Judy Keller
WASHINGTON, DC – CONTAMination control is the first line and the bottom line when it comes to protecting a company’s image. When contamination control is breached, how a company handles the crisis can make or break the business.
When Tylenol handled the now famous case of cyanide poisoning in its product, analysts were sure the brand would never sell again. A decade later, it's still a trusted name. On the other hand, Hudson Beef went under within weeks after what might have been a minor meat recall save for public perception on how they managed it.
So what makes the difference between protecting a trusted brand name and seeing that trust instantly unravel?
“It's too late to handle a crisis after something happens. Companies must have checks and balances in place ahead of time. Monitoring critical control processes is essential. Everything from analyzing raw materials to ensuring that personnel are trained is essential. If you have a good quality control system then the frequency of problems will be very low,” says Hank Rahe, technical advisor, Containment Technologies Group Inc. (Indianapolis).
But sometimes the fail-safe fails. Then what?
“Nothing is fail safe. You can't prevent everything that could go wrong, so you have to do your best when something happens,” says Jenny Scott, senior director of food safety programs for the National Food Processors Association, Washington, DC. She says companies should anticipate what could happen and have plans in place to deal with it, right down to who within the company will handle the crisis.
“Some companies even have mock recalls where personnel are assigned to find a certain batch of a product and learn where it was distributed,” she says. Scott suggests this is a good way to see how quickly a company can respond to a contamination crisis.
When a crisis does happen, a company should do as Coca-Cola did, she says. The company took out ads, put statements on its Web page, and dodged discussion of it in the public press, communicating only through its own official channels.
“A company has to look at a situation and decide how to respond appropriately. It should get the word out fast and never deny when a problem comes up. Rather to say what is being done to solve it,” Scott advises.
Scott points out that food companies have a vested interest beyond the profit motive when it comes to their products. Not only do food manufacturers have to meet federal regulations, many of them have years of trust vested in their brand name, and most of the company workers are also consumers of the product.
“I would say that 99.9 percent of food manufacturers would make their product safe and of high quality even if there were no laws mandating that they do so. They are consumers, too, and they want clean, safe products,” Scott says.
Bill Spain, senior vice president and chief corporate affairs officer for Del Monte Foods in San Francisco, says his company has procedures in place and that they do test them periodically. He says that most food businesses have a crisis management plan that includes recall procedures. But even more critical to a trusted brand name is the day-to-day quality assurance through good manufacturing processes and compliance with regulations.
“If you've inherited a brand name like we did with more than a 100 years of trust behind it, then it's a duty as well as an opportunity to do all you can to keep the integrity of that trust on a daily basis,” Spain says.
He says that problems like the recent listeriosis outbreak that has been making headlines in the United States for the past year rarely affect companies like Del Monte, which is primarily a canning company and uses high heat in its processes to kill bacteria.
He says that the food industry may not know as much as it could about the various listeria strains and which ones it should test for. He points out that more is known about botulism and salmonella, but that it could take years before all the toxic listeria strains are identified and studied.
The Chicago-based Sara Lee Corp. learned some things about listeria last year when its subsidiary Bil Mar Foods Inc. in Zeeland, MI, recalled 15 million pounds of hot dogs and lunchmeats sold under a variety of names because of suspected contamination with a rare strain of the bacteria listeria monocytogenes. The outbreak was linked to 17 deaths and six miscarriages or stillbirths. The Zeeland plant is under investigation by a federal grand jury and the U.S. Attorney's Office in Grand Rapids, MI. The incident marked the first time genetic DNA blueprinting of bacteria strains was used to identify the source of an outbreak of illnesses.
To muster up some good publicity following the incident, Sara Lee Corp. started an aggressive food safety initiative, bringing one of the nation's top food safety scientists into the private sector.
Ann Marie McNamara, former director of the Microbiology Division of the U.S. Department of Agriculture's (USDA) Office of Public Health and Science in the Food Safety and Inspection Service, is now a Sara Lee Corp. vice president. McNamara has authored or co-authored many food safety papers. She was a USDA representative to President Clinton's Food Safety Initiative and served on the USDA committee that drafted the agency's Hazard Analysis and Critical Control Point (HACCP) rules.
The company's announcement comes as part of its new food safety initiative, which includes using state-of-the-art food safety technology throughout its U.S. packaged meats operations. The company also established a $1 million research fund at the Center for Food and Nutrition Policy at Georgetown University.
That's a master move to protect a brand image, claims Brian Delaney, executive vice president of Clarke & Co., a Boston-based public relations firm specializing in crisis communication.
“It' best in a crisis to create the image that you are in control, that you'll do the right thing,” Delaney admonishes. “Perception becomes reality. If you don't communicate properly, you'll go out of business like Hudson Beef did – in three weeks.”
He said that the Tylenol cyanide scare set a new standard for the retail food and pharmaceutical industries. No one thought Tylenol would make it as a brand name, but it's stood the test of time, he says. The Sara Lee Corp. will likely survive the latest hit to its image, despite the fact that people died from eating contaminated food from one of its plants.
What goes around comes around
Sheila Galatowitsch
SYRACUSE, NY – FLORAtech Industries, whose chairman founded Clestra Cleanroom in 1984, has purchased Clestra's air conditioning manufacturing business for an undisclosed sum. The division makes air conditioning units for cleanrooms and environmental control units for minienvironments. Both companies are located in Syracuse, NY.
