Monthly Archives: March 2001

Hank Hogan

ARMONK, NY—IN A MOVE that could signal stormy legal weather for various cleanroom industries, the IBM Corp. (Armonk, NY) has settled the “Ruffing case,” a lawsuit involving two cleanroom employees who sued IBM in 1997. The couple contended that their 15-year-old son's birth defects were the result of exposure to gases and chemicals in IBM's East Fishkill, NY, cleanroom.

Terms of the settlement were not disclosed. In a statement, IBM noted that most civil lawsuits settle out of court and human factors often come into play, as in this case.

“This one was kind of unique in terms of the condition of the effected party and the connections being drawn versus most of the [other cases],” explains IBM spokesman Bill O'Leary.

The others O'Leary refers to are the hundreds of similar lawsuits brought by cleanroom workers against IBM and National Semiconductor Corp. (Santa Clara, CA). In addition to the IBM plant in East Fishkill, the other lawsuits involve an IBM disk drive plant in San Jose, CA, and a National semiconductor facility in Greenock, Scotland. The swarm of lawsuits alleges cancer among adult workers and birth defects among their children.

None have yet come to trial, and it may be years before any of them do. For its part, IBM does not say the Ruffing settlement will prove a bellwether for other cases. Indeed, in its statement announcing the settlement, the company carefully pointed out that it didn't believe it had any liability in the case. O'Leary notes that the company maintains worker health and safety as a top priority.

“We use extraordinary means to maintain a safe and healthful environment within our manufacturing lines,” O'Leary says.

He adds that the company considers the lawsuits to be without merit. That's a sentiment echoed by the other cleanroom defendant. “We do not plan to settle since we believe the lawsuit is completely without merit,” asserts LuAnn Jenkins, a spokeswoman for National.

No matter what happens to these lawsuits, however, they could have a lasting impact on at least one cleanroom industry. Partly in response to the allegations, the San Jose-based Semiconductor Industry Association (SIA) has formed a scientific advisory committee to look into cleanroom worker health claims. It's expected that the committee will make recommendations based on a review of the data by early 2002. That's when the wider influence of these cases may be felt, according to SIA spokeswoman Molly Mar.

“Once the recommendation comes to us by this independent scientific panel, then we'll move from there,” she says.

_______________________

Plaintiffs in IBM lawsuit appear on Today show

He's blind, has facial and skeletal deformities and must breathe through a tracheotomy at night to survive.

Meet Zachary Ruffing, the 15-year-old kid with Hallermann-Streiff syndrome who is suing IBM Corp. because of his birth defects.

He, and his parents appeared on NBC's Today show to talk about the case and the settlement a judge is expected to sign off on out of court. That same judge must also rule on 200 similar lawsuits, some of which were filed by other IBM employees who either worked at the East Fishkill, NY, or Essex Junction, Vt., facilities.

Zachary's parents, Fay Calton and Mike Ruffing, told Today that they believes the chemicals they were exposed to while working in East Fishkill's cleanrooms, namely chip coatings like glycol ethers, xylene and enambuterol acetate, caused Zachary's abnormalities.

“In a cleanroom, you use the same air over and over and over again,” says Mike Ruffing. “It recirculates, so it's not like fresh air is bought in to make it less toxic.

It's there, and as you dump more chemicals in the air, it just gets worse and worse and worse.”

In a prepared statement, IBM says it does not believe any of the lawsuits have any merit. “There is no scientific evidence linking these health issues to our cleanrooms or other work environments. We intend to defend our company vigorously,” says Laura Wessner, IBM's manager of broadcast media relations. “We have no comment on our litigation plans for future cases. Our decision to settle the Ruffing case has no bearing on future decision regarding any other cases.”

The report from Today also indicated that Zachary's condition has never been linked to chemical exposure or any other cause. Animal studies, however, have shown a link between glycol ethers and head and facial deformities.

In 1983, two years before Zachary was born, the National Institute for Occupational Safety and Health (NIOSH), warned computer companies that glycol ethers could “be regarded as having the potential to cause adverse reproductive effects in male and female workers.

NIOSH urged employers to “give this information to their workers,” but Calton says IBM never warned her, a charge IBM fervently denies.

The Ruffings are not the only ones suing IBM. In fact, 48 current and former employees have pending lawsuits against the company, citing their children's birth defects were cause d by IBM's negligence.

Today noted that IBM's lawyers declined to speak on camera, but said that although they feel compassion for workers and their children, the scientific evidence does not support employee claims.

Ron Murray Sr., who worked at IBM for 27 years, says he was exposed to the same chemicals as Calton and Mike Ruffing. The first two children Murray and his wife had died as newborns. Edwina, he said, was born with 40 broken bones and had a rare bone disease. She died at 10 months, while a second daughter, Catherine, died as soon as they brought her out of an incubator. Catherine was 3-days-old. An autopsy revealed that what appeared to be two lungs was actually one lung and a giant tumor.

Murray and his wife eventually had two children, and both have health problems. Their 32-year-old son has testicular cancer, while a daughter, 29, has an undiagnosed illness that causes her chronic pain.

Others, who requested anonymity from Today, are also coping with health problems that they hold IBM accountable for.

One man said he was diagnosed with testicular cancer, while another said his wife has cervical cancer.

IBM did stop using glycol ethers, and sought alternatives in the 1980s and fazed them out completely in 1995, 10 years after government warnings.

For people like Zachary Ruffing, it was 10 years too late. “The still should have told people, because they should value people over profit” he says.—MAD

FAA, ASHRAE studies underway to determine if airplane air causes illness

Sheila Galatowitsch

WASHINGTON, DC—IF YOU'VE gotten sick after traveling by air recently, it probably won't make you feel better to know that there is no direct evidence linking air contamination in airplanes with health-related problems.

In fact, the Federal Aviation Administration (FAA) contends that the air in airplanes is cleaner than in the average office building. Various monitoring studies over the years have confirmed this view.


Jones: Standards body is regrouping.
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But complaints from the traveling public and a mounting stack of medical records from flight attendants indicate more research is necessary. Several studies are underway to determine if the air you breathe on cross-country flights has the potential to make you sick. Even the most ardent advocate of higher air quality standards in aircraft—the Association of Flight Attendants (AFA)—sees cause for optimism in recent developments.

According to the AFA's Judith Murawski, an industrial hygienist in the labor group's Department of Air Safety and Health, there are three main problems with air quality in airplanes. The first is the 8,000 feet altitude level maintained inside the aircraft cabin itself, a level established in a 1957 FAA regulation.

The amount of oxygen in pressurized air at this altitude is significantly less than in air on the ground. Less oxygen in the air could lead to dizziness, headaches and nausea for flyers with health or weight concerns. The AFA is pushing the FAA to review the 8,000 feet requirement, which was originally based on blood oxygen data collected from “superfit” pilots and military men, says Murawski, not from flight attendants or passengers.

A second problem centers on ventilation rates. There is no fresh air ventilation standard for aircraft flying today, most of which recirculate cabin air to save on fuel costs, a practice begun in the 1980s. In 1996, the FAA did establish a minimum fresh air ventilation rate of 10 cubic feet per minute per person (cfm/p), but that requirement applies only to new aircraft designs that are not yet in the air.

“Current aircraft types don't have to meet that standard. They can operate at whatever flow rate they want to,” says Murawski. Most aircraft operate with fresh air ventilation rates of 5 to 10 cfm/p. The minimum recommendation for public buildings, set by the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE), is 15 cfm/p.

A lack of fresh-flowing air leads to a third problem with air quality in planes: the levels of contaminants in the air. For in-flight air supply, air is siphoned or “bled” off from engine thrust. Air passing through engine compressors and rear-mounted engines on its way to the cabin could be contaminated with lubricating oils, hydraulic fluids, lavatory water and even sewage. The auxiliary power unit (APU) used for power and air supply while the plane is on the ground can also prove a source of contaminants.

