CleanRoon 2008.pdf

T H E M A G A Z I N E O F C O N T A M I N A T I O N C O N T R O L T E C H N O L O G Y

Combination medical devices

Barrier systems

Planetary protection

Environmental monitoring

VOLUME 22, NO. 1, JANUARY 2008


Barrier systems




Barrier systems




Barrier systems



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Contents Zoom In Zoom Out For navigation instructions please click here Search Issue Next Page

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Combination device manufacturers need to consider the biocompatibility and restrictions of all components to achieve a successful product design. Shown here is STMicroelectronics’ In-Check lab-on-chip device, which combines a MEMS microfl uidic chip with a DNA microarray for medical diagnostics and microbial detection. Photo courtesy of STMicroelectronics.

®

contents 16 Plan ahead for combo device success By Sarah Fister Gale

24 Using RABS and isolators in pharmaceutical applications By Jack Lysfjord, Lysfjord Consulting LLC

28 New detection methods reinforce protocols for planetary protection By Patrick Hogue, Johns Hopkins University, Applied Physics Laboratory

32 Planning and installing an environmental monitoring system By Mark Hallworth and Edward Applen, Particle Measuring Systems

16

Volume 22, Number 1, January 2008© CleanRooms magazine (ISSN 1043-8017) is published monthly, 12 issues per year, by PennWell Corporation, 1421 South Sheridan Rd., Tulsa, OK 74112. Entire contents copyright 2008. No portion of this publication may be reproduced in any form without written permission of the publisher. Views expressed by the bylined contributors should not be construed as refl ecting the opinion of this publication. Every precaution is taken to ensure the accuracy of the information that is published. The publisher cannot accept responsibility of the accuracy of the information supplied. Publication of product/service information should not be deemed as a recommendation by the publisher.Editorial Contributions: CleanRooms accepts manuscripts from the contamination control industry. Contact the Editor for Editorial Guidelines. Product/Service Information: Should be submitted in accordance with guidelines available from the Editor. Editorial closing date is two months prior to month of publication.European Subscriptions: PennWell European Journal Service, P.O. Box 4456, London SW12 8AX, United Kingdom. Change of Address: Send old label as well as new address to: Circulation Manager, CleanRooms, Omeda Communications, PO Box 3282, Northbrook, IL 60065-9592.Authorization to photocopy items for internal or personal use, or the internal or personal use of specifi c clients, is granted by CleanRooms, ISSN 1043-8017, provided that the appropriate fee is paid directly to Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923 USA, 978-750-8400. Prior to photocopying items for educational classroom use, please contact Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923 USA 978-750-8400. For further information check CCC Online at the following address: http://www.copyright.com/A controlled circulation publication, CleanRooms is distributed without charge to qualifi ed subscribers. Nonqualifi ed Subscription Rates: U.S. — $95 per year; U.S. 2-year — $152; Canada/Mexico — $127 per year, $202 2-year; International Air — $159 one year, $254 2-year. Single copies $12.00 (US), $17 (Int’l Surface), $17 (Int’l Air). Buyers Guide Issues: $58 (US), $69 (Int’l Surface), $81(Int’l Air). All rates are payable in U.S. funds. Periodicals Postage Paid at Tulsa, OK 74112 and at Additional Mailing Offi ces. Return Undeliverable Canadian Addresses to: P.O. Box 122, Niagara Falls, Ontario CANADA L2E 6S4. POSTMASTER: Send address changes to CleanRooms, Omeda Communications, PO Box 3282, Northbrook, IL 60065-9592.

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®

E D I T O R I A L A D V I S O R Y B O A R D

Frank X. AustinClean Air Technology

C.W. BerndtC.W. Berndt Associates

David BrandeNNE US Inc.

Roger DienerAnalog Devices

Anne Marie DixonCleanroom Management Associates

Dr. Johann DornerFraunhofer Institute Manufacturing Engineering & Automation

Gordan M. ElyNelson Laboratories, Inc.

Jan EudyCintas Corporation

Adam GiandomenicoAdams Instruments

Thomas E. Hansz AIAFacilities Planning & Resources

Allyson Hartzell Exponent Failure Analysis Associates

Eric Kastango Clinical IQ

Elaine Kopis-Sartain Steris Corporation

Dr. Sowmya Krishnan Ultra Clean Technology

Richard Matthews Filtration Technology

Kathy MiscioscioCleanroom Consultant

Dr. Richard Pavlotsky, P.E.Greene Engineers

Henry D. RaheContain-Tech

Michael RatajAramark Cleanroom Services

David J. RuedeEntegris, Inc.

Scott SaltonLighthouse Worldwide Solutions

Dr. Hans H. SchichtSchicht AG

Dr. R. VijayakumarAerfi l, LLC

Jim WagnerControlled Environments Consulting

Top news 8 Experts cite missed opportunity in NIH risk assessment of BSL-4 lab

11 Survey says: PPE compliance remains ‘a top workplace concern’

11 FDA advisors declare ‘FDA science and mission at risk’

Columns14 Setting the standard IEST marches on to nanotech beat

36 Product spotlight Cleanroom garments

40 New products

48 Calendar

JOHN HAYSTEAD Publisher/Editor/[email protected]

CARRIE MEADOWS Managing Editor/[email protected]

SARAH FISTER GALE Correspondent (Chicago, IL)

BRUCE FLICKINGER Correspondent (Princeton Junction, NJ)

HANK HOGAN Correspondent (Austin, TX)

GEORGE MILLER Correspondent (Littleton, MA)

JASON T. BLAIR Manager, Magazine Presentation

CLARK BELL Presentation Editor

RAE LYNN COOPER Production Manager

ILLUSTRATION TEAM Kermit Mulkins, Kay Wayne, Mike Reeder

KIMBERLEE SMITH Ad Traffi c Manager

MICHELLE BLAKE Circulation Manager

KRISTEN JONES Marketing Communications Manager

KATRINA FRAZER CleanRooms Show Management

Editorial /Executive Offi ces 98 Spit Brook Road Nashua, N.H. 03062-5737 Phone: (603) 891-0123 Fax: (603) 891-9200 www.cleanrooms.com

LETTERS TO THE EDITOR ARE WELCOME. Please include your postal address (even on e-mail) and a telephone number. Letters will be edited for length and style.

CLEANROOMS ON THE INTERNET. Visit our Internet site (www.cleanrooms.com) for news, features and product information.

BUYERS GUIDE INQUIRIES should be directed to Linda Smith-Quinn at (603) 891-9370 or [email protected].

SUBSCRIPTIONS: To order or renew, or to change your address, or for back issues, contact circulation department at 847-559-7500 or www.omeda.com/custsrv/crm. We make portions of our subscriber list available to carefully screened companies that offer products and services that may be important for your work. If you do not want to receive those offers and/or information, please let us know by contacting us at List Services, CleanRooms, 98 Spit Brook Road, Nashua, N.H. 03062.

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ATD Publishing DepartmentsJUDITH M. SIMERS ATD Buyers Guide Director

SANDY TAYLOR Buyers Guide Database Administrator

Corporate Offi cersFRANK T. LAUINGER Chairman

ROBERT F. BIOLCHINI President and CEO, PennWell

MARK C. WILMOTH Chief Financial Offi cer


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from the editor

ChangesDuring this election season, we’ve all heard a lot of talk about “change.” It’s the favorite buzzword of just about every candidate’s campaign and seems to impart some magical meaning of its own. The problem is that no one is at all clear as to what kind of change they are advocating, planning to implement—or voting for, for that matter. Of course, the truth is that change is simply that—change. And it can be good or bad depending on what it actually involves and where you sit.

Here at CleanRooms, we’re experiencing change as well—the real kind, the kind you can identify. But what I want to talk about most is much more important than that—the things that aren’t changing, and won’t.

The most obvious change here at CleanRooms is our Publisher. After many years of dedicated service, Jim Enos will now be putting his talents and energy into a new career. It will certainly be a personal change for me not to have his tremendous enthusiasm, advice, and leadership but, at the same time, the total commitment to the contamination control industry and to the community of professionals that make it up, exemplifi ed by CleanRooms under Jim’s direction, will not change in any way, shape or form. In fact, I am extremely proud to have been passed the responsibility of making sure of that.

Since fi rst being introduced to the contamination control community some twelve years ago, I have never lost my appreciation for its vitality, dedication to excellence, and innovative spirit. Nor have I forgotten the fact that we’re also a tight-knit group very much based on personal relationships and trust as well as shared experiences, challenges, and objectives. This also will not change.

CleanRooms has always taken a leadership role in the industry, seeking out new technology developments and innovative implementations for our readers and identifying and targeting emerging business opportunities for our advertisers. This will not change either.

Going forward CleanRooms will also not change our philosophy of welcoming, listening to, and learning from the feedback and suggestions of you, our readers. This will always be a cornerstone of our business strategy.

We have a great many new and exciting plans for the year ahead and beyond. I look forward to both bringing them to you and working with you on them. In fact, this brings me to one fi nal thing that will not change—how much fun I have being a part of this great industry.

I’m John Haystead and I not only approved this message, I wrote it myself.

John Haystead,Publisher & Editor


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8 C L E A N R O O M S J A N U A R Y 2 0 0 8

news

w w w . c l e a n r o o m s . c o m

Summary of recommended biosafety levels for infectious agents

BSL Agents Practices Primary barriers and Facilities safety equipment (secondary barriers)

1 Not known to consistently Standard microbiological None required Laboratory bench and cause diseases in healthy practices sink required adults

2 • Agents associated with BSL-1 practice plus: Primary barriers: BSL-1 plus: human disease • Limited access • Class I or II BSCs or other • Autoclave available • Routes of transmission • Biohazard warning signs physical containment devices include percutaneous injury, • “Sharps” precautions used for all manipulations ingestion, mucous membrane • Biosafety manual defi ning of agents that cause exposure any needed waste splashes or aerosols of decontamination or medical infectious materials surveillance policies Personal protective equipment (PPE): • Laboratory coats, gloves, face protection as needed

3 • Indigenous or exotic BSL-2 practice plus: Primary barriers: BSL-2 plus: agents with potential for • Controlled access • Class I or II BSCs or • Physical separation from aerosol transmission • Decontamination of other physical access corridors • Disease may have serious all waste containment devices • Self-closing double-door access or lethal consequences • Decontamination of used for all open • Exhaust air not recirculated laboratory clothing before manipulation of agents • Negative airfl ow into laboratory laundering PPE: • Baseline serum • Protective laboratory clothing, gloves, respiratory protection as needed

4 • Dangerous/exotic agents BSL-3 practices plus: Primary barriers: BSL-3 plus: which pose high risk of life- • Clothing change before • All procedures conducted in • Separate building or isolated threatening disease entering Class III BSCs or Class I zone • Aerosol-transmitted • Shower on exit or II BSCs in combination • Dedicated supply and exhaust, laboratory infections have • All material decontaminated with full-body, air-supplied, vacuum, and decontamination occurred; or related agents on exit from facility positive-pressure personnel systems with unknown risk of suit • Other requirements outlined in transmission the text

Experts cite missed opportunity in NIH risk assessment of BSL-4 labBy George MillerA National Research Council (NRC) committee of experts provided a boost to neighbors opposing construction of a biocontainment research lab at the Boston University Medical Center by declaring in late November that a draft environmental impact report concerning

the facility is “not sound and credible.”The declaration compounds the complex-

ity of a labyrinthine approval process whose players span neighborhood activists to offi cials at the city, state, and federal levels, all result-ing from Project Bioshield legislation enacted following the 9/11 and anthrax letter attacks

of 2001. The NRC experts viewed the report as an opportunity to quell fears about the safety of biocontainment facilities.

The National Institutes of Health (NIH) is now implementing a construction pro-gram that will complete four new BSL-4 fa-cilities—including the $200 million BU lab,

Source: Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition, U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Institutes of Health, February 2007.


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J A N U A R Y 2 0 0 8 C L E A N R O O M S 9w w w . c l e a n r o o m s . c o m

now 70 percent complete—as well as 14 BSL-3 facilities within the next few years [see “Lab Biosafety Hearings Conjure Cold War Fears,” CleanRooms, December 2007, p.7. Differences in biosafety level protocols are shown in the ac-companying table].

Neighbors who oppose the facility question BU’s ability to protect their Boston neighborhood while running a BSL-4 facility, given the institution’s track record: At an existing BSL-2 lab in 2004, for example, researchers violated safety procedures and became infected with tularemia; at an advanced biomedical research building in early 2007, a medical waste fi re led to the building’s evacuation.

Chief among the NRC expert committee’s concerns is the lack of inclusion of highly infectious agents in the NIH draft assessment, and the subsequent lack of a credible worst-case scenario. “A more acceptable analysis would have included agents that are readily transmissible and would have demonstrated that the modeling approach used recognizes biological complexities, refl ecting what is known about disease outbreaks and being appropriately sensitive to population density,” according to an NRC statement.

In addition, the draft assessment contains too little information to compare the risks as-sociated with alternative BU campus locations in suburban (Tyngsborough, MA) and rural (Peterborough, NH) settings for the laboratory. Considering pathogens that spread more eas-ily would improve analyses of how risks vary depending on location, the committee said. It was also dissatisfi ed with the draft assessment’s consideration of environmental justice issues and how the biocontainment facility could af-fect the inner-city population in particular.

Missed opportunityExpert committee member Gary Smith, chief for epidemiology and public health at the

University of Pennsylvania School of Veterinary Medicine, said that, given the type of model that NIH researchers used in preparing the draft statement, “this seems to have been a missed opportunity, especially when the three locations were considered.” The NIH draft could have presented a more refi ned analysis of the

risks presented by a facility like BU’s, he said, and evaluated comprehensively the impact of a worst-case scenario event on public health and safety. Doing so might have provided greater assurances for the neighbors and might also have been viewed as relevant to assessments

continued on page 10

The NRC experts viewed

the report as an opportunity to

quell fears about the safety of

biocontainment facilities.


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The BU Medical Center BSL-4 biocontainment lab facility, now about 70 percent complete, is part of the Biosquare II project on Albany Street in Boston. Image courtesy of Boston University Medical Center.


news


BSL-4 continued from page 9

for other biocontainment facilities.The experts question whether the NIH fully

exploited the agent-based model used in the analysis. The committee writes that such models are “particularly good at revealing the infl uence of heterogeneities in the host population.” Relevant examples, with respect to comparing the three locations, include host characteristics that may affect susceptibility and case fatality rates. “But there was no reference to expected or plausible differences on transmission probability for those at special risk (the very young, the very old, those with preexisting conditions, and those with compromised immune systems),” according to the report.

In addition, NIH appears to have made the assumption in its model that each person has 10 contacts per day, regardless of the population density of the location. “This assumption about the number of contacts further reduces the opportunity for transmission and effectively eliminates one of the most important differences between locations,” the report said.

Environmental justice concernsNRC expert committee member Gigi Kwik Gronvall, assistant professor of medicine and senior associate at the University of Pittsburgh Medical Center’s Biosecurity Center in Baltimore, added during the NRC press conference that the draft NIH document also took into account neither the health status of the population, nor the Boston neighborhood’s status as a U.S. Environmental Protection Agency environmental justice community. “We didn’t see accommodations for public health access in the report,” she said. “We don’t know if it makes a difference. We just want to know that it was addressed.”

The neighborhood is acknowledged to have among the highest rates of HIV infections in Boston, as well as a high rate of intravenous drug use and correspondingly high incidence of hepatitis C.

“One of several things that affects how diseased one becomes during an outbreak is health status [of residents],” said expert committee member Smith. That status varies with age distribution, pregnancy rate, and proportion of immunocompromised individuals, among other factors.

The experts make clear in both their report and cover letter that their conclusions concern only the “scientifi c adequacy” of the NIH draft supplementary risk analysis, and not the previously submitted, original risk assessment and site suitability analysis document submitted by NIH as a standard part of the NEPA process.

