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Related Experiment Video

Updated: May 30, 2025

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

Changeover method for biosafety cabinets using ozone gas.

Mitsuru Mizuno¹, Daisuke Suda², Chima Matsumura²

¹Center for Stem Cell and Regenerative Medicine, Institute of Science Tokyo, Bunkyo-ku, Tokyo, Japan.

|January 28, 2025

Summary

Ozone generators in biosafety cabinets effectively reduce bacteria, including resistant endospores and endotoxins. This technology enhances aseptic environments for cell product manufacturing, ensuring safer and reproducible production changeovers.

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Area of Science:

Microbiology
Biotechnology
Environmental Science

Background:

Maintaining aseptic conditions is critical in cell product manufacturing due to the inability to sterilize living cell products.
Raw materials from human tissues often harbor bacteria, necessitating effective environmental decontamination between production batches.
Conventional cleaning methods struggle against highly resistant contaminants like bacterial endospores and endotoxins.

Purpose of the Study:

To evaluate the efficacy of a biosafety cabinet equipped with an ozone generator for environmental decontamination.
To assess the device's effectiveness against challenging microorganisms including endotoxins, endospores, and fungi.
To determine the potential of ozone treatment for simplifying production changeovers in cell manufacturing.

Main Methods:

The study utilized a biosafety cabinet with an integrated ozone generator.
Specific bacterial strains were tested: Pseudomonas aeruginosa (endotoxin producer), Bacillus subtilis (endospore-former), and Aspergillus brasiliensis (spore-forming fungus).
Colony-forming units (CFUs) and endotoxin levels were measured post-ozone exposure compared to a control group.

Main Results:

Ozone treatment significantly reduced Pseudomonas aeruginosa CFUs and endotoxin levels.
A marked decrease in Bacillus subtilis endospore and Aspergillus brasiliensis spore formation was observed.
The ozone generator demonstrated effectiveness against disinfectant-resistant bacteria, endospores, and endotoxins.

Conclusions:

The ozone-generating biosafety cabinet shows significant potential for bacterial control in Grade A environments.
The device offers a simplified, reproducible method for decontamination, potentially reducing operator stress.
Further validation is needed, but the technology could enhance safety in cell product manufacturing.