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Knowledge Hub · FDGtwo™ Radiosynthesizer

Two reaction vessels, one setup — two [18F]FDG batches per session.

A cyclotron radiopharmacy that runs back-to-back PET lists wants the second [18F]FDG batch to come from the same operator setup as the first. FDGtwo holds two independent reaction-vessel sets in one module — two productions from one setup, plus the chemistry headroom to run [18F]FMISO, [18F]FLT and [18F]FCh from the same equipment when the tracer menu grows. Basic-hydrolysis FDG in under 28 minutes, radiochemical purity above 98 %, guaranteed RCY 65–85 %.

The two-batch session

Four steps from operator setup to a ready-for-tomorrow module

Step 1

One setup

Operator loads cassette / reagents once per session

Step 2

Batch 1

First [18F]FDG production runs in vessel set A

Step 3

Batch 2

Second [18F]FDG production runs in vessel set B — no second setup

Step 4

Self-clean

Built-in 45-min cleanup cycle, ready for tomorrow

Why this matters

Six things FDGtwo delivers, explained simply

Two-vessel architecture

Two [18F]FDG batches from one operator setup

The module holds two independent sets of a single synthesis unit. That means the operator can run two consecutive [18F]FDG productions after one setup — the second batch does not need a second cassette load, a second reagent prep or a second pre-run. For an Indian PET-CT centre running back-to-back morning lists, that halves the manual overhead per shift.

Based on: FDGtwo product page — "two independent sets of a single synthesis unit allow two [18F]FDG productions with one setup"

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Multi-tracer chemistry

Beyond FDG — FMISO, FLT, FCh and other nucleophilic [18F] tracers

The module is not single-tracer. The published chemistry list covers [18F]FDG, [18F]FMISO (hypoxia imaging), [18F]FLT (cell-proliferation imaging), [18F]FCh (choline for prostate / HCC) and other nucleophilic [18F] compounds. A tertiary PET centre that wants to grow its tracer menu does not need a second synthesizer to start running a non-FDG list.

Based on: FDGtwo product page — nucleophilic [18F] chemistry list

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Inside one F-18 half-life

Synthesis completes in under 28 minutes (basic) / 22 minutes (acid)

F-18 has a 109.8-minute physical half-life. Per the manufacturer spec, basic-hydrolysis [18F]FDG completes in under 28 minutes and acid-hydrolysis in under 22 minutes. That leaves a comfortable margin for QC release, dispensing, transport and patient injection — the workflow does not have to compress to chase the isotope.

Based on: FDGtwo product page — published synthesis times

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Specified yield and purity

Radiochemical purity > 98 %, guaranteed RCY 65–85 %

Radiochemical purity above 98 % and a manufacturer-guaranteed radiochemical yield of 65–85 % under optimal conditions. Six shielded radiation detectors monitor activity at points across the synthesis path, so an off-spec batch can be traced to a stage rather than simply being recorded as a low-yield event.

Based on: FDGtwo product page — purity, yield, and in-process monitoring spec

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Fits the cyclotron radiopharmacy stack

Drops into a SYNT-class synthesis hot cell

At 42 × 50 × 48 cm and ~25 kg, the module is sized for a SYNT synthesis hot cell envelope (55 × 55 × 50 cm minimum). The chemistry produced inside the cell flows downstream into a FLEX dispensing hot cell; off-gas flows through a WGHS waste-gas handling system. The four pieces — host cell, synthesizer, dispensing cell, off-gas handler — are sourced as one chain with a single AERB import file.

Based on: FDGtwo dimensions + SYNT / FLEX / WGHS product pages

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AERB licensing input

Synthesis equipment the regulator expects to see

The AERB Regulatory Requirements for Medical Cyclotron Facility (2017) sets out the licensing framework under the Atomic Energy (Radiation Protection) Rules 2004. An automated synthesis module with closed reaction vessels, in-process radiation monitoring and a self-cleaning cycle is the engineering response the licensing path expects — the operator owns the GMP recipe, batch records and Pharm.Eur. monograph release.

Based on: AERB Regulatory Requirements & Guidelines for Medical Cyclotron Facility (2017)

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FDGtwo at a glance

2-batch

Per setup

Two independent vessels

< 28 min

Basic FDG

Acid < 22 min

> 98 %

RC purity

RCY 65–85 %

4-tracer

FDG · FMISO · FLT · FCh

Published literature

Where FDGtwo sits in the peer-reviewed record

An honest scoping note. A 2026 search of PubMed, Europe PMC and Google Scholar — using every name variant ("Synthra FDGtwo", "FDG-two", "FDG two", "FDG2") — returns no original-methods peer-reviewed papers that name the FDGtwo as the synthesizer used. The product is documented through the manufacturer specification and IAEA cyclotron-radiopharmacy training material, not through site-published validation. Where Synthra platforms do appear in the peer-reviewed [18F] chemistry literature, the cited module is most often the company's sister synthesis platform — the RNplus Research. The two recent verifiable examples below illustrate what Synthra-platform F-18 chemistry looks like in published methods.

Mol Imaging Biol · 2022

[18F]FSPG radiosynthesis on a customised RNplus Research

Brown, Soloviev and Lewis report a fully automated synthesis of the cystine/glutamate-antiporter PET tracer (S)-4-(3-[18F]fluoropropyl)-L-glutamic acid on "a customised RNplus Research automated radiosynthesis system (Synthra GmbH, Hamburg, Germany)" — verbatim from the Methods.

Brown G, Soloviev D, Lewis DY. Radiosynthesis and Analysis of (S)-4-(3-[18F]Fluoropropyl)-L-Glutamic Acid. Mol Imaging Biol 2022. doi:10.1007/s11307-022-01793-3.

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EJNMMI Radiopharm Chem · 2025

GMP-compliant [18F]fallypride synthesis on a Synthra RNplus Research

Alfteimi, Zhao and colleagues report a GMP-compliant fast and high-yielding automated synthesis of the dopaminergic D2/D3 PET tracer [18F]fallypride without HPLC purification, naming the synthesizer as "the RNplus Research module from Synthra…operated by the SynthraView software" — verbatim from the Methods.

Alfteimi A, Zhao et al. GMP compliant simplified fast and high yielding automated synthesis of [18F]fallypride without the need of HPLC purification. EJNMMI Radiopharm Chem 2025;10:21. doi:10.1186/s41181-025-00343-w.

Open in PMC ↗

Read this honestly

Neither paper uses the FDGtwo specifically. Both are included because they are recent, verifiable, peer-reviewed examples of GMP-grade nucleophilic [18F] chemistry on the Synthra synthesis platform — the same chemistry family the FDGtwo runs, on a sister module from the same manufacturer. For FDGtwo-specific assurance on a particular deployment, the load-bearing evidence is in-house process validation against the European Pharmacopoeia monograph for Fludeoxyglucose (18F) injection — that is what an AERB inspection (and EU GMP equivalent) actually looks at. The manufacturer specification on the product page sets the engineering envelope; the validation runs on the site demonstrate the recipe inside it.

Scope of this page

The yield band (65–85 %), purity (> 98 %), synthesis times and chemistry list are the published manufacturer figures and are quoted as such — actual per-site yield will vary with precursor lot, cyclotron starting activity, QC release criteria and the recipe the radiopharmacy authors. The module is the engineering; the GMP recipe, the Pharm.Eur. monograph release and the batch-records sit with the radiopharmacy. We do not publish comparative claims against other commercial synthesizers — confirm against the brochure for the specific chemistry your site needs.