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Batch-driven PET radiopharmaceutical production records held in a validated LIMS: complete electronic batch records per production run (explicitly replacing paper-based batch record keeping), instrument data captured directly from cyclotrons, synthesis modules, dose calibrators and radiochromatography (HPLC/TLC) instruments, QMS records, isotope inventory, and — as a named capability of the product — batch trending management, i.e. longitudinal aggregation of batch performance across runs. Includes specialised batch configurations such as a Dilute FDG batch prepared for initial clinical delivery.
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