March 11-13, 2008
Tag Archives: Clean Rooms
Contract manufacturers are realizing that risk assessments demonstrating the absence of cross-contamination between products are essential for regulatory inspection.
By George Miller
Regulators are raising the bar for the majority of drugs in development, causing some problems for manufacturers but wreaking havoc with contract manufacturing organizations. CMOs
A cleanroom should be planned as an environmental control system for best results
By Thomas E. Hansz, Facility Planning & Resources, Inc.
Not too long ago, I sat down with a prominent researcher in advanced materials to discuss his upcoming cleanroom requirements. He was currently working in an ISO 6 or Class 1000 laboratory. I asked him to describe the critical nature of the contamination control required for his research. His response was, “I need Class 100.” All right, but what about the type, size, and concentration of “killer particles” that would negatively affect his work? Again, his response was, “I need Class 100.” It took quite a while to convince him that cleanroom design does not begin with designing to the next higher level of cleanliness, but that understanding the contamination characteristics detrimental to the process leads to determining the appropriate level of cleanroom classification. We finally concluded with a sound understanding of his needs.
This example is not uncommon. When one equates cleanroom quality with cleanroom classification levels, it can become a very expensive trap. One of the main objectives of a cleanroom design should be to establish and maintain the appropriate level of contamination control. This will be a recurring theme in both this article and the next part on ISO 7 cleanrooms.
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Like art, the condition of “cleanliness” depends on the point of view of the cleanroom user. So it is important to bear in mind that there are no absolutes for cleanliness. Think of a cleanroom as an environmental control system (part fixed facility and part continuous process) that, once in use, requires regular monitoring and strict adherence to defined operational protocols for the life of the facility.
Therefore, unlike other facility types, there are three critical aspects required in establishing a successfully functioning cleanroom:
- Defining the cleanroom program (identifying contaminants; determining size and concentrations; establishing contamination control criteria; identifying process services; and defining facility systems)
- Developing design and construction (proceeding from a thoroughly developed definition; coordinating process systems with facility systems; developing operational protocols; and coordinating intent with realization)
- Implementing/operating the cleanroom (finalizing operational protocols; developing an appropriate cleaning and maintenance program; and instituting effective management over cleanroom operations)
Who needs an ISO 5 cleanroom?
So, how does all this apply to an ISO 5 cleanroom and who needs one? Generally, the aerospace/defense, microelectronics, and semiconductor industries have been the primary users of ISO 5 cleanrooms. This is by and large due to the scale of their work with silicon-based wafer fabrication. During the 1970s and into the 1980s, protecting silicon-based products during the fabrication process relied primarily on reducing the number of 0.5-
The successful implementation of a CIP system is determined by cost effectiveness, completion on schedule, and reliable cleaning
By Sally J. Rush, Seiberling Associates, Inc.
Regardless of the type of facility
Isolators play an important role in reducing contamination through exposure to airborne particles and human contact. Developers of enclosed environment equipment must not only focus on the cleanliness of the internal atmosphere, but also keep in mind how the design will affect user experience and safety.
Compiled by Jason Andrukaitis
Built-to-order isolation equipment
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Clean Rooms International has been providing built-to-order isolation equipment since 1982 and has developed the expertise necessary to provide flexible solutions for customers. The company develops creative products for adding clean air, extracting contaminants, isolating major problem areas, and more. An isolator can mean many different things, so Clean Rooms International provides customization of isolation equipment. Customers produce the requirements, and the company will develop an approach that is unique to each business. For product questions, estimates, or to place an order call 616-452-8700 or e-mail sales@clean
roomsint.com.