Carbon monoxide and the neurotoxin tricresyl phosphate (TCP), an agent added to engine oil, are two contaminants topping the AFA's concerns. Flight attendants have reported symptoms consistent with carbon monoxide poisoning and exposure to TCP, including severe nausea, tunnel vision and memory loss. In some cases, these symptoms have been correlated to mechanical problems on a specific flight, says Murawski.

Humidity levels, the presence of ozone and other factors also impact whether people flying in airplanes get sick. Sitting near an infectious person, of course, ranks high on the list. Some airlines have voluntarily installed HEPA filters on planes to filter out contaminates in recirculated air, but there's no FAA requirement for the filters, their maintenance, inspection or replacement. While HEPA filters are a step in the right direction, they are not a cure-all, says Murawski, especially because they don't capture gases, ozone or viruses.

Two FAA-sponsored studies are assessing these air-quality concerns and associated health effects. A group of experts convened by the National Academy of Sciences (NAS) is reviewing data on aircraft contaminants and their toxicological effects, and potential approaches for improving cabin air quality, including the replacement of engine and APU “bleed” air with an alternative supply of air. The committee is scheduled to complete its work later this year.

In addition, the National Institute for Occupational Safety and Health (NIOSH) is in the midst of a multi-year study on the transmission of communicable diseases and general air quality in planes. Results of that study are due in 2003.

ASHRAE is also sponsoring two studies to support its development of an aircraft air quality standard. Results from the first study, released in June 1999, found no significant air quality-related health hazards for passengers or crews, but determined that more studies on different airlines and aircraft were necessary before the issue is resolved. In this study, researchers from Consolidated Safety Services Inc. (Fairfax, VA) measured contaminants and environmental parameters and surveyed comfort levels of passengers and flight attendants.

Results of the second study were scheduled for release at ASHRAE's winter meeting in Atlanta in late January and were not available at press-time. This study, conducted by Dr. Niren Nagda, principal investigator at Energen Consulting Inc. (Germantown, MD), identified, quantified and documented potential air supply system contaminants.

Nagda, who declined to comment on his research prior to its release, says that although earlier data has not shown evidence of a link between airplane air quality and human health, certain contaminant—such as semi-volatile organic compounds emanating from engine oil or hydraulic fluid leaks—were not measured in previous studies. Nagda edited the recently released “Air Quality and Comfort in Airliner Cabins,” a collection of 15 scientific papers on the topic available from the American Society for Testing and Materials (www.astm.org).

ASHRAE will evaluate results of Nagda's research in its Standard Project Committee 161P, formed in 1996 to write a standard for air quality in commercial aircraft carrying 19 or more passengers. The proposed standard will encompass ventilation, thermal comfort and filtration, and consider chemical, physical and biological contaminants and factors such as moisture, temperature and pressure that may affect air quality. When completed, the standard will be the first to address air quality in airplanes.

The committee has already defined a preliminary minimum outside air ventilation rate of 5 cfm/p, but that definition is back on the table after a restructuring of the committee last year. Murawski, a committee member, says it was expanded to make membership more evenly balanced among interested parties. Committee members now include the airline operators, manufacturers, flight attendants, passengers, academia and government representatives.

Newly appointed committee chairman Dr. Byron Jones says the standards body is in the process of re-grouping, and he doesn't expect a public review draft of a proposed standard until later this year or early 2002. “People need to understand that these are consensus standards, requiring a long and difficult process to develop,” says Jones, a professor of mechanical engineering and associate dean for research and graduate programs in the College of Engineering at Kansas State University.

He adds that the 15 cfm/p recommendation for public spaces, just one of the criteria for public air quality defined in ASHRAE Standard 62, was never deemed applicable to air ventilation systems in aircraft and that Standard 62 itself is under review. The 5 cfm/p preliminary ventilation rate proposal for aircraft, which provoked public criticism, is still up for discussion.

“It's too early to speculate on what the recommendation will be,” says Jones. Adherence to ASHRAE standard recommendations is purely voluntary, but regulatory authorities, such as the FAA, could impose ASHRAE standards on the industry.

Among the interested parties, debate continues on whether air quality in aircraft is even a problem. But the AFA is convinced it is and would like to see a justification from the FAA for the 8,000 feet cabin altitude limit and a requirement for continuous air monitoring that would determine appropriate ventilation rates. “It's a slow process, but we are optimistic that the FAA appears to be addressing this issue,” says Murawski.

If the FAA fails to act, however, there's always Congress. Last year, legislation was introduced in the U.S. House of Representatives that would have established a minimum fresh air standard on commercial flights. But lawmakers decided to postpone action until the NAS study is complete. For now, the question of air quality on airplanes is circling the ground, with no landing strip in sight.

Chris Anderson

PITTSBURGH—Seagate Technology Inc.'s decision to build a research facility here is providing opportunity to two distinct classes of workers. There are the researchers whose job it is to divine what devices will store data 10 years from now and steamfitters whose skills are needed to provide the piping and ventilation for the facility.

The new building, slated to open later this year, will replace Seagate's existing research facility in Pittsburgh that employs about 90 people. The current building, like the new one, has ISO Class 4 (Class 10) cleanrooms and should be attractive to other tech companies once Seagate moves out. “Let's put it this way, I think the landlord of that building will have a big smile on his face when we move out,” says Herb Blomquist, vice president and deputy director for Seagate.


Seagate's Pittsburgh facility.
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At Steamfitters Local 449, the Seagate project is welcome work for a union that has seen its membership ranks dwindle by 40 percent since the heady days of the 1970s when steel was the engine of the local economy. While Seagate's research building needs only a relative few steamfitters compared to a full-fledged wafer fab or other manufacturing plant, the company's arrival has provided new skills to the union's members.

As a result of Seagate coming to town, Local 449 set up night training classes in orbital welding. To date, more than 70 members of the union have completed the training. In addition, the union signed a no-strike agreement with the contractors to ensure that once construction started on the Seagate project, the union would staff it until completion.

“It's not the same world as it was in the past,” says Ken Broadbent, business manager of Local 449. “If we want to get these kinds of companies coming to Pittsburgh we need to give them these kinds of assurances.”

Blomquist says the union did a good job of stepping up to the plate to make sure the project is a success. “They provided the training to their members to make sure they had the skills necessary,” he says.

But Broadbent is realistic that this is only the first step to convincing large-scale manufacturers that the work force is available to help build production plants. “One of the things with orbital welding is that you can only learn so much in the classroom, you have to be out in the field to really learn how to do it right,” says Broadbent.

Because the research facility was a smaller project, the union didn't need to deliver a couple of hundred steamfitters. “I don't want to give the illusion that we could have taken on a large construction project for the semiconductor industry right away,” Broadbent says. “But we are able to mobilize a workforce and provide the training that is needed through our apprentice school and training center.”


The exterior of Seagate's new research facility in Pittsburgh.
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The United Association of Plumbers and Pipefitters, the national arm of the union, also lent a hand to Local 449 both via a grant to buy an orbital welding machine and loaning another to use for training. “They are very aware of the (shortage of steamfitters) because members do most of the orbital welding for cleanrooms work across the country. So they have equipment available for training and regional training centers to train our instructors.”

Further, Broadbent says, the union understands the needs of its customers and is willing to provide the kind of specialty labor agreements, including no strike guarantees, as needed. “There is so much money involved in these industries that they can't afford a labor problem and they don't care whether it's union or not,” he says. “They just want the job done on time. So we have to move into modern times and assure them that our people will be trained and will be on the job until it is done.”

Pulling the supply chain


March 1, 2001

Hank Hogan

SYRACUSE, NY—While cleanrooms are often used to manufacture products, they also are products. Assembled from cleanroom panels, HEPA filters, HVAC units and other components, a finished cleanroom sits at the end of a long supply chain. And that supply chain has been whipping around.

