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The safety of beta-propiolactone as a biologic sterilizing agent

The safety of beta-propiolactone as a biologic sterilizing agent

Angiology 12(2): 80-83

The article describes B-propiolactone as an unusual and much needed sterilizing agent for biological materials. The author gives his 9 years experience with the clinical limitations and the usefulness of the blood products and homotransplants sterilized with this agent. He also elaborates upon the objections being raised against the use of B-propiolactone because of its reported carcinogenic properties. The biological materials sterilized have shown no toxic, allergic or carcinogenic manifestations in animals, tissue culture or man. Even large transfusion volumes of treated plasma administered intravenously to man produced no ill effects. This is due to the fact that B-propio-lactone is completely degraded by the time the treated materials are used clinically and the small amounts of the degradation products are normal metabolites of body tissues. Clinically, a total of 2000 transfusions of treated plasma has been administered to 806 patients; over 300 patients have received arterial homografts, and at least 150 bone and 19 cartilage transplants have been performed. In none of these cases (followed over a period of 4 to 8 years) has any evidence been noted of carcinogenicity attributable to the B-propiolactone treated material.

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