“It is important to recognize,” the experts write, “that these conclusions are based solely on the committee’s technical review of the [NIH draft], and thus they should not be viewed as statements about the risks of proposed biocontainment facilities in Boston, or in cities more generally. The Committee acknowledges the need for biocontainment laboratories in the United States, including BSL-4 laboratories, and recognizes that BSL-4 facilities are being operated in other major urban areas.”

The NIH, while acknowledging via e-mail correspondence that “the NRC has raised important concerns,” makes no apologies for the document it drafted: “NIH followed the NEPA procedures in preparing a fi nal environmental impact statement and in issuing a record of decision” on the BU lab, according to a statement issued after the NRC report was released in late November.

NIH said it will continue to follow the standard NEPA process and will consider and respond to all comments received, including those of the NRC experts.

For its part, the Boston University Medical Center said in a statement, “We recognize that the NRC report states concerns regarding the NIH methodology and analysis and are confi dent that the NIH will address those issues in its fi nal report. In the meantime, we stand ready to provide whatever information we can in order to respond to questions and concerns, and to document that the South End site is as safe as or safer than alternative locations.”

P A R T I C L E Scompiled by Carrie Meadows

Gerbig Engineering introduces new cleanroom construction featureMinnesota-based Gerbig Engineering, a specialist in the design, build, installation, and certifi cation of cleanrooms, now offers a raceway that is integrated into the framing system of its cleanroom constructions. The raceway allows wiring, cabling, and plumbing to be threaded throughout the cleanroom and remain totally hidden. The system will work for both hardwall and softwall systems, and for portable or stationary cleanrooms. Existing AireCell Cleanrooms can be retrofi tted with this raceway system.

New England Peptide opens instrumentation labNew England Peptide, LLC (NEP), a company that designs and produces custom peptides and polyclonal antibodies for drug and vaccine discovery organizations, has opened a new production instrumentation laboratory at its Massachusetts facility. NEP’s engineering staff will use the dedicated lab to develop new instrumentation, qualify newly acquired production equipment, and effi ciently bring instrumentation offl ine for maintenance.

David Savage lands at Ultra CleanUltra Clean Technology, a developer and supplier of critical subsystems for the semiconductor capital equipment industry, announced the appointment of David Savage as president and CEO, effective Jan. 8. Leonard Mezhvinsky retired from the position of president as of Dec. 31. Savage brings to Ultra Clean more than 20 years of executive experience. Before joining UCT, Savage was CEO of Litel Instruments, Inc., a semiconductor optical metrology business. He has also served as president of the Electronics Division of Meggitt USA, Inc., and as CEO at DigMedia, a media delivery business focused on broadband service providers.


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news


Survey says: PPE compliance remains ‘a top workplace concern’For the second year in a row, a survey of safety professionals has found that non-compliance with personal protective equipment (PPE) proto-cols continues to be an issue in the workplace.

Eighty-seven percent of respondents said they had observed workers failing to wear PPE when they should have been, according to a survey of attendees at the 2007 National Safety Council (NSC) Congress, conducted by Kimberly-Clark Professional, last fall. Eighty-fi ve percent of safety professionals answered yes to the same question in a survey undertaken by Kimberly-Clark Professional at the 2006 NSC Congress.

“Despite the undisputed need for PPE when undertaking hazardous tasks, people continue to risk bodily harm by failing to protect themselves,” said Randy Kates, general manager of the safety business for Kimberly-Clark Professional. “In this survey, we not only asked why people did not comply with PPE protocols but what could be done to alter these behaviors.”

The main reason 62 percent of respondents gave for noncompliance is that PPE was “uncomfortable.” This was followed by workers thinking PPE was not necessary for the task, was “too hot,” fi t poorly, or was “unattractive looking.” So it’s no surprise that when asked what could be done to improve the PPE they were currently purchasing, 75 percent of survey respondents said they would make it more comfortable.

The survey also investigated the effect of environmental considerations on purchasing PPE and other personal safety products. Ninety-four percent of respondents said environmental considerations and reducing the impact on the environment were important to them. Sixty-four percent ranked these as “very important,” while 20 percent described them as “somewhat important.” Ten percent said environmental factors were “increasingly important now,” as compared to a few years ago.

The survey also asked respondents to choose

between two types of industrial wiping products: a recycled cloth towel that is laundered and reused, releasing chemicals and metal contaminants in the wastewater of industrial laundries, or a disposable paper or paper/polymer wiping product that is discarded into a landfi ll after use. Fifty-six percent said they would choose the disposable wiper. Twenty-seven percent selected the laundered towel. Seventeen percent said they did not know which product they would pick.

Survey questionnaires were fi lled out by 197 safety professionals who reported being re-spon-sible for purchasing, selecting, or infl uenc-ing the purchase or selection of, or compliance with, PPE. Respondents were from fi elds such as industrial manufacturing, construction, hazmat, emergency response, clean manufacturing, labo-ratories and science, health care, transportation, law enforcement, and government. For full sur-vey results, visit http://www.kcprofessional.com/us/mkt/nscpressrelease.

FDA advisors declare ‘FDA science and mission at risk’According to a subcommittee of the U.S. Food and Drug Administration’s Science Board, the nation’s food supply is at risk, as are the regulatory systems that oversee the nation’s drug and device supplies. In a report presented in December, the subcommittee attributed the defi ciencies to increased demands on FDA and resources that have not increased in proportion to those demands. Committee members conclude that “this imbalance is imposing a signifi cant risk to the integrity of the food, drug, cosmetic, and device regulatory system, and hence the safety of the public.”

The result of a year-long review by a dis-tinguished panel of experts, the subcommittee’s 300-page report concludes that the state of FDA’s scientifi c and regulatory programs could not be separated from the lack of resources. It urged funds to support the agency’s scientifi c base, hire a broadly capable scientifi c workforce, and build a sophisticated, modern information tech-nology infrastructure.

Upon the report’s release, Don Kennedy, PhD, a former FDA commissioner and editor-

FDA continued on page 13


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news

P A R T I C L E Scompiled by Carrie Meadows

USP <797> revisions now availableThe U.S. Pharmacopeia has posted the Revision Bulletin containing changes to General Chapter Pharmaceutical Compounding—Sterile Preparations <797> on its web site at http://www.usp.org/USPNF/pf/generalChapter797.html. The revisions will become offi cial on June 1, 2008, and will be included in USP 32–NF 27 and the upcoming second edition of Pharmacists’ Pharmacopeia. USP says that the revised standards are being published online “to give the compounding community time to implement changes before the offi cial date.”

BASF completes European electronic materials centerThe Electronic Materials Center Europe at BASF’s Ludwigshafen, Germany site is complete after approximately 15 months under construction. The production plant will provide process chemicals for the semiconductor industry throughout Europe. The center includes state-of-the-art purifi cation facilities as well as cleanroom fi lling stations to ensure high purity and consistent quality of the products. After completion of the qualifi cation activities at the end of 2007, routine production was scheduled to commence on Jan. 1.

Microtest expands facilities and servicesMicrotest, a provider of testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries, has doubled the size of its medical device/pharmaceutical stability storage capabilities, as well as signifi cantly expanding its medical device packaging laboratory and its GMP pharma fi ll/fi nish contract manufacturing services at its Agawam, MA-based headquarters. “Package validation is needed to support our medical device clients. We’re also dedicating additional new space to our growing product stability testing laboratories as well as our GMP drug manufacturing services,” says president and scientifi c director Steve Richter.

FDA continued from page 11

in-chief of Science magazine, and also a member of the FDA Alliance, an advocacy organization formed in 2006, commented that “FDA can’t improve its science, prepare for the future, or protect American consumers without signifi cant additional resources. Congress is negotiating FDA’s FY 2008 [current year] budget right now and can start to fi x this critical problem.”

The cry for more FDA resources was echoed by the Coalition for a Stronger FDA, which comprises patient groups, non-profi t organizations, consumer and public health advocates, and innovative companies with the goal of working alongside policymakers to bolster and preserve public confi dence in FDA. “Over the last decade, complex scientifi c advances, globalization, and challenging new safety issues have combined to multiply the responsibilities of the FDA. As this new report makes clear, our expectations cannot exceed the resources we give FDA to accomplish its mission. In this regard, more is defi nitely better,” said Mark McClellan, MD, former FDA commissioner and chairman of the new Reagan-Udall Institute.


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setting the standard


IEST marches on to nanotech beatIEST sets goals for new nanotechnology Recommended Practice Working Group activities

By John R. Weaver II, Senior Member, IEST

The Institute of Environmental Sciences and Technology (IEST) is taking a leading role in addressing the needs of the important nanotechnology discipline through the formation of relevant Recommended Practices. The IEST Nanotechnolo-

gies Standards and Practices (S&P) Committee has defi ned its scope as follows: “To take the lead in the development of Standards and Recom-mended Practices and to establish related educational efforts in the fi eld of nanotechnology by building on the established experience and expertise of IEST’s membership. In addition, the Nanotechnologies S&P Commit-tee will strive to enhance IEST’s participation in this fi eld by seeking out experts outside of the IEST from business, academia and government.”

Working Group 200 (WG-CC200) is developing an overview docu-ment, “Nanotechnologies Overview: Planning, Design, Construction, and Operational Considerations for Facilities Engaged in Research or Pro-duction at the Nanometer Scale.” This work is well underway and should be completed and ready for publication in 2008 as a Recommended Practice/Guideline.

In addition, Working Group 205 (WG-CC205), “Nanotechnology Safety: Applying Prevention through Design Principles to Nanotechnol-ogy Facilities” has recently been formed and held its inaugural meeting on November 14 at the IEST Fall Conference in Chicago, with a subse-quent meeting planned for ESTECH 2008. The National Institute of Oc-cupational Safety and Health (NIOSH), through the Centers for Disease Control and Prevention, has indicated its interest in participating in this Working Group’s activities through a Memo of Understanding (MOU).

End users, vendors, and governmental and public participants are encouraged to attend the nanotechnology working group meetings.

ESTECH 2008, the 54th annual technical meeting and exposition of IEST, will be held May 4–7 at the Hilton Chicago/Indian Lakes Resort in Bloomingdale (Northwest Suburban Chicago), IL. In addition to the scores of presentations, tutorials, and working groups of interest and importance to the design, test, and evaluation, product reliability, and contamination control technical communities, a signifi cant portion of the event will center on the burgeoning science of nanotechnology (see

ESTECH 2008: Focus on nanotechnology

KeynoteIEST is pleased to announce that E. Clayton Teague, PhD, will give the keynote address at the Annual Awards and Membership Luncheon on Tuesday, May 6, 2008. Teague is director of the National Nanotechnology Coordination Offi ce (NNCO), and previously served as chief of the Manufacturing Metrology Division in the Manufacturing Engineering Laboratory of the National Institute of Standards and Technology (NIST).

Teague also served as editor-in-chief of the journal Nanotechnology for 10 years and is currently a member of its editorial board. He received a BS and an MS in physics from the Georgia Institute of Technology and a PhD in physics from the University of North Texas. He has authored or co-authored 70 papers, has presented 50 invited talks in the technical fi elds described, and has six patents jointly with colleagues. Teague has received the Gold Medal, Silver Medal, and Allen V. Astin Measurement Science Award from the Department of Commerce.

Nanotechnology trackIn addition to the keynote address, immerse yourself in all things nano at ESTECH 2008.

John Weaver, facilities manager of the Birck Nanotechnology Center

(BNC) at Purdue University, will give a full-day tutorial on nanotechnology facility design on Monday, May 5. Nanotechnology working groups will meet on Tuesday and Wednesday, May 6 and 7. A seminar (technical session) on nanotechnology will take place on May 6 and will be chaired by David S. Ensor, PhD, IEST Fellow and delegate to the U.S. Technical Advisory Group (TAG) to ISO Technical Committee 229 Nanotechnologies. The ESTECH nanotechnology track is sponsored by HDR Architecture, Inc., the architects of the BNC.

Birck Nanotechnology Center TourConcluding ESTECH 2008 on Thursday, May 8, will be an optional all-day tour by motor coach departing from Hilton Chicago/Indian Lakes Resort to the Birck Nanotechnology Center at Purdue University in West Lafayette, IN. The BNC leverages advances in nanoscale science and engineering to create innovative nanotechnologies addressing societal challenges and opportunities in com-puting, communications, the environment, security, energy independence, and health. In turn, the BNC exploits the accelerating progress in nanotechnology, utilizing the most advanced nanoscale instrumentation to pursue answers to fundamental questions in the life and physical sciences. The interplay between these two complementary arcs of inquiry fosters a stimulating interdisciplinary environment for discovery well into the 21st century.

Watch for information about ESTECH 2008 at www.iest.org.


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setting the standard


“ESTECH 2008: Focus on nanotechnology”).

John R. Weaver II serves as the facility manager for the Birck Nanotechnology Center at Purdue University. He is responsible for the facility infrastructure, safety and train-ing activities, and cleanroom and laboratory operations. Weaver is a senior member of IEST, president of the Indiana Chapter, member of the editorial board for the Journal of the IEST, vice-chair of SPC-7: Nanotechnology, chair of WG205: Nanotechnology Safety, and is a principal member of the NFPA 318 committee, which writes fi re standards for cleanrooms. He has published numerous papers in both the process development and contamination control fi elds, has two patents in process development, and authored a book and two book chapters in contamination control technology.

About IESTFounded in 1953, IEST is an international technical society of engineers, scientists, and educators that serves its members and the industries they represent (simulating, testing, controlling, and teaching the environments of earth and space) through education and the development of recommended practices and standards. IEST is an ANSI-accredited standards-developing organization; secretariat of ISO/TC 209 Cleanrooms and associated controlled environments; administrator of the ANSI-accredited U.S. TAG to ISO/TC 209; administrator of the ANSI-accredited U.S. TAG to ISO/TC 142 Cleaning equipment for air and other gases; and a founding member of the ANSI-accredited U.S. TAG to ISO/TC 229 Nanotechnologies.


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special report


The best combination medical device makers select product materials, process steps, and

monitoring strategies in the early stages of product development to ensure biocompatibility and

product stability throughout the manufacturing process.

By Sarah Fister Gale

Plan ahead for

combo device

success


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special report


The drug-eluting cardiovascular stent has changed the landscape of medical device manufacturing. These small implantable devices, which incorporate a device that can prop open an artery with a pharmacologic agent that interferes with reblocking after surgery, were among the fi rst successful products to combine two unique medical tools in a single package.

Prior to the drug-eluting stent’s success, few companies were producing or even talking about combination medical devices. Limited to cutting-edge research, they were solely the focus of forward-looking researchers and manufacturers. Today, however, combination medical devices are a common part of the medical industry lexicon.

The U.S. Food and Drug Administration (FDA) defi nes combina-tion medical devices as products comprised of two or more regulated components, such as a drug and a device, or a biologic and a device, that are combined and produced as a single entity; or those that are comprised of two unique entities, but are packaged together, or pack-aged separately but intended only to be used together.

Manufacturers are increasingly combining novel technologies that hold great promise for advancing patient care and making treatment options more convenient, customized, and self-regulated. Drug and biologic products can also be used in combination to enhance the safety or effectiveness of either product when it is used alone.

Some more recent examples of successful combination devices include proteins incorporated into orthopedic implants to facilitate bone growth that can stabilize the implant, drug-device inhalation systems for insulin delivery, and implantable timed-release medication delivery systems.

Rapid growthThe recent rapid growth of the combination medical device industry is undeniable. Independent fi rm Navigant Consulting (Chicago, IL) estimates the market has grown 10 percent per year since 2004 when it was an estimated $5.9 billion, to hit $9.5 billion by 2009.

