Standards issues dominant on ICCCS/IEST agenda
By George D. Miller
Phoenix — Among the headliners from the recently concluded joint gathering of the International Confederation of Contamination Control Societies (ICCCS) and the Institute of Environmental Sciences and Technology (IEST) is — not surprisingly — international standards for contamination control.
In spite of its painstaking and slow-moving reputation (cynics compare the standards-development process to the paint-drying process), the standards sessions were a big draw at this year`s conference. According to IEST President John Goodman, who is also vice president of engineering at Fluoroware Inc. (Chaska, MN), some ISO standards sessions were getting double the usual attendance. In fact, an ISO overview session chaired by Åke L. Möller, president of Cogito Consult AB (Ängelholm, Sweden), was presented to an international standing-room-only crowd that exceeded 100.
Among the standards-related developments from the gathering, which was the 44th annual technical meeting and exhibition for the IEST and the 14th international symposium on contamination control for the ICCCS jointly conducted in Phoenix in late April, were development of a working group on molecular contamination and a working group name change. Presenters also took pains to point out the imminent arrival and impact of global cleanrooms standards.
“Molecular contamination is an emerging and complicated subject,” says Martin Reeves, chairman of ISO/TC209 Working Group 1 on class ifications of air cleanliness and cleanroom testing. “At the ISO/TC209 meeting here, we discussed the proposition of molecular contamination as a standard. It was unanimously decided that a document was required, and the scope was agreed. Working Group 8 [on molecular contamination] was then delegated to the United Kingdom as convenor.” Reeves, of MC Air Filtration (Kent, UK), is also chairman of European cleanroom committee CEN TC243, which is now working in parallel with ISO/TC209.
“Major semiconductor chip manufacturers are more and more interested in molecular contamination,” says William Bowers, president of Femtometrics Inc. (Irvine, CA). “It seemed to start when semiconductor line widths got to 0.25 micron, and I haven`t seen a dropoff since.” Bowers was one of four presenters in a session on molecular contamination. Femtometrics provides cleanroom monitors, process gas analyzers, solvent NVR analyzers and contract services for molecular contamination issues.
Molecular contamination is an issue that affects all industries that use contamination control technology, which explains the unanimous agreement that a standards document was required. Finding the common denominators of contamination control issues among the various industries is an important function of the standards-development process, according to Richard Matthews, a technical committeee chairman and president of Filtration Technology Inc. (Greensboro, NC). Along these lines, Matthews explains that the name of Working Group 7 was changed during the meeting to “Enhanced clean devices” from its earlier designation, “Minienvironments and isolators.” “This is evidence of the spread of contamination control technology across industries,” says Matthews. “Minienvironment,” he ex plains, is a term from the electronics industry. “Process isolator” is a term from the pharmaceutical industry. “Yet both refer to a clean area in which a process is going on, but people are outside of the clean space,” says Matthews. He adds that the previous nomenclature for the working group was simply “too restrictive.”
Regarding standards updates, both Matthews and Dr. Hans Schicht, a contamination control consultant from Zumikon, Switzerland, presented papers in the ISO overview session. Conference attendees were in agreement concerning the need for international standards on contamination control. Deborah A. Leonard, vice president of sales and marketing at Micronova Manufacturing Inc. (Torrance, CA), a supplier of cleanroom cleaning products, says that “ISO standardization is a godsend to us. Federal Standard 209 was too prone to inter pretation.” She explains that there are country-to-country issues as well as industry-to-industry issues. “Only in the past three years have they focused on biotechnology,” says Leonard. “The concerns are different in biotech than they are in the traditional industries for contamination control.”
Schicht agrees: “International standardization is a coming topic. The markets are global. Common rules are the best thing that can happen.” Schicht, as the Swiss delegate to ISO/TC209 and secretary of the Swiss contamination control society, relates that the classification standard, which is in the final draft international standard (FDIS) stage [see related articles, page 1, CleanRooms, February, March, and April 1998 issues] has a good chance of passing this year; it received no negative votes in the last round of balloting. The remaining nine documents that comprise ISO/TC209, “Cleanrooms and associated controlled envi ronments,” are at the draft international standard (DIS) stage, which is typically less than a year away from becoming a formal ISO standard.
The imminence of the documents achieving standard status prompted Matthews` presentation, “Cleanroom globalization is here — Hello ISO, are you ready?” Matthews points out that the process of “sunsetting” national standards will begin upon publication of the new ISO standards; they will be completed by the end of 1999, a short 18 months from now. Many national standards are expected to be eliminated in favor of the new ISO standards to reduce redundancy.
At the same session, Schicht spoke on international cleanroom standards and their impact on the pharmaceutical industry. He examined ISO/DIS 13408-1, an aseptic processing standard developed under the auspices of the International Technical Committee/TC 198 to address the sterilization needs of both the pharmaceutical and the medical device industry. The standard describes a three-zone concept for aseptic production facilities that agrees “in its intentions and principles — if not necessarily in its numerical determinations — with the corresponding European Pre-standard ENV 1631:1996.” According to Schicht, the pharmaceutical industry is confronted with three different basic zone concepts for aseptic processing areas: a two-zone concept established by the United States Food and Drug Administration; the three-zone concept of ISO/DIS 13408-1 and ENV 1631:1996; and the four-zone concept favored by the GMP authorities of the European Union.
“This problem is rapidly assuming central relevance,” says Schicht. Under today`s circumstances, a world market-oriented manufacturer would have no option but to design his facility according to the most restrictive combination of the requirements established: it would have to meet the GMP and inspection requirements of all the nations where its products are consumed.
“A GMP codification harmonized on a worldwide scale is a must, as it would serve both the objectives of the health authorities in their quest for cheaper drugs and the industry in its quest for reducing manufacturing costs,” Schicht says.