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NOVEMBER/DECEMBER 2014

Maintaining Relative Humidity

Designing a Clean Environment Future of the Nanotech Workforce CDC Regulations and Clean Procedures

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4 TABLE OF CONTENTS

Controlled Environments

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NOVEMBER/ DECEMBER 2014 Vol. 17 • No. 10

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10 The Sticky Challenge

of Relative Humidity

Photo courtesy SMRT; Randall Perry photographer.

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Advancing Health and Safety for the 21st Century Nanotechnology Workforce The growth of the nanotech industry is outpacing occupational risk assessment.

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Best Practices for Building a Clean Environment From specification to installation, clients, designers, and contractors need to collaborate closely and establish clear guidelines and detailed project plans.

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Containment Without the Typical Container The Pirbright Institute design maintains safety within a light-filled atmosphere.

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Promoting Preparedness and Standards in the Wake of Infectious Disease

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Recent cases of Ebola in the United States have raised concern about CDC regulations and clean procedures.

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2020 Vision: Green, Safe, Sustainable — Part 2 The future of organic solvents and regulatory policy.

21

Construction Delivery Methods What to consider when selecting a construction delivery methodology.

23

Flooring, Walls, and Ceilings Product Showcase

23 18 DEPARTMENTS 6 From the Editor 24 How It Works

25 Trending on the Web 26 Index

6 FROM THE EDITOR

November/December 2014 • www.cemag.us

A Laser Look at 2014 s each year draws to a close, Controlled Environments evaluates the news stories published on our website to look for trends so that we may better address the topics that our readers wish to see.

Two similar stories took the top spot of our list for 2014.

Our most-read news story of the year was about a team of physicists at Australian National University that has developed the first long-distance optical tractor. This technique only requires a single laser beam, and it could be used for MaryBeth DiDonna Managing Editor controlling atmospheric pollution or for the retrieval of tiny, delicate or dangerous particles for sampling.

The second most-popular story, released in mid-November, also came from Australian National University. Physicists were able to engineer a spiral laser beam, used to create a whirlpool of hybrid light-matter particles called polaritons; this could connect conventional electronics with new laser and fiber-based technologies.

Also popular was a story about a Boston-based research team that is using nanotechnology to develop an unbreakable and efficient condom, as part of an initiative funded by the Bill & Melinda Gates Foundation. The goal is to create a new type of nanoparticle polymer coating for condoms to reduce the risk of breakage, making them more durable and better able to prevent the spread of HIV/AIDS and other sexually transmitted diseases.

Aerospace and NASA-related news continues to be of interest to our readers, such as the story about a team of scientists who has combed through the aerogel and aluminum foil dust collectors of NASA’s Stardust spacecraft, delivered back to Earth in 2006. The team discovered seven dust motes that probably came from outside our solar system, perhaps created in a supernova explosion millions of years ago. Other news describes how NASA’s Spitzer Space Telescope spotted an eruption of dust around a young star, which is thought to be the result of a smashup between large asteroids and could eventually lead to the formation of planets. A third aerospace-related news story details plans for the first 3D printer to go into space, which will enable astronauts to create necessary supplies on the spot rather than wait for shipments from Earth.

We also learned about a cheap, simple spray technique that deposits a graphene film able to heal manufacturing defects and produce a high-quality graphene layer on a range of substrates. Researchers hope to develop industrial-scale applications of graphene with this method.

In a follow-up to the deadly meningitis outbreak in 2012, we posted an article about the arrest of a pharmacist who oversaw the sterile cleanrooms at a Massachusetts compounding pharmacy, as he was about to board a plane to Hong Kong.

Harry Potter fans likely enjoyed a July news release about a new method of building materials using light that could one day enable technologies such as invisibility cloaks and cloaking devices.

Rounding out our top 10 news stories of the year was President Obama’s announcement that North Carolina State University will lead the new Next Generation Power Electronics Innovation Institute. This $140 million initiative will look to develop new energy solutions through the use and evolution of wide bandgap semiconductors.

We will keep an eye on these trends for 2015, and we’ll also be on the lookout for exciting new developments in the world of contamination control, semiconductors, and nanotechnology. See you next year!

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Controlled Environments Vol. 17 • No. 10 EDITORIAL DIRECTOR Patrice Galvin patrice.galvin@advantagemedia.com MANAGING EDITOR MaryBeth DiDonna marybeth.didonna@advantagemedia.com Press Releases: CEeditors@viconmedia.com EDITORIAL ADVISORY BOARD Charles W. Berndt, C.W. Berndt Associates Ltd. Adam Giandomenico, Particles Plus Inc. Scott Mackler, Cleanroom Consulting LLC Gregg A. Mosley, Biotest Laboratories Inc. Robert Nightingale, Cleanroom Garments Bipin Parekh, Ph.D., Entegris Inc. Michael Rataj, Aramark Cleanroom Services Howard Siegerman, Ph.D., Siegerman and Associates LLC Scott Sutton, Ph.D., Microbiology Network Inc. Art Vellutato, Jr., Veltek Associates Inc. Bob Vermillion, CPP/Fellow, RMV Technology Group LLC PRODUCTION MANAGER Christine Wong christine.wong@advantagemedia.com AD TRAFFIC MANAGER Alice Scofield alice.scofield@viconmedia.com ASSOCIATE PUBLISHER/SALES DIRECTOR Luann Kulbashian 603-249-9424; luann.kulbashian@viconmedia.com AUDIENCE DEVELOPMENT DIRECTOR Michael Bennett 973-920-7025 michael.bennet@advantagemedia.com AUDIENCE DEVELOPMENT MANAGER Harvey Swaine 973-920-7096 harvey.swaine@advantagemedia.com FOR SUBSCRIPTION RELATED MATTERS Contact: ABM@omeda.com or phone them at 847-559-7560 for assistance.

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CLEAN APPLICATIONS

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Advancing Health and Safety for the 21st Century Nanotechnology Workforce The growth of the nanotech industry is outpacing occupational risk assessment.

Sara A. Brenner, MD, MPH Michael Liehr, PhD College of Nanoscale Science & Engineering State University of New York

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he U.S. National Nanotechnology Initiative (NNI) defines nanotechnology as the understanding and control of matter at dimensions of 1-100 nanometers, where unique biological, chemical, and physical properties emerge.1 Its increasing use in nano-enabled consumer products has been tracked by the Project on Emerging Nanotechnologies (PEN) since 2006 and has shown a dramatic increase of 768% from 212 products to 1,628 in October 2013.2 It is expected that by this year (2014), nanotechnology will impact many manufacturing sectors with 15% of all products utilizing nanotechnology, totaling nearly $2.6 trillion in manufactured goods.3 Meanwhile, the nanotechnology workforce is also growing, with an estimated total of 6 million in 2020, of which 2 million are projected to work in the U.S.4

Worker health Currently, risk assessment for workers in nanotechnology is still in its infancy because occupational exposure assessment strategies and physiologic and health outcomes of occupational exposure to engineered nanomaterials (ENMs) have not yet been well characterized or established. Due to their size and the novel physical and chemical properties that emerge at the nanoscale, some ENMs may be more toxic than their bulk counterparts, particularly when considering inhaled aerosolized nanoparticles (potential pulmonary toxicity) or nanoparticle penetration of skin (dermal trans-

location and biodistribution to other organs). It is suspected that particle count, size, and surface area are among the most important determinants of toxicity,5,6 but other physiochemical parameters (e.g., size, shape, surface characteristics, charge, functional groups, crystal structure, and solubility) may also influence biological activities.7,8 While assessment of the potential toxicity of nanoparticles is at an early stage, the development of occupational health and safety programs, including hazard surveillance and risk management, is strongly recommended. Currently, numerous organizations including the National Institute for Occupational Safety and Health (NIOSH) recommend treating ENMs “as if” they are hazardous, having identified nanotechnology as a critical emerging issue with the potential to impact work-related respiratory diseases.9 The NIOSH Respiratory Disease Research Program has conducted lab-based studies that already indicate that engineered nanoparticulate exposures represent potentially preventable occupational health hazards.10 Similarly, NIOSH recently published several guidance documents to address occupational exposure to ENMs, specifically regarding exposure to titanium dioxide (TiO2) and carbon-based ENMs, such as carbon nanotubes (CNTs) and carbon nanofibers (CNFs).11,12 These guidance documents recommend controlling worker exposure to CNTs and CNFs below 1µg/m3 for an 8-hour time-weighted average during a 40-hour workweek.11 The recommended exposure limit for ultrafine and engineered nanoscale TiO2 is 0.3mg/m3 for up to 10 hours per day during a 40-hour workweek.12 The rapid growth and projected acceleration of nanotechnology creates urgency in understanding, predicting, and managing the health risks associated with occupational exposure to nanomaterials.

Critical research areas

Dr. Brenner conducting exposure assessment with workers using a combination of directreading nanoparticle counters and personal sampling filters.

Occupational health researchers setting up nanoparticle counters in the vicinity of a work task of interest in a semiconductor fab.

NIOSH’s Nanotechnology Research Center (NTRC) has developed a strategic plan for nanotechnology research and guidance for fiscal years 2013-2016 which includes five strategic goals and expansion of research activities in ten critical areas: toxicity and internal dose; measurement methods; exposure assessment; epidemiology and surveillance; risk assessment; engineering controls and personal protective equipment; fire and explosion safety; recommendations and guidance; global collaborations; and applications.13

8 CLEAN APPLICATIONS

Current challenges

Vacuum pumps used for personal breathing zone sampling strapped on a worker’s belt during an exposure assessment field study.