Clean Rooms International
Grand Rapids, MI
www.cleanroomsint.com
Stent coating isolator
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EnGuard Systems, an established leader in the design and manufacture of isolators, has developed a stent coating isolator for use as an integral part of the safe and efficient development of coronary artery stents. In this custom application, the company’s ability to understand the process resulted in ergonomic integration of the process, the equipment, and the isolator. The stent coating isolator employs multiple safety devices and a process logic controller for the complex management of hazardous gases and interlock systems. EnGuard’s practical approach to isolation technology was developed from many years of hands-on pharmaceutical manufacturing experience. In addition to this application, the firm provides isolators for totally contained processing of potent compounds, aseptic applications, and parenteral products. EnGuard’s portable enclosures provide maximum interaction with the process while protecting the product and the personnel. EnGuard Systems provides complete isolator service from initial concept to validation support.
EnGuard Systems
Indianapolis, IN
www.enguardsystems.com
Controlled atmosphere gloveboxes
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Precise™ controlled atmosphere gloveboxes offer high-end construction and features at economical prices. These gloveboxes maintain a leak-tight, controlled condition environment for applications such as organometallic chemistry, alternative energy cells, and hydrophilic chemicals. The boxes are capable of maintaining low levels of oxygen (as low as 5 ppm) or moisture (as low as 50 ppm). Features include a one-piece molded, medium-density polyethylene shell, which is chemical-resistant and easy to clean; a viewing window of 1/4-inch thick laminated safety glass; and six manual valves for purging, filling, and drying train connections. Space-saving inner and outer transfer chamber doors that pivot upward are counterbalanced and equipped with quick-latches and pressure relief valve. The generous 13 ft3 interior of the main chamber meets Class 1 atmosphere conditions for leak rate per ISO 10648-2 test methods. The transfer chamber is 11 inches long and also features a pressure gauge with readings from 0 to
Compiled by Jason Andrukaitis
Wireless temperature monitoring system
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Accsense’s wireless monitoring system helps medical, pharmaceutical, and laboratory personnel keep track of temperatures, CO2 levels, humidity, and other measurements. The system works well with refrigerators, freezers, and incubators, keeping automated logs and sending alarm notifications via e-mail, phone, or pager. The system can be set up quickly with no additional hardware or software. An internet connection is all that is required to run the system. The device complies with USP 797, CLIA, JCAHO, FDA, AABB, and other industry regulations.
Accsense, Inc.
Santa Barbara, CA
www.accsense.com
Two-component mixing packages
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APS’s Meg-A-Pak™ is now available in 800-g packs for two-component reactive adhesives and sealants in flexible pouches. The package is simple, safe, and easy to use, and provides a combination packaging/mixing burst seal container for a variety of resin systems such as epoxies, acrylics, urethanes, silicones, conductives, polysulfides, adhesives, and other materials. For more information call 800-222-1117.
Adhesive Packaging Specialties, Inc.
Peabody, MA
www.adhesivepackaging.com
Stainless-steel overbraided PTFE hose
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AdvantaPure is now offering stainless-steel overbraided PTFE hose in six variations. Called APFOS, the hose offers the purity of PTFE fluoropolymer with the durability and enhanced pressure carrying capabilities of stainless steel. The hoses can be used for applications in the chemical, food and beverage, pharmaceutical, and other high-purity industries. The core provides non-restrictive flow and an inert surface to transport critical fluids. The hose handles temperatures ranging from
Contamination control is an international industry. And, as you read this special show issue of CleanRooms magazine, there can be no doubt as to the international breadth and scale of the contamination control profession. Being distributed at this year’s CleanRooms Europe Conference and Exhibition, CleanRooms magazine is proud to be at the forefront in advancing and disseminating the very latest in contamination control technology and expertise to users and providers around the globe.
A quick scan of this year’s all-new comprehensive conference program for CleanRooms Europe gives a good indication of the health and vitality of the contamination control industry, covering both long-established user industries like microelectronics and pharmaceutical manufacturing as well as rapidly emerging opportunities in new industries such as photovoltaics, biotechnology, and automotive manufacture. In addition, there is continuing cross-over and penetration into the infection control arena with new solutions for hospital health care and hospital pharmacies. Europe continues to be both a major marketplace and center of new contamination/infection control technology development and production. You can read all about it in the special “European Contamination Control Market-place” supplement also being distributed at the show and to be mailed with your March issue.