FDA has had an offi ce of combination products since 2004, and there are a growing number of conferences and resources discussing the challenges and triumphs of the latest combination innovations. Christine Ford, event director for PharmaMedDevice, an annual medical device manufacturers’ conference (Norwalk, CT), reports that 30 percent of devices currently in development are combination products and that these devices have become the most popular topic at the events. “Every multibillion dollar medical device company seems to have a combination device in their pipeline,” she says. “And if they don’t, they need to know what’s going on because it’s a big trend.”

Cutting-edge device companies who want to fi nd a foothold in this burgeoning market are scrambling to identify innovative ways to combine device technologies with drugs or biologics that meet a range of medical needs.

The category of products promises to bring new business to these fi rms—if they can fi gure out how to produce them successfully. “It has become an emerging growth area, particularly in the last few years, and many fi rms are looking at these devices as an opportunity for market growth,” says Sharad Rastogi, principal in the life sciences group of



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Figure 1. Foster-Miller designed an ergonomic insulin injector pen for Becton Dickinson to treat diabetes patients (top) and worked with G.D. Searle to create a transdermal nitroglycerine patch for angina treatment (bottom). Photos courtesy of Foster-Miller.

Figure 2. A medical device sterility test vessel with a medical device immersed in TSB (Trypticase soy broth). Photo courtesy of Microtest Labs.


special report


PRTM, a management consulting fi rm (Waltham, MA). “But it’s a high risk, high reward market.”

“It can test a company’s resolve,” adds PRTM’s Sam Baldwin, manager of the life sciences group, who notes that developing the fi rst product in particular can be very diffi cult. “The time to develop is signifi cantly longer and the cost is much greater than with conventional medical devices. But if you go in with your eyes open you have a good chance of success.”

Regulatory red tapeThe rapid growth of this market has left the medical device industry in unfamiliar territory as it fi gures out how to characterize and regulate this hybrid category of products. Even FDA is struggling to defi ne a roadmap for these devices. While its offi ce of combination products offers guidance and development considerations to manufacturers, it has yet to clearly defi ne a set of good manufacturing practices (GMPs) specifi c to this product category. That has left companies to defi ne their own path using a combination of drug GMPs (21 CFR 210/211), biologics product standards (21 CFR 610), and medical device quality system regulations (QSRs; 21 CFR 820). Trying to strike that balance correctly is where the challenges begin to pile up.

“The combination product regulatory framework requires a unique perspective on both medical devices and pharmaceuticals/biologics,” says Steven Richter, founder and CEO of Microtest Labs in Agawam, MA.

“The fi rst step to producing one of these products on a commercial scale is determining which regulations impact which steps in the process and come up with a plan for process validation.”

A combination product manufacturer must have a robust pharmaceutical GMP system in place that addresses some of the issues with the device QSRs, but the main regulatory foundation must be the drug GMPs, Richter says. “There are a lot of factors to consider to meet FDA standards, and a lot of clean manufacturing environments for devices won’t be sustainable for drug manufacturing.”

Baldwin suggests that manufacturers partner with FDA in the early development stages to ensure they are making sound choices and documenting their progress. “The last thing you want is to get to the end of your project and discover you didn’t validate it properly,” he says. “Working with the FDA, you can make your case for your approach, and they can tell you if you are going in the right direction.”

Medicine takes precedenceAside from meeting regulatory compliance, combination medical device manufacturing is complex, particularly because it combines two or more distinct and delicate elements that will ultimately be used by the most vulnerable consumers. Because of this, contamination control must be complete and provable at all times.

“Most people who do medical product development are familiar with issues such as temperature and humidity control, airfl ow mainte-nance, management of particulates and pyrogens, and gowning,” notes Clair Strow, senior engineer and program manager in the medical divi-sion of Foster-Miller, a technology and product development company (Waltham, MA). “But it’s more diffi cult with combination products be-cause of the subtle differences.”

Devices that have been engineered from plastic, metals, silicon, or other materials have contamination control issues that will differ from the medical or biologic needs of the product. They can also create contamination issues, through off-gassing or particulates, that can contaminate exposed biologic or pharmaceutical material, damaging its effi cacy, says Foster-Miller’s Bob Andrews, medical division manager.

continued from page 17


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special report

Biologics are also more temperature and light sensitive and have shelf life issues that need to be considered—many biologics are only able to maintain stability for a few hours outside of a tightly controlled environment.

If the combination product uses multiple biologics or chemicals, cross-contamination among materials is an additional concern, Strow says.

If a technician is working with a nanoparticle in one cleanroom zone, it could contaminate biologics in another area if the facility uses a common air system. “The pharmaceutical industry is very sensitive to spills,” Strow says. “In a combination product, you have to be extremely careful, particularly of chemicals coming in contact with biologics.”

Depending on the delicacy of the product and the risks in the environment, that might mean the use of gloveboxes, laminar fl ow hoods, and control over the exhaust air around a fi ll station, or it could be as extreme as total isolation with separate air handling for the biologic component of the product to prevent particulates and other contaminants from the manufacturing process from coming in contact with biologic material.

Adding to the diffi culty is that device material and biologics or chemicals can have confl icting requirements for stability in the manufacturing environment. “Humidity control for a device may be too high for a biologic,” Andrews points out. “But if humidity levels are too

low, you can build static in the room that can affect the device.”This is not an uncommon problem, adds Foster-Miller’s Strow, who

recently worked with a client facing just such a dilemma. The client was developing a combination diagnostic product that included chemicals that would be stored in a nylon device. For the chemical to remain viable it had to be dispersed in an environment that maintained 1 to 2 percent relative humidity. The client was producing the product on a commercial scale, packing 100,000 units per 24-hour shift.

“In that environment at the low humidity level, there is a lot of static so materials need to be stable,” Strow points out. The nylon, however, became brittle in the low humidity, ultimately shattering.

Fortunately, they were able to create a solution that allowed the nylon device to be isolated in a 30 percent humidity room. The two elements of the device are now packaged separately using moisture barrier packaging that allows the chemical to remain at low humidity levels and the device to maintain higher humidity. Once the package is opened it must be used within 20 minutes, during which time the humidity levels won’t be an issue.

These kinds of problems can be avoided if proper product development planning is done with all of these issues given careful up-front consideration by the design team before establishing the



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Figure 3. An analyst inoculates a 96-well plate to perform an endotoxin assay on a combination product. Photo courtesy of Microtest Labs.


special report


manufacturing operation, says Andrews of Foster-Miller. “Once the room is assembled it’s much harder to make changes.”

Maintenance and monitoringControlling contamination in the environment during manufacturing requires an end-to-end process that ensures the cleanest materials go in and remain clean throughout the manufacturing process. The most successful operations begin contamination control steps well before materials ever enter the facility, says Richter, who notes that at Microtest, new batches of drug or biologic material are tested upon arrival for content, quality, moisture, purity, and contaminants before use.

Storage of device materials is also critical and must be closely evaluated when manufacturing processes are being established for combination devices. From an environmental control standpoint, you must consider both what a material is made of and where it has been, because the storage environment can affect how it performs in the cleanroom, says Strow.

“If I have a particular polymer piece that has been stored in a warehouse that has 90 percent humidity levels, then I bring it into a cleanroom with low humidity, that stored moisture will be sucked to the surface,” he points out. “If you seal a drug product into that polymer, you contaminate your fi nal product.”

Strow suggests that materials be placed in isolation with environmental conditions comparable to the clean environment for 24 hours to stabilize them.

Once the material is in the environment and process steps are taking place, manufac-turers should perform round-the-clock moni-toring, not just of the cleanroom, but also of the building management system, with a focus on airfl ow, temperature, humidity, and any motor malfunctions that could compromise the manufacturing or storage spaces, says Microtest’s Richter. They should also include backup generators to ensure the process is continuous.

Richter notes that newer HVAC systems can include specialized levels of pre-fi lters to eliminate toxic contaminants before they can be released downstream of the manufacturing space. This is particularly important if the device contains hazardous chemicals, such

as cytotoxic drugs that could be deadly to personnel.

Microtest has two 1,500-sq.-ft. manufac-turing spaces, each with separate airfl ow sys-tems and dedicated chillers to manage relative humidity and temperature. The facilities are also designed with walkways above the main room for maintenance and servicing. “It’s critical for the service people to be able to get above the cleanroom to pull fi lters, change traps, or look for problems,” Richter says. “We can do visual inspection and maintenance freely without compromising the cleanliness of the room.”

The product Microtest manufactures in this space includes a powder stored in an injection system, which makes the risk of airborne particles an issue. This is addressed

in the design and management of the room: It incorporates a conductive ESD fl oor, and high humidity levels above 60 percent to prevent dryness. The HVAC system was designed with an integrated vacuum system to suck out any particles that are generated from equipment or process steps. The company also does ongoing monitoring with particle counters and air samples at critical control points.

To maintain cleanliness and avoid bacterial issues, the sanitation team regularly rotates the intermediate-level disinfectants used to clean the room to prevent resistance. If problems with microbial status of the room arise, a high-level sporicide is used.

Once processing is complete, samples of the fi nished product are analyzed for contaminants using high-performance liquid



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[email protected]

Even FDA is

struggling to defi ne

a roadmap for

combination medical

devices.

special report


chromatography, and the product is bagged and terminally sterilized.

Sterility optionsHow the product is sterilized at the end of the manufacturing process is one of the most diffi -cult decisions developers of combination medi-cal devices will make, says PRTM’s Baldwin. It’s another decision that must be made early on in the product development process because it can affect every product development and environ-mental choice that will follow.

With traditional medical devices, steriliza-tion can almost be an afterthought. A common sterilization process is the use of ethylene ox-ide, which is a potent antimicrobial agent that can kill all known viruses, bacteria, and fungi. But such a strategy could destabilize biologic or pharmaceutical materials that are a part of the product.

“Once you add the biologic or pharma-ceutical component, your available steril-ization options drop considerably,” Baldwin says, explaining why sterilization methods must be determined well in advance of pro-duction. “Sterilization can have critical im-plications on your design. The companies that have the most success are the ones that include the sterilization group from the start of the design.”

Some options include low-dose or low-temperature radiation; a dry heat sterilization process, which can be an option for most small-molecule combination products; or the drug or biologic may be lyophilized, or rapidly frozen, to stabilize it during sterilization to allow for additional options.

Engineers also need to think carefully about working in an aseptic environment, and they need to be very careful about the bioburden that is brought in on equipment, materials, devices, and most importantly on personnel, Baldwin advises. “That means better training programs, daily operator assessments using touch plates or hand swabs, and a design process that minimizes human interaction.”

Whenever possible, he recommends automating key processing steps to remove the possibility of human error and contamination from the system.

Working togetherThe willingness to look at each product as hav-

ing an original set of needs and contamina-tion control issues is critical to a successful design process, but that attitude comes more naturally to medical manufacturers than to device manufacturers, who are accustomed to more controlled decision making options. This cultural difference and the need for prioritiza-

tion of medical materials represent signifi cant challenges for companies looking to move into this niche industry.

“While both elements of a combination device have unique sets of requirements for the manufacturing environment, you have to defer to the needs of the biologic,” says Strow. “They are the key to the device.”

That doesn’t mean the non-biological material should be compromised. Rather, it means the device material, along with the assembly methods, airfl ow handling, contamination monitoring, room layout, and isolation methods should be chosen based on the requirements of the biology in the product, with device materials selected to complement or coexist with those choices.

The trick is ensuring that you have biocompatibility between the materials, chemicals, biological elements, and the fl uids they might come in contact with, says Rob Hodges, biomedical business unit director for STMicroelectronics, a Dallas, TX-based global



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Figure 4. Semiconductor manufacturers such as STMicroelectronics are delving into the combina-tion medical device market. The company’s In-Check lab-on-chip platform incorporates silicon-based MEMS microfl uidic technology to facilitate the diagnosis of specifi c diseases or detect bacterial contaminants in liquid biological samples. Photo courtesy of STMicroelectronics.


special report



supplier of microfl uidic devices. “In many cases, the things you worry about are easy to handle, and the things you think will be easy take a lot longer than you expected.”

He notes that a big mistake companies make in their fi rst attempt at a combination product is to de-sign the elements independently of each other. “It’s not going to work if you design them separately then bring them together in the end. You need an integrat-ed system from the beginning for the fi nal product to work.”

However, many of the products coming to market now are the result of partnerships between medical device companies and pharmaceutical makers, who each bring a unique set of manufacturing skills and knowledge to the table. The gut reaction in these partnerships is to leave control of the key components of the product in the hands of the experts, who may work in separate labs or organizations. The medical device company designs the delivery mechanism, while the pharmaceutical team develops the drug or diagnostic. But if the two groups work in isolation with intent of combining the two elements later on, they are going to run into trouble, says Hodges.

“There is a lot of interaction between materials that can’t be predicted, especially when you work with biologics,” he points out, adding that engineers in particular don’t expect these kinds of problems because they don’t occur when working with pure electronics.

Hodges learned this lesson the fi rst time he developed a combination product. Working with a diagnostics company, the two teams decided to develop their own sides of the product individually with the goal of bringing them together later on in the project. “We tried to avoid the biology for as long as we could, and we stuck to electronic consumables, because it’s what we knew,” he says of his team. “We later realized that was an impossible approach.”

Hodges learned through that process that many unpredictable problems can arise when you incorporate biologics or drugs into a product, and ST has since added teams of biologists, chemists, physicians, and engineers to its staff who work together in the R&D phase ensure they achieve successful convergence between the technology and the biology.

“Combination products are a nice fi t for the semiconductor manu-facturing process,” he says, now that ST has the development process fi g-ured out. “We are driven by quality. That’s the mindset of semi and it’s the mindset of the medical industry.”

Hodges is currently working on ST’s lab-on-chip combination de-vice, which facilitates the diagnosis of specifi c diseases or the monitoring of food and water for bacterial contaminants by allowing the rapid detec-tion of particular genetic material in liquid biological samples.

The lab-on-chip product includes a silicon-based MEMS microfl u-idic chip that is printed with DNA molecules using equipment similar to a very large ink-jet printer. The DNA is arranged in a microarray that requires precision and a contamination-free environment.

“The combination of our historical knowledge of microelectronics with other multidisciplinary teams gives us the potential to develop

disruptive innovations,” he says. “It’s the kind of innovation we need for the growth of our future.”

Resources and contactsFoster-Miller, Inc.Waltham, MA781-684-4000www.foster-miller.com

Microtest LabsAgawam, MA425-446-4519www.microtest.com

Navigant ConsultingChicago, IL312-573-5600www.navigantconsulting.com

PharmaMedDeviceNorwalk, CTwww.pharmameddevice.com

PRTMWaltham, MA781-434-1200www.prtm.com

STMicroelectronicsDallas, TX512-225-6161www.st.com


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Figure 1. Active RABS pressure zone. Photo courtesy of Bosch Packaging Technology, Valicare Division.


barrier systems


Using RABS and isolators in pharmaceutical applicationsBarrier technology offers clean spaces for pharmaceutical fi lling and packaging, as well as protection for operatorsBy Jack Lysfjord, Lysfjord Consulting LLC

Barrier technology is designed to replace the use of con-ventional ISO 5 cleanrooms in pharmaceutical fi lling and packaging (i.e., ampoules, vials, cartridges, and pre-fi lled syringes). The goal of barrier systems, isolators and restrict-

ed barrier access systems (RABS), is to segregate people from the prod-uct, ensuring that pharmaceuticals are not exposed to viable organisms or particulate contamination. When dealing with highly potent formula-tions, these systems can protect operators as well.

Isolators are enclosed, usually positively pressurized units with high effi ciency particulate air (HEPA) fi lters supplying ISO 5 airfl ow in a unidirectional manner to the interior. Air is typically recirculated by returning it to the air handlers through sealed ductwork. Cleaning can be manual or automated (clean-in-place). Bio-decontamination occurs through an automated cycle typically using vaporized hydrogen peroxide. Access to an isolator is through glove ports and sterile transfer systems. Isolators can be located in an ISO 8 or better environment.

