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Purpose. In this article, the authors propose useful operational indications to approach in the best possible way the issues concerning the design of a facility for manufacturing radiopharmaceuticals, with focus on organizational and safety aspects. Methods. Several documents produced by authoritative bodies, national and international scientific institutions and associations were examined and referenced, to the purpose of reviewing all available information in the field. Results. Indications are gathered for the design stage, including the organization of accesses and routes and characteristics and requirements of premises and systems. Conclusions. Main goal is to guide the reader in evaluating and choosing the most suitable features and equipment to limit the risks due to ionizing radiation and to prevent contamination of the workers and the environment.

The transposition of Directive 2013/59/Euratom has projected Italian radiation protection into the new safety culture, in which optimization is a multidisciplinary process pursuing a suitable balance among different risks. The fundamental tools in the application of the optimization principle are source-related dose constraints, introduced by the Directive to define the range of options to be considered. This article analyzes some critical issues in their use when managing radiation protection at work in any planned, existing or emergency exposure situation, which involves a risk from exposure to ionizing radiation. Simplified procedures and customized guidelines are outlined from international organizations, such as IAEA, OECD/NEA, and the European ALARA Network (EAN), paving the way to a correct implementation of the optimization principle.