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Updated: May 29, 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

Risk analysis approaches for microbial ingredients in microbial-based cleaning products.

Diane Boesenberg¹, Chris Brueck¹, Cindy Chhuon²

¹Exponent, Inc., Washington, District of Columbia, USA.

Risk Analysis : an Official Publication of the Society for Risk Analysis

|February 6, 2025

Summary

This summary is machine-generated.

This study outlines risk assessment methods for microbial-based cleaning products (MBCPs). It provides guidance for manufacturers and regulators to characterize, assess, and manage risks associated with microbial ingredients in MBCPs.

Keywords:

microbial cleaning products microbiological hazards product safety risk analysis

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Area of Science:

Microbiology
Risk Assessment
Product Stewardship

Background:

Microbial-based cleaning products (MBCPs) utilize viable microorganisms for cleaning and odor control.
Existing risk analysis frameworks are insufficient for MBCPs, lacking methods for microbial ingredients.
Standardized risk assessment is needed for MBCP development and regulation.

Purpose of the Study:

To provide information for developing risk assessment approaches for MBCPs.
To assist manufacturers and regulators in evaluating microbial ingredients.
To facilitate consistent risk analysis for MBCP formulations.

Main Methods:

Summarizing approaches for strain identification of microbial ingredients.
Evaluating hazards, human exposure potential, and population effects.
Recommending hazard and risk characterization strategies.

Main Results:

Proposed methods for characterizing microbial ingredients in MBCPs.
Guidance for risk managers on decision-making and communication.
Framework for assessing risks of current and future microbial ingredients.

Conclusions:

Conceptual approaches can standardize MBCP risk analysis.
Effective risk management ensures safe use of microbial ingredients.
This framework supports both current MBCPs and future innovations.