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EU24CEMAR1/SES306 - Radiopharmaceutical Dispensing Systems

‐ Mar 12, 2024 2:35pm

Radiopharmaceuticals are medicinal formulations containing radioisotopes that are utilized for clinical diagnosis or therapy. They are typically injectable products, and as with most injectable products their preparation, dispensing, and use are stringently regulated by healthcare regulators (eg. EMA in the EU and FDA in the USA). Owing to the radioactive hazards associated, additional regulations may apply during the transportation or dispensing of radiopharmaceuticals. The preparation of radiopharmaceuticals may be further divided by the manufacturer, from non-industrial sites (hospital pharmacies, nuclear medicine departments, PET centers) and industrial grade manufacturers and facilities (centralized radiopharmacies, contract manufacturer - CMO, and larger scale production facilities). The distinction between the two types of manufacturers presents differing challenges when discussing the dispensing of radiopharmaceuticals in a GMP setting. We will focus the attention on therapeutic and diagnostic radiopharmaceutical dispensing processes and technologies which represent one of the most critical aspects of the whole process. Dispensing systems can be fully automated and/or remotely controlled systems used to prepare the individual radiopharmaceutical doses, starting with the “bulk” radiopharmaceutical solution, usually contained in a suitable glass vial or single-dose syringes.