In addition, Gordon Inc. (Bossier City, LA), a cleanroom ceiling grid and wall system manufacturer, has purchased Clestra's components division and will move the operation to its facility in Louisiana. The components division manufactures cleanroom ceiling grid and filter systems, including the Fantom HEPA/ULPA fan filter unit.
Clestra will continue to support its turnkey design/build division and promote its wall and ceiling products to life sciences companies in the U.S. The wall and ceiling products are manufactured for the pharmaceutical and biotech industries in a facility in Strasbourg, France. Clestra Cleanroom Inc. President and CEO Jean-Luc Bikard will be named chief financial officer of Clestra SA in Strasbourg.
Floratech Chairman Lawrence Wetzel founded Cleanroom Technology Inc. in 1984, then sold it in 1989 to Clestra SA, a division of Strafor-Facom. Strafor-Facom announced earlier this year it would sell the cleanroom manufacturer to focus on the auto repairs market.
Floratech manufactures air conditioning products for niche markets. Its main product line is refrigerated floral cases for supermarkets, but it recently introduced HEPAir, a small, patented air conditioning unit used for environmental control applications.
The Clestra acquisition will allow Flora tech to expand its product lines and build more units in the same factory, Wetzel says. The combined businesses will operate under the name Cleanroom Systems Inc. and relocate to Clestra's North Syracuse, NY, facility.
Cleanroom Systems will form two product divisions. The HEPAir line will manufacture cleanroom air conditioning units, which will be sold to end users, other cleanroom contractors and component manufacturers. The AdvanceAir line will target minienvironment control unit sales to OEMs.
Gordon's purchase of Clestra's components division gives it the largest cleanroom ceiling grid product offering in the industry, says President Rand Falbaum. Other than moving the operation and creating a cleanroom products division within Gordon, Falbaum says very few changes are planned.
“We will continue to offer the entire Clestra product line,” he says. Gordon expected to complete the manufacturing consolidation by August.
Experts refute cleanroom cancer claims
Hank Hogan
SAN JOSE, CA – JUST AS THE semiconductor industry starts to see healthy sales once more, along comes news to make it shiver. A lawsuit brought by some of the employees and their families of IBM's East Fishkill, NY, semiconductor plant is finally headed to court this October. The multi-billion dollar action against IBM and its chemical suppliers alleges that cancer, miscarriages and birth defects resulted from exposure to solvents and other chemicals used in the company's semiconductor cleanrooms.
National Semiconductor is the target of a similar lawsuit, brought by the workers and their families of a plant in Greenock, Scotland. That also is headed to the courts.
At the San Jose-based Semiconductor Industry Association (SIA), Lee Neal sees no evidence to indicate that this industry fits the profile of one that would have a cancer problem. Neal was director of Safety, Health, and Environmental Affairs until his retirement this July.
Neal argues that the dynamic nature of the semiconductor industry prevents it from fitting the cancer-causing industry profile. In the case of asbestos, for example, workers were exposed to the material for decades. In the case of solvents used in semiconductor cleanrooms, however, exposure is at low levels with ventilation. Because of the rapid innovation in the industry and relatively high worker turnover, Neal contends that cleanroom employees do not experience high, steady levels of exposure.
How, then, to explain the cancer claims?
“One out of four or one out of five of us in our lifetime will experience some sort of cancer,” notes Neal. He points out that heredity and lifestyle play a part in cancer chances. While he sympathizes with those stricken, he doesn't believe that the semiconductor industry is responsible for their ailments.
Donald Lassiter is a consultant in occupational and environmental health. As managing consultant for Occupational Health System (OHS), Lassiter dissects semiconductor workplace health and hazard statistics. While the OHS is sponsored, financially, by the SIA via annual dues paid by member companies, Lassiter contends the methods and results of OHS are compatible with the Bureau of Labor Statistics (BLS) annual survey of workplace health and injuries. The BLS figures are for a wide range of industries, and Lassiter compares the semiconductor industry's track record to others.
“It's been in the top five of safest industries,” says Lassiter. However, he also notes that these statistics are for immediate illnesses and accidents, not those that appear years later.
According to the American Cancer Society, one out of four deaths in the United States is due to cancer. In 1999, the Society predicts 1.2 million new cancer cases will be diagnosed in the U.S. alone. Counterbalancing these statistics are studies that indicate a high level of birth defects and miscarriages among semiconductor workers. To be fair, there are also studies which have concluded just the opposite.
But if exposure to chemicals in a cleanroom were a problem, Neal believes the situation would be much worse.
“A lot of the chemicals that we are using are actually used in other industries and under much less restriction or controls. So if they were going to have a problem, if exposure was a potential risk, then you would see rampant problems in some of those other industries as well,” remarks Neal.
Exposure guidelines
All of the chemicals used in semiconductor manufacturing have material safety data sheets. According to Neal, the semiconductor industry takes care to meet or exceed all of the exposure guidelines outlined on those data sheets.
Early this year, the Washington, DC-based Chemical Manufacturers Association (CMA) announced a five year, $100 million research effort targeting 10 environment and health research areas it deems “critical.” One of the areas targeted is chemical exposure and the long-term health effects of such exposure. This research will be done in partnership with the Environmental Protection Agency, the Environmental Defense Fund and other watchdog groups.
According to published reports, the main targets of the IBM lawsuit are such large chemical manufacturers as Union Carbide, Eastman Kodak, J. T. Baker Chemical, KTI, Shipley, Ashland Oil, E. I. DuPont de Nemours, and others. This particular lawsuit focus may be largely because of a New York law which prevents workers from suing their employers. Nevertheless, it illustrates that it's not only semiconductor manufacturers that are at risk.
