Overall UPW market expected to grow through 2010

By Robert McIlvaine and Alpa Bagga, The McIlvaine Company

In the semiconductor industry, ultrapure water is used for cleaning and etching of wafers. Wafer rinsing, in particular, is responsible for the largest consumption of ultrapure water in the wafer fab. In the pharmaceutical industry, high-purity water is used as a product component as well as within production processes. Cleanroom laundries constitute a small share of the overall ultrapure water market, but within the cleanroom market, they are a major user of ultrapure water. Other industries that require ultrapure water include flat panel displays, biotech, and laboratory services.

Ultrapure water is potable, municipal water purified on-site to reduce the concentration of contaminants such as dissolved solids and ions, and especially the hardness components, calcium and magnesium.

A typical 200 mm wafer fab that processes approximately 40,000 wafers per month uses between 2 and 3 million gallons of water per day. About 70 percent of this water is used to produce ultrahigh-purity water (UHPW), which is part of the wafer-cleaning process. Much of this water is either recycled or reclaimed for use in other areas of the fab. Approximately 20 percent of the water is used for other, non-UHPW processes, such as cooling towers and heat exchangers. The remaining 10 percent is used for non-process-related parts of the fab, such as lawns, bathrooms and sprinkler systems.

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The pharmaceutical industry uses water for injection (WFI), which is water that has been further purified for use in medicinal products and for cleaning in place (CIP) processes in the pharmaceutical cleanroom. WFI water is typically produced using distillation or reverse osmosis.

Cleanroom laundries have developed various methods for clean processing of garments soiled with body oils, dirt, lint and chemical stains, while retaining only very low amounts of surface residuals. Many of these developments are proprietary, especially water (or solvent) polishing, wash chemistry and formulation. Other improvements have been made by upgrading the laundry environment to that of a modern cleanroom. Fully garmented workers, HEPA-filtered room and dryer air, low-shedding room and work surfaces, barrier washers, bag sealers, and protection of garments during handling and transport can have an impact on cleanroom garment quality. The basic requirement of the cleanroom laundry is that its clean facility be equal to or better than the cleanrooms in which the garments are used. This necessitates the use of high-purity water.

A typical ultrapure water system for the semiconductor industry includes reverse osmosis, ion-exchange, instruments and controls, degasification equipment, filtration equipment, pumps and valves, storage and piping, and disinfection. It is vital that every component of the ultrapure water system consistently maintain high purity.

Christ is a major supplier of ultrapure water systems. U.S. Filter provides central systems, pretreatment and point-of-use ultrapure water polishing systems. GE Water offers electrodeionization (EDI) systems, which remove not only residual salts but also ionizible aqueous species such as carbon dioxide, silica, ammonia and boron. Kurita supplies systems that utilize reverse osmosis, ultrafiltration and ion exchange technologies.

Reverse osmosis (RO) is the most widely used crossflow technique and produces the finest level of filtration of all the membrane processes. In RO, influent water is forced through a semipermeable membrane from a region of higher salt concentration to a more dilute region by applying a pressure that is greater than normal osmotic pressure. (Under normal osmotic pressure, water would move from the more dilute side to the more concentrated side.) RO is most often utilized to provide water that is almost free of solids, salts, organics and colloids to subsequent final polishing processes, such as ion exchange.

Reverse osmosis has made big inroads in serving as pretreatment for the ion-exchange system and, as such, greatly reduces the chemicals used for regenerating the ion-exchange resins and ultimately reduces resin consumption. The water produced by a combination ion-exchange and reverse osmosis system is considerably better than that produced by either system alone.

Dow is a large supplier of membranes that are used for reverse osmosis within the ultrapure water process. Other membrane suppliers include Nitto Denko and Toray. Korea-based Saehan has been gaining membrane market share. Equipment suppliers include GE Water, which participates through its acquisition of market leaders Ionics and Osmonics. Privately held Koch is also a player. Pall and Millipore contribute as well.

