专家解读：实时空气监测中的BFPC应用（EU GMP Annex 1）
Expert insights on BFPCs for Real-Time Air Monitoring
欧盟GMP附录1要求A级环境在关键工艺全过程中持续进行活性空气监测，其近期修订改变了监管对实时检测的态度。本次网络研讨会将讨论生物荧光粒子计数器（BFPC）在哪些场景可简化工作流程、提升生产效率并满足当前及未来监管要求，以及需克服的挑战。议题涵盖A级环境实时监测、BFPC与传统采样结合、监管与验证及运营挑战、整合与确认及成本效益考量。
Recent regulatory changes and technological advances are leading pharmaceutical manufacturers to consider new technologies for microbial air monitoring. EU GMP Annex 1 requires continuous viable air monitoring in Grade A environments for the full duration of critical processing, and its recent revision has changed regulatory attitudes toward real-time detection. Manufacturing is evolving, too: novel biologicals are increasingly being produced with minimal operator intervention in gloved or even gloveless isolators.
These developments have catalyzed broader interest in advanced biofluorescent particle counters (BFPCs) for fluorescence-based continuous active air monitoring in real-time, available in combination with integrated traditional microbial air sampling onto plates. In this webinar, our panel of environmental monitoring specialists will discuss in which settings a BFPC can streamline workflows to boost manufacturing productivity while meeting present and future regulatory demands, and the challenges that need to be overcome.
During the webinar, you will:
- Discover real-time air monitoring in Grade A environments under the latest EU Annex 1.
- Learn how BFPCs pair with traditional sampling to enable real-time decisions.
- Understand regulatory, validation, and operational challenges.
- Explore practical options for integration, qualification, and cost/benefit considerations.
To register go to: BFPCs.
Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
来源：Pharmaceutical Microbiology Resources · pharmamicroresources.com