Trend Towards Machine-Based Release in X-ray Sterilization
Damien PRIEELS1, Christian Vogel2, Xavier Declerck1, Joerg Leske2, Brian McEvoy4, Hervé Michel3, Pierre Reppert3.
1Industrial, IBA, Louvain-la-Neuve, Belgium; 2Dosimetry, IBA, Schwarzenbruck, Germany; 3STERIS, Däniken, Switzerland; 4STERIS, Tullamore , Ireland
Trend toward the use of irradiator parameter release (also called machine-based release) emphasizes the requirement on equipment data accuracy and reliability of monitored process parameters. Critical data must be available from both radiation sources and product conveyance systems. In the case of X-ray processing there is a further requirement of parametric data from the converter, which currently is not available today, thus limiting the opportunity for parametric release.
To bridge this gap, this study presents a novel method to verify, in real-time, the consistency of certain X-ray field properties. It covers the description of an X-ray flux monitor and its experimental characterization. The proposed detector can be used as a control and monitoring tool in addition to the conventional “passive” dosimetry per ISO 11137-1 and ISO 11137-3.
After a successful validation of a prototype in the 7 MeV X-ray beam concept at Aerial [1), an improved version of the detector was built and installed in the X-ray facility of STERIS in Däniken. The new detector allows monitoring in real-time the X-ray flux between the pallets being processed. The detector is currently under continuous test in order to verify its robustness and its ability to verify the stability of the X-ray field.
This talk will present the results of a 9-month experience in the X-ray facility of Däniken and the roadmap to include such detector in a broader parametric release and Process Control Systems.
[1] C. Wilson and J. Logar, “Real Time Parametric Release for X-ray Sterilization”, Kilmer conference 2022, Athena.