I have a question regarding a zone concept for a production room that is currently ISO 9 but has a few ares (over equipment) with ISO 8 status that are separated by a displacement airflow over 0.2 m/s.
I want to replace ISO 9 by CNC (controlled not classified) as the only reason why we have ISO 9 is that there is ISO 8 in the same room. ISO 8 is verified annually.
My question: Does the existence of the ISO 8 zone necessarely require that there is ISO 9 around?
Or can I also ensure the ISO 8 requirements with my CNC zone that fullfills ISO 9 requirements but does not need the annual verification as ISO 9?
I cannot find a clear regulatory statement regarding the transition from ISO 8 to ISO 9 or controlled environment.
Can anyone help me out?