Because the reactivity and toxicity of ENMs depends on size, surface area, and shape, traditional industrial hygiene sampling techniques and analytical methods, which rely on mass-based approaches, may not be sufficient for assessing nanomaterial exposures. For example, a study comparing toxicity of bulk and nanoscale metal oxides in different bacteria found that silica and alumina showed higher toxicity at 20mg/L than the bulk material.14 Thus, new protocols based on the critical physiochemical properties that determine toxicity of ENMs are needed to inform the development of more appropriate exposure assessment methods and guidelines. Current best-known methods for ENM exposure assessment in occupational settings are based on using air and surface sampling tools in tandem to characterize and quantify ENMs; these include real-time direct reading instruments to measure particle counts and filter-based methods for direct visualization techniques (off-line analysis by, for example, electron microscopy).15,16 Current methods used for direct visualization of ENMs, based on those developed two decades ago for micron-sized asbestos,17,18 may not be appropriate for the real-world nanomaterial exposures encountered today. Additionally, the associated costs, time, and lack of standardization and validation of methods make it difficult for industries to implement an occupational exposure assessment program for workers who handle ENMs, or attempt to comply with NIOSH’s newly recommended occupational exposure limits (ROELs) for ENMs. One fundamental hurdle where research is critically needed in the development of validated analytical techniques which consistently, reliably, and accurately identify and characterize ENMs captured in the occupational settings. Significant progress must be made in regarding measurement methods for ENMs and specifically in “developing and field-testing practical methods to accurately measure airborne nanomaterials in the workplace” as well as in “developing testing and evaluation systems to compare and validate sampling instruments.”13 Additionally, these refined and validated measurement methods must have high practical utility in real and anticipated exposure assessment scenarios. When these challenges are overcome, the occupational health community will have access to a streamlined set of assessment protocols at several levels, including a rapid screening method for routine exposure assessment, which will include a set of criteria for determining if and when a more intensive direct visualization protocol should be applied to a particular sample for further analysis.

Industry-academia-government partnership SUNY’s College of Nanoscale Science and Engineering (CNSE) is the first college in the world dedicated to educa-

tion, research, development, and deployment in the emerging disciplines of nanoscience, nanoengineering, nanobioscience, and nanoeconomics. With more than $20 billion in high-tech investments, CNSE offers students a one-of-a-kind academic experience and provides over 300 corporate partners with access to an ecosystem for leading-edge research and development (R&D) and commercialization of nanoelectronics and nanotechnology innovations, including a 1.3 million square foot megaplex with the only university-based fully-integrated, 300mm wafer, computer chip pilot prototyping and demonstration line within 140,000 square feet of Class 1 capable cleanrooms. This provides ready access for field-based assessments of semiconductor research and development operations utilizing nanoparticles. The facilities and unique co-location model at CNSE has facilitated an environment of innovation and collaboration between academia and industry that is continuing to lead to critical advancements in the semiconductor industry. CNSE is leading the way in transformative research focused on the detection, measurement, and characterization of ENMs. By combining knowledge gained from the an industry-standard 300mm wafer processing line and state-of-the-art characterization facilities, researchers are positioned to study industrial use of ENMs in a real-world environment, with the scientific rigor inherent in an academic research laboratory.

Proactive, interdisciplinary strategy Detailed information about the risks associated with new technologies is often missing during the early stages of research, development, and commercial marketing.19 Working with the diverse faculty, staff, students, and international leaders in the semiconductor industry provides a remarkable opportunity to implement a proactive approach to identifying, assessing, and monitoring the potential health, safety, and environmental impacts of ENMs. CNSE is setting an innovative paradigm for internal monitoring and compliance where screening, surveillance, and research are done in a collaborative partnership within and among academic, government, and corporate institutions.

Broader impacts Knowledge gained by setting an innovative paradigm in one industry can be extrapolated to improve the health and safety environment for workers in a variety of industries, academic settings, and research laboratories that use or manufacture ENMs. Where there are currently dozens of different protocols, determination of a best known methods will enable investigators to standardize and track exposures across multiple platforms and facilities. Fundamental to this is the development of techniques such as hyperspectral imaging, which can rapidly screen ENMs in any environment in which they appear. With the establishment of fingerprint libraries for identifying hazard levels based on size, shape, and agglomeration of ENMs, only those samples truly needing further analysis need be referred offline for slower crystallographic analysis by TEM.

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The availability of faster, more flexible screening tools will enable a more nimble response to daily exposures as well as spills and other hazards, as well as reduce the risk to the general public by informing WWT processes and the waste handling of industrial ENM-related byproducts. Additionally, the learning gained from field-based research has the potential to impact not only the thousands of semiconductor workers, but also the hundreds of thousands of workers employed by participating companies’ manufacturing facilities, and can be bridged to other industrial sectors and/or other types of worksites where ENMs are handled. Exposure assessment findings may also inform better design principles in constructing and managing facilities that use or produce ENMs.

References 1. National Nanotechnology Initiative. What is Nanotechnology?

2009. Available at: http://www.nano.gov/html/facts/whatIsNano.html.

2. National Institute for Occupational Safety and Health (NIOSH). Strategic plan for NIOSH nanotechnology research and guidance: Filling the knowledge gaps. 2008.

Available online: http://www.cdc.gov/niosh/topics/nanotech/strat_plan.html.

3. Lux Research. The Nanotech Report, 5th Edition. New York: Lux Research 2007.

4. Roco MC, Mirkin CA, Hersam MC. WTEC Panel Report on Nanotechnology Research Directions for Societal Needs in 2020: Retrospective and outlook. WTEC 2010.

5. Schulte PA, Trout D, Zumwalde RD, Kuempel E, Geraci CL, Castranova V, Mundt DJ, Mundt KA, & Halperin WE. Options for occupational health surveillance of workers potentially exposed to engineered nanoparticles: State of the science. J Occ Environ Med 2008;50(5);517-526.

6. Oberdörster G, Oberdörster E, Oberdörster J. Nanotoxicology: An emerging discipline involving studies of ultrafine particles.

Environ Health Perspect 2005;113(7);823-839.

7. National Institute for Occupational Safety and Health (NIOSH). Current Intelligence Bulletin 60: Interim guidance for medical screening and hazard surveillance for workers potentially exposed to engineered nanoparticles. DHHS (NIOSH) Publication No. 2009116. 2009. Available online: http://www.cdc.gov/niosh/ docs/2009-116/.

8. Schulte PA, Geraci C, Zumwalde R, Hoover M, Castranova V, Kuempel E, Murashov V, Vainio H, & Savolainen K. Sharpening the focus on occupational safety and health in nanotechnology. Scandinavian J Work Environ Health 2008;34(6);471-478.

9. National Institute for Occupational Safety and Health (NIOSH). NIOSH program portfolio: respiratory diseases.

Inputs: NIOSH strategic goals. 2013. Available at: http://www. cdc.gov/niosh/programs/resp/goals.html 10. CDC/NIOSH/NTRC. Progress towards Safe Nanotechnology in the Workplace. 2007.

11. National Institute for Occupational Safety and Health (NIOSH). U.S. Centers for Disease Control. Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers. 2013.

12. National Institute for Occupational Safety and Health (NIOSH). U.S. Centers for Disease Control. Current Intelligence Bulletin 63: Occupational Exposure to Titanium Dioxide. 2011.

13. National Institute for Occupational Safety and Health (NIOSH). Protecting the nanotechnology workforce: NIOSH nanotechnology research and guidance strategic plan, 2013– 2016. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication 2014–106.

14. Jiang W, Mashayekhi H, & Xing B. Bacterial toxicity comparison between nano- and micro-scaled oxide particles. Environ Pollution 2009;157(5);1619-1625.

15. Methner M, Hodson L, & Geraci C. Nanoparticle Emission Assessment Technique (NEAT) for the Identification and Measurement of Potential Inhalation Exposure to Engineered Nanomaterials - Part A. J Occ Environ Hyg 2009;7;127-132.

16. Methner M, Hodson L, Dames A, & Geraci C. Nanoparticle Emission Assessment Technique (NEAT) for the Identification and Measurement of Potential Inhalation Exposure to Engineered Nanomaterials - Part B: Results from 12 Field Studies. J Occ Environ Hyg 2010;7;163-176.

17. National Institute for Occupational Safety and Health (NIOSH). Asbestos by TEM. Method 7402.

18. American Society for Testing and Materials. Standard test method for microvacuum sampling and indirect analysis of dust by transmission electron microscopy for asbestos structure number concentrations. Method ASTM D 5755.

19. Murashov V, & Howard J. Essential features for proactive risk management. Nature Nanotechnology 2009;4;467-470.

Sara A. Brenner, MD, MPH is Assistant Vice President for NanoHealth Initiatives, Assistant Professor of Nanobioscience at the College of Nanoscale Science & Engineering, State University of New York. Dr. Brenner is a preventive medicine physician whose research focuses on occupational and environmental health and safety of engineered nanomaterials by advancing occupational risk assessment strategies, monitoring materials that may impact public health, and developing industrial standards for product safety. sbrenner@sunycnse.com Michael Liehr, PhD is Executive Vice President of Innovation and Technology, Vice President for Research at the College of Nanoscale Science & Engineering, State University of New York.

Dr. Liehr focuses on the creation of new business opportunities and manages integrated industry-university consortia and public-private partnerships and is responsible for operation of the CNSE core strategic semiconductor and packaging partnership engagements, including the IBM, GLOBALFOUNDRIES, SEMATECH, AMAT, TEL, and LAM partnerships. mliehr@sunycnse.com

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10 FACILITY MONITORING

The Sticky Challenge of Relative A host of evils lurk within the realm of humidity control. Maintaining the integrity Brad Hodges, PE SMRT Architects and Engineers

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lectronics. Pharmaceuticals. Medical devices.

