Review: Antimicrobial efficacy validation using in vitro and in vivo testing methods.

Pre-clinical antimicrobial validation testing for single and combination products, and parameters that should be considered when testing the antimicrobial performance of a medical device, are discussed. Guidance is provided on key elements required for in vitro and in vivo antimicrobial validation, including validation of microbial growth, microbial recovery, neutralization, and antimicrobial activity. An important consideration, both in terms of practicality and economics, is designing in vitro studies that bridge to in vivo testing: A representative in vitro model is used to generate data on many clinically relevant microorganisms, and then one microorganism is selected for use in in vivo testing. If the in vivo results correlate to the in vitro results, it can reasonably be extrapolated that the same would be true for the remaining microorganisms tested in vitro. Thus, the selection of relevant in vitro models for testing is critical for successful antimicrobial validation testing.