Unique BFPC for Real-time Viable Air Monitoring

The new EU GMP Annex 1 requires continuous environmental monitoring in production lines and validated rapid/alternative methods (RMM) are supposed to be a good option. However, the continuity of microbial measurements when transitioning from the traditional method to RMM has raised many questions. Here, we present a new and unique instrument for continuous monitoring, also known as a bio-fluorescent particle counter (BFPC), which combines real-time air microbial monitoring and the traditional growth-based method of agar sampling in a single device. It has three essential features to comply with regulations: 1) viable particle counting, 2) total particle counting, and 3) long-period of aseptic sampling on traditional agar medium for microbial identification, placed outside of clean area and reducing the risk of contamination. The real-time technology employs multi-angle scattered light pattern analysis and fluorescence spectra measurement resolved over 16 channels for real-time total and viable particle counting. The presentation will cover the method's validation approach and implementation in aseptic filling. We will explain the methodology for validating our BFPC that users can perform in-house. Finally, we will present the results of primary validation: excellent and consistent results for real-time viable counting compared to established growth-based method.