Open AccessThe environmental risk assessment of cell-processing facilities for cell therapy in a Japanese academic institution
Author(s) -
Mitsuru Mizuno,
Kentaro Endo,
Harutaka Katano,
Ayako Tsuji,
Naomi Kojima,
Ken Watanabe,
Norio Shimizu,
Tomohiro Morio,
Ichiro Sekiya
Publication year - 2020
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0236600
Subject(s) - humidity , microorganism , toxicology , psocoptera , biology , environmental science , ecology , bacteria , geography , meteorology , genetics
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.