BACKGROUND: This study evaluated the effect of routine, uncontrolled, Israeli field storage conditions on the stability and efficacy of Lyo-Plas N freeze-dried plasma (FDP). We evaluated clotting factors V, VIII, and XI; proteins S and C; fibrinogen; partial thromboplastin time (PTT); antithrombin III (ATIII); von Willebrand factor (VWF); and international normalized ratio (INR) in FDP stored at 4 C, 25 C, and 40 C for 6 and 12 months, as well as FDP returned from field units after uncontrolled storage for 15 months (manufacturer's shelf life). METHODS AND MATERIALS: After reconstitution,clotting factor levels were compared to those of freshly supplied FDP doses. ABBREVIATIONS: ALS = advanced life support; ATIII = antithrombin III; FDP = freeze-dried plasma; FFP = fresh frozen plasma; IDF = Israel Defense Forces; INR = international normalized ratio; PTT = partial thromboplastin time; VWF = von Willebrand factor.From the * Average clotting factor levels in samples that were significantly lower than those in freshly supplied FDP. ATIII = antithrombin III; FDP = freeze-dried plasma; INR = international normalized ratio; PTT = partial thromboplastin time; SE = standard error; VWF = von Willebrand factor.

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.

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Objective: To characterize the differences in stability of L-adrenaline in adrenaline ampoules from different manufacturers that are used by the Israel Defense Forces (IDF). Methods: Adrenaline ampoules from three different vendors (Products A, B and C; 52, 13, and 19 batches, respectively) were purchased by the IDF and were stored under the recommended storage conditions (room temperature) for different time periods. The content of L-adrenaline in these samples was determined using a chiral high-performance liquid chromatography (HPLC) assay with UV detection. Results: The three analyzed drug products showed very dissimilar patterns of L-adrenaline degradation. The content of L-adrenaline in Product C was variable and declined below the 85% threshold much earlier than at the end of the 24-months storage period. Products A and B had less variable content of L-adrenaline and were more stable. Conclusion: L-adrenaline is prone to degradation in solution. Its content in adrenaline ampoules from certain vendors can decline rapidly, below the stipulated threshold, and compromise their clinical effectiveness (e. g., during resuscitation). Stability of adrenaline ampoules from individual vendors should be analyzed at different storage conditions, using a chiral HPLC-based assay, to define the shelf-life period that can differ substantially between the vendors.