Scott Mackler, a principal with Syracuse, NY-based Cleanroom Consulting LLC, puts the standard, conservative lead time for a HEPA filter at 10 weeks as of October 2000. Delivery of HVAC units was running 12 weeks. Cleanroom panels appeared 10 weeks after being ordered. According to Mackler, these numbers represent a bad news/good news scenario.

“In the fourth quarter of 2000, deliveries had lengthened,” he remarks. “Now they're being pulled in again.”

Just how much is difficult to determine. Throughout 2000, there were reports of cleanroom construction delays due to a lack of contractors and a shortage of critical components. Now, the economic slowdown may be changing that. For instance, anecdotal stories tell of scarce valves that suddenly are abundant. Valve lead times that were months are now days. Reportedly, this surge in availability is due to the sudden canceling of overseas cleanroom projects.

John Bazinet, a principal with cleanroom component manufacturer SBB Inc. (Topsfield, MA), has seen fluctuations in some basic cleanroom components.

Over the last year, the one-time stable promised delivery of HEPA filters has been anything but.

“One day you call up the vendors and they say you have to wait 12 weeks, and then two weeks later, you can get it out of stock,” says Bazinet.

Manufacturers of cleanroom components are experiencing the supply chain bullwhip effect. A small change in demand by the ultimate end consumer, cleanroom users, translates into a large change as seen by the makers of filters and valves.

In semiconductor and other manufacturing, the solution is to share information about changes in market demand. In this way, the small downstream ripples don't amplify into wild upstream waves.

That smoothes out both perceived demand and actual delivery. Lead times become more predictable, and delivery can be just-in-time.

However, those approaches may not work well when manufacturing cleanrooms

“You really can't because they are specialized,” says William Lynch, a Rochester, NY-based business segment leader for High Tech and Life Sciences at the engineering firm Bergmann Associates PC. “Typically, you can't just buy parts and pieces off the shelf and put a cleanroom together.”

What can be done, according to Lynch and others, is extensive planning upfront. That can avoid some unpleasant surprises later, when it's discovered that the HEPA filters originally ordered won't meet regulatory requirements. Ordering the right filters then leads to a delay in the project and a postponement of cleanroom completion.

Mark A. DeSorbo

PORT WASHINGTON, NY—Extracting specific contents from spent blood filters to develop a remedy for an infectious disease may seem rather unusual, but that's just what filter manufacturer Pall Corp. and drug developer Viragen Inc. plan to do now that the companies have entered into an agreement that may yield a potential treatment for Hepatitis C. Under the terms of the agreement, Pall (Port Washington, NY) will grant an exclusive worldwide license, which excludes Japan, to a proprietary technology that will enable Viragen (Plantation, FL) to recover leukocytes, white blood cells, from used blood filters.

The filters are used to separate red blood cells, platelets and plasma from blood that is donated for transfusions. The remaining component, known as “buffycoat,” is rich in leukocytes, which fight disease and make the immune system function in a donor but can cause adverse reaction in a transfusion recipient.

Fighting disease, naturally
Mel Rothberg, Viragen's executive vice president, says interferons, proteins from leukocytes that are produced by the human body daily, will be used to make OmniFeron, one of the company's multi-subtype alpha interferons. OmniFeron is presently in the second phase of clinical trials in Europe for treating Hepatitis C, a blood and liver disease that afflicts millions.


Blood filters like these from Pall Corp. are used to filter donor blood, and scientists at Viragen believe harvesting proteins from them can provide treatments for diseases.
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“Having more access to white blood cells will give Viragen the ability to produce more OmniFeron products,” Rothberg says, adding that the agreement allows Viragen to use Pall's technology with other filter companies. Along with Pall, Viragen has leukocyte-sourcing agreements with various blood organizations, including the American Red Cross, America's Blood Centers and the German Red Cross.

The human body, Rothberg explains, can develop antibodies to the recombinant treatments. Because interferons are produced naturally, tthe body accepts this therapy preferably and more effectively. In fact, the body produces 22 subtypes of Alpha interferons, many of which have been targeted as the basis for broad-spectrum utilized drugs to treat multiple sclerosis and cancer.

Dr. Judy Angelbeck, senior vice president of Pall's Cell Therapy Division, says removing leukocytes from filters has a two-fold advantage.

“Taking leukocytes out makes blood purer and safer,” she says. “We are now discovering that those leukocytes are an excellent resource, a raw material that could be available to add to the supply of white blood cells for Viragen to make their drugs.”

Known as leukocyte reduction, Angelbeck says the process has been mandated in 10 countries, including Canada, England, Scotland and Portugal. Another 14 countries, like the United States, are moving toward routine blood filtration.

“In the U.S., more than 50 percent of the blood supply is already leukocyte-reduced,” she adds.

Proposed FDA guidance
At the time of this report, the U.S. Food and Drug Administration (FDA) a proposed guidance labeled, “Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion.”

The document is the FDA's present stance on pre-storage leukocyte reduction of whole blood and blood components intended for transfusion. It was formulated following discussions held at a FDA workshop, “Implementation of Universal Leukocyte Reduction” in Bethesda two years ago as well as at the 66th meeting of the Blood Products Advisory Committee last June in Silver Spring, MD.

At a recent meeting of the U.S. Department of Health and Human Service's Advisory Committee for Blood Safety and Availability, several advantages of leukocyte reduction were noted.

For instance, Nancy Chance, blood bank coordinator at Riverview Hospital (Noblesville, IN), reports an approximate $3.25-million savings, the majority of that stemming from a reduction in post-operative infections.

In a study of cardiac surgery patients, Dr. Neil Blumberg of the University of Rochester Medical Center reports a two-percent reduction in patient mortality as well as a cost saving of $1700 per patient who received leukocyte-reduced blood. He also notes that if leukocyte-reduced blood were used for cardiac surgery patients, 10,000 to 30,000 lives would be saved each year, a savings of $6 to $12 billion annually.

“Leukoreduction for cardiac surgery has the potential to prevent a greater number of deaths annually in the U.S. than deaths that have occurred in the last two decades from the entire AIDS epidemic due to transfusion,” Dr. Blumberg says. “We urge the committee to consider recommending a policy of leukoreduction of all transfusions to surgical patients.”

Comments on the FDA draft document should be submitted by Monday, April 23. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, room 1061, Rockville, MD 20857. All comments should be identified with the docket number listed.

Additional copies of this draft guidance document are available from: the Office of Communication, Training and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1448, or by calling 1-800-835-4709 or 301-827-1800, or from the Internet at http://www.fda.gov/cber/ guidelines.htm.

New Products


March 1, 2001

Capsule filter assembly
The 10-inch size gamma-irradiatable Kleenpak Nova capsule filter assembly features an integral positive action vent and drain valves. The self-contained, sanitary filters are intended for critical filtration applications such as the sterilization of pharmaceuticals, biopharmaceuticals, biologics, diagnostic reagents, serum, tissue culture media and culture media components. According to the manufacturer, key benefits of the product include high radiation resistance, low extractables, integral positive action vent/drain valves and high flow rates and throughputs.
Pall BioPharmaceuticals
East Hills, NY
(516) 484-5400

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Pallet
A custom “U-shaped” pallet fits underneath and moves wafer cleaning/polishing machines. The pallet has a four-zone regulation control to each caster (X & Y axis guide wheels), a low-profile aluminum extrusion and a quick-attach/detach handle.
AeroGo
(800) 426-4757

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Mass flow meter
The 760S/780S UHP ultra-high-purity thermal mass flow meters provide self-diagnostic and field-adjustment features as well as the ability to confirm or field-validate the meter's calibration and measurement accuracy. According to the manufacturer, the microprocessor-based transmitter integrates the functions of flow measurement, flow-range adjustment, meter validation and diagnostics in an explosion-proof housing. The meter is designed for gas distribution service in semiconductor fabs, pharmaceutical production and other ultra-clean processes.
Sierra Instruments Inc.
Monterey, CA
(831) 373-0200

