Authorised Indian Distributor
Saxsons Group
New Delhi, India · Since 1997
Bench-top single-detector radio thin-layer chromatography scanner. NaI(Tl) scintillation detection across the full radiopharmacy isotope panel — Tc-99m, F-18, Ga-68, Lu-177, I-131 and Cu-64. Motorised low-noise scan stage. USB / Ethernet to QC software running on a Windows workstation — peak detection, Eur.Ph. / USP <823> %RCP calculation, 21 CFR Part 11 audit trail. The daily radiochemical-purity release instrument for the hot lab.
| Detector | Single NaI(Tl) scintillation head; full radiopharmacy gamma-energy coverage |
| Scan stage | Motorised low-noise drive; 50 mm and 100 mm strip-travel modes |
| Strip compatibility | Standard TLC / ITLC strips; narrow and wide widths |
| Isotope panel | Tc-99m, F-18, Ga-68, Lu-177, I-131, Cu-64 (extensible) |
| Interface | USB or Ethernet to Windows QC workstation |
| Software | Eur.Ph. / USP <823> %RCP calculation, per-isotope method library, 21 CFR Part 11 audit trail |
| Compliance framework | AERB hot-lab QC, Eur.Ph. radiopharmacy monographs, USP <823>, 21 CFR Part 11 |
| Validation | IQ / OQ / PQ protocols supplied; site PQ scheduled during install |
Daily radiochemical-purity release — Tc, F, Ga, Lu, I, Cu, in one instrument
Daily release of cold-kit Tc-99m radiopharmaceuticals — MDP, DMSA, MIBI, ECD, MAG3 — %RCP against the monograph threshold before the morning patient list. Two-strip ITLC method, 2–3 min per release.
Per-batch [18F]FDG, [18F]NaF and other F-18 tracer release — radiochemical purity above the Eur.Ph. monograph limit before despatch to the imaging room.
Per-batch Ga-68 DOTATATE / DOTATOC / PSMA-11 release from the generator-fed labelling rig — %RCP > 95 % gating the patient injection.
Per-batch Lu-177 DOTATATE, PSMA-617 and FAPI release — %RCP ≥ 99 % per the labelling chemistry expectation, paired with the dose calibrator activity figure on the batch record.
Sealed I-131 capsule and oral-solution batch QC against the Eur.Ph. monograph — chemical and radiochemical purity verified before dispense to the therapy room.
Investigator-initiated radiopharmaceutical work — novel chelator + Lu-177 / Ga-68 / Cu-64 labelling — uses the same instrument with a custom method, separately versioned in the software.
A NaI(Tl) scintillation head spans the entire nuclear-medicine gamma range from the 140 keV Tc-99m photopeak to the 511 keV F-18 / Ga-68 annihilation line and the Lu-177 113 / 208 keV emissions. One detector, one calibration, every isotope the hot lab handles.
QC software computes peak areas, derives %RCP, and compares against the monograph threshold per isotope. The operator sees PASS / FAIL against the threshold; the audit trail captures every release, signature and override.
AERB inspection looks for the chain: who released which batch against which monograph. The instrument software ships 21 CFR Part 11 compliant — every method version, every release record, every operator signature is timestamped and retained.
Pharmacopeial + IAEA references that anchor the radiochemical-purity release workflow. Contact Saxsons for India pricing, install scheduling and IQ / OQ / PQ documentation.
The US Pharmacopeia general chapter for PET radiopharmacy that defines radiochemical-purity test methods and the per-monograph release thresholds.
European Pharmacopoeia general monograph + per-isotope monographs that define radiochemical-purity thresholds for Tc-99m, F-18, Ga-68 and Lu-177 radiopharmaceuticals.
IAEA framework covering the operational radiation-protection and QC expectations for hospital-radiopharmacy facilities.
miniGITA Single
Each card opens a focused post for a specific specialty — peer-reviewed evidence and clinical workflow, written for the persona you select.
Contact Saxsons Group for miniGITA Single supply, India install scheduling, IQ / OQ / PQ documentation and AERB-aligned operator training.