ISO releases final draft of separative devices standard

By Mark A. DeSorbo

ROLLING MEADOWS, Ill.—When the ISO Technical Committee 209, ISO/TC 209, sat down to hammer out a draft standard on separative devices, the members—some from the semiconductor side and some from the life science side—immediately concluded that their needs were unique.

“After the third meeting, they determined that we had a common denominator,” says Richard Matthews, committee chairman and a member of the CleanRooms Editorial Advisory Board.

That common denominator is spelled out in the ISO's final draft international standard 14644-7, “Cleanrooms and associated controlled environments—Part 7: Separative devices (clean air hoods, gloveboxes, isolators and minienvironments)”.

In developing this groundbreaking standard, the ISO/TC 209 Working Group considered the needs of various industries and introduced the term “separative devices” to encompass the wide continuum of configurations from open unrestricted air overspill to wholly contained systems. Working group members represent ten member countries: Belgium, Finland, Germany, Italy, Japan, Korea, Russia, Switzerland, the United Kingdom, and the United States.

The result of their effort is “an overarching, unifying document for all industries using separative devices,” says David Ensor, the committee's U.S. convener. “A common set of terminology resulting from this effort will greatly improve communications within the industry.”

Common terms-of-trade, such as clean air hoods, gloveboxes, isolators, and minienvironments, have different meanings depending on the industry. That part of the ISO 14644 series provides a generic overview and specifies the minimum requirements for the design, construction, installation, testing, and approval of separative devices ranging from open to closed systems.

Annex A presents a nomenclature of separation approaches to describe various configurations. Annex D provides examples of transfer devices by configuration. Other Annexes cover systems for air handling and gas, access devices, and leak detection and testing.

“It's one of the best documents we have produced,” says Matthews, chief executive officer of Filtration Technology Inc. (Greensboro, N.C.) “It's the one that has the most original content. We established a separation continuum concept, and this didn't exist before. This takes you from as plain Jane as an air curtain to a welded stainless steel box.”

Matthews refers to separative devices as cleanrooms without people, with a separate set of issues.

“Some of the ramifications are: how to use the isolator, 'what makes it different than a cleanroom and how do you clean it?',” he adds. “How you test it and how you make sure the cleaning materials are not causing further contamination of the process—all of these issues are covered in this document.”

And that is great news, says Bill Mangan, business development manager for Premier Technology Inc., a Pocatello, Idaho-based design, build and engineering firm. “Anytime that an industry can help formalize and come up with some definitive requirements, it's good for the industry,” says Mangan, a member of the American Glovebox Society.

The hazards and the exposure rates may vary from industry to industry, as does the application, but the similarities make for a comprehensive standard that all industries need and can embrace.

“In the pharmaceutical and semiconductor industries, it's protect the product, protect the worker and complete the process,” Mangan says. “In nuclear, it's was protect the process, but with some nuclear processes, it will directly mirror the pharmaceutical and semiconductor industries.”

ISO/FDIS 14644-7 may be used as a trade reference per agreement between a customer and supplier. The document is in balloting by voting nations, and if approved will be issued as a formal ISO standard later this year.

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