Successful retrofitting of XiltriX EMS in Theranostics Erasmus MC

After a decade of service, the EMS monitoring solution installed in the Erasmus MC cyclotron facility named Theranostics Erasmus MC was obsolete and in need of replacement. Being a GMP accredited production facility for radiopharmaceuticals used in the diagnosis and treatment of disease, stopping production of these short-lived radioisotopes for a longer time is costly and creates issues for the treatment of patients. Retrofitting a new system in a working facility, with no room for error and first time right, is no easy feat. Specifically, because it needed to be calibrated, validated and commissioned in an extremely short time frame of only 10 days.

When XiltriX was chosen by Theranostics Erasmus MC, a lot of meticulous preparation and design went into the project. Together with the Theranostics Erasmus MC staff and the XiltriX Functional Administration Department of the Erasmus MC, the project was broken up into manageable pieces, and all risks were assessed and mitigated beforehand. The project was successfully executed during a short shutdown period of only 10 days, after which the XiltriX system was fully commissioned and validated, ready for use.

The laboratory for nuclear medicine Theranostics Erasmus MC was built in 2014 and 2015 on the grounds of Erasmus MC. It uses a cyclotron, a particle accelerator, to produce short-lived radionuclides, which can be used to make radiopharmaceuticals, radioactive medicines, for patient care and research, for example to trace and locate cancerous tumours. Because the amount of radioactivity in these radiopharmaceuticals decreases rapidly, Theranostics Erasmus MC produces these particles on site at Erasmus MC, eliminating the risk of transportation delays and of treatment with pharmaceuticals with too little radioactivity left.

The cyclotron itself is a relatively small device, surrounded by a shield which largely blocks the radiation. To neutralise the remaining traces of radiation, the cyclotron is housed in a bunker surrounded by 500 mm of concrete. Radioactivity is only produced when the cyclotron is switched on. The actual radioactive medicine is produced in so-called hot cells, a type of safety cabinet in which the product is protected against bacteria and particles, clad with lead so the operator is protected from radioactive radiation. The whole facility is GMP accredited and adheres to the highest quality standards.

Source: Erasmus MC Scanner, April 2014.

In recent years, the use of radionuclides produced by cyclotrons has witnessed significant advances worldwide. Modern cyclotrons enable the efficient production of a broader range of radioisotopes, including novel tracers for advanced diagnostic imaging and targeted radiotherapy. These innovations have improved the precision and effectiveness of PET and SPECT scans, enhancing early disease detection and personalised treatment planning. The cyclotron of the Erasmus MC for example received its trade licence for 18F-FDG Hoboken 250 MBq/mL in 2018. This solution is used for diagnostic purposes for various forms of cancer.

Ms. Anouk van Dapperen, Head of Quality Assurance and Qualified Person, Theranostics Erasmus MC B.V., commented: "Production of radionuclides in our cyclotron under GMP conditions needs a next-level quality system. Using obsolete Environmental Monitoring Systems (EMS) without proper support simply was too big a risk, not good enough for our department."

The retrofitting process was a very challenging one. The cyclotron is a very well-shielded facility. Wireless signals will not penetrate this shielding properly. Downtime could not exceed 10 days, which meant the existing hardware, sensor and signalling solutions needed to be reused as much as possible. The cyclotron runs a maximum of 3 productions every day. If a delay of only one week had been incurred, the damage in production costs alone would have easily exceeded EUR 100,000.

Mr. Maarten Weening, Head of Production at Theranostics Erasmus MC B.V., added: "Our jobs in Theranostics Erasmus MC are not just about money. We, for example, treat patients with serious brain tumours that have only weeks to live. Being able to produce high quality radiopharmaceutical products for us is literally a matter of life and death."

The process of the actual implementation was a very meticulous one. Firstly, all existing cabinets and cables needed to be disconnected from the existing system. An already prepared build-to-fit interior panel for the cabinets was then placed and one by one all cables were reconnected to the new XiltriX installation. Every cable was checked, labelled and verified for functionality and correct connection. Also, all local signalling lights and visualisation screens were recommissioned in a very short time frame.

Mr. Han Weerdesteyn, CCO for XiltriX International, observed: "The process of retrofitting the XiltriX system was well prepared and well executed. We are exceptionally proud of the short amount of time in which our team was able to complete the work. During the installation of the visualisation screens in cooperation with the IT department, our ISO 27001 certification proved very useful."

The XiltriX monitoring system has been used for more than two decades in Erasmus MC. The campus wide XiltriX installation boasts more than 3500 sensors used in many departments, safeguarding many billions of euros of sample value. Supported by a team of Functional Administrators led by Mr. Pascal van Elzakker, the XiltriX monitoring solution is an integral part of the Erasmus MC drive for next-level monitoring and quality.

Ms. Anouk van Dapperen commented: "I was one of the driving forces in the retrofitting selection process. Knowing that there is a well-trained support team in the Erasmus MC and with my previously positive experience working with the XiltriX team, I knew this project was going to be a success. The result has been very positive so far. The system has been functioning very reliably."

All critical parameters in the GMP accredited environment of Theranostics Erasmus MC have to be monitored in real time. This means that temperatures, CO₂, differential pressures and even cyclotron technical status information are continuously monitored by XiltriX. Only if all parameters fall within the predetermined limits may a production run be started. The quality staff also makes monthly and three-monthly checks to make sure all parameters stay within the limits, as a production run may influence the facility's functions.

Ms. van Dapperen added: "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."

All critical parameters are displayed on a large visualisation screen that retrieves its information through the secure XiltriX API. These screens make it very convenient to get information on the functionality of all important sensors for a specific part of the facility in one glance. The tiles on the screen show the sensor identifier, description, actual value and state of every sensor in real time. These screens are remotely maintained by the XiltriX support team and can be remotely programmed to show different values if so desired by the customer. There is no need for logging into the XiltriX server, since the values are of a read-only nature. The screens automatically recover after reboots and power failures.

After the successful retrofit of XiltriX in the Theranostics Erasmus MC facility, it is now time to look ahead. Having one system for all critical parameters is very convenient for the users in the cyclotron, because it eliminates duplicate maintenance and support costs and lowers the time needed to get to the desired data. The radioactivity monitors are not yet connected into the XiltriX monitoring solution, but the option to do so exists.

Ms. van Dapperen commented: "The improvement of the granularity with which we can see our critical data and how we can set up alarms in XiltriX compared to our previous solution is very big. Adding the radioactivity monitoring into the centralised XiltriX solution would complete the single source of truth for all our critical monitoring parameters."

Alongside the visualisation of data, integration of XiltriX data with third party systems is something to be desired. The on-call schedule currently used by the Theranostics Erasmus MC department is regularly changed. Having to change this manually is very laborious and prone to errors.

Mr. Han Weerdesteyn said: "The XiltriX API integrations are very important in getting laboratories the information automation they desire. XiltriX is able to integrate with existing message brokers, automating the on-call schedules without the need for manual intervention. This step will lower the risk of alarms being missed and provides additional risk mitigation for the whole monitoring solution."

Would you also like support in setting up an accredited laboratory, or in upgrading your existing one? Talk to us, or write to sales@xiltrix.com.