Cyclotron produced radionuclides: Guidelines for setting up a facility

Establishment of a cyclotron based radionuclide and radiopharmaceutical production facility is a major undertaking regardless of the scope and size of the facility. Regulatory demands of radiation protection and pharmaceutical manufacturing only add to the need for meticulous attention to a large number of factors in overall planning and successful implementation. Also, a significant commitment of resources, not just during the onset of the project, but also for sustained continuity further adds to the already difficult decision making process. In this publication, all these issues have been addressed and discussed conceptually for the benefit of planners and stakeholders of a new facility. The need for a clear vision and realistic scope of the programme has been repeatedly emphasized throughout this book as this aspect of project planning is absolutely vital for defining and achieving the mission and objectives of the facility. The most critical aspects in conceptualization, planning and subsequent implementation have been discussed in detail and are highlighted below as necessary actions: - Performing a feasibility study which balances wishful thinking with project viability; - Forming a task force composed of the stakeholders to evaluate strategically the various aspects of project planning to ultimately recommend the scope and objectives of the facility, and also to formulate the project plan; - Assessing the financial aspects of the project, including the set-up and operating costs of the facility through the development of business models and cost-benefit analyses; - Designing a facility and layout that encompasses the scope of the project and also takes into consideration the regulatory requirements; - Ensuring the availability of appropriately qualified and trained staff, critical for efficient and high quality operation of the facility; - Applying GMP regulations for the production of radiopharmaceutical products which are consistently safe for human use; - Integrating the radiation protection regulations in building design and formulating procedures to ensure personnel radiation safety. Finally, the central theme of this publication is to develop a realistic scope for the facility based upon rational vision of the stakeholders, and in line with the available resources. It is aimed to provide information for an informed decision making process. (author)