Radiopharmacy with AI — short half-life, no margin to rebuild the batch afterwards.

The problem

The clock is running, the sources sit on five islands, and the signature has to be in before decay.

Radiopharmacy is one of the few cases in pharma where time is the governing regime of the process:

1. Short half-life — FDG lasts hours, [11C] lasts minutes, therapeutic isotopes somewhat longer. The batch decays, and with it the possibility of injecting it. There is no next day for rebuilding the dossier.
2. Five sources that have to reach the QP at once for the signature: radiochemical purity from the HPLC, radionuclidic purity from the gamma counter, sterility from the protocol applied, the dose calculated per patient (weight, injection time, PET geometry) and traceability from the synthesis module (precursors, columns, program). If one is missing, the batch does not go out.
3. A double regulatory regime — pharma GMP (EudraLex Vol. 4, radiopharmaceuticals annex) and radiation protection (Euratom Directive 2013/59 + national regulation). The QP signs; the radiation protection supervisor is answerable too.

The QP, the radiopharmacist and the supervisor are juggling five systems — an HPLC with its own software, a gamma counter with a spreadsheet, a synthesis module on an old isolated PC, the hospital schedule, the ERP. The clock is running. The classic system works 99% of the time. That 1% is the batch that falls through — and a batch that falls through in radiopharmacy is a patient who does not get injected.

How it fits the IRIS system

iLEAN does not add a sixth system — it seals the cracks between the five you already have.

The problem in radiopharmacy is not a lack of information: it is information living on five islands that has to be cross-checked before decay. iLEAN acts as the putty that fills those gaps, without asking you to change the HPLC, the synthesis module, the gamma counter, the schedule or the ERP.

Connect captures the five sources at second zero. The agent cross-checks against the monograph and leaves the dossier pre-signed. The QP signs — the system does not decide alone. Rings 1-2-3 working with radioactive material in the line.

The iLEAN pieces applied to radiopharmacy:

• Connect is the star piece here, not Edge. It captures the HPLC whether the data comes from the manufacturer's software or from the ticket printer; it reads the gamma counter even on a PC that has been isolated for years; it extracts the synthesis module log without touching firmware; it reads the hospital schedule with the planned injection times; it cross-checks with the ERP. Three modes: manual (a photo of the panel), intermediate (isolated PC), integrated (modern interface).
• Edge comes in wherever there is visual inspection or a critical reading — the injectable vial, patient-dose labeling, reading a unit syringe, the closure seal. A lightweight CNN, a stack light actuator. It works with no network.
• Agent — cross-checks HPLC + gamma + synthesis + dose + monograph + sterility protocol. If all five data points comply, it leaves the dossier pre-assembled for the QP to sign. If they do not, it holds the decision and alerts the QP with the deviation spelled out. It never releases on its own — never. The three rings guarantee that the human signature is mandatory at release.

See the full IRIS architecture →

Before and after

Manual radiopharmacy release vs. release cross-checked with iLEAN

Aspect	Classic release + 5 systems on islands	With iLEAN Connect + Agent + Edge
HPLC, gamma, synthesis, schedule, ERP	Each on its own island; the QP joins them by hand	Captured at second zero, cross-checked automatically
QP decision before decay	Dossier rebuilt under pressure	Dossier pre-assembled; the QP signs with full context
Old isolated synthesis module	“It cannot be integrated”	Connect reads the local PC without touching firmware
Dose per patient	Spreadsheet + the radiopharmacist's calculator	Calculation cross-checked with weight, time, PET geometry
Batch dossier for the regulator / inspection	Rebuild it across 5 systems, days of work	Generated continuously, with JSON signed by ring 2
Radioactive material on the OT network	An informal isolation protocol	Rings 1-2-3 formalized (IEC 62443, AI Act)

Impact estimate

Impact estimate for your plant — to be validated with your numbers.

The block below is an estimate to be validated with the specific data of your plant. We put it forward so the committee has an order of magnitude; we refine it during the diagnostic.

• Hospital radiopharmacy with one or two synthesis modules (FDG + a second tracer), HPLC + gamma counter, and a patient schedule integrated in the HIS.
• Pilot focused on Connect (bridging HPLC + gamma + synthesis + schedule) + one pre-assembled release agent. Edge optional over unit vial labeling. First value expected within a few weeks.
• Indicative payback between 4 and 9 months, depending on the current frequency of batches discarded because the dossier was not complete in time, QP hours spent on manual reconciliation and the workload on the radiation protection supervisor.
• The hard lever is every PET batch saved from decay because the dossier was ready in time + workload taken off the QP. A single batch rescued per week pays for the pilot in a few months.
• Quality bar per million anchored in automotive (a cross-sector reference): on the order of 25 PPM ^[1]. Radiopharmacy is not automotive, but the logic of the bar holds.

And the QP's reasonable doubt

“What if the AI gets it wrong cross-checking the HPLC with the monograph?” — hallucination is a problem of free generation, not of anchored tasks. In tasks where the AI simply recontextualizes a piece of data from one system into another (reading the HPLC chromatogram and comparing it with the spec), the best models brought error below 1.5% ^[2]. And even so: in radiopharmacy the agent never releases. It leaves the dossier pre-assembled; the QP signs. The three rings are there precisely to make that inviolable.

^[1] The 25 PPM standard in automotive quality — Symestic.

^[2] OpenAI paper “Why Language Models Hallucinate”, 2025 — on the reliability of AI in anchored tasks.

Related: Drug-device combination products · Always-ready FDA/EMA audit · EBR — electronic batch record.