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Dear Covers,
Excuse my question but to many ISO 13485 - ISO 146444 experts may sound as elementary school one....It has been over 2 years since i was employed to a medical device company so i am a little bit rusty concerning ISO 14 644 requirements, but a colleague asked me whether it is an ISO 14 644 requirement to use SPC as a control measure for the airborne particles for any Controlled Environment areas (> class 100,000) ?
I remember that there is a requirement to conduct some kind of statistical evaluation ( i dont remember any details , please share also any of your thoughts on this subject) but i dont think that SPC was a specific requirement.
Any help would be gratefull!!
Vassilis
Excuse my question but to many ISO 13485 - ISO 146444 experts may sound as elementary school one....It has been over 2 years since i was employed to a medical device company so i am a little bit rusty concerning ISO 14 644 requirements, but a colleague asked me whether it is an ISO 14 644 requirement to use SPC as a control measure for the airborne particles for any Controlled Environment areas (> class 100,000) ?
I remember that there is a requirement to conduct some kind of statistical evaluation ( i dont remember any details , please share also any of your thoughts on this subject) but i dont think that SPC was a specific requirement.
Any help would be gratefull!!
Vassilis