Ion exchange resins are used to remove mineral and heavy-metal contaminants from high-purity water. When minerals dissolve in water, they form electrically charged particles called ions. Certain natural and synthetic materials have the ability to remove mineral ions from water in exchange for others. Sybron Chemicals, Inc., a LANXESS Company, provides ion exchange resins for the ultrapure water market. Dow also manufactures ion exchange resins.

The selection of piping materials is critical to the performance of high-purity water systems because piping can contribute contamination. Corrosion from the piping material, biofilms and other organics are common problems associated with high-purity water storage and distribution systems. Georg Fischer is a supplier to the semiconductor industry and has expanded to include TFT/LCD displays and the solar industry as well. Harvel Plastics produces piping from a PVC compound that has been specifically formulated to reduce leachable contamination when exposed to ultrapure water environments. Saint-Gobain also provides high-purity material piping.

Maintaining the integrity of the high-purity chain requires valves and pumps designed for use in ultrapure water systems. Valve suppliers include Georg Fischer and Burkert Fluid Control. Saint Gobain and Teqcom Industries are also suppliers, and the latter also participates in the pump market. Other high-purity pump market participants include Grundfos, Pentair and ITT.

Instrumentation and controls are a major investment for the user of ultrapure water. The trend is toward continuous monitoring of critical aspects of the pure water system. In addition to particulate, it is common to measure pH, flow, resistivity, conductivity, temperature, pressure and contaminants such as total organic carbon (TOC). Conductivity, resistivity, and pH meters are normally located in the pretreatment system. Multiple TOC monitors are normally utilized. Pressure should be monitored at several locations, including those adjacent to critical components such as pumps and heat exchangers.

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Mettler Toledo provides instrumentation for ultrapure water systems. Swan Analytical Instruments and Analytical Technology are suppliers as well. Invensys, Emerson and Hach share the market also.

The largest user of ultrapure water is the semiconductor industry, and the most rapidly growing segment is flat panel displays. Purchases of ultrapure water systems for pharmaceutical applications continue to grow at a steady rate and will exceed $300 million worldwide in 2009. Within this sector, biotech is growing much faster than the total pharmaceutical UPW market. The world market for 2007 for these 3 industries can be seen in Figure 1.

Asia will have the largest market share in 2007. According to a new study by SEMI, Chinese semiconductor fab capital expenditures from 2006 through 2008 are expected to exceed U.S. $9.8 billion, which is larger than the total capital expenditure of U.S. $8.7 billion in the last five years from 2001 to 2005, according to a recent survey of major semiconductor manufacturers in China. Fab material spending is projected to grow steadily over the next three years. Fab material spending in 2007 may be as much as 58 percent higher than in 2006, since the new 300 mm capacity built in 2006 will be largely ready in 2007.

Figure 2 shows the 2007 geographical breakdown of the ultrapure water market. This breakdown includes ultrapure water used in the power industry, which does not utilize cleanrooms.

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The overall market for ultrapure water will grow 28 percent from 2007 levels to reach roughly $5 billion in 2010, as shown in Figure 3. This includes the power industry.

Robert McIlvaine is president and founder of The McIlvaine Company 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].

Alpa Bagga is a market research analyst for The McIlvaine Company

Participants’ remaining questions are answered

The CleanRooms Webcast, USP 797-Facts and Fallacies, which originally aired on October 18, 2006, focused on USP 797 and raised a number of questions-so many, in fact, that several went unanswered due to time constraints. However, the panel that lead the Webcast has since reviewed the remaining questions and formulated answers based on the panel members’ familiarity with both the current and proposed changes to USP 797.

The answers provided by the panel are based on sterile product experiences in areas such as pharmacy, engineering controls and quality assurance. In some cases, the experiences of panel members resulted in differing viewpoints, which are reflected in the answers here.

In a hospital setting, how can you plan for a cleanroom if the standards keep changing?

The USP process for developing standards is one of continued change. Each year, the general chapters are open to comments and proposed changes. The chapter’s Expert Committee reviews the proposed changes and determines whether a change is warranted. This process makes it difficult for fixed facilities required to meet the standard to plan and implement changes.

