Authorised Indian Distributor
Saxsons Group
New Delhi, India · Since 1997
miniGITA DualRadio-TLC + Basic Gamma Spectrometry — One Instrument, Two Release Checks
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.
Key Features
- Two-position chassis: motorised scanning radio-TLC head + fixed gamma-spectrometry probe — one instrument, one software session
- Interchangeable scintillation probes on both positions — V-shaped BGO + PMT (OFA) default for SPECT + PET gamma; ZnS(Tl) Alpha and self-shielded PMT (3SA) probes optional
- Four tungsten collimators per position cover 0–60 keV / 60–250 keV / 250–450 keV / > 450 keV
- Radio-TLC side: standard TLC / ITLC strip support, 50–100 mm motorised travel, low-noise drive
- Gamma-spectrometry side: vial / sealed-source presentation geometry, multi-channel analyser, energy-calibrated against Cs-137 + Co-57 + Co-60
All Features
- Two-position chassis: motorised scanning radio-TLC head + fixed gamma-spectrometry probe — one instrument, one software session
- Interchangeable scintillation probes on both positions — V-shaped BGO + PMT (OFA) default for SPECT + PET gamma; ZnS(Tl) Alpha and self-shielded PMT (3SA) probes optional
- Four tungsten collimators per position cover 0–60 keV / 60–250 keV / 250–450 keV / > 450 keV
- Radio-TLC side: standard TLC / ITLC strip support, 50–100 mm motorised travel, low-noise drive
- Gamma-spectrometry side: vial / sealed-source presentation geometry, multi-channel analyser, energy-calibrated against Cs-137 + Co-57 + Co-60
- Combined release: %RCP from the radio-TLC scan AND nuclide-identity peak-match from the gamma spectrum, on the same batch record
- Per-isotope method library — Tc-99m, F-18, Ga-68, Lu-177, I-131, Cu-64 — with paired TLC + spectrometry method
- 21 CFR Part 11 compliant audit trail across both detection chains; signed release records retained per-batch
- Eur.Ph. / USP <823> %RCP thresholds carried in the TLC methods; nuclide-identity tolerance windows carried in the spectrometry methods
- AERB hot-lab QC fit: single instrument footprint, single licensed-isotope handling, two release checks per batch
- Compatible with the radio-HPLC release workflow for chromatographic impurity quantitation; pairs with the dose calibrator for the activity gate
- Documentation: datasheet, IQ / OQ / PQ protocols, calibration certificate, 21 CFR Part 11 validation evidence
Technical Specifications
| Configuration | Two-position bench-top chassis — radio-TLC + gamma-spectrometry |
| Radio-TLC detector | Interchangeable scintillation-probe head — default OFA (V-shaped BGO + PMT) for SPECT + PET gamma; motorised low-noise scan stage; 50 / 100 mm travel |
| γ-spec detector | Interchangeable scintillation probe — OFA (BGO) for routine SPECT + PET gamma identity; ZnS(Tl) Alpha probe for α / β characterisation; self-shielded PMT (3SA) for spectrum analysis. Multi-channel analyser; energy-calibrated against Cs-137 / Co-57 / Co-60 |
| Energy range | Four tungsten collimators per position — 0–60 keV / 60–250 keV / 250–450 keV / > 450 keV |
| 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 |
Applications
Two release checks per batch — built for the theranostic-era hot lab
Lu-177 theranostic release
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.
Ga-68 PET tracer release
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.
Cu-64 investigational work
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.
Generator-elution validation
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.
Outgoing-shipment release
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.
AERB / inspection-ready QC
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.
Why miniGITA Dual?
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.
Catalogs & Resources
Pharmacopeial + IAEA references that anchor the paired purity + identity release workflow. Contact Saxsons for India pricing, install scheduling and IQ / OQ / PQ documentation.
IAEA TRS 466 — Quality Assurance for PET and PET/CT Systems
IAEA technical report on PET radiopharmacy QC including nuclide-identity and radiochemical-purity expectations.
Eur.Ph. — Radiopharmaceutical Preparations general monograph
European Pharmacopoeia general + per-isotope monographs defining radiochemical-purity AND radionuclidic-identity thresholds.
IAEA Operational Guidance on Hospital Radiopharmacy
IAEA framework covering hospital-radiopharmacy operational radiation protection and QC.
miniGITA Dual
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Each card opens a focused post for a specific specialty — peer-reviewed evidence and clinical workflow, written for the persona you select.
Paired radiochemical-purity + nuclide-identity release for the theranostic hot lab
Contact Saxsons Group for miniGITA Dual supply, India install scheduling, IQ / OQ / PQ documentation and AERB-aligned operator training.