Cleanroom Certification Duration

T

tebusse

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Hi everyone,

The medical device company for which I work recently moved into a facility that had an established cleanroom. The cleanrooms were annually certified by a 3rd party to meet ISO 6, ISO 7, and ISO 8 standards. Currently, my company only requires the EM to meet ISO 8.

Since the cleanroom has been certified within the past year, do we have to re-qualify the cleanroom if we are able to produce a copy of the certificate?

I'm currently working on creating the environmental monitoring procedure and associated forms, so I'm also wondering about the number of points/areas within one room must the sampling take place (I believe this is based on square footage).

If it helps, we are only sampling non-viable airborne particles and pressure differentials.

Any assistance would be most helpful.

Tonia
 
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