Evaluation of in-line electron beam system requirements and capabilities

Abstract

Medical device manufacturers have recently began to study and implement in-line electron beam irradiators for device sterilization instead of relying heavily on centralized locations serving multiple manufacturing sites. Before deciding to install such a system, the sterilization needs should be systematically considered. The evaluation includes • Technical specifications for in-line systems, including energy requirements balanced against size and shielding requirements. • Economics of in-line systems, balancing capital expenditure and increased operational costs at a single location versus costs of transporting products to the central location and the operational costs, including institutional and quality assurance requirements on operating a system.