The broad international circulation of CleanRooms magazine is itself a testament to the global scope of contamination control science. In addition to our wide circulation in the Americas and Europe, Asia is, of course, one of the most rapidly growing geographic regions for industries requiring advanced contamination control technology. Our CleanRooms China publication is one information product specifically targeted to this market with Chinese (Mandarin) language editorial content and distribution to thousands of contamination control professionals in mainland China. CleanRooms China provides both an informational and educational vehicle for China’s growing contamination control community as well as a unique product and service exposure opportunity for contamination control companies around the globe interested in penetrating this critical market.
Going forward, CleanRooms will continue to cover the entire world scene of contamination control science and technology. Whether through our on-line directories and buyers guides, our informational web site, our print and digital publications and newsletters, CleanRooms is committed to meeting the information needs of the worldwide contamination control community. If you’re not already a subscriber, make sure you join our family of informed professionals today. We look forward to serving you.
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John Haystead,
Publisher & Editor
Electronic documentation could make keeping up a little less daunting
By Gregg Mosley, Communications Vice President, and Roberta Burrows, Executive Director, IEST
Do you ever feel lost in trying to keep up with new and revised international standards and recommended practices? If feedback from our many colleagues is a good indicator, you are not alone in wishing there was something akin to a GPS system to guide you through the ever-changing landscape of standards. While the GPS system may be wishful thinking, the Institute of Environmental Sciences and Technology (IEST) is working the roadway to both increased standards awareness and improved standards access.
In the not-so-distant past, Fed. Std. 209 was the main document used in the United States in contamination control operations and contracts. The revisions moved along the alphabet from “A” to “E,” making it easy to keep up with any changes. We now live in a world dominated by global events, global businesses, and global economies. Standardization is not only integral but necessary, resulting in the need for publication of generic guidance documents (ISO standards) and more specific Recommended Practices (IEST RPs). As of this writing, ISO Technical Committee 209, Cleanrooms and Associated Controlled Environments (ISO/TC 209), has ten published International standards, one document under development, and four published documents under revision. IEST has 27 published recommended practices and standards with many more in various stages of development.
To steer you down the express lane to the official ISO standards, IEST will soon be providing all ISO cleanroom standards in searchable electronic format. No more worrying about where you left your dog-eared printed copy of contamination control’s cornerstone ISO 14644-1, Cleanrooms and Associated Controlled Environments
The cleanroom industry must consider the current global energy
situation and its impact on manufacturing in order to forge a path to energy efficiency
By Robert McIlvaine, The McIlvaine Co.
There has been quite a bit written about the amount of energy consumed by cleanrooms. However, the impact of direct energy costs on the industry is very small compared to the indirect energy impacts, which include:
- Energy security
- Regional distribution of the industry
- Reduction in expenditures for products made in cleanrooms
Energy security
The price of oil topped $100 per barrel in early January 2008. Negative political news in Iran, Iraq, Venezuela, and other oil-producing regions, along with unrest in neighboring countries such as Pakistan, creates a potential for sudden disruptions in oil and gas supplies.
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The reality is that the Middle East has nearly 4,000 quadrillion BTUs of oil reserves, which is more than the rest of the world combined. The U.S. reserves are small, dwindling year by year. Therefore, an interruption in Middle Eastern oil supplies would have enormous consequences on the world economy.
Fossil fuel reserves
Disruptions would soon cause reduced output by semiconductor, pharmaceutical, flat-panel display, and other industries utilizing cleanroom technology. Unless there are alternative sources of supply, the world economy would be downsized. With energy consumption on the rise and oil and gas reserves peaking, the long-term outlook is not bright, whether the Middle Eastern oil supply is disrupted or not.
