Eaton T, Wardle C, Whyte W
Sterile Manufacturing Specialist, AstraZeneca, Macclesfield, UK.
PDA J Pharm Sci Technol. 2014 Mar-Apr;68(2):172-84. doi: 10.5731/pdajpst.2014.00952.
A sampler that detects and counts viable particles in the air of cleanrooms in real-time was studied. It was found that when the sampler was used to monitor airborne particles dispersed from a number of materials used in cleanrooms, including garments, gloves, and skin, the number of viable particles dispersed from these materials was greater than anticipated. It was concluded that a substantial proportion of these viables were of a non-microbiological origin. When the sampler was used to monitor a non-unidirectional airflow cleanroom occupied by personnel wearing cleanroom garments, it was found that the airborne viable concentrations were unrealistically high and variable in comparison to microbe-carrying particles simultaneously measured with efficient microbial air samplers. These results confirmed previously reported ones obtained from a different real-time sampler. When the real-time sampler was used in a workstation within the same cleanroom, the recorded viables gave results that suggest that the sampler may provide an effective airborne monitoring method, but more investigations are required.
The airborne concentrations measured by a real-time microbial air sampler within an operational, non-unidirectional airflow cleanroom were found to be unrealistically high due to a substantial numbers of particles of non-microbiological origin. These particles, which resulted in false-positive microbial counts, were found to be associated with a number of materials used in cleanrooms. When the sampler was used within a cleanroom workstation, the counts appeared to be more realistic and suggest that this type of real-time airborne microbial counter may provide a useful monitoring method in such workstations, but further investigations are required.
研究了一种可实时检测和计数洁净室内空气中有活力颗粒的采样器。结果发现,当使用该采样器监测洁净室内多种材料(包括工作服、手套和皮肤)散发的空气传播颗粒时,这些材料散发的有活力颗粒数量比预期的要多。得出的结论是,这些有活力颗粒中有很大一部分并非微生物来源。当使用该采样器监测由穿着洁净室工作服的人员占用的非单向气流洁净室时,发现与同时使用高效微生物空气采样器测量的携带微生物颗粒相比,空气中有活力颗粒的浓度高得离谱且变化不定。这些结果证实了先前从另一种实时采样器获得的报告结果。当在同一洁净室内的工作站中使用该实时采样器时,记录的有活力颗粒结果表明该采样器可能提供一种有效的空气监测方法,但还需要更多的研究。
在一个运行中的非单向气流洁净室内,通过实时微生物空气采样器测量的空气传播浓度被发现由于大量非微生物来源的颗粒而高得离谱。这些导致微生物计数出现假阳性的颗粒与洁净室内使用的多种材料有关。当在洁净室工作站内使用该采样器时,计数似乎更符合实际情况,这表明这种类型的实时空气微生物计数器可能在此类工作站中提供一种有用的监测方法,但还需要进一步的研究。