Mountain View, CA-based Semiconductor Equipment and Material International (SEMI) is a trade organization that represents semiconductor equipment manufacturers. Although some of these are large concerns with budgets that rival those of the device makers, many are small. SEMI has an environment, health, and safety (EHS) division that is only a few years old.
Aimee Bordeaux, EHS division director at SEMI, says one of her tasks is to aid members in such areas as compliance and regulatory issues. She also works to partner semiconductor and equipment manufacturers. As processes change, the two groups can work together to minimize any environment, health or safety issues. However, Bordeaux says that she has only two full time staff members, while there are 2,300 members of SEMI, and that limits her group's activities.
Global perspective
On a global scale, there may not be much more help in the way of guidelines for employee health and safety or for environmental concerns. Bob Spector, president-elect at the Institute of Environmental Sciences and Technology (IEST), notes that both IEST documents and those of the American Society for Testing and Materials (ASTM) specifically state they do not address health and safety issues.
Although the semiconductor industry represents one of the largest groups of cleanroom users, there are others. According to Seth Ayers, standards manager for the International Disk Drive Equipment and Materials Association (IDEMA) of Santa Clara, CA, IDEMA has no specifications regarding disk drive manufacturer employee health and exposure. But in the pharmaceutical industry, there are hybrid cleanrooms. (See “Biotech companies create biosafety/cleanroom hybrid,” CleanRooms, March 19999, page 20.)These are designed to not only protect the product but also the worker.
Robert Powitz is principal consultant with R.W. Powitz and Associates of Old Saybrook, CT. He started his career in cleanroom consulting by working with semiconductor manufacturers on eliminating microbial contamination of water. He now works with pharmaceutical and biotechnology cleanrooms. He notes that some employee protection guidelines may be applicable across all cleanroom industries.
“The principles remain the same. The approach is somewhat different,” he says. “There are several strategies that are used with everything. And that's barrier, distance, time, modifying the energy or modifying the release, lowering the dose.”
A mixed bag of market trends
Judy Keller
NASHUA, NH – Changes in the semiconductor, pharmaceutical, medical device, flat panel display and electronics industries cause fluctuations in the growth of cleanrooms construction and in the demand for cleanroom supplies. Some market prognosticators are openly optimistic for the cleanrooms industry for the next few years, while others expect a continued slow period before seeing an upturn.
For example the Information Network, a New Tripoli, PA-based market research and consulting company headed by industry analyst Dr. Robert N. Castellano, is calling for slower growth, and explains that the move to 300mm wafers by integrated circuit (IC) manufacturers will have a negative impact on cleanroom growth.
Why the negative impact? The use of standard mechanical interface (SMIF) minienvironments originally intended to provide fab operators with a low cost way to stop defect-causing particles from touching wafers paved the way for fabs to back off the elaborate and expensive systems used to purify air inside cleanrooms. “Even the expensive cleanroom bunny suits could be elimi-
nated, according to some fab experts, if chip makers decide to exploit fully the minienvironments,” Castellano says.
“For the 300mm generation, SMIF systems have become so entwined with automation systems that suppliers of SMIF pods and subsystems are rushing to add workflow management features to wafer carriers. With the basic SMIF standards for 300mm front-opening unified pods (FOUPS) defined to carry either 13 or 25 mm wafers weighing between 10 and 17 pounds, nearly 60,000 SMIF pods will be needed by the chip industry once the 300mm movement takes off in about five years,” Castellano says.
A growing number of pods and minienvironments for 300mm wafers are expected to protect wafers against water vapor, gases and acid molecules that are prevalent in fabs. These impurities are nearly impossible to remove with a traditional cleanroom air filtering system, Castellano points out.
Minienvironment pods with purging capabilities will be important for processing wafers with copper interconnect technologies. Oxygen corrodes the metal. To protect new metal and new thin-film materials, SMIF pods will be routinely purged with clean dry air, nitrogen or argon gas.
Behind the move to 300mm wafers is IC manufacturers' prospect of saving an estimated 20 to 40 percent in making each chip compared to 200mm wafers. The saving is a result of 2.25 times more chips per month on the larger wafer after spending only 1.5 times more to build and equip, Castellano says.
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Fab production estimates for 1998 to 2003 are based on these assumptions: In 1998 worldwide IC sales of $140.4 billion and in 2003, worldwide IC sales of $317.3 billion.
The Information Network predicts that from 1998 to 2003, between 71 and 236 new fabs must be built to support a projected $177 billion worldwide growth in IC sales. These fabs are about 35,000 square feet with 15,000 200mm wafer starts per month.
Right now, there are 120 worldwide wafer fab facilities projects planned from 1998 to 2003, according to The Information Network. (See figure, page 4.)
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As the wafer fabs move to the 300mm size, the trend toward using minienvironments and SMIF containers will reshape fab operations. The FOUPS will not only transport 300mm wafers in air-tight, localized clean zones, but will also carry a range of information about the wafers as silicon is processed at various stations in the fab. Some SMIF pods will be able to deliver process recipes to the tools along with the wafers. Other pod designs will use radio-frequency transmitters to automatically track work in progress, Castellano explains. He adds that most U.S. and European producers, as well as some Japanese chipmakers, plan to use FOUPS in their 300mm fabs.
“About 20 new fabs and 10 retrofits each year account for most of the IC production equipment sold. But with the boom and bust over capacity cycles that have been occurring in the IC industry every three years or so, the 2.25 times more chips on a 300mm wafer will negatively impact fab construction to the point that only 10 fabs will be needed each year through the first half of the next decade,” Castellano says.
