What is BS EN 17141 about?

BS EN 17141 establishes the requirements, recommendations, and methodology for microbiological contamination control in clean controlled environments.

BS EN 17141 sets out the requirements for establishing and demonstrating microbiological control in clean controlled environments.

Who is BS EN 17141:2020 for?

EN 17141 on cleanrooms biocontamination control can be adopted by individuals associated with microbiological contamination control from:

Engineering and technical support
Production
Quality assurance and control
Regulatory authority compliance functions

Industries using clean controlled environments include:

Pharmaceutical
Biopharmaceutical
Medical devices and other life science industries
Healthcare and hospitals
Food

Why should you use BS EN 17141:2020?

BS EN 17141 on cleanrooms biocontamination control will help:

Increase the effectiveness of possibility 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 approval

BS EN 17141 describes requirements for microbiological contamination control, giving information on the qualification and verification of clean controlled environments. BS EN 17141 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.

BS EN 17141 retains and updates information relating to microbiological air sampler verification requirements that are included, and widely referenced, in BS EN ISO 14698–1:2003.  

EN 17141 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.

BS EN 17141:2020

Cleanrooms and associated controlled environments. Biocontamination control

Current

Published:

31 Aug 2020