European contamination control practices tighten across the board

06/01/2001

Hank Hogan

WEST SUSSEX, UK—With news of hoof and mouth and mad cow disease sweeping across the world's headlines, Europe's contamination control acumen is firmly fixed under a global spotlight. And while the attention-grabbing animal diseases have little to do with cleanrooms, European industry players say that the news stories, paired with the adoption of two new international standards, will certainly impact Europe's understanding of contamination control across all end-user markets.

"An increase in investment in pharmaceutical, veterinary and medical research cleanrooms may result from this current situation," says Clive Hayler, a principal consultant for United Kingdom-based Primarius Ltd., a cleanroom training and consulting company.

Even more prodding may arise after the new European Food Agency begins operation in 2002. But more directly, European contamination control, across all markets, will tighten up with the adoption of two new international cleanroom standards: ISO 14644 covering airborne cleanliness and ISO 14698 covering biocontamination control.

Neither standard is complete, but their presence forces the establishment of uniform quality and performance objectives.

Hans Schicht, principal of Contamination Control Consulting Ltd. of Switzerland, says that ISO 14644 will comprise eight parts. Three of these have already been published as international and European standards—one is established as a draft international standard. When these documents are released, there will be, for the first time, universal cleanroom standards. Unfortunately, that's only part of the equation.

Schicht notes a need to harmonize regulations internationally as well. "There is increasing agreement about good manufacturing practice (GMP) requirements in the U.S. and Europe, but the rate of convergence could be faster," Schicht says.

Another problem is that harmonization is restricted to the European Union, the U.S. and Japan. Confronted with a hodgepodge of worldwide regulations, manufacturers must adhere to the most stringent rule. "That, of course, is not the cheapest way to manufacture medical drugs," observes Schicht.

Even with these constraints, Europe is a leader in medical devices and pharmaceuticals, industries that tend not to experience the roller coaster economic cycles of semiconductors. That fact hasn't escaped the notice of European suppliers to the cleanroom industry.

"Most of them [suppliers] have refocused their core efforts onto the life science or pharmaceutical side of the business because that is a steady growth area," says Mark Dalziel, U.K.-based managing director for cleanroom flooring manufacturer Dycem, Ltd.

However, suppliers cannot escape the fact that Europe remains a major semiconductor producer. According to Dataquest's January 2001 rankings, two of the top ten semiconductor manufacturers are European: Swiss STMicroelectronics and German Infineon Technologies. A third, Philips Semiconductors of the Netherlands, lies just outside the top ten. These companies, like others worldwide, are feeling the pinch of an economic slowdown.

However, in semiconductors, Europe also follows its own path, and that impacts contamination control.

For instance, Europe is a wireless leader, with some of the highest cell phone penetration rates in the world. The continent is also home to leading wireless phone manufacturers. European research organizations, such as IMEC of Belgium, have been looking at the challenges of integrating all the different components found in a wireless application. These include high-quality passive elements, noise-sensitive analog amplifiers, high-speed digital circuits and others.

A solution is to build everything on a single piece of silicon. This approach often compromises the performance of every component so that the system will work. The other solution, the one favored by IMEC, is to build a system in a package. Components are placed on a substrate, which is then sealed into a small carrier. This presents several advantages over the system-on-a-chip method.

"You don't increase in size, and you have much more flexibility to keep the specifications tight," says Ludo Deferm, vice president of business development of IMEC.

With this approach, there's a contamination control impact. For one, cleanliness requirements don't stop until the entire package is sealed. For another, the system can't be tested before completion. Thus, contaminants must be controlled while the various elements are brought together and manufacturing completed.

This focus on systems and wireless is also found in a new chip venture. German startup Communicant Semiconductor Technologies claims to be the world's first foundry focusing on the specialized needs of the communications industry. Using a silicon-germanium carbon BiCMOS process and backed by technology partners Intel and the German Institute for Semiconductor Physics, Communicant plans to pump out 30,000 200 mm wafers a month in a SMIF-equipped fab beginning in the first quarter of 2003.

Communicant isn't building a 300 mm fab and has no firm plans to do so. According to Klaus Weimer, Communicant's CEO, the small size of telecommunications chips eliminates much of the cost benefit of a larger wafer size. So, the company is counting on its innovative manufacturing process, which could present its own contamination control challenges.

As Weimer says, "The silicon-germanium carbon BiCMOS technology is really what differentiates us from the competition."