RABS also process in an ISO 5 environ-ment, with varying degrees of contact with the surrounding room, which is generally clas-sifi ed ISO 7 or better. Bio-decontamination is performed manually in a RABS. Although doors can be opened, this is a rare occurrence, after which the system must be appropriately sanitized, a necessary line clearance per-formed, and the intervention documented.

Key differences between RABS and isolatorsCompared to isolators, RABS can allow for faster start-up and ease of changeover, and, accepting certain restrictions, offer increased operational fl exibility and reduced validation and revalidation expenditure. Contract manu-facturers tend to gravitate to RABS because of speed of changeover.

RABS air handling units operate in a fashion similar to laminar fl ow hoods (LFHs)

in that they are fed clean air from fan units through HEPA fi lters and air vents from the unit into the RABS. Air exit is through openings to the room at a low level on the equipment. RABS provide separation by the barrier and by positive airfl ow. Isolator air handling requirements are more complicated because air is recirculated, necessitating return fans and ductwork. In order to maintain positive pressure, the air handling unit must be leak tight.

There are also differences in cleaning and bio-decontamination for RABS and isolators as mentioned previously. Cleaning must occur fi rst, removing stoppers, broken glass, and spilled product 9the dirt), and then bio-decontamination can occur. RABS are typically cleaned manually, or a CIP system can be used after manual clean-up of commodities. Isolators are bio-decontaminated through an automatic sequence by injecting vaporized hydrogen peroxide (VHP). Validation of the


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Shortridge Instruments, Inc.7855 E. REDFIELD ROAD / SCOTTSDALE, ARIZONA 85260-3430

TELEPHONE (480) 991-6744 / FAX (480) 443-1267WWW.SHORTRIDGE.COM

Figure 2. Aseptic powder fi lling in a passive RABS. Photo courtesy of Bosch Packaging Technology, Valicare Division.

barrier systems

C L E A N R O O M S J A N U A R Y 2 0 0 8 25w w w . c l e a n r o o m s . c o m

manual cleaning is more challenging than the automated cleaning cycle of a CIP system.

Environmental monitoring is necessary to ensure the integrity of the ISO 5 environment in both systems. Monitoring in isolator systems can only be achieved though built-in sampling ports or sterile transfer of sampling devices. The environmental monitoring requirements of an isolator system are therefore key design considerations. These same methods can be employed in RABS, but there is also the option of using portable sampling devices inserted into the fl oor-level air exit openings.

Responding to current trends in the pharmaceutical marketThere are a number of trends within the pharmaceutical industry that will make RABS and isolators critical components of any successful packaging and processing operation.

Biotechnology is having a big impact and reshaping the processing demands on

pharmaceutical fi rms. Live vaccines, large molecules, and protein-based drugs are increasingly the trend and require highly aseptic conditions. These products are preservative free and are usually a growth medium; therefore, they are easily contaminated.

Toxic, cytotoxic, and otherwise highly po-tent applications—immunosuppressive cancer drugs are a key example—also demand strin-gent barrier technology to protect operators.

Broadly speaking, there is a trend toward continued on page 26

Environmental

monitoring is

necessary to ensure

the integrity of the

ISO 5 environment in

both systems.


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Figure 3. FLC vial fi lling in a passive RABS. Photo courtesy of Bosch Packaging Technology, Valicare Division.

w w w . c l e a n r o o m s . c o m26 C L E A N R O O M S J A N U A R Y 2 0 0 8

barrier systems

smaller volume, higher value pharmaceuticals. Manufacturing in high-throughput, mass production systems that produce millions of dosages is declining and the ultimate cost-effectiveness of constructing a large ISO 5 cleanroom facility must be addressed in the long term.

Smaller systems that meet high regulatory standards and can be customized to small product runs are an increasingly attractive option. More compact, adaptable lines allow for fl exible confi gurations and en-able manufacturers to respond rapidly to changes in market demand.

Isolators are ideal for smaller facilities that employ fl exible, reduced-footprint systems. Compared to conventional cleanroom processing, isolators offer pharmaceutical fi rms signifi cant capital and operational cost savings. Furthermore, with a smaller isolator sys-tem there are minimized gowning costs and reduced labor and mainte-nance expenses.

Regulatory issues to considerThe critical regulatory concern for barrier systems is so-called “open door” interventions in a RABS. Such interventions introduce undesirable variables into the operation and potentially compromise the aseptic envi-ronment and so should be avoided or minimized.

However, when such interventions are unavoidable, appropri-ate measures must be taken to ensure the aseptic environment is

maintained. Open door interventions inevitably prompt heightened regulatory scrutiny, demanding particularly scrupulous observance of standard operating procedures (SOPs).

When open door interventions are necessary, an ISO 5 vertical unidirectional airfl ow system outside of the RABS reduces risk of a breach in ISO 5 conditions and further safeguards the aseptic integ-rity of the system. Each intervention that requires opening of a door of the RABS is regarded and documented as an intervention. Interlocked RABS doors facilitate control and documentation. Following an open door intervention, appropriate line clearance and disinfection com-mensurate with the nature of the incident are required.

Challenges in implementing a RABS or isolatorMany companies forget the “systems” aspect of RABS and isolators. For successful implementation of these technologies, operators, mainte-nance personnel, and engineers must take an expansive, holistic view of their system, ensuring that it is integrated into its surrounding en-vironment and instituting the appropriate maintenance and oversight regimes.

This includes appropriate surrounding building and room design, including HVAC and air handling systems. Proper disposal systems for bio-decontamination waste, both within the building and in relation to the exterior natural environment, are also key considerations. Drainage systems and building HVAC should also be taken into account. Building system utilities can impact isolator pressure control schemes.

Management oversight is indispensable. Proper gowning pro-cedure, adequate training in current good manufacturing practice (cGMP), SOPs for interventions, and documentation protocols must be instituted, rigorously executed, and consistently enforced. Continuous system monitoring is also a must.

A RABS or isolator system should be understood not merely as a discrete piece of a larger manufacturing process but as deeply integrated with every other aspect of an operation. The line itself must be well integrated. Moreover, a holistic view encompassing all of these exterior concerns will ensure the successful implementation of a RABS or isolator system. Integration is easiest through the use of experienced vendors, especially those that can produce many components of the system. More vendors means more customer project management and more tasks to juggle, which can lead to potential project risk.

Jack Lysfjord is principal consultant for Lysfjord Consulting LLC. He previously served as vice president of consulting for Valicare, a division of Bosch Packaging Technology (www.boschpackaging.com).


Smaller systems that meet

high regulatory standards

and can be customized to

small products runs are an

increasingly attractive option.


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For more information on print or digital media advertising or exhibiting opportunities at CleanRooms shows, contact Barbara Kovalchek, National Sales Manager, at 603-891-9296 or [email protected].

With 25,5001 BPA-qualifi ed, international subscribers, CleanRooms magazine is the undisputed leader in providing contamination control technology information and expertise to contaminaton control professionals. Providing in-depth news, comprehensive staff-researched reports, authoritative contributed technical articles, extensive new products coverage, and insightful columns and commentary, CleanRooms reaches contamination control professionals in the semiconductor, bio/pharmaceutical, food processing, compounding pharmacy, cosmetics, hospital hygiene, and all other industries requiring clean or ultraclean manufacturing environments and processes.

And, together with its complete multimedia family of products and services including International Conferences & Exhibitions, twice-monthly eNewsletters, information-packed Website, and interactive, on-line Webcast presentations, CleanRooms is unsurpassed in its educational and informational service to the entire contamination control community, worldwide.

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planetary protection


New detection methods reinforce protocols for planetary protectionNASA planetary protection programs charged with keeping biocontamination out of spaceBy Patrick Hogue, Johns Hopkins University, Applied Physics Laboratory

National Aeronautics and Space Administration (NASA) missions to solar system bodies with the potential to sus-tain life, or that could potentially contain life in a fun-damental evolutionary state, have stringent requirements

on the maximum spore count permissible on spacecraft surfaces; and these levels are likely to become lower as cleanroom protocols become more effi cient. Several promising technologies can help contractors reduce spore counts to acceptable levels, provide for the rapid deter-mination of microorganisms, and determine the genomic inventory of spacecraft microorganisms.

Establishing planetary protection policyThe need for planetary protection, and protection of Earth by sample return missions, was recognized at the dawn of the Space Age through the Committee on Space Research (COSPAR).1 Article IX of the Outer Space Treaty of 1967 states, in part, “...parties to the Treaty shall pursue studies of outer space including the Moon and other celestial bodies, and conduct exploration of them so as to avoid their harmful contamination and also adverse changes in the environment of the Earth resulting from the introduction of extraterrestrial matter and, where necessary, shall adopt appropriate measures for this purpose.”2

NASA Policy Directive (NPD) 8020.7 establishes NASA policy for implementing planetary protection (PP), which includes protection of planetary bodies for future exploration and of Earth from extraterrestrial sources of contamination. Depending upon the target, implementation may range from obtaining a letter from NASA approving mission design as adequate planetary protection (e.g., New Horizons Pluto fl y-by, category II) all the way to full implementation (e.g., Mars sample return, category V). For samples returned from a solar system body with the potential for life (e.g., Europa) mission design must “break the chain of contact”; furthermore, “for un-sterilized samples returned to Earth, a program of life detection and biohazard testing or a proven sterilization process shall be undertaken as an absolute precondition for the controlled distribution of any portion of the sample.”3 Depending upon the nature of samples returned to Earth quarantine up to Biosafety Level (BSL) 4 may be required.

In reaching these decisions, NASA seeks the opinion of scientifi c advisory groups such as the Space Studies Board of the National

Academy of Sciences. NASA Procedural Requirement (NPR) 8020.12 delineates a uniform set of planetary protection requirements for all NASA robotic extraterrestrial missions and references NPR 5340.1, which provides a uniform set of procedures for performing microbial assays for enumerating bioburden levels of spacecraft and facilities used to assemble, test, and launch spacecraft with planetary protection requirements (it is written primarily for use by microbiologists). This year, NPR 5340.1 will re-release as NASA HDBK 6022, which will not set requirements but will list approved protocols. The two Viking Landers, which received dry heat sterilization at 125°C, are considered the gold standard for planetary protection.

Detailed microbial burden requirementsNPR 8020.12 allows alternatives to 125°C dry heat sterilization provided that procedures and quality controls are approved by the NASA Planetary Protection Offi cer (PPO). These methods are then spelled out in the approved PP plan. Flight hardware drawings may call for these unique microbial reduction methods by citing their specifi cation numbers. Microbial barriers may be used to prevent recontamination of previously sterilized areas; a pressure of at least 1,244 Pa (5 inches H

2O) is considered satisfactory to prevent the entry of microorganisms.

High effi ciency particulate air (HEPA) fi lters (99.97 percent effi cient for 0.3 μm) are also considered effective microbial barriers. NASA requires that spacecraft assembly occur in a cleanroom meeting ISO class 8 (Fed. Std. 209E Class 100,000) as a minimum.

For a Mars Lander mission, the maximum spore count is 300,000 for the entire spacecraft (or <300 bacterial spores/m2); all other tar-gets still have a probabalistic requirement. The quantity of 300,000 spores per total spacecraft surface area applies to non-special regions of Mars (most of the surface); the total allowed, including organisms inside hardware (e.g., encapsulated in potting) is 500,000. The Vikings, and spacecraft accessing “special regions” or looking for life, met/must meet 300,000 and then reduce the surface bioburden by 10,000 with dry heat sterilization—meaning no more than 30 viable spores total on the surface. Alternatives to dry heat are discussed later. Based upon Viking experience, NPR 8020.12 assumes spore content as shown in the table. Possible reduction methods are noted and also will be explained in another section.


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Gloveboxes

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Hundreds of standard enclosures• Stainless steel • Dissipative PVC • Polycarbonate • Polypropylene • Acrylic • More!

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Origin of spores Requirement Possible reduction

Electronic parts 3–150/cm3 Burn-in, radiation screening

Other non-metallics 1–30/cm3 Dry heat sterilization in bulk

Class 10k highly controlled 50/m2 Preferred for PP mission

Class 10k normal control 500/m2 Described in “Reduction” section

Class 100k highly controlled 1,000/m2 Described in “Reduction” section

Class 100k normal 10,000/m2 Described in “Reduction” section

Uncontrolled manufacturing 100,000/m2 Clean tent; upgrade discipline

Assessing microorganism levelsMost aerospace cleanrooms have unknown mi-crobial deposition rates and surface microbial populations and usually do not have a micro-biology laboratory readily available. While a proper microbiology laboratory is being cre-ated to implement NPR 5340.1, PP programs may choose to get a head start in making their cleanrooms as aseptic as possible. To this end an interim laboratory can be constructed, using a Class 100 (ISO class 5) fl ow bench with table-top incubator. Initial assays of the cleanrooms (including thermal vacuum chambers, acoustic, and vibration facilities) and associated equip-ment can be performed using commercially available settling plates (to capture microbial fall-out) and contact plates (to assay cleanroom surfaces) based on Tryptic soy agar (TSA). These procedures are designed primarily for the detec-tion and enumeration of heterotrophic, meso-philic, aerobic, and anaerobic microorganisms; consult NPR 5340.1 for details. Microorganisms likely to survive space and planetary environ-ments are halophiles, certain Bacillus species and extremophiles.

It is recommended that these initial as-sessment techniques, and others that may be recommended by local microbiology or phar-maceutical laboratory suppliers, be included in the PP plan and that they, along with the full NPR 5340.1 implementation plan, be approved by the NASA PP offi cer.

During this initial phase of assessing cleanrooms for fall-out and “hot spots,” a por-table aerosol particle counter may be used to scan HEPA fi lter outlets for leaks and any re-pairs or replacements made before the start-up of PP program work. A rotary centrifugal impactor equipped with TSA strips can be used to validate the biological effectiveness of each HEPA outlet in the overall cleanroom. An al-ternative would be to place one settling plate

for each HEPA outlet at a distance of approxi-mately 1 m; of course, timely retrieval and in-cubation are essential.

