Data sharing needed in cleanroom research

Data sharing needed in cleanroom research

Judy Keller

Fremont, CA — There are reasons why pharmaceutical industry cleanrooms and microelectronics industry cleanrooms are different — and it`s likely to stay that way. At least that`s what most people in the cleanrooms business say. But some contamination control officials believe if there`s a reason and a profit margin, both kinds of technologies can be married — and in a few special cases they have already been combined.

“It`s industrial prejudice that both camps aren`t doing more listening to each other,” says Joyce Steakely, head of the Institute of Environmental Sciences and Technology`s (IEST) working group on product cleanliness levels and contamination control and director of operations technology at Lockheed Martin Missiles and Space`s contamination control lab (Sunnyvale, CA). “Unless there`s a disaster or some need, they just stay in their own camps.”

The conventional wisdom that there are two divergent technologies within the cleanrooms field should change according to Alvin Lieberman, generally known as “father of the particle counter” and consultant for Powder Measuring Systems Inc. (Fremont, CA).

“I believe the niche that`s been overlooked in cleanroom research is the sharing of data between the semiconductor and the pharmaceutical industries,” Lieberman says. “Yes, it`s true that the pharmaceutical firms are concerned with federal regulations and their issue is not what size particle causes contamination, but what type. Still, some semiconductor cleanrooms are cleaner than the pharmaceutical ones. And each has something to teach the other side.”

In an ideal world, the information and data gathered would be common to all in the contamination control field, and all could benefit from the research and experience of others in the field. In some cases, information from one industry could be crucial to those in the other.

Lieberman tells the story of a medical device manufacturer who was struggling with the problem of how to measure whether the inside of the tiny devices his company made met FDA regulations. How, the manufacturer wondered, could one measure contaminants inside a minuscule space?

“I told him the disk drive manufacturers already solved this sort of problem,” Lieberman says. “Then there are instances where microelectronics firms who use deionized water in their process suddenly have mold growing in the tank. Where should they turn for help? To the pharmaceutical and medical device manufacturers who already solved that sort of dilemma.”

The advantages of sharing information could be counted in money saved on research and development because companies won`t be trying to break “new” ground unnecessarily. Also, sharing information potentially prepares the way for new technology incorporating elements of both sides of historically separate industries, contends Lieberman.

This is already happening when special needs call for a hybrid cleanroom like the one at Affymetrix, a biotechnology firm in Santa Clara, CA, where the genetic research being done is so proprietary, company officials refused to discuss the cleanroom they use. The technology used at Affymetrix involves inserting DNA or RNA onto a silicon chip and then having a computer monitor the behavior and location of the cells and record information. Such work requires the cleanliness levels of a semiconductor cleanroom as well as concern about microbial contamination commonly found in the pharmaceutical industry.

And, if you`re the National Aeronautics and Space Administration (NASA) and want to collect samples from another planet, you have a whole set of other cleanroom concerns — both when building the craft that will come in contact with another world and when protecting samples from contact with Earth.

John Rummel, NASA`s planetary protection officer, says NASA will have to build a new contamination containment facility by the time Mars samples are brought back in late 2007 or early 2008. Ideally, plans for a facility similar to a Level 4 biotech laboratory should be in the works sometime in late December 1998 or early January 1999. Level 4 laboratories are used for working with deadly airborne viruses, have high ventilation, and workers must have separate oxygen lines and protective suits. NASA workers would wear space suits while working with the Mars soil samples. Construction plans include consulting with the Centers for Disease Control as well as with companies such as Lockheed Martin.

“Not much is new technology when it comes to the level of cleanliness we need to build a space craft,” Rummel says. “We use a Class 100,000 cleanroom to assemble most space craft, and use areas of laminar flow when necessary, but when we bring samples back from Mars, we are looking for signs of past or present life, and we don`t want to `discover` ourselves, so we have more concerns than usual.”

Those concerns go right down to the swabs used in the cleanroom for spacecraft assembly — just one cotton fiber from a swab could skew results. Cotton is an organic fiber and could be detected as life. Jack Barengoltz of NASA`s Jet Propulsion Lab (Pasadena, CA) says he`s turned to the pharmaceutical firms to solve some of the upcoming cleanroom challenges.

“I`ve been talking to the people who make cotton swabs for cleanrooms, trying to find a firm that can help us develop a non-organic swab for this project,” Barengoltz says. “Believe me, the cleanliness requirements will be extra stringent, and if our usual procedures won`t meet what we need, then we can either up the ante by using a new cleanroom or by using different equipment. Once the samples are returned, there will be no room for error.”

But those are special circumstances, say contamination control officials — and even if the benefits of comparing data from both sides of the cleanroom contamination control issue could be measured in dollars, unique instances like these are asking companies to make a new product that might never be needed again, something most would discount as not profitable to attempt.

That bottom line with the dollar sign on it is probably the biggest deterrent to sharing information across the entire cleanroom community. Blake Hodess, president of Hodess Building Co. (North Attleboro, MA) believes there just aren`t enough reasons to justify using technologies from both industries when it`s not required.

“Why build a Class 10 cleanroom if you need a Class 100,000 cleanroom?” Hodess asks. “It makes sense moneywise to only build what you need.” [For other ideas on this topic, see “Market drives need to make cleanrooms `cleaner`,” CleanRooms, July 1998, p. 1.]

He says his company has built various cleanrooms where bacterial contamination was a primary concern and ones where particle counts were the main issue. Hodess says company executives meet regularly with representatives of product-makers for both kinds of cleanrooms. Within the company, lessons learned from one kind of construction are already being applied to answer design problems in another.

“For example, similar filters can be used for both sorts of cleanrooms,” Hodess says. “And we`ve taken some materials for walls that are commonly used in the microelectronics field and used them for biotech applications. Sure, the biotech cleanrooms aren`t always as super progressive or as cutting edge, and there are significant differences between them in usage and requirements, so there never will be a total transfer of technologies, but there is a bit of crossover already.

“And while we have not actively pursued a cross-over in our own company, we do have one. So I think that if others in the industry see strategic advantages to think outside their own box, maybe there would be more cross-over,” Hodess says.

An industry-wide cross-over between pharmaceutical cleanrooms designers and microelectronics cleanrooms designers is unlikely asserts Michael Fitzpatrick, head of IEST`s working group on considerations in cleanroom design.

“The main problem with the two groups is that design of a microelectronics facility is driven by the latest technological advancement and the pharmaceutical industry is driven by FDA regulation. Technological advancement is much slower, and each group answers to a different set of demands,” says Fitzpatrick. “While they have many issues in common, there isn`t enough to justify collaboration all of the time. It would just be too expensive.”

However, Fitzpatrick isn`t totally opposed to partial cross-over, and says he`d like to see more voluntary joint activities between the two design camps.

Judy Keller is a freelance writer in Milford, NH.


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