Innovative Solutions for Ethylene Oxide Mitigation Used in Sterilization Processes (Direct to Phase II)
ID: DHA244-D002Type: BOTH
Overview

Topic

Innovative Solutions for Ethylene Oxide Mitigation Used in Sterilization Processes (Direct to Phase II)

Agency

Department of DefenseN/A

Program

Type: SBIRPhase: BOTHYear: 2024

Topic Link

https://www.sbir.gov/node/2601963

Additional Information

https://www.defensesbirsttr.mil/SBIR-STTR/Opportunities/
Timeline
    Description

    The Department of Defense (DOD) is seeking proposals for innovative solutions to mitigate ethylene oxide (ETO) used in sterilization processes. The goal is to promote environmentally friendly and sustainable practices in the field of sterilization technologies. ETO is commonly used in the manufacturing of medical devices for its effective sterilization properties, but its use raises environmental and health concerns due to its potential carcinogenicity. The DOD is specifically looking for advancements in sterilization technologies that prioritize environmental sustainability and health by minimizing or eliminating ethylene oxide emissions during medical device sterilization. The technology should be compatible with current ETO sterilization equipment and processes, and should not require significant alterations to existing setups. The proposal should include a plan for FDA clearance and EPA review, and the technology should be capable of operating continuously without becoming the rate-limiting step in current manufacturing processes. The Phase I of the project requires a feasibility study and documentation demonstrating the technical viability and strategic planning of the proposed solution. Phase II focuses on comprehensive development and refinement of the ETO byproduct mitigation solution, including prototype development, efficacy testing, regulatory compliance, and a scale-up strategy or commercialization plan. Following successful development, the technology has potential applications in various industries reliant on ETO sterilization, including medical, pharmaceutical, food, laboratory, veterinary, cosmetic, and textile sectors. The ultimate goal is to transition the ETO mitigation solution from development to widespread implementation across diverse industries, contributing to a safer and more sustainable future for medical device manufacturing. The proposal submission deadline is March 31, 2025. For more information, visit the DOD SBIR 24.4 Annual solicitation notice on grants.gov.

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