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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FAQ
Synthesis hot cell — questions we hear from Indian cyclotron and radiopharmacy teams
Why F-18 synthesis needs a shielded hot cell rather than a bench, what 100 mm Pb India-config matches on the AERB dossier, which synthesizer modules SYNT hosts, and how the synthesis-dispensing-waste-gas stack fits together.
Q.What does a synthesis hot cell actually do that a bench setup can't?
F-18 chemistry runs at very high initial activity — hundreds of GBq at end-of-bombardment leave the target and enter the synthesizer within seconds. Any human intervention during the run would exceed operator dose limits within one production. A synthesis hot cell shields the automated chemistry module, provides remote access for maintenance and column changes, and contains the volatile off-gas that comes off the synthesis reactor. The hot cell is the physical infrastructure that makes the closed automated synthesis run safely inside an Indian cyclotron site.
Q.Why does SYNT ship in a 100 mm Pb India configuration?
AERB Regulatory Requirements for Medical Cyclotron Facility (2017) is the framework Indian cyclotron sites license against. 100 mm Pb is the typical build tier for the synthesis cell handling the full F-18 activity load at end-of-bombardment — that is the number the AERB dossier expects. Under-spec'ing the shielding forces re-work at inspection; over-spec'ing wastes money. 100 mm Pb matches the AERB expectation exactly.
Q.Which synthesis modules fit inside a SYNT-class cell?
The SYNT envelope hosts the standard F-18 FDG synthesis modules and multi-tracer synthesizers — including the FDGtwo two-vessel synthesizer that runs two F-18 batches per setup and also handles FMISO / FLT / FCh chemistry. A single SYNT cell can carry the FDG production plus a second synthesizer for a multi-tracer PET-radiopharmacy programme.
Q.How does SYNT connect to the FLEX dispensing cell and the WGHS off-gas handler?
The three cells form the cyclotron radiopharmacy stack: SYNT (synthesis) receives target contents, runs the closed chemistry, hands the bulk radiopharmaceutical to FLEX (dispensing) through a shielded transfer line, and vents synthesis reactor off-gas through a shielded connection to WGHS (waste-gas handling) for decay-and-release. The stack is sourced as one chain from Saxsons with one AERB import file.
Q.How is SYNT supplied and installed in India?
SYNT is distributed by Saxsons Group. Supply covers the cell, 100 mm Pb India-config shielding, integration with the on-site synthesizer module, the SYNT + FLEX + WGHS radiopharmacy stack option, and the AERB Regulatory Requirements for Medical Cyclotron Facility documentation dossier. Saxsons handles the CDSCO medical-device import registration and installation across the Indian cyclotron network.
SYNT Synthesis Hot Cell supplier in India — Saxsons Group
Saxsons Group has supplied cyclotron equipment to over 1,000 Indian hospitals since 1988. Every consignment of SYNT Synthesis Hot Cell ships with cold-chain logistics, AERB import documentation, CDSCO registration references and a Certificate of Analysis delivered before dispatch — the paperwork your radiation-safety and procurement teams need, pre-assembled.
- Nationwide delivery footprint — every metro and tier-2 city in India, scheduled to your treatment / procedure calendar.
- AERB & CDSCO documentation — import licence, radiation-safety paperwork and RSO briefing pre-assembled for the audit file.
- 40+ years in Indian oncology — long-standing supply relationships with AIIMS, Tata Memorial, and hundreds of tertiary-care centres.
- Single point of accountability — one purchase order, one delivery contact, one after-sales team across the whole product family.
Also supplied by Saxsons Group across India
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.