February 2021 is the date by when the 34 CEN nations (primarily Europe and Turkey) have to implement EN 17141:2020 as a national standard. This new Cleanrooms and associated controlled environments – Biocontamination control standard, sets expectations for risk assessment, viable contamination control, viable monitoring methodology and monitoring frequency.
The new standard applies to pharmaceutical, medical device, hospital/healthcare and food cleanrooms. EN 17141:2020 covering microbiological contamination sits nicely alongside the ISO 14644 series that relates to cleanroom non-viable contamination monitoring and classification.
