The effect of storage at 4°C on canine‐specific albumin on product sterility and albumin concentration

Objectives To determine if lyophilized canine‐specific albumin (CSA) can be stored beyond the manufacturer recommended 6 hours post‐reconstitution without significant concern for bacterial growth. Design Laboratory research. Setting Large private teaching hospital. Interventions Six bottles of lyophilized CSA were retrieved from a medical grade (4°C) refrigerator and were reconstituted with 0.9% NaCl to a 5% solution. Time to complete dissolution of all bottles at room temperature without agitation was recorded in minutes. A 1.5‐mL sample was collected from each bottle at the following time points: time 0 (at the time of complete dissolution), and then 6, 12, and 24 hours after removal from 4°C. Each aliquot was inoculated into a blood culture tube and was immediately submitted for aerobic and anaerobic bacterial culture. A positive and negative control were cultured at the 24‐hour time point. At each time point, an additional 0.5‐mL aliquot from each albumin bottle was collected, and these were combined to determine the average albumin concentration (g/L, g/dL) as measured by an in‐house analyzer. The albumin was stored at 4°C between sample collection. Measurements and Main Results The reconstitution of CSA and storage at 4°C for up to 24 hours did not result in anaerobic or aerobic bacterial growth in any of the 24 cultured samples. Storage did not have a clinically significant effect on the albumin concentration of the solution. The average albumin concentration of all samples was 42 g/L (4.2 g/dL). No growth was noted in the negative control, and the positive control grew 4 strains of bacteria. Conclusions It appears safe to use lyophilized CSA up to 24 hours post‐reconstitution without significant risk of bacterial growth or change in albumin concentration.