Request for Information (RFI) - Mid‑energy electron beam (eBeam) systems

The RFI aims to define specifications for an anticipated RFP concerning self-shielded eBeam sterilization systems, primarily focusing on end-of-line deployment with optional in-line capabilities. PNNL clarifies that the 2.0 MeV energy refers to the most-probable energy and provides definitions for “end-of-line” and “in-line” systems, emphasizing end-of-line for broader integration and product variety. The government intends to purchase initial units for integration by medical device manufacturers to catalyze commercial sales. The RFI seeks insights on various aspects, including product accommodation, traceability, relevant ISO/ASTM standards, and vendor support for regulatory engagement. PNNL anticipates a preference for metal shielding due to adaptability and targets 2 MeV to facilitate deployment in diverse production environments, acknowledging its limitations compared to higher energy systems.

This government RFI from PNNL seeks detailed information to help define specifications for a future Request for Proposal (RFP) related to self-shielded electron beam (eBeam) systems for medical device sterilization. The RFI clarifies that 2.0 MeV refers to the most-probable energy. It differentiates between “inline” and “end-of-line” eBeam systems, with an emphasis on end-of-line systems for broader integration and product variety. The initial units are intended for government purchase and integration by medical device manufacturers, with the goal of catalyzing commercial sales. PNNL welcomes insights on various aspects, including interface, communication schemes, cleanroom/GMP requirements, product handling (tray design, securement, conveyor incline), traceability, relevant ISO/ASTM standards, and vendor support for qualification processes. Pricing information is not requested at this RFI stage. The RFI also indicates a preference for metal shielding due to adaptability, and seeks feedback on specification flexibility to promote eBeam technology adoption.

Pacific Northwest National Laboratory (PNNL) has issued Request for Information (RFI) No. 42426-RD to gather data on mid-energy electron beam (eBeam) systems. The RFI, released on April 24, 2026, with responses due by June 1, 2026, aims to inform a future Request for Proposal (RFP) for systems supporting medical device sterilization. PNNL is seeking self-shielded, continuous conveyance systems optimized for single-sided exposure of low-density products. Key information requested from vendors includes technical solutions, product application fit, self-shielding details, controls, data, cybersecurity, testing support, project execution, schedule, service, sustainment, and rough order of magnitude (ROM) pricing. The RFI emphasizes compliance with technical requirements, safety, and operational needs in regulated environments, ultimately to select a system deployable for end-of-line or in-line sterilization.