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 (e.g., EMA in EU and FDA in 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 classified by the manufacturer, i.e., 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. In this chapter, we will focus the attention on 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 individual radiopharmaceutical doses from the “bulk” radiopharmaceutical solution, usually contained in a suitable glass vial or single-dose syringes.

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Radiopharmaceutical Dispensing Systems

  • Mario Malinconico,
  • Aureliana Esposito,
  • William Tieu,
  • Michela Aurilio

摘要

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 (e.g., EMA in EU and FDA in 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 classified by the manufacturer, i.e., 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. In this chapter, we will focus the attention on 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 individual radiopharmaceutical doses from the “bulk” radiopharmaceutical solution, usually contained in a suitable glass vial or single-dose syringes.