As Annex 1 of the EU GMP Guide refers to the ISO Standard 14644, this standard is very important for the GMP Community. As already mentioned in the GMP News from 17. November 2010, a revision of this standard is awaited. The Draft to comment has been now issued by the ISO Committee.
Concerning the contents, there have been no major changes from our pre-press release of November. The most essential changes still concern the deletion of the requirements on 5 µm particles in ISO class 5 (respectively clean room class B at rest) and the implementation of a table to fix the minimum number of measuring points. This reveals to be noticeable for very large clean rooms. Yet, regarding the requirements on the maximum number of particles for clean rooms in pharmaceutical industry, Annex 1 of the EU GMP Guidance is still applicable. To measure macro particles (bigger than 5 µm), the standard refers to the Institute of Environmental Sciences and Technology's document IEST-G-CC1003.
You can find part 2 of the draft document at www.scribd.com.
Dr Robert Eicher