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11th February 2025 Content supplied by: MicronView Ltd
Real-Time Viable Monitoring for Isolators with Remote BAMS
Biofluorescent particle counters (BFPCs) offer a faster, more efficient approach to viable particle monitoring. Instead of relying on culture-based methods that take days, BFPCs detect intrinsic fluorescence in biological particles. When airborne microbes pass through the instrument’s laser, naturally occurring fluorophores like NADH and riboflavin absorb the energy and emit fluorescence, signaling the presence of viable particles. This happens in real time, eliminating delays and allowing for immediate contamination response and better process control.
MicronView’s Remote BAMS (BioAerosol Monitoring System) is built around this technology to provide continuous viable particle monitoring in isolators and cleanrooms. The Remote BAMS monitors continuously, delivering real-time data without disrupting aseptic workflows, so manufacturers can catch contamination risks as they happen and respond quickly to maintain sterility and compliance with Annex 1.
A Smarter Alternative to Culture-based Sampling Methods
Traditional viable particle monitoring methods have inherent drawbacks:
- Settle plates passively collect airborne microbes over long periods but do not provide quantifiable real-time data and are highly dependent on air movement and positioning.
- Active air samplers, while more controlled, provide only snapshot data at periodic intervals, increasing the likelihood of missing contamination events between samples.
The Remote BAMS eliminates these gaps by continuously monitoring viable particles in the air with no reliance on passive collection or manual sampling intervals. This real-time capability improves contamination detection, reduces intervention delays, and enhances contamination control.
Built-In Gelatin Filter for Species Identification
While BFPCs provide immediate viable particle detection, microbial identification remains a requirement in regulated environments. The Remote BAMS includes a built-in gelatin filter, allowing users to perform microbial culturing and identification when action or alert levels are exceeded. This ensures compliance with Annex 1’s emphasis on understanding contamination sources while maintaining the efficiency of real-time monitoring.
Validated for Confidence
The Remote BAMS has been fully validated according to USP <1223> / Ph. Eur. 5.1.6, confirming its accuracy as a rapid microbiological method. Additionally, MicronView has conducted extensive internal validation of the gelatin filter, ensuring reliable microbial collection for culturing. These validations provide confidence that Remote BAMS delivers accurate, actionable contamination monitoring.
Why Remote BAMS?
- Real-Time Viable Monitoring: Continuous detection of airborne microbes, eliminating the blind spots of settle plates and active air samplers.
- Gelatin Filter for Species Identification: Enables microbial culturing when contamination thresholds are exceeded.
- Regulatory Compliance: Validated through USP <1223> / Ph. Eur. 5.1.6 and additional internal testing.
- Seamless Installation: Compact and lightweight, it integrates easily into isolators and cleanroom environments.
- Improved Process Understanding: Generates more consistent contamination data, supporting root cause analysis and regulatory reporting.
- Flexible Data Management: Works with MicronView’s monitoring software or existing facility systems.
Whether replacing traditional microbiological sampling or integrating it into an existing monitoring program, MicronView’s Remote BAMS delivers the immediate, actionable data needed to maintain sterility and meet regulatory requirements in isolator-based manufacturing.
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Date Published: 11th February 2025
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