IES Progresses on ISO Cleanroom Standards
By John Haystead
Anaheim, CA–Three of seven ISO Technical Committee Working Groups met in Anaheim, CA last month during the IES`s annual technical meeting and exhibition to continue work on a package of international standards for “Cleanrooms and Associated Controlled Environments” (ISO/TC209). The IES was appointed in 1993 as the ISO Secretariat organization responsible for this activity by the American National Standards Institute (ANSI). According to Richard Matthews of Filtration Technology, Inc. and Chairman of ISO Technical Committee 209, when completed, “the standards will basically encompass the `how-to`s` of designing, building and living in a cleanroom environment.”
At one of the three meetings, Working Group One (WG01) reviewed a working-draft document on “Classifications of Air Cleanliness.” The group had previously circulated this document to industry for comments, and their feedback is now being incorporated into a revised version. Plans call for the modified document to be presented at the next ISO/TC209 technical committee meeting being held this month in London, England. If accepted by the committee, the draft standard will be circulated to all of the participating nations for comment and then for a final acceptance vote. The full process could be completed by early 1996.
Working Group 3 (WG03) on “Metrology and Test Methods” also met to review a list of the various tests and test methods for maintaining the integrity of a clean environment, such as how to test a HEPA filter, measure air flow, etc. Ultimately, the group will compile their lists into a standard set of tests and procedures. The WG03 group will meet next at the ISO/TC209 meeting in Milan, Italy in March of `96.
Meeting formally for the first time, the Working Group on “Cleanroom Operations” standards (WG05) established preliminary parameters and agenda items for their group`s area. WG05 will also have their next meeting in Milan.
The Standing Committee of the International Confederation of Contamination Control Societies (ICCCS) also convened a meeting in Anaheim. Ac-
cording to Matthews, most of these discussions were also centered around the efforts of the ISO body. “The committee attempted to use the ICCCS group as a preliminary international sounding board to informally and non-politically hash out and identify some of the technical issues on the table.” In fact, many of the ICCCS standing committee members are also delegates to various ISO working groups.
There are two levels of participation defined for the ISO standard development process. Sixteen “participating,” or P-Nations, have actual voting authority on the standards, but another group, or “observer” nations, can provide comments on the documents. At the working group level, each P-Nation is entitled to send two delegates to each panel, but in reality, only 8 to 12 are usually represented on any one group. There is, however, a minimum requirement for at least five nations to be represented.
The other four TC209 working groups are: WG02 dealing with Biocontamination standards and scheduled to meet in Washington, D.C. in September; WG04 on Cleanroom Design and Construction which met in Berlin, Germany in February and will meet again in London in July; WG06 on Terms, Definitions and Units, which will first meet formally next spring; and WG07 on Clean Air Devices which had its initial meeting in Geneva in early April and will also meet in Washington in September.
According to Matthews, there are no major roadblocks ahead for any of the standards processes, but there is one area of concern. This is the entire area of biocontamination and how this should be handled in light of its close scrutiny and monitoring by various government regulatory agencies. “When we get into these regulatory issues, things get more stringent, and go beyond the scope of TC209,” says Matthews. He points out that, whereas in many countries, the national standards organization is also a government agency, this is not the case in the United States.
Matthews is certain, however, that the standards put in place by the ISO/TC209 Committee will ultimately have a very definite economic impact on the cleanrooms industry as well as on the industries that rely on contamination control technology. “The standards are partially designed to reduce trade barriers and to create a level playing field. Anybody building a cleanroom anywhere in the world will be working from the same common denominator and the same set of parameters. This should open up the international market for users as well as suppliers, since products manufactured in ISO-approved facilities will be marketable anywhere in the world.”
ISO cleanroom standards will have a particularly strong and immediate impact in Europe. Through the mandated process set up by the 19 European Community participants in the Council of European Nations (CEN), each individual nation`s own standards must be replaced by a common European CEN standard. And, since as a result of the “Vienna agreement,” ISO standards can be adopted in place of CEN standards, a decision which has already been made in the case of cleanrooms standards (CEN TC243), ISO standards will therefore be mandatory for European nations.
Although ISO standards will in principle be voluntary in the United States, if a regulatory agency such as the FDA steps in, that could also change. The FDA is already intimately involved with U.S. Technical Support Activity Groups (TAGs) and has delegates on many IES working groups.
According to Matthews, the overall target of ISO/TC209 is to have at least portions of the standard published by October, 1996. The first meeting of IES TC209 was held in Chicago in September of 1993, and although the average ISO standard takes roughly 84 months to complete, the committee felt they could shorten this time considerably to 36 months because of the level of desire and incentive expressed by both the cleanroom user and supplier communities.n