Knowledge Hub · FLEX™ Dispensing Hot Cell
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
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
Built for cyclotron sites
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
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
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
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
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
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 the Radiopharmacist's compliance post. That's the page to send your QA / RA lead.
The Manufacturer product page with specification, automation options and accessory catalogue.
Where next
Product page →
Specs and the manufacturer page
100 mm Pb India configuration, F-18 + Lu-177 capability, µ DDS-A automatic dose drawing, AERB import path.
Compliance map →
Full GMP / AERB requirement map
Annex 3 + Annex 1 + Annex 11 + AERB row-by-row against the FLEX feature set — for the QA / RA team.