Evaluation of concepts for an automated production module for astatinated radiopharmaceuticals

Important results from the project

This project involved the planning and execution of experiments aimed at analysing a product concept based on an already completed risk analysis. For each identified risk, a risk score had been calculated as a reflection of the risks probability and effect. The focus in this projekt was to reduce the risk score for identified risks with a "Very High" risk score. The aim of the project was to generate a report detailing the results of the experiments, the implication of those results on the identified risks, and the implications for upcoming development phases.

Expected long term effects

A report was written detailing the experiments that were planned, the execution of those experiments, the results generated, the effect of those results on individual risk´s "Risk Score", and conclusions that could be drawn based on the work completed. In the case that an experiment was not completed, a clear description as to why this decision was taken is offered. This report will guide the work in upcoming development phases and will be a valuable resource during product certification and validation.

Approach and implementation

In collaboration with a sub-contractor, 21 experiments were planned related to identified risks with a "Risk Score" deemed to be "High" or "Very High". 11 of these experiments were executed in Gothenburg and/or in Holland by Alpha Therapy Solutions (ATS) and the sub-contractor. The results of the experiments were detailed in a report, together with the implications for individual risks as well as the development projekt as whole. The report was analysed by ATS, the sub-contractor, as well as ATS´ consulting quality expert.