On-Site Production and Sterilizatoin of Intravenous Solutions

Period of Performance: 06/01/1999 - 12/01/1999

$70K

Phase 1 STTR

Recipient Firm

Lynntech, Inc.
COLLEGE STATION, TX 77845
Principal Investigator
Firm POC

Research Institution

Texas A&M University
400 Harvey Mitchell Pkwy South Suite 300, 3578 TAMUS
College Station, TX 77845
Institution POC

Research Topics

Abstract

The shelf-life of whole fresh blood and the bulk nature of intravenous (IV) fluids have been logistic problems during military operations. Advanced, compact and even mobile technologies are needed to improve medical support capabilities onboard ships and in field hospitals. Lynntech, Inc. proposes development of a system and methods for preparing and maintaining pyrogen-free sterile water for injection (WFI) and also includes a capability for terminal sterilization of typical IV solutions (i.e., lactated Ringer's). An innovative method will be used to maintain the ultrapure water free of microorganisms and their toxic by-products (pyrogens). Preliminary test results are presented that verify the process capability. The second innovation is a new method for terminal sterilization which will meet the requirements set forth by the FDA and USP for packaged IV fluids. The goals of Phase I are: (I) to demonstrate the feasibility of preparing and maintaining WFI combined with a terminal sterilization method, and (ii) to develop design options and engineering solutions for a pilot-scale system to be built during Phase II. The system will be developed for semi-automated operation with the capability of self-diagnosis and self-sanitization. The outcome will be a highly reliable system for use in limited operational environments, and one which will also meet FDA approval requirements.