The January 2004 USP 797, which is the current standard, specifies an ISO Class 8 cleanroom, though it does not specify under what conditions the air quality standard is to be met. ISO offers three choices: at rest, as built or in operation. ISO 14644-1-Part 1 defines the classifications of air cleanliness.

The proposed changes to the 2004 standard, published in 2006, upgrade the air quality to ISO Class 7 and specify that this is to be under operational conditions. It is important to remember that USP 797 is in effect today.

The pharmacy expert on our panel suggests the following approach given the uncertainty of the proposed changes. To optimize planning in a hospital setting, form a committee of stakeholders, including the infection control officer, the chief engineer, the pharmacy director and IV admixture supervisor, as well as representatives from administration, risk management and finance. This group should work together to develop a strategic plan for the cleanroom.

What is the name of the group being discussed?

The panel was discussing the U.K. (United Kingdom) Pharmaceutical Isolator Group. At the CleanRooms Boston 2006 conference last March, Brian Metcalf, a member of the group, gave a presentation on USP 797 that examined the use of isolators in hospital pharmacy in the U.K.

Why does ASHP resist regulatory or implied regulatory control of CSPs under USP 797 by saying that “persons who compound sterile preparations should exercise their professional judgment to obtain the education and training necessary to prove their competence in managing sterile compounding facilities and in sterile compounding process and quality assurance”?

In 1993, the American Society of HealthSystem Pharmacists (ASHP) was among the first to adopt professional standards for compounding sterile preparations. Since 2004, ASHP has developed many printed, electronic, online and educational program resources that explain and support USP Chapter <797>. I believe what ASHP means is that each pharmacy must examine its strengths and weaknesses in sterile compounding and train its personnel to the competence level needed in the institution.

There were two questions concerning gowning:

Does proposed USP Chapter <797> affect gowning requirements for cleanrooms? Are their any significant changes to aseptic gowning and facewear requirements?

Gowning is an essential element for product protection in a cleanroom environment. The gown and supporting items, such as head and foot coverings, act as barriers to prevent personnel shedding particulate while working in the cleanroom. Proper gowning attire and gowning sequence are critical to minimizing contamination levels.

The proposed 2006 changes to USP 797 describe the sequence for gowning. Personnel must don garb in the following order: dedicated shoes or shoe covers, head and facial hair covers, and facemasks. Eye shields are optional unless working with irritants like germicidal disinfecting agents. After this garb, personnel must clean their nails and wash their hands and arms as described in the chapter, then they must dry hands with lint-free, disposable towels or an electric hand dryer. After hands are dry, personnel must don a non-shedding gown. Once inside the buffer room, prior to donning sterile, powder-free gloves, personnel must clean their hands with an alcohol-based surgical hand scrub per manufacturer’s recommendations.

Do you foresee quantitative microbial sampling in isolators to ensure the prevention of cross-contamination in these hoods?

Microbial sampling for all ISO Class 5 environments is critical. It is important to realize that, unlike manufacturing processes, aseptic compounding environments and the outside of components are not sterile. Two articles published in AJHP have shown that contamination rates during media fill tested far above acceptable limits. In one article, a rate of 5.2 percent was reported for medium-risk conditions. The second article noted little difference between media fills in a cleanroom and those conducted in a traditional practice site. The studies point to touch contamination as the likely source for the high failure rate.

The proposed 2006 revisions to USP Chapter <797> require quantitative air and fingertip microbial sampling and recommend surface microbial sampling. The purpose is to quality control the environment inside the isolator in order to minimize the chances of contaminating preparations during compounding.

There were four questions concerning beyond use dates (BUD) for multidose vials (MDV):

What is the agreed upon expiration date we should use on commercial multidose vials? Does the 28-day BUD need to be adhered to for all MDV? Regarding MDV expirations of 28 days, what is the recommendation for insulin? There are conflicting opinions on MDV expirations once opened; please comment.