Cosmetics. Foods and beverages. These are just some of the products requiring careful control of relative humidity levels in controlled environments.

Failure to properly measure and control relative humidity in the cleanroom can result in lower yields, increased scrap and waste, contaminated product inadvertently reaching consumers, customer lines down, increased liabilities and decreased revenues—among other situations best avoided.

Carefully monitoring and controlling the relative humidity in a cleanroom is an absolute requirement—with no options.

What is relative humidity?

The amount of water vapor in the air at any given time is usually less than that required to saturate the air. According to Georgia State University1,the relative humidity is the percent of saturation humidity, calculated in relation to saturated vapor density.

Relative Humidity = actual vapor densityy x 100% saturation vapor density Relative humidity (RH) can be defined as “the amount of moisture in the air compared to what the air can ‘hold’ at that temperature. When the air can’t ‘hold’ all the moisture, then it condenses as dew.”1 However, the argument continues that, “The air doesn’t ‘hold’ water vapor in the sense of having some attractive force or capturing influence. Water molecules are actually lighter and higher speed than the nitrogen and oxygen molecules that make up the bulk of the air, and they certainly don’t stick to them and are not in any sense held by them.”1

Why is relative humidity important?

Particulate count. Temperature. Airflow. Humidity. These five words are among the environmental factors that must be measured and controlled in the cleanroom environment.

Sometimes the ‘stickiest’ of these is humidity. Measuring and controlling it within prescribed parameters can be a challenge.

Too little or too much RH can impact much more than the personal comfort of cleanroom employees. Too little humidity can be quite electrifying—creating issues of static build-up and discharge. Too much humidity brings its own woes: encouraging the growth of bacteria and microbes, corroding sensitive metals whether in products or equipment, and manifesting itself in moisture condensation and water absorption. Then there’s photolithographic degradation. Photoresist processes are among the most sensitive to humidity, and can be among the most costly to control for, due to their tightly required parameters. The bottom line: any of these conditions can result in cost overruns, scrapped products, and shortened equipment life. In short, the diminution of cleanroom performance, which is costly in itself.

Some of these evils deserve a bit more discussion, as the cleanroom facilities staff finds itself in a role not unlike that of the carnival plate spinner—trying to balance sometimes conflicting, and certainly not aligned, humidity requirements for different control factors.

For employee comfort working in a controlled environment, the generally accepted ideal range for humidity levels is 40 to 60 percent. The ‘bunny suits’ worn by cleanroom employees exacerbate warmth and moisture effects so it’s important not to discount employee comfort and the impact that can have on productivity. High levels of humidity can depress even the most energetic employee; levels that are too low are clinically proven to increase the rate of respiratory infections, skin issues, and general discomfort.

Target humidity and temperature control decisions impact costs in both construction and operating budgets. (All images courtesy SMRT; Randall

Consistent accuracy—over an extended period of time—is the most impor-

Perry photographer)

tant factor in selecting RH monitoring equipment.

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Humidity of RH measurements is an ongoing effort.

While humans typically thrive in 40 to 60 percent humidity ranges, most microscopic nasties do not. Viruses, mold, bacteria, fungi, and mites tend to flourish when the relative humidity exceeds 60 percent. While some types of biological contaminants can grow robustly above 30 percent, the majority do not.

On the flip side, the build-up of static electrical charge (and the resulting discharges that can be extremely destructive in a cleanroom) accelerates at lower levels of humidity. Cleanroom surfaces below 30 percent relative humidity are particularly fraught with the build-up of static electrical charges, particularly if ungrounded. Taken alone, relative humidity exceeding 50 percent is the sweet spot for minimizing electrical static discharge problems. Typically in the management of electrostatic discharges (ESD), additional standard processes ranging from static dissipative shoes and cleanroom garments, ESD protective flooring, air ionizers, and insulative grounders, among other tools, are deployed. ESD is not conquered by humidity levels alone.

Other selected impacts The point of a cleanroom is clean, with particulate counts strictly controlled. When the humidity is too high, the adhesion of particles to surfaces can increase. Kelvin condensation can become the dominant factor in particle adhesion issues when the RH is 70 percent or more, and becomes generally unimportant below 50 percent. Higher humidity leads to capillary forces—creating a bonding bridge between the surface and the contaminant, increasing particle adhesion to substances such as silicon.

Controlling for resist stability and resulting dimensional precision are impacted not only by temperature but also relative humidity. Increasing RH, even without a change in temperature, can quickly decrease photoresist viscosity. This can cause changes to the thickness of a resist film using a fixed coating recipe. Too high humidity can also intensify water absorption, increasing resist swelling after a bake cycle. Low humidity aids resist adhesion, while it can be negatively impacted by high relative humidity.

Cost considerations in controlling RH Simply put, because humidity is relative to temperature, controlling RH within very tight tolerances or at extremely low levels can end up costing you more money in both construction and operating budgets. It’s important to understand that target humidity and temperature control decisions impact costs.

A cleanroom target temperature of 65 degrees will have a lower relative humidity than a target temperature of 60 degrees. The lower your controlled temperature goes, more is required to “dry out” the air to reach a set RH level. Driving lower moisture content drives cost.

Similarly, driving RH to tight tolerances can be costly, as you need to take your chilled water down to pull the moisture from the cleanroom. Tighter tolerances could require a larger chiller, or the requirement to derate the chiller by introducing glycol to maintain flow. That reduces heat transfer and drives the requirement for a larger chiller to due to decreased efficiencies.

The outside climate impacts humidity levels, and how best to control it, inside the cleanroom. Tropical climes with consistently high humidity will pose quite a different challenge than that found in an area with warm summers and brutally cold, dry winters— dishing up a double whammy of humidity and below freezing temperatures, with an added bonus of possible snow intrusion through the air systems.

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The holy trinity of measuring RH Accurately measuring relative humidity is the initial step to control. Selecting the most appropriate sensors and transmitters to monitor and measure RH is the first item of business in ensuring trouble-free operations. The second critical factor is ensuring the selected equipment performs in a stable manner over the long term. The third factor in the holy trinity of RH monitoring is proper placement of the monitors; it’s important to avoid background environmental conditions that can impact accuracy. While RH monitors probably aren’t the first thing most facilities professionals would name among their top concerns, their failure can create huge headaches. A quick overview of each of these factors: • Equipment selection: Required accuracy specifications are the first items to consider and delineate when comparing RH monitoring equipment. This is the time to review process and product requirements, narrowing the field of potential equipment under consideration. However, equipment selection based solely on performance claims can fall short. “Accuracy” can be in the mind of the salesperson—as a qualitative term in the ambiguity of measurement.

• Accurate performance over the long term: Monitoring relative humidity is a never-ending requirement—a marathon, not a 5k. Consistent accuracy, consistent accuracy, consistent accuracy—over an extended period of time.

This is the most important factor in selecting RH monitoring equipment.

Chemical vapors lurk in controlled environments and pose the biggest threats to stability over the long haul.

Because vapors can keep water molecules from the sensor, they can cause inaccurately low RH readings when the humidity is high. Conversely, they can also cause falsely high readings in low humidity settings. Features on some monitors, including a heat-driven chemical purge function, protect some RH monitors.

• Monitor placement: RH monitors are extremely sensitive to factors in the surrounding environment—temperature, heat generation, isolated moisture—any of which can produce inaccurate measurement.

RH is ruled by temperature; requiring careful consideration when placing and installing RH sensors. Some factors to consider: • Install devices away from heat sources, include heat generating equipment. It’s important to avoid false readings created by temperature variations localized to heat radiated from isolated equipment. While good airflow throughout the controlled environment can minimize this impact, discrepancies around equipment can occur.

• Make sure the RH measuring device doesn’t become its own worst enemy. Some, when contained in enclosures, will heat up, resulting in an erroneous RH reading. Segregating the humidity sensing element from the monitor’s electronics will circumvent this problem.

• Given that the RH monitor is measuring moisture, avoiding environments that falsely increase or decrease detection of RH is critical. A few places to avoid when placing monitors: humidification systems – including ultrasonic and steam injection, and too close to cooling coils. While integrated filters shield the sensors from water, microclimates can be created from water in the filter, creating an erroneous reading.

Calibration Maintaining the integrity of the RH measurements is an ongoing effort, requiring careful and consistent calibration.

Whether manufacturing to GMP rules in the pharmaceutical industry or developing parameters in new product development, careful calibration will ensure accuracy.

Maintaining a data log of RH readings verifies cleanroom conditions—particularly important if product integrity questions arise.

Conclusion While the measurement and control of relative humidity can literally be a ‘sticky wicket’ the central role it plays in process and product integrity, as well as equipment life and employee comfort, demands careful attention. A carefully designed monitoring program is the best insurance policy to avoiding operations and quality problems.

References 1. http://hyperphysics.phy-astr.gsu.edu/hbase/kinetic/relhum.html

Measuring and controlling RH within prescribed parameters in a cleanroom can be a challenge.

Brad Hodges, PE, LEED AP, CxA, is Principal, Science, Technology and Industry Group at SMRT Architects and Engineers (www.smrtinc.com). He has more than 20 years of experience engineering controlled environments and labs for clients in life sciences, electronics, pharmaceutical, education, government, and healthcare sectors. Brad can be reached at bhodges@smrtinc.com.

CLEAN ENVIRONMENTS

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Best Practices for Building a Clean Environment From specification to installation, clients, designers, and contractors need to collaborate closely and establish clear guidelines and detailed project plans.

George Wiker M+W Group Kurt Gilson Total Facility Solutions

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n efficient, safe, and cost-effective cleanroom is often vital to the manufacturing process for therapeutics, particularly biologics. Strategic planning, practical design, and careful fabrication that build in the aspects of “clean” from the very beginning all contribute to the creation of an environment that is easy to maintain and operate.

