Authorised Indian Distributor
Saxsons Group
New Delhi, India · Since 1997
GABI NovaRadio-HPLC Flow Detector — Radiochemical-Purity Release Across SPECT + PET
Online radioactivity flow detector for radio-HPLC radiopharmaceutical QC. Swap-in scintillator probe options match the isotope energy — Tc-99m at 140 keV, F-18 / Ga-68 at 511 keV, Lu-177 at 113 / 208 keV. Lead-castle background shielding. Adjustable flow-cell volumes for different activities and flow rates. Eur.Ph. / USP <823> %RCP release on the HPLC chromatogram, 21 CFR Part 11 audit trail.
Key Features
- Online radioactivity flow detection — continuous radio-HPLC chromatogram, not offline batch counts
- Swap-in scintillator probe options match isotope energy: low (Tc-99m / I-131), medium (Lu-177), high (F-18 / Ga-68 / Cu-64)
- PMT and digital detection front-ends — sensitivity-vs-dynamic-range trade-off configured per site
- Adjustable flow-cell volumes — pick the cell that matches batch activity, HPLC flow rate and resolution requirement
- Lead-castle background shielding configurable to the bench layout; protects against adjacent hot-lab activity
All Features
- Online radioactivity flow detection — continuous radio-HPLC chromatogram, not offline batch counts
- Swap-in scintillator probe options match isotope energy: low (Tc-99m / I-131), medium (Lu-177), high (F-18 / Ga-68 / Cu-64)
- PMT and digital detection front-ends — sensitivity-vs-dynamic-range trade-off configured per site
- Adjustable flow-cell volumes — pick the cell that matches batch activity, HPLC flow rate and resolution requirement
- Lead-castle background shielding configurable to the bench layout; protects against adjacent hot-lab activity
- Direct integration with standard HPLC towers — radioactive trace overlaid on the UV / PDA chromatogram in one window
- GMP / GLP design; 21 CFR Part 11 electronic records and electronic signatures for batch release
- Eur.Ph. / USP <823> radiochemical-purity calculation against per-monograph thresholds
- AERB hot-lab QC fit: instrument operates inside the radiopharmacy licence covering Tc-99m / F-18 / Ga-68 / Lu-177 handling
- Compact footprint suited to a standard 600 mm bench depth alongside the dose calibrator and radio-TLC scanner
- Documentation: datasheet, IQ / OQ / PQ protocols, calibration certificate, 21 CFR Part 11 validation evidence
Technical Specifications
| Detection principle | Online scintillation flow counting in the HPLC eluate stream |
| Detector probes | Multiple scintillator options across low / medium / high gamma-energy bands |
| Front-end | PMT or digital detection; configured per sensitivity-vs-dynamic-range trade-off |
| Flow cell | Adjustable cell volumes for analytical, prep and micro-HPLC use cases |
| Shielding | Configurable lead-castle housing; background attenuation tuned to hot-lab background |
| HPLC compatibility | Standard chromatograph integration; radioactive + UV / PDA channel overlay |
| Interface | Instrument communication protocol to QC workstation; multi-instrument session |
| Software | Eur.Ph. / USP <823> %RCP calculation, per-isotope method library, 21 CFR Part 11 audit trail |
| Compliance framework | GMP / GLP, 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
Continuous radio-HPLC — the radiochemical-purity gold standard for the daily hot lab
Radiochemical-purity gold standard
Radio-HPLC is the gold-standard radiochemical-purity method for radiopharmaceutical release — continuous radioactivity chromatogram identifies free radionuclide, intended product and impurity peaks in a single 10–20 min run. Eur.Ph. monographs cite the radio-HPLC method explicitly for several radiopharmaceuticals.
F-18 PET tracer release
Per-batch [18F]FDG, [18F]NaF and emerging F-18 tracer release — radio-HPLC %RCP against the Eur.Ph. monograph threshold before despatch to the imaging room. High-energy probe captures the 511 keV annihilation line at HPLC flow rates.
Ga-68 PET tracer release
Per-batch Ga-68 DOTATATE / DOTATOC / PSMA-11 release from the generator-fed labelling rig — radio-HPLC catches Ga-68 colloid and uncomplexed Ga-68 that radio-TLC may not resolve at the same threshold.
Lu-177 theranostic QC
Per-batch Lu-177 DOTATATE, PSMA-617 and FAPI release — radio-HPLC complements the radio-TLC %RCP for the theranostic release record. NETTER / VISION-aligned QC programmes use both methods.
Investigator-initiated work
Investigator-initiated novel-chelator work, method development and stability studies — adjustable cell volume + swap-in probe means one instrument across a research-radiopharmacy programme.
Routine batch release
21 CFR Part 11 audit trail with electronic signatures and per-method versioning supports per-batch release documentation under AERB inspection and external GMP audit.
Why GABI Nova?
Unlike offline TLC, radio-HPLC produces a continuous radioactivity chromatogram alongside the UV / PDA trace. Free radionuclide, intended product and impurities are resolved in one 10–20 min run — the release decision and the impurity profile come off the same chromatogram.
A swap-in scintillator probe matches the isotope energy band. Tc-99m, F-18, Ga-68, Lu-177 and Cu-64 are all read on the same instrument with the appropriate probe — capital investment scales across the full radiopharmacy isotope panel without an instrument swap.
GMP / GLP design and 21 CFR Part 11 audit-trail compliance make the release record acceptable to AERB inspection and external GMP audit. Electronic signatures, method versioning, override capture — all retained per batch.
Catalogs & Resources
Pharmacopeial + IAEA references that anchor the radio-HPLC release workflow. Contact Saxsons for India pricing, install scheduling and IQ / OQ / PQ documentation.
USP <823> — Positron Emission Tomography Drugs
US Pharmacopeia general chapter for PET radiopharmacy defining radiochemical-purity test methods and the per-monograph release thresholds.
Eur.Ph. — Radiopharmaceutical Preparations general monograph
European Pharmacopoeia general + per-isotope monographs defining the radio-HPLC release method and per-product %RCP thresholds.
IAEA Operational Guidance on Hospital Radiopharmacy
IAEA framework covering hospital-radiopharmacy operational radiation protection, QC and instrument validation expectations.
GABI Nova
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The radio-HPLC backbone for the daily-release hot lab
Contact Saxsons Group for GABI Nova supply, HPLC integration options, IQ / OQ / PQ documentation and AERB-aligned operator training.