One year's experience of the WA medical cyclotron and radiopharmaceutical production facility

Full text: The WA PET Centre Medical Cyclotron, a facility novel in Western Australia, produced its first bolus of FDG for patient injection for PET scanning in August 2003. This paper describes the methodology and practices employed during the past 12 months for ensuring that reliable routine provision of FDG is maintained, in parallel with facilitating the development and production of achievable new radiopharmaceuticals. An FDG production team of six staff and, a maintenance and development team of 4 staff were created from the 3.4 staff specifically recruited for this service and from incumbent staff. Teams were also set up to carry out development projects related to the service. Training procedures were created under the department's ISO9001:2000 accreditation system for the certification of production and maintenance staff. Practices and documentation systems were put in place in anticipation of a pending cGMP audit. Several unplanned major changes to equipment and infrastructure were necessary post commissioning. These changes included purchase of a different FDG synthesis module from that originally supplied, and modifications to engineering services, including changes to air conditioning, changes to supply of vacuum and upgrading of drainage in the laboratory area. A device for the measurement of end of bombardment yield was built, so that the efficiencies of the various synthesis modules could be accurately determined. Strict radiation protection procedures were put in place. All staff were provided with luxels and finger TLDs for monthly reporting of their radiation levels, as well as electronic monitors for real-time monitoring. From August 2003 to June 2004 (11 months) 2229 FDG patient doses were produced and dispensed by this facility. An average of 8.0 patient doses per available working day were dispensed during the 2003 period, rising to 11.1 patient doses per day in 2004. Several 11NH3 doses were also delivered. The cyclotron was unavailable for 9 days owing to scheduled maintenance, and a total of 35 (1.6%) patients were cancelled owing to unscheduled maintenance on 7 days. The following major initiatives are now in place for the further development of this facility: 1. Development of a solid targetry facility for the production of 123I, 124I, 64Cu, and other isotopes. Two prototype external beam lines have been developed and trialled. Experiments designed to measure the beam profile at the end of the external beam line are underway. 2. A synthesis module for the production of 18FMISO and 18FLT is being developed in-house in collaboration with the cyclotron manufacturer. 3. A module for the synthesis of 18F-Choline has been installed. 4. A prototype synthesis module is under development which will allow experimentation in the production of novel radiopharmaceuticals based on isotopes produced from liquid targetry. Normalised over 12 months, production staff received on average 3.28 mSv whole body effective dose, with the worst case being 8.46 mSv. Finger doses were 35.6 mSv on average, 70.6 mSv worst case. (Note that production staff also dispense patient doses into individual syringes). Similarly, maintenance staff received 1.41 mSv (avg), 2.56 mSv (max) whole body effective dose, and 33.0 mSv (avg), 124.3 mSv (max) finger dose. A facility for the production and development of short-lived PET radiopharmaceuticals has been created with a capacity that is expected to satisfy Western Australian demands for the next ten years. This facility reliably and routinely produces FDG, and incorporates a well supported and vigorous radiopharmaceutical development function. Copyright (2004) Australasian College of Physical Scientists and Engineers in Medicine