Mizuno Mitsuru, Abe Koki, Kakimoto Takashi, Yano Keiichi, Ota Yukiko, Tomita Kengo, Kagi Naoki, Sekiya Ichiro
Center for Stem Cell and Regenerative Medicine, Tokyo Medical and Dental University (TMDU), 1-5-45, Bunkyo-ku, Yushima, Tokyo 113-8519, Japan.
Medical Environment Engineering Group, Center for Environmental Engineering, Institute of Technology, Shimizu Corporation, 3-4-17, Koto-ku, Etchūjima, Tokyo, 135-0044, Japan.
Regen Ther. 2023 Jul 18;24:211-218. doi: 10.1016/j.reth.2023.07.002. eCollection 2023 Dec.
Cell processing operators (CPOs) use a variety of disinfectants that vaporize in the workspace environment. These disinfectants can induce allergic reactions in CPOs, due to their long working hours at cell processing facilities (CPFs). Ionic substances such as CHCOO generated from peracetic acid, nitrogen oxides (NOx) and sulfur oxides (SOx) from outdoor environment are also known to pollute air. Therefore, our objective was to assess the air quality in CPFs and detect volatile organic compounds (VOCs) from disinfectants and building materials, and airborne ionic substances from outdoor air.
Sampling was conducted at three CPFs: two located in medical institutions and one located at a different institution. Air samples were collected using a flow pump. Ion chromatographic analysis of the anionic and cationic compounds was performed. For VOC analysis, a thermal desorption analyzer coupled with capillary gas chromatograph and flame ionization detector was used.
Analysis of the ionic substances showed that Cl, NOx, and SOx, which were detected in large amounts in the outdoor air, were relatively less in the CPFs. Ethanol was detected as the main component in the VOC analysis. Toluene was detected at all sampling points. As compared to the other environments, air in the incubator contained larger amounts of VOCs, that included siloxane, tetradecane, and aromatics.
No VOCs or ionic substances of immediate concern to the health of the CPOs were detected during the non-operating period. However, new clinical trials of cell products are currently underway in Japan, and a variety of new cell products are expected to be approved. With an increase in cell processing, health risks to CPOs that have not been considered previously, may become apparent. We should continue to prepare for the future expansion of the industry using a scientific approach to collect various pieces of information and make it publicly available to build a database.
细胞处理操作人员(CPO)会在工作空间环境中使用多种可挥发的消毒剂。由于他们在细胞处理设施(CPF)工作时间较长,这些消毒剂会在CPO中引发过敏反应。过氧乙酸产生的CHCOO等离子物质、室外环境中的氮氧化物(NOx)和硫氧化物(SOx)也会污染空气。因此,我们的目标是评估CPF中的空气质量,检测消毒剂和建筑材料中的挥发性有机化合物(VOC)以及室外空气中的空气传播离子物质。
在三个CPF进行采样:两个位于医疗机构,另一个位于不同机构。使用流动泵收集空气样本。对阴离子和阳离子化合物进行离子色谱分析。对于VOC分析,使用与毛细管气相色谱仪和火焰离子化检测器联用的热解吸分析仪。
离子物质分析表明,在室外空气中大量检测到的Cl、NOx和SOx在CPF中相对较少。在VOC分析中检测到乙醇是主要成分。在所有采样点都检测到了甲苯。与其他环境相比,培养箱中的空气中含有更多的VOC,包括硅氧烷、十四烷和芳烃。
在非运营期间未检测到对CPO健康有直接影响的VOC或离子物质。然而,目前日本正在进行细胞产品的新临床试验,预计将批准多种新的细胞产品。随着细胞处理量的增加,以前未考虑到的CPO健康风险可能会显现出来。我们应该继续采用科学方法为该行业未来的扩张做准备,收集各种信息并公开提供,以建立一个数据库。