Post‐expiry stability of freeze‐dried plasma under field conditions – Can shelf life be extended?

Abstract

BACKGROUND: This prospective study evaluated the effect of routine, uncontrolled, Israeli field storage conditions on the safety and efficacy of Lyo-Plas N Freeze-Dried Plasma (FDP) at the end of the manufacturer's shelf life, and up to 24 months post expiry. Clotting factors V, VIII and XI, proteins S, C, fibrinogen, PTT, ATIII, VWF, and INR as well as TEG, DDM, residual moisture, pH, and sterility of FDP returned from field units after uncontrolled storage were evaluated. STUDY DESIGN AND METHODS: Parameters measured at the end of manufacturer shelf life, as well as 6, 12, 18, and 24 months after expiry, were compared to those of freshly supplied FDP doses. RESULTS: Changes were found when comparing freshly supplied FDP to all field-stored groups in INR, PT, PTT, pH, fibrinogen, and factor VIII. A significant change was also seen in Factor XI in the 12, 18, and 24 months post-expiry samples, Factor V and R in the 24 months post-expiry samples, MA in the 12, 24 months post-expiry group, and Protein C in the 18 months post-expiry group. An increase in the residual moisture from 0.90% in freshly supplied FDP to 1.35% in 24 months post-expiry FDP.; all p < .05. No growth was found in sterility analysis. CONCLUSION: Despite uncontrolled field storage conditions, the findings demonstrate that the safety and efficacy of FDP units, stored in uncontrolled conditions are only slightly affected, even beyond their expiration date. This information allows consideration of possibly extending the shelf life.