While the concept is fairly straightforward, the actual process of building or renovating a cleanroom is anything but.

It requires alignment between the client, construction, and design team, and an open line of transparent communication.

when a manufacturing facility needs to be finished; for example, to accommodate a planned project launch. It also helps determine the workload and turnaround time for each production line.

Creating the specifications

The specifications for the build of cleanrooms—for example, the type of piping or the use of modular units—are driven by guidelines such as good manufacturing practices (GMP), as well as the ASME bioprocessing equipment (BPE) standard (see sidebar). Specifications for the cleanroom will also vary from customer to customer.

Using high-purity process piping as an example, what the Designing in the concept of ‘clean’ pipe needs to carry and where it is located will drive The primary role of a biopharmaceutical its specification, as laid down in the ASME cleanroom is to safely and effectively BPE standard and other guidelines. produce products for people. Closely These sources include the pipe’s aligned with this role is the need to mechanical and chemical properprotect operators from contact ties; its internal product contact with certain ingredients, excipimaterials (including their ents, and other compounds, traceability); external coating such as powders used to make and surface finish; and how up buffers and media. A the pipe is connected to other cleanroom arrangement and equipment as well as how it adjacency can mitigate conis attached to the cleanroom’s tamination between one prosuperstructure. The welds that duction line and another, reducing connect pipes are also covered by the risk of cross-contamination. the standards; for example, welds To build a space that is clean, the must create a smooth and cleanable surBuilding information modeling (BIM) includes not only design and construction teams need face on the inside and the outside of the the three-dimensional geometry of the building and its pipe. There are also specifications for the to first understand the user requirecontents, but can also include time, cost, and maintements of the project by developing user alignment and the profile of the weld. nance information. (All images courtesy of M+W Group) requirement specifications and becomThe specifications for the layout of ing familiar with the entire process. This will enable personnel the piping will be influenced by the client’s needs, and the to fully realize the manufacturing process, from the arrival and ergonomics for the operators. As this part of the project can storage of the drug manufacturing components through to the be a significant amount of the cost of the installation, the clipackaged products leaving the building. It is also important to ent needs to define requirements as early as possible, in colknow how those working in the space will interact with each laboration with the designer and contractor. other and with the equipment, which drives effective ergonomic Environmental concerns are increasingly important, from design. Knowing the timelines, cost targets, and expected product the perspective of reducing the carbon footprint of a facilROI (or NPV) will also be important. All of these aspects affect ity to managing energy usage, as well as protecting the local

14 CLEAN ENVIRONMENTS

The ASME BPE Standard The ASME bioprocessing equipment (BPE) standard provides details of best practices for the design, build, inspection, testing, and certification of equipment used in the bioprocessing, pharmaceutical, and personal care products industries. Its aim is to ensure product purity and safety, and according to the ASME, “companies that rigorously apply ASMEBPE often can achieve production efficiencies, lower development and manufacturing costs, and increase quality and safety, while complying with regulations.”2 The ASME BPE standard was created as a consensus standard across the industry, and provides a harmonized and objective approach for the industry.

Throughout fabrication and installation, the team will need to implement and maintain a clean development process.

ecosystems from any hazardous chemicals effluent. These requirements are likely to vary between products and processes, may differ according to the facility’s location, and will need to be built into the specifications.

as well as different perspectives on the issues. Even more so, each has an interactive role in challenging what is and what is not needed, through clear, open, and transparent dialogue.

The next move: model to installation Moving from design to model Once all the user specifications are in place and approved, the next step is to build a three-dimensional model that will eventually be used to create the construction drawings. This step, known as building information modeling (BIM), includes not only the three-dimensional geometry of the building and its contents, but can also include time, cost, and maintenance information, as well as specifics and quantities of building materials and components. Setting out clear definitions of the levels of development, a reference can be used to specify the content and reliability of building information models at different stages of the design and construction process. It will also help all users understand the usability and limitations of the models created.1 Creating a model with this level of detail is a time-consuming process, and the tools required to create the detail are, at times, not efficient. Improved design platforms and additional interface technology are in development, which will make this step more efficient.

Typically all of the project components need to be modeled individually before they can be used in the BIM process.

Once the model has been created, even the smallest changes in components—for example, switching a valve used as a placeholder for the one wanted in the finished fabrication— can have quite a major impact. It may even mean a complete redesign of a section of the model, leading to delays downstream, from planning and costing materials required for construction, to gaining approval to begin fabrication.

As standardized components become more commonly utilized, there is almost always the need to make changes throughout the process, which demonstrates the need for an early focus on selecting the right components early in the development of the project.

Clients, designers, and contractors need to collaborate closely, working with clear guidelines and detailed project plans throughout the process, and particularly in this phase. They also need to recognize that each has different skills, strengths, and weaknesses,

Once the client and the designer sign off on the model, it is then handed on to the contractor, and the next step is to create the fabrication drawings and get approval to begin work.

This requires a set of shop drawings to demonstrate that the design was fully developed, and the contractor built the cleanroom component(s) to the design requirements.

The cleanroom unit operations can be prefabricated offsite as modules/components (often on stainless steel skids) in a dedicated hygienic fabrication facility and moved into place, or built in place on-site (stick-built). The choice is dependent on the requirements for the cleanroom, the timelines, budget, and the need for flexibility during the installation process.

Generally, smaller process systems/components are built remotely, factory-tested, and then shipped to the site. This can include a wide variety of process unit operations such as bioprocessing, filtration, centrifuge, separation purification, or aseptic unit operations. Using prefabricated modules with little customization means a facility can be up and running much faster (and therefore generating revenue more quickly). It does not rely primarily on sourcing local qualified labor; ensures the most cost-effective and efficient use of time and resources; and reduces the number of people needed on the construction site. Fewer people on-site can also improve on-site safety and help to maintain the cleanliness of the facility by reducing the opportunity for contamination.

If the same design can be implemented over a number of sites, this makes staff training easier and allows people to be moved from site to site with little downtime. It can also make troubleshooting easier. However, it is more expensive than building on-site, and there is less flexibility for change.

Building on-site is implemented when the building structure is used to support, and is integral to, the equipment.

This approach is used for very large systems that would be impractical to build off-site, and can be a more flexible process; however, it takes longer to develop.

In the end Whether the units are fabricated on- or off-site, it is important to ensure that clean principles are maintained throughout.

This approach will mitigate risk of operational failure(s).

Throughout fabrication (and in some cases, shipping) and installation, the team will need to implement and maintain a clean development process, including keeping construction components and areas clean, and for personnel to wear appropriate protection for cleanliness.

During the design, build, and installation process, the paperwork that tracks the components and materials used, and monitors the quality of the installation (for example, inspection and product records for weld pressure tests)

November/December 2014 • www.cemag.us

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The specifications for the

must be managed appropriately. Many companies (like TFS) are taking the step toward a paperless process, to make tracking seamless and lower costs from concept to finish in the build process.

layout of the piping can be a significant amount of the cost of the installation. The client needs to define requirements

Providing a solution

as early as possible, in

There are many factors that must be considered when creating a new clean facility, or upgrading an existing one.

Using a specialty contractor for the design, planning, and building of clean environments for biopharmaceutical and biotechnology development and manufacturing can make the process more cost-effective and quicker, reducing the time to ROI. Specialty contractors, with demonstrated experience in the life science industry, understand the complexity of good practice guidelines and the importance of compliance to laws and regulations to provide successful, stress-free turnkey solutions.

collaboration with the designer and contractor.

References

George Wiker, Vice President at M+W Group, brings more than 23 years of global experience in biopharmaceutical facility analysis and design to his role as Vice President of M+W Group.

He applies a hands-on approach to guiding his team from concept through to qualification, and is an active voice in the industry, often contributing his time as an author and lecturer.

1. BIMForum, 2013 Level of Development [LOD] Specification. 22 August 2013. Available at https://bimforum.org/lod/ 2. ASME, Bioprocessing Equipment BPE - 2012. 2012.

Available at https://www.asme.org/products/codes-standards/bpe-2012-bioprocessing-equipment

Kurt Gilson, Vice President of the Western U.S. Region for Total Facility Solutions, has over 26 years of process experience to cleanroom construction for clients in the life sciences industries. His extensive credentials also feature process experience for the high technology and semiconductor industries.

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16 NANOtalk

Containment Without The Pirbright Institute design maintains safety within

Ahmad Soueid, AIA, LEED AP BD+C HDR Architecture

W

hile in the countryside of Sussex, England, a new containment facility for the Pirbright Institute will focus on the way people work with viral diseases effecting animal and human health. Based on careful responses to assessed risk, the design satisfies security and containment requirements for high-consequence research within a highly interactive environment. The design ushers in a new paradigm for Category 4 bio-containment, (similar to the U.S. BSL-3 enhanced), in which researchers work in labs and offices with large windows and expansive views, gather in an open light-filled atrium, and eat in the cafeteria—all within the containment boundary.

A radical departure from traditional bunker-like Category 4 containment facilities, this new model is safer,

enhances research productivity, and is exponentially more comfortable and pleasant for researchers and staff. Through an in-depth understanding of the facility’s user groups and their preferred and optimal work processes, HDR developed a approach to containment that resulted in safe, collaborative and light-filled work environment.

Of particular note is the glass three-story atrium topped by a glass oculus with views to the sky. On the ground floor, the atrium is not within the containment barrier, but visitors have views to containment spaces. Shared, unassigned write-up space is located on the first floor, within the containment barrier, and offers views through the atrium to other floors. The second floor houses the canteen—which offers seating both within and outside the containment barrier. Containment areas within the atrium are accessible to all researchers in the facility, fostering the cross-disciplinary interaction that is conducive to safety and efficiency. In alignment with the trend in science taking place around the world, it is expected that these new synergies and collaborations will lead to innovation and breakthroughs that are not currently even on the radar.

