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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FAQ
Dispensing hot cell — questions we hear from Indian cyclotron and radiopharmacy teams
Why dispensing is a separate GMP operation from synthesis, what 100 mm Pb India-config solves for AERB licensing, how FLEX combines shielding + Grade A airflow + containment, and how the cell is configured for multi-isotope theranostics.
Q.Why does a cyclotron radiopharmacy need a dispensing hot cell separate from the synthesis cell?
Synthesis and dispensing are two distinct GMP operations. Synthesis is a closed automated chemistry inside a heavily-shielded cell — the operator does not intervene during the run. Dispensing takes the bulk radiopharmaceutical solution and splits it into individual patient doses under EU GMP Annex 1 (aseptic manufacturing) with Grade A airflow around the syringe or vial. Mixing the two operations in one cell forces the aseptic Grade A environment to sit inside a synthesis-grade cell — a much more complex and costly build than separating them.
Q.What problem does 100 mm Pb shielding solve for an Indian cyclotron site?
AERB Regulatory Requirements for Medical Cyclotron Facility (2017) sets shielding expectations for the isotope activity a cyclotron site handles at peak load. For an F-18 FDG production site handling several hundred GBq at end-of-synthesis, 100 mm Pb is the typical build tier for the dispensing cell — that is the number the AERB dossier cites for the facility. Under-shielding a dispensing cell forces re-work of the entire vault at AERB inspection.
Q.How does FLEX combine shielding, containment and aseptic environment in one enclosure?
The FLEX dispensing hot cell is a lead-shielded cell (100 mm Pb India-config) with an internal Grade A laminar airflow envelope and a HEPA-filtered exhaust path. The bulk radiopharmaceutical arrives from the synthesizer through a shielded transfer line, the CRP dispensing automation runs inside the FLEX cell, and individual patient doses come out through a shielded pass-through. One enclosure, three simultaneous controls: radiation shielding (lead), aseptic environment (Grade A HEPA) and containment (negative-pressure exhaust).
Q.Does FLEX handle Lu-177 and Ga-68 theranostics alongside F-18 FDG?
Yes. The cell footprint accommodates the CRP dispensing module and can be configured for the multi-isotope dispensing workflow — F-18 (511 keV), Ga-68 (511 keV), Lu-177 (β + gamma). The shielding tier and inside-cell automation module are configured per site against the isotope mix and peak activity.
Q.How is FLEX supplied, installed and licensed in India?
FLEX is distributed by Saxsons Group. Supply covers the dispensing cell, 100 mm Pb India-config shielding, integration with the CRP inside-cell automation, and the AERB Regulatory Requirements for Medical Cyclotron Facility documentation dossier the site needs for the AERB licensing path. Saxsons handles the CDSCO medical-device import registration and installation across the Indian cyclotron network.
FLEX Dispensing Hot Cell supplier in India — Saxsons Group
Saxsons Group has supplied cyclotron equipment to over 1,000 Indian hospitals since 1988. Every consignment of FLEX Dispensing Hot Cell ships with cold-chain logistics, AERB import documentation, CDSCO registration references and a Certificate of Analysis delivered before dispatch — the paperwork your radiation-safety and procurement teams need, pre-assembled.
- Nationwide delivery footprint — every metro and tier-2 city in India, scheduled to your treatment / procedure calendar.
- AERB & CDSCO documentation — import licence, radiation-safety paperwork and RSO briefing pre-assembled for the audit file.
- 40+ years in Indian oncology — long-standing supply relationships with AIIMS, Tata Memorial, and hundreds of tertiary-care centres.
- Single point of accountability — one purchase order, one delivery contact, one after-sales team across the whole product family.
Also supplied by Saxsons Group across India
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.