The Information Network warns that the cost of a semiconductor fab facility has shown logarithmic growth between 1975 and 1993 and will continue to do so until the year 2000. Costs have skyrocketed at a compound annual growth rate (CAGR) of 19.2 percent, from $25 million in 1975 to $2 billion in 2000. The price tag includes the building, cleanroom, equipment, materials, chemicals and personnel.
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Castallano says the market share for filters used for photoresist, acids and solvents will increase at a CAGR of 13.6 percent from revenues of $45 million in 1998 to $85 million in 2003. Filters used for gases will exhibit a CAGR of 14.6 percent from revenues of $82 million in 1998 to $163 million in 2003. Deionized water filters will grow from sales of $63 million in 1998 to sales of $115 million in 2003, a CAGR of 12.6 percent. During the 1998 to 2003 period, the worldwide filter market will grow at a CAGR of 13.7 percent to revenues of $363 million in 2003.
The McIlvaine Co., a Northbrook, IL, market research concern, predicts that annual growth in the cleanroom industry will average about 8.5 percent from 1995 to 2000. The company predicts slow growth in the cleanrooms industry for 1999, citing reduced growth rate in the semiconductor industry as part of the reason for lower growth than has been seen steadily in the double digits since the late 1960s. Yet, this is expected to be accompanied by higher growth rates in the pharmaceutical, medical device and other industries using cleanroom technology, balancing the seesaw just a bit. “Cleanrooms is still a healthy industry,” Robert McIlvaine says.
McIlvaine predicts that orders for cleanrooms for all industries will grow to $2.3 billion per year in 2000, up from $1.5 billion in 1995. Orders for the semiconductor segment will fall from $595 million in 1995 to $571 million in 2000. A 12 percent growth rate in the pharmaceutical, automotive, medical device and other segments more than offsets a reduction in the semiconductor sector says “World Cleanroom Markets 1999 addendum” published by the McIlvaine Company in March.
And the McIlvaine Company says that suppliers of disposables such as garments and wipers have experienced slower growth than in the 1990 to 1995 period. But the reduction in the semiconductor segment has not been as pronounced. The semiconductor segment for disposables shrinks from 45 percent to 32 percent of the total over the 1995 to 2000 period while the semiconductor segment for hardware drops from 38 percent to just 24 percent of the total in this time frame.
Bill Jewell, America's vice chairman for World Semiconductor Trade Statistics (WSTS), an independent, non-profit group representing about 90 percent of the world semiconductor industry, says the semiconductor industry definitely is in recovery and is expected to grow 14 percent over the long term, with the driving force behind growth to be in communications and Internet-access-related devices. The industry expects good growth and a significant upturn through 2002 as sales of cellular phones remain strong and with moderate growth in the PC sector, digital consumer devices, digital TV and cameras. “During the 1999 to 2002 period, the world total semiconductor market should grow at a compound rate of 14.2 percent, which is lower than in the past, but slowed growth is still better than no growth,” Jewell contends.
The Semiconductor Industry Association reported in May that worldwide semiconductor sales totaled $11.16 billion in March 1999, up 6.7 percent from a year ago. SIA President George Scalise hailed this as a sign of “continued industry growth and a rebounding Asian Pacific market.”
The Global Sales Report showed an increase in all markets from March 1998 to March 1999. Chip sales in the Americas improved 1.6 percent from April to May 1999 and Japan sales increased 5 percent in the same period. The Asia Pacific market posted an 11 percent increase in sales from last year and European sales increased 1.4 percent.
Ultrapure water market
The semiconductor segment was the fastest growing and largest segment of the ultrapure water market according to the McIlvaine Company. In 1999, however, the power industry and the semiconductor industries will be equal in the ultrapure water market with $1 billion in revenue for systems and chemicals. The total market will grow from $2.2 billion in 1997 to $2.4 billion in 1999 despite downturns in the semiconductor sector. The pharmaceutical/biotechnology segment along with power has experienced sufficient growth to raise the total market.
Flat panel display
Chris Chinnock, editor of the Microdisplay Report, says that the industry has experienced boom and bust cycles and is just coming out of a slump that put a few companies out of business. Active matrix or thin film transistor LCDs used in notebooks; flat desktop monitors and Personal Digital Assistants (PDAs) dominate the market.
From the perspective of cleanrooms, a trend toward larger glass substrate size requires more cleanroom floor space, but with the Japanese dominating the industry, it is not expected that in the United States, there will be much increase in the need for clean manufacturing space.
In fact, during the past few years, many colleges set up partnership programs with industry and built cleanroom facilities with an eye toward training people for flat panel display manufacturing. One such facility at Brevard Community College in Florida has its administrators scrambling to find new uses for the cleanroom. The same story unfolds nationwide, according to Chinnock, and is part of the larger picture of the industry.
“Projects were funded, money was invested, foundries were established and then the whole thing collapsed. It was a disaster,” Chinnock notes.
He says the U.S. still sees some LCD manufacturing, but it is not considered a growth industry here. But it's not all doom and gloom for those suppliers whose customers were flat panel display manufacturers.
In the area of microdisplays, such as those used in PDAs or head-mounted display panels, the U.S. is still a major player. And that technology requires a hybrid kind of cleanroom, similar to those used for a semiconductor wafer where cleanliness is critical. Half the work is done in a silicon foundry, the other half in an LCD foundry.
