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Regulatory Affairs Medtech
ISO 14644: cleanroom classification and monitoring changes ahead
10 January 2011
Tony Harrison

Tony Harrison explains why the key revisions in the draft of international standard ISO 14644 will affect GMP-compliant companies.

Parts 1 and 2 of the international standard for cleanrooms and associated controlled environments, ISO 14644, have undergone revision and have recently been released for public comment in draft international standard (DIS) form1,2...

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