USP Chapter <51>, Antimicrobial Effectiveness Testing, requires that commercial sterile multidose product manufacturers not perform sterility and stability testing beyond 28 days after the vial has been punctured with a needle. USP chapters, such as Chapter <797>, must remain consistent with other USP chapters. Manufacturers do have the option, however, of testing their products’ sterility and stability beyond 28 days. If their FDA-approved labeling specifies a BUD longer than 28 days, you may adhere to the manufacturer’s labeling and use the longer date. Adhering to the 28-day BUD means that some expensive multidose drugs, like insulin, will be wasted.

With regard to disinfectant efficacy and wet contact times, are pharmacies relying on the disinfectant manufacturer’s EPA-registered label claims or are they validating them internally?

USP Chapter <797> only mentions one disinfectant, 70 percent isopropyl alcohol. Rather than perform their own efficacy and wet contact time testing, most pharmacists rely on labeled disinfectant manufacturer claims.

Will ultraviolet cabinets remain an acceptable method for sterilizing goggles?

USP 797 (current or proposed) does not discuss methods for sterilizing goggles or eye shields.

What furniture is allowed in the cleanroom (i.e., buffer room) and how much storage is allowed in this space?

Both the current and proposed USP 797 address fixtures and support materials in the cleanroom (i.e., buffer room). According to the chapter: “Only the furniture, equipment, supplies, and other material required for the compounding activities to be performed should be brought into the room. The fixtures should be nonpermeable, nonshedding, cleanable, and resistant to disinfectants.”

Items that are brought into the room should first be cleaned and disinfected. Storage space in the buffer room is limited to working components and supplies needed for compounding. No long-term storage is permitted in the cleanroom.

Regarding preparing medications on a nursing unit, must administration begin within 1 hour of preparation and then administration be no longer than 12 hours? Will this be the standard?

The official 2004 USP 797 does not address immediate use. Although interim communications from USP have mentioned an administration period of no longer than 12 hours, the published proposed changes for 2006 do not. This is because USP 797 is not intended to govern drug administration, only sterile drug preparation and storage before medication administration begins.

Currently there do not appear to be uniform testing standards for compounding isolators. How is the consumer supposed to select one product over another without relying totally upon manufacturers’ own promotional literature and statements?

The question seems to have two parts. First, regarding testing standards, USP 797 requires ISO Class 5 conditions for isolators and other primary engineering controls. ISO has published a series of relevant documents (ISO 14644-1 through ISO 14644-7): ISO 14644-1 defines classifications of air cleanliness; ISO 14644-2 describes specifications for testing and monitoring to prove continued compliance with ISO 14644-1; ISO 14644-3 provides test methods; ISO 14644-7 covers separative devices (clean air hoods, gloveboxes, isolators and minienvironments).

ISO is the worldwide federation of national standards bodies. The work of preparing international standards is normally carried out through ISO technical committees. These standards are internationally recognized and represent the thinking of experts in the field. Referencing the ISO standard (e.g., ISO 14644-1) would seem to indicate testing to meet this standard. Manufacturers should use the ISO 14644 series for testing of the isolators used in pharmacy compounding.

The proposed 2006 changes to USP 797 include a reference to the Controlled Environment Testing Association’s (CETA) recently published guidelines for testing sterile compounding isolators. Susan deMars, Chief Legal Officer for USP, has indicated that the proposed language does not specifically require the use of the CETA testing guide, rather it simply lists the guide as an example of a suitable certification procedure. She further cautions that the language in the proposed revisions is still under review by USP. She also points out that USP produces public standards and has no authority to establish law or regulations.

Regarding the second part of the question, manufacturers should be able to provide user references as well as studies of their equipment. Check out the company history and the individuals representing the company. Product testing should always be conducted to the USP standard, which in the case of pharmacy isolators is ISO Class 5 air cleanliness.

The pharmacy community has a variety of communication forums, and information about products that do not meet expectations soon becomes common knowledge.

