Radiopharmacist's Notes · miniGITA Single

Notes for the radiopharmacist running thedaily radiochemical-purity release.

Each post covers one aspect of the daily release workflow — seven-step %RCP SOP, per-isotope monograph thresholds, the 21 CFR Part 11 audit trail the AERB inspector reads off the release record.

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Posts in this section. New ones land here as they're added.

Daily SOP

Seven steps from strip in the scanner to signed batch release

The seven-step daily %RCP release SOP, per-isotope monograph thresholds (Tc-99m, F-18, Ga-68, Lu-177, I-131), and the 21 CFR Part 11 audit trail the AERB inspector reads off the release record.

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Where next

Two more pages, depending on what you need.

Knowledge Hub →

Radio-TLC in plain English

Why thin-layer chromatography is the right release-grade purity test for the daily hot lab.

Product page →

Specs and AERB documentation

Interchangeable BGO + PMT scintillation probe (OFA default), motorised scan stage, USP <823> / Eur.Ph., 21 CFR Part 11 audit.