Guide de surveillance de l'environnement des unités de préparation des médicaments radiopharmaceutiques de la Société française de radiopharmacie

The preparation of radiopharmaceutical drugs refers to the assessment of both pharmaceutical drugs and radionuclides preparations regulations. It should avoid microbiological contamination while ensuring staff as well as environmental protection from radioactive exposure. Therefore, in order to warranty sterility of injected doses, the environmental quality, specifically units indoors air quality and surfaces quality must be guaranteed. The aim of this work is to propose guidelines pertaining to environmental quality monitoring in the special field of radiopharmacy. These propositions are based on available guidances, including regulations, treating about methodology to apply for evaluation and control of hospital's environment. Throughout this report, the French College of Radiopharmacy proposals both improve the methodology for control and data analysis (targeted grade of environment, threshold for notification and corrective actions) and ensure follow-up and management of nonconformities. These recommendations represent a model for harmonization of radiopharmacists practices with regards to frequency of environmental quality controls for facilities and equipments in their centralised radiopharmacy units.