Cleanroom Classification Change

#1
Hi everyone,

I need help with one thing. We recently had an audit for our cleanroom and we were claiming an ISO 7 cleanroom and average of the samples (in total) were meeting the requirement but there were a about two out of nine samples in which 1.0 micron size exceeded the requirement of ISO 7 as a result we got a major non conformity from our notified body stating that a corrective action was not taken.

My question is that can we change our claim from ISO 7 to ISO 8? The only problem is with the air changes, it is that we meet all ISO 7 requirements but is there any standard of air changes that we have to meet or not? If there is no standard then we can easily change our claim.
 
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Jen Kirley

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#2
Hello noumanumar,

Your notified body will be the correct recipient of this question. They will probably want to know why you originally specified ISO 7, and why you now believe ISO 8 will be correct.

In general, we don't loosen our control parameters because we find we are unable to meet them. The argument you present to your notified body will need to be compelling and convincingly show that the new specification would always have been the correct one, but you erred in citing a requirement that was "too tight."

I look forward to see what ofther Covers have to offer for this question.
 

monoj mon

Quite Involved in Discussions
#3
Hi everyone,

I need help with one thing. We recently had an audit for our cleanroom and we were claiming an ISO 7 cleanroom and average of the samples (in total) were meeting the requirement but there were a about two out of nine samples in which 1.0 micron size exceeded the requirement of ISO 7 as a result we got a major non conformity from our notified body stating that a corrective action was not taken.

My question is that can we change our claim from ISO 7 to ISO 8? The only problem is with the air changes, it is that we meet all ISO 7 requirements but is there any standard of air changes that we have to meet or not? If there is no standard then we can easily change our claim.
I am just wondering, didn't you have a third party to validate your cleanroom classification at the very beginning! If so then they should be able to help you out to maintain your original ISO 7 cleanroom claim.
 
#4
I am just wondering, didn't you have a third party to validate your cleanroom classification at the very beginning! If so then they should be able to help you out to maintain your original ISO 7 cleanroom claim.
Yes we did, the testing and the cleanroom manufacturing company was the same, and their reports had the slight deviations which, due to the short duration in hand, we did not notice in the reports.

So I am thinking right now is that either we get the effected areas re-tested from them and meet the requirement or we classify our cleanroom as ISO 8 rather than ISO 7.

A question is regarding the air changes. Is there any ISO classification regarding air changes that we have to meet? Or is it just the particle counts?

We have to pack medical devices in the cleanroom and we can in both, class 7 and class 8 cleanroom.
 
#5
Hello noumanumar,

Your notified body will be the correct recipient of this question. They will probably want to know why you originally specified ISO 7, and why you now believe ISO 8 will be correct.

In general, we don't loosen our control parameters because we find we are unable to meet them. The argument you present to your notified body will need to be compelling and convincingly show that the new specification would always have been the correct one, but you erred in citing a requirement that was "too tight."

I look forward to see what ofther Covers have to offer for this question.
I asked the auditor laterwards if we could change our claim and he said that if you meet the requirements then that could happen.

In our validation document ISO Class 7 is mentioned 4 times, it can be said that due to a human error instead of 8 it was written as 7 or that we can do the same work in a class 8 environment and as we meet them we would like to change our claim.
 

John Predmore

Trusted Information Resource
#6
a major non conformity from our notified body stating that a corrective action was not taken
The non-conformity, from what I read, is not that you had 2 of 9 points out of limits, but that corrective action was not taken. What does your procedure say to do when there is an indication your cleanroom is out of limits? Do you take more readings? Do you stop production? Do you start an investigation? Do you do continuous monitoring of air quality? Are there any clues in your data about when or where air quality decreases?
 
#7
The non-conformity, from what I read, is not that you had 2 of 9 points out of limits, but that corrective action was not taken. What does your procedure say to do when there is an indication your cleanroom is out of limits? Do you take more readings? Do you stop production? Do you start an investigation? Do you do continuous monitoring of air quality? Are there any clues in your data about when or where air quality decreases?
Yes that is right but this was the first time that we got the tests done for particles for the validation and we do not have an in house testing system at the moment.

Getting the tests done again and now making a corrective action would that suffice?

There’s also another thing that according to all the research that I have done there are only mentions of 0.5 microns and 5 microns and there is no mention of 1 micron, what does that mean that 1.0 micron does not matter?
 

John Predmore

Trusted Information Resource
#8
I am not currently working with a cleanroom, and I no longer have ISO 14644 to read. When I was in the cleanroom, we had ISO 5, so the requirements I remember are different from what you need. I hope someone else here jumps in to answer your specific questions.
 
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