Allergists state that they adhere to the Practice Parameters for the expiration dates for allergen dilutions and that nothing can grow in the allergy extract because of the high phenol content. What is your recommendation for the preparation of allergens given the above facts?

Technically, the preparation of allergenic extracts and dilutions is covered by the standards set in USP Chapter <797>. It is good compounding practice to assure that these products meet their purported characteristics of sterility, purity, accuracy of strengths, and non-pyrogenicity. This means purchasing allergenic extracts from FDA-approved manufacturers when possible or, if such extracts are not available, having a pharmacy compound the extracts using USP Chapter <797> standards.

The manufacturers should provide written documentation concerning their sterility claims.

CleanRooms would like to thank the experts who served on the Webcast panel: Jack Lysfjord, vice president of consulting for Valicare; Russell E. Madsen, president of The Williamsburg Group, LLC; and E. Clyde Buchanan, M.S., FASHP, pharmacy consultant, private practice. Please visit www.cleanrooms.com for information on the next CleanRooms Webcast, as well as access to USP 797-Facts and Fallacies in its entirety.

In its current space mission on board the international space station (ISS), NASA is using air-sampling equipment from the Goettingen-based technology group Sartorius. The battery-operable AirPort MD8, which was brought to the ISS on a previous mission, is now being utilized in space for microbiological testing.

NASA is using air-sampling equipment on board the ISS (shown here). Photo courtesy of NASA.Click here to enlarge image

The air sampler is being used to gather information for protection of the ISS crew. The purpose of the test program is to collect and analyze microbes and allergens with which the space station crew might come in contact. Preflight, in-flight and post-flight samples are taken to determine the base contamination and to evaluate new sources of contamination. Crew members are also collecting data.

The AirPort MD8 is also being used to help prepare molecular primers, or nucleotide sequences, to further develop general microbial methods of detection at NASA and other laboratories.

The battery-operable AirPort MD8 is being utilized in space for microbiological testing. Photo courtesy of Sartorius.Click here to enlarge image

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I don’t often use this page to highlight articles running in the issue-that’s why we have a cover and table of contents. But, I’m making an exception this month because the Special Report addresses a growing and particularly important trend in contamination control, especially right now for the microelectronics industry, but one that, with the evolution of nanotechnology, will ultimately impact many other user industries as well.

The subject is tool-level contamination control. While cleanroom and minienvironment designers are already facing the challenges of molecular-level contamination, this level of control alone will clearly not suffice to effectively deal with the problem. The reason: the process tools themselves are not protected from collecting, generating and containing product-deadly contaminants.

It’s a complex problem that will ultimately require more than one single solution. Basically though, to keep molecular contaminants from entering a tool’s process environment, the ambient cleanroom or minienvironment must either be kept totally free of contaminants, or filtration systems must be put in place at the tool. In either case, this begs the question of how process materials and product are to be brought into the tool and removed from it without compromising one or both environments. Perhaps it raises the more challenging question of who is going be responsible for the solution. Should it be the cleanroom or minienvironment designer, the cleanroom user, or the tool vendor?

There will no doubt be a lot of debate, finger-pointing, and hard negotiation before the final answer is reached, but nevertheless, that final answer will inevitably be that the problem must be solved at the source of the problem, the tool vendor. It will not be acceptable for a process tool vendor to require that the user provide a specified cleanliness level in order to guarantee the proper operation of their equipment-not when the tool itself is a principle contributor to contamination levels.

The sooner that tool vendors accept this inevitability, the sooner affordable, working solutions can be brought to the market. These solutions will require process tools to incorporate tightly integrated contamination control and cleaning systems, rigid operational protocols, and highly sensitive and accurate monitoring instruments. Tool vendors should begin working immediately and intensively with the contamination control industry toward developing and implementing these capabilities in their systems. Better to bite the bullet now than be taken out by it later.