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Pressure transmitter
The LPM/LPX 1000 Series will tolerate condensate on both sides of the sensing element without becoming unstable. The sensors utilize a proprietary Variable Inductance Technology and offer standard accuracy of 0.5 percent FS. Standard ranges are 0.1, 0.25, 0.5, 0.75 and 1 inch H2O in 2-wire, 4-20mA; or 3-wire, 1-5 Vdc outputs. Excitation voltage is 12-30 Vdc. An optional Local Loop-powered scaleable LED display is available.
Druck Inc.
New Fairfield, CT
(203) 746-0400

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High-temperature flowmeter
Mounted horizontally, vertically or upside-down, the HFF series require neither inlet nor outlet straight plumbing. The instruments withstand temperatures up to 400 degrees Fahrenheit and pressures up to 3500 psig. According to the manufacturer, the flowmeters deliver an accuracy of ±2.5 percent across the middle third of their scale. Three models are available: HFH-2-05 with a scale of 0.5-5.0 GMP, HFH-2-10 with a scale of 1-10 GPM and HFH-4-25 with a scale of 5-35 GMP. Units are priced from $275.
Dwyer Instruments Inc.
Michigan City, IN
(219) 879-8000

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Electric cylinders
Well suited for applications with a high concentration of airborne contaminants, the N2 series offers an improved anti-rotation guide flange system, smaller and more economical limited switches, free customized stroke length and a selection of factory-engineered options, according to the manufacturer. The products provide thrust to 2670 N (600 lbs.), speed to 760 mm/s and stroke to 420 mm. Four motor types are offered.
Industrial Devices Corporation
Petaluma, CA
(707) 789-1000

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Lockout/tagout line
Lockout hasps, valve covers, ball and butterfly lockouts, circuit breaker lockouts and lock-a-switch lockouts comprise a line of lockout/tagout products. Production safety personnel use these products to prevent accidents that could be caused by the unexpected start-up of equipment or the uncontrolled release of energy.
North Safety Products
Cranston, RI
(401) 943-4400

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Air-flow modeler
For optimizing HVAC systems, Flovent 3.1 software features an 'Explorer-style' browser and new solver technology offering significantly faster solution times. An enhanced CAD interface makes it easier to import geometry from CAD tools, and a new 'Command Center' module provides for efficient parametric studies and distributed processing. LACI and LMA can be calculated and plotted directly during post processing. Other enhancements include Contamination Removal effectiveness diagnostic tool, a heat exchanger 'SmartPart,' a multi-grid solver, simplified gridding and a Flo/MCAD module. Price starts at $19,500.
Flomerics Inc.
Southborough, MA
(508) 357-2012

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Inspection system
The FXS-160.40 X-ray inspection system is designed for the PCB manufacturing industry and is well-suited for off-axis inspection of planar devices. According to the manufacturer, the system is assembled according to a modular manufacturing principle—with x, y and z axes manipulation, tilt and rotate features and the company's X-ray tube. The detector can be rotated by 360 degrees and angled up to 50 degrees for complete oblique angle viewing without sample repositioning. The “high-brilliance” X-ray tube design provides image resolutions to less than 2 micrometers with geometrical magnifications up to 200x at any inspection angle.
FeinFocus USA Inc.
Stamford, CT
(203) 969-2161

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Circulating bath
The CC245 refrigerated and heated circulating bath automatically switches between air and water cooling. The unit is suitable for a variety of laboratory applications that require heating and cooling from -40 to +200 degrees Celsius. Features include a programmable controller, digital and analog interface, visual and audible alarms and connection for external temperature sensor.
Caron
Marietta, OH
(740) 373-6809

PTFE membrane
The Poro-Tex family of customizable expanded polytetrafluoroethylene (ePTFE) materials for medical and laboratory uses offers uniform porosity in pore sizes from 5 to 0.05 microns. The films are suitable for use in high-performance liquid chromatography, micro-filtration, venting media, test strip blotters and other uses in which the filtering of gases and liquids or wicking of liquids is required.
DeWAL Industries Inc.
Saunderstown, RI
(401) 789-9736

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Hose storage station
The HSU sanitary hose storage stations are designed for wall mounting and hold several hose assemblies from 0.5 to 2 inches in the vertical position to allow total drainage. The unit stores hoses, clamps and gaskets and conforms to FDA and 3A regulations. Featuring electropolished and passivated stainless steel construction, the unit measures approximately 6 inches square by 5.13 inches deep. Four models hold various combinations of sanitary clamp hose assemblies and accessories. Price is $145 each, including mounting hardware.
Integra Companies Inc.
Bedford, MA
(781) 275-2520

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Low-outgassing tape
Arclean 8906 has a permanent adhesive on one side and a cleanly strippable adhesive on the other side. The permanent low-outgassing adhesive is exposed upon removing the white polyester film release liner. Arclean 8906-61 includes a non-silicone polyester release liner protecting the strippable adhesive coating. According to the manufacturer, both products eliminate contamination and labor costs associated with adhesive residue during rework and also minimize HDD system crashes due to contamination. The bonding tapes are acrylic acid-free and feature ultra-low total VOCs and low extractable ions.
Adhesives Research Inc.
Glen Rock, PA
(717) 235-7979

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Flowmeter
Series RSF rotatable flowmeters provide fast turnaround direct readings of air and water on the same instrument. The polycarbonate tubeshield, which helps protect the borosilicate glass flowtube, is marked with an airflow scale on one side and a water flow scale on the other. To switch from one 127mm scale to the other, the user simply rotates the shield. Models can be configured for either vertical in-line or panel mounting as well as with or without valves. Maximum airflow rates are from 5 scfm to 30 scfm and maximum water flow rates are from 1.2 GPM to 5 GMP.
Dwyer Instruments Inc.
Michigan City, IN
(219) 879-8000

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Vacuum gauge
The DigiLine digital gauges include Piezo, Pirani, Piezo/Pirani and Bayard-Alpert/Pirani along with controllers for single and multiple gauge heads. The digital signal can be read directly into a PC or PLC. The products come with Profibus interface capabilities or an optional DeviceNet converter for implementation into an existing system controller. According to the manufacturer, all gauges offer a rugged metal housing, a choice of two serial interfaces and simple calibration through PC or Pfeiffer Vacuum controllers.
Pfeiffer Vacuum Inc.
Nashua, NH
(603) 578-6500

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Eyewash system
The Deluge line of plumbed emergency showers and eye/face washes offers emergency drenching and flushing. All products are made of stainless steel then powder coated for durability in harsh and corrosive environments. According to the company, the shower heads deliver full and complete body coverage, while the eye/face wash outlets direct smooth aerated water across the eyes and face to wash away contaminants. Two combination models are available: Model 940-00 combination shower and eye/face wash and Model 950-00 combination eye/face wash with foot actuator. Eye/face washes are available in four models: Model 960-00 floor-mounted, Model 970-00 floor-mounted with foot actuator, Model 980-00 wall mounted and Model 990-00 wall-mounted with foot actuator.
Fendall
Arlington Heights, IL
(847) 577-7400

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Chemical pressure transducer
Designated the PC-501 series, the transducers are for applications in the semiconductor, food and pharmaceutical industries. The diaphragm of the sensor, which is in contact with the media, is treated with a 0.1mm coating of Teflon and the housing in contact with media is constructed of all Teflon (PTFE). The series is available in dead-end or flow-through configurations, with a variety of fitting types. According to the manufacturer, accuracy is specified as ±25 percent full scale with a pressure range from 25 psig to 200 psig.
Pureron U.S.A. Inc.
Arleta, CA
(818) 775-0381

