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.

在制药行业中，确保洁净室的无菌性至关重要。生物荧光颗粒计数器（BFPCs）已成为一种成功的快速微生物检测方法，其大大减少了生产时间和经济损失。这类系统利用生物颗粒的固有荧光特性，实现微生物污染的实时监测和即时检测。BFPCs简化了环境监测流程，提高了产品安全性，并确保符合法规/标准的要求。随着对可存活颗粒物监测的法规变得更加严格，对高效、用户友好且具有成本效益的这类仪器的需求也在增加，从而使终端用户无需进行大量的工艺变更即可满足这些法规的要求。

在线式BAMS 概述

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.

由MicronView设计和制造的在线式BAMS（浮游菌实时监测仪）代表了新一代的生物荧光颗粒计数器。这款具有创新性的设备能够在隔离器系统内实现简便安装和效率最大化。它可以无缝集成到现有的空气供应系统中，并且无需进行大规模的改动。对于小范围的操作，设备还可以配备一个小型外置泵。MicronView在线式BAMS的价格不到其他BFPC系统的一半，是提升环境监测计划的一种相对经济的解决方案。此外，在线式BAMS还可配备软件系统，便于数据管理，也可以集成到用户现有的软件系统中，以简化监测流程。

在线式BAMS在隔离器中的应用优势：

EU GMP 附录1的合规性

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.

连续监测：

满足附录1关于连续监测可存活颗粒物的要求，提供对环境污染水平的连续监测。

污染物种类识别：

内置可移除的凝胶滤膜，当荧光计数达到报警水平或行动限时，可以培养该滤膜，从而应对附录1中对污染物种识别的重点要求。该凝胶滤膜允许从正在进行荧光检测的同一气流中进行微生物采样。

简便安装 

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.

紧凑轻巧的设计：

简化了安装过程，使其成为新建和现有隔离器系统的实用选择。

灵活的气流选项：

允许该设备与现有的空气供应系统配合使用，或使用外部动力单元以达到所需气流，从而适应各种隔离器设置的需求。

软件集成

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.

在线式BAMS可以配备软件系统，以简化数据管理。或者，该系统可以集成到用户现有的软件系统中，确保监测和报告的无缝衔接。

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.

在线式BAMS提高了快速微生物监测的效率，尤其体现在隔离器环境中的应用。其符合法规要求、易于安装、高效的设计、合理的价格以及强大的软件集成功能，使其成为确保生产过程无菌性和安全性的关键工具。通过将在线式BAMS集成到您的隔离器系统中，您可以实现连续、可靠的可存活颗粒物监测，从而保护您的产品并优化运行效率。

原文链接：www.rapidmicrobiology.com/news/remote-bams-continuous-viable-monitoring-for-isolators