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Theranostics Erasmus MC: a cyclotron retrofit in a ten-day window

The monitoring system in a GMP radiopharmaceutical production facility was a decade old and obsolete. The replacement had to succeed first time right, in ten days.

Facility built
2014 to 2015
Shutdown window
10 days
Sensors across campus
3,500+
The Theranostics Erasmus MC cyclotron facility

A production facility that cannot stand still

Theranostics Erasmus MC uses a cyclotron, a particle accelerator, to produce short-lived radionuclides and turn them into radiopharmaceuticals for patient care and research. Because radioactivity decays rapidly, production happens on site, up to three runs per day.

The facility is GMP accredited. Stopping production is costly, and it touches patients directly: among them people with serious brain tumours who have only weeks to live. A delay of a single week would have cost well over EUR 100,000 in production alone.

Why the old system had to go

After roughly ten years of service, the environmental monitoring system in the cyclotron facility was obsolete. Running GMP production on a system without proper support was a risk the quality department was not willing to take.

A replacement had its own constraints. The cyclotron is heavily shielded, so wireless signals do not penetrate properly, and downtime could not exceed ten days. That meant the existing hardware, sensors and signalling had to be reused as far as the assessment allowed.

Ten days, first time right

The project was prepared meticulously with the Theranostics staff and the Erasmus MC functional management team, broken into manageable pieces with every risk assessed and mitigated beforehand.

During the ten-day shutdown, every cabinet was disconnected and fitted with a build-to-fit interior panel, then every cable was reconnected, checked, labelled and verified for functionality. Local signalling lights and visualisation screens were recommissioned, and the system was calibrated, validated and commissioned within the window.

Who responds when something happens

Production alarms are answered by Theranostics' own people, following the department's on-call schedule. Quality staff additionally check the parameters monthly and quarterly, because a production run can influence the facility's behaviour.

The XiltriX 24/7 team is reachable for technical issues with the monitoring system itself, and maintains the visualisation screens remotely so they recover automatically after reboots or power failures.

Results and what is next

The retrofit was completed, calibrated, validated and commissioned inside the ten-day window, and the system has functioned reliably since. One platform now covers temperature, CO₂, differential pressure and cyclotron technical status, and a production run may only start when every parameter is within its limits.

Next steps under discussion: bringing the radioactivity monitors into the same system, and integrating the on-call schedule through the XiltriX API and message brokers, so alarm escalation follows the schedule automatically instead of being maintained by hand.

"By having the ability to retrofit the XiltriX system to our existing infrastructure, it really helped us with the speed of finishing installation. The XiltriX team was very cooperative during the whole process and provided a high-quality installation finish."

Anouk van Dapperen, Head of Quality Assurance and Qualified Person, Theranostics Erasmus MC B.V.

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