Authorised Indian Distributor
Saxsons Group
New Delhi, India · Since 1997
Two independent reaction-vessel sets inside one synthesis module — two [18F]FDG productions from a single setup, plus the chemistry headroom for FMISO, FLT, FCh and other nucleophilic [18F] tracers. Basic hydrolysis under 28 minutes, radiochemical purity above 98 %, guaranteed RCY 65–85 %.
| Type | Automated F-18 radiosynthesizer (nucleophilic-substitution chemistry) for cyclotron radiopharmacy |
| Primary tracer | [18F]FDG — basic hydrolysis < 28 min, acid hydrolysis < 22 min |
| Other tracers supported | [18F]FMISO, [18F]FLT, [18F]FCh and other nucleophilic [18F] compounds (per manufacturer spec) |
| Radiochemical purity | > 98 % (per manufacturer spec) |
| Yield | Guaranteed RCY 65–85 % under optimal conditions |
| Max starting activity | 555 GBq (15 Ci) per run |
| Reaction vessels | Two closed glassy-carbon units, 11 mL volume, room temperature to 200 °C |
| Temperature control | Integrated air cooling |
| In-process monitoring | Six shielded radiation detectors across the synthesis path |
| Dispenser | 5 mL syringe; 0–24,000 step resolution |
| Cleanup time | 45 minutes (built-in self-cleaning cycle) |
| Independent synthesis sets | Two — supports two [18F]FDG batches with one setup |
| Operation modes | Manual + automatic; user-defined synthesis-protocol editor |
| Software | Proprietary graphical user interface (GUI) with customisable protocols |
| Dimensions | 42 × 50 × 48 cm (W × D × H) |
| Weight | ~25 kg |
| Minimum hot-cell envelope | 55 × 55 × 50 cm (W × D × H) — fits a SYNT-class synthesis cell |
| Pairing | SYNT synthesis hot cell (host) → FLEX dispensing hot cell (downstream) → WGHS off-gas handling |
| Indian regulatory path | AERB Atomic Energy (Radiation Protection) Rules 2004 + AERB Regulatory Requirements for Medical Cyclotron Facility (2017); GMP recipe and Pharm.Eur. monograph release sit with the radiopharmacy |
Two-batches-per-setup F-18 production for a multi-tracer cyclotron radiopharmacy
The two-vessel architecture turns one operator setup into two consecutive [18F]FDG batches. For an Indian PET centre running back-to-back morning lists, that halves the dispense-prep overhead per patient batch and keeps the radiochemist away from a second handling cycle on the same shift.
Beyond FDG, the module covers [18F]FMISO (hypoxia imaging), [18F]FLT (proliferation), [18F]FCh (prostate and HCC choline imaging) and other nucleophilic [18F] chemistries. One synthesis module supports the tracer menu a tertiary PET-CT centre typically wants to expand into without adding a second cabinet.
At 42 × 50 × 48 cm and ~25 kg, the module is sized for the SYNT synthesis hot cell envelope (55 × 55 × 50 cm minimum). The radiopharmacy stack — synthesis cell, synthesizer, dispensing cell, off-gas handler — is sourced as one chain with a single AERB import file.
Six shielded radiation detectors track activity at multiple points across the synthesis path. The chemistry is observable in real time rather than as a single end-of-run yield reading, which makes the cause of a low-yield batch easier to trace.
A 45-minute built-in cleanup cycle prepares the system for the next run without manual intervention. Combined with the two-vessel architecture, the workflow is: setup → batch 1 → batch 2 → self-clean → ready for tomorrow.
Sits inside the AERB Regulatory Requirements for Medical Cyclotron Facility (2017) licensing path. Supplied with the import documentation an Indian cyclotron site needs; GMP recipe authorship, batch-release QC and Pharm.Eur. monograph compliance remain with the site radiopharmacy.
The module holds two independent reaction-vessel sets. After one setup the operator can run two consecutive [18F]FDG batches — the headline workflow advantage for any site running back-to-back PET lists. The second batch does not require a second setup.
Radiochemical purity above 98 % and guaranteed yield 65–85 % under optimal conditions — published specification from the manufacturer. The synthesis path is monitored at six shielded detectors so a low-yield batch can be traced rather than just observed.
Under 28 minutes for basic hydrolysis and under 22 minutes for acid hydrolysis — the synthesis window stays inside one F-18 half-life (109.8 min) with plenty of margin for QC, dispensing and patient injection downstream.
Manufacturer product page. Manufacturer brochure available on request — contact Saxsons for direct delivery.
FDGtwo™ Radiosynthesizer
Each card opens a focused post for a specific specialty — peer-reviewed evidence and clinical workflow, written for the persona you select.
For Radiopharmacist
The two-vessel architecture saves the second setup, not the second Pharm.Eur. release. Three columns: shared per session, per batch, session closure — plus four SOP guard-rails.
Read this RadiopharmacistAnnex 3 + Annex 11 + AERB + Pharm.Eur. — four overlapping rule-sets the F-18 synthesizer has to fit inside. Sourced requirement→feature map plus four distinctive engineering features against the single-vessel baseline.
Read thisContact Saxsons Group for pricing, SYNT-host configuration, multi-tracer chemistry options, demo arrangement, AERB import documentation and installation support for the FDGtwo radiosynthesizer.