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GMP News No. 155
17 December 2001
Preview of Standards for Cleanroom Technology
In addition to the national guidelines, in Germany e.g. the VDI guideline series no. 2083, there are several internationally applicable guidelines. The Federal Standard 209 /1/ in its latest, the "E", version is widely known but will certainly be superseded by the ISO 14644 guideline series.
The first generation of the international standards for cleanroom technology will comprise a total of 10 titles. Seven of these are devoted to general cleanroom technology and three specifically to the control of biocontamination.
ISO/TC 209: Cleanrooms
and associated controlled environments
The table provides an overview and illustrates at the same time the progress of the work. The column Status 07-01 indicates the state of development of the individual documents, namely when and in what stage of maturity these were last circulated. There are three different stages of circulation, namely:
Committee Draft CD,
Draft International Standard DIS,
Final Draft International Standard FDIS,
Three documents already have the status of a definitively approved and effective standard and are also already available as a DIN standard:
DIN EN ISO 14644-1:
DIN EN ISO 14644-2:
DIN EN ISO 14644-4:
Work on a second generation of cleanroom technology standards has started. The preparation of the definitions for molecular contamination, i.e. the contamination risks emanating from gaseous foreign matter in the air, has made the greatest progress. Standards on surface cleanliness and on high-purity gases, high-purity water and other high-purity liquids are to follow.
What effects do the new international standards have on the practice of planning, construction, start-up and qualification as well as on the operation of cleanrooms? The implications are far-reaching; namely as soon as an international standard achieves DIS status or the equivalent CEN status prEN:
It is therefore recommended that these standards be given priority over national codices as well as over guidelines issued by specialist associations as soon as they achieve DIS status.
Source: Dr H. H. Schicht