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ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Class 7


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Some Related Topic Tags (Not all threads are Tagged)
cleanroom classification, cleanrooms, iso 14644 - cleanrooms and controlled environments, particle counts
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  Post Number #1  
Old 1st November 2011, 08:03 AM
SGquality

 
 
Total Posts: 253
Thank You! ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Class 7

I have a question on the ISO Class 7 clean rooms.

When do perform particle counts of the clean rooms, it complies as per the requirements of ISO Class 7 (10,000) consistently as defined per ISO 14644 standard.

Is this requirement okay to label the clean room as per ISO Class 7 ? My question is specifically because when we built the clean room, it was to comply per ISO Class 8 clean rooms (100,000) but since the particle counts are met per Class 7 areas, our Management label it as ISO Class 7 area.

Is this acceptable ? Or is there anything that needs to be carried out seperately per ISO Class 7 ?

Thanks in advance


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  Post Number #2  
Old 2nd November 2011, 01:39 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,197
Re: ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Clas

Quote:
In Reply to Parent Post by SGquality View Post

I have a question on the ISO Class 7 clean rooms.

When do perform particle counts of the clean rooms, it complies as per the requirements of ISO Class 7 (10,000) consistently as defined per ISO 14644 standard.

Is this requirement okay to label the clean room as per ISO Class 7 ? My question is specifically because when we built the clean room, it was to comply per ISO Class 8 clean rooms (100,000) but since the particle counts are met per Class 7 areas, our Management label it as ISO Class 7 area.

Is this acceptable ? Or is there anything that needs to be carried out separately per ISO Class 7 ?

Thanks in advance

Can someone help?

Thank you very much!!

Stijloor.
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  Post Number #3  
Old 2nd November 2011, 03:53 AM
harry

 
 
Total Posts: 6,289
Re: ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Clas

Quote:
In Reply to Parent Post by SGquality View Post

...................when we built the clean room, it was to comply per ISO Class 8 clean rooms (100,000) but since the particle counts are met per Class 7 areas, our Management label it as ISO Class 7 area. .........................
Amazing! Unless somebody replaced the filters. Otherwise, my first suspicion will be on how the particles counts were measured. Did you get an independent lab to verify it?
  Post Number #4  
Old 2nd November 2011, 04:12 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,233
Re: ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Clas

Quote:
In Reply to Parent Post by SGquality View Post

I have a question on the ISO Class 7 clean rooms.

When do perform particle counts of the clean rooms, it complies as per the requirements of ISO Class 7 (10,000) consistently as defined per ISO 14644 standard.

Is this requirement okay to label the clean room as per ISO Class 7 ? My question is specifically because when we built the clean room, it was to comply per ISO Class 8 clean rooms (100,000) but since the particle counts are met per Class 7 areas, our Management label it as ISO Class 7 area.

Is this acceptable ? Or is there anything that needs to be carried out seperately per ISO Class 7 ?

Thanks in advance

The other way could happen, but from what you say, I would take an other validation run with workload situation to reassess if indeed it meets the class 7 consistently.
To maintain class 7 the man and material control could be a lot different, and you must consider this.
If I were you, I would apply caution and wait for repeated validation over time.
  Post Number #5  
Old 2nd November 2011, 04:55 AM
Kwesifaiola

 
 
Total Posts: 4
Re: ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Clas

Hello
Thanks for provide me information about ISO standards class because this will help me.
Thanks
Regards
Kwesifaiola
  Post Number #6  
Old 3rd November 2011, 12:52 AM
SGquality

 
 
Total Posts: 253
Re: ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Clas

Quote:
In Reply to Parent Post by harry View Post

Amazing! Unless somebody replaced the filters. Otherwise, my first suspicion will be on how the particles counts were measured. Did you get an independent lab to verify it?
Yes harry - all the particulates are measured by an external laboratory and there is no doubt on measurements. In fact the limits for particulate counts are so huge that most ISO Class 8 clean rooms areas would be acceptable at the higher classification too as the particle counts are low.

Quote:
In Reply to Parent Post by somashekar View Post

The other way could happen, but from what you say, I would take an other validation run with workload situation to reassess if indeed it meets the class 7 consistently.
To maintain class 7 the man and material control could be a lot different, and you must consider this.
If I were you, I would apply caution and wait for repeated validation over time.
Thanks somashekhar. That was my precise question. What would be different in these 2 areas ?
  Post Number #7  
Old 5th November 2011, 01:19 AM
SGquality

 
 
Total Posts: 253
Question Re: ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Clas

Pls help

  Post Number #8  
Old 5th November 2011, 02:41 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,233
Re: ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Clas

Quote:
In Reply to Parent Post by SGquality View Post

Pls help

Not knowing your product that you handle in the clean room, it is not too easy to suggest. However the selction of the clean room class and the processes performed thereafter as against requirement is a matter of risk assessment and supported by valid product testing.
Calling out your clean room as Class 7 and yourself is far less important than claiming meeting or exceeding class 8 and supporting the same with periodic validation and product test reports meeting to requirements.
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