Bio Products Laboratory, Elstree, UK.
J Appl Microbiol. 2014 Jun;116(6):1495-505. doi: 10.1111/jam.12487. Epub 2014 Mar 21.
To assess the different operational states within a biopharmaceutical grade clean room, using a rapid microbiological method. The method was a novel system, based on spectrometry, designed for sampling, discriminating, and enumerating airborne particles. Central to the study was the aim to determine the microbiological levels as a clean room went from standard use through maintenance and shutdown, disinfection, and then back to standard use. The objective was to evaluate whether a rapid method could replace conventional environmental monitoring using growth-based media.
The instrument evacuated was a BioVigilant IMD-A(®) System, which is a real-time and continuous monitoring technology based on optical spectroscopy that can differentiate between biological particles and inert ones (biological particles expressed as bio-counts based on the detection of microbial metabolites). The results indicated that certain activities lead to a high generation of biological particles and in showing an increase over the baseline, would be regarded as presenting a microbiological risk to the cleanroom. These activities include removing HEPA filter grilles, turning off an air handing unit, and tasks which requires an active personnel presence, such as cleaning and disinfection.
The optical instrument can be used to process sufficient information, so that clean rooms can be returned to use following a period of unexpected downtime or following maintenance without the need to wait for the results from growth-based methods. As such, this type of rapid microbiological method is worth exploring further for clean room air monitoring.
Few studies have been undertaken which examine air-monitoring devices that can both enumerate and discriminate particulates, in a volume of air as 'inert' or 'biological'. This study extends this limited field. Furthermore, the data collected in relation to cleanrooms is of interest in helping microbiologists understand that risks posed by different activities in relation to clean air-handling systems and personnel particle shedding.
使用快速微生物方法评估生物制药级洁净室中的不同运行状态。该方法是一种新颖的系统，基于光谱学，用于采样、区分和计数空气传播颗粒。研究的核心是确定洁净室从标准使用到维护和停机、消毒，然后再回到标准使用的过程中的微生物水平。目的是评估快速方法是否可以替代基于生长的传统环境监测。
所使用的仪器是 BioVigilant IMD-A(®) 系统，这是一种基于光学光谱的实时连续监测技术，可以区分生物颗粒和惰性颗粒（生物颗粒表示为基于微生物代谢物检测的生物计数）。结果表明，某些活动会导致大量生物颗粒的产生，并且如果生物计数超过基线，则会被视为对洁净室存在微生物风险。这些活动包括拆卸高效空气过滤器格栅、关闭空气处理机组以及需要人员在场的清洁和消毒等活动。
光学仪器可以处理足够的信息，因此，在意外停机或维护后，洁净室可以在无需等待基于生长的方法结果的情况下恢复使用。因此，这种快速微生物方法值得进一步探索用于洁净室空气监测。
很少有研究检查能够同时计数和区分空气中“惰性”或“生物”颗粒的空气监测设备。这项研究扩展了这一有限的领域。此外，与洁净室相关的数据对于帮助微生物学家理解不同活动对洁净空气处理系统和人员颗粒释放所构成的风险具有重要意义。
