Contamination microbiologique en radiopharmacie : problématiques et mise en œuvre de contrôles dans le cadre d'une démarche qualité

Microbiological contamination (bio-contamination) of the preparation room of injectable radiopharmaceutical drugs must be controlled to guarantee their sterility, but appears difficult to be obtained because of the principles related to the radioprotection of the staff. In order to fulfil the two requirements (sterility and radioprotection), the Radiopharmacy Unit of the University Hospital of Tours implemented a step quality including a system of Quality-Control, in 2004. Material and methods: This system contains, on the one hand, control of the sterility of preparations by direct sowing within culture mediums and, on the other hand, control of the bio-contamination of surfaces of the preparation room by tacking a swab on several representative points. Results: The bio-contamination of surfaces between 2004 and 2005 was frequent and did not stop increasing. After analysis of probable causes, new means of prevention came to supplement this step quality: application of new protocols for the bio-cleaning of surfaces; compliance with rules described in the Good Manufacturing Practices; a continuous formation of the personnel on the principles of hygiene. Thus, between 2005 and 2006, a significant fall of the bacterial colonies number (α < 0.05) and the disappearance of filamentous fungi were obtained. Discussion/Conclusion: This work shows the impact of the implementation of these controls on the microbiological contamination reduction in Radiopharmacy and on the improvement of a step quality.