Steam sterilization and automatic dispensing of [18F]fludeoxyglucose (FDG) for injection.

Unlabelled: For the purpose of implementing steam sterilization of 2-[18F]FDG (FDG) in the final container into routine production, we have validated and established a fully automated dispensing and sterilization system, thereby considerably reducing the radiation burden to the personnel.

Methods: The commercially available system combines aseptic dispensing of the product solution under a miniaturized laminar flow unit with subsequent steam sterilization, realized by heating of the product in the final containers by an autoclave included in the dispensing unit, thus incorporating current pharmaceutical manufacturing standards for the production of parental radiopharmaceuticals. The efficiency of the used sterilization cycle, the stability of FDG under the conditions of sterilization and the stability of the final product towards radiolysis was investigated with respect to various pH-formulations.