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 Cleanroom standard and associated controlled environments – Biocontamination control standard, sets expectations for risk assessment, viable contamination control, viable monitoring methodology and monitoring frequency.
The new cleanroom 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.
What is a cleanroom?
A cleanroom is a controlled environment where pollutants like dust, airborne microbes, aerosol particles and chemical vapours are kept at specific levels to minimize contamination. These environments are used in industries such as pharmaceuticals, biotech, medical device and life sciences where small particles can adversely affect manufacturing processes.
In a cleanroom, the concentration of airborne particles is controlled to specified limits. To achieve this, the air in a cleanroom is repeatedly filtered through High Efficiency Particulate Air (HEPA) or Ultra Low Particulate Air (ULPA) filters to remove internally generated contaminants.
Cleanrooms are classified based on the cleanliness level of the air inside them. This classification is determined by the number and size of particles permitted per volume of air. For example, no more than 100 particles (0.5 microns or larger) per cubic foot of air.
Associated controlled environments are areas adjacent to or within the cleanroom that also have controlled levels of contamination. These areas may include gowning rooms, pass-throughs, and material airlocks. They play a crucial role in preventing the ingress of contamination into the cleanroom.
The new Biocontamination control standard sets expectations for risk assessment, viable contamination control, viable monitoring methodology and monitoring frequency in these controlled environments. It aims to ensure that cleanrooms and their associated controlled environments maintain the necessary cleanliness levels to prevent product contamination, thereby ensuring quality and safety.