The environmental risk assessment of cell-processing facilities for cell therapy in a Japanese academic institution
The environmental risk assessment of cell-processing facilities for cell therapy in a Japanese academic institution
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DOI：
10.1371/journal.pone.0236600
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发表时间：
2020-08-05
期刊：
影响因子：
3.7
通讯作者：
Sekiya, Ichiro
中科院分区：
文献类型：
--
作者：
Mizuno, Mitsuru;Endo, Kentaro;Sekiya, Ichiro
细胞疗法是一种很有前途的治疗方法。细胞处理产品的一个关键方面是确保细胞处理设施（cpf）的无菌性。本研究的目的是评估CPFs内部和外部的环境风险因素。在一年多的时间里，我们每月监测CPF内部和周围的温度、湿度、颗粒数、微生物、细菌、真菌和有害昆虫的菌落数。CPF内的温度是恒定的，但湿度随外界湿度的变化而波动。粒子数与进入房间的人数相关。除冬季外，根据房间的清洁度，检测到微生物和有害昆虫的菌落。经PCR鉴定出7种细菌和2种真菌。鞘翅目和蜱螨各占捕获昆虫总数的41%。这些结果为采取适当步骤保持整个cpf清洁提供了有用的数据。
Cell therapy is a promising treatment. One of the key aspects of cell processing products is ensuring sterility of cell-processing facilities (CPFs). The objective of this study was to assess the environmental risk factors inside and outside CPFs. We monitored the temperature, humidity, particle number, colony number of microorganisms, bacteria, fungi, and harmful insects in and around our CPF monthly over one year. The temperature in the CPF was constant but the humidity fluctuated depending on the humidity outside. The particle number correlated with the number of entries to the room. Except for winter, colonies of microorganisms and harmful insects were detected depending on the cleanliness of the room. Seven bacterial and two fungal species were identified by PCR analyses. Psocoptera and Acari each accounted for 41% of the total trapped insects. These results provide useful data for taking the appropriate steps to keep entire CPFs clean.