Regional distribution of the industry
The United States is the Saudi Arabia of total energy reserves. With 5,800 quadrillion BTUs of coal reserves, the U.S. has more energy reserves than any other country. Since coal can be converted to gasoline at a cost that is competitive with oil priced at $50 to $60 per barrel, the U.S. has the opportunity to become energy self-sufficient.
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Concerns about global warming, however, are making it difficult for developers to site coal-to-liquids plants. These concerns are also making it difficult to site new coal-fired electricity generators. The utilities are forced to build natural gas-fired generators dependent on liquefied natural gas transported from Qatar and other areas of the Middle East.
The cost of electricity will easily double if coal becomes a smaller portion of the fuel mix. However, the fate of coal also impacts other costs. The manufacture of steel, paper, and many other products requires large amounts of energy. Rising production costs will drive semiconductor, pharmaceutical, and other industries to locations where costs are lower.
China and other developing Asian countries argue that developed countries are the cause of global warming, not developing nations. However, developing countries require inexpensive energy sources to maintain their growth. China has built more coal-fired power plants than the rest of the world combined over the last five years and will continue rapid construction of these plants in the future.
Europe and the U.S. will find themselves less and less competitive. The result will be an acceleration of the present trend toward Asian manufacturing of products made in cleanrooms.
Reduction of sale of products made in cleanrooms
If families spend an additional $3,000 each year for electricity and fuel, and additional thousands of dollars on products for which energy cost is a significant percentage of the selling price, then that money will not be spent on electronics, pharmaceutical products, health care, flat-panel TVs, and so on.
One of the big growth areas in the cleanroom industry relates to end-of-life health care expenditures. There has been great progress in developing equipment and drugs to allow life extensions from months to years. The problem is that more money can be spent to extend life in the last few months than is spent in all the preceding years. The reality is that there will be a limit on these expenditures, which is a function of the society’s wealth. To the extent the wealth is drained by energy cost increases, the less money will be available for health care.
A further reality is that alternative energy does not currently offer a low-cost supply of large amounts of electricity. There are significant improvements being made in both wind and solar technologies, but few experts would claim that these technologies would be cost-competitive in the next two decades.
Alternative energy manufacturing resources are limited as well. It now takes two years to obtain a wind turbine. The nuclear industry will struggle to build enough nuclear plants to offset those being retired in the next 10 years.
The developing countries of the world are increasing their energy usage at a rapid rate, and all available resources will be needed in order to keep up with the demand. If the use of coal is restricted, the cost of living will rise substantially.
Reducing cleanroom energy expenditures
Increases in energy costs will have a significant, direct effect on the cost of cleanroom products. However, there are ways to reduce the consumption of energy.
A web site devoted to semiconductor energy reduction has been set up at Lawrence Berkeley National Labs (http://ateam.lbl.gov/cleanroom/technical.html), showing the distribution of energy consuming operations in semiconductor plants.
Efficiency opportunities exist in all aspects of semiconductor manufacturing, but the supply and exhaust air systems account for 26 percent of the total. Recommendations for lowering energy consumption in the HVAC system include the following:
- Lower cleanroom make-up and exhaust airflow rates conserve energy and reduce costs. For example, a properly designed exhaust system eliminates exhaust fluctuations and allows the airflow rate to be reduced, reducing the energy consumption in a fabrication facility by 10 to 20 percent.
- Low face velocity cooling coils have lower pressure drops and less energy loss through ducts and filters, saving 3 to 7 percent on cleanroom electricity usage.
- Higher-performance air filters clean supply air more efficiently, reducing energy consumption in the process.
- Variable-speed drives in recirculation, make-up, and exhaust fan motors use 15 to 30 percent less energy than constant-speed drives.
- High-efficiency motors, fans, and pumps use less energy.
- Minimizing cleanroom volume reduces recirculation airflow requirements and the associated energy usage. Cleanroom minienvironments are designed to capture these savings.
