Old standard is still kicking — for now

06/01/2003

By HANK HOGAN

GREENSBORO, N.C.—To paraphrase Mark Twain, reports of the death of Federal Standard 209E have been greatly exaggerated.

Although the decades old cleanroom specification rode off into the sunset in late 2001, facilities are still referred to as Class 100 instead of by the equivalent ISO Class 5. The old nomenclature shows up in advertising, conversations among end users, and seminars.

It's a situation that many in the industry don't find surprising.

"I think this is probably going to be a 10-year ride before a transition is made. We are halfway there," notes Richard Matthews, chairman of Filtration Technology Inc. (based here) and chairman of the ISO Technical Committee responsible for the new standards.

That the old standard is still preferred is clear in a recent survey conducted at the CleanRooms website, www.cleanrooms.com. Visitors were asked why the global cleanrooms community still classified areas according to the retired 209E. Of those who responded, 30 percent claimed that the ISO documents for cleanroom standards, 14644, hurt the brain. A larger and perhaps more serious group, 39 percent, didn't see anything wrong with 209E. Finally, 30 percent admitted that they were too lazy to make the switch.

The last two views are ones that Lara Soltis, a product manager with Biotest Diagnostics Corp. (Denville, N.J.), can understand. Her company makes particle counters and other gear for cleanroom environmental monitoring. Soltis says that ISO Class 5 is, for all practical purposes, the same as the old Class 100. For regulated industries, such as pharmaceutical manufacturers, switching to a new standard isn't a simple matter. There are standard operating procedures that have to be updated, specifications rewritten, and training done. Such changes must all happen and be documented in a manner that satisfies regulators. Furthermore, the changes are not likely to lead to any substantial improvement in product quality or performance. So, Soltis sympathizes with those who might want to cling to a proven system instead of switching to something new.

"There's really no reason why you'd want to because it's more of a headache for you. 'I've been doing this (209E) for so long and it's worked fine, so why the heck do I have to change it?'" she explains from an end user's point of view.

This lack of a clear driver for making the change is also cited by Ken Goldstein, principal at Cleanroom Consultants, Inc. (Scottsdale, Ariz.). He, like Soltis and others, think that the semiconductor industry may adopt the new standard first. The lack of regulation is one reason. Another is the greater need for very low contamination levels demanded by semiconductor manufacturing. Such cleanliness is more suited to the ISO designation than the old specification.

Goldstein thinks that the old standby will eventually die. Like others, he thinks it may take some time. In the meantime, he doesn't see any great harm being done.

As he says, "There is not that big a difference between the two, and it just takes awhile for people to stop using one language and use another."