Authorised Indian Distributor
Saxsons Group
New Delhi, India · Since 1997
FLEX™ Dispensing Hot CellCyclotron PET + Lu-177 Dispensing Isolator
The dispensing isolator built for the cyclotron radiopharmacy. F-18 PET tracers — FDG, NaF, F-DOPA, PSMA-1007 — handled in the same Grade A shielded enclosure that takes Lu-177 theranostic doses when your programme expands. Configured to the 100 mm Pb shielding that Indian cyclotron sites need.
Key Features
- Designed for cyclotron PET radiopharmacy — F-18 FDG, NaF, F-DOPA, PSMA-1007 dispensing
- Lu-177 theranostic dispensing in the same isolator — DOTATATE and PSMA-617 dose preparation
- 100 mm Pb shielding configuration for Indian cyclotron sites (Saxsons-supplied)
- GMP Grade A shielded isolator — vertical laminar flow across the working area
- Designed against EU GMP Annex 3 (radiopharmaceuticals) and Annex 1 (sterile, revised 2022)
All Features
- Designed for cyclotron PET radiopharmacy — F-18 FDG, NaF, F-DOPA, PSMA-1007 dispensing
- Lu-177 theranostic dispensing in the same isolator — DOTATATE and PSMA-617 dose preparation
- 100 mm Pb shielding configuration for Indian cyclotron sites (Saxsons-supplied)
- GMP Grade A shielded isolator — vertical laminar flow across the working area
- Designed against EU GMP Annex 3 (radiopharmaceuticals) and Annex 1 (sterile, revised 2022)
- Optional µ DDS-A automatic dose-drawing system — closed vials (septum piercing), open vials (with crimping), shielded syringes
- Optional CRP vial dispenser for automated PET unit-dose workflow
- Vial extraction system with automatic shielded-container retrieval (front, back or sides)
- Optional AUT 1500 autoclave for terminal sterilisation of dispensed product
- Touch-screen operational panel — audit-trail-friendly per EU GMP Annex 11 / 21 CFR Part 11
- Remote teleassistance for aftersales support
- The manufacturer markets the FLEX as the smallest GMP-compliant shielded dispenser isolator on the market; 35+ units installed worldwide
- Available through Saxsons Group with full AERB import documentation
Technical Specifications
| Type | GMP Grade A shielded dispensing isolator — cyclotron PET + theranostic |
| Shielding — baseline | 75 mm Pb all sides (per FLEX product page) |
| Shielding — India configuration | 100 mm Pb all sides (Saxsons-supplied for Indian cyclotron sites) |
| Airflow | Vertical laminar flow across the working area (Grade A) |
| Primary isotope use | F-18 PET tracers (FDG, NaF, F-DOPA, PSMA-1007) |
| Secondary isotope use | Lu-177 theranostic doses (DOTATATE, PSMA-617) when programme expands |
| Automatic dispenser | Optional µ DDS-A — closed-vial (septum piercing), open-vial (with crimping), shielded syringes |
| Vial dispenser option | Optional CRP vial dispenser |
| Vial extraction | Automatic shielded-container retrieval from front, back or sides |
| Terminal sterilisation | Optional autoclave (AUT 1500) |
| Control | Touch-screen operational panel; remote teleassistance supported |
| Standards alignment | EU GMP Annex 3 (radiopharmaceuticals); Annex 1 (revised, eff. 2023-08-25); Annex 11 (computerised systems / audit trail) |
| Indian regulatory path | AERB Regulatory Requirements & Guidelines for Medical Cyclotron Facility (2017) |
Applications
Cyclotron PET first — Lu-177 ready when you scale
F-18 PET tracer unit-dose dispensing
Routine FDG, NaF, F-DOPA and PSMA-1007 unit doses dispensed from cyclotron-produced bulk into patient syringes under Grade A conditions. The µ DDS-A option scales the workflow as PET volumes grow.
Lu-177 theranostic dispensing
When the centre adds Lu-177 PRRT (DOTATATE) or Lu-177 PSMA, the same isolator handles the higher-activity therapy preparation — 100 mm Pb shielding plus the Grade A barrier was sized for it.
Cyclotron-site radiopharmacy
Built for the cyclotron + hot-cell + dispenser + QC workflow defined by EU GMP Annex 3, where dispensing into sterile vials and syringes is the Grade A step that follows synthesis and QC release.
EU GMP Annex 1 / Annex 3 compliance
Annex 3 covers cyclotron radiopharmaceutical manufacturing; Annex 1 (revised 2022) requires Grade A inside the isolator with a documented Contamination Control Strategy. FLEX is positioned for both.
LIMS / data integrity (Annex 11)
The touch-screen control panel and remote teleassistance support fit the audit-trail / ALCOA+ data-integrity expectations of EU GMP Annex 11 and 21 CFR Part 11. The LIMS integration is owned by the site's LIMS vendor (the manufacturer does not publish a turnkey LIMS module).
India — AERB cyclotron facility path
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 FLEX for the cyclotron?
Indian cyclotron radiopharmacies typically specify 100 mm Pb shielding for the dispensing isolator. The manufacturer configures the FLEX accordingly for the Indian market — the manufacturer baseline is 75 mm; the India-spec build is 100 mm all sides, supplied by Saxsons.
F-18 PET volume is what fills the calendar today. Lu-177 PRRT and PSMA programmes are where the next decade of growth lives. The FLEX handles both — same isolator, same Grade A barrier, no second capital purchase when the programme scales.
Annex 3 is the radiopharmaceutical GMP; Annex 1 (revised 2022) is the sterile-processing standard the dispensing step has to clear. FLEX is designed against both at once — Grade A inside the isolator, closed-system dispensing, audit-trail-friendly controls.
Catalogs & Resources
Manufacturer product page. Cyclotron GMP standards, AERB cyclotron document and the comparator product pages are on the Knowledge Hub — link above.
Configuration Demonstrations
the manufacturer product demos showing the four main FLEX configurations — back-up dispensing, CRP vial dispenser, CRP + AUT 1500 autoclave, and µ DDS-A automatic dose drawing. Click a tile to play in-page.
FLEX™ Dispensing Hot Cell
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Equip your cyclotron radiopharmacy with an Annex-3-ready dispensing isolator
Contact Saxsons Group for pricing, 100 mm Pb India configuration, demo arrangement, AERB import documentation and installation support for the FLEX dispensing hot cell.