GABI NovaRadio-HPLC Flow Detector — Radiochemical-Purity Release Across SPECT + PET

A standard HPLC UV detector reads absorbance — great for the labelling ligand, blind to the radioactivity. On a Lu-177-DOTATATE or Ga-68-PSMA labelling batch, the UV chromatogram shows all the DOTATATE / PSMA peaks including the un-labelled ligand. The QC question the batch release actually needs to answer is "what fraction of the radioactivity is bound to the correct peptide" — that is a radioactivity-vs-retention-time chromatogram, not a UV chromatogram. A radio-HPLC flow detector reads the online activity as it elutes off the HPLC column, so the %RCP release value comes off the radio-chromatogram directly.

Different clinical isotopes emit at wildly different photon energies — Tc-99m at 140 keV, Lu-177 at 113 / 208 keV, F-18 / Ga-68 at 511 keV. A single fixed detector optimised for one energy under-reads at another. GABI Nova ships with swap-in probe options so the department picks the probe that matches the isotope on the bench that morning — Tc-99m QC in the morning, Ga-68 in the afternoon, no compromise on detection sensitivity.

A radiopharmacy is a radioactive environment — dose calibrators, dispensing benches, vial shields all contribute background counts to any detector sitting on the bench. Without shielding, the radio-HPLC baseline drifts with what happens in the room, and small clinically-relevant impurity peaks disappear into the noise. The configurable lead castle around the detector cuts the ambient background so the chromatogram baseline is stable and small peaks are actually visible.

USP <823> and Eur.Ph. both require documented radiochemical purity for every batch before patient release; the audit trail on that measurement has to be tamper-evident. GABI Nova software integrates the radio-chromatogram, calculates %RCP against the specification, produces the signed pass/fail digital record and stamps every action with the 21 CFR Part 11 audit trail — user ID, timestamp, action performed. That file is what AERB / EU GMP Annex 3 inspection reads to verify the QC chain.

Distributed across India by Saxsons Group under SKU NM-007. Supply covers the flow detector, scintillator probe options for the department's isotope mix, lead-castle shielding, integration with the existing HPLC tower, commissioning against the department's QC method library and 21 CFR Part 11 software validation.