“Perhaps six companies have set up facilities with higher levels of cleanrooms just for this kind of work,” Chinnock says.
Medical technology
It's a different story in the medical technology market where the news is good and the growth rate steady. The Health Industry Manufacturers Association, a Washington, DC-based trade association, reports that medical technology exports for the first quarter of 1999 show a strong market in Japan, steady growth in France and Germany, and a significant increase in exports to Spain, compared to the first quarter of 1998. In Asia, the Korean and Chinese markets rebounded with an increase in purchase of U.S. exports of 25 percent and 44 percent, respectively, while in Latin America, Chile showed a strong increase of 25 percent. In the U.S., the medical technology products market is a $62.3 billion industry with a growth rate of 7 percent projected for 1999.
Design philosophy shifts to product point of view
George Miller
FRANKFURT, GERMANY – There is a “new philosophy” in the making regarding cleanroom design, according to Johann Dorner, Dipl. Ing. at the Fraunhofer Institute.
The philosophy involves a shift from facilities-centric to product-centric thinking about contamination control. This shift in thinking is required if the many industries that are beginning to
realize how they might benefit from contamination control technology are to truly embrace it, says Dorner, who heads the Fraunhofer Micro Production department. Dorner spoke at the second CleanRooms Europe conference held here in June. The conference and exhibition was sponsored by PE Schall GmbH and PennWell, the parent organization of this newspaper.
It's time for the philosophy shift, according to Dorner, because there is no patent solution for using cleanroom technology to improve product quality. “Many different individual solutions need to be developed,” he says, “and sometimes the necessity of this technology, which is often costly, must be considered.”
Put yourself in the place of the product, suggests Dorner, and then view the production process with an eye toward identifying all process-, equipment- and material-related contaminants that can be harmful.
Dorner describes a host of industries ripe for the adoption of contamination-control technology. In contrast to the existing users of the technology – e.g., semiconductor, pharmaceutical, disk drive, etc. – these new adopters are not caught in a cycle of further refining existing cleanroom facilities, techniques and practices to achieve the next level of cleanliness. These existing industries will find it more difficult to adopt the new philosophy because of the huge financial investments they've made to support the “old philosophy.”
From Dorner's product-centric viewpoint, it's only after you've put yourself in the place of the product and examined contamination sources from the manufacturing process that you're ready to think of the next “shell” – the cleanroom itself. He suggests that with a product-centric viewpoint, cleanrooms might look a lot different than those of today. He further suggests that because clean space is so costly, the emphasis in cleanroom design will be on providing such space only where necessary – smaller clean areas and minienvironments connected by tunnels, for example. Such local clean environments will need a second shell, but Dorner suggests it may not need to measure 2,000 square meters.
Dorner explains that an underpinning of this new philosophy for cleanrooms is that, in contrast to the case today, it's not driven by the companies that make cleanrooms and cleanroom components. It's driven by the user industries who make products in clean environments. He suggest that the term cleanroom is problematic in itself now: new adopter industries react negatively to it, believing it implies ample very expensive manufacturing area, when the focus really belongs on clean production processes, rather than rooms. Dorner speculates that should this philosophy become widespread, end users would populate standards bodies, in contrast to the case today where such bodies tend to be populated by the makers of cleanroom products.
Cleanroom laundries plan global operation
International Cleanroom Services (Salt Lake City) and Micronclean International B.V. (Ede, The Netherlands) have teamed to deliver worldwide cleanroom laundry services. The two companies will share key operational and quality data and combine forces to support international customers throughout Europe, the U.S., South America, Asia and Australia. – SG
PolySpec to produce Flowcrete anti-microbial industrial flooring
Flowcrete Plc, a U.K.-based resin manufacturer of industrial flooring, has formed a strategic alliance with PolySpec Corp. (Houston) that allows PolySpec to manufacture and market its proprietary polyurethane concrete toppings in North America. Based on technology that provides improved application, appearance and resistance to defects, the products incorporate an anti-microbial that inhibits the growth of bacteria, fungi, molds and mildew. They are suitable for use in pharmaceutical, chemical processing, food processing and other industrial facilities. – SG
Jenoptik Infab wins court decision in Asyst suit
A U.S. district court judge has granted Jenoptik Infab's motion that its IridNet Tracking System does not infringe on Asyst Technologies' U.S. patents, which Asyst had charged in a lawsuit against the company. The current decision, made by U.S. District Judge Jeremy Fogel in the Northern District of California at San Jose, reconfirms non-infringement decisions made last year and rules that a remaining claim was also not infringed. Jenoptik Infab (Jena, Germany) is a supplier of 200mm and 300mm semiconductor fab automation systems. – SG
USFilter files second patent infringement suit against Ionics
United States Filter Corp. (Palm Desert, CA) has filed a second patent infringement lawsuit against Ionics Inc. (Watertown, MA). The second suit alleges that Ionics developed and marketed products that infringe six additional patents covering USFilter's electrodeionization technology, which produces ultra high purity water for microelectronics and pharmaceutical manufacturers. The complaint seeks an injunction against further infringement by Ionics and other relief. The company filed its first suit against Ionics in March 1998, claiming a similar infringement. A trial for that suit is scheduled next year. Earlier this year, USFilter filed a patent infringement lawsuit against Glegg Water Conditioning Inc. (Guelph, Ontario) and its subsidiary E-Cell Corp., also alleging infringement of its patented electrodeionization technology. – SG
Asyst completes PSI acquisition
Asyst Technologies Inc. (Fremont, CA) has completed its acquisition of Progressive System Technologies Inc. (PSI; Austin, TX). PSI, now a wholly owned subsidiary of Asyst, manufactures substrate handling, isolation technology equipment and automation systems for the semiconductor and flat panel display industries. Asyst is a leading supplier of standard mechanical interface automation systems. The acquisition was accounted for as a pooling of interests and is valued at $11 million. – SG
Patheon to buy Hoechst Marion Roussel plants
Pharmaceutical contract manufacturer Patheon Inc. (Toronto) has signed a letter of intent with the Hoechst Marion Roussel (HMR) Group to purchase HMR's manufacturing facility in Swindon, England. The 262,000-square foot plant, a sterile site approved by U.S. and U.K. regulatory authorities, manufactures 55 products for sale worldwide, which Patheon will continue to produce. Last year it purchased a facility in Monza, Italy.
