The Irradiation Panel, an international organization gathering experts in radiation dosimetry and process control, is preparing a comprehensive guidance document on RBIP, highlighting the significance of this paradigm shift in sterilization practices and the collaborative efforts underway to facilitate its adoption.

Irradiation sterilization of medical devices and bio-pharma products is considered a parametric release process, where the sterility is not demonstrated by directly performing sterility tests, but by the use of physical  process variables and dose measurements. A step further in the product release process is implementing a concept called Release Based on Irradiator Parameters (RBIP).

We aim to share the content of the guidance document currently in preparation. It describes current release practices, introduces RBIP, and identifies the changes required for its implementation in the sterilization modalities specified by ISO 11137 (Gamma, E-beam, and X-ray), with E-beam as the focus due to its technological specificity.

It demonstrates the correlation between control over irradiation parameters and routine dose monitoring frequency and details the relation between delivered dose and irradiation variables in E-beam, proposing a "virtual" dose concept for RBIP implementation while retaining absorbed dose as the primary release parameter.

Anticipated challenges such as uncertainty management, sensor characteristics, and risk analysis are also addressed, highlighting the need for thorough consideration during implementation. The guidance document will provide a comprehensive overview of the transition towards RBIP in E-beam sterilization, offering insights into its potential benefits and challenges.