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Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
Airborne particle monitoring in clean room environments for stem cell cultures
Fernando Cobo1, David Grela, Angel Concha
1Stem Cell Bank of Andalucía (Spanish Central Node), Hospital Universitario Virgen de las Nieves, Granada, Spain. fernando.cobo.sspa@juntadeandalucia.es
Abstract:
Modern high-technology industrial practices like pharmaceutical and stem cell line production demand high-quality environmental conditions to avoid particle contamination in the final product. Particles are important because their presence can affect both the output and the productivity and because they can have repercussion on human health. In this kind of production practice it is necessary to implement optimal methods for particle management and to introduce an environmental monitoring program. This should also address the regional regulatory requirements and will depend on local conditions in each processing center. Each center must evaluate its specific needs and establish appropriate monitoring procedures.

