Radiopharmacist's Notes · miniGITA Dual

Notes for the radiopharmacist runningpaired-release theranostic QC.

Each post covers one aspect of the paired-release workflow — per-isotope SOP for Tc-99m, F-18, Ga-68 and Lu-177, the spectrometry methods that catch parent-breakthrough, and the 21 CFR Part 11 audit trail the AERB inspector reads.

miniGITA Dual

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

Per-isotope SOP

Six isotopes, two release checks each, one signed batch record

Per-isotope paired-release methods for Tc-99m, F-18, Ga-68, Lu-177, Cu-64 and I-131 — %RCP threshold + nuclide-identity peak match, both on one 21 CFR Part 11 audit trail.

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Where next

Two more pages, depending on what you need.

Knowledge Hub →

Paired QC in plain English

Why theranostic-era radiopharmacy needs both radiochemical purity and nuclide identity.

Product page →

Specs and AERB documentation

Two interchangeable BGO + PMT scintillation chains (OFA default), paired release, USP <823> / Eur.Ph., 21 CFR Part 11.