Airborne particle counter
The Met One R2313/R2315 particle counters offer a NEMA 4X IP66 type enclosure for pharmaceutical and bio-technical environments where exposure to chemicals such as solvents and disinfectants is common. According to the manufacturer, using a sample rate of 1 cfm, the counters give statistically good evaluations of cleaner environments such as ISO Class 5. The exterior metal components, including the box, are manufactured from 316L stainless steel. Extensive use of gaskets and O-rings prevents intrusion of dust and fluids into the counter enclosure.
Pacific Scientific Instruments
Grants Pass, OR
(541) 472-6500

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High-speed dispenser
The Millennium M-2010 dispensing system delivers high-speed and highly accurate dispensing for surface mount applications. It can be configured with the DJ-2100 DispenseJet non-contact head or the DV-7000 Heli-flow pump. The system comes with Fluidmove for Windows NT software. Pipelined fiducials speed up visual processing to improve throughput.
Asymtek
Carlsbad, CA
(760) 431-2678

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Filters
Filters are made of polypropylene with 74-, 149- or 177-micron screens, and 3/16-inch or 1/4-inch I.D. tubing can be adapted. Male or female threads or luer quick releases for removing and cleaning or replacing are available. According to the manufacturer, the filters protect mechanisms while cleaning fluid drawn through the tubing. Check valves can be added to operate as a foot valve. The offsetting feet in the filter assure that liquid passage can not be blocked.
Industrial Specialties Mfg. Inc.
Englewood, CO
(303) 781-8486

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Ball valve system
Type 265X modular ball valve system offers a variety of customized temperature, pressure, level and flow control products. Two basic versions are available: A standalone on/off unit with single or double action or a complete continuous process control valve system with the Type 8630/31 TOP control head unit. Applications include food and beverage processing, water treatment and water distribution systems, chemical and process engineering and general processing industries.
Burkert Contromatic Corp.
Irvine, CA
(949) 223-3100

Static decay meter
Model 406D is a two-part system consisting of a Faraday cage, which houses the non-contacting sensor and sample holding electrodes, and the control unit, which houses the power supply, analog meter readouts, timer circuitry and user controls. According to the company, the product meets the test requirements for static charge dissipation as required by applicable DoD, NFPA and EIA test specifications. The system can be used in research and development or quality control applications.
Electro-tech Systems Inc.
Glenside, PA
(215) 887-2196

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Datalogger
Flash Link comes in a variety of models for temperature and temperature/humidity, with combinations of external and internal probes. In addition to the rugged water-resistant ABS case, 8K non-volatile memory and direct printer port connection, the product features a green “On” and red “Alarm” LED indicators and a replaceable, one-year battery. The product's Program Manager operates on Windows/Windows NT with customizable features including file naming and programmable data fields.
DeltaTrak Inc.
Pleasanton, CA
(510) 467-5940

Monitor
The M100 provides continuous monitoring of multiple ground points at workstations or within process equipment. The product offers either 8 or 16 channel ground monitoring with audible and red/green LEDs per channel for standalone operation and a digital output for direct interface with the manufacturer's multiplexing software system. The product can detect low level reference ground problems, AC spikes or complete ground loss.
Novx Corporation
San Jose, CA
(408) 998-5555

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Quick-disconnect couplings
For high-flow, ultra-pure aggressive chemical fluid applications, the ChemQuik CQN08 series features a patented non-spill design that enables safe, instant line disconnects and a metal-free, spring-free flow path. The couplings are made of ultra-pure virgin PTFE and feature Chemraz seals, which minimizes extractable contaminants, making them well suited for most wet process chemicals used in semiconductor, pharmaceutical and laboratory applications. They are designed to operate within a pressure range of 0 to 80 psig and a fluid temperature range of 0 degrees Fahrenheit to 150 degrees Fahrenheit.
Colder Products Company
St. Paul, MN
(651) 604-4336

Multipolymer compound
Transparent Vu-Stat C-37—a static-dissipataive acrylic multipolymer compound—provides permanent ESD protection to static-discharge-sensitive electronic parts, even after repeated washing, and is not dependent on humidity. It provides 80 percent light transmittance in standard 1/8-inch thicknesses. The compound is used in the packaging and transportation of electronic components as well as cleanroom instruments, medical applications and business machines.
CYRO Industries
Rockaway, NJ
(973) 442-6000

Soles
Quantum soles 2100 series features a non-skid interior for greater wearer comfort and an extended life cycle. The sole's design accommodates cross-industry applications for gamma compatibility or ESD performance. According to the manufacturer, the product returned exceptional test results in the following categories: abrasion resistance, ESD, rapid static decay time, chemical testing, gamma sterility and the wash-n-wear test.
Prudential Cleanroom Services
Irvine, CA
(800) 767-5536

Pressure sensor/switch
Type 8311 is designed to switch a valve, relay or pump and establish a simple On/Off control loop. The unit measures line pressure ranges up to 720 psig and offers accuracy specified at ±1 percent of full scale with 0.25 percent repeatability. A programmable set point can be set locally with the three push buttons on the display or externally from a PLC/computer over a 4-20mA loop. Applications include control of air or fluid pressures in tanks, the monitoring of flow pressures in water treatment systems or control of tank level via hydrostatic head.
Burkert USA
Irvine, CA
(949) 223-3100

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Microcentrifuges
Ventilated Models 5520 and 5521 and refrigerated Models 5522 and 5523 have applications in medical, industrial and scientific laboratories. The units can achieve centrifugal force of up to 16,250 xg, a speed range of 1000 to 13,200 RPM and a temperature range (refrigerated models only) from -9-+40 degrees Celsius. Full speed is reached within 15 seconds. Operation modes include automatic time run, momentary spin and continuous operation.
Thermo Forma
Marietta, OH
(740) 373-4763

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Particle counter
The KS-17A is compatible with semiconductor process chemicals, including HF from 0.06 micron and measures at the sensitivity limit >0.06 micron as well as >0.1 micron. It operates at 10 ml/min using an external flow controller. The built-in leak detector protects the electronics from etching. The counter operates in two modes: with computer and monitoring software for maximum 20 RION-counters of any type or with the controller KZ-70 and a printer as a standalone system.
Fluid System Partners GmbH
Germany
+49-7250-76-520

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Dry strip system
The Enviro advanced dry strip system is a solvent- and acid-free photoresist stripper and residue removal tool. According to the manufacturer, it completely eliminates the need for wet stripping processes that use hydroxyl-amine-based or other types of solvents. This multi-chamber, single-wafer (150-200mm) dry resist and polymer-removal system incorporates both microwave downstream and low-energy RIE plasma. Resist removal is monitored by optical emission with automatic endpoint detection. Six process gases can be used for resist stripping and residue cleaning.
Ulvac Technologies Inc.
Methuen, MA
(978) 686-7550

Air filter
An all synthetic media filter, the Z-Line MR-11 pleated air filter achieves a MERV 11 rating under the ASHRAE Standard 52.2-1999 test method. The product is available in 1-, 2- and 4-inch depths in most standard and special face dimensions.
Glasfloss Industries Inc.
Dallas, TX
(214) 741-7056

Liquid particle counter
Intended for the semiconductor, hard disk drive and flat panel display industries, the ChemShield online LPC system enables fast yield ramps and tight production control of critical liquid systems. Utilizing PCX counter technology, the product offers 32 programmable channels for collection of particle count data over standard RS-485 communications line. It was designed for use with Particle Vision online software, but a software developer's kit is available for end users to develop their own drivers using FIX- and OCX-based protocols.
Pacific Scientific Instruments
Grants Pass, OR
(541) 479-1248

