ISO 14644 Airborne Particle Count Testing Requirements

mpfizer

Involved In Discussions
#1
Hi,

We recently had a NB audit and were told that as per the latest version of ISO 14644 we are supposed to get this airborne particle count test done everytime for At rest AND in operation condition. we were doing only for in operation condition. The NB has recorded a NC for this.

Are both test required ? or any one could do ?

Views and comments are welcome ....

Thanks

michelle
 

Ninja

Looking for Reality
Trusted
#2
The NC should state the clause violated...where that requirement is...

What clause was referenced?...I'm not seeing it in there...
 

optomist1

A Sea of Statistics
Trusted
#3
Has ISO 14644 totally replaced the previously used Class 10/100/10000 for clean rooms? If so does anyone have a copy of the ISO spec? I checked the attachments section and came up short.

Thank You....
 

Ninja

Looking for Reality
Trusted
#4
Has ISO 14644 totally replaced the previously used Class 10/100/10000 for clean rooms? If so does anyone have a copy of the ISO spec? I checked the attachments section and came up short.
Not that I'm aware of...it's all up to whether you want a cert, or a different cert...

I continue to notice a distinct migration from the old 1K, 10K, 100K terminology toward ISO6, ISO7, ISO8...
but as far as I can tell it is in words only, the support data is still in cubic feet, not cubic meter...

You can buy the standard for a couple hundred bucks...I'm not aware of anywhere free.

HTH
 

AgnieszkaSz

Involved In Discussions
#7
"For processes that inherently produce particles as part of the process and where these particles are not a threat to the process or products, it may be appropriate to rely on periodic at-rest classification, or operational classification of simulated operations, rather than monitoring of airborne particles in operations. Other performance and cleanliness attributes may still be required to be monitored".

This is quotation from ISO 14644-2 - perhaps it is the case for your process? Still, I don't see any requirement here ("may be appropriate").
 

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