RADIOPHARMACEUTICAL PRODUCTION AND CYCLOTRON

ABOUT US

Since 2014, when the installation of the cyclotron TR-19 has launched the radiopharmaceutical production, the activity of the center is focused on the preparation of various radiotracers for Medical Nuclear diagnosis, permitting an increasing development of the service and attracting numerous patients from all over Italy.

The facility has at its disposal a proper cyclotron for the production of radionuclides and several laboratories for the radiopharmaceutical preparation, addressing both diagnostic and therapy. The radiopharmaceutical production stands out in its attention for the innovation without omitting the daily radiopharmaceutical production for diagnostic use.

After having consolidated the production for the internal use during the last years, the facility has recently obtained the GMP certification and permission on behalf of AIFA (Agenzia Italiana del Farmaco) for the production of industrial radiopharmaceuticals for both, the experimental and commercial use. This goal makes our facility unique in Italy, where the industrial production gets integrated with the daily production for the internal use of our Hospital.

Director and Qualified Person (QP): Dr. Giancarlo Gorgoni

WHERE

IRCCS Sacro Cuore Don Calabria Hospital – Radiopharmaceutical Production and  Cyclotron

CONTACTS

Administrative Office: (+39) 045.6014761
Fax: (+39) 045.6014583
e-mail: radiofarmacia@sacrocuore.it

THE FACILITY

The radiopharmaceutical production is located in an independent, 4-floors building inside of the IRCCS Sacro Cuore Don Calabria Hospital.

On the ground floor is situated the A.C.S.I. TR 19 cyclotron performing accelerations of proton beam up to 13-19 MeV. The proton beam, generated by an external source, can reach a power of 300 µA and can be directed to two target stations concurrently. The target stations, designed for the production of radionuclides in liquid, gas or solid form, permit the synthesis of several radionuclides as, for example, fluorine-18, nitrogen-13, zirconium-89, iodine-124, copper-61/64, manganese-52 and terbium-155. The ground floor is completed by a laboratory with gamma spectrometer, equipped with high-purity germanium detector, and incubators for microbiological contamination control, as well as two research laboratories designed for the development of new radionuclides and radiopharmaceuticals.

On the first floor is situated the pharmaceutical production area, designed according to GMP (Good Manufacturing Practice) requirements, which is made of 4 production laboratories in classified pharmaceutical environment with isolating shields (cells), suitable for radiopharmaceutical synthesis modules such as: FastLab GE, ITD-Terimo, Mosaic ORA-Neptis, AIO Trasis, ModularLab EZAG.

The administrative offices, a meeting room and the Air Treatment Unit (UTA) are located on the second floor.