If the trial-and-error methods described previously are not satisfactory for character-izing the cleanroom, then recourse can be made to real-time microbial particle detection technology. Most of these are based upon the fl uorescence of energetic metabolic chemicals (e.g., adenosine triphosphate, or ATP, ribofl a-vin) induced by ultraviolet light4,5, although continued on page 30


immunoaffi nity-based phosphorescent sensors are being developed for detection of bacterial spores.6 Recently individual bacterial cells have been detected using Raman spectroscopy.7

Spot-checks of surfaces can be accomplished using commercially available portable systems based on the luciferin-luciferase reaction produced in the common fi refl y. These methods usually consist of reagent-dampened sterile swabs that lyse (chemically open) living cells and then react with ATP, the energy currency of living cells, to produce a brightly colored species that can be quantitatively measured with a luminometer. This kind of spot-check was recently performed on the Space Station surfaces using a NASA-developed variant called LOCAD-PTS, which is expected to become an approved protocol in NASA HDBK 6022 (see Fig. 1).8

Rapid microbial detection using fi lter-based media with ATP bioluminescence enumeration


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Figure 1. Astronaut Suni Williams, Expedition 14/15 fl ight engineer, works with the Lab-on-a-Chip Application Development–Portable Test System (LOCAD-PTS). Williams is placing the sample mixed with water from the swabbing unit into the LOCAD-PTS cartridge. Photos courtesy of NASA.8





by a CCD camera equipped with a microchannel plate photomultiplier can reduce assay times from 72 hours to 5 hours or less as demonstrated by NASA/JPL.9 A recent addition to this technology is the use of a 16-base RNA probe that can be used to identify specifi c organisms after the non-specifi c fl uorescence enumeration measurement is accomplished.10

Implementation of NPR 5340.1The cost of a fully equipped microbiology laboratory to support a spacecraft program with full PP requirements—a Mars Lander, for example—is estimated to be $50,000 and will require at least two technicians, preferably three, to provide 24/7 coverage.11 The cost associated with PP implementation is estimated to have added 2 months to an 18-month assembly, test, and launch operations program for Mars Polar Lander (MPL) and required 1,200 assays.12 Viking program PP cost was 10 percent or about $7 million.13 A successful PP implementation hinges on the following:

1. Careful and thorough integration of PP into all aspects of the program2. Management buy-in and support of the PP engineer3. Universal personnel training (including purchasing and support groups)4. Pre-planned bio-assay database that parallels the assembly fl ow5. Lessons learned from the MPL program:

■ Daily change of cleanroom garments■ Purchase of 200 new sets■ Strict enforcement of aseptic techniques—a departure from the usual■ Sterile, powder-free cleanroom gloves■ Daily janitorial service (IPA used instead of ammonia for fl oors and walls)■ Facility modifi cations to better isolate anteroom■ Special cleaning and isolation techniques for vibration, acoustics, and thermal vacuum facilities■ A standard assembly drawing note: “Perform bio-assay sampling prior to close-out”■ Launch site processing facilities needed similar steps to main-tain spacecraft biocleanliness; assessment of these facilities may occur early in the program■ A portable clean tent was needed for the launch site■ It is important to fl ow PP requirements to subcontractors—anticipate helping them understand and properly implement PP requirements for their hardware elements■ Integration and test planning staff should strive to have parallel paths so that a delay associated with bio-assay could be accommodated by a shift in tasking

6. MPL lessons learned that were successfully applied to the Phoenix program:

■ Daily management briefi ng that includes PP lab lead■ PP assay database must be robust and web-based for easy access■ Program PP engineer should coordinate with JPL or NASA counterpart■ Phoenix robotic arm (complex geometry) was sheathed in

easily cleaned/verifi ed biobarrier (it tears through this barrier when deployed)■ Be prepared: NASA’s independent bio-assay testing might re-quire re-cleaning or re-sterilization of spacecraft—could impact launch date

Reducing microorganism levelsSeveral technologies are available that have the potential to reduce airborne and surface bioburden levels.

Cleanrooms and other facilities used for PP hardware can be sterilized using commercially available fogging systems based on hy-drogen peroxide (H

2O

2) or a combination of H

2O

2 and peracetic acid

(CH3COOOH); chlorine dioxide is also very effective. Compatibility of

these chemicals with materials of construction should be verifi ed with the supplier prior to use. Spore strips are used to determine the effec-tiveness of the kill. H

2O

2 fogging of spacecraft followed by immediate

vacuum bake-out is one possible method of meeting the 10,000 spore reduction for probes accessing “special” regions or that search for life.

Various sterilization techniques exist for air streams: free radicals with scrubber; glow discharge; non-thermal corona discharge; ultraviolet light to lyse organisms (254 nm) and oxidize residue (185 nm); water impingement to mechanically entrain particles; electrostatic precipitation; biocidal fi lters; and ozone infusion.

Cold plasma has been shown to destroy microorganisms and their component proteins, including misfolded proteins called prions.14,15

Daily janitorial service with proven antiseptic solutions (e.g., 10 percent IPA in deionized [DI] water) can also be effective in reducing surface bioburden levels.

A word of caution is in order regarding DI water systems: Their internal wetted surfaces are almost always coated with biofi lm. Sterilization, and verifi cation of effectiveness, may be performed prior to the start of a PP program.

Genomic inventory of spacecraftA widely known but unfortunate fact is that between 0.1 percent and 10 percent of viable microorganisms grow when cultured on standard agar media. Identifying and cataloging what microbes survive sterilization is important in interpreting results of life detection missions to other planets. If similar microbes turn up in alien samples, researchers


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• No-hands activation of sinks and dryers

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• Isolated, insulated motor minimizes noise, vibration

• Also ideal for drying tools, bottles, and other small parts

Dryers and washing stations in

many confi gurations

Brushless motor eliminates carbon contaminants for ultra-clean operation.

Figure 2. Genome Sequencer FLX from 454 Life Sciences with “hood up,” showing picotiterplate drawer and optical system aperture to left and nucleotide sequencing reagents and fl uidics system to right. Image courtesy of APL/454 Life Sciences.



could disregard the results as contamination and not evidence of extraterrestrial life.

A recent paper describes the fi rst of its kind sampling of three spacecraft assembly cleanrooms ( JPL, KSC, and JSC) using gene sequencing technology; despite the highly desiccated, nutrient-bare conditions within these cleanrooms, a broad diversity of bacteria was detected, covering all the main bacterial phyla.16 Ribosomal RNA sequence analysis allowed the researchers to identify a

greater number and diversity of bacteria than previously detected in the rooms. Although a few microorganisms, like those common on human skin, were found at all three sites, the study discovered that each room had a bacterial community largely unique to itself. Many factors could be responsible for this diversity, the researchers said, including the differing types of air fi lters and cleaning agents used and the facilities’ different geographic locations. Current cleaning techniques kill most common microbes and the resulting lack of competition could contribute to the number and diversity

of the durable survivors found by the genetic testing approach.

Future PP missions are expected to include genomic inventory.17 A good primer on this subject, with links to automated sequencing suppliers, is given on the Wikipedia web site: http://en.wikipedia.org/wiki/Gene_sequencing. Figure 2 shows one such gene sequencer.

ConclusionMissions with PP requirements demand careful and thorough integration of aseptic manufacturing into every aspect of training, manufacture, purchase, integration, test, and launch operations. Several technologies exist to reduce airborne and surface bioburden, cold plasma being one of the more promising. Rapid methods of microbial detection and enumeration are advancing; PP programs that want to use them may obtain NASA PP offi cer approval. In the not-too-distant future, genomic inventory is likely to become a PP

mission requirement. Many of the protocols common to pharmaceutical cleanrooms are expected to become common in aerospace cleanrooms with PP requirements.

Patrick Hogue is senior member of the professional staff in the Applied Physics Laboratory at Johns Hopkins University in Maryland.

References1. Astrobiology, Vol. 6, No. 5, 2006, “The Astrobiology

Primer: An Outline of General Knowledge—Version 1,” 2006 section 7C.

2. Treaty on Principles Governing the Activities of States in the Exploration and Use of Outer Space, Including the Moon and Other Celestial Bodies (entered into force Oct. 10, 1967).

3. NPR 8020.12C, Appendix A, paragraph 3.2.4. V. Agranovski, Z. Ristovski, “Real-time Monitoring of

Viable Bioaerosols: Capability of the UVAPS to Predict the Amount of Individual Microorganisms in Aerosol



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Figure 1. Project plan outline as a GANT chart. Image courtesy of Particle Measuring Systems.


environmental monitoring


Planning and installing an environmental monitoring systemThe latest regulations call for a shift in particle monitoring strategies

By Mark Hallworth and Edward Applen, Particle Measuring Systems

For aseptic manufacture of pharmaceutical products there has been a shift, primarily due to legislative regulations.1 Traditionally, monitoring has involved the classic portable monitoring of a cleanroom. New regulations have led to a

requirement for an automated, remote monitoring solution. Various steps must be undertaken to implement an automated monitoring solution for a non-viable particle counting system. The steps also apply if you later enhance the non-viable system to include a viable monitoring or other environmental parameter component.

There are several steps to be followed for the implementation of a system and the Good Automated Manufacturing Practices (GAMP2) guidance for the validation of these systems certainly forms the core of the requirements. A typical project follows the format design, build, install, test, and validate. Each of these has its own timeline.

Building the timelineThe key to a successful project is to ensure that all phases of the implementation are executed in a timely manner. The identifi cation of each of the major steps can be presented as a GANT chart, which will also identify when obstacles, such as shut downs, need to be accommodated. Figure 1 shows a typical timeline GANT chart for a complete project.

Each of these summary tasks can be broken down into individual tasks so that resources—both material and labor—are available. This

becomes more critical when multiple components of a project are encroaching on each other. This often occurs during installation when different trades are vying for the same space and during validation when deadlines are tight.

System designThere are several documents3,4 that identify how best to design a particle monitoring system. Considerations include selection of sample points, which hardware to use for each application, and the relationship be-tween risk vs. instrumentation. Figure 2 shows a typical system designed to monitor the environmental conditions within a cleanroom.

The driving factors in designing a cleanroom monitoring system should be defi ned in the User Requirement Specifi cation (URS), the contents and format of which is fully described in the GAMP guidance documentation. Any changes required to a system that make it user-friendly should be incorporated as early in the project as possible to avoid costly changes to project scope later. When the speed required to implement a system does not allow suffi cient time for the generation of a “perfect” URS, it can be subcontracted to a design company for preparation. It is important to ensure the end users or system owners review the document because the liability of using a system lies with them.

System installationAs can be seen from Fig. 2, there are many components to the installation of a monitoring system.

Wiring. The infrastructure of wiring includes power cables (24 VDC, 120–240 VAC, and 3 phase); signal wiring 4–20 mA analog, Ether-net, and RS-485 data communications; and I/O connections for process controls, starting/stopping of vacuum pumps, and the integration of functional hardware switches for state changes, etc. The choice of wire depends on load, fi re hazards, length of runs, and signal speed. Cables are normally run in either cable tray or conduit specifi c for a location, where existing support infrastructure can be incorporated to reduce re-dundancy in the installation.

Tubing. There are primarily two types of tubing: one that draws a sample to the sensor (sample tubing) and one that enables a sensor to operate (vacuum tubing). Particle counter tubing should not exceed 2 m due to excessive losses of large particles.5 It is also important to ensure that any bends are maintained at the largest possible radius to reduce losses


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Laminar Flow

To order: 714-578-6000Fax: 714-578-6020

Application-specific materials and configurations —

• HEPA/ULPA filtration • Exhaust fume purification• Stainless steel • Chemical-safe polypropylene• Static-dissipative plastics • Thermal-resistant polycarbonate

Horizontal and vertical airflow designs.Dozens of standard tables and chemical benches.

and Exhaust Fume Hoods

Free-standing and bench-top designsIonization, UV/germicidal lighting, airflow monitoring

Customized to your requirements

PLC control over shield, FFU

and light

Figure 2: Facility monitoring system schematic

Central vacuumsystem

Viableatrium

Non-viablesensor

Control andautomation

T/RH, DP, etc.

Alarms

Viable monitoring(flow meter)

Viable control (valve)

Vacuumheader

ENODE Ethernetswitch

Server Networkstations

Site LAN

Real-timestation

Portable data download

Cleanroom HMI



through transportation.If the sensor does not have an integrated

vacuum pump and requires an external vacu-um source, the pump should be installed at a distance from the sensor in a technical space (mezzanine) and the tubing run via a manifold header and a tubing drop to the sensor. The de-sign of the manifold is site specifi c. It is desired to install a loop manifold as this reduces differ-ences in pressure drop across the system. The limitation of distance and installation criteria for the vacuum system is different than for sam-ple tubing, as airfl ow is now post-measurement. Figure 3 shows a loop manifold design and inde-pendent drops down to each individual sensor.

Sensors. During installation, measure-ment sensors are either mounted inside the fi ll-ing equipment, on the fi lling equipment with sample tubing to draw a sample to the sensor, on/in the wall of the background room, or on a supply/exhaust duct. The services, wiring, and tubing are run to the sensor via local conduit or service runs through equipment. These services are then taken back to a central location where the vacuum system and data cabinet reside.

Data cabinet and vacuum pump. Cen-tral to the system is the control data cabinet and vacuum system pump(s). They are typi-cally mounted in the technical space since ac-cess for maintenance is required on a routine

basis. The size and type of cabinet and vacuum pump depend on the size of the system, number of sensors, voltage requirements, and so on.

Computing and network. All sensors report to a centralized monitoring system. Con-trol and reporting occurs here. The location of this system is fl exible. All sensors are on an Ethernet network; therefore, only a single con-nection is required to the central computer. If displayed or reported data is required at remote locations, a classic network architecture can be designed. Connections to site networks can be made via system routers, gateways, or other bridging means. A suitable desk in an offi ce is used for the central computer, and remote ter-minals can be installed into the fabric of the cleanroom using suitably compatible computer terminals or HMIs.

System validationThe validation of the installed system follows



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®

Figure 3: Vacuum manifold schematic

Header: 2-inch diameter - schedule 80 PVCBraided PVC tubingconnects to hose barb

Looped design maintains consistant vacuumthroughout the header

Pump

Check valve

Ball valve

Vent

To sensors

Figure 4. Compact, rugged AirNet 510XR (left) and IsoAir PLUS (right) particle counters from Particle Measuring Systems offer real-time aerosol monitoring and reduced maintenance costs. Photos courtesy of Particle Measuring Systems.





the GAMP guide. This continues from the ini-tial URS and the design documents. A matrix of key components identifi ed in the URS is linked to suitable tests to prove the robustness of the system, including error reporting and data ar-chiving. This allows a traceable link between the requirements and the fi nished system, relative to the risk of the system. The testing proves that the installation of all the system components has been done in accordance with standards and as per the detailed design document (IQ) and that the system operates in accordance with the expectations made of it (OQ), i.e., when it exceeds a pre-confi gured threshold and alarm annunciation is activated.

Validation typically takes a few weeks, de-pending on the size and complexity of the de-sign. Once the validation testing is completed, it can be turned over to the end user to begin the process of integration. This is an addition-

al layer of validation to prove that it does what it was intended to do, i.e., support the release of a batch through proof of control over the

manufacturing environment (PQ).

System implementationThis fi nal stage causes the most concern with many new users of systems because the volume of data generated is much greater than that historically generated using a portable solution. The data can no longer be seen as a single page of information. A single particle counter can generate 5–10 pages of data per day. If this is extrapolated to a 10-sensor system, 50–100 pages can be reported; so how do you deal with this volume of data?

System training provides the users with the skills they need. Training is in two parts. Part one shows operators how to use the sys-


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SmartDesiccator™

To order: 714-578-6000Fax: 714-578-6020

• Automates dry benchtop storage to eliminate moisture-related degradation and optimize yields

• First-of-its-kind RH control design optimizes gas purge to cut recovery time and conserve nitrogen

• Fully integrated system takes less than 30 seconds to install and program!

Miniaturized LED monitors humidity and displays set

point

Stainless steel, acrylic and dissipative PVC cabinets

Drastically reduces nitrogen expense!



tem, change alarm limits, create new reports, add and disable user accounts, and modify confi guration variables (change control per-mitting, of course). Part two of the training occurs after the system has been in use for sev-eral months. This second part of training is the key to a successful implementation—reading the data to deliver information relative to proving environmental control, necessary for compliance to the current standards.

SummarySolid planning, following GAMP guidelines, and proper training to understand how to

interpret the system data are essential for an effective monitoring program. A successful implementation requires planning, implemen-tation, testing, and training to understand the results.

Mark Hallworth is pharmaceutical business manager and Edward Applen is project services manager at Par-ticle Measuring Systems based in Boulder, CO (www.pmeasuring.com).

References1. EC Guide to Good Manufacturing Practice, Revi-

sion to ANNEX 1, European Commission, Enter-

prise Directorate General, September 2003.2. GAMP Guide for Validation of Automated

Systems, ISPE, December 2001.3. M. Hallworth, “Choosing the Most Suitable Non-

viable Sample Point Locations,” Technical Note 79, Particle Measuring Systems, 2007.

4. M. Hallworth, “Particle Monitoring Requirements in Pharmaceutical Cleanrooms,” Application Note 41, Particle Measuring Systems, 2005.

5. M. Hallworth, “An Analysis of Acceptable Particle Losses in Tubing,” Application Note 81, Particle Measuring Systems, 2007.

planetary protectioncontinued from page 31

Particles,” J. Aerosol Sci., Vol. 36, 2005.5. C. Bolotin, “Instantaneous Microbial Detection”

(white paper), BioVigilant, Tucson, AZ, 2006.6. P. Scholl et al., “Immunoaffi nity Based Phosphorescent

Sensor Platform for the Detection of Bacterial Spores,” Proc. SPIE, Vol. 3913, 2006.

