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

Abstract

To determine if lyophilized canine-specific albumin (CSA) can be stored beyond the manufacturer recommended 6hours post-reconstitution without significant concern for bacterial growth. Laboratory research. Large private teaching hospital. 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 24hours 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. The reconstitution of CSA and storage at 4°C for up to 24hours 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 42g/L (4.2g/dL). No growth was noted in the negative control, and the positive control grew 4 strains of bacteria. It appears safe to use lyophilized CSA up to 24hours post-reconstitution without significant risk of bacterial growth or change in albumin concentration.