Microbial integrity of preservative-free alfaxalone in a multiple-use system for two storage conditions and three handling techniques

Abstract OBJECTIVE To evaluate the microbial integrity of preservative-free cyclodextrin-based alfaxalone in a multiple-use system. SAMPLE 22 vials of preservative-free alfaxalone. PROCEDURES 2 storage conditions (room temperature, 22°C; refrigerated temperature, 4°C) and 3 handling techniques (closed system transfer device, nonclosed dispensing pin, and manufacturer-supplied vial stopper) comprised 6 treatment groups (3 replicates/group). An aliquot (0.5 mL) was withdrawn from each vial daily for 14 days. Samples were immediately inoculated into tryptic soy broth and incubated at 36°C for 24 hours; samples were subcultured onto 5% Columbia sheep blood agar and incubated for 48 hours. Isolated colonies were evaluated for identification. RESULTS There was no evidence of microbial contamination of vials stored for 7 days in refrigeration and handled with a protected port (closed system transfer device or nonclosed dispensing pin). CONCLUSIONS AND CLINICAL RELEVANCE The US FDA prohibits the use of alfaxalone beyond 6 hours after the vial stopper is broached (punctured), as mandated for a preservative-free injectable medication. Findings for the study reported here supported the use of alfaxalone for 7 days when refrigerated and handled with a single puncture of the stopper by use of a protected port (closed system transfer device or nonclosed dispensing pin). This would appear to be a practical alternative for an injectable anesthetic. It would minimize drug waste and the subsequent environmental impact for disposal of unused drug and allow standardization of storage and handling protocols for alfaxalone use in veterinary practices across the United States.