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Piping system
The Flo Clear HPC (high purity clear) pipe and fittings product line is molded from polyvinylchloride to ensure system uniformity and consistency in clarity. The products are manufactured from FDA Title 21 and NSF Standard 61 Drinking Water Systems Components-approved materials. Systems are available in sizes from 0.5- through 6-inch IPS sizes with “Streamline” socket style fitting configurations.
Flo Safe Inc.
Kansas City, KS
(800) 517-2002

Personal compliance monitor
An accessory designed for CleanTech Automatic Hand and Glove Washing Systems, CleanTech Personal Compliance Monitor enables employers to measure and review individual employee hand and glove washing compliance. Each employee has a number, which he/she enters into a keypad attached to the system. The system monitors the frequency and duration of the hand or glove wash. At the end of the shift, or whenever the supervisor desires, he can download the data into a plastic key. The key holds a computer chip that downloads into the supervisor's computer. The information can be stored, sorted, printed, reviewed or deleted.
CleanTech Handwashing Systems
Englewood, CO
(800) 932-7707

Gas purifier
GateKeeper model 10M inert gas purifier is used for removing ammonia in high-flow point-of-use applications. The unit removes moisture, oxygen and other contaminants, is hydrocarbon-release free and requires no heat or power. The body is constructed of 316L stainless steel, internally electropolished to 10Ra, and is cleanroom welded, tested and packaged for maximum contamination control. The product is rated up to 1000 slm of NH3. According to the manufacturer, the purifying media does not contain organics that can outgas. In addition to ammonia, arsine, phosphine and silane can be purified with this product.
Aeronex Inc.
San Deigo, CA
(858) 452-0124

Membrane adsorbers
Mustang Q disposable membrane adsorbers remove DNA from downstream processes, offering an alternative to traditional chromatography columns that need packing, cleaning and cleaning validation. Capsules and cartridges, which can be sterilized prior to use, are available in a variety of sizes for process batches of 10-10,000 L. A companion product, Mustang Q Coins and coin holder aid in scaled-down process development and validation. The 0.35-ml bed volume enables the user to examine a variety of process parameters, including host cell protein reduction, with minimum consumption of product.
Pall BioPharmaceuticals
East Hills, NY
(800) 859-3245

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Vacuum inlet trap
The MV Multi-Trap Model IC features water-cooled internal coils that provide more than 200 in2 of surface area, along with two customizable filtration stages to condense and collect heavy particles. According to the manufacturer, this high-capacity vacuum inlet and exhaust trap has more than 500 in3 of space to accumulate solids and keep production lines operating longer. It is constructed from all stainless steel and is offered with ISO-80 or ISO-100 flanges.
MV Products, Division of Mass-Vac Inc.
North Billerica, MA
(978) 667-2393

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Customizable ePTFE
The Poro-Tex family for medical and laboratory uses, including venting media, microfiltration and analytical equipment, offers uniform porosity in a range of pore sizes from 5 to 0.05 microns. Poro-Tex is used in cleanroom garments and in protective laboratory and medical clothing. Its anti-stick properties make it resistant to particle buildup, and its porosity results in a breathable fabric.
DeWAL Industries Inc.
Saunderstown, RI
(401) 789-9736

Decontamination chamber
The UV-360 decontaminates pre-sterilized materials entering a cleanroom. The operator removes an outer wrap, then places an inner package in the chamber. The package is exposed to the germicidal frequency of ultraviolet light from 45 seconds to four minutes, which reduces the bioburden by up to 6 logs. The package then passes into the asceptic area.
Despatch Industries
Minneapolis, MN
(612) 781-5361

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UVC emitter
The Twist Lock UVC Emitter is designed for side access installations in commercial HVAC systems where access to within the plenum is difficult or restricted. Up to six units can by physically and electrically connected, forming a string that slides in and out of an air handler. The product's high output in moving and/or cold air prevents microbial growth and destroys microorganisms.
Steril-Aire Inc.
Cerritos, CA
(562) 467-8484

Tube benders
Two new bench-top tube benders deliver consistent bends from 1-180 degrees for such tubing materials as carbon steel, stainless steel, copper and aluminum in sizes up to 1 inch (30mm) in outer diameter. A manually operated and an electrically operated unit are available. The aluminum benders can be located on a bench or placed on an accessory tripod.
Swagelok Company
Solon, OH
(440) 349-5934

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Impeller
Multiflow is reportedly the first fully adjustable blade, mixed flow impeller. According to the manufacturer, the technology incorporates extensively researched and patented impeller blade geometry and a unique adjustment between special inner and outer fixed shrouds. The impeller blade angles are positioned in one of five standard settings for each impeller diameter to give a range of flow/pressure and power alternatives.
Continental Fan Manufacturing Inc.
Buffalo, NY
(800) 779-4021

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Quality control cultures
For use in quality control testing of microbiological media, reagents and identification systems, the Bactrol Plus vials of lyophilized microorganisms offer advantages over the Bactrol Disks, which they replace. To use the product, the vial must be reconstituted with 0.25 ml of Trypticase Soy Broth, saline or distilled or deionized water for aerobic bacteria and fungi. Anaerobic and microaerophilic bacteria should be rehydrated with 0.25 ml of Thioglycollate Broth. The resulting suspension is ready for inoculation onto appropriate plating media. According to the manufacturer, cultures contained in the vials are derived from nationally recognized culture collections such as the American Type Culture Collection. The vials are for single use and come packaged in pouches of five vials.
BD Diagnostic Systems
Sparks, MD
(410) 316-4467

Humidity controller
Model 514 automatic humidity controller indicates and controls relative humidity over the entire 0-100 percent range in any sealed chamber. The system comprises the controller, which is housed in an ABS plastic case, and the sensor assembly connected by a five-foot cable. The sensor is mounted inside of the environment to be controlled. The user selects the mode of operation (humidify or dehumidify) and depresses the momentary selector switch to dial in the desired set point. The product compares the set point with the humidity level inside the chamber and will raise or lower the level as required and maintain the selected level to within ±0.5 percent RH, according to the manufacturer.
Electro-Tech Systems Inc.
Glenside, PA
(215) 887-2196

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Filter assembly
The PhotoKleen EZD filter assembly speeds filter changeout, minimizes operator exposure and decreases system downtime, according to the manufacturer. It also minimizes photochemical waste. The filter assembly consists of a PTFE head manifold interface and an HDPE capsule filter. The capsule-style design provides top in/top out flow direction and one-step quick filter disconnect.
Pall Corporation
East Hills, NY
(516) 484-3600

Dust collector cage
The dust collector cages are constructed of 11-guage galvanized wire using a 12 vertical wire design, which extends extra life support. Previously, the cages were only available via OEM equipment suppliers. Special venturi/ cage assemblies and 304 and 316 stainlees steel and epoxy-coated cages are also available.
Sly Inc.
Cleveland OH
(800) 200-9530

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Seating vinyls
Grade 2 upholstery vinyls have been added to BioFit's line of ergonomic seating for cleanrooms. One series has an abrasion-resistant rating exceeding 75,000 double rubs. The other rates in excess of 60,000 double rubs. The vinyl provides comfort, and the textured surface provides friction between the garmented worker and the chair. Several patterns are available for use in ISO Class 3-6 cleanrooms. The vinyls also meet several nationally recognized flammability standards.
BioFit Engineered Products
Waterville, OH
(419) 823-1089

Portable particle counter
Model 3313 and Model 3315 deliver a 1.0 cfm (28.3 lpm) sampling rate with either 0.3 micron sensitivity (3313) or 0.5 micron sensitivity (3315). Operating from either AC mains or batteries, the Model 3313 can provide continuous monitoring of clean areas, storing up to 2000 readings in its memory buffer. The stored data can be reviewed on the front panel, printed or downloaded to a computer. All six channels are displayed simultaneously on the front-panel display, plus optional environmental sensor data, such as relative humidity, temperature or air velocity. Alarms can be set for all measurements.
Pacific Scientific Instruments
Grants Pass, OR
(541) 479-1248

Dust collector
The unit has been used to collect limestone dust at this process. It uses a settling chamber designed to eliminate the need for a cyclone pre-filter, which is used in similar applications. Dust enters the collector through a high-side inlet, which reduces the settling velocity and lets the dust drop out of the air stream. With less suspended dust, wear on the filter bags is reduced.
Sly Inc.
Cleveland, OH
(800) 200-9526

by Laureen Belleville

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Antistatic flooring is especially important for the electronic manufacturing industry for safety and product performance. Further, electronics manufacturing requires that flooring posses both consistent cleanliness and static dissipative properties.