The new facility was sited to create an entirely new entrance and entrance sequence to the Institute’s campus.

Visitors and staff will pass through a security gatehouse— designed with a similar vernacular as the new DP1 Building.

The building and the entrance sequence is to take advantage of views into the adjacent woods. The exterior materials were selected for their strong visual impact to reinforce the revolutionary nature of this facility—and, in particular, to move away from the conventional, sterile containment environments. The use of wood timber paneling, multi-colored window casings, transparent glass panels, and a carefully

November/December 2014 • www.cemag.us

the Typical Container a light-filled atmosphere. detailed metal brise soleil were all selected to create a place that enhances, and helps to brand the Pirbright Insitute as a new, vibrant place to work. The atrium offers a feeling of spaciousness, while the labs are clinical, but with pockets of color.

Containment facilities were always a box within a box.

How could there be windows? How would a building with windows be sealed? Tested? Still, the leaders of Pirbright and the design team persisted. This facility would usher in a new model of containment, in which researchers would have natural light, views, interaction with others outside their group, and a cafeteria—all within the containment barrier.

A risk assessment identified and ranked potential risk, including the severity of those risks. The design mirrored the level of risk with a layered approach to containment.

The basic engineering would assure that the labs be sealable and would realize a negative-pressure air cascade to areas working with the most dangerous infectious diseases. Nonsolid waste would be processed through an in-house effluent plant, and all solid waste would be autoclaved. All air would go through the air systems’ HEPA filters. No infectious virus would be able to “get out.”

Ahmad Soueid, AIA, LEED AP BD+C, serves as HDR Architecture’s Director for the S+T Advanced Research program. With over two decades of focused experience on buildings, he is considered a leader in the planning, design, and construction of technically advanced facilities. Soueid is co-chair of nanoBUILDINGS.com Buildings for Advanced Technology Workshop series. He can be reached at ahmad. soueid@hdrinc.com.

Image courtesy of HDR Architecture, Inc.; © 2014 James Brittain

Image courtesy of HDR Architecture, Inc.; ©2014 Dan Schwalm/HDR, Inc.

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18 STANDARDS AND PROCEDURES

Promoting Preparedness and Standards in the Wake of Infectious Disease Recent cases of Ebola in the United States have raised concern about CDC regulations and clean procedures.

An interview with Darrell Henry, Executive Director MaryBeth DiDonna of The Healthcare Coalition for Emergency Preparedness, Managing Editor

cannot pick and choose which regulations to follow; all must be upheld.

based in Washington, D.C.

T

he Healthcare Coalition for Emergency Preparedness (HCEP) was formed in an effort to raise awareness and educate people about often overlooked issues in plans to maintain healthcare facility operations during a crisis and develop efficient methods to reduce healthcare costs.

As such, the HCEP has repeatedly requested the Centers for Disease Control and Prevention (CDC) to clarify standards related to healthcare facility protocols for the safety of workers, specifically related to the disinfection and transportation of medical waste. As spelled out in a recently released fact sheet, the HCEP believes CDC standards should follow international standards in regards to the handling and disposal of medical waste, to protect healthcare workers as well as the public at large.

HCEP is pleased that CDC has now clarified Ebola waste as a Category A infectious material, which the Department of Transportation (DOT) determines is capable of posing an unreasonable risk to health, safety, and property when transported in commerce, and should not be treated like normal regulated medical waste (RMW).1

Which CDC standards must be upheld when cleaning and disinfecting cleanrooms and controlled environment facilities?

The CDC is the national public health institute of the United States that is a federal agency under the Department of Health and Human Services (HHS). The CDC recommends hospitals to be prepared to follow certain infection control and worker safety protocols.

CDC’s recommendations (guidelines) for infection protection include avoiding contact with blood and bodily fluids of an infected person and not handling any items that may have come in contact with an infected person’s blood or body fluids.

Like the CDC, World Health Organization (WHO), and other health policy experts, the Coalition recognizes and agrees that the practice of inactivating cultures and stocks of microorganisms onsite during medical waste treatment is a best practice.

It is important to acknowledge and remember that international Ebola infection control standards should be followed precisely. You

Can you talk a bit about personal protective equipment (PPE) and personnel procedures?

With healthcare workers on the front lines in the battle to contain Ebola, the need for proper personal protective equipment and infection control protocols is paramount. We know that there is not much information and research on disease transmission in the healthcare setting, including the potential for infectious particles to be suspended in the air around a symptomatic patient. Thus, it only seems appropriate to adopt more conservative measures to protect healthcare providers.

What must the CDC do in order to contain further outbreak of Ebola in the USA? Properly handling and disposing of Ebola waste is an often-misunderstood danger and public risk that we must responsibly and realistically address if we are to implement a complete “creation to sterilization” infection control process on-site where such patients are treated. In essence, it is vital that on-site sterilization of Ebola waste be performed before it is removed from the facility. Likewise, liquid waste must be disinfected before it is put into a municipal sewer system. Utilizing autoclave sterilization and bleach solutions works best, as the CDC notes.

We hope that Congress, along with the CDC, National Institutes of Health (NIH), Assistant Secretary for Preparedness and Response (ASPR), medical trade associations such as the American Hospital Association (AHA), State and County Health Officials, and HCEP, can all work cooperatively toward implementing simple, effective solutions using readily available technologies to implement appropriate protocols, establish designated treatment centers, and utilize the best American and international guidelines regarding infection control procedures and preparedness in our hospitals.

Here are a few simple solutions that the CDC can ensure are implemented in a hurry: utilize mobile triage centers; establish protocols for patient movement; disinfect solid and liquid waste on-site and as close to the source as possible; and deploy mobile waste sterilizers to medical centers. We should also rout patients to designated health care facilities that have the proper protocols, highly trained staff, and necessary bio-containment units to treat and contain Ebola and similarly infectious, lethal diseases.

References 1. http://www.cdc.gov/vhf/ebola/hcp/medicalwaste-management. html

CONTAMINATION CONTROL IN AND OUT OF THE CLEANROOM

November/December 2014 • www.cemag.us

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2020 Vision: Green, Safe, Sustainable — Part 2 Barbara Kanegsberg Edward Kanegsberg BFK Solutions LLC

I

n Part 1, we gave you views of practical people in industry and the academic world about how realistic, sustainable critical cleaning processes may develop over the next five years; we covered many ideas including process design, energy efficiency, and congruent chemistries.1 Let’s move on to organic solvents, regulatory policy, and hope for peace on earth.

The majesty of the ‘and’ Organic solvents and organic-based process fluids are a mainstay of industry. We think solvents for liquid/vapor phase degreasing will continue to be used in 2020, particularly where a high degree of wetting is needed to remove thin film and particles from miniature components and from complex structures, like those produced using 3D printing. We’ll go out on a (short) limb and say that “classic” solvents will remain under regulatory scrutiny.

Dr. Donald Wuebbles, Professor, Department of Atmospheric Sciences and the Department of Electrical and Computer Engineering at the University of Illinois at Urbana-Champaign, is an expert in atmospheric chemistry and climate issues. Wuebbles sees a trend toward “continuing emphasis on compounds with low ODP (ozone depletion potential) and low GWP (global warming potential) for use as solvents, degreasers, and in related processes.” He expects some HFCs (hydrofluorocarbons) to be phased out due to their higher GWP. However, Wuebbles takes a pragmatic view; he indicates that, in contrast with what he sees as the position of some policymakers, “the ODP should not have to be zero.” He views continued use of a compound “that has an extremely small (negligible) effect on stratospheric ozone” as a realistic approach.

There are promising new solvents. “Industry can’t wait until 2020,” explains David Cooper, Global Business Director for Honeywell in Morris Township, N.J. “The drive toward higher environmental and safety requirements will only grow, both in the U.S. and globally,” asserts Cooper. “We see industry making changes now.”

Cooper explains that “it’s the majesty of the ‘and.’ Whereas industry was once forced to choose between effective cleaning or environmental preferability, there is now global pressure for solutions that provide effective cleaning and environmental preferability; worker safety and cost-effectiveness. Industry cannot accept yesterday’s tradeoffs.”

Azeotropes “I’m banking my research on blended solvents, particularly on azeotropes (constant-boiling mixtures),” explains Dr. Darren Williams, Associate Professor of Physical Chemistry at Sam Houston State University in Huntsville, Texas, “because you can tailor the composition to meet the requirements of the process.”

Williams directs a laboratory focused on practical aspects of cleaning chemistry and cleaning verification. Williams explains

that azeotropes “give us the promise to achieve process consistency and can be fine-tuned in terms of chemical and physical properties to achieve fluids that are safer for workers and the environment.” Williams adds that “where chlorinated solvents are essential, if an azeotropic blend were to allow us to use 30% chlorinated solvent rather than 100%, it would be a great improvement.”

Williams cautions that in developing alternative solvent blends, issues such as VOC levels and flammability must be considered. He adds that, because cleaning processes involve chemicals, equipment, and product, evaluation in a relevant manufacturing environment is essential. “Everyone is trying to pick the demon they are trying to avoid (VOC, halogen, etc).

Blending will help expand the range of options, but there are only so many choices,” concludes Williams.

