This report presents the abridged validation results of the MicronView BAMS (BioAerosol Monitoring System), a device for real-time environmental microbial monitoring. The validation process is critical to demonstrate the reliability of BAMS as an alternative microbiological method, ensuring it meets rigorous industry standards for accuracy and performance.
The BAMS uses advanced laser-induced fluorescence technology to detect viable airborne particles by exciting metabolic compounds, such as NADH and riboflavin, with a 405 nm laser. This produces fluorescence directly related to the number of biological particles in the air, enabling real-time monitoring and trend analysis. In parallel, BAMS employs Mie scattering to measure particle size distribution and total airborne particles, providing comprehensive viable and non-viable environmental data.
To validate the BAMS as a rapid microbial detection method (RMM), the study followed the guidelines of USP <1223> and EP 5.1.6, using the Andersen six-stage sampler (referred to throughout this report as Andersen) as the reference instrument. Key validation parameters assessed include:
| - Accuracy - | - Precision - |
| - Linearity - | - Specificity - |
| - Limit of Detection - | - Limit of Quantification - |
| - Range - | - Ruggedness - |
| - Robustness - | - Equivalency - |
This report highlights the results and significance of these tests, demonstrating BAMS's capabilities as a reliable and efficient tool for microbiological quality control.
MicronView BAMS Validation Report Summary - 2024.pdf