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cleanroom validation

mattie11 at ix.netcom.com mattie11 at ix.netcom.com
Wed Jun 11 22:17:24 EST 1997


In article <5nktmq$dkg$1 at news9.gte.net>,
  max at gte.net wrote:
>
> Microjz wrote:
> >
> > does anyone know the frequencies for monitoring a cleanroom in the medical
> > device industry.  This cleanroom will be used to make devices which will
> > be sterilized via gamma.  The cleanroom is class 100,000.  I need info on
> > viable and nonviable monitoring.
>
> The pharmaceutical company I worked for did their monitoring in the
> cleanrooms weekly. Try the US Pharmacopiea and the CFRs for
> pharmaceutical companies.
> Cynthia

The USP doesn't currently address environmental monitoring.  Depending on
the type of device manufactured will help determine the fequency. 
Typically clean rooms are class 100.  A industry standard for a class
100,000 controlled area is once per week for both viable and none viable.
TR-

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