Processes Many cleaning process techniques could improve the safety and environmental impact of chemicals. Anselm Kuhn, Manager at Finishing Publications Ltd., Stevenage, U.K. predicts that increasing regulation on chemicals will favor the use of more physical energy including high pressure water and CO2 ice blasting technology. He also sees “an increase in the use of ultrasonic cleaning to boost the effectiveness of mild cleaning agents as well as the use of intelligent ultrasonic tanks that regulate power in order to save energy.” We might add the hope that chemical containment, such as in well-sealed solvent systems, be visited as an option within the next few years.

Steve Derman, President of MediSHARE Environmental Health & Safety Services in Santa Clara, Calif., explains that process change has to be holistic and coordinated. “If you were going to do something to improve the safety of a process, the change has to be integrated into the process. For example, in solvent vapor degreasing, adding cooling coils lowers worker exposure, minimizes air and water pollution, and increases efficiencies.” Derman recalls, however, that when the concept was first introduced, “there was reluctance from industry because of increased costs and higher maintenance activities.

Industry was pleasantly surprised at the decreased evaporative solvent losses.”

Robotics Kuhn sees that one consequence of the increased worker safety and environmental regulations might be the increased use of robots. “Robots are progressively being more and more widely used in industry, mainly because of the labor (and thus cost) saving they can bring. I could easily imagine an entirely new phase of robotization based on the premise that their use would allow a process to be carried out, which would be prohibited if human beings were involved.” Building on the approach used in decommissioning nuclear power plants, Kuhn could envision “a sealed production plant or part of a plant where chlorinated hydrocarbons can be used as if they were water. No human beings routinely work in such a plant,

20 CONTAMINATION CONTROL IN AND OUT OF THE CLEANROOM

just the occasional supervisor wearing an airtight suit. There are no emissions from the building even though the concentrations of organics inside might be quite high.”

World peace—or at least detente “Can general manufacturing safety and sustainability be improved? Absolutely. The U.S. is quite capable of improving manufacturing. Will things change any time soon? That would be challenging,” asserts Jason Marshall, Director of the Cleaning Laboratory at the Toxics Use Reduction Institute (TURI) at the University of Massachusetts Lowell. “It’s too big for any one president to decide. Any move will have to be a long-term activity. There will be baby steps contrasted with pressure from other countries who make things cheaper.”

Business and regulatory pressures are global. Across the EU, Kuhn sees growing resentment from industry in that regulations may emanate from “what are seen as faceless European Union bureaucrats in Brussels. The view is that regulations are enacted without thoughts on implications of use of alternatives. There is concern that REACH may have become excessive; for example, boric acid is now registered under REACH. Restrictions on use of hexavalent chromium are just about manageable. Many fear that next in line is nickel. This will cause dynamic tension to increase.”

Tony Revier, Past President of the National Association for Surface Finishing (NASF), adds that “a lot of people would have predicted that the plating industry would be gone

by now. But it’s still here, because plating serves an essential role in certain crucial products; and, by being engaged and proactive, NASF has been essential in getting that message across.”

It seems to us that all too often, the relationship between regulatory world and the world of manufacturing is adversarial.

Derman suggests that “if regulators and regulatees could work together, the collaboration would make for a more effective situation, one that would improve worker safety, be more protective of the overall environment, be sustainable, and foster technology and manufacturing.”

References 1. B. Kanegsberg and E. Kanegsberg, “2020 Vison: Green, Safe, and Sustainable—Part 1,” Controlled Environments Magazine, October 2014. http://digital.cemag.us/controlledenvironments/october_2014#pg20 2. For additional insight from contributors to this series, please see “Clean, Green, Safe, and Sustainable” in the November 2014 issue of Clean Source, the BFK Solutions newsletter. http://bfksolutions.com/sustainable-2020 Barbara Kanegsberg and Ed Kanegsberg (the Cleaning Lady and the Rocket Scientist) are experienced consultants and educators in critical and precision cleaning, surface preparation, and contamination control. Their diverse projects include medical device manufacturing, microelectronics, optics, and aerospace.

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ASK THE FACILITIES GUY

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Construction Delivery Methods

Q:: A

Richard Bilodeau, PE SMRT Architects and Engineers

Could you outline some considerations in selecting a construction delivery methodology?

“The most powerful force ever known on this planet is human cooperation - a force for construction and destruction.”

- Jonathan Haidt

When thinking about undertaking a construction project—whether a new greenfield facility or the renovation of an outdated or compromised building—one of the major considerations a facilities engineer faces is which construction delivery methodology to deploy. While many factors will influence the decision of a “best fit” methodology, this column will present a high level overview of the major options and key factors to consider. Underlying each is a sense of human cooperation.

While there are several flavors of each delivery method, in today’s world we can comfortably group these variations on a theme into four categories: Design-Bid-Build (DBB): This is the standard delivery method used for generations in the United States. In short, the owner retains an architect to design a building, which is then bid out for construction and finally built. Each segment of the sequence is relatively discrete, with both the architect and the contractor having a direct contractual relationship with the owner.

Construction Management At Risk (CMAR): In this evolution, the owner contracts with a construction manager who acts as an owner’s representative/consultant during the design phase, but then assumes the risk for construction, basically as a general contractor.

During construction, all subcontractors work for the construction manager, without direct contractual relations with the owner.

Design-Build (DB): According to the Design-Build Institute of America (DBIA), “Design-Build is a method of project delivery in which one entity—the design-build team—works under a single contract with the project owner to provide design and construction services. One entity, one contract, one unified flow of work from initial concept through completion—thereby re-integrating the roles of designer and constructor.”

Integrated Project Delivery (IPD): The American Institute of Architects defines IPD as “A project delivery method that contractually requires collaboration among the primary parties—owner, designer, and builder—so that the risk, responsibil-

ity and liability for project delivery are collectively managed and appropriately shared.” In the design and construction world, you will hear reference to “IPD lite” and “full bore IPD”—each refers to varying degrees of entwinement among the contractual parties. In IPD lite, for example, the parties may not have waived all claims but are undertaking the project in the spirit of collaboration. Full bore IPD is a slang expression that generally references an IPD contract encompassing all major parties which often include the major subcontractors, with each a signatory to the contract, waiving future claims.

What’s a facilities engineer to do? Behind which contract door does the dream of a well-run project, or even a project that delivers the holy grail of completion ahead of schedule and under budget, become reality?

Things to think about No two construction projects are alike. When considering which project delivery method to use, it helps to first identify the key driving factors, critical paths, and desired outcomes attached to the undertaking. Is the move-in deadline inflexible? Is there an absolute budget ceiling? Renovation or new construction? Employees who will be working on-site during construction? Tolerance for disputes and change orders? The unique characteristics of each project will point the way to the best fit delivery method.

Following are the fundamental items to ascertain before selecting a delivery methodology: • Design and function: The first and constant consideration is carefully identifying the type of building required, how it must function, and key program components. However you structure your team, you need to be sure the design and engineering firm is experienced and competent in your building type. A residential architect, however beautiful his/her house portfolio may be, has no business designing a clean manufacturing facility!

• Budget: In the end, the proposed building must fit the budget.

No way around that one. Everything traces back to the dollar: financing, risk assessment, building size, and scope. When developing your initial budget, be sure to include the total budget cost, including items like legal fees, regulatory approvals, design and engineering fees, furniture, moving costs, etc.

For a detailed checklist, see my earlier column on budgeting for total project costs: http://www.cemag.us/articles/2011/03/askfacilities-guy

MaineGeneral’s 640,000 square foot Alfond Center for Health was delivered ten months ahead of schedule using IPD. (All images courtesy SMRT)

22 ASK THE FACILITIES GUY •

Collaborative planning sessions involving owner representatives, architects, engineers, construction, and major subcontractor personnel from the early stages of a project are trending.

•

•

•

Schedule: The project timeframe will have an outsize impact on selection of delivery methodology. If you have a short lead time and a drop dead move-in date, you need to think hard and realistically about how to best deliver the project. Bringing a highly collaborative, experienced full team to the table from the outset can dramatically shorten the project delivery timeline. Several methods can accomplish that objective. Recently, SMRT Architects and Engineers delivered a 640,000 square foot LEED Gold hospital ten months ahead of schedule as part of an Integrated Project Delivery team. Among other schedule-cutting strategies, the architects and engineers handed off drawings to the contractors for detail work, major components of the building were pre-fabricated onsite, and the co-located team from designers to major subcontractors were working together under one roof for the duration of the project.

Your own level of expertise: This is a time to be brutally truthful in your evaluation of your own experience, compared against the size and complexity of the proposed project. Building a greenfield clean manufacturing facility isn’t a yearly event in most people’s careers.

It’s what you don’t know that can be a career killer. Getting experts on board early, whether through design-build, construction management, or IPD, can save you a universe of headaches and costs.

Risk tolerance and risk assignment: Project construction is a risky undertaking. As the owner, it’s important to evaluate your organization’s level of risk tolerance, while also ensuring that potential risks are appropriately allocated and assumed by responsible parties.

How to decide Every delivery method has its pros and cons, with attributes that may make it more applicable to a specific set of circumstances. While this column only allows a brief overview, below are some primary considerations for the four major delivery methods outline above.

• Design-Bid-Build (DBB): While DBB is the “grandfather” of construction delivery methods, DBB generally is not the go-to when time is of the essence, as design documents must be fully developed before the contractor can be procured and construction begins. This tends to drag out project schedules. DBB can also lead to increased change orders, and the risk of conflict can be high as the designer, engineer, and contractor will each likely have independent contracts with the owner, and collaboration between the contractor and designer during the design phase is typically non-existent. While DBB offers clear roles among the parties and because of its long term use is generally well understood, the assessment of realistic schedule and cost may be more limited during the design phase, while the lack of contractor input can, in some cases, lead to issues of constructability later.

The contractor may also opt for low cost selection of subcontractors, with the potential to undermine quality and scope.

