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
Combination
medical devices
Barrier systems
Environmental
monitoring
Combination
medical devices
Barrier systems
Environmental
monitoring
Combination
medical devices
Barrier systems
Environmental
monitoring
Contents Zoom In Zoom Out For navigation instructions please click here Search Issue Next Page
Contents Zoom In Zoom Out For navigation instructions please click here Search Issue Next Page
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Previous Page Contents Zoom In Zoom Out Front Cover Search Issue Next Page M S a
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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 microfuidic 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
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Features
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CleanRooms
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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. Austin
Clean Air Technology
C.W. Berndt
C.W. Berndt Associates
David Brande
NNE US Inc.
Roger Diener
Analog Devices
Anne Marie Dixon
Cleanroom Management Associates
Dr. Johann Dorner
Fraunhofer Institute Manufacturing
Engineering & Automation
Gordan M. Ely
Nelson Laboratories, Inc.
Jan Eudy
Cintas Corporation
Adam Giandomenico
Adams Instruments
Thomas E. Hansz AIA
Facilities 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 Miscioscio
Cleanroom Consultant
Dr. Richard Pavlotsky, P.E.
Greene Engineers
Henry D. Rahe
Contain-Tech
Michael Rataj
Aramark Cleanroom Services
David J. Ruede
Entegris, Inc.
Scott Salton
Lighthouse Worldwide Solutions
Dr. Hans H. Schicht
Schicht AG
Dr. R. Vijayakumar
Aerl, LLC
Jim Wagner
Controlled 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
Columns
14 Setting the standard
IEST marches on to nanotech beat
36 Product spotlight
Cleanroom garments
40 New products
48 Calendar
JOHN HAYSTEAD Publisher/Editor/jhaystead@pennwell.com
CARRIE MEADOWS Managing Editor/carriem@pennwell.com
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 Traffc Manager
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KATRINA FRAZER CleanRooms Show Management
Editorial /Executive Offces 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 linda@pennwell.com.
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CleanRooms
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from the editor
Changes
During this election season, weve all heard a lot of talk about change. Its the
favorite buzzword of just about every candidates 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 implementor voting for, for
that matter. Of course, the truth is that change is simply thatchange. And it can be
good or bad depending on what it actually involves and where you sit.
Here at CleanRooms, were experiencing change as wellthe real kind, the
kind you can identify. But what I want to talk about most is much more important
than thatthe things that arent changing, and wont.
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, exemplied by CleanRooms under Jims 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 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 were 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 nal thing that will not changehow much fun I have being
a part of this great industry.
Im John Haystead and I not only approved this message, I wrote it myself.
John Haystead,
Publisher & Editor
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CleanRooms
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8 C L E A N R O O MS 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 defning 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 airfow 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 lab
By George Miller
A 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 ofcials
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-
cilitiesincluding 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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CleanRooms
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news
J A N U A R Y 2 0 0 8 C L E A N R O O MS 9 w w w . c l e a n r o o m s . c o m
now 70 percent completeas 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
BUs ability to protect their Boston neighborhood
while running a BSL-4 facility, given the
institutions 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 re led
to the buildings evacuation.
Chief among the NRC expert committees
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, reecting 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 dissatised with the draft assessments
consideration of environmental justice issues
and how the biocontainment facility could af-
fect the inner-city population in particular.
Missed opportunity
Expert 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 rened analysis of the
risks presented by a facility like BUs, 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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CleanRooms
__________________
__________________________________________
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 inuence
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 concerns
NRC expert committee member Gigi Kwik
Gronvall, assistant professor of medicine
and senior associate at the University of
Pittsburgh Medical Centers 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 neighborhoods
status as a U.S. Environmental Protection
Agency environmental justice community. We
didnt see accommodations for public health
access in the report, she said. We dont 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 scientic 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 committees 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 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
condent that the NIH will address those issues
in its 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 S
compiled by Carrie Meadows
Gerbig Engineering introduces
new cleanroom construction
feature
Minnesota-based Gerbig Engineering, a
specialist in the design, build, installation,
and certifcation 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 retroftted with this
raceway system.
New England Peptide opens
instrumentation lab
New 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. NEPs
engineering staff will use the dedicated lab
to develop new instrumentation, qualify
newly acquired production equipment, and
effciently bring instrumentation offine for
maintenance.
David Savage lands
at Ultra Clean
Ultra 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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CleanRooms
CleanRooms
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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-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, t poorly, or was unattractive looking.
So its 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 landll 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 lled out by
197 safety professionals who reported being re-
spon-sible for purchasing, selecting, or inuenc-
ing the purchase or selection of, or compliance
with, PPE. Respondents were from 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 Administrations Science Board,
the nations food supply is at risk, as are the
regulatory systems that oversee the nations
drug and device supplies. In a report presented
in December, the subcommittee attributed the
deciencies 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 signicant
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 subcommittees
300-page report concludes that the state of FDAs
scientic and regulatory programs could not be
separated from the lack of resources. It urged
funds to support the agencys scientic base,
hire a broadly capable scientic workforce, and
build a sophisticated, modern information tech-
nology infrastructure.
Upon the reports 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 S
compiled by Carrie Meadows
USP <797> revisions now available
The U.S. Pharmacopeia has posted the Revision Bulletin containing
changes to General Chapter Pharmaceutical CompoundingSterile
Preparations <797> on its web site at http://www.usp.org/USPNF/
pf/generalChapter797