Pilot scale production of pyrogen-free human hemoglobin for research.

A pilot scale production facility for the preparation of 20 to 30 liters of stroma-free hemoglobin is described. The system is capable of producing pyrogen-free solutions for research purposes. It is not certified for production of parenteral solutions for human use, but the plan could be implemented to meet standards for such materials. Products of the facility should be of adequate quality to address most of the toxicity and efficacy issues facing further development of hemoglobin-based red cell substitutes.