Bioburden control in the manufacturing facility is a serious concern regarding biologics due to the possibility of an significant economic impact due to batch failure from a bioburden incident. As a case study on effectively establishing a microbiological environmental monitoring program for cleanrooms, we focused on Time-lapse Shadow Image Analysis as a kind of Rapid Microbiological Method. In this study, the superior rapidity and accuracy were indicated for reference strains and environmental microbial on both 90 mm plate and RODAC plate at 25–30 °C. Especially superior performance in the counting was observed for B.subtilis, P.aeruginosa and A.brasiliensis. The first and the median of colony detection speed for environmental microbial were 12 h and 26 h, respectively. The colony detection rate was 90% at 40 h incubation. Additionally, the characterization of swarming behavior was recognized based on time-lapse image acquisition data at 30 min intervals. This case study indicated that the application for environmental monitoring can contribute to reducing the bioburden excursion risk due to both the rapid detection of colonies and real-time detection for swarming behavior. TSIA would be more acceptable and easier option for biologics due to providing simple interpretations for the results and reducing the time consumption.

由于生物负荷事件导致批次失败，可能会对经济产生重大影响，因此生产设备中的生物负荷控制是生物制剂的一个严重问题。作为有效建立洁净室微生物环境监测程序的案例研究，我们将延时阴影图像分析作为一种快速微生物方法进行了研究。在这项研究中，在25–30°C的温度下，90 mm平板和RODAC平板上的参考菌株和环境微生物均具有优异的快速性和准确性。观察到在计数特别优越的性能枯草杆菌，铜绿假单胞菌和A.brasiliensis。环境微生物的菌落检测速度的第一时间和中值分别为12 h和26 h。孵育40 h时菌落检出率为90％。此外，基于以30分钟为间隔的延时图像采集数据识别了群体行为的特征。该案例研究表明，由于可以快速检测菌落和实时检测群体行为，因此环境监测的应用可以有助于降低生物负担的迁移风险。由于对结果进行简单的解释并减少了时间消耗，TSIA将是生物制剂的更可接受和更容易的选择。