Operations

Cyclomedical personnel have been involved in operating radiopharmaceutical production sites since 1970. Members of Cyclomedical’s team have operated sites in the U.S. since 1998. We've participated in PET development from the first NDA to its current unique CFR 212 special status. Cyclomedical has managed production facilities in this country since 2003 and in the Gulf Region (UAE, Qatar, Oman) since 2010. We have shown we are capable of what it takes to make a facility profitable, reliable, efficient, and incompliance with international regulatory requirements.

For PET sites we can routinely maintain production of [18F]FDG, [18F] NaF, and [13N]Ammonia without restrictions regarding daily product mix or number of doses requested during single shift operation.

Facility operation may include:

  • personnel,
  • consumables,
  • first line maintenance of the cyclotron, targets, and synthesizers (for maintenance not covered by a service contract),
  • routine maintenance of laboratory equipment, required annual and semiannual maintenanceand requalification of the equipment,
  • compliance with regulatory agencies, including radiation monitoring and aseptic processing
  • maintenance of documentation as required by principles of Good Manufacturing Practices,
  • periodic performance audits, continuing education and training of all facility staff.
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