EN 17141 Cleanrooms and associated controlled environments. Biocontamination control

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.

See: https://shop.bsigroup.com/ProductDetail/?pid=000000000030329442

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)