Clean Room Validation and Certification Methods and Definitions

N

Neverclue

#1
My company has a clean room that we currently classify as a class 100,000. We are moving to a new facility and building a much larger one, and I need some help with a few things.

My question involves the concepts of certification and validation. I have read through the ISO standard on clean rooms, and while it is helpful in defining which characteristics to monitor, it does not say much (that I saw, I may have missed something) to define what certifying or validating actually means.

I assume that it is permissible to do both internally (I say both even though there is nothing anywhere to suggest to me that the terms "certification" and "validation" are not used interchangeably), given that the protocols consider the necessary data (temp, pressure, particle count, etc.), and that proving out that the room in an operational state is capable of exhibiting results that fall under the minimum requirements specified in the standard.

In short, I want to have documentation to prove that our clean room achieves whatever level our customer requires, but I need some guidance toward my options for accomplishing that.

I appreciate any help I can get!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
My company has a clean room that we currently classify as a class 100,000. We are moving to a new facility and building a much larger one, and I need some help with a few things.

My question involves the concepts of certification and validation. I have read through the ISO standard on clean rooms, and while it is helpful in defining which characteristics to monitor, it does not say much (that I saw, I may have missed something) to define what certifying or validating actually means.

I assume that it is permissible to do both internally (I say both even though there is nothing anywhere to suggest to me that the terms "certification" and "validation" are not used interchangeably), given that the protocols consider the necessary data (temp, pressure, particle count, etc.), and that proving out that the room in an operational state is capable of exhibiting results that fall under the minimum requirements specified in the standard.

In short, I want to have documentation to prove that our clean room achieves whatever level our customer requires, but I need some guidance toward my options for accomplishing that.

I appreciate any help I can get!
Doesn't ISO 14644 series provide the answers?...

Maybe have a go at some of the other standards mentioned here (I have no affiliation with the publisher):

http://www.gelaire.com.au/files/documents/BulletinISOcleanroomclassifications.pdf

Cheers,
Ronen.
 

Ajit Basrur

Staff member
Admin
#3
My company has a clean room that we currently classify as a class 100,000. We are moving to a new facility and building a much larger one, and I need some help with a few things.

My question involves the concepts of certification and validation. I have read through the ISO standard on clean rooms, and while it is helpful in defining which characteristics to monitor, it does not say much (that I saw, I may have missed something) to define what certifying or validating actually means.

I assume that it is permissible to do both internally (I say both even though there is nothing anywhere to suggest to me that the terms "certification" and "validation" are not used interchangeably), given that the protocols consider the necessary data (temp, pressure, particle count, etc.), and that proving out that the room in an operational state is capable of exhibiting results that fall under the minimum requirements specified in the standard.

In short, I want to have documentation to prove that our clean room achieves whatever level our customer requires, but I need some guidance toward my options for accomplishing that.

I appreciate any help I can get!
Welcome to the Cove :bigwave:

I agree with Ronen ... ISO 14644 will have all your questions answered. If there are more questions, pls come back :)
 
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