Cefiderocol For Injection: Compatibility Testing Using the MINI-BAG Plus Container System and the VIAL-MATE Adaptor.

Abstract

Background: Cost-effective and convenient modalities are required to facilitate the administration of antibiotics in hospital and outpatient settings. Objective: This study investigated the physical compatibility of the MINI-BAG Plus Container System and VIAL-MATE Adaptor with the 1 g drug product vials used for cefiderocol. Methods: Qualitative testing of the MINI-BAG Plus Container System (50 and 100 mL of 5% dextrose injection or 0.9% sodium chloride injection), using empty vials and vials containing lyophilized cefiderocol powder, was conducted in triplicate on MINI-BAGs that were hung and observed over 3 hours. Connection security between empty vials and the VIAL-MATE Adaptor was assessed in triplicate. Results: All predefined physical compatibility criteria between cefiderocol 1 g vials and the MINI-BAG Plus Container System were met, including a secure connection, successful multiple transfers of solution between vial and bag, successful reconstitution of cefiderocol, and lack of leaking into the vial or from the connections. There was no particulate matter in the prepared solution and no precipitation or discoloration. Secure connections between the VIAL-MATE Adaptor and cefiderocol vials were demonstrated. Conclusion and Relevance: Use of these systems is relevant even where resources are limited and may increase the efficiency of cefiderocol administration in hospitals, outpatient settings, or long-term healthcare facilities.