In November 2007, the ISO TC/209 working group decided to revise the current version of the ISO 14698 norm (Cleanrooms and associated controlled environments – Biocontamination Control). This decision came from scientific and industrial communities willing to integrate innovations from the last decade and to make the content of this text easier to implement in a cleanroom’s routine activities.

Cleanroom installation and monitoring have indeed become an important issue not only in pharmaceutical, cosmetic, and food industries, but also in healthcare establishments and biotech, since product batch contamination and/or a human contamination can have huge financial or sanitation consequences.

Biological contamination control of these environments (water, surface, and air), especially air quality control, are now necessary to master and guarantee production processes and quality control but also to insure staff safety.

Specific texts give recommendations — especially for aerobiocontamination — and methods to implement the monitoring and to classify the cleanroom according to an acceptable level of inert and biological contamination.

ISO 14698 NORM
Beyond the ISO 14644 norm (Cleanrooms and associated controlled environments) which describes the airborne contamination control, the ISO 14698 norm deals specifically with the microbiological contaminants and how to manage an efficient control plan. It explains the general principles and global methodology to evaluate and monitor the aerobiocontamination control in such “mastered” environments. It also specifies the required methods to guarantee a coherent monitoring of the critical areas, and to apply the right preventive and corrective actions in case of contamination.