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

Questions & Answers / Clarifications

This document provides responses from PNNL to questions submitted by potential vendors regarding Request for Information (RFI) No. 42426-RD, which pertains to self-shielded electron beam (eBeam) systems for medical device sterilization.

• Energy Definition: The "2.0 MeV energy" specified refers to the most-probable energy (peak of the distribution), not the average energy. This distinction is important for understanding LINAC beam characteristics.
• Inline vs. End-of-Line Systems:
  • Inline: Integrated directly into a continuous production line, requiring automated part movement.
  • End-of-Line: Placed separately from a specific product line, allowing for processing of various products, partially or fully assembled, and in different packaging.
• Procurement Model: Initial units are intended for government purchase and integration by medical device manufacturers at their expense. The program aims to catalyze future commercial sales.
• RFI Focus: The RFI seeks to define specifications for an anticipated Request for Proposal (RFP). Vendor input on configuration, interface, communication, cleanroom, GMP requirements, product handling, and traceability is welcomed to inform the RFP. Pricing information is not requested at this stage.
• Tray Design: The eBeam vendor is expected to provide a recommended tray design that is compatible with the conveyance system and approved for the products being processed.
• Product Size: While a 1m scan width is mentioned, vendors should consider providing input on the maximum product size (dimensions and mass) to inform RFP specifications for minimizing labyrinth size and complexity.
• Energy Target (2 MeV vs. 7 MeV): The 2 MeV target is chosen for its versatility in highly variable production environments and smaller footprints, critical for end-of-line and optional in-line applications. A 7 MeV solution, while more adaptable to thicker products, presents a different integration challenge for compact spaces.
• Shielding: The RFP anticipates a preference for metal shielding due to its adaptability to various facilities, despite concrete or hybrid enclosures potentially being more cost-effective for certain installations.
• Regulatory Responsibility: The medical device manufacturer hosting the equipment is responsible for regulatory engagement, though support from the eBeam vendor for Installation Qualification (IQ), Operational Qualification (OQ), and Process Qualification (PQ) is necessary.

This Q&A document clarifies key technical and operational aspects of the eBeam systems being considered. Vendors should use this information to prepare their responses to the RFI and to anticipate the requirements that will be detailed in the upcoming RFP. Specific details regarding product dimensions, interface requirements, and regulatory support will be further defined in the RFP.

Questions & Answers / Clarifications

This document provides responses from PNNL to questions submitted regarding RFI No. 42426-RD, clarifying specifications for an anticipated Request for Proposal (RFP) concerning self-shielded eBeam systems.

• Energy Definition: The "2.0 MeV energy" refers to the most-probable energy (peak of the distribution), not the average energy, which is typically lower for LINACs due to asymmetric energy spectra.
• Inline vs. End-of-Line Systems:
  • Inline: Integrated directly into a continuous production workflow, requiring parts to move automatically through the system. Often requires greater customization.
  • End-of-Line: Placed away from a specific production line, allowing for processing of various products (partially or fully assembled, in packaging) from multiple lines. Assumed to be more easily integrated into factories and potentially achieve higher throughputs.
• Procurement Model: Initial units are envisioned to be purchased by the government for integration by medical device manufacturers at their expense. The program aims to catalyze increased future commercial sales.
• Pricing Information: Pricing details are not requested in response to the RFI. The RFI seeks insight into specifications for the anticipated RFP, including configuration, interface, communication, cleanroom, and GMP requirements.
• Tray Design: The eBeam vendor is expected to provide a recommended tray design that is compatible with the conveyance system and approved for the products to be processed.
• Product Handling: Bidders are asked for insights on product securement, movement without jostling, and handling of inclined conveyors.
• Traceability: Bidders should provide insights into desired traceability levels (tray, lot, package, etc.) and whether product identification will be supplied or needs to be affixed.
• Standards: While specific ISO/ASTM standards will be defined in the RFP, recommendations are welcome to inform specifications.
• Qualification & Regulatory: The medical device manufacturer is responsible for regulatory engagement, but vendor support for IQ, OQ, and PQ is necessary. Recommendations for vendor support are welcome.
• Maximum Product Size: A maximum product envelope (dimensions and mass) will be provided in the RFP to minimize labyrinth size. Insights on conveyance and scan horn dimensions relative to maximum product size are requested.
• Dose Uniformity (DUR): Section 3.2 describes penetration for a DUR <= 1.5. Section 3.5 characterizes throughput where minimum dose is a requirement, and DUR is a result, not a pre-defined requirement.
• Shielding: While concrete or hybrid enclosures are options for some units, the RFP anticipates a preference for metal shielding due to the need for adaptability to various facilities.

These clarifications provide essential details for potential bidders to understand the technical scope, operational models, and procurement intent, enabling them to prepare more informed responses to the upcoming RFP. Pricing is explicitly excluded from RFI responses.

Request for Information (RFI)

This RFI is issued by Battelle Memorial Institute (Battelle) on behalf of the U.S. Department of Energy's Pacific Northwest National Laboratory (PNNL). PNNL is seeking information from qualified suppliers regarding mid-energy electron beam (eBeam) systems for medical device sterilization applications. The goal is to gather technical approaches, configurations, safety/shielding concepts, integration constraints, and lead times to inform a future Request for Proposal (RFP).

Vendors are asked to provide information on:

• Technical Solution Description: Accelerator technology, energy spectrum, uptime performance, scan-horn details, beam monitoring, and expected surface dose rates.

• Product/Density Application Fit: System efficiency, examples of previously handled products, and fixturing/packaging considerations.

• Self-Shielding and Facility Interface: Shielding materials, thicknesses, dose maps, facility requirements (power, cooling, exhaust, environment), and clearance for installation.

• Controls, Data, and Cyber/Connectivity: HMI/PLC platform, data logging capabilities, and interface protocols.

• Testing Support and Validation: Details on Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) criteria, commissioning, dosimetry support, and documentation for process validation.

• Project Execution and Schedule: Typical lead times, FAT to SAT timelines, and major project phases.

• Service and Sustainment: Preventive maintenance, spare parts lists (lifetimes, lead times, prices, availability), and service contract options.

• Rough Order of Magnitude (ROM) Pricing: Budgetary estimates for the base system, shipping, installation/commissioning, training, optional features, and annual service/support costs.

• Risks and Constraints: Key technical or operational risks and mitigation strategies.

• RFI Release Date: April 24, 2026

• Questions Deadline: May 18, 2026

• RFI Response Due Date: June 1, 2026

• Submission Format: Searchable PDF (Excel for pricing/spares optional). Narrative response limited to 25 pages (excluding datasheets/appendices). Include a requirements compliance matrix.

• This RFI is for informational purposes only and does not constitute a commitment to contract or purchase.

• Responses will be used to inform future procurement decisions.

• Proprietary information must be clearly identified.

• The desired configuration is a self-shielded system deployable at end-of-line (EOL) with optional in-line capability, supporting continuous conveyance.