Publish Time: 2025-10-09 Origin: Site
This technical report presents the validation of an external gelatin filter used with the MicronView Remote BAMS (BioAerosol Monitoring System). The objective is to demonstrate reliable culture-based recovery (CFU/m³) when the Remote BAMS is operated with an external gelatin filter under conditions representative of pharmaceutical isolators and cleanrooms. The Remote BAMS integrates biofluorescent particle counting (BFPC) with conventional particle monitoring while the external gelatin filter enables downstream culture and organism identification from the same airflow path.
Two studies were executed to reflect typical deployment scenarios:
- Gelatin Filter Stability (Time-Based):
Evaluates CFU recovery after a defined sampling duration to confirm that the gelatin filter preserves viability over the intended operating window.
- Tubing Configuration (Installation Geometry):
Evaluates CFU recovery across representative tubing layouts (varying length, number of bends, and bend angle) to confirm that common routing choices do not introduce meaningful bias.
The series of validation studies presented in this technical report collectively demonstrate the robustness and practicality of the Remote BAMS with an external gelatin filter.
Reliable Performance: Testing confirmed that prolonged sampling and various tubing configurations do not compromise microbial recovery (CFU/m³).
Installation Flexibility: The system delivers consistent data integrity even with extended tubing lengths and bends, allowing for adaptable installation in isolators and cleanrooms.
Annex 1 Compliance: The solution successfully combines continuous, real-time biofluorescent particle counting with a practical, culture-based confirmation path, supporting rapid investigation and regulatory compliance.