7. J. Popp, “Identifi cation of Micro-organisms by Raman Spectroscopy,” Proc. SPIE Biomedical Imaging, 2007.

8. Space.com, “Astronaut Suni Williams, Expedition 14/15 fl ight engineer, works with the Lab-on-a-Chip Application Development-Portable Test System (LOCAD-PTS, Charles River Laboratories, Charleston, SC),” June 26, 2007.

9. F. Chen et al., “A Rapid Micro-Detection System for the Enumeration of Bacterial Endospores,” IEEEAC, Paper 1501, Version 2, updated Nov. 28, 2005.

10. Private communication with W. Miller at Millipore Corp. re: “Milliprobe.”

11. Private communication with A. Baker of Technical Administrative Services, during the 2007 NASA PP Policy and Practices Workshop, Santa Cruz, CA.

12. As presented by D. Tisdale, Lockheed Martin Corp., during session 10 of the 2007 NASA PP Policy and Practices Workshop, Santa Cruz, CA.

13. As presented by P. Stabekis, Windmere Consulting, during session 10 of the 2007 NASA PP Policy and Practices Workshop, Santa Cruz, CA.

14. “Plasma Sterilization,” The Futurist, p. 17, September/October 2003.

15. Q. Yu et al., “Sterilization Effects of Atmospheric Cold Plasma Brush,” Appl. Phys. Lett., 88, 013903, 2006.

16. C. Moissl et al., “Molecular Bacterial Community

Analysis of Cleanrooms where Spacecraft are Assembled,” FEMS Microbiology Ecology, 61, pp. 509–521, 2007.

17. As presented by Dr. Catherine Conley, acting NASA PP Offi cer, during the 2007 NASA PP Policy and Practices Workshop, Santa Cruz, CA.


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product spotlight


cleanroom garmentsSince human-generated contamination plays a large role in critical environments, special care must be taken to provide appropriate garments to minimize the human impact on the cleanroom. Other important factors include specialty fabrics to safeguard technicians, as well as proper laundering and care of reusable attire.

Compiled by Carrie Meadows

Chemical-resistant gloves with new grip technologyAnsell offers AlphaTEC™ gloves, the fi rst chemi-cal-resistant gloves to incorporate Ansell Grip Technology™. Designed as a liquid-proof product requiring less force to grip oily or wet objects, the

gloves integrate microscopic channels in a patented ultra-thin nitrile layer to

direct fl uids away from the grip surface, leaving a signifi cant dry contact area that provides almost the same grip that is possible under fl uid-free con-ditions. This improved adher-ence promotes greater worker comfort while minimizing stress and fatigue. The production pro-cess ensures an exceptionally safe chemical barrier. The gloves’ polymer coating does not pen-etrate into the liner during the manufacturing process, which results in consistent protec-tion for the skin. The nitrile coating is also designed for greater fl exibility. For more

information about new Al-phaTEC gloves or any of Ansell’s line of protective gloves and apparel, visit the web site or contact Customer Service at 800-800-0444.AnsellRed Bank, NJwww.ansellpro.com

Cleanroom garment tracking serviceCleanTrak™ is ARAMARK’s proprietary web-based garment management system, which provides high information availability and timeliness. CleanTrak™ provides customers with an easy-to-use web interface that allows them to manage their garment program online. The information is

actual data taken directly from ARAMARK’s i barcode system, Garment Tracking System (GTS). CleanTrak™ is easy to use with almost no instruction. The web-based system allows the customer to see garments that are assigned to their inventory by item code or barcode; weekly in and out counts by line item; individual barcode history; a customer report that provides a fi ve-week summary that can be downloaded into an Excel fi le or viewed onscreen; and receiver review. To learn more, call 800-759-0102 or visit the web site.ARAMARK Cleanroom ServicesBurr Ridge, ILwww.ARAMARK-Cleanroom.com

Custom garment and consum-ables programs availableAmeripride and Canadian Uniform Services announce their CleanStyle Cleanroom Division. CleanStyle represents fi ne reusable and consumable cleanroom services and products. With multiple certifi ed ISO 4/Class 10 cleanroom laundry facilities in the United States and Canada, and service locations throughout North America, the company provides comprehensive service solutions. The CleanStyle Superior Apparel Management System (SAM) using state-of-the-art RFID tracking for reliability is exclusive to Ameripride and Canadian Uniform Services and provides an immediate data history, enabling the company to track the life of all reusable garments. Cleanroom technical support and vast experience allows CleanStyle to assist with customers’ growth and provide new solutions

and fl exibility as needs change. On-site inventory management programs ensure excellent product availability and accountability while saving both time and money; and CleanStyle’s large product inventory of cleanroom reusable and consumable products makes it an ideal single source provider for cleanroom requirements. For more information, contact a cleanroom specialist at 416-849-5100 or toll free at 866-539-7575.CleanStyle Cleanroom DivisionVancouver, BC, Canada

Extensive in-house quality testing on garment offeringsEstablished in 1979, Dastex Reinraumzubehör is among the most experienced companies within the cleanroom business in Europe. Dastex specializes in the production of high-quality cleanroom garments and undergarments. To meet customers’ requirements, the company produces a multitude of different designs of cleanroom textiles in various fabrics, colors, and sizes. Products are


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product spotlight


tested by independent and internationally accepted research institutes before suppliers are approved. Dastex also operates its own “body box,” equipped with a Helmke drum test facility to determine fi lter effi ciency of cleanroom fabrics and other tests to determine air permeability and retention of particles in technical fabrics. Continuous development in the fi eld of garments and the company’s participation in research projects help to guarantee high quality standards, allowing Dastex to provide customers with professional advice and supply them with technical fabrics according to their demands.Dastex Reinraumzubehör GmbH and Co. KGMuggensturm, Germanywww.dastex.com

Line of personal protection productsDuPont is dedicated to the science of protection. The goal of DuPont Controlled Environments is to

provide high-performance so-lutions for today’s demanding controlled environments. Com-bining a heritage of scientifi c innovation and material, gar-ment, and manufacturing ex-pertise, the company’s products are specially engineered to enhance productivity in today’s demanding biotechnology, pharmaceutical, medical device manufacturing, and electronics cleanroom environments. Du-Pont Controlled Environments offers a wide range of protective garments and products, includ-ing DuPont™ Tyvek® IsoClean™ garments for premium protec-tion, DuPont™ Suprel® LS for a

balance of comfort and protection, and a range of accessories such as DuPont™ Gripper™ shoe and boot covers with high coeffi cient of friction properties. In addition, DuPont Controlled Environ-ments specialists are industry experts who can help customers with site assessment and a variety of contamination control issues to help ensure each customer’s critical environment is as effi cient as possible.DuPont Controlled EnvironmentsRichmond, VAwww.dupont.com

Disposable and reusable garmentsInnotech Products, Inc. launderable contamina-tion-control garments provide comfort and du-rability while minimizing overall apparel costs. The company offers a wide selection of fabric that meets specifi c ESD and cleanliness require-ments. Available fabrics are Taffeta, ChemStat® 909A, Burlington C3, and other materials specifi c to controlled environments. DuPont’s Tyvek®, Iso-clean®, and Proclean® disposable items exhibit superior cleanliness and ensure maximum par-ticle containment. These disposable garments are durable enough to be used more than once, yet inexpensive enough to be discarded, sav-ing laundering expense. Innotech’s cost-effec-tive line of non-linting, 100 percent spun-bond polypropylene disposable apparel is individu-ally inspected for stitching, sizing, material, and

workmanship to guarantee quality. Many styles of bouffant caps, hoods, shoe/boot covers, sleeves, frocks, coveralls, and aprons are available to meet needs from Class 100,000 to Class 10. To speak to a cleanroom specialist regarding your clean-room needs or for info on how to achieve USP <797> compliance, call 888-270-0458 or e-mail [email protected] Products, Inc.Minneapolis, MNwww.innotechprod.com

Low-linting face masksKIMTECH PURE* M3 Face Masks from Kimberly-Clark Professional are ideal for use in clean-room environments. Two versions of the mask are available: a pleat-style mask with knitted earloops and a pleat-style mask with soft ties. The masks’ low-linting apertured polyethylene

fi lm outer layer provides protection from con-tamination, and a BICOSOF* fabric inner facing provides comfort. These masks provide excellent bacterial and particle fi ltration, along with good breathability.Kimberly-Clark ProfessionalRoswell, GAwww.kcprofessional.com

100 percent nylon glovesMagid Glove and Safety offers the Fiberlock® 132NYA cleanroom glove, which provides great dexterity and touch sensitivity and is low-linting. The glove is seamless and 100 percent nylon. Its high-density construction and double-hemmed edge deters paint penetration to the skin, limits

snags, and eliminates lint releasing into the environment, making it suited to particulate-restrictive areas in the electronic, semiconductor, and automotive paint industries. The 132NYA is manufactured entirely in a cleanroom with an ISO 6 rating using heat-treated, texturized, stretched, cleaned, and packaged yarn. Once produced, the gloves are then taken to an onsite laundering facility and pre-laundered to retain



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38 C L E A N R O O M S J A N U A R Y 2 0 0 8 w w w . c l e a n r o o m s . c o m

their size after multiple launderings and then packaged in heat-sealed, BHT-free polybags. In addition to the signature Magid products, the company offers products from Aearo, Ansell, Best, 3M, Uvex, MSA, and more.Magid Glove & Safety Manufacturing Co. LLCChicago, ILwww.magidglove.com

Garment replenishment programPrudential Cleanroom Services, a leader in cleanroom laundry service systems, has an IN-STOCK reusable cleanroom apparel program that represents many of the industry’s most respected fabrics and styles. The garment replenishment program inventories IN-STOCK garments utilizing industry recognized fabrics that will allow for customer installation in two weeks or less. This service eliminates the long lead times that are common from cleanroom garment manufacturers. Prudential Cleanroom Services is a division of Prudential Overall Supply, established in 1932. Since 1960, Prudential

Cleanroom Services is recognized as a leader in cleanroom laundry processing services. The company’s network of ISO 9001:2000 certifi ed ISO 3 cleanroom laundry-processing facilities extends throughout the United States, along with an operation in Malaysia.Prudential Cleanroom ServicesIrvine, CAwww.pcs-clean.com

Clean apparel for multiple industriesTransforming Technologies provides high-technol-ogy garments, cleanroom fabric, cleanroom boot

soles, and specialized cleanwear accessories. Hypalon™ shoe covers, temperature-resistant Nomex™ Gloves, and other performance wear are designed for controlled environments and other critical applications. Serving semiconduc-tor, disk drive, pharmaceutical, and medical de-vice manufacturers, Transforming Technologies works continuously to develop improved offerings for meeting the most demanding requirements. Recent product innovations include conductive cleanroom soles and gamma-compatible Hyp-alon™ shoe covers.Transforming Technologies, LLCSylvania, OHwww.transforming-technologies.com

Ultra-clean boot covers with non-skid solesValutek, a partner in contamination control since 1988, offers a variety of disposable and reusable cleanroom apparel designed to provide complete protection. The company’s ultra-clean, breathable, lightweight boot covers are made from polyethylene-coated polypropylene. De-signed to protect operators exposed to splashes from certain chemicals, blood, and particulates, Valutek boot covers are impervious to liquids and lint-free, and have excellent tensile strength and tear resistance. A durable, non-skid PVC

sole ensures a safe step where additional trac-tion is needed. Valutek will be launching a new and improved web site in early 2008, with eas-ier navigation, greater functionality, and a better customer experience.ValutekPhoenix, AZwww.valutek.com

Sterilizable boots available in various fabricsGripLine® boots by White Knight are designed to withstand the rigors of the cleanroom as well as gamma sterilization. The sturdy, gray molded sole provides an effective barrier between workers and potential contaminants on the cleanroom fl oor. These anti-skid, scuff-resistant boots protect against slips while they help keep cleanrooms clean. GripLine® boots come standard in white taffeta or white Maxima® ESD

for electrostatic protection. They are constructed with full elastic at the top and ankle, as well as snap adjustments and a single strap over the arch to ensure a proper fi t. Other fabrics and confi gurations are available on request.White Knight Engineered ProductsCharlotte, NCwww.wkep.com


product spotlight


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CleanRooms magazine is now soliciting contributed stechnical article submissions for entry into its double-blind, peer-review process. As the contamination controlcommunity’s largest international circulation (and the onlyBusiness Press Association-audited), professional journalserving the fi eld, acceptance and publication of original,peer-reviewed technical content inCleanRooms magazineswill ensure broad, targeted recognition and distribution ofyour work throughout the entire professionalcontamination control community worldwide.

TheCleanRooms peer-review board is a voluntary panel of sexperts representing a wide range of contamination controldisciplines and industries, as well as a mix of both academ-

ic and industry expertise. The double-blind peer-reviewprocess assures the objectivity and integrity of the reviewprocess by ensuring that the identity and affi liation of theauthor(s) are not made known to the panel of experts thatwill be evaluating their submission and vice versa.

Accepted articles submitted through the peer-reviewprocess will be published with a special “seal of merit,”identifying the paper as having successfully met therequirements and standards of the independentreview board.

Topics of interest include (but are not limited to):particulate, microbial and molecular contamination;cleanroom design and construction; barrier isolation andseparative devices; disinfection, sanitation and hygiene;certifi cation and validation; cost control; fi ltration andmaterials handling; practices and protocols; personnelsafety; ESD protection; industry standards and guidelines.