John Haystead,
Editor-in-Chief

W. L. Gore & Associates, Inc. (Newark, DE) recently donated a supply of cleanroom garments to be used in the semiconductor research space of the Birck Nanotechnology Center’s Scifres Nanofabrication Laboratory, an ISO Class 3 (Class 1) facility at Purdue University.

At a recent reception, Purdue University honored W.L. Gore & Associates for its donation of cleanroom garments to the Birck Nonotechnology Center’s Scifres Nanofabrication Laboratory. Shown here: Sean Doyle and bill Hanna of W.L. Gore & Associates; a Purdue student; Alan rebar, executive director of Discovery Park; and John Weaver, BNC facility manager. Photo courtesy of W.L. Gore & Associates.Click here to enlarge image

John Weaver, facility manager of the center, said in a recent press release, “I have used GORE Cleanroom Garments since they were first de­signed. When I heard about this donation, I was thrilled because these are state-of-the-art garments that will help us to achieve the maximum level of cleanliness in the cleanroom.”

GORE™ Cleanroom Garments are made with a proprietary expanded polytetrafluoroethylene (ePTFE) membrane laminated to a 100 percent polyester knit. The ePTFE membrane does not allow particulates to pass through, making it an ideal protective barrier in a cleanroom garment. This membrane provides filtration efficiency of 99.9999 percent or better for particles measuring 0.12 μm or greater. However, the microporous structure of the membrane allows air to flow freely through the garment so that the wearer does not retain so much heat. The garments are non-shedding, and flame- and chemical-resistant. During testing, the garments dissipated static in less than 0.1 second at 500 to 5,000 volts when the wearer was making contact with grounded or antistatic flooring.

W. L. Gore has nearly 50 years of research experience in the field of fluoropolymers, enabling the company to engineer the types of products needed in a cleanroom environment. “During the 20 years I have worked with Gore engineers,” Weaver said, “I have found them to be very strong technically and extremely responsive to ideas about their products. They have worked closely with me in every cleanroom project I have managed to make sure that we had the best production or research facility possible.”

The leadership role of IEST in shaping future research and practices

By Tengfang Xu, PhD, PE, Technical Vice President, IEST; Jan Eudy, Past President, IEST; Chuck Berndt, Communications Vice President, IEST

A leading industrial standards-writing organization since 1953, IEST has established seven tracks of Recommended Practices (RP) in the Standards and Practices (S&P) portion of the Contamination Control (CC) program, including the most recent program in Nanoscience and Nanotechnology. In addition, there are other parallel activities in IEST’s Design, Test, and Evaluation and Product Reliability divisions. Within each of these programs, scientists, engineers and contamination control professionals from all over the world interact closely in working group meetings, seminars and tutorials. Together they have developed, published and disseminated technical information and industrial standards, including RPs, reference documents (RDs), and ISO standards to address ever-evolving challenges in contamination control and sustainable development of the industries served by IEST.

The series of standards, RPs, and RDs are developed through years of discussion, deliberation and review, thus providing peer-reviewed best practices, standardized procedures and test methods to furnish guidance and address problems in contamination control. In general, IEST’s procedures for the development of standards, RPs, or RDs are in accordance with its status as an ANSI-accredited Standards Developer Organization (SDO). Specifically, RPs and RDs are formulated by IEST Working Groups (WGs) through a cooperative exchange of knowledge, experience and ideas that culminates in useful and timely information invaluable to all that avail themselves of this knowledge. These documents are reviewed every three years so that new knowledge, information and methods may be integrated into them in a timely manner.

All WG member contributions are provided by professionals on a volunteer basis. There are increasing challenges associated with keeping up with new knowledge requirements. However, IEST has successfully relied on ever-evolving leadership and concerted efforts by numerous volunteers to develop, revise and publish new documents at a faster pace than had been seen in recent decades. For example, eight updated revisions of existing or brand new RPs have been published since 2005, and approximately seven more RPs and RDs are well positioned in the pipeline for official publication by early 2007.

