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ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Class 7 - Page 3


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cleanroom classification, cleanrooms, iso 14644 - cleanrooms and controlled environments, particle counts
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  Post Number #17  
Old 15th December 2011, 11:10 AM
Nigel D Lenegan

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

Hi,
In my view assuming your verification procedures are acceptable for ISO 8 and you dont propose to change products or processes and your people / process / product controls are robust then there should be no significant changes up-scaling to validation at ISO 7.

To reiterate my own feelings, I believe that if you dont need to be ISO 7 and not forced by internal or external quality reasons or marketing and sales reasons then keep at ISO 8 - this will enable a number of steps, energy reduction, safety margins and confindence. You up-scale to ISO 7, and your margins for comfort on unforseens reduce.

I think the industry is moving towards fit-for-purpose facility operation, and beleive you are moving in the wrong direction by going from ISO 8 to ISO 7 - unless you are forced this way by competition or customer demand - change of product etc.

Best of luck
Nigel
Thanks to Nigel D Lenegan for your informative Post and/or Attachment!

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  Post Number #18  
Old 15th December 2011, 11:20 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,011
Re: ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Clas

Hi Nigel,

I appreciate your thoughts and what you have put up is a different set of thoughts that would change the way that generally is perceived.

Yes, I believe there is a lot that could go into the Clean Rooms
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  Post Number #19  
Old 19th May 2017, 01:17 PM
patilrahuld

 
 
Total Posts: 21
Re: ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Clas

Can someone share the SOP for cleanroom certification?
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