This Recommended Practice (RP), IEST-RP-CC023.3, provides guidelines for the control and quantitative measurement of viable contamination in the air and on surfaces in environments that require control of such contamination. This includes areas designated as aseptic and those considered non-sterile. The procedures and techniques employed to achieve the desired level of microbial control are dependent on the level of bioburden that can be tolerated. This RP presents an introduction to the currently accepted methods for bioburden control and environmental monitoring as well as the devices available for the quantification of airborne and surface viable contamination.
This document also describes disinfectants, their lethality spectrum, and techniques for their application.
IN THE 2025 REVISION
This document provides insight into the management of bacteria, fungi, and other types of viable particles in the cleanroom. While there are other documents with a similar focus that are published by other organizations (e.g. PDA, USP), this document is targeted for use by anyone who may operate a cleanroom that is not subject to regulation by a government agency.
This document was updated to include:
- Recent standards and reference articles that address microorganisms in controlled environments.
- Recent developments and additions to disinfection regimens and products that are available to control microbes.
- Explanation of the current methods for sterilization of products.
First printing, March 2025 (Supersedes previous versions, including IEST-RP-CC023.1 and IEST-RP-CC023.2)
Microorganisms in Cleanrooms was prepared by Working Group 023 of the IEST Contamination Control Division (WG-CC023).
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