Radiopharmacist's Notes · FLEX™ Dispensing Hot Cell
Annex 3 covers the radiopharmaceutical manufacture; Annex 1 covers the sterile dispensing step; Annex 11 covers the LIMS and audit trail; the AERB cyclotron-facility document covers Indian site licensing. The FLEX dispensing isolator is the node where they all converge — configured to the 100 mm Pb Indian cyclotron norm, Grade A inside the box, closed-system dispensing, audit-trail-friendly controls. This page maps the requirement set against the FLEX feature set with every row cited.
Each card is a published standard or regulator document; each defines a separate compliance surface the dispensing isolator has to face.
The cyclotron + synthesis + QC + dispensing chain. Grade C is allowed inside a closed, automated synthesis hot-cell — dispensing for injection still hands off to Annex 1.
EU Commission, EudraLex Vol. 4 Annex 3 (PIC/S PE 009 mirror).
Revised 2022, in force 2023-08-25. Grade A inside the dispensing isolator is the expected minimum. Site-wide Contamination Control Strategy (CCS) is mandatory.
EU Commission, EudraLex Vol. 4 Annex 1 (rev. 2022).
In-force text governs validation, audit trails and ALCOA+ data integrity of the cyclotron-site computerised systems — the dispenser's touch-screen control PC is one node. Annex 11 revision is in EMA consultation (2025).
EU Commission, EudraLex Vol. 4 Annex 11; EMA concept paper, 2025.
AERB Regulatory Requirements & Guidelines for Medical Cyclotron Facility (2017) — Atomic Energy (Radiation Protection) Rules 2004 licensing path. Self-contained controlled radioactive area + automatic dose-dispensing unit required.
AERB (India), 2017.
Each row maps a specific requirement from the GMP / AERB stack onto a documented FLEX feature. Source for each map cited inline.
100 mm Pb shielding (Indian cyclotron-site norm)
FLEX is configured at 100 mm Pb all sides for Indian cyclotron sites — supplied by Saxsons. The manufacturer baseline on the Manufacturer product page is 75 mm; the India-configured build is the 100 mm variant.
Source: Saxsons Group configuration for the Indian market. FLEX product page (75 mm baseline).
Grade A working area inside the dispensing isolator (Annex 1)
Vertical laminar flow across the working area — marketed as a "GMP Grade A shielded isolator" on the Manufacturer product page.
Source: FLEX product page.
Closed-system aseptic dispensing of sterile injectables (Annex 1 + Annex 3)
Optional µ DDS-A automatic dose-drawing — closed-vial dispensing via septum piercing, open-vial dispensing via integrated crimping station, and shielded syringe dispensing. CRP vial dispenser option for automated PET unit-dose workflow.
Source: FLEX product page — µ DDS-A and CRP descriptions.
Audit-trail-friendly control system (Annex 11 / ALCOA+)
Touch-screen operational panel for dispensing parameters and batch logging. Remote teleassistance for aftersales support without a console-side install. The LIMS integration itself is the cyclotron site's responsibility — the manufacturer does not publish a turnkey LIMS module.
Source: FLEX product page; EU GMP Annex 11 §9 (audit-trail requirement).
Terminal sterilisation where the product tolerates steam
Optional AUT 1500 autoclave — available as an integrated accessory for a dispensed-then-sterilised workflow.
Source: FLEX product page — AUT 1500 description.
Container retrieval without breaking the Grade A barrier
Automatic shielded-container retrieval from front, back or sides — vial extraction integrated with the isolator body.
Source: FLEX product page — vial extraction system.
The GMP and AERB stack is a programme, not a piece of equipment. The FLEX gives you a compliant dispensing node; the cyclotron operator still owns the rest.
Sources: EU GMP Annex 1 (2022 revision); EU GMP Annex 11; AERB 2017 Regulatory Requirements; WHO TRS 1025 Annex 2.
Two live workstreams a cyclotron radiopharmacy should track when buying capital today:
Sources: EMA concept paper on Annex 11 revision (2025); joint EANM/SNMMI/IAEA theranostics-centre enabling guide.
Scope of this page
We do not claim "FLEX is GMP-certified" — Annex 3 / Annex 1 / Annex 11 / AERB are programme-and-facility frameworks, not equipment certifications. The manufacturer designs the FLEX against these requirements; the GMP licence and AERB consent sit with the cyclotron operator. The 100 mm Pb Indian-site shielding figure is a market-practice norm — the AERB 2017 document defines the licensing path and self-contained-area requirement, but does not publish a single isolator-thickness number that we could quote verbatim.
Sources cited on this page