by Richard A. Matthews
It is with mixed emotions that I write this column. I have been personally involved with US Federal Standard 209 for over 20 years and I was a member of the Institute of Environmental Sciences & Technology (IEST) Working Group 50 that wrote Federal Standard 209C, then 209D and eventually 209E. As you know, Federal Standard 209E was officially retired by the US Government on November 29, 2001. This was done at the IESTs suggestion, so that incarnation of 209 is, in fact, dead.
I have also been involved with the work of the International Standards Organization (ISO) Technical Committee charged with writing global cleanroom standards. This activity started in 1993, again at the instigation of the IEST. Coincidentally, this ISO Technical Committee was assigned the next sequential ISO number, which was ISO/TC209. So that is the 209 for which we now celebrate long life.
ISO/TC209 is working on a comprehensive package of ten global cleanroom standards, three of which (ISO 14644-1, ISO 14644-2 and ISO 14644-4) have been published (see CleanRooms, December 2001). Five more of these are expected to become formal ISO Standards this year and the final two in early 2003.
With news circulated, the question remains: What does the demise of Federal Standard 209E mean to the US cleanroom business?
There are two opposing answers: 1) Probably nothing. 2) It's the beginning of significant change.
The answer applicable to you depends upon your point of view, your industry and your involvement.
Federal Standard 209E has been formally replaced by ISO 14644-1 and 14644-2. These two ISO Standards specify classes of air cleanliness, specify which tests are required to prove compliance with these classes of air cleanliness and specify how often these tests must be conducted.
Basically, the quality of air in a cleanroom or clean zone has not changed. What has changed is the measuring system. FS209E had metric measurements but they were rarely used in favor of the easier-to-understand English measuring system. The English measurement system of particles per cubic foot has been completely replaced by the metric system of particles per cubic meter. ISO Standards use only the metric system.
If you understand the metric system, ISO will be easy for you. If you don't, you will have a learning curve to overcome. Some of you will remember when automobiles were sold only by number of cylinders, then by horsepower, then by cubic inches, then by liters, and then back to horsepower or some combination of the above. Remember though, that all of today's automotive parts, even the cup holder, are measured by the metric system.
Your best bet is to buy a copy of ISO 14644-1 and ISO 14644-2 so you can become intimately familiar with their content, just like you are now with the defunct US FS209E. There are mandatory criteria in each with which you must become familiar and with which you must comply from this time forward. Educate yourself now.
Copies of the ISO Cleanroom Standards are available for a nominal fee from the Institute of Environmental Sciences & Technology, 940 East Northwest Highway, Mt. Prospect, IL, Ph: (847) 255-1561, Fax: (847) 255-1699, or e-mail [email protected].
There is, however, one additional reality yet to be defined. That is the position of the US Food & Drug Administration (FDA).
The FDA has been involved with creating the new ISO Cleanroom Standards since 1993. Personnel from the FDA have been delegates to ISO/TC209 Working Groups, as well as delegates to the US Technical Advisory Group (TAG) to ISO/TC209. The US TAG is responsible for instructing the US delegates on how to vote on proposed ISO cleanroom standards; and the FDA, along with every other US Government agency, was given an opportunity to comment on the recommendation to cancel US FS209E and replace it with ISO 14644-1 and ISO 14644-2.
To my knowledge no comments were offered.
The pharmaceutical, medical device and biotech industries regulated by the FDA are deserving of a position paper stating the FDA's position in comparison with using these new ISO Cleanroom Standards.
This should be done post-haste. It will alleviate potential confusion in the healthcare industry.
In retrospect, the US should be proud of the integral role it has played in the cleanroom business. The laminar flow concept was developed at the Sandia Labs in Albuquerque, New Mexico, and the cleanroom business continued to evolve in the US. Our technologies have been adopted and copied by industrialized countries all over the world.
The end of FS209E is the end of an era, the end of an icon. Yet it portends the beginning of a new, broader, more mature era. For many of us, terms such as Class 100 and Class 10,000 are indelibly imprinted on our minds and in our speech. It will be hard to change and adjust to new terminology. How many of you today remember when cleanrooms used to be called “white rooms” and “gray rooms?” Twenty years from now who will recognize Class 100 and Class 10,000?
I personally expect FS209E will go quietly. There will be an orderly transition to the new ISO/TC209 generated cleanroom standards.
“209 is dead. Long live 209.”
Richard A. Matthews is founder of Filtration Technology Inc. (Greensboro, NC) and president of Micron Video International. He is chairman of the International Organization for Standardization Technical Committee ISO/TC209 “Cleanrooms and associated clean environments,” and past president of the Institute of Environmental Sciences and Technology. He is on the CleanRooms Editorial Advisory Board.
“Unfiltered” has quickly become one of CleanRooms' most popular monthly features. In an effort to give our readers more voice, I'd like to put the direction of this column in your hands for 2002. What issues would you like to see explained, argued or demystified? Drop me a line at [email protected].