Due to their quality and timeliness, many IEST RPs are primary references and sources of information for compliance with the ISO 14644 series of international standards developed by ISO Technical Committee (ISO/TC) 209, Cleanrooms and associated controlled environments. Additionally, IEST conducts technical seminars, workshops and tutorials at its annual technical meeting (ESTECH), its Fall Conference, and online to assist related industries to better understand the “state-of-the-art” philosophies and effectively utilize IEST Recommended Practices and ISO standards.

Being the leading organization and a voting member of the ANSI-accredited U.S. Technical Advisory Group (TAG) to ISO/TC 229, Nanotechnologies, IEST is in a unique position to contribute its expertise in developing international standards for controlled environments to anticipate the unique needs of the emerging nanoscience/nanotechnology industry. For example, the IEST has formulated a new program to address the complex issues relevant to all industries working in this area. It includes nanoparticles, other relevant contamination control issues, and building facilities to conduct research and produce products related to nanotechnology. Leading industry experts in this area have been gathering at IEST conferences since the Fall Conference in 2005 and are working diligently on a first-ever industry road map and subsequent RPs in the IEST Recommended Practices NANO200 series. The first document, titled “Planning, Design, Construction & Operations Considerations for Facilities Engaged in Research or Production at the Nanometer Scale,” is, as mentioned earlier, the “road map document” for all industries building facilities to perform research and manufacturing at nanoscale levels. The document is scheduled for publication in the latter part of 2007.

IEST leaders are continually embracing new challenges and taking advantage of new opportunities to lead the way in the development of groundbreaking documents. We invite you to join in and participate in the relevant WGs, whether you are from the industrial sector or from academia. To increase your knowledge of the constantly evolving issues of the contamination control industry, you will want to obtain the most recent versions of these documents and become an active part of the organization. For further information, please visit www.iest.org.

The following is an overview of the IEST Working Groups and Recommended Practices.

WG-CC001: HEPA and ULPA Filters

This RP covers basic provisions for HEPA (high-efficiency particulate air) and ULPA (ultra-low penetration air) filter units as a basis for agreement between buyers and sellers. Filters that meet the requirements of this RP are suitable for use in clean air devices and cleanrooms that come within the scope of ISO 14644-1 and -2 (formerly Federal Standard 209) and for use in supply air and contaminated exhaust systems for which extremely high filter efficiency (99.97 percent or higher) for submicrometer particles is required. Six levels of performance and six grades of construction are included in this discussion. IEST-RP-CC001.4 was published in November 2005 and is due for review in November 2008.

WG-CC002: Unidirectional Flow Clean-Air Devices

This RP covers definitions, procedures for evaluating performance, and major requirements of unidirectional-flow clean-air devices. It may be used to define a basis of agreement between customer and supplier in the specification, procurement, and certification testing of unidirectional flow clean-air devices with self-contained motor-blowers and nonpowered terminal units with replaceable filter. It also presents recommendations for recertification under direction of the customer on devices owned by the customer. IEST-RP-CC002.2 was reviewed and validated in June 2004 and is due for review in June 2007.

WG-CC003: Garment System Considerations for Cleanrooms and Other Controlled Environments

This RP addresses the gowning of personnel as an important aspect of cleanroom contamination control. It provides non-mandatory guidance for the selection, specification, maintenance, and testing of apparel and accessories appropriate for use in non-aseptic and aseptic cleanrooms and other controlled environments. IEST-RP-CC003.3 was published in August 2003 and the Working Group is currently planning version 3.4.

WG-CC004: Evaluating Wiping Materials Used in Cleanrooms and Other Controlled Environments

This RP describes methods for evaluating, selecting and testing wipers used in cleanrooms and other controlled environments for characteristics related to both cleanliness and function based on intended usage. IEST-RP-CC004.3 was published in August 2004 and is due for review in August 2007.

