Aseptic Technique Monitoring Evaluated by Media Fill Test

The purpose of this study is to evaluate the aseptic technique of a compounding person- nel or process via media fill test, which is recommended by USP Chapter 797. The procedure of the test is designed based on the media fill test for low risk. For each set of exper- iments, five 50 ml vials each with 25 ml of TSB (Bacto TM Tryptic Soy Broth, BD) medium and three 50 ml autoclaved empty vials are used; TSB medium used for the experiment had gone through a suit- ability test for sterility and growth promotion by a department of laboratory medicine. The experi- ment is conducted at the end of the compounding task. A 60 ml Luer-Lok TM syringe is given to each compounding personnel to transfer 40 ml of the TSB medium from the given 5 vials to the 3 auto- claved empty vials, making three 40 ml vials and one 5 ml vial with TSB. The transferred media are then checked for bacteria infiltration after two weeks of incubation under 35℃. No evidence of bacteria was observed, implying that the compounding personnel had done the task with an appropriate aseptic technique. Throughout the paper, this study has significance in monitoring aseptic technique of compounding personnel via a procedure similar to the actual compounding of an intravenous injectable drug. When the suggested method is taken into a regular performance assessment drug quality and dis- pensing practice improvements are expected.