New ISO/TC 209 document outlines master plan for cleanroom construction
By Tammy Wright
Geneva — After almost four years of hammering out the fundamental elements of clean installations, the International Organization for Standardization Technical Committee, ISO/TC 209, has released a draft international standard that has the capability to serve as a master blueprint for building controlled facilities worldwide.
ISO/DIS 14644-4, Cleanrooms and associated controlled environments – Part 4, is a non-industry-specific document outlining the requirements for the design, construction, start-up and qualification of cleanrooms and clean air devices.
“14644-4 is a generic guideline that covers a broad package of things to be concerned about (when creating cleanroom facilities),” explains ISO/TC 209 Chairman Richard Matthews. “It`s different from previously published documents 14644-1 and 14644-2, which replaced Federal Standard 209. This new document is really global in nature and provides an opportunity to put in place a truly international standard.”
ISO/DIS 14644-4 is the product of ISO/TC 209 Working Group 4, which used two guidelines, the Institute of Envi ronmental Sciences and Technology`s Recommended Practice-12 and CEN 243, as a starting point for negotiations. It is divided into normative and informative sections and, according to Philip Naughton, an American delegate to WG-4 and the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) representative of the U.S. Technical Advisory Group, its substance was contributed primarily by North Americans and Europeans.
“Seven nations mainly worked on the document,” Naughton says, citing “the Americans, Brits, French, Germans, Australians, Japanese, Swedes, and occasionally the Russians and Italians,” as key players in its formulation.
Naughton, an engineering project manager for new construction at Motorola Inc. (Austin, TX), believes the draft standard reflects a balance between the delegates who wanted more specific regulations and those who wanted good content with built-in “freedom” or flexibility that would allow people to actually use the document.
Their give-and-take approach yielded normative or mandatory sections that discuss scope; terms and definitions; planning and design procedures; construction and start-up requirements; testing and approval; and documentation, including maintenance and training records. Also outlined is a range of specifications to be agreed upon between the purchaser and supplier, such as general purpose of the proposed cleanroom, cleanliness class, critical environmental parameters, contamination control concepts and desired occupancy states under which required conditions must be met.
The informative or voluntary annexes provide users with illustrations and suggested concepts for building and maintaining operational clean installations. For example, Annex A discusses the segregation of contamination control zones and airflow patterns, with graphics detailing various configurations. The most important part of this section, Naughton contends, is a comprehensive specification checklist in Annex H, which was compiled by Americans with the help of a series of outside experts.
“We put a lot of thought into the checklist — it`s all-encompassing. An inexperienced person could look at it and see all the parts and pieces that go into a cleanroom,” he explains.
What the document does not do, ISO/TC 209 officials say, is prescribe definitive technological or contractual means to meet requirements. Guidelines concerning specific cleanroom applications, fire regulations and process-driven safety issues are dictated by applicable national and local codes.
ISO/DIS 14644-4 will remain in the draft stage for the next five months, during which time ISO nations can vote on it and suggest changes. After that, it enters into a final 60-day stage where it is either voted down or adopted as a formal standard. ISO/TC 209 officials are confident that the document will be finalized in its current form.
“I feel good about it. The working group came up with a pretty strong, comprehensive document that should be easily accepted by the cleanroom communities,” says Matthews.