Construction Management (CM): The two most cited advantages to CM are the ability to have a contractor’s input during the design phase, and the opportunity to compress the construction schedule when compared to DBB. In the first, the CM can assist with issues like constructability, projected cost, and materials. In the latter, the CM can undertake construction before the design is fully executed, and even detail segments of the design. The most cited pitfall is the potential for disputes over assumptions made about what is included in the guaranteed maximum price, and the handling of subcontractor bids—in short, transparency. Other common disputes involve completeness of design, quality of construction, and of course budget. Many contracts under this method include a provision that the construction manager’s books, including subcontractor bids, be fully open and transparent.

• Design Build (DB): Design Build has grown in popularity, primarily because its simplified contractual structure allows projects to be completed more quickly, with the contractor and designer/engineer acting as a team under one owner contract, with the designer/ engineer typically contracting directly with the contractor. With a single party accountable for project execution, and the contractor and designer/engineer working together as a team through the entire project, costs can be reduced. Additionally, constructability is addressed from the outset which tends to reduce change orders. In fact, most change orders are initiated by the owner. This structure, however, may put more responsibility on the owner, who must be decisive and respond to requests for information or decision in a timely manner as DB moves at a faster pace.

• Integrated Project Delivery (IPD): The newest project delivery contender, IPD is constructed on a multi-party agreement with the owner, CM and general contractor, architect, engineer, and many times the major subcontractors, knitting these possibly antagonistic parties into a single, collaborative team. The goals are to optimize quality and efficiency from initial design concept through occupancy, while reducing schedule, time, cost, and waste. On the plus side, the team functions as a single entity, totally aligned to the project goals. Issues that arise during project execution tend be viewed as “everyone’s problem to solve” without playing the blame game. IPD takes the best components of DB and CM, and expands the concept into a new arena.

However, because the concept is relatively new, contract negotiations and establishing an insurance program can be challenging.

Because success is so heavily dependent upon true collaboration, an uncooperative party can have outsized detrimental effects on the project. The team should move quickly to remove non-players. For more, see my earlier column on IPD: http://www.cemag. us/articles/2012/04/integrated-project-delivery Project delivery methods will continue to evolve, mutating as new technologies and materials enable different approaches and the barriers between designer, contractor, and owner continue to dissolve. For today’s facilities professional, staying up-to-date on the possibilities can mean smoother projects, significant savings in dollars and schedule, and a superior facility.

Richard Bilodeau, PE, is director of engineering at SMRT Architects and Engineers (www.smrtinc.com). His 30 year career includes plant engineering positions in clean manufacturing. Richard has engineered, designed, operated, and supervised the construction of numerous controlled environments and labs for advanced technology, life sciences, industrial, healthcare, academic, and corporate clients. Dick can be reached at rbilodeau@smrtinc.com or TheFacilitiesGuy@smrtinc.com

November/December 2014 • www.cemag.us

FLOORING, WALLS, CEILINGS

23

Modular Wall System

Layered Mats for Contamination Control

The CAS-797 Wall System with ACT! (Active Channel Technology) from CleanAir Solutions Inc. allows the user to adjust the insert channel of the frame for different sizes of solid inserts from 1/8-in. to 3/8-in.

The ACT! design creates a snug interior mounting of the insert that is flush with the frame and can be fitted for wall panel inserts of ABS, polycarbonate, aluminum composite, acrylic, tempered glass, or other materials. Easy-to-clean features are suited for USP <797> applications and medical device applications. The modular wall system is suitable for ISO Class 8 (Class 100,000) applications to Class 4 (Class 10). www.cleanroomspecialists.com

Hutchins & Hutchins Inc. is a primary distributor of Protective Industrial Products Layered Contamination Control Mats. These mats are designed with an adhesive coating to reduce footborne dust and particulates from entering controlled environments, such as hospitals, laboratories, and construction areas. These mats offer a cost-effective means of particulate control for low-profile carpet, tile, and concrete surfaces.

The product features a 99.9% dust removal, as well as heat- and cold-proof resistance. The polyethelene material comes in a variety of colors and each layer is numbered. www.yourcleanroomsupplier.com

Push Button Switches Dortronics Systems offers its line of WR5276 heavy duty push button switches. The exterior grade switches are constructed of brushed stainless steel rated to a sealing degree of IP65. The WR5276 Series is available in four configurations. The illuminated LED ring color is red or green and switch contacts are isolated normally open and normally closed. A neoprene gasket is included for mounting the switch plate. The IP65 rating protects against water projected from a nozzle from any direction. www.dortronics.com

Cleanroom Door The Plexline Clean door from Rytec maximizes efficiency and compliance in harsh conditions by combining high speed, a tight seal, and composite construction. The durable fiberglass composite frame and stainless steel-clad bottom bar are chemical- and corrosion-resistant. For an effective environmental barrier the standard door features front and rear panel seals, a vinyl loop along the leading edge, and a USDA/FDAcompliant header seal.

The direct-drive motor operates the door at up to 50 inches per second to quickly contain and separate environments and for rapid traffic flow. www.rytecdoors.com

United States Postal Service STATEMENT OF OWNERSHIP, MANAGEMENT, AND CIRCULATION 1. Publication Title: CONTROLLED ENVIRONMENTS 2. Publication Number: USPS # 021-493 3. Filing Date: October 1, 2013 4. Issue Frequency: Published 10 times a year 5. No. of Issues Published Annually: 10 6. Annual Subscription Price: US $120, Canada, Mexico and other foreign air $180 7. Complete Mailing Address of Known Office of Publication: Vicon Business Media, Inc. a subsidiary of Advantage Business Media, PO Box 779, Amherst, NH 03031. Contact Person: Harvey Swaine, Telephone: (973) 920-7096 8. Complete Mailing Address of Headquarters or General Business Office of Publisher: Advantage Business Media, 100 Enterprise Drive, Suite 600, Box 912, Rockaway, NJ 07866-0912 9. Full Names and Complete Mailing Addresses of Publisher: Elizabeth Vickers, Advantage Business Media, 100 Enterprise Drive, Suite 600, Box 912, Rockaway, NJ 07866-0912; Editor: Patrice Galvin, Advantage Business Media, 100 Enterprise Drive, Suite 600, Box 912, Rockaway, NJ 07866-0912 10. Owner: Advantage Business Media, LLC, 100 Enterprise Drive, Suite 600, Box 912, Rockaway, NJ 07866-0912 11. Known Bondholders, Mortgagees, and Other Security Holders Owning or Holding 1 Percent or More of Total Amount of Bonds, Mortgages, or Other Securities: none 12. Tax Status: The purpose, function, and nonprofit status of this organization and the exempt status for federal income tax purposes has not changed during preceding 12 months 13. Publication Title: CONTROLLED ENVIRONMENTS

14. Issue Date for Circulation Data Below: September 2014

15. Extent and Nature of Circulation:

a. Total Number of Copies (Net Press Run) b. Legitimate Paid and/or Requested Distribution (1) Outside County Paid/Requested Mail Subscriptions Stated on PS Form 3541 (2) In-County Paid/Requested Mail Subscriptions Stated on PS Form 3541 (3) Sales Through Dealers and Carriers, Street Vendors, Counter Sales, and Other Paid or Requested Distribution Outside USPS ÂŽ (4) Requested Copies Distributed by Other Mail Classes Throught the USPS (e.g. c. Total Paid and/or Requested Circulation (Sum of 15b. (1), (2), (3) and (4)) d. Nonrequested Distribution (1) Outside County Nonrequested Copies Stated on PS Form 3541 (2) In-CountyNonrequested Copies Stated on PS Form 3541 (3) Non-Requested Copies Distributed Through the USPS by Other Clases of Mail (4) Non-Requested Copies Distributed Outside the Mail e. Total Nonrequested Distribution (Sum of 15d (1), (2), (3) and (4)) f. Total Distribution (Sum of 15c and e) g. Copies Not Distributed h. Total (Sum of 15f and g) i. Percent Paid and/or Requested Circulation (15c divided by f times 100) 16. Publication of Statement of Ownership for a Requestor Publication is required and will be printed in the October 2013 issue of this publication.

17. Signature and Title of Editor, Publisher, Business Manager, or Owner

R. Harvey Swaine, Audience Development Director (signed)

Average No. Copies No. Copies of Single Each Issue During Issue Published Preceding 12 Months Nearest to Filing Date 10,353

10,274

7,559 0

8,923 0

0

0

0 7,559

0 8,923

2,456 0

801 0

0

0

236 2,692 10,251 102 10,353 73.7%

450 1,251 10,174 100 10,274 87.7%

24 HOW IT WORKS

November/December 2014 â&#x20AC;˘ www.cemag.us

Modular Tall-Walls Satisfy the Demand for Larger Controlled Environments

Problem:

In the past, modAdvantages of building with modular ular cleanrooms were primarily Both PortaMax and SteelSpan utilized for specialized functions product lines offer all the advanwithin a facility. Common applicatages of building with modular tions included labs, quality consystems. Most notably is the trol areas, and sensitive materials cost-savings advantages. Modular storage. While these applications systems offer reduced design and still exist today, there is also a labor costs due to their pre-engigrowing need for more expansive Extra-tall modular wall systems provide a cost-effective solution for neered and pre-fabricated nature. cleanroom environments includ- large-scale cleanroom design-build solutions.

There are tax write-offs associated ing the segmentation of entire with modular construction, furthering their cost-savings advantage. manufacturing, packaging and processing areas within a facility.

Modular systems are inherently green due to their low mess Until recently, these larger applications have been reserved for more installation and re-usable nature. As highly sustainable products, certraditional cleanroom construction methods due to size restrictions tain benefits like LEED points are awarded to companies that utilize when building with modular systems. modular systems for interior construction.