- Lower water flow rates in cooling towers reduce chilled water piping pressure drops and pumping energy usage. This efficiency measure can reduce facility energy consumption by 3 to 7 percent.
- Separating chiller loops for sensible and latent cooling functions, with correspondingly different supply temperatures and energy inputs, can save energy.
Recommendations for the cleanroom industry
Reducing direct energy consumption without sacrificing product quality or increasing cost is one obvious recommendation.
A larger opportunity is to participate in the important debate on energy sources and help shape the most sensible policy. Unfortunately, there has been what one journalist calls an “availability cascade” on the dangers of global warming. Many readers believe global warming is a big problem and will read stories about the dire consequences. When one obscure scientific journal carried an article claiming that global warming caused hurricanes, it was reported in many mainstream publications. At the same time, a prestigious scientific journal carried an article claiming that global warming did not affect hurricane severity. The second article received no media attention. Therefore, it is difficult for the average person to obtain an accurate assessment of the situation.
There are significant costs associated with an energy policy that severely limits coal consumption. There are also considerable energy security risks. These must be considered in shaping the choices and in obtaining the right balance between environmental and economic outcomes.
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Robert McIlvaine is president and founder of The McIlvaine Co. in Northfield, IL. The company first published Cleanrooms: World Markets in 1984 and has since continued to publish market and technical information for the cleanroom industry. He can be reached at [email protected].
By Hank Hogan
Just in time for Christmas last year, Lam Research (Fremont, CA) gave itself a present: the company announced it was buying the SEZ Group (Zurich, Switzerland) in an all-cash deal valued at 641 million Swiss francs (about $568 million). Lam began a public tender offer of 38 Swiss francs (about $34) for SEZ shares in early January that will run through mid-February. The acquisition should close in the first quarter of 2008, subject to regulatory and SEZ share holder approval.
This deal is a way for Lam, which is primarily an etch company, to enter the cleaning market. In a statement issued at the time of the announcement, Lam president and CEO Steve Newberry said, “Together, Lam and SEZ will create a stronger, established presence in the clean segment of the wafer fab equipment industry with the ability to deliver the broadest set of leading edge high productivity clean solutions to
our customers.”
SEZ, with 2007 sales of 330 million Swiss francs (about $292 million), has the world’s largest installed base in the single-wafer wet cleaning market. In buying SEZ, Lam acquires a product line and expertise that don’t overlap its own. It also buys credibility, particularly since the SEZ management team and most, if not all, of the Swiss firm’s products will
be retained.
That stamp of trustworthiness could be very valuable. Dean Freeman, Gartner research vice president, notes that Lam has developed its own proprietary cleaning product line but the company has faced a challenge in penetrating the market. “It’s very conservative because this is the final step the wafers usually see before they see a critical process.”
As for why SEZ agreed to the deal, Freeman notes that it costs a great deal to be a player in the worldwide semiconductor equipment market. Today, that figure could be upwards of $200 million in annual sales. SEZ may have felt that it needed the heft that Lam’s $2.6 billion in sales offered.
The two firms might also have needed each other, or at least each other’s technology. It is expected that semiconductor manufacturers will look to reduce manufacturing costs by better process step integration, particularly with the move from 45- to 32-nm technologies. Etch and clean processes are closely related, and so the capability to combine the two under one roof could prove an important advantage.
There are problems, however, that could derail the acquisition or impede its success. It is possible that another suitor for SEZ could appear. Also, mergers and acquisitions don’t have a good record in the semiconductor equipment manufacturing industry.
On the plus side, Freeman notes that Lam and SEZ are each gaining something from the deal. In addition, both management teams seem to be committed to making the deal work. These positives have to be balanced against the typical merger and acquisition negatives that arise when transplanting corporate cultures, manufacturing systems, and practices from one company to the other.
The deal’s success or lack thereof may not be apparent for some time. “We’ll have to see,” says Freeman.