Consider that an integrated circuit can suffer catastrophic damage from as little as 50 volts, while manufacturing personnel can generate more than 10,000 volts by simply walking across a production floor. The use of electro-static discharge (ESD) safe flooring, in conjunction with ESD footwear, is common practice to combat this problem.

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Most ESD flooring manufacturers test and report their flooring products based on three electrical tests: the static decay test, body voltage generation and electrical resistance. Additional tests should be performed in conjunction with ESD footwear and street footwear to determine the floor's true capability of preventing ESD-induced damage.

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Top: UTP's ESD Quartz Series 9000; Middle: Dycem's Work-Zone flooring; Bottom: A sampling of UTP's ESD VinylTile.

Also, consider traffic levels when choosing flooring. In areas with very little traffic, such as an engineering lab, vinyl tile with infrequent ESD wax applications may be appropriate. In heavy traffic areas, the use of vinyl tile is not recommended if aesthetics are a priority. Rubber floors maintain their appearance for longer periods. “Poured” and “rolled on” floors require greater maintenance.

Distributors of Cleanroom Antistatic Flooring:

  • Architectural Floor Systems Inc., Arlington Heights, IL, Tel: (800) 323-6792, Fax: (847) 394-3753, www.techtonics.com
  • Clean Rooms West Inc., Tustin, CA, Tel: (800) 772-6634, Fax: (714) 258-7777, www.cleanroomswest.com
  • Liberty Industries Inc., East Berlin, CT, Tel: (860) 828-6361, Fax: (860) 828-8879, www.Liberty-Ind.com
  • MSS Clean Technology Inc., Tucker, GA, Tel: (770) 938-1700, Fax: (770) 938-5991, www.msscleantech.com
  • Ultrapure Technology, Suwanee, GA, Tel: (800) 932-0309, Fax: (770) 932-0809, www.ultrapuretechnology.com


Manufacturers of Cleanroom Antistatic Flooring
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Too many shades of gray


March 1, 2001
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by Richard A. Matthews

Webster's dictionary defines ethics as “standards of conduct adopted by professionals… study of right and wrong in actions.” I see a deterioration of ethics in the cleanroom industry. There are too many shades of gray in the cleanroom business. I started in this business when cleanrooms were called “white rooms.”

A less clean “white room” was called a “gray room,” and unfortunately, there was no clear definition of what “gray” was.

So the term cleanroom was adopted with specific definition. There were three cleanrooms (Class 100, Class 10,000, and Class 100,000) per the original US Federal Standard 209. With the new ISO Standards, there are now nine major classes of air cleanliness, plus an additional 72 sub-classes for a total of 81 classes of air cleanliness. This is certainly enough to define the very particular shade of gray you need. The air cleanliness class nomenclature system has saved the cleanroom community from having to create sample paint chips like the kind you can pick up at your local paint store.

But these are not the shades of gray I am most concerned about. Specifically, I am disturbed by the ethical “shades of gray” currently found in the cleanroom business environment.

There will always be a need for “buyer beware.” Quality levels vary, construction methods vary, attention to detail varies, business philosophies differ, and some people are downright dishonest while others are just ignorant. Buyers must carefully assess with whom they are doing business.

The same is true for vendors. They need to be conscious of whom their customers are. All business is conducted based upon the good faith concept. The Uniform

Commercial Code, which covers all business activity in the USA and in many other countries, is a law whose foundation is this good faith concept.

But to assume all business is conducted in good faith is naive. Let me cite a few examples from my own experience.

A potential customer called and asked for help in solving a contamination control problem. We visited his facility and offered a series of options for fixing his problem. Actually, there were six options with different cost levels.

There were further discussions and value engineering, and the potential customer agreed that one particular option met all of his technical and financial criteria. We were advised that we would receive a purchase order shortly.

However, we found out that this client put our proposal on his letterhead, put his title block on our drawings, and sent our design out for competitive bidding to some other vendors. One of these other vendors, who had no investment of time or cost in solving the client's problem through site visits, design and engineering talent received the client's order for this project at a lower cost than we proposed.

I give you this example not for the purpose of crying sour grapes. I ask for your professional opinion: who owned what and, in turn what are the professional responsibilities of each party?

As I view it, a customer has four clear options for solving a contamination control problem:

  • Take care of the problem in-house with internal people and talent.
  • Hire an A & E firm or consultant to prepare a plan and specification and put this out for competitive bid.
  • Invite two or three design/build contractors to offer competitive solutions but use care not to divulge competitive information.
  • Hire a design/build contractor to solve the problem.

Shades of gray ethics intrude when a client gets greedy. He either plays one vendor against another vendor from option (3) by revealing competitor's information, or he reverts to fraud by taking a vendor's information and re-labeling it as his own, then seeking lower costing as cited in the example above.

In our company we use a statement that essentially says, “The information contained in the proposal is the property of Filtration Technology Inc. and may not be reproduced or transmitted to other parties without the consent of Filtration Technology Inc.” This statement is designed as a starting point for further business activity with a client.

I have personally been involved in over 500 turnkey cleanroom projects as well as being a component supplier for many others. I recognize that in a competitive business world everyone wants the best value for his or her money. But there seems to be a creeping philosophy of “I deserve something for nothing.” “I really do not have time to solve my own problems. You do it for me so I can go out and buy it cheaper.”

This brings us to the issue of when does the solution to a contamination control problem belong to the cleanroom end-user? In my second example we solved a significant contamination control quality/yield problem for a client. He purchased a number of units from us and we continued to modify and improve our design, thereby increasing his yield and profit. Then, he decided to bring in a competitor of ours to see if there was a cheaper, better way to build our units. To make things easy for this competitor, he gave him a set of our drawings, the same “as built” drawings that we had provided to the customer as part of our obligation to him.

Now, to whom do these drawings belong? Should they be given to our direct competitor? What obligation, if any, does this customer have to us for solving his problem and improving his yield?

Customers with problems should recognize from the beginning that when they ask for help they have an ethical obligation to that vendor if they use his ideas. Should it be necessary for vendors to ask customers to sign secrecy agreements before solving problems? The reverse is almost always true.

You always hear the adage “Let the buyer beware.” I say, “Let the vendor beware.” I recognize that we are all busy. But we should never be too busy to compromise our ethics.

One of the key strengths of our democratic society is good business ethics. Do we really want to contribute to the internal deterioration of this society through poor business ethics?

Richard A. Matthews is founder of Filtration Technology Inc. (Greensboro, NC) and president of Micron Video International. He is chairman of the International Organization for Standardization Technical Committee ISO/TC209 “Cleanrooms and associated clean environments,” and past president of the Institute of Environmental Sciences and Technology. He is on the CleanRooms Editorial Advisory Board.

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by Ken Goldstein, Ph.D.

>We recently looked at the subject of cosmetics in cleanrooms. It appears that people are once again asking if it is acceptable to wear these substances inside contamination-sensitive areas. The short answer suggested was a definite “no.”

The sole exception to this rule was moisturizing lotions for those people with dry flaking skin. The implication here was that while lotions were a potential contaminant, the significant numbers of skin flakes were more likely to pose a serious contamination risk than the lotion used to minimize them. The reasoning behind the rule of “no cosmetics” was given as the first rule of contamination control: never bring anything into the cleanroom unless it really and truly needs to be there (as defined by process and product requirements). Because cosmetics do not pass this first critical test, they should be excluded from the cleanroom. Always.