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new productsCompiled by Carrie Meadows


High-purity foams for insulation and construction applicationsKynar® PVDF-based closed cell foam is the fi rst polymeric foam to meet the requirements for Factory Mutual (FM) 4910 test protocols for cleanroom materials fl ammability. The fl ame propagation and smoke generation values obtained for the foams were well below the requirements imposed by the FM protocols. The high-purity foams are easily cut without creating dusts or particles and have very low thermal conductivity and a wide operating temperature range. The foams also resist mold and fungi, as well as most solvents, chemicals, and typical sterilization methods. In addition to cleanroom pipe and duct insulation, Kynar® foams can also be used to construct lightweight, sound dampening structures and partitions, seals and gaskets, and chemical wet benches. They are suitable for use in pharmaceutical, biological, nuclear, semiconductor, or chemical industries, and can be used in processing food, dairy and cosmetics.Arkema, Inc.Philadelphia, PAwww.arkema-inc.com

Dusting system and microfi ber wipersKimberly-Clark Professional has introduced a new line of KIMTECH SCIENCE* brand products for laboratory maintenance: the KIMTECH SCI-ENCE* dusting system, lens-cleaning microfi ber wipers, and large microfi ber wipers. The products are designed to pick up more dust in more plac-es, meeting the cleaning needs of laboratories and other controlled environments. The dusting system features a duster head, with 380,000 soft, fl exible, dust-trapping polyester fi bers that change shape for dust pick-up in crevices and contours where dust cloths can’t reach. The en-vironmentally friendly system dusts without the need for chemicals and leaves no residues. Large, disposable microfi ber wipers have excel-

lent wet and dry strength and excellent water and oil absorbency (absorbing 4.5 times their weight). The lens-cleaning microfi ber wipers are designed for high-end optical lens cleaning. Both types of wipers are extremely low-linting and clean without streaking, smearing, or scratching delicate surfaces.Kimberly-Clark ProfessionalRoswell, GAwww.kcprofessional.com

Nitrile, powder-free exam gloveSempermed, a leading manufacturer of hand protection, now offers the SemperCare Tender Touch™ nitrile powder-free exam glove, as an alternative to natural rubber latex. The product delivers fi t, feel, tactile sensitivity, strength, and value in a latex-free glove. The company designed

the glove to improve comfort to help customers reinforce hand hygiene, compliance, and safety at their facilities. SemperCare Tender Touch™ is 4.0 mils in the textured fi ngertips. A standard-sized box holds 200 gloves.SempermedClearwater, FLwww.SempermedUSA.com

Custom-colored hose allows quick identifi cation of process linesAdvantaPure’s APSM reinforced silicone hose is

now offered in custom colors for easy line rec-ognition. APSM is used for applications involv-ing elevated pressure levels in pharmaceutical, bioprocess, biomedical, food, beverage, chemi-cal, cosmetic, and pure fl uid transfer. The hose is constructed of a core of low volatile, platinum-cured silicone for purity. APSM is durable and heavy-duty yet fl exible for pressure-rated dis-

charge applications. It may be sterilized by auto-clave, CIP, SIP, and gamma radiation processes. The material has undergone extensive testing and meets USP Class VI, FDA, ISO, European Pharmacopoeia, and 3-A standards. In addition to custom colors, AdvantaPure offers a wire-rein-forced version of the same hose, called APSW.AdvantaPureSouthampton, PAwww.advantapure.com

Wet-vacuum sample collection systemMicrobial-Vac Systems®, Inc., an innovator in pathogen surface sampling, has released a new tool for pathogen collection. The Microbial-


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new products


Vac (M-Vac™) wet-vacuum collection system utilizes LAMDAC™ principles (Liquid and Air-assisted Microbial Detachment and Capture) to collect laboratory or fi eld samples—typically from 1 to 2 sq. ft. of surface area per sample in 100–150 ml liquid. The M-Vac is designed to sample this larger area while recovering higher levels of pathogens in each sample than traditional methods. Validation tests have demonstrated the pathogen recovery rate of the M-Vac to be up to 90 percent higher than traditional sampling methods. The system reduces materials required for sampling, lab processing, and detection for cost-effective and effi cient sampling.Microbial-Vac Systems®, Inc.Bluffdale, UTwww.m-vac.com

ESD-safe binocular microscopesLuxo’s ESD-safe, 23mm System 273 binocular microscopes are designed for inspection and assembly applications in static-sensitive environments. The ESD-safe lenses and body guard against uncontrolled static dissipation. The achromatic lenses and eyepieces are protected with an anti-refl ective coating that alters the electrical characteristics at the surface of the material. The microscopes provide 270X total optical magnifi cation, 8-inch working distance, and 15 percent greater fi eld of view than comparable Luxo System 250 models. The working distance not only provides additional space for operator maneuverability, but also decreases the chance that products

may become damaged during inspection. The instruments rotate 360° in their focus mounts and have a zoom range of 0.7 to 4.5, giving

them a magnifi cation range of 7X to 45X. LuxoElmsford, NYwww.luxous.com

Shipper for 300-mm wafersThe Entegris 300-mm multiple fi lm frame shipper (MFFS) provides manufacturers increased safety and security while shipping fully processed wafers or singulated die mounted to fi lm frame rings. The shipper is an economical alternative

to cumbersome, heavy cassettes and is suitable for high-volume shipping between back-end assembly operations. The MFFS design prevents fi lm frame movement and reduces particle generation. The new shipper is stackable with both Entegris 300-mm and 200-mm fi lm frame shippers and can accommodate 13 wafers, making it economical for storage and shipping applications. It is available in ESD-safe materials, is reusable, and has the fl exibility to accommodate either metal frames or Entegris plastic frames.Entegris, Inc.Chaska, MNwww.entegris.com

Food-grade, FDA-approved cleanroom hoseA fl exible, white thermoplastic rubber hose for service in cleanrooms and other applications requiring an FDA-acceptable hose is being introduced by Flexaust. The Flexadux® T-7 White is a fl exible, medium-weight, white thermoplastic hose that is reinforced with a spring-steel helix and operates over a –40° to +250°F range.

Featuring a smooth interior to promote effi cient airfl ow, it is designed for a wide range of fume and dry material extraction applications in cleanrooms. Offered in standard 2- to 12-inch I.D. sizes and custom to 24-inch I.D., the hose is supplied in standard 25- and 50-ft lengths. It exhibits high resistance to chemicals, abrasions, moisture, and UV damage.FlexaustWarsaw, INwww.fl exaust.com

Chemical concentration monitor for semiconductor processesThe Swagelok® CR-288 concentration monitor addresses a critical requirement in the semiconductor industry for improved monitoring and control of liquid chemicals employed in device manufacturing. Installed in the process stream or at point-of-use, the technology delivers real-time, accurate measurements of the concentration and temperature of process fl uids. The CR-288 is the fi rst compact device in the industry to provide in-line analysis of liquid chemical concentration, featuring an accuracy of ±0.1 percent. Proprietary software enables the technician to calibrate the unit for chemical mixtures used in semiconductor laboratory or



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manufacturing processes. Able to monitor up to four separate fl uid streams with one digital display unit, the device can help the industry reduce chemical consumption, improve process control and visibility, detect process problems, reduce wafer scrap, and improve productivity.Swagelok Semiconductor Services Co.Solon, OHwww.swagelok.com/semiconductor

Class 10/ISO 3 modular cleanroomsTerra Universal’s BioSafe™ modular cleanrooms meet cleanliness requirements to Class 10/ISO 3 at a lower cost than conventional rooms. The rooms feature ultra-smooth stainless or pow-

der-coated steel surfaces that eliminate cracks, which harbor microbes and other contaminants. Rounded corners simplify cleaning. Accessories include A/C, pass-throughs, and furnishings.Terra UniversalFullerton, CAwww.terrauniversal.com

Polymers for SPE-based analysisVarian, Inc. has released Bond Elut Plexa™ PCX, a new addition to the Plexa family. Bond Elut Plexa and Plexa PCX comprise an advanced generation of polymers for solid phase extraction (SPE), designed for ease of use and improved analytical performance. SPE is used by analytical chemists to concentrate and clean up compounds of interest from their surrounding sample matrices for analysis by liquid chromatography/mass spectrometry (LC/MS). Bond Elut Plexa is a general-purpose choice for a wide range of acid, basic, and neutral analytes. Plexa PCX is designed specifi cally to provide a single, simple extraction method for basic compounds. Both are targeted for applications in pharmacokinetics, pharmacodynamics, forensics, toxicology, food safety, and environmental investigation.Varian, Inc.Palo Alto, CAwww.varianinc.com

Glass fi lter productsRobu® VitraPOR™ borosilicate glass fi lter products, distributed by Andrews Glass Co., offer extremely high chemical resistance, minimal thermal expansion, and high thermal shock resistance. Made from borosilicate glass according to international standards, these glass fi lter products are designed for use in chemical, biochemical, pharmaceutical, and laboratory applications. Standard fritted discs are available in round shapes from 5- to 400-mm diameters. Custom fi lters can be provided in any shape up to 400 mm, in almost any thickness. Any cylindrical or conical fi lter candle can be produced to customer specifi cations. The glass fi lters are available in porosities ranging from 1 to 550 μm, following ISO and NIST standards. Each batch is carefully tested to ensure uniformity. The sintered glass fi lters can be used safely in applications

where operating temperatures reach 515°C.Andrews Glass Co.Vineland, NJwww.andrews-glass.com

Mobile, ductless fume hoodsAir Science USA has introduced the Model EDU, a new mobile, ductless fume hood. The Model EDU is suited for classroom demonstrations and industrial training with its self-contained design and all-around visibility. It can be easily moved to various locations. The ductless design allows easy installation and the base is mounted on large, heavy-duty wheels for ease of transport.

The height is 77.5 inches, which allows it to easily pass through a standard door. The multi-layered EDU fi lter has been independently tested to have 99.9 percent fi ltration effi ciency for chemicals normally found in a typical chemistry curriculum. The units exceed OSHA, ANSI, BSI, and AFNOR safety standards.Air Science USAFort Myers, FLwww.air-science.com

Imprinted liquid-dispensing bottlesMenda HDPE Pure-Touch liquid dispensing bottles are now available printed with the most commonly used chemical names: Item 35395



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new products


“Acetone,” Item 35396 “Isopropanol,” and Item 35397 “DI water.” The imprints are non-smearing and non-running and make it easy to determine the bottle contents, ideal for when multiple chemicals are being used at a single workstation or work area. The square shape provides stability and allows compact storage. Pure-Touch pumps do not allow liquid already pumped into the dish to drain back into the bottle, so the bottle’s contents remain uncontaminated. Pure-Touch pumps are a genuine Menda product and made in America. Bottle capacity is 4 oz.MendaChino, CAwww.mendapump.com

Thermoform machine incorporates CIP systemMultivac’s latest R 535 form-fi ll-seal system simplifi es and accelerates the cleaning process for food processors, and provides enhanced performance, ergonomics, and effi ciency. The machine is equipped with an integrated clean-in-place (CIP) system, which automates the cleaning of component groups inside the machine. After a pre-cleaning, a cleaning program can be started at the push of a button. The standardized, logged process ensures adherence to predetermined cleaning cycles and dosages/mixtures of sanitizing chemicals. Exterior cleaning is executed manually with an attached spray gun and is also integrated into the CIP procedure for process control.MultivacKansas City, MOwww.multivac.com

Residual gas analyzer familyThe Hiden Analytical family of residual gas analyzers features three system types to accommodate applications from basic HV

vacuum diagnostics through precision gas analysis and fast-event UHV/XHV studies. The HALO system, a multi-purpose spectrometer for HV/UHV vacuum applications, features partial pressure measurement to 10E-13 mbar, along with exceptional low mass performance for high-sensitivity leak detection. The 3F series with triple mass-fi lter technology offers precise analytical capability with high contamination resistance, high abundance sensitivity, and detection capability to 5 ppb. Application-specifi c ionization sources are available to enable system confi gurations for precision gas analysis, molecular beam and laser interaction studies, and UHV/XHV applications. The 3F PIC is suitable for fast event studies. It is compatible with the full range of ionization sources in the 3F series and extends performance with a fast pulse counting detector capable of continuous measurement at rates to 500 samples/sec.Hiden AnalyticalLivonia, MIwww.hidenanalytical.com

Autoclavable mechanical pipettorsIn the new Proline Plus pipettor, Biohit has com-bined the basic functionalities of the traditional Proline mechanical model with new pipettor de-sign and technology that emphasizes safety, er-gonomics, and effi ciency. New features include a more ergonomic design, reduced pipetting force, autoclavability, and improved UV light resistance, as well as easier and faster maintenance. Proline Plus is a mechanical liquid-handling device with a robust design suitable for all types of applica-tions. It is easy to maintain and calibrate—no opening tools are needed and only a few parts need to be cleaned. The pipettors are equipped with replaceable tip cone fi lters that give addi-tional protection against contamination.Biohit OyjHelsinki, Finlandwww.biohit.com

ISO 14611-1 certifi ed cablesIgus® Inc., the developer of Energy Chain Systems®, Chainfl ex® continuous-fl ex cables, and iglide® plastic bearings, recently achieved certifi cations in cleanroom environments for both its Chainfl ex cables and Energy Chain® cable

carriers. These products meet ISO cleanroom standard 14644-1, which replaces Federal Standard 209E. Igus now offers both control and servo cables for near-sterile environments, as well as ISO-approved cable carriers within the families of System E3, System E4/100, System E6, and E-Z Chain. Cleanroom-approved Chainfl ex cables and Energy Chains provide customers with off-the-shelf cable management solutions that require no modifi cations, leading to faster, easier installations in applications for the electronics and pharmaceutical industries, medicine technology, and food processing. Igus® Inc.East Providence, RIwww.igus.com

Spill detectorKD Scientifi c has released the new OS-250, a system that detects spills and leaks before they cause a problem around HPLCs. As little as three drops of liquid will cause the unit to react. The system consists of a moisture-sensing mat and control unit. The mat is made from a material

specially developed for detecting liquid spills and connected to the control unit by a simple cable. When liquid is detected on the sensing mat, the controller will sound an audible alarm, fl ash an LED, and turn off the power of any device plugged into the single-outlet, solid-state power controller. The OS-250 spill sensor is supplied with the controller and four reusable 30x30 cm mats that can be cut to any size. It also includes the connector cable between the mat and the controller.K-D Scientifi cHolliston, MAwww.kdscientifi c.com



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Atomic force microscopy accessoryAsylum Research, a manufacturer of advanced atomic force microscopes (AFMs), introduces the iDrive cantilever holder. The microscope ac-cessory simplifi es AFM fl uid imaging and allows auto-tuning of cantilevers in fl uid. It is exclusively available for use with Asylum Research MFP-3D™

AFMs. iDrive uses a patented technique to mag-netically actuate the cantilever by driving a small current through the cantilever legs in the pres-ence of a magnetic fi eld. Multiple peaks that are typically associated with piezo driven fl uid tunes are eliminated. Unlike other magnetic actuation techniques, iDrive does not require expensive magnetically coated cantilevers. Such coatings can cause unwanted cantilever bending, may expose the sample to potentially harmful metal ions, may corrode in biological solutions, and have a limited shelf life.Asylum ResearchSanta Barbara, CAwww.asylumresearch.com

Portable air samplerThe DUO SAS 360 portable microbiological air sampler from International PBI features a single body with two aspirating heads. Two separate plates may be used for simultaneous sampling to differentiate microorganisms (onto two different media or onto the same media) to calculate an average value and obtain a more representative result. The sampler exhibits an airfl ow of 180 lpm per head.International PBI S.p.aMilan, Italywww.internationalpbi.it

Disinfectant for manual and automated processingMetrex Research Corp. has added MetriCide OPA Plus™ solution, a high-level disinfectant, to its line of infection prevention products. Effective for use in both manual and automated reprocessing, the new ortho-phthalaldehyde (OPA) product is a lower-cost alternative, and can process up

to 40 percent more endoscopes per gallon than Cidex® OPA. Metrex also offers MetriCide OPA Plus™ solution test strips, which provide a 33 percent faster reading time compared to other OPA test strips. The disinfectant is non-corrosive, gentle on endoscopes and other surgical instruments, and provides a broad kill spectrum including Tuberculosis, Hepatitis A (AER), Hepatitis B, HIV-1 and Polio Virus Type 1. It does not require activation or dilution and may be reused for up to 14 days (when monitored according to label instructions for use).Metrex Research Corp.Orange, CAwww.metrex.com

Integral water purifi cation systemMillipore Corp. has announced the availability of the new Milli-Q Integral water purifi cation system, which uses tap water to supply constant-quality Type II (pure) and Type I (ultra-pure) water from a single water production unit. The system combines Millipore’s proven Elix® technology with the Milli-Q solution to produce pressurized pure and

ultra-pure water. The system produces pure and/or ultra-pure water for needs ranging from 60 to 300 L/day. Separate points-of-delivery (PODs), dedicated either to ultra-pure water (Q-POD®) or pure water (E-POD™), ensure convenient delivery at a fl ow rate adjustable from drop-by-drop to 2 L/min. The fl exible PODs can be adapted with a choice of fi nal polishers to remove specifi c contaminants, including pyrogens, nucleases, bacteria, particulates and organics.Millipore Corp.Billerica, MAwww.millipore.com

Aseptic vial-fi lling equipmentTo accommodate special handling for liquids and lyophilized injectables, Flexicon America Inc. introduces the FMB210 fi ller. It offers an aseptic fi lling process that combines sterile containment and gentle peristaltic dispensing action to safely and accurately fi ll injectable products into vials.