In a separate announcement, Patheon has also signed a letter of intent to purchase an HMR subsidiary that operates a manufacturing facility in Bourgoin, near Lyon, France. Both agreements call for Patheon to provide long-term manufacturing services to HMR companies. The Bourgoin facility adds a flexible solid dosage manufacturing site to Patheon's operations, which now encompass eight plants in North America and Europe. – SG
ISO 14644-1 finalized
The International Organization for Standardization (ISO) has released ISO 14644-1, “Cleanrooms and associated controlled environments-Part 1: Classification of air cleanliness.” The international standard, published May 1, assigns ISO classification levels for the specification of air cleanliness in cleanrooms and associated controlled environments. It also prescribes the standard method of testing and the procedure for determining the concentration of airborne particles.
The Institute of Environmental Sciences and Technology's Working Group 100, which is the custodial entity for Fed-Std-209E, will wait until ISO 14644-2 is near completion before reviewing the ISO standards in relation to the Federal Standard, says David Swinehart, chair of Working Group 100 and a contamination control engineer at Delphi Delco Electronics Systems (Kokomo, IN). ISO 14644-2, which covers monitoring practices used to prove continuing compliance with 14644-1 specifications, will likely be finalized later this year. – SG
Honeywell acquires Arrowhead Environmental Control
Honeywell Inc. (Minneapolis) has acquired Arrowhead Environmental Control Inc. (Broadview, IL), a company that services and retrofits commercial heating, ventilating, air-conditioning and related equipment. The acquisition is part of Honeywell Home and Building Control's strategy to grow its building services business. Arrowhead is a nine-time winner of the American Society of Heating, Refrigeration and Air-conditioning Engineers Excellence in Engineering award. Terms of the purchase were not disclosed. – SG
VWR to merge with Merck KGaA
VWR Scientific Products Corp. (West Chester, PA), a $1.3 billion distributor of cleanroom products and services, has agreed to merge with a subsidiary of the pharmaceutical giant Merck KGaA (Darmstadt, Germany). The VWR acquisition, together with the recently established Merck Eurolab N.V., the holding and management company for Merck KGaA European laboratory distribution activities, will enable Merck to offer its customers enhanced services in the laboratory supply business. The companies expect to complete the merger in the third quarter. – SG
Something to consider
George Miller
FRANKFURT, GERMANY – “You must decide,” as the person responsible for the quality of products produced in a cleanroom, what types of protocol and behavior are acceptable, according to Bill Whyte, a 35-year veteran of contamination control technology.
Of primary importance, though, according to Whyte, is to get the people who work in the cleanroom to appreciate the problems of the cleanroom. Take photographs of your cleanroom and of people working in it and preparing to enter and exit; get images of correct and incorrect behavior and protocol and use them as training aids.
“The science isn't high here,” says Whyte. “You're looking for consistency.” Whyte, who is currently research fellow in the mechanical engineering department at the University of Glasgow and general secretary of the Scottish Society of Contamination Control, spoke at the second CleanRooms Europe conference held here in June. The conference and exhibition was sponsored by PE Schall GmbH and PennWell, the parent organization of this newspaper.
Following are considerations as presented by Whyte.
* Consider it accepted practice to work from the top down while gowning (mask and hood first).
* A bench in the gowning area distinguishes the less clean from the cleaner sides of the gowning room.
* Provide a long mirror in the gowning area so employees can check themselves before entering the cleanroom. Post your cleanroom entry procedures there.
* People need to be trained in removing and storing gowns as well as donning them.
* Daily gowning changes are frequently unnecessary. Research has shown that most people-generated particles come not from cleanroom apparel, but from gaps between the apparel and the employee, through which particles escape.
* Don't allow workers to wear uncovered street shoes in the cleanroom (even when a shoe brush and 20 feet of cleanroom mat are used, there is still too much particle contamination). Cleanroom shoes dedicated to each user are generally cost effective. If that's out of the question, smooth-soled slippers are better than street shoes.
USFilter buys rights to water particle counter from TEAM Engineering
Sheila Galatowitsch
BRADLEY, IL – United States Filter Corp.'s Stranco Products subsidiary (Bradley, IL) has acquired exclusive distribution rights to a water particle counter that promises greater reliability and absolute counting accuracy.
The company acquired the rights from TEAM Engineering (Merlin, OR), which owns North American distribution rights to products designed and manufactured by Dr. Holger T. Sommer, president of ART Instruments (Grants Pass, OR), a long-time particle counter developer.
The particle counter incorporates a sensor with verified accuracy through a procedure traceable to scanning electron microscopy. It meets the Japanese water particle counting industry standard B9925-1997, and the Institute of Environmental Sciences and Technology's Recommended Practice 14.
