An Automated Hollow Fiber System for the Deglycerolization of Thawed Frozen Human Blood

Period of Performance: 03/15/1995 - 08/14/1997

$749K

Phase 2 SBIR

Recipient Firm

Rasor Assoc., Inc.
253 Humboldt Court
Sunnyvale, CA 94089
Principal Investigator

Research Topics

Abstract

The objectives of this proposed Phase II program are to develop a complete, automatic system for the rapid deglycerolization of thawed frozen human blood with the capability of long term refrigerated storage of the washed red cells in an additive solution. This system uses a hollow fiber separator to remove glycerol and saline wash solution from red cells in a efficient recirculation process. The anticipated advantages of this system are: a completely closed sterile disposable; fully automatic operation; reduced processing time; reduced disposable costs; reduced hardware size and costs; and greater ease of use compared to current systems. The proposed program will establish optimal system performance parameters; design, construct, and test first-generation systems; design, construct, and test second-generation or pre-production systems; prepare test data and documentation to meet FDA requirements for long-term washed red cell storage; and demonstrate through thawed frozen human blood testing and user evaluations that all established system objectives, requirements and specifications have been met. One first-generation system and three second-generation systems will be delivered for independent evaluations during this program.