Fed-Std-209 shelved, ISO reigns

Mark A. DeSorbo

Federal Standard 209, a benchmark the contamination control industry lived and died by for more than 40 years, has been officially cancelled, paving the way for worldwide harmonization promised by new cleanroom protocols from the International Organization for Standardization (ISO).

The cancellation comes less than a year after the Institute of Environmental Sciences and Technology (IEST; Mount Prospect, IL) submitted a request to the U.S. General Services Administration (GSA) to retire the federal standard and eliminate a potential economic disadvantage the United States would have had for maintaining one cleanroom standard too many.

“It was an American document, and that was the problem,” says Al Lieberman, a member of the ISO/TC 209 committee and one of the original authors for Fed-Std 209. “If it is a document from another country, people will be unhappy with it.”

Long time coming
The IEST, the secretariat for ISO/TC 209, was first asked by the U.S. Technical Advisory Group to initiate the replacement of 209 with the ISO 14644 standard in October 1999. In January 2000, the IEST submitted a formal request to the GSA to retire the standard, and the GSA officially did so late last November.

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“We've been waiting for this for a long time.” —Richard Matthews

“We've been waiting for this for a long time and it finally happened,” says Richard Matthews, chairman of the ISO Technical Committee, ISO/TC209, which continues to fine-tune the eight-part ISO-14644-cleanroom standard. “This is really significant because a lot of people don't realize this is happening.”

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“Fed-std 209 has served the United States and the world well.” —Robert Mielke, secretary of ISO/TC 209

The last revision of the federal standard, 209E, was published in 1992. Aside from it being a potential economic setback, it has long been targeted for cancellation in order to elevate cleanroom qualifications that are spelled out in ISO 14644-1: Classification of air cleanliness and ISO 14644-2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1.

“I don't think [the ISO standards] will make a whole lot of difference, because the cleanrooms classes under 14644 are very similar to those of 209,” Lieberman says.

However, he adds, the 14644 standard offers a wider range of guidance to previously unanswered questions about reclassifying a cleanroom and the procedures to verifying cleanroom cleanliness.

“Fed-Std 209 has served the United States and the world well,” says Robert Mielke, secretary of ISO/TC 209. “The whole idea was to get everybody working with one standard, so that there wasn't three of four standards to deal with. Fed-Std 209 was the world standard de facto, and that is demonstrated by the fact that most companies around the world were using it.”

Mielke, who was involved in latter 209 publications, adds that although it sometimes seems to take a very long time for documents to get published, or in the case of 209, withdrawn, GSA was always made sure “the Is were dotted and the Ts were crossed.”

“The GSA and the IEST have a great relationship,” he adds.

Now that the decision to retire 209 is official, CleanRooms will exclusively use the ISO 14644 classifications and cease the use of the Fed-Std-209 nomenclature. That means the magazine will no longer refer to an ISO classified cleanroom with the 209E classification (starting with the February issue).

14644 ball in FDA court
From a pharmaceutical standpoint, Matthews warns that the U.S. Food and Drug Administration (FDA) will now have to take a position on the ISO 14644 cleanroom standard.

An FDA official who spoke with CleanRooms on the condition of anonymity says the ISO 14644 is a good reference, but it cannot be considered official guidance for drugs and biologics.

“A company may meet the criteria of 209E or ISO 14644, but that doesn't mean they are complying with current Good Manufacturing Practices (cGMPs),” he adds. “Neither standard suits all processes, and some processes are more microbiologically at risk.”

The FDA official further contends that ISO documents are often written to meet multi-constituent industries, and often the result is “the dilution of standards to the lowest common denominator.”

“I would use it as one of the baseline documents. There are guidelines available from the FDA,” the FDA official adds. “ISO standards are not official FDA guides.”

ISO/TC 209, however, is evaluating particle size ranges, which will most likely be extended to the nanometer, Lieberman says.

“Right now it's 0.1 micrometers, which was basically in standard 209E and other cleanroom standards,” he says. “The product dimensions keep dropping, so it's not a matter of wanting to, they need to. They want to make sure that the filters in the cleanroom remove particles.”


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