RESUMO
In 2013, Sterigenics undertook the addition of a 10-MeV electron beam (e-beam) accelerator at its facility in Jarinu, Brazil. A gamma irradiator was already located at this facility, which processed materials and provided irradiation services in Brazil. The decision to implement an e-beam accelerator at the same facility was made in order to diversify the technology that could be offered and to rapidly increase the overall capacity of the facility. In addition, the e-beam technology was complementary to the existing gamma pallet irradiator and thus provided an internal backup for some processes. The main challenge for staff at the Brazil facility was cross-validating processes carried out by the existing gamma irradiator with processes performed with the new e-beam accelerator. The overall success rate in the cross-validation of processes between the two modalities was positive. Products for healthcare, laboratory testing, and other low-bulk-density products that basically consisted of commonly used polymeric materials were most suitable for cross-validation. Products of higher bulk density, greater heterogeneity, or variability between packaging systems and products with dose specifications for a tote rather than a pallet gamma irradiator presented limitations in the cross-validation success rate. This article focuses on the transition approach, discusses the types of products that were successfully cross-validated in e-beam from gamma, and presents examples where such cross-validation was not pursued.
