Quality Control
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The responsibility of biochemical evaluation of radiopharmaceuticals in terms of quality assurance and quality control lies with the radiopharmacy sections. This includes chemical and radiochemical purity determination as well as pharmaceutical validation. In addition, when receptor site mapping and quantitation are investigated, measurement of the specific activity of the radiopharmaceutical must be carried out.
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Each radiolabelling procedure is validated by testing batches of production for sterility, presence of endotoxins, heavy metal contamination, pH, chemical purity, radiochemical purity, radionuclide identification and radionuclidic purity. Initial validation and continual quality assurance is vital since PET radiopharmaceuticals need to be utilised immediately due to their short half-lives and therefore not all quality control procedures, such as sterility and endotoxin tests, can be performed prior to use. The retrospective testing of each batch produced ensures a continued safety check on the manufacturing process.
However, immediately prior to human studies, some quality control of each batch of PET radiopharmaceuticals produced is performed. This consists of testing for pH, radiochemical and chemical purity using thin layer chromatography (TLC), high performance liquid chromatography (HPLC), gas chromatography (GC) and radionuclide identification. All injectables are also adjusted to isotonic if necessary. All procedures are performed in a biological class II laminar flow cabinet and strict aseptic techniques are employed throughout. The present system has been in operation for seven years and has proved to be a safe and efficacious method for delivery of PET radiopharmaceuticals.
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