Bob Mielke was the Institutes technical vice president of the Contamination Control Division,

Bob Mielke was the Institute`s technical vice president of the Contamination Control Division, completing a two-year term just ended on July 1. A senior metrology engineer for Abbot Laboratories, he`s been involved in the Institute`s standards and practices program since its inception in 1982. He was the chairman of Standards and Practices for the Contamination Control Division from 1987 to 1995 and is also the secretary for ISO TC209, the International Organization for Standardization`s Technical Committee for establishing global cleanroom standards.

Q:How did the original cleanroom standards evolve?

A:The original standards were written starting in the late 1950s by corporations. Corporation A might be a contractor for three different corporations, each one having their own cleanroom, or “white room” specifications. They would have to try and conform to all three standards, and that wasn`t good. So, the Air Force came out with a standard in 1961 — U.S. Air Force TO00-25-203. Soon thereafter, in January, 1962, the first laminar-flow cleanroom was announced by Sandia National Labs. Soon thereafter, the GSA (General Services Administration) contracted with Sandia to write a federal standard on cleanrooms, Fed-Std-209. That first one was put together roughly in about a year or a year and a half.

Fed-Std-209 was a pretty comprehensive standard that set up classes plus testing methods in the appendices. Then a number of military and NASA standards came out about that same time. It was pretty active between 1962 and 1968. Then the standards activity went into a lull. A2C2 wrote about five recommended practices that were published as tentative Recommended Practices, but that`s about the time that A2C2 kind of faltered. Then the Institute of Environmental Sciences came on the scene and Bob Peck took the initiative putting standards back on the front burner. He and Gabe Danch (former president of IES) contacted the GSA and told them that Federal Standard 209 was somewhat outdated. They got permission from GSA to redo it, and with that, the Recommended Practice Program on the contamination control side of the Institute took hold. The whole program took off then, including the rewrite of 209, and by that time there was version A and B. The first version the Institute of Environmental Sciences gave to GSA was Version C, which was published by GSA on October 27, 1987. Soon thereafter, it was discovered that there were numerous errors in the document, and revision D was published on June 15, 1988. Subsequent to that, the Institute of Environmental Sciences went through Federal Standard 209D and issued another version that GSA published on September 11, 1992 — today`s Federal Standard 209E.

Q: What is happening with European standards?

A: At the beginning of the 1990s, the European Union decided that all European nations would have to conform to one standard — be it toasters, refrigerators, or cleanrooms. The European Committee of Normalization Technical Committee 243: CEN/TC243 was formed. Although other countries had standards that were similar to Federal Standard 209, they were not exactly like it. So it became the de facto standard. We realized in the U.S. that it only made sense to get an international standard together. So the U.S., through the Institute of Environmental Sciences, made the effort to establish an ISO Technical Committee. Otherwise, probably what would have happened was that we would have had a U.S. standard, a European standard, and a Japanese standard, and they`d all be different, and we`d all be having this constant battle. However, that`s when the ISO activity began. The Institute of Environmental Sciences petitioned ANSI, which then petitioned ISO, and it was put to a ballot. Thirty nations responded and twenty-nine voted in favor of the ISO proposal to establish the ISO committee. Nine nations offered to become participating members.

ISO designated a technical committee on cleanrooms (TC209) — a total coincidence in the numbering between that and Federal Standard 209. The first meeting was held in Chicago in November 1993, and there have been five subsequent meetings so far of ISO Technical Committee 209. To date, ISO has seven working groups encompassing the following topics: airborne contamination, biocontamination, metrology, design, operations, glossary, and minienvironments.


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