Att. A - Brief Application Template - eBeam Irradiator Donation.docx
DOCX document 34 KB Posted
- Solicitation number
- 10826-RD
- Issued by
-
Department of Energy
About this file
This is an application template for organizations seeking to receive a donated mid-energy electron beam (eBeam) irradiator system for medical device sterilization. The template is a three-page form issued by the Pacific Northwest National Laboratory (PNNL) under RFI No. 10826-RD, sponsored by the Department of Energy.
Applicants must provide comprehensive information across three main sections: (1) organizational details including mission, current sterilization methods, and the medical need driving the transition to eBeam technology; (2) product and technical readiness, encompassing device specifications, regulatory classifications, technical rationale for eBeam adoption, validation approach, facility infrastructure requirements, and identified budgetary gaps; and (3) implementation planning, anticipated impact, organizational commitment, and a self-assessment scoring matrix evaluating confidence in product validation, cost savings, sustained growth, market adoption potential, and stimulation of demand for U.S.-manufactured accelerators. Applicants must address specific technical elements including product geometry, materials, packaging configuration, radiation sensitivities, proposed dose and processing parameters, site modifications needed, utilities availability, material flow logistics, radiation safety and security program preparedness, milestone timelines, estimated annual throughput, and sustainability plans. The template also requires applicants to identify supporting documentation available for submission, such as device master information, regulatory history, prior eBeam test data, validation plans, and logistics details. This RFI is a pre-solicitation instrument designed to identify qualified medical device manufacturers for potential receipt of donated equipment as part of the Department of Energy's initiative to advance mid-energy eBeam sterilization technology adoption in the U.S. medical device industry.
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| File | Type | Posted |
|---|---|---|
| RFI No. 10826-RD (E-BEAM DONATION).pdf |
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ATT. A – RFI NO. 10826-RD
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).
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.
Three-page template | Complete concisely; attach supporting documents as needed.
3. Implementation, Impact, and Supporting Information A. Implementation plan, milestones, and product volumes List major steps, responsible parties, milestone dates for integration and operation, dependencies, and estimated initial and mature annual throughput.
B. Anticipated impact and sustainability Describe certainty of continuous production and/or growth of use of this proposed eBeam line; describe specific steps host will take to publicize successful implementation of mid-energy eBeam in device sterilization.
C. Management commitment Describe process and status of organizational commitment to host donated mid-energy eBeam irradiator.
D. Self-assessment of opportunity readiness (1 = low; 5 = high)
| Criterion |
| Score |
| Brief basis |
| Confidence of successful product validation with mid-energy eBeam |
| ___ |
| Cost-savings rating for switching product to mid-energy eBeam sterilization |
| ___ |
| Confidence of sustained growth of product volume for ten years or more |
| ___ |
| Likelihood of growing adoption outside of host company of mid-energy eBeam by publicizing this product’s success |
| ___ |
| Impact of growing adoption inside host company of mid-energy eBeam |
| ___ |
| Impact of stimulating new demand for USA-manufactured accelerators |
| ___ |
E. Supporting information available. Check items that can be shared.
| ☐ Company/contact details |
| ☐ Device master information |
| ☐ Regulatory history |
| ☐ Product details |
| ☐ Prior test data with eBeam (at any energy) |
| ☐ Re-Validation plan |
| ☐ Product-handling proven method |
| ☐ Risk-management details |
| ☐ Logistics/site information |
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