Hall 1 Level 2, H22
EU standard on bio-contamination control
Participants will get an overview of the current standard on biocontamination control, ISO 14698:2003 and some of the limitations in its practical application. Experts from 10 European countries, working in Cleanroom Microbiology and Engineering, across many industries have been collaborating since 2016 in working group, WG-05 CEN TC243 on this important subject of biocontamination control. The result of this CEN activity is out for final ballot at present, FprEN17141, This revision adopts the principles of QRM and is written to be more usable in terms of practical applications for Pharmaceuticals, Medical Devices, Hospital and Food industries. The result of the ballot will be discussed and plans to integrate this standard within the wider ISO 14644 family of cleanroom standards.