Radiopharmacist's Notes · SYNT™ Synthesis Hot Cell
Europe\'s pharmaceutical rulebook treats the synthesis step (where the chemistry happens) and the dispensing step (where unit doses are drawn) under different chapters. Annex 3 explicitly allows a closed automated synthesis hot-cell like SYNT to run at a lower internal cleanliness class — because the operator never opens it. The dispensing step in FLEX, by contrast, has to be Grade A. This page maps the synthesis-cell scope against the SYNT feature set, row by row, with every claim cited.
Putting sterile dispensing in a synthesis cell — or chemistry in a dispensing isolator — fails the audit. The split is structural to the GMP framework, not just operational.
Annex 3 allows Grade C inside a closed automated synthesis hot-cell. The chemistry runs without operators reaching in — they interact through the control PC, not through glove ports. SYNT is built for this carve-out.
EU GMP Annex 3 — closed-automated-system Grade C provision.
Annex 1 (revised 2022) requires Grade A inside the dispensing isolator — that's where the bulk synthesised product is divided into individual sterile patient unit doses. The operator interacts via gloves; the workspace must be the cleanest pharma class.
EU GMP Annex 1 (rev. 2022, eff. 2023-08-25).
Each row maps a specific requirement onto a documented SYNT feature. Sources are cited inline; nothing is invented.
100 mm Pb shielding (Indian cyclotron-site norm)
SYNT is configured at 100 mm Pb for Indian cyclotron sites — supplied by Saxsons. The manufacturer baseline shielding spec for SYNT is not published on the (the manufacturer )public page; the India-configured build is the Saxsons-supplied variant.
Source: Saxsons Group configuration for the Indian market.
Closed system during synthesis runs (Annex 3 Grade C carve-out)
Inflatable seals provide ISO 10648:2 air-tightness when the cell is running. The synthesis module operates as a sealed system — no operator hands inside the cell during a run.
Source: SYNT product page (ISO 10648:2 air-tightness spec).
GMP-grade clean-air environment
The ventilation system maintains a GMP Class B clean-air environment per the (the manufacturer spec) — exceeding the Grade C minimum Annex 3 allows for closed synthesis cells.
Source: SYNT product page (the manufacturer ventilation spec).
Pharma-grade cleanable interior
AISI 316L stainless steel inner finishing — the same austenitic stainless grade pharma uses for clean-in-place vessels. Smooth, corrosion-resistant, easy to decontaminate.
Source: SYNT product page (the manufacturer inner-finish spec).
Service access without breaking the GMP environment
The tray module can be completely extracted for module servicing and cassette changeovers. Air-tight pass-through system for radio-fluids and gases keeps the cell sealed during synthesis.
Source: SYNT product page (tray-module extraction + pass-through spec).
The GMP and AERB stack is a programme, not a piece of equipment. SYNT gives you a compliant synthesis enclosure; the cyclotron operator still owns the rest.
Sources: EU GMP Annex 1 (2022 rev.); Annex 3; Annex 11; AERB 2017 Regulatory Requirements.
Scope of this page
We do not claim "SYNT is GMP-certified" — Annex 3 / Annex 1 / Annex 11 / AERB are programme-and-facility frameworks, not equipment certifications. The manufacturer designs SYNT against these requirements; the GMP licence and AERB consent sit with the cyclotron operator. The 100 mm Pb Indian-market configuration is supplied by Saxsons; the Tema public product page does not publish a shielding figure verbatim. The sibling FLEX compliance post covers the dispensing-cell scope and the full Annex 3 + Annex 1 + Annex 11 + AERB stack.
Sources cited on this page