GMP NEWS 2003

The VDI1 Guideline 2083 Sheet 8 "Cleanroom Suitability of Operating Materials" describes a standardised approach that makes it possible to examine equipment with regard to all relevant contamination factors and to define its usability in cleanrooms of the different international airborne particulate cleanliness classes. Up to date, there has not been any standard or guideline worldwide including a standardised approach for evaluating the suitability of equipment for the use in cleanrooms or associated controlled environments by means of scientific methods.