Att. A - Brief Application Template - eBeam Irradiator Donation

Application to Receive eBeam Irradiator Donation for Device Sterilization Three-page template | Complete concisely; attach supporting documents as needed.

1. Applicant and Opportunity Summary

Organization

Location

Primary contact

Email / phone

Product(s) to irradiate

Device class(es) to irradiate

A. Organization details and medical need

Briefly describe the organization, mission/market, ownership, intended uses of eBeam, and patient population affected.

B. Current product, manufacturing, and sterilization context Summarize the product and packaging materials, manufacturing/supply chain, current sterilization method, constraints, and reasons for considering a change to mid-energy eBeam.

C. Proposed use/location of the donated eBeam irradiator Explain the intended operating model, how the irradiator would be integrated by device manufacturer into manufacturing/sterilization, the proposed site location, and the products expected to use it (product details are requested in next section).

Application to Receive eBeam Irradiator Donation for Device Sterilization Three-page template | Complete concisely; attach supporting documents as needed.

2. Product and Technical Readiness

A. Product and packaging details (can be for multiple products) Provide device type, regulatory classification, product geometry, materials, packaging configuration, radiation sensitivities, and, if known, eBeam compatibility. Note: This answer drives targeted eBeam system configuration.

B. Technical rationale and validation approach

State the rationale for mid-energy eBeam; for proposed dose/processing basis and required DUR, if known; the process planned for qualification or sterilization validation; and the current/forecast product volume.

C. Host contributions: facility, infrastructure, and operational readiness Describe site modifications envisioned, utilities’ availability, material flow, staffing and logistics, preparedness for radiation safety/security program and permitting, as well as expected timetable for all infrastructure steps and investments needed to achieve eBeam-validation for product. Note: site upgrades to accommodate eBeam system to be provided by host.

D. Anticipated budgetary gaps and risks for implementation Identify project risks for integration of eBeam into sterilization line, project ownership, and external project partners, and identify any specific equipment, services, or support requested from ORS.

Application to Receive eBeam Irradiator Donation for Device Sterilization Three-page template | Complete concisely; attach supporting documents as needed.