Importance of ultrasonication conditions in recovery of microbial contamination from material surfaces

Abstract

The conditions of ultrasonication to recover micro‐organisms from material surfaces are not standardized and often not validated. This leads to discrepancies in experimental results which can affect the sterilization dose setting, cycle development and process validation, and can have an impact on sterilization processing economics and product sterile quality. The sample loading pattern, species of micro‐organism, materials and configurations of sample containers were examined under defined conditions. All of these were found to be important factors contributing to the efficiency of microbial recovery from material surfaces by ultrasonication. Validation of sonication conditions in routine laboratory operations is therefore important for an accurate estimate of the surface contamination to assure the medical device processing and the product sterile quality.