It performs both accurate sizing and counting, its designer says. “In the past, sensors in particle counters have been able to count only relative numbers, and they were not capable of being verified through absolute accurate numbers,” Sommer says.
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The counter's ability to count absolute correct numbers is a significant improvement over current technology and will ultimately enhance filter performance, says Dr. Yong Kim, project manager at USFilter Stranco.
Designed primarily for drinking water treatment applications, the counter monitors processes that control microorganism contamination in water. It optimizes the water treatment process for removing Cryptosporidium and Giardia, two parasites dangerous for human consumption. It also provides information about the process that optimizes use of chlorine and other disinfectant materials, Sommer says.
USFilter will sell the monitoring instrument under its own trademark in the U.S. and Canada. The counters will be used in USFilter membrane and conventional filtration packages and sold as stand-alone systems for large-scale water treatment plants.
VIEWPOINT
The growing case for smallness
Every once in a while, the universe conspires to tell us something. This time, it's about isolators and minienvironments-two separate technologies, to be sure.
But nonetheless, they share in some fundamental characteristics. To begin, in this month's Special Report (“Investing in isolation technology,” pg 23), correspondent Sheila Galatowitsch finds that determining the return on an isolation technology investment in pharmaceutical applications is no straightforward task. In fact, because ROI calculation is inherently an exercise in relativity – it seeks to quantify the financial or other gain in one investment relative to an existing investment – and because the pharmaceutical industry is subject to strict regulations, some implementors don't even attempt the calculation. They seek other means of justifying their investment. Yet they are seeking and getting those justifications in something that is beginning to look suspiciously like a trend.
Isolation technology was chosen for this Special Report months ago, with the knowledge that this topic is and will remain timely and useful to a large and important segment of our readers: the 30 percent of you who work in the pharmaceutical industry. In fact, Galato witsch approached the story first by examining her previous coverage of the topic over the last several years, and then determining the starting point for this month's coverage. What we didn't know when we chose this topic to appear in this issue was that simultaneously, the universe would be concocting a parallel argument for minienvironment technology to an equally large and important segment of our readers: the 30 percent of you in the semiconductor field.
In the case of minienvironments, supporting data comes from industry analyst Dr. Robert N. Castellano of The Information Network and Johann Dorner of Germany's Fraunhofer Institute. Castellano foresees great growth in demand for standard mechanical interface minienvironments (“A mixed bag of market trends,” pg 1). The SMIF minienvironment, Castellano predicts, will enable fab designers to cut back on the elaborate air purification systems inside cavernous cleanrooms; so much so, in fact, that Castellano predicts a negative impact on cleanroom growth.
And Dorner takes things a step further (“Design philosophy shifts to product point of view,” pg 1). He suggests that by taking a product-centric (rather than cleanrooms-centric) viewpoint, contamination control professionals would begin to develop cleanrooms that look a lot different than those of today. Because clean space is so costly, says Dorner, the emphasis in cleanroom design will shift to providing such space only where necessary: in smaller clean areas and minienvironments connected by tunnels, for example.
Dorner views this philosophy shift from facilities-centric to product-centric thinking about clean space as an enabler for industries that might embrace contamination control technology but currently shy away due to sticker shock.
Yes, every once in a while, the universe conspires to tell us something. But then again, maybe it's just the markets speaking and the technologies responding.
George D. Miller
Editorial Director
Unfiltered
Join SAUP
I would like to enlist you in SAUP. This is the Society Against the Use of 'Particulates.' Members of this society are convinced that 'particulates' is the adjective of 'particles' and should never be used as a noun. They are convinced that someone made a grammatical slip a number of years ago and because 'particulates' sounds grander than 'particles' and people did not know any better, this was never corrected (except by people like me). The Society challenges anyone to demonstrate any difference in meaning between 'particulate' and 'particle' and, by failing to do so, accept never to use 'particulates' as a noun.
I find the use of 'particulates' instead of 'particles' very annoying. As you know, clarity in the English language has to be continually fought for. Although the incorrect use of 'particulate' is a very small mistake, I think it is worth fighting for every piece of ground or we will lose the war.
I am making good progress and have managed to cut out any use of 'particulates' in the new ISO standards being produced. I would like to enlist you and your troops in the War/
Society. You can give yourselves any position in the Society you wish, except Chairman as that is mine.
Bill Whyte, Chairman SAUP
Secretary, Scottish Society
for Contamination Control
Glasgow, Scotland
Editor's Note: Thank you for the very important work you are doing. CleanRooms magazine wishes to join you in your efforts, and claims the position of Director of Membership. Readers who wish to join us are encouraged to send an e-mail message to [email protected] – GM
Program certifies cleanroom manufacturing processes
Sheila Galatowitsch
LIVONIA, MI – AFTER LAUNCHING AN independent program to certify the cleanliness of cleanroom products earlier this year (“Third-party testing lab certifies product cleanliness levels,” CleanRooms,, May 1999, page 1), Dr. Philip R. Austin has now introduced a similar program to certify the cleanliness of the processes used in the manufacture of such products.
Engineers with the Ultraclean Manufacturing Process Approval Program (UMPAP) completed their first certification in June on Terra Universal's (Anaheim, CA) processes. The cleanroom product manufacturer was one of the first to have its products certified under Austin's other service, the Ultraclean Products Approval Program (UPAP). Both programs are divisions of Austin's Acorn Industries (Livonia, MI), which provides precision parts cleaning and packaging services.
