Alternative Environmental Monitoring Plate Evaluation

This white paper presents a study conducted by Rapid Micro Biosystems in collaboration with Rutgers University, evaluating the effectiveness of the Growth Direct® System EM application as an alternative to traditional 90mm settle plates for passive air sampling. The study addresses the limitations of conventional methods, particularly the manual incubation of 90mm agar plates, which can delay product release timelines in high-throughput environments. The research focuses on the performance of the 55mm Growth Direct® EM cassettes compared to the traditional plates, particularly in terms of microbial recovery rates. The experimental design involved testing with Staphylococcus epidermidis as the challenge microorganism, assessing the recovery rates and statistical equivalency between the two methods. Results indicated that using two Growth Direct® System EM cassettes met the acceptance criteria for equivalency, while the single cassette configuration did not. The findings suggest potential improvements in efficiency for environmental monitoring in pharmaceutical settings.