Qualification of a new radiopharmacy department

4 October 2018

L. Breuil 1, M. Sebti1, G. Ventroux1, L. Filin2, E. Barré1, N. Jourdan1, I. Madelaine1 1 Pharmacy unit, Saint-Louis Hospital, 1 avenue Claude Vellefaux 75010 Paris
2 Nuclear medicine unit, Saint-Louis Hospital, 1 avenue Claude Vellefaux 75010 Paris

Introduction and aim

After the construction of a new radiopharmacy department, certification of the controlled atmosphere areas has to be done. It includes the installation, operational and performance qualifications (respectively IQ, OQ and PQ).

The aim of the work is to set up a schedule in order to monitor the equipment and working areas inside the radiopharmacy.

Materials and methods

The department is composed to three rooms of which there are two Grade C rooms (preparation and control laboratories) and one grade D (airlock). In addition, three Grade A equipment (two shielded isolators and one unidose dispensing machine). Control types are defined by several norms such as regulatory texts, good manufactory practices and feedback from other radiopharmacy’s facilities. Meetings have been set in order to organize a schedule for the quality control of the department following different guideline, and we choose qualified companies and hospital’s personnel for those missions. A risk analysis inspired from the FMECA method (Failure Modes, Effects, and Critical Analysis) has been done allowing to know the location of the different sampling points.


To conclude, various certified subcontractors realized the IQ and OQ tests. The microbiological assays (air, surfaces) were part of the realized controls. The risk analysis results were relayed to all the contributors. The location of the sampling points is the same for OQ and PQ. In one hand, concerning air particular tests, the number of samplings is defined according to the NF 14644-1 norm composed of twelve points.

In the other hand, concerning air and surfaces microbiological cleanliness, the number of samplings is asses by infectious risk studies. There is twelve points as well. The highest criticality index allowed us to choose the best location of the sampling points. Finally the estimated duration for the qualification program is around thirteen days.

Discussion and conclusion

Thanks to this study, the closing time of the unit has been optimized in the new radiopharmacy department. Targeted qualifications are currently more exigent than the guideline in place for ours nuclear exercises. Indeed a well-organized and controlled work area will let us the space for developing new activities.

Moreover the risk analysis would be used to periodic monitoring of the controlled atmosphere area.

Key words : Radiopharmacy, Qualification, Controlled atmosphere area.

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