN plays a fundamental role in radiopharmaceuticals supply for all the country. However, due to its an old installation, built in the 70's, its structure today is inadequate regarding the good manufacturing practices recommended by the National Agency of Sanitary Surveillance (ANVISA) and the rules that the country's legislation imposes for radiopharmaceutical production, so there is a fundamental need for an update project. In order to adapt and increase the country's production and research capacity, a new plant to be built and integrated with the existing IEN facilities, together with a new 30 MeV Cyclotron, is in the process of being detailed for approval by the Ministry of Health. The objective of this work is to make a survey of the current standards of CNEN and ANVISA regarding requirements for the installation of radiopharmaceutical production, as well as the radiological protection analysis of the plant areas, following the recommendations of good manufacturing practices adopted nationally. As a result, this work will contribute to the future IEN / CNEN flexibility to produce several radioisotopes required for nuclear medicine procedures, with greater efficiency, less exposure to radiation and considerable savings in operating costs. (author)