Authorised Indian Distributor
Saxsons Group
New Delhi, India · Since 1997
SYNT™ Synthesis Hot CellCyclotron F-18 Synthesis Cell
The shielded enclosure where the chemistry happens. Designed to host the automatic synthesis modules that turn cyclotron-produced F-18 into FDG and other PET tracers — under GMP Class B ventilation, behind 100 mm of lead for Indian cyclotron sites.
Key Features
- Built for cyclotron-site synthesis — turns cyclotron-produced F-18 into FDG, NaF, F-DOPA, PSMA-1007 and other PET tracers
- Designed to host automatic radiopharmaceutical synthesis modules ((the manufacturer spec))
- GMP Class B clean-air environment provided by the ventilation system ((the manufacturer spec))
- ISO 10648:2 air-tightness from inflatable seals ((the manufacturer spec))
- AISI 316L stainless-steel inner finishing — pharma-grade surface, easy to clean ((the manufacturer spec))
All Features
- Built for cyclotron-site synthesis — turns cyclotron-produced F-18 into FDG, NaF, F-DOPA, PSMA-1007 and other PET tracers
- Designed to host automatic radiopharmaceutical synthesis modules ((the manufacturer spec))
- GMP Class B clean-air environment provided by the ventilation system ((the manufacturer spec))
- ISO 10648:2 air-tightness from inflatable seals ((the manufacturer spec))
- AISI 316L stainless-steel inner finishing — pharma-grade surface, easy to clean ((the manufacturer spec))
- Complete tray-module extraction for module servicing and changeover ((the manufacturer spec))
- Air-tight pass-through system for radio-fluids and gases
- 100 mm Pb shielding configuration for Indian cyclotron sites (Saxsons-supplied)
- Designed against EU GMP Annex 3 — Manufacture of Radiopharmaceuticals
- Pairs with the FLEX dispensing hot cell to complete the synthesis → QC → dispensing chain
- Optional the manufacturer accessories — WGHS waste-gas handling, GMP Monitor supervisory software
- Available through Saxsons Group with full AERB import documentation
Technical Specifications
| Type | GMP shielded synthesis hot cell — hosts automatic radiopharmaceutical synthesis modules |
| Ventilation grade | GMP Class B clean-air environment ((the manufacturer spec)) |
| Air-tightness | ISO 10648:2 — inflatable seals |
| Inner finishing | AISI 316L stainless steel |
| Tray module | Complete extraction for module servicing and changeover |
| Pass-through system | Air-tight pass-through for radio-fluids and gases |
| Shielding — India configuration | 100 mm Pb (Saxsons-supplied for Indian cyclotron sites) |
| Primary isotope use | F-18 (FDG, NaF, F-DOPA, PSMA-1007) — synthesis from cyclotron output |
| Standards alignment | EU GMP Annex 3 (radiopharmaceuticals) — synthesis-cell scope |
| Indian regulatory path | AERB Regulatory Requirements & Guidelines for Medical Cyclotron Facility (2017) |
| Optional accessories | WGHS waste-gas handling; GMP Monitor supervisory software |
Applications
The synthesis half of the cyclotron radiopharmacy — F-18 first
F-18 FDG synthesis
Hosts the automated synthesis module that converts cyclotron-produced [18F]fluoride into FDG ready for QC release. The most common daily workload at a clinical PET cyclotron site.
F-18 PET tracer production
Same cell handles other F-18 tracers — [18F]NaF for bone imaging, [18F]F-DOPA for movement-disorder PET, [18F]PSMA-1007 for prostate-cancer PET — by swapping the synthesis cassette and module.
Closed automated chemistry
Synthesis modules run as closed systems inside the shielded cell. Operators interact through the control PC, not through gloves — the cell stays sealed during synthesis runs.
Pairs with FLEX dispensing
SYNT runs the chemistry; the bulk product transfers to the FLEX dispensing hot cell where individual patient unit doses are drawn under Grade A conditions. One manufacturer-supplied workflow, end-to-end.
GMP Class B ventilation
(the manufacturer spec)ifies the ventilation system maintains a GMP Class B clean-air environment — the standard the European pharma rules expect for the background around an aseptic radiopharmacy.
India — AERB cyclotron facility
Configured to the 100 mm Pb shielding that Indian cyclotron sites typically specify under the AERB Regulatory Requirements for Medical Cyclotron Facility (2017). Saxsons handles AERB import documentation end-to-end.
Why SYNT for the cyclotron?
Indian cyclotron radiopharmacies typically specify 100 mm Pb shielding for the synthesis cell. The manufacturer configures the SYNT accordingly for the Indian market — supplied by Saxsons as the India-spec build.
The ventilation system provides a GMP Class B clean-air environment per the (the manufacturer spec) — the cleanliness class the European rules expect for the background around aseptic radiopharmacy operations.
SYNT is where the chemistry happens; FLEX is where unit doses are dispensed for patients. Buying both as a the manufacturer pair means one calibration chain, one teleassistance contract and one consistent GMP audit trail across synthesis and dispensing.
Catalogs & Resources
Manufacturer product page. The SYNT brochure PDF is gated behind a contact form — contact Saxsons for direct delivery.
SYNT™ Synthesis Hot Cell
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Bring the synthesis half of your cyclotron radiopharmacy to India-spec
Contact Saxsons Group for pricing, 100 mm Pb India configuration, demo arrangement, AERB import documentation and installation support for the SYNT synthesis hot cell.