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In the pharmaceutical industry, ensuring the sterility of cleanrooms is essential. Biofluorescent particle counters (BFPCs) have emerged as a successful rapid microbiological method for detecting contamination, significantly reducing production time, and financial losses. These systems leverage the innate fluorescence of biological particles, enabling real-time monitoring and immediate detection of microbial contamination. BFPCs streamline environmental monitoring processes, enhance product safety, and ensure compliance with regulatory standards. As regulatory guidelines for viable particle monitoring become more extensive, the demand for efficient, user-friendly, and cost-effective instruments increases, allowing end users to meet these requirements without extensive process changes.
Remote BAMS Overview
The Remote BAMS (BioAerosol Monitoring System), manufactured and designed by MicronView, represents the next generation of biofluorescent particle counters. This innovative device allows for maximum efficiency and ease of installation within isolator systems. It can be seamlessly integrated into existing air supply systems, eliminating the need for extensive modifications. Alternatively, a small external pump can be supplied with the device for smaller operations. MicronView’s Remote BAMS is less than half the cost of other BFPC systems, making it a relatively inexpensive solution for enhancing environmental monitoring programs. Additionally, a Remote BAMS software system is available for easy data management, or it can be integrated into existing software systems to streamline monitoring processes.
Benefits of Remote BAMS for use in Isolators:
Annex 1 Compliance:
- Continuous Monitoring: Meets the Annex 1 requirement for continuous viable particle monitoring, providing ongoing monitoring of environmental contamination levels.
- Species Identification: Incorporates a removeable gelatin filter that can be cultured if alert or action levels of fluorescent counts are reached, addressing the Annex 1 emphasis on identifying contaminating species. This gelatin filter allows for biologic sampling from the same air stream being assessed for fluorescence.
Easy Installation:
- Compact and lightweight design:The compact and lightweight design simplifies installation, making it a practical choice for both new and existing isolator systems.
- Flexible airflow options:Flexible airflow options allow the unit to be used in conjunction with an existing air supply system or with an external blower to achieve the necessary airflow, allowing for adaptability to various isolator setups.
Software Integration:
- The Remote BAMS can be supplied with a software system for streamlined data management. Alternatively, the unit can be integrated into existing software systems, ensuring seamless monitoring and reporting.
The Remote BAMS brings a new level of efficiency to rapid microbiological monitoring, particularly within isolator environments. Its compliance with regulatory standards, ease of installation, efficient design, price point, and robust software integration make it an essential tool for ensuring the sterility and safety of production processes. By integrating the Remote BAMS into your isolator systems, you can achieve continuous, reliable, viable particle monitoring, protecting your products and optimizing operational efficiency.
Source Link:www.rapidmicrobiology.com/news/remote-bams-continuous-viable-monitoring-for-isolators