Synthetic Microbial Surrogates Consisting of Lipid Nanoparticles Encapsulating DNA for the Validation of Surface Disinfection Procedures

[Image: see text] Effective cleaning and disinfection procedures are an integral part of good manufacturing practice and in maintaining hygiene standards in health-care facilities. In this study, a method to validate such cleaning and disinfection procedures of surfaces was established employing lipid nanoparticles (LNPs) encapsulating DNA. It was possible to determine and distinguish between the physical cleaning effect (dilution) and the chemical cleaning effect (disintegration) on the LNPs during the cleaning and disinfection procedure (wiping). After treatment with 70 v % ethanol as a disinfectant and SDS solution as a cleaning agent, LNPs showed log(10) reductions of 4.5 and 4.0, respectively. These values are similar to the log(10) reductions exhibited by common bacteria, such as Escherichia coli and Serratia marcescens. Therefore, LNPs pose as useful tools for cleaning validation with advantages over the already existing tools and enable a separate detection of dilution and chemical disinfectant action.