Radiopharmacist's Notes · FDGtwo™

One setup, two batches — but two batch records.

The two-vessel architecture saves the second operator setup. What it does not save is the second batch record — radiochemical purity, residual solvents, endotoxin and Pharm.Eur. release are per-batch attributes, not session-level ones. This page draws the line between what is shared across the session and what each batch has to carry on its own paperwork.

Three lanes of session paperwork

The middle column is what the two-vessel architecture does not change — both batches need it.

Shared once per session

Operator login / authorisation for the session
Cassette + precursor + reagent kit load — one setup, two vessels primed
In-cell radiation-area survey and pressure / flow checks
GUI selection of the synthesis programme (basic vs acid hydrolysis)
End-of-session self-clean cycle (45 min) — runs once after batch 2

Source: FDGtwo product page — "two independent sets… two productions with one setup"

Per batch

Per batch — both batch records must show

Batch number + vessel set used (A or B) — the audit trail has to identify which vessel produced which batch
Cyclotron starting activity for the batch (GBq, up to 555 GBq)
In-process detector readings across the synthesis path (six detectors)
Synthesis time and end-of-synthesis activity — RCY calculation per batch
Sample drawn for QC: radiochemical purity, residual solvents, sterility, endotoxin
Pharm.Eur. monograph release sign-off before dispense

Source: Pharm.Eur. monograph for [18F]FDG injection + site batch-record SOP

Session-level closure

Confirmation that batch 2 self-clean completed before the cell is reopened
Off-gas cycle log reconciliation (WGHS log paired with the two synthesis windows)
Daily radioactive-waste record updated with both batches
Equipment-use log entry for the session (operator, total runs, faults if any)
Cell decontamination check before next-day setup

Source: AERB cyclotron-facility licensing path; site SOPs.

Four guard-rails when you write the SOP

Vessel set A and vessel set B must be identifiable on the batch record by a stable code, not just "first" or "second" — if the operator runs them out of order one day, the trail still has to be unambiguous.
Each batch needs its own Pharm.Eur. release. The two batches share a setup, not a release — radiochemical purity, residual solvents and endotoxin are per-batch attributes.
The 45-minute self-clean is a session closer, not a batch-to-batch step. Don't schedule a third batch into the slot the clean cycle owns.
The WGHS off-gas log will record two synthesis windows. Reconcile them against the two batch records at end of session — a mismatch is a finding to investigate before tomorrow.

Sources: FDGtwo product page; Pharm.Eur. monograph for [18F]FDG injection; AERB cyclotron-facility licensing path; site SOPs.

Scope of this page

The three columns above reflect the workflow a two-vessel synthesizer enables, mapped against the per-batch release attributes the Pharm.Eur. monograph for [18F]FDG injection requires. They are a starting framework for SOP authoring, not a substitute for site SOPs signed off by the radiopharmacy programme. The exact GUI field names, the cleanup-cycle interlocks and the vessel-set identifier convention should be confirmed against the brochure and the in-house validation.

Sources cited on this page

Manufacturer. FDGtwo — Automated F-18 Radiosynthesizer. Manufacturer product page ↗
European Pharmacopoeia. Fludeoxyglucose (18F) Injection — monograph. Council of Europe (current edition).
Atomic Energy Regulatory Board (India). Regulatory Requirements and Guidelines for Medical Cyclotron Facility. AERB, 2017. AERB PDF ↗

Knowledge Hub →

FDGtwo in plain English

Two-vessel architecture, the chemistry list, and the radiopharmacy stack the module fits into.

Sibling →

WGHS off-gas audit trail

The off-gas log that pairs with each FDGtwo synthesis window at end-of-session.

FDGtwo™ Radiosynthesizer

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