Today there are modular wall systems available that Modular systems offer a high degree of flexibility and adaptcan meet the demand for larger cleanroom environments while also ability. As pre-engineered components, they allow for easy retaining the benefits of modular construction. Spanning heights of integration of new features like doors, windows, or equipment up to two to three stories tall, these extra-tall wall systems provide pass-throughs. The ability to disassemble, modify, and relocate cleanroom contractors with a cost-effective solution to not only modular buildings or their individual components allows a build larger and taller environments, but also to provide a versatile modular structure to adapt to changing business needs, offersolution for changing business needs. ing significant future advantages.

As the market for controlled environments expands beyond traPortaFab Corporation is a modular cleanroom manufacturer who ditional applications in the medical and pharmaceutical industries, provides extra-tall wall systems that are suited for larger cleanroom the growth in alternative cleanroom building products is adapting. applications. Two of their product lines in particular offer unique There are also a growing number of opportunities for cleanroom enadvantages to cleanroom contractors who wish to meet the requirevironments within the manufacturing industry where these tall-wall ments for larger environments. systems are often utilized.

The SteelSpan product line does not require a framing system, Todayâ&#x20AC;&#x2122;s manufacturers who are looking to meet current GMPs and is suited for quickly and economically dividing plant space from need cost-effective and flexible solutions. Due to the size of most floor to roof. With virtually unlimited heights and R-values reaching manufacturing plants, the majority of industrial cleanrooms require 43, SteelSpan provides contractors with a high-end solution for secextra heights and greater clear-spans so that they can accommodate tioning off entire facilities to control dust, thermal breaks, vapor barthe transfer of large equipment in and out of the enclosure. Some rier, temperature, humidity, noise, and other environmental needs.

An alternative solution is the PortaMax wall system. Also used of these industrial cleanrooms can reach heights up to 40 feet, to divide plant space, this wall system is also suited for creating requiring walls that can extend from floor to ceiling in order to fully free-standing buildings and cleanroom envelopes taller and segregate space and provide optimal environmental control. The stronger than ever before possible with modular systems. The PortaMax and SteelSpan extra-tall modular wall systems provide a increased wall heights with this system allow contractors to solution for these types of applications.

By utilizing these new extra-tall modular wall systems, achieve specific clearance for machinery or ceiling plenums to cleanroom contractors can now provide a cost-effective soluconceal and house equipment. PortaFab offers a variety of wall tion for clients within a variety of markets that are looking for panels that can be utilized with the PortaMax wall system, each large-scale cleanroom design-build solutions that offer the featuring a variety of core materials and panel finishes for meetflexibility for reconfiguration as business needs change. More ing specific requirements for acoustic and thermal insulation, information is available at www.portafab.com. chemical resistance, and static control.

Solution:

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Management Tip: Talent v.

Determination in Workplace 5 Things to Consider Determination and perseverance are important traits in the workplace. Employers want employees who are determined to get things done, to make things happen, and to constantly look for better ways of doing things. We are more likely to continue in the face of adversity if we think that talent is only peripheral to our future success.

Read the full article on cemag.us

Online Exclusive: The Need for Harmonization of Water for Hemodialysis Standards in Pharmacopoeia Monograph Applications Harmonization of specifications can ensure consistently higher quality water. The United States Pharmacopoeia (USP), in 2004, instituted a monograph titled “Water for Hemodialysis”. AAMI’s long established recommendations for water for hemodialysis have become the standard in the United States. Although based on the AAMI published recommendation, the USP Water for Hemodialysis monograph has some notable differences.

Read the full article on cemag.us

Cleanroom Tips: Check out the Top Cleanroom Tips of 2014 • Cleaning Costs Checklist Production engineers need a cleaning process that is safe, sustainable, and affordable. Plan your expenses wisely. http://www.cemag.us/ articles/2014/10/cleaning-costs-checklist • Understanding the Implications of the Classification System Over the past few years there has been an increasing trend to change from previous classification systems used to the ISO classification systems in ISO 14644-1. http://www.cemag. us/articles/2014/04/understanding-implicationsclassification-system • Fixture Styles for Cleanroom Lighting The need for multiple air filters in cleanroom facilities leaves minimal space for light fixtures.

There are three common fixture styles that maximize the use of the space. http://www. cemag.us/articles/2014/08/fixture-stylescleanroom-lighting • 7 Rules of the Road for Commissioning Over time, equipment falls out of sync, building interiors are reconfigured, and building systems are upgraded. http://www.cemag.us/ articles/2014/05/seven-rules-road-commissioning

BUSINESS MARKETPLACE

November/December 2014 • www.cemag.us

26 CLEANROOM TIP & INDEX

OOM CLEANR

Establishing a Cleanroom Safety Plan TI P here are many similarities with establishing and maintaining quality and safety cultures.

Successful quality and safety cultures are top management driven using defined procedures and protocols based on Federal regulations, industry standards, and best management practices. A cleanroom safety program may be established, implemented, and maintained using resources such as OSHA standards, IEST recommended practices, national consensus standards (such as the American National Standards Institute Z10), and internal company requirements.

A cleanroom safety program will include proper gowning procedures – home activities include daily bathing or showering, shaving, brushing of teeth and hair, and application of non-silicone containing skin moisturizers to reduce skin flakes. This activity enhances the health and well-being of the cleanroom operator. At work, all employees must wash hands before entering the cleanroom and after eating and/or using the toilet. This activity decreases the number of microorganisms that could cause contamination in the cleanroom and

T

illness to the cleanroom operator. Cleanroom-compatible hand cream may be applied prior to gowning.

The plan should define how personal protective equipment or cleanroom garments are worn to enhance operator safety. Safety criteria should include information on how to properly wear hoods, masks, goggles/safety glasses, coveralls, and boots/shoe covers.

IEST-RP-CC018.4, Cleanroom Housekeeping: Operating and Monitoring Procedures, provides guidelines to establish and validate an effective cleaning program. This recommended practice defines the sequence of cleaning and the methods of cleaning the cleanroom walls, floors, and work surfaces.

The recommended cleaning methods are validated for both viable and nonviable particle removal. Basic cleaning safety requirements would consist of how to maintain safety data sheets; proper use of cleaning agents and disinfectants used to clean the walls, floors, and surfaces of the cleanroom; hazards of cleaning chemicals and exposure limits of chemicals.

Equipment validation and continuous monitoring for efficacy should also be included.

This cleanroom tip was taken from “Working Safely in the Cleanroom,”

by Jan Eudy.

EDITORIAL INDEX American Hospital Association . . . . . . . . . . . . . . . . . . . .18 BFK Solutions LLC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 Centers for Disease Control and Prevention . . . . . . . . . .18 CleanAir Solutions Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . .23 Department of Health and Human Services . . . . . . . . .18 Department of Transportation . . . . . . . . . . . . . . . . . . . . .18 Design-Build Institute of America . . . . . . . . . . . . . . . . . .21 Dortronics Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 European Union . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20 Finishing Publications Ltd. . . . . . . . . . . . . . . . . . . . . . . . .19 Georgia State University . . . . . . . . . . . . . . . . . . . . . . . . . .10 HDR Architecture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 Honeywell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 Hutchins & Hutchins Inc.. . . . . . . . . . . . . . . . . . . . . . . . . .23 M+W Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 MaineGeneral. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 MediSHARE Environmental Health & Safety Services . .19 National Association for Surface Finishing . . . . . . . . . . .20

ADVERTISERS’ INDEX National Institute for Occupational Safety and Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 National Institutes of Health . . . . . . . . . . . . . . . . . . . . . .18 Pirbright Institute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 PortaFab Corporation . . . . . . . . . . . . . . . . . . . . . . . . . . . .24 Protective Industrial Products . . . . . . . . . . . . . . . . . . . . .23 Rytec . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 Sam Houston State University . . . . . . . . . . . . . . . . . . . . .19 SMRT Architects and Engineers . . . . . . . . . . . . . . . . . . . .10 SUNY’s College of Nanoscale Science and Engineering . .7 The American Institute of Architects . . . . . . . . . . . . . . . .21 The Healthcare Coalition for Emergency Preparedness 18 Toxics Use Reduction Institute . . . . . . . . . . . . . . . . . . . . .20 U.S. National Nanotechnology Initiative . . . . . . . . . . . . .7 United States Pharmacopoeia . . . . . . . . . . . . . . . . . . . . .25 University of Illinois at Urbana-Champaign . . . . . . . . . .19 University of Massachusetts Lowell. . . . . . . . . . . . . . . . .20 World Health Organization . . . . . . . . . . . . . . . . . . . . . . . .18

Arizona Polymer Flooring................................ 25 ..................................... www.apfepoxy.com Azbil BioVigilant, Inc ........................................ 2 ....................................www.biovigilant.com Berkshire Corporation ..................................... 27 .....................................www.berkshire.com Contec, Inc. ..................................................... 28 .....................................www.contecinc.com Dwyer Instruments, Inc................................... 11 .................................www.dwyer-inst.com/ Goodway Technologies Corporation ................ 15 ......................www.goodway.com/vacuums Mar Cor Purification ........................................ 20 ..........................................www.mcpur.com Met One Instruments, Inc. .............................. 25 ... www.metone.com/particle-counters.php Monroe Electronics ......................................... 25 .....................www.monroe-electronics.com S-Curve Technologies ...................................... 25 ........................................www.s-curve.com TSI, Inc. ............................................................ 5 .................................. www.tsi.com/aerotrak Ultratape Industries, Inc..................................25. ...........................www.cleanroomtape.com Veltek Associates, Inc. ...................................... 3 ...........................................www.sterile.com

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