Industry weighs proposed global cleanrooms standards against Fed-Std-209E

By John Haystead

This is part two of a two-part series.

As announced last month, Technical Committee 209 of the International Organization for Standards (ISO/ TC209) is close to completing its work on a new set of international cleanroom standards. The importance of the activity was clearly demonstrated by the record attendance and interest level generated by the ISO/TC-209 conference session at CleanRooms East `98 last month in Baltimore. Last month`s article described the organizations and procedures involved with adopting the new standard. This month`s installment looks at the standard itself.

For users and manufacturers alike, the overriding question is what, if anything, will be the differences between the existing Fed-Std-209E and the proposed ISO/ TC209 standards. The short answer is metric measurement. According to Richard Matthews, technical committee chairman of ISO/TC209 Working Group 1, the difference in particle count ceilings between the two standards is infinitesimal, but as opposed to FS209E, which references both the English (cubic feet) and metric (cubic meters) systems for the same air measurement, both ISO 14644-1 and ISO 14644-2 documents (Cleanroom Testing for Compliance) are based exclusively on metric measurements.

Another change with the ISO/TC209 standards is a broader segmentation of cleanroom classification levels. ISO 14644-1 classification levels are based on a specific formula incorporating parameters such as allowable count-levels of specific-size particles. As a result, users will be able to define their own cleanroom performance parameters, generating new classification levels that fall between those established by Fed-Std-209E (i.e., ISO Class 4.5 would fall between Fed-Std-209E Class 10 and 100.)

According to Scott Mackler, general sales and marketing manager at Clestra Cleanrooms (N. Syracuse, NY), the minimal difference in particle counts between ISO/TC209 and Fed-Std-209E for a given class is a factor in favor of the new standard, as well as the fact that “the ISO classifications also force both contracting parties to specify not only the particle counts of interest, but also the specific particle size as well as the environment status at the time of measurement such as `as-built,` `at-rest` or `operational`. “

What`s in it for industry?

According to Matthews, the new ISO standards will have a very positive impact on the cleanroom industry. “ISO/TC209 will change the way the cleanroom industry thinks,” he says, “giving it a single universal language for companies to do business across national boundaries.”

The international factor may in fact play a role in the General Services Administration`s (GSA, Fort Worth, TX) decision. Says Mackler, “though the ISO document carries no legal status in the U.S. today, I expect to see its usage increase leading the GSA to `sunset` 209E over the next few years in the interest of international harmonization.”

Others are not quite as optimistic about the benefits of the new standards. Says John Nappi, Jr., president of Liberty Industries Inc. (East Berlin, CT), “I`m concerned whether the ISO/TC209 standards will improve the situation or worsen it.” From Nappi`s point of view, cleanrooms standards took a step backward with the latest version of Fed-Std-209. “When the IEST (Institute of Environmental Sciences and Technology) and GSA came out with version E of FS209, they took something that was very straightforward and made it both more complicated and less definitive. I would certainly hope that the ISO standard will be easier to interpret with clarifications on a number of issues.”

Bob Mielke, secretary to ISO/TC209 and previous chairman of the IEST`s Standards & Practices Committee, acknowledges that these are legitimate concerns for users, pointing out that a great deal of attention has been given to preventing and removing any ambiguities in the ISO documents. In particular, because the document is written in the mandatory ISO format, its annexes are divided between “normative” (integral parts of the body of the document) and “informative” (information-only) sections, a structure aimed at providing as much explanation as possible to users. In addition, Mielke points out that “in the case of ISO, users will have only one standard to contend with as opposed to multiple national standards.”

How will the regulatory agencies respond?

Regardless of the official status of ISO/TC209 relative to Fed-Std-209E, individual user-industry regulatory agencies will still play a large role in how universally the standards are actually implemented. Observes Matthews, “although the GSA decision should influence what the regulatory agencies do, history has shown this has not always been the case. Even today, for example, many in the FDA still insist on citing FS209B, a standard which has been superseded twice.”

Nappi agrees with this assessment. “The extent to which the new standard will be actually implemented is the overriding question. With the confusion surrounding 209E many people just go their own way; in many cases, simply referencing FS209 generically to avoid the confusion between the versions.”

The central message according to Matthews, however, is that the ISO standards are a reality today and the bottom line is that it will be no more difficult to build to an ISO standard than to Fed-Std-209E. “The standards documents that will be approved this year aren`t going to change significantly from their current form and astute people are going to start building to and promoting their adherence to ISO standards today. Once the ISO documents are in the marketplace, it will become increasingly difficult to justify maintaining a separate federal standard.”