What are air changes are required for ISO Class 8 Clean Room?

[SGquality]

We manufacture medical devices in an ISO Class 8 cleanroom - all along we had specified min 20 air changes per hour. There is no customer requirement for us and we had kept at min 20 based on the industry practice.

Is there any FDA, ISO or any other regulations which mention the minimum air changes per hour ?

Appreciate a prompt response.

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[Ninja]

I am not familiar with any FDA requirements, I do not work in that industry.

For automotive, aerospace and medical, the requirement is on cleanroom air quality as measured...regardless of how it is achieved.

Various techniques include air velocity, air changes, gowning, behavior and processes enclosed, lab practice, misting, local exhausts, etc.

I have never been dinged on any of the above...the air particulate is measured and the number is either "in" or "out"...end of story.

Again, I do not know if this same approach is valid for FDA or not.