Flexicon fi lling technology features a sterile fi ll channel that ensures repeatable accuracy in fi ll volumes. Since product comes in contact only with the medical-grade silicone tubing and the fi lling needle, there is no risk of product cross-contamination between batches or between product change-over. With only a simple change of the tubing, fi ll needle, and format change to accommodate size variations in vials and caps, the system can accommodate a new product in less than 10 minutes.Flexicon America Inc.Burlington, VTwww.fl exiconamerica.com

Environmental monitoring systemsRLE Technologies has released the Falcon F-Se-ries F1000 and F3400, stand-alone systems that enable remote environmental monitoring of critical operating parameters via embedded fi rmware that handles all data collection, alarm reporting, and multiple concurrent communica-tion media. The standard F-Series systems allow for direct plug-and-play integration with up to eight RLE SeaHawk leak detection systems via Modbus connectivity. Both the F1000 and F3400 accommodate up to four analog, four digital (dry



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contact), or thermistor signals. The F3400 allows for an additional 24 digital inputs. Inputs can be used to monitor simple contact closure signals such as summary alarms, thermistor tempera-ture sensors, or analog inputs (4–20 mA) that provide variable information such as tempera-ture, humidity, voltage, current, or pressure.RLE TechnologiesFort Collins, COwww.rletech.com

Proof of sterilization labelsLGInternational, a manufacturer of advanced labeling products, has launched a line of ster-ilization indicating labels for steam autoclaves, gamma radiation sterilization, and ethylene oxide (ETO) gas sterilization. These durable labels use specialty inks that change color when exposed to specifi c sterilization procedures. LGI’s steriliza-tion labels are able to withstand moisture, chem-ical exposure, and extreme temperatures without smearing, cracking, or fading while maintaining adhesion throughout the sterilization process. Labels can be customized to meet specifi c re-quirements for a variety of applications. Standard autoclave labels for proof of sterilization can be ordered online in rolls of 500 with either perma-nent or removable adhesive.LGInternationalPortland, ORwww.lgintl.com

Barrier-coated non-woven fabricsJen-Coat polymer coated non-woven fabrics pro-vide barrier reinforcement for medical products such as surgical and isolation gowns, drapes,

blankets, cold packs, and disposables. Imper-meable to blood, fl uids, and most chemicals, they can be made to exhibit specifi c performance characteristics such as softness, durability, heat retention, and sterilizability. Supplied as roll goods up to 90 inches wide, the fabrics feature a pinhole-free polymer coating that is as thin as 0.5 mils on materials such as spun-bond polyes-ter, polypropylene, polyester, and airlaid. The fi rm also coats, laminates, and metallizes a full range of fi lms, foils, and papers with a host of resins and offers print, slit, and rewind services. Jen-Coat fabrics for medical products are made to specifi cation. Price quotations and samples are available upon request.Jen-Coat, Inc.Westfi eld, MAwww.jencoat.com

new literature

Lab safety productsVWR International has published its 2007–2009 Safety Catalog, a comprehensive and diverse col-lection of safety products for the research labo-ratory industry, including customers in industrial, production, and controlled environments. The 560-page catalog features more than 7,000 products from leading suppliers, as well as the VWR Collection portfolio. Quick indices, color-coded product sections, and intuitive cross-ref-erences quickly direct customers to the products they need. Concise explanations of industry safe-ty regulations and standards are placed through-out to help customers stay safe and up to code with the appropriate supplies.VWR International, LLCWest Chester, PAwww.vwr.com

Tubing and hose selection informationTwo updated brochures are available from tubing and hose manufacturer NewAge Industries that are designed to ease the selection and buying processes. Titled “The Top 12 Tubing and Hose Buying Errors... and Their Solutions” (called the Top 12 for short), this brochure lists details that tend to be overlooked when choosing fl exible tubing or hose for an application. The Top 12 points out

situations such as failing to know all temperatures involved, not being aware of pressure or vacuum requirements, and neglecting to consider fi ttings and clamps for attachment. NewAge Industries’ Products & Services brochure gives an overview of the company’s tubing, hose, fi ttings, clamps, and accessories. Products are listed by material with each style—unreinforced, braid or wire reinforced, overbraided, coiled—highlighted. The brochure details sizes stocked as well as the many custom options available, such as heat-formed shapes, hose assemblies, and thermal bonding.NewAge IndustriesSouthampton, PAwww.newageindustries.com

Updated gas and fl ow control siteCONCOA’s enhanced web site, www.concoa.com, has been designed with a comprehensive presentation of features and benefi ts of specialty gas, industrial, medical, laser, semiconductor, and gas distribution products. A continually updated reference section offers downloading of technical data sheets, catalogs, and user manuals. The site also allows authorized distributors powerful software programs—the Regulator, Blender, Laser, and Flowmeter Wizards—that facilitate design and pricing of complete systems, in addition to the selection of individual components online. Users can request additional information, catalogs, or a visit from CONCOA’s technical sales engineers.CONCOAVirginia Beach, VAwww.concoa.com


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sales representatives


National Sales ManagerBARBARA KOVALCHEK

(603) [email protected]

Digital Media Sales ManagerBARBARA KOVALCHEK


Exhibit Sales ManagerBARBARA KOVALCHEK


ReprintsDIANE TROYER(603) 891-9385

[email protected]

List RentalsBOB DROMGOOLE


United Kingdom, ScandinaviaAMANDA LOFTUS+44 (0) 1793 641571+44 (0) 1793 610001

[email protected]

France, Netherlands, Belgium, Greece, AndorraSouth Switzerland, Spain,

Portugal, MonacoLUIS MATUTANO33-1-39-66-16-8733-1-39-23-84-18

[email protected]

Austria, Eastern Europe, Germany, Northern Switzerland

JOHANN BYLEK(49) 89 904 80 144(49) 89 904 80 145

[email protected]

Singapore, Malaysia, Indonesia, Thailand

ADELINE LAM65-6-836-227265-6-735-9653

[email protected]

KoreaKEVIN HWANG(82) 2 3142 4151(82) 2 323 5324

[email protected]

JapanMANAMI KONISHI

(81) 3 3556 1575(81) 3 3556 1576

[email protected]

Taiwan CINDY YANG

(886) 2 2396 5128(886) 2 2395 9571

[email protected]

ItalyVITTORIO ROSSI PRUDENTE

(39) 04-9723548(39) 04-98560792

[email protected]

IndiaRAJAN SHARMA

91-11-686111391-11-6861112

[email protected]

IsraelDAN ARONOVIC972-9-899-5813

[email protected]

China, Hong KongADONIS MAK

(86) 755-25988572(86) 755-25988567

[email protected]

ad index

Advanced Cleanroom Micro Clean . 47 ................... www.advcleanroom.com

ARAMARK Cleanroom Services ... 5..........www.ARAMARK-Cleanroom.com

CleanRooms International .......... 13 ................... www.cleanroomsint.com

CleanRooms Call for Papers ....... 39 .........................www.cleanrooms.com

CleanRooms Europe 2008 ............ 2.............. www.cleanrooms-europe.com

CleanRooms eNewsletter ........... 47 .........................www.cleanrooms.com

CleanRooms Subscription .....15, 27, 34 ................www.cr-subscribe.com

DuPont Safety & Protection ........C2 ........... personalprotection.dupont.com

Dwyer Instruments, Inc.. .............. 15............................www.dwyer-inst.com

Hach Ultra Analytics .................... 19 ..............................www.hachultra.com

INTERPHEX 2008 ........................23 ............................www.interphex.com

KNF Clean Room Products ....... 11, 47 .................www.knfcorporation.com

Modular Cleanrooms, Inc.. .......... 21 ...................................www.mcr-1.com

NanoCon 2008 ............................. 12............................ www.SmallTech.com

Noblemen International.. .............. 9.................www.clogs4cleanrooms.com

Perfex Corporation ....................... 7..........................www.perfexonline.com

Quality Air Control ........................ 47 ......................................www.qac.com

Shortridge Instruments, Inc. ........ 25 ............................www.shortridge.com

Terra Universal, Inc. ........ 29, 31, 33, 35, C4..........www.terrauniversal.com

The ConFab..................................C3 ............................www.theconfab.com

Veltek Associates, Inc. .................1 ..................................www.sterile.com

Advertiser Page URL Address Advertiser Page URL Address

The information contained in this publication is for general information purposes and is not intended to be advice on any particular matter. No subscriber or other reader should act on the basis of any matter contained in this publication without considering appropriate professional advice. PennWell, and the authors and editors, expressly disclaim any and all liability to any person, whether a purchaser of this publication or not, in respect of anything (and the consequences of anything) done or omitted to be done by any subscriber, reader, or other person in reliance upon the contents of this publication.


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J A N U A R Y 2 0 0 8 C L E A N R O O M S 47


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CalendarTo announce your organization’s upcoming conferences and meetings (date, location, and information), e–mail: [email protected].


FEBRUARY 5–8The Aseptic Filling Conference 2008. Danubius Hotel, Regents Park, London, U.K. For more information: www.iir-events.com

FEBRUARY 14–15INTERPHEX Puerto Rico 2008. Puerto Rico Convention Center, San Juan. For more information: www.interphexpuertorico.com

MARCH 1–7PITTCON 2008, 59th Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy. Ernest N. Morial Convention Center, New Orleans, LA. For more information: www.pittcon.org

MARCH 11–13CleanRooms Europe 2008 Conference & Exhibi-tion. Neue Messe Stüttgart, Stüttgart, Germany. For more information: www.cleanroomseurope.com

MARCH 17–19Food Safety & Security Summit 2008. Washington DC Convention Center, Washington, DC. For more information: www.foodsafetysummit.com

MARCH 18–20SEMICON China 2008. Shanghai New International Expo Center, Shanghai, China. For more information or to register: www.semi.org

MARCH 25–29Semiconductor Environmental Safety & Health Association (SESHA) 30th Annual International High Technology ESH Symposium & Exposition. Double Tree Hotel, Portland, OR. For more information: www.semiconductorsafety.org

MARCH 26–28INTERPHEX 2008. Pennsylvania Convention Center, Philadelphia, PA. For more information: www.interphex.com

MARCH 26–28PharmaMedDevice Conference and Exhibition. Pennsylvania Convention Center, Philadelphia, PA. For more information: www.pharmameddevice.com

MARCH 31–APRIL 22008 Surface Preparation and Cleaning Conference, “Emerging Technologies in Semiconductor Surface Preparation,” sponsored by SEMATECH. Sheraton Austin Hotel, Austin, TX. For more information: www.sematech.org

APRIL 6–9Food Automation & Manufacturing Conference and Expo 2008. Sheraton Sand Key, Clearwater Beach, FL. For more information: www.bnpevents.com/FE/FAM/

APRIL 12–15Controlled Environment Testing Association (CETA) 16th Annual Meeting. Crown Plaza Hotel, San Antonio, TX. For more information: www.cetainternational.org

APRIL 14–18Parenteral Drug Association (PDA) Annual Meeting. The Broadmoor, Colorado Springs, CO. For more information: www.pda.org

APRIL 21–22ESD Device/Design Seminar. ESD Association Headquarters, Rome, NY. For more information: www.esda.org

APRIL 21–25Hannover Fair/Microtechnology 2008. Hannover Messegelände, Hannover, Germany. For more information: www.ivam.de

MAY 4–7ESTECH 2008, 54th IEST Annual Technical Meeting. Hilton Bloomingdale Indian Lakes Resort, Bloomingdale, IL. For more information: www.iest.org

MAY 5–7SEMICON Singapore 2008. Suntec Singapore International Convention & Exhibition Center, Singapore. For more information: www.semi.org

MAY 5–719th Annual IEEE/SEMI Advanced Semiconductor Manufacturing Conference (ASMC). Boston, MA. For more information: www.semi.org

MAY 12–152nd Annual International Electrostatic Discharge Workshop (IEW). Port D’Albret, France. For more information: www.esda.org

MAY 18–21The ConFab, semiconductor conference and exhibition. Loews Las Vegas Resort, Las Vegas, NV. For more information: www.theconfab.com

MAY 28–29International Pharmaceutical Regulatory and Compliance Congress, sponsored by the Pharmaceutical Compliance Forum. Paris Marriott Rive Gauche Hotel and Convention Center, Paris, France. For more information: www.InternationalPharmaCongress.com

JUNE 1–5Nano Science and Technology Institute (NSTI) Nanotech 2008. Hynes Convention Center, Boston, MA. For more information: www.nsti.org

JUNE 1–5American Society for Microbiology (ASM), 108th General Meeting, Trade Show and Conference. Boston Convention and Exhibition Center, Boston, MA. For more information: www.gm.asm.org

JUNE 2–5Medical Design & Manufacturing (MD&M) East. Jacob K. Javits Convention Center, New York, NY. For more information: www.mdmeast.com

JUNE 15–1821st international Symposium, Exhibit, & Work-shops on Preparative/Process Chromatography. Doubletree San Jose Hotel, San Jose, CA. For more information: www.prepsymposium.org

JUNE 17–20BIO International Convention 2008. San Diego Convention Center, San Diego, CA. For more information: www.bio2008.org

JUNE 23–252008 AAPS National Biotechnology Conference. Metro Toronto Convention Centre, Toronto, Ontario, Canada. For more information: www.aapspharmaceutica.com


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MAY 18–21, 2008LOEWS LAKE LAS VEGAS RESORT, LAS VEGAS, NEVADA

The Meeting for Key Decision Makers on Semiconductor Fabrication

WWW.THECONFAB.COM

Loews Lake Las Vegas Resort in Las Vegas. An ideal destination for The ConFab offering flexible meeting and function space in an intimateand relaxed setting.

Semiconductor Equipment and Material Suppliers: If you would like more information on our list of participants for the 2007 event or want to become a sponsor of The ConFab in 2008, please call Jay Novack at(603) 891-9186, or email [email protected].

Semiconductor Device Manufacturing Executives: If you are a seniorlevel decision maker and would like to attend our event, please email Luba Hrynyk at [email protected], or visit us at www.theconfab.comto find out how to qualify as our VIP guest.

WHAT YOUR COLLEAGUES SAY ABOUT THE CONFAB

“The ConFab is still one of the best conferences out there and it’s arguably the best place for suppliers to network with chip makers inthe world… it was one of the best third-year conferences I’ve been to,which shows PennWell still has a winning formula… As for the presentations, they were generally excellent and the topics were superb.”

G. DAN HUTCHESON, CEO OF VLSI RESEARCH, INC. AND PUBLISHER OF THE CHIP INSIDER (JUNE 15, 2007)

“Keeps getting better each year, the change of venue was very positive.”DIRECTOR 300MM FAB OPERATIONS ALBANY NANOTECH,

IBM

“Excellent format and well worth the time.”VP, AMKOR TECHNOLOGY

“The ConFab continues to differentiate itself from other conferences byproviding opportunities to meet with top executives and to engage inopen discussions within an informal setting. The event is well organizedand the conference is conducive to attracting senior level executives.Overall, a great conference.”

VICE PRESIDENT, TECHNICAL SALES AND MARKETING, NIKON PRECISION INC.

“The entire conference was most informative and the networking wasgreat. We set up a number of follow-up meetings in our facility as a result of our discussions at The ConFab. We also wish to thank you andyour team for a flawless execution and logistic support to make ourwhole experience so much more enjoyable.”

COO AND CFO, CSMC TECHNOLOGIES CORPORATION

THE CONFERENCE:Managing the New Economics of Semiconductor ManufacturingHear industry experts on critical manufacturing issues and gain practical information that can be applied in fabs and manufacturing strategies.

THE MEETINGS:Private Boardroom Meetings with Leading Equipment & Material Suppliers & Device ManufacturersParticipate in private executive meetings with material and equipment suppliers and device manufacturers. Build alliances with new and current business partners.

THE NETWORKING:Peer-to-Peer CollaborationJoin your semiconductor manufacturing peers, suppliers and industrythought leaders.

2005 THE CONFAB IS A HIT!

2006THE CONFAB… A SECOND GREAT YEAR!

2007ONE OF THE BEST THIRD-YEAR CONFERENCES…PENNWELL’S WINNING FORMULA!

Meeting theChallenges.Building the Future.

OWNED & PRODUCED BY:MEDIA SPONSORS:

Previous Page Contents Zoom In Zoom Out Front Cover Search Issue Next Page F


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Documents

CleanRoon 2008.pdf