Authorised Indian Distributor
Saxsons Group
New Delhi, India · Since 1997
miniGITA SingleSingle-Detector Radio-TLC Scanner for Daily Radiochemical-Purity Release
Bench-top single-detector radio thin-layer chromatography scanner. Interchangeable scintillation-probe family — V-shaped BGO + PMT default probe (OFA) covers SPECT and PET gamma across Tc-99m, F-18, Ga-68, Lu-177, I-131 and Cu-64; ZnS(Tl) Alpha probe for α / β work and self-shielded PMT (3SA) for spectrum analysis are optional. 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.
Key Features
- Interchangeable scintillation-probe family — default V-shaped BGO + PMT (OFA) covers SPECT and PET gamma in one probe; ZnS(Tl) Alpha probe and self-shielded PMT (3SA) probe optional
- Motorised low-noise scan stage with redesigned drive — bench operation does not interrupt aseptic dispensing alongside
- Standard TLC / ITLC strip support (50 mm and 100 mm travel ranges, narrow + wide strip widths)
- Lead collimator / shielding insert reduces background from adjacent activity on the bench
- USB or Ethernet to a Windows QC workstation; multi-instrument sessions supported on one workstation
All Features
- Interchangeable scintillation-probe family — default V-shaped BGO + PMT (OFA) covers SPECT and PET gamma in one probe; ZnS(Tl) Alpha probe and self-shielded PMT (3SA) probe optional
- Motorised low-noise scan stage with redesigned drive — bench operation does not interrupt aseptic dispensing alongside
- Standard TLC / ITLC strip support (50 mm and 100 mm travel ranges, narrow + wide strip widths)
- Lead collimator / shielding insert reduces background from adjacent activity on the bench
- USB or Ethernet to a Windows QC workstation; multi-instrument sessions supported on one workstation
- QC software computes peak areas and %RCP per Eur.Ph. monograph + USP <823> general chapter
- Per-isotope method library — Tc-99m, F-18, Ga-68, Lu-177, I-131, Cu-64 — and per-product method versioning
- 21 CFR Part 11 compliant audit trail — every method change, every release, every operator signature timestamped
- AERB hot-lab QC fit: licensed-isotope manipulation, sealed-source friendly, no separate licence for the instrument itself
- Compatible with the radio-HPLC release workflow when chromatographic separation is required for impurity quantitation
- Documentation: datasheet, IQ / OQ / PQ protocols, calibration certificate, 21 CFR Part 11 validation evidence
Technical Specifications
| Detector | Single interchangeable scintillation-probe head — default OFA (V-shaped BGO + PMT) covers SPECT + PET gamma; ZnS(Tl) Alpha probe and self-shielded PMT (3SA) probe available as alternates |
| Energy range | Four tungsten collimators cover 0–60 keV / 60–250 keV / 250–450 keV / > 450 keV |
| 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 |
Applications
Daily radiochemical-purity release — Tc, F, Ga, Lu, I, Cu, in one instrument
Tc-99m kit release
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.
F-18 PET tracer 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.
Ga-68 PET tracer release
Per-batch Ga-68 DOTATATE / DOTATOC / PSMA-11 release from the generator-fed labelling rig — %RCP > 95 % gating the patient injection.
Lu-177 theranostic QC
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.
I-131 capsule + solution QC
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.
IIP / investigator-initiated
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.
Why miniGITA Single?
The default OFA (One Fits All) probe is a V-shaped BGO scintillator + PMT — a single probe that 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 probe, one calibration, every routine isotope the hot lab handles. Specialty work — α / β characterisation or self-shielded spectrum analysis — uses the ZnS(Tl) Alpha or 3SA PMT probes on the same instrument chassis.
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.
Catalogs & Resources
Pharmacopeial + IAEA references that anchor the radiochemical-purity release workflow. Contact Saxsons for India pricing, install scheduling and IQ / OQ / PQ documentation.
USP <823> — Positron Emission Tomography Drugs
The US Pharmacopeia general chapter for PET radiopharmacy that defines radiochemical-purity test methods and the per-monograph release thresholds.
Eur.Ph. — Radiopharmaceutical Preparations general monograph
European Pharmacopoeia general monograph + per-isotope monographs that define radiochemical-purity thresholds for Tc-99m, F-18, Ga-68 and Lu-177 radiopharmaceuticals.
IAEA Operational Guidance on Hospital Radiopharmacy
IAEA framework covering the operational radiation-protection and QC expectations for hospital-radiopharmacy facilities.
miniGITA Single
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The daily-release radio-TLC scanner for the radiopharmacy bench
Contact Saxsons Group for miniGITA Single supply, India install scheduling, IQ / OQ / PQ documentation and AERB-aligned operator training.