Authorised Indian Distributor
Saxsons Group
New Delhi, India · Since 1997
Two-position bench-top instrument combining radio thin-layer chromatography with basic gamma spectrometry. One position drives the motorised scanning radio-TLC head; the other holds a fixed gamma-spectrometry probe. Radiochemical purity and radionuclidic identity on the same instrument, the same batch record, the same release. Built for the theranostic-era hot lab where both checks matter on every batch.
| Configuration | Two-position bench-top chassis — radio-TLC + gamma-spectrometry |
| Radio-TLC detector | NaI(Tl) scintillation head; motorised low-noise scan stage; 50 / 100 mm travel |
| γ-spec detector | NaI(Tl) scintillation probe; multi-channel analyser; energy-calibrated against Cs-137 / Co-57 / Co-60 |
| Isotope panel | Tc-99m, F-18, Ga-68, Lu-177, I-131, Cu-64 (extensible) |
| Interface | USB or Ethernet to Windows QC workstation; both detectors in one software session |
| Software | Eur.Ph. / USP <823> %RCP, paired nuclide-identity peak match, 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 |
Two release checks per batch — built for the theranostic-era hot lab
Per-batch Lu-177 DOTATATE / PSMA-617 / FAPI release — %RCP from the radio-TLC scan AND nuclide-identity peak match (113 / 208 keV doublet) on the gamma spectrum. Catches Lu-177m / Yb-176 contamination, not just labelling yield.
Per-batch Ga-68 DOTATATE / DOTATOC / PSMA-11 release — %RCP plus nuclide-identity 511 keV annihilation + 1077 keV pair-line check. Confirms the elution is Ga-68 from a calibrated generator, not breakthrough Ge-68 contamination.
Investigator-initiated Cu-64 labelling (PSMA, DOTATATE, ATSM) — paired radiochemical-purity and nuclide-identity QC; pairs with the dose calibrator activity figure for a four-document batch record.
Periodic validation of generator eluate (Tc-99m, Ga-68) — radiochemical purity + radionuclidic identity + parent-breakthrough check, all on the same instrument, all signed to the same record.
Centralised radiopharmacy distributing to satellite imaging sites — paired %RCP + nuclide-identity release captures both labelling chemistry and shipment-integrity confirmation before the dose leaves the building.
Inspection-ready release records: %RCP from the TLC scan plus nuclide-identity peak-match from the gamma spectrum, both on the same 21 CFR Part 11 audit trail. The inspector reads one record per batch, not two.
Radio-TLC tells you the labelling chemistry worked (%RCP). Gamma spectrometry tells you the radionuclide you labelled with is actually what you think it is (nuclide identity). For Lu-177 and Ga-68 theranostics where parent-breakthrough is a real failure mode, both checks belong on every batch record.
Two functions on one instrument means one IQ / OQ / PQ, one validation evidence pack, one bench footprint, one operator workflow. The alternative is two separate instruments occupying twice the bench, twice the validation effort and twice the consumable budget.
Both detection chains write to the same 21 CFR Part 11 audit trail. The batch record carries the paired release — %RCP from the TLC scan and nuclide-identity from the gamma spectrum — signed by one operator at one workstation. The AERB inspector reads one record per batch, paired data.
Pharmacopeial + IAEA references that anchor the paired purity + identity release workflow. Contact Saxsons for India pricing, install scheduling and IQ / OQ / PQ documentation.
IAEA technical report on PET radiopharmacy QC including nuclide-identity and radiochemical-purity expectations.
European Pharmacopoeia general + per-isotope monographs defining radiochemical-purity AND radionuclidic-identity thresholds.
IAEA framework covering hospital-radiopharmacy operational radiation protection and QC.
miniGITA Dual
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 Dual supply, India install scheduling, IQ / OQ / PQ documentation and AERB-aligned operator training.