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Temperature-Controlled Transport Container for Packed Red Blood Cells


OBJECTIVE: Develop and demonstrate a materiel solution for a passive and thermally efficient temperature-controlled transport container (cold chain container) that has a service life of not less than 5 years without a need for normal repairs and maintenance. Identify method(s) to reduce or eliminate the need for preconditioning of the container. DESCRIPTION: Delayed casualty evacuation from far-forward battle areas necessitates the need for medical personnel to carry small amounts of payload (packed red blood cells (pRBCs), etc.) far-forward on the battlefield. The extreme hot and cold temperatures make it difficult to store payload in containers with wet ice at the right refrigerated temperature for very long. To resolve this shortcoming, personnel utilize lightweight, insulated containers to carry up to 2 liters (L) of payload (approximately 10 pounds when full) at required refrigerated temperatures of 1-10 degrees C for up to approximately three days. The current Army solution needs no power source (passive) to maintain its internal temperature. A combination of vacuum-insulated panels (VIPs) and phase-change material (PCM) maintains the refrigerated temperature. However, both the VIPs and PCM have limited effectiveness over time. Historically, VIPs have proven unreliable and original equipment manufacturers (OEMs) cannot guarantee efficacy beyond a two-year period. PCMs are subject to repeated thermal stress and will not consistently change phase at the appropriate temperature. No feedback is provided to the user regarding the suitability of the container for its next mission. The current solution can also be utilized for other products that require temperature control during transport. However, limitations of preparation, reliability and shelf life persist in the current technology and must be reduced or eliminated. PHASE I: 1. The materiel solution for a container shall have the following considerations: a) Maintains temperature (110 degrees C) for 48+ hours (preferably 72+ hours) in any climate i) Duration between 28 degrees C should be considered for pharmaceutical applications b) Evaluate all containers at external temperatures of -27 degrees C and 40 degrees C for expected duration c) Consider mass, volume, and portability i) Device mass should not exceed 10 pounds (lbs) fully loaded ii) Device volume should not exceed 0.5 cubic feet (ft3) iii) Payload volume should be approximately 2 liters iv) One-person"hands-free"carry (ex: adjustable shoulder strap, belt or clip, etc.) d) Minimize/Eliminate preconditioning (technology preparation) e) Maximize/Eliminate useful life or shelf life. 2. Determine if unique container shapes (non-parallelepiped), such as cylinders or spheres can be realized. These shapes can eliminate or minimize edge heat losses of VIP applications. This is a particular concern when the seam length and surface area are of similar magnitude. Edge heat losses of VIP applications can be much higher than those of the VIP itself. 3. Determine through vendor research and current literature if VIP reliability may be extended beyond two years through good manufacturing practice (GMP) or empirical data. At the conclusion of this phase, the contractor will develop an initial concept design and model key elements, including but not limited to thermal simulation, weight and cube. The contractor will also provide a white paper not to exceed 2 pages regarding VIP reliability as stated in bullet 3. PHASE II: Transition the Phase I concept(s) into six (6) prototypes delivered ready for temperature control testing. These prototypes will be of the best quality that can be produced with the design considerations specified for 1-2 of Phase I. Suggestions for constant monitoring of internal temperature of the container during transport. VIP evaluation (point 3 of Phase I) of reliability versus shelf-life will continue with literature updates and the acquisition of any additional empirical data. At the conclusion of this phase, the contractor will have produced six (6) prototypes that successfully pass temperature control testing. In addition, the contractor will provide: 1. Options (3 minimum) that will constantly monitor the internal temperature of the container with high reliability and minimal power requirements 2. An analysis of current OEM VIPs (if viable) as a candidate for the shelf life extension program (SLEP). PHASE III: Focus on commercialization and technology development. Explore tailoring to user needs (fit and form) and system integration. Address and assess additional test requirements, such as MIL-STD-810. The usefulness of the technology developed under this SBIR can benefit all military medical centers worldwide, especially those in far-forward areas. The feasibility of this container for temperature-controlled supply chain transport is expected to extend to other biologics (e.g., vaccines, organs, etc.) and non-biologics requiring transport in the desired temperature range (28 degrees C). We envision that the contractor that develops reusable and reliable technology can become a market driver in transfers of longer than 1 day in the commercial sector. This includes a majority of the Third World, where vaccines and medical assistance are in high demand and short supply. The temperature-controlled supply logistics community is moving to highly reliable, reusable containers. These efforts have shown to be cost effective and provide significant risk reduction. At conclusion of this phase, the contractor will provide: 1. No fewer than 10 preproduction articles for technical testing and demonstration in an operational environment. 2. A commercial transition plan, including projections for the implementation for similar containers of larger scales (payload volume) and contents (biologics, etc.) 3. A detailed plan for life-cycle (logistics) analysis and routine validation of the design REFERENCES: 1. 21 CFR 600.15. Temperatures during shipment. Code of Federal Regulations - Title 21: Food and Drugs. April 1, 2010 Edition. Washington, DC: U.S. Government Printing Office. 2. Discussions with experts and sources of supply. Cold Chain Temperature Management Global Forum, September 26-30, 2011. Retrieved from Philadelphia, PA. 3. MIL-STD-810G. Environmental Engineering Considerations and Laboratory Tests. October 31, 2008. 4. Rentas, F.J., Macdonald, V.W., Houchens, D.M., Hmel, P.J., & Reid, T.J. (2004). New insulation technology provides next-generation containers for"iceless"and lightweight transport of RBCs at 1 to 10 degrees C in extreme temperatures for over 78 hours. Transfusion, 44(2), 210-216. 5. U.S. Army. (2007). Operational Procedures for the Armed Services Blood Program Elements. TM 8-227-11. Retrieved from Washington, DC: Author.
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