COMPARISON OF INTERNATIONAL STANDARDS

GENERAL DESCRIPTION

At international level, although all now overridden by the ISO 14644-1 standard, except for the GMP standard still used in the pharmaceutical field, the most frequently used international standards are:

  • • EU GGMP 2008
  • • VDI 2083
  • • B.S. 2295
  • • F.S. 209D/E

The purpose of the comparative table below is to compare the various standards with each other and to reduce them to the ISO 14644-1 standard. The table also indicates the functional specifications of the Clean Rooms in terms of flow type, number of air changes and percentage coverage of the elements diffused in the air compared to the total surface of the Clean Room.

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