Knowledge Hub · FLEX™ Dispensing Hot Cell
What the FLEX does —without the GMP textbook.
A cyclotron site has to deliver patient-ready radiopharmaceutical doses that pass pharmaceutical inspection. That responsibility sits on a stack of European, global and Indian rulebooks. This page explains, in plain language, what each rule asks for — and how the FLEX answers it. The source link under each card takes you to the underlying standard if you want to go deep.
Where the FLEX sits
From the cyclotron to the patient — four steps
Step 1
Cyclotron
Particle accelerator makes the F-18 (and Lu-177)
Step 2
Hot lab
Chemistry inside a shielded cell turns it into a drug
Step 3
FLEX
Each patient dose is drawn here, in the cleanest workspace class
Step 4
Patient
Syringe leaves the cell, scanned/injected within hours
Why this matters
Six things the FLEX delivers, explained simply
Built for cyclotron sites
Designed for the PET radiopharmacy, not adapted to it
Europe's pharmaceutical rulebook has a dedicated chapter for places that make PET tracers from a cyclotron. The FLEX is engineered for that exact workflow — it doesn't try to be a generic isolator.
Based on: EU GMP Annex 3 — Manufacture of Radiopharmaceuticals
Read source ↗Highest pharma cleanroom class
Patient doses are filled inside the cleanest workspace pharma defines
When the new sterile-medicines rulebook took effect in August 2023, it set "Grade A" — the strictest cleanroom class — as the expected baseline for filling sterile injections. The space inside the FLEX is Grade A by design.
Pharma cleanroom classes
A
cleanest
B
C
D
least
FLEX = Grade A inside the isolator.
Based on: EU GMP Annex 1 — Manufacture of Sterile Medicinal Products (revised 2022, effective 2023-08-25)
Read source ↗Every dispense recorded
A touch-screen log auditors can review
Each dose drawn is recorded on the cell's touch-screen — who, what, when. Modern pharma regulations expect that kind of digital paper trail; the FLEX is built to fit a LIMS-style data integrity workflow.
Based on: EU GMP Annex 11 — Computerised Systems
Read source ↗Configured for the Indian market
100 mm of lead — the thickness Indian cyclotron sites specify
The standard FLEX ships with 75 mm of lead — Indian cyclotron radiopharmacies typically want more. Saxsons supplies the FLEX at 100 mm of lead on all sides and handles the AERB import licence end-to-end.
Based on: AERB — Regulatory Requirements & Guidelines for Medical Cyclotron Facility (2017)
Read source ↗Globally recognised framework
The same rulebook the WHO and IAEA publish for the world
Beyond Europe, the World Health Organization and the IAEA jointly publish the global GMP standard for radiopharmaceuticals. The FLEX is built against this same global frame — so a site that wants to export PET products, run multi-national trials or align with WHO sits on solid ground.
Based on: WHO TRS 1025 Annex 2 — Joint IAEA/WHO GMP for Radiopharmaceutical Products (2020)
Read source ↗One cell, two isotopes
PET tracers today, Lu-177 therapy when you scale
F-18 (FDG, NaF, F-DOPA, PSMA-1007) is the primary daily workload. Lu-177 PSMA / DOTATATE theranostic doses can be drawn in the same isolator — no second capital purchase when the programme grows.
Based on: FLEX product page
Read source ↗FLEX at a glance
100 mm
Lead shielding
India cyclotron configuration
Grade A
Cleanroom class
The strictest pharma defines
F-18 + Lu
Two isotopes
PET today, theranostic tomorrow
35+
Sites worldwide
manufacturer-published install base
For the technical reader
The plain-English cards above are buyer-facing. The full GMP / LIMS stack — EU Annex 3, Annex 1 (revised 2022), Annex 11, WHO TRS 1025 Annex 2 and the AERB cyclotron-facility document — is mapped requirement-by-requirement against FLEX features in theRadiopharmacist's compliance post. That's the page to send your QA / RA lead.
Manufacturer reference
The Manufacturer product page with specification, automation options and accessory catalogue.
Where next