Validation of the Growth Direct System for Microbial Environmental Monitoring and Define Optimal Incubation Conditions

Abstract

The validation of the Growth Direct system is described for the automated incubation and enumeration of microbial colonies on TSA LP80 and TSA LP80HT media plates. The analytical validation strategy and data generated are given to demonstrate the technology is validatable following the requirements of USP <1223> for microbial recovery. Single and serial temperature incubations were evaluated to optimize microbial detection. Data is provided to demonstrate equivalence to the current compendia test method for environmental monitoring.