Preview of Standards for Cleanroom Technology

GMP News No. 155

GMP News
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 The Federal Standard 209 /1/ in its latest, the "E", version is widely known but will certainly be superseded by the ISO 14644 guideline series.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
Standards projects in process

Document no.

Short title

Status 07-01

ISO 14644-1

Classes of air cleanliness

Standard 05-99

ISO 14644-2

Specifications for testing and monitoring to prove continued compliance with ISO 14644-1

Standard 09-00

ISO 14644-3

Metrology and test methods

CD 11-98

ISO 14644-4

Design, construction and start-up of cleanrooms

Standard 04-01

ISO 14644-5

Operations

DIS 07-01

ISO 14644-6

Vocabulary

CD 06-01

ISO 14644-7

Separative enclosures (clean air hoods, gloveboxes, isolators, mini-environments)

 

DIS 02-01

ISO 14698-1

Biocontamination control: General principles and measurement of biocontamination of air, surfaces, liquids and textiles

DIS 02-99

ISO 14698-2

Evaluation and interpretation of biocontamination data

DIS 02-99

ISO 14698-3

Measurement of the efficiency of processes of cleaning and/or disinfection

DIS 02-99

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,
an advance circulation limited to the countries participating actively in ISO/TC 209

Draft International Standard DIS,
the first official circulation to all ISO and CEN nations for survey purposes (ISO and CEN enquiry)

Final Draft International Standard FDIS,
the second official circulation to all ISO and CEN nations for survey purposes (ISO and CEN voting).

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:
Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness

DIN EN ISO 14644-2:
Cleanrooms and associated controlled environments – Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1

DIN EN ISO 14644-4:
Cleanrooms and associated controlled environments – Part 4: Design, construction and start-up.

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:

  • the drafts may be purchased via the national standards associations or specialist bookshops;
  • they may be made use of as the basis for specifications as well as for agreements between planners, plant builders and service providers, on the one hand, and their customers, on the other hand;
  • they are regarded in court as state of the art.

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

Writer: 
Harald Martin,
CONCEPT HEIDELBERG

 

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