A Small, Portable, and Powerless Sterilization System for Medical/Dental Instruments

Lynntech proposes to develop a small, light-weight, and powerless steam sterilization system for the DOD to sterilize medical and dental instruments in environments where standard non-portable, power-consuming sterilization methods are limited and/or unavailable. The system includes small, disposable cartridges that exploit well-known exothermic and endothermic reactions to rapidly sterilize and cool medical/dental instruments. In Phase I, we demonstrated successful inactivation of 6 log10 of both G. stearothermophilus spores and B. atrophaeus spores using a bench-scale prototype sterilization canister. Commercially available sterilization validation indicator strips were identified and used and preliminary engineering drawings of the Phase II deliverable were prepared. In Phase II, we will assemble and deliver a deployable prototype sterilization system optimized for performance, size, weight, and ruggedness in accordance with feedback from the COTR. The workplan was developed in accordance with the FDA’s regulatory requirements to facilitate the transition of an FDA-approved technology to the DOD. The Phase II team consists of experts in heat transfer and thermodynamics, virtual manufacturing and simulation, and FDA regulatory submission requirements. In addition, Lynntech will exploit an on-going relationship with a potential Phase III partner that has extensive experience in developing and manufacturing innovative products for the outdoor and military markets.