Knowledge Hub · SYNT™ Synthesis Hot Cell
A PET tracer like FDG doesn\'t come out of the cyclotron ready to inject — it has to be synthesised first, by an automated chemistry module sitting inside a shielded cell. SYNT is that cell. This page explains, in plain language, why it\'s different from the dispensing cell (FLEX), and what the Indian-market 100 mm Pb configuration means. The source link under each card takes you to the underlying spec or standard.
Where SYNT sits
Step 1
Cyclotron
Particle accelerator makes the F-18 (and other PET isotopes)
Step 2
SYNT
Automated chemistry turns the isotope into a PET tracer (e.g. FDG)
Step 3
FLEX
Each patient dose is drawn here, under the cleanest workspace class
Step 4
Patient
Syringe leaves the cell, scanned within hours
Why this matters
Where the chemistry happens
PET tracers like FDG are made by automated chemistry modules that mix the cyclotron-produced isotope with reagents and purify the product. SYNT is the shielded enclosure where those modules sit — it doesn't do the chemistry, it hosts it.
Based on: SYNT product page
Read source ↗GMP Class B ventilation
The ventilation system maintains a GMP Class B clean-air environment per Tema's spec — the cleanliness class the European pharmaceutical rules expect for the background around aseptic radiopharmacy operations.
Pharma cleanroom classes
A
FLEX dispensing
B
SYNT ventilation
C
D
least clean
SYNT ventilation = Class B. FLEX dispensing = Grade A.
Based on: SYNT product page (the manufacturer ventilation spec)
Read source ↗Sealed and serviceable
Inflatable seals provide ISO 10648:2 air-tightness during synthesis runs. When a module needs a cassette change or maintenance, the tray module can be fully extracted — without losing the cell's pharma-grade interior.
Based on: ISO 10648:2 air-tightness spec on SYNT product page
Read source ↗Configured for the Indian market
Indian cyclotron radiopharmacies typically specify 100 mm of lead shielding on the synthesis cell. SYNT is supplied at this Indian-market configuration by Saxsons, who also handles the AERB import licence end-to-end.
Based on: AERB Regulatory Requirements & Guidelines for Medical Cyclotron Facility (2017); Saxsons Indian-market configuration
Read source ↗Pairs with the FLEX dispensing cell
SYNT runs the chemistry; the bulk product transfers to FLEX where individual patient unit doses are drawn under Grade A. Buying both as a the manufacturer pair means one calibration chain, one teleassistance contract and one consistent audit trail across the cyclotron radiopharmacy.
Based on: SYNT + FLEX product pages
Read source ↗EU GMP Annex 3 scope
Europe's pharmaceutical rulebook has a dedicated chapter for places that make radiopharmaceuticals from cyclotrons. It explicitly allows closed automated synthesis cells like SYNT to run at a lower internal cleanliness class than the dispensing step — which sits separately, in the FLEX.
Based on: EU GMP Annex 3 — Manufacture of Radiopharmaceuticals
Read source ↗SYNT at a glance
100 mm
Lead shielding
India cyclotron configuration
Class B
Ventilation grade
(the manufacturer )ventilation spec
F-18
Primary isotope
FDG, NaF, F-DOPA, PSMA-1007
316L
Stainless inner finish
Pharma-grade, easy clean
Scope of this page
The SYNT public product page is brochure-light — shielding thickness, isotope list, synthesiser-module compatibility and install-base figures are gated behind a contact form, not published on the open web. The verified-on-page facts (GMP Class B ventilation, ISO 10648:2 air-tightness, 316L stainless interior, automatic-module compatibility) are what this knowledge hub is built on. The 100 mm Pb Indian-site configuration and the F-18 primary-use focus are supplied by Saxsons as the in-country market reality — not a verbatim (the manufacturer spec). Send the QA / RA team to the Radiopharmacist's compliance post for the deeper standards map.
SYNT product page and the FLEX dispensing hot cell that pairs with SYNT to complete the cyclotron radiopharmacy.
Where next
Product page →
SYNT specs and brochure
100 mm Pb India config, ventilation spec, 316L inner finish, AERB import path.
Sibling →
FLEX — dispensing cell
The Grade A dispensing isolator that draws unit patient doses after SYNT finishes the synthesis.
Compliance →
Radiopharmacist's notes
How the Annex 3 synthesis-cell scope differs from Annex 1 dispensing — for the QA / RA team.