The standard for
cleanroom contamination control has been issued. This is titled “Cleanrooms and
associated controlled environments. Biocontamination control”.
What is EN
17141:2020 about?
This new European
standard establishes the requirements, recommendations and methodology for
microbiological contamination control in clean controlled environments. It also
sets out the requirements for establishing and demonstrating microbiological
control in clean controlled environments.
Replacing BS EN
ISO 14698-1:2003 and BS EN ISO 14698-2:2003 , this new standard provides
updated guidance and further information on best practice for establishing and
demonstrating control of airborne and surface microbiological contamination in
clean controlled environments.
The standard will
help:
- Increase the effectiveness of risk management associated with microbiological contamination
- Improve efficiency
- Develop the risk management expertise of individuals who engage with its principles
- Where applicable, provide alignment with the regulatory authority’s expectations for continued compliance and process approvals
EN 17141:2020
describes requirements for microbiological contamination control, giving
information on the qualification and verification of clean controlled
environments. It includes considerations for medical devices and food
applications.
Informative
annexes give tables of cleanliness levels for monitoring of microbiological
contamination in specific types of clean controlled environments and offer
additional guidance on the choice of environmental monitoring sampling methods;
the management and trending of collected data; and the role of alternative and
real-time microbiological detection systems.
The standard
retains and updates information relating to microbiological air sampler
verification requirements that is included, and widely referenced, in EN ISO
14698–1:2003.
EN 17141:2020 will provide users with the methodology and understanding to derive an effective formal system of microbiological control that identifies, controls and monitors microbiological contamination on an ongoing basis.
For regulated
industries, the standard provides guidance which is consistent with the
expectations of the regulatory authorities.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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