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Changes To GMP Force Cleanroom Re-Classifications

2016-03-04 12:44:01| oilandgasonline Downloads

According to both USA cGMP and EU GMP cleanroom classification should be carried out according to ISO 14644-1. The 19994 version of this ISO standard has been re-written by a group of international subject matter experts and ISO 14644-1:2015 was published on December 15, 2015. ISO 14644-1:2015 contains substantial revisions impacting both the way the cleanrooms are classified and the performance requirements of the air particle counting instruments used to carry out the classification.

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