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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