Qualification of a shielded class A hot cell for the preparation of radiopharmaceutical drugs
9 October 2015I. Le Borgne, L. Masson, H. Larbre, JB. Rey Institut Jean Godinot, CLCC of Reims, France
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Within the radiopharmacy laboratory, the aim is to qualify and validate the new shielded class A MEDI 9000® hot cell for the preparation of radiopharmaceutical drugs before it becomes operational.
Equipment and methods
The qualification operations follow validation guidelines including :
- The description of the device to be qualified.
- 25 actors of the qualification, especially radiopharmacists responsible for the qualification.
- The studied qualification fields : Rooms, Dose calibrator, Radiation protection and Hot cell. This cell is unloaded for the operational qualification and in operation for the performance qualification.
- Methodology : schedule of the qualification, documentary traceability, desired limits and reference frames (standards ISO 14.644-1, NF EN 12.464-1, Good Manufacturing Practices, ASPEC recommendations).
Given the conformity of all the qualification tests, we can establish the reproducible operation of MEDI 9000® hot cell, in accordance with the pre-established specifications, and consequently, validate its qualification.
The hot cell proved it is reliable and respects the pharmaceutical and nuclear regulatory. It allows the control of the contamination risks and the optimization of the production line of radiopharmaceutical drugs. Its qualification guarantees on the one hand, the quality of the radiopharmaceutical drugs dispensing to the nuclear medicine department, on the other hand, products, staff and patients safety.