Radiation Sterilization And Health Informatics In Nuclear Pharmacy Practice: A Safety And Quality Perspective With Applications In Emergency Care

Abstract

Nuclear pharmacy practice operates at the intersection of sterile preparation, radiation safety, and time-sensitive clinical service delivery, where small-batch production, short radionuclide half-lives, and rapid handoffs increase vulnerability to preventable harm if sterility or documentation fails. This integrative review synthesizes contemporary evidence and authoritative guidance on (1) radiation sterilization principles relevant to healthcare materials and components, (2) radiopharmacy quality systems and quality risk management, and (3) health informatics capabilities that strengthen traceability, auditability, and workflow reliability, with emphasis on applications in emergency care environments where interruptions and surge conditions are common (Gillings et al., 2021; Gillings et al., 2022; ISO, 2025; WHO, 2018; WHO, 2021). Evidence converges on five themes: sterility assurance as a validated process outcome requiring controlled parameters and documented evidence; irradiation compatibility as conditional and material-specific, necessitating stability and performance verification; quality risk management as the governance “decision engine” for substitutions and process adaptation; informatics as an operational safety-control layer enabling end-to-end traceability, audit trails, and deviation learning loops; and emergency care as a reliability stress test that clarifies which controls must remain functional under pressure (Jacobs, 2022; Charoo et al., 2023; Gómez Perales, 2022; Hansen et al., 2020; Owens et al., 2020; Mulac et al., 2021). The synthesis supports a unified “sterility assurance + data assurance” model in which change control, traceability, and data integrity are treated as core patient-safety functions rather than administrative tasks.