Recall also that we briefly mentioned the list of possible contaminants found in cosmetics: iron (Fe), aluminum (Al), titanium (Ti), magnesium (Mg), potassium (K), sulfur (S) and carbon (C). In the microelectronics world (semiconductors, integrated circuits, storage media and devices, flat panel displays, etc.) these are all capable of harming both quality and reliability levels. Aerospace products are similarly susceptible to contamination. When considering pharmaceutical products, these contaminants are suspect because they commonly slough off people with the potential for carrying bacteria and other bio-burden with them.

The history of this subject is interesting as much as for what is not there as for what is.

During the early 1980s, just a few significant studies told us all we needed to know about contamination, cosmetics and human debris. Since then, this has been essentially a closed topic.

The early studies were sufficiently alarming that the practice of wearing cosmetics in cleanrooms was simply banned. And short of refuting the early research, additional studies were unlikely to be worth the time and cost.

The seminal research was reported in “Cosmetics in Clean Rooms” by Phillips, Auser, Meikel, Baldwin and Washington and published in the proceedings of the Institute of Environmental Sciences, 1984 (p. 317-323). At the time, the researchers were working for IBM's disk drive division in San Jose, CA.

First, note that the term “clean room” was written as two separate words in the title and throughout the article, standard terminology at the time. As described in the paper, “This study was made to determine if the use of cosmetics by clean room personnel would add contamination to the clean room environment and/or to the product.”

It was suggested that these particles might be “transferred by air currents or by touch.” First the researchers divided the cosmetics into classes representing the most commonly used items: lipstick, blush, powder, eye shadow and mascara. Then, using a professional cosmetologist to assist them, the researchers determined the approximate average amount of cosmetic applied in a single facial application. Finally, they looked at the transfer rates of these materials from the faces of the test subjects to contamination-sensitive target areas. Recall that previous to this study, no one had looked at this.

The results were startling. First, using SEM/EDX, they identified 15 separate elements in the cosmetics. These included sodium, magnesium, aluminum, silicon, phosphorus, sulfur, chlorine, bismuth, potassium, calcium, titanium, manganese, iron, barium and zinc.

Just scanning the list of ingredients on the packages yielded 48 different compound chemicals. With the assistance of the cosmetologist, the researchers found that the average number of particles (0.5 micrometers and larger) contained in a typical facial application ranged from a low of 82,000,000 for eye shadow to a high of 3,000,000,000 for mascara. The total particle count was 5,100,000,000 per application.

The particle transfer data was similarly alarming. The air current test was done at velocities of 0.25 to 0.3 m/s, well under the typical figures found in most unidirectional flow cleanrooms. The only good news was that lipstick and mascara showed no transfer by air currents. Unfortunately, the blush, powder and eye shadow all transferred moderate to heavy amounts of the cosmetics.

The transfer by touch test involved a subject's cheekbone being touched by another individual, wearing freshly gloved hands, very lightly in order to transfer the least number of particles. According to the researchers:

“The touch was barely felt by the individual wearing the cosmetics and in no case was the surface of the skin visibly depressed.

This 'touch' is considerably lighter than that used to relieve an irritation.” After this face-to-glove transfer, the glove was used to pick up a contamination-sensitive manufactured part at a specific location. This specific location was then subjected to SEM/EDX analysis. The results here ranged from bad to worse. The eye shadow transferred moderately heavy amounts using the touch test. The lipstick, blush, powder and mascara all transferred very heavy amounts.

Summarizing, the cosmetics all contained significant numbers of particles per facial application. These numbers ranged from the tens of millions to the billions. The blush, powder and eye shadow transferred moderate to heavy amounts via low velocity air currents.

All of the cosmetics transferred heavy amounts using an extremely light touch. The authors concluded: “Cosmetic products contain large numbers of particles which are of the size associated with …defects. The particles can easily be transferred by air currents and touch. In fact, individuals who use cosmetic products have been shown to shed particle materials associated with the cosmetic products. The individuals therefore pose a threat to the 'clean room environment' which is necessary for the production of efficient electronic products.” Finally, note that while the researchers were involved specifically in microelectronics, the particle transfer rates established would be valid for any contamination-sensitive industry and product.

With all of this as background, the no-cosmetics rule is easy to understand. But if we take a long-term look at the future of cleanroom technologies, we may arrive at some surprising conclusions that contradict everything I have suggested until now. Stay tuned and keep an open mind.

Dr. Ken Goldstein is a principal with Cleanroom Consultants Inc. (Scottsdale, AZ) and is an expert in planning and designing cleanrooms and ultrahigh purity systems. He has been associated with the cleanrooms industry for 20 years, and is a senior member of the IEST. He is active in WG-012 (Cleanroom Design) and WG-028 (Minienvironments).

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by Elaine Kopis

As a trainer, I have found that focusing on standard operating procedures (SOPs) alone, while important, does not benefit an organization as much as providing a holistic approach to training cleanroom personnel.

Control of cleanrooms begins and ends with effective training of the personnel who work within these highly controlled environments. To put it simply, training equals compliance.

It is through training that cleanroom personnel gain an understanding not only of specific job functions but also of the foundational rationale for the restrictions that govern cleanroom operations.

This foundational education should include training in the core competencies required for proper operation of drug manufacturing environments. These core competencies include: Current Good Manufacturing Practices (cGMP) requirements; basic microbiology; particle control principles; and principles of cleaning and microbial control. An understanding of these core competencies will provide a strong foundation for training in other specific practices designed to prevent contamination, such as gowning and aseptic practices.

Current GMPs govern the production of drugs and medical devices. These are the laws they apply to manufacturers. Training in cGMPs is not only a legal requirement but also makes sense from the perspective of enforcing and justifying specific required functions and behaviors.

In many facilities, cGMP training for all full-time employees and even vendors is routine. Current GMP training should include a brief history of the development of the Food, Drug and Cosmetics Act in order to reinforce the need for this legislation and the events that led to the development of these laws. Bringing this historical element to the training program adds a sense of importance to the training and provides a key element of successful training driven by the human element of this story—a story that illustrates that lack of appropriate control in drug production can lead to serious injury and death.

Anyone involved in cleanroom operations for drug or medical device products should receive training in basic microbiology principles. The value of this training is that it provides a foundational understanding of the nature of microorganisms, including growth properties and risk factors associated with microorganisms. Compliance is greatest where understanding is complete.

Cleanrooms are classified by particle counts and size. Cleanroom staff should be trained on particle sources and the fact that most microorganisms do not exist as discrete cells, but rather as aggregates attached to particles of some type.

Measures to minimize particle shedding should be addressed during training and through SOPs. These measures should include gowning practices, traffic flow, personnel movement practices and personnel hygiene.

Training should focus on the nature of particles, the sources of particles and prevention of particles. Additionally, the risk factors contributed by particle contamination should be included. This is the issue that ties together the relevant SOPs with the core issues being addressed by the SOPs, namely prevention of contamination.

Nowhere is an understanding of these principles more important than in drug and medical device manufacturing areas. This is especially true of aseptic manufacturing areas. In addition to training on specific job functions and cleaning SOPs, cleanroom personnel should be given an overview of the chemistry of cleaning and microbial control. This will allow for a greater appreciation for the technology involved in cleaning and decontamination—and for the necessity of using harsh and potentially toxic materials.

A thoughtful, holistic approach to training cleanroom personnel, which includes core competencies and job functions, will lead to compliance based on a complete understanding of the issues behind the procedures.

Elaine Kopis is the Director of the Technical Services Department for the Scientific Division of STERIS Corporation. Her focus area is microbial control in cleanrooms and other critical environments. She is a member of the CleanRooms Editorial Advisory Board.