While UPAP tests and certifies the cleanliness of any product used in the construction or operation of a cleanroom, UMPAP certifies the processes used to manufacture the product. Like ISO 9000 certification, UMPAP engineers audit manufacturers' documentation, drawings and processes, and interview personnel operating each piece of equipment.
If improvements are required, the UMPAP engineers return to ensure the corrections were made. During the certification process at Terra Universal, Austin suggested several changes, including one on HEPA filter placement, that the manufacturer implemented, says Janice Jordan, director of sales and marketing.
UMPAP aims to let buyers know which manufacturers “understand cleanrooms and cleanroom products, and how to run a cleanroom manufacturing business,” Austin says.
“It's one thing to have a product acceptable for cleanroom use, and quite another to actually manufacture clean. You certainly don't want to have manufacturing materials, dust or dirt trapped in a unit,” or deliver products capable of releasing contamination after they are used in a cleanroom, he says.
In addition, many cleanroom product buyers assume that packaged incoming supplies arrive cleanroom-ready. Manufacturers must ensure that products are packaged clean so that manufacturing dirt and debris don't enter their customers' cleanrooms, Austin says.
By participating in UPAP, buyers of its off-the-shelf products – stamped with an Ultraclean seal of approval – know at a glance that the products are cleanroom-compatible, Jordan says. UMPAP will give its customers requesting custom products the same assurance that the products are cleanroom-ready and manufactured with cleanroom-compatible processes.
“Instead of having Dr. Austin certify every single custom product, which would be impossible, custom buyers will know that we are addressing their concerns, and that they don't have to worry about our products causing contamination in their cleanrooms,” Jordan says.
Coca-Cola damage control
One recent example of how a major company does damage control after a contamination crisis is the recall of Coca-Cola in Belgium in June after a few dozen school children became sick after drinking Coke. The news hit Belgium during a time when European government agencies were calling for reforms in the food industry there and furiously trying to protect their status as watchdogs.
The Belgian government immediately banned Coca-Cola products. French, Luxembourgian, Dutch and Swiss government agencies restricted the products and the Swiss demanded that Coke publish information that would inform customers where products were made or bottled. The French consumer affairs minister complained that it took Coca-Cola two days to provide information on how to identify which soft-drink cans could pose risks. Some French people in Dunkirk had become ill after drinking from the same batch that supplied the Belgian town where the school children fell ill. For Coca-Cola, this became a public relations nightmare.
Meanwhile, Coca-Cola retained British toxicologist Robert Kroes who reviewed data from company laboratories and from independent laboratories in France and the U.S. The labs tested soft drinks in glass bottles from plants in Antwerp, Belgium, and cans from Dunkirk, France.
Kroes reported that glass bottles of Coca-Cola and Coca-Cola Light from Antwerp had defective carbon dioxide, which gives products a rotten egg odor. Kroes reported that the glass bottles contained “very low quantities, just about the detection limit” of hydrogen sulfide and carbonyl sulfide, both well known for their characteristic off odor.”
The report also said that in Dunkirk, the lacquer on the bottom of cans, which prevents cans from rusting “had possibly taken up” a fungicide, p-chloro-m-cresol, that was sprayed on wooden shipping pallets. This imparted a medicinal odor to the cans.
Kroes reported that the impurities present in the carbon dioxide in some of the glass bottles could not, “even in worst case scenarios, explain the health concerns experienced, since levels to cause such health concerns are at least 1,000 times higher.”
Furthermore, the amounts of the fungicide that anybody would possibly have inhaled or absorbed by drinking from a can was 5,000 to 7,500 times lower than what is considered an acceptable or safe intake.
A spokesman for corporate headquarters of Coca-Cola Enterprises, Atlanta, GA, said that the company is not ready to discuss further the findings or to say what lessons were learned as far as contamination control and protecting brand image are concerned. But the Kroes report was good news for the company, as it prompted lifting the ban on Coke products in Europe.
The company lost an estimated $60 million on this incident, an estimate which doesn't include reduced sales due to consumer concern. Just two weeks after the ban, on the same day the ban was lifted (June 24) shares of Coca-Cola Enterprises, the leading worldwide bottler, distributor and marketer of Coca-Cola beverages, were down 2.5 percent on the New York Stock Exchange.
Coca-Cola Co. holds a 40 percent stake of Coca-Cola Enterprises, which owns and runs the plants at the center of the contamination crisis. According to Belgian health officials, people who drank Coke products reported some 249 cases of illness in Belgium since June 9.
In response, the company placed full-page ads in major Belgian newspapers apologizing for the incident. In the ads, Coca-Cola Co. Chairman M. Douglas Ivester acknowledged that the company had been slow to respond to consumer concerns about the health fears that led to bans in several countries. The company took out ads in other nations as well, assuring consumers their drinks were safe, but the scare continued to spread, with a Portuguese newspaper reporting that government health inspectors there were looking into alleged reports of dark residue found inside some cans.
In a company statement dated June 16, Ivester said, “The Coca-Cola Company is taking all necessary steps to ensure that all our products meet the highest quality standards. Nothing less is acceptable to us, and we will not rest until we ensure that this job is complete. We deeply regret any problems encountered by our European customers in the past few days.”
And in a statement on June 17, the company responded to the Belgian Ministry of Health with a public statement that reiterated the company's commitment to work with government officials. The statement also said the company respected the need for more analytical data. The statement concluded, “The results of the extensive testing we have submitted to the government conclusively reveal there are no health threats associated with Coca-Cola and our other beverages in the Belgian marketplace.” – JK