Antimicrobial Effectiveness Testing: A Case Study in Finding the Right Balance

Antimicrobial effectiveness testing (AET) is used to confirm that preservative included in a formulation or diluent is effective at inhibiting growth of microorganisms, and AET is a requirement for multi-use drug products. This talk summarizes basic concepts of AET and discusses when testing is necessary. A case study is presented that highlights the need to understand AET variability and its relationship to preservative concentration during early development of a multi-dose program.