Microbiology-PTM-OMA_Modules_1-5

Matrix Study Designs – Recent Trends

• FDA and USDA will accept studies done according to ISO 16140‐2 if  BAM (FDA) and MLG (USDA) reference methods are used. • Validation of Environmental Surfaces • Comparison to FDA BAM method • For single surface claims, test with and without background organism present. • 12” x 12” surface claims – comparison is to 4” x 4” for the reference method  with the same number of organisms applied, but in 9‐fold larger volume for  12” x 12” (analogous to validating a composite test portion). • New proposal under consideration to add sanitizer to the environmental  surface evaluation scheme.