WG-CC005: Gloves and Finger Cots Used in Cleanrooms and Other Controlled Environments

This RP describes procedures for testing, selecting and evaluating gloves and finger cots used in cleanrooms and other controlled environments. Tests are provided for determining cleanliness, physical and chemical integrity, and other relevant properties. Guidelines are also provided to assist users in the proper selection of gloves or finger cots. IEST-RP-CC005.3 was reviewed and validated in September 2006 and is due for review in September 2009.

WG-CC006: Testing Cleanrooms

This RP covers testing methods for characterizing the performance of cleanrooms. It is intended to assist planners, designers, manufacturers and buyers in preparing detailed specifications for cleanroom procurement and for assuring cleanroom operational compliance. Performance tests are recommended for three types of cleanrooms at three operational phases. Where the test method is affected by the type of cleanroom, alternative procedures are defined. For some of the tests, several different methods and instruments are allowed so that different end-use considerations can be accommodated. The test methods also may be used or adapted for periodic monitoring of cleanroom or clean zone performance capability. IEST-RP-CC006.3 was published in August 2004 and is due for review in August 2007.

WG-CC007: Testing ULPA Filters

This RP covers production testing of filters for particle penetration and pressure drop of ultra-low penetration air filters (ULPA). The penetration range of the procedure is 0.001 percent to 0.0001 percent, using particle counters. This procedure describes the equipment, aerosol properties, processes, and calculations for determining the efficiency of ultra-low penetration air filters, using particle counters. The procedure may be applied to production applications. Guidelines are provided for constructing a suitable test duct and sampling system. Also provided are test criteria for quantifying penetration in the range of 0.001 percent to 0.0001 percent, using test aerosol particles in the size range of 0.1

This year’s ESTECH event, which will be held April 29-May 2 at the Indian Lakes Resort in Bloomingdale, IL, will feature a number of new seminars.

Chemical and Biological Defense will focus on test design, analysis, and evaluation of equipment or processes including: chemical and biological defense systems; chemical demilitarization equipment and facilities; and hazardous chemical transportation.

A new seminar and panel discussion, presented by members of the 797 committee and CleanRooms magazine, will be providing the latest information on areas of contamination control implementation through US Pharmacopeia (USP) Chapter 797, Pharmaceutical Compounding: Sterile Preparations. This is the first set of such standards issued by the USP.

The Vacuum Testing seminar will explore two case histories: the Automated Transfer Vehicle and the Mars Rover. Leak rate testing and the selection and use of data acquisition and control systems for vacuum chambers will also be discussed.

Risk Assessment, Disaster Recovery will focus on the risks, both foreseen and unforeseen, that may impact cleanroom operations, as well as disaster recovery plans upon exposure of these risks.

The Vibration/Shock Test Equipment Technology seminar will focus on test equipment technology advances and control systems, which have dramatically improved laboratory testing capabilities for electrodynamic, servo-hydraulic, and pneumatic test systems since the inception of dynamic testing.

For more information on the seminars or to register for the event, visit www.iest.org.

ISPE recently announced that it will collaborate with FDA to facilitate the implementation of the new quality guidelines (Q8 and Q9) developed by the International Conference on Harmonization (ICH).

Following ISPE’s Annual Meeting in Orlando, Florida, last November, representatives from ISPE’s Regulatory Affairs Committee (RAC) met with Dr. Moheb Nasr of FDA’s Center for Drug Evaluation and Research (CDER) and Joe Famulare of FDA CDER/Compliance to discuss a vision and roadmap for implementation of the ICH Q8 and Q9 guidelines.

The ISPE is planning a workshop, which will be held June 6-7, 2007, at the Crystal Gateway Marriott in Alexandria, Virginia. It will include FDA participation to discuss the issues and gain industry input on the initiative.

According to a press release, Paul D’Eramo, Johnson & Johnson’s Executive Director for Quality and Compliance Worldwide and Chair of ISPE’s Regulatory Affairs Committee, said, “This initiative will have a significant impact for companies interested in FDA’s offer to provide regulatory flexibility by providing new ways to file drug applications, supplements, and implement modern quality systems. We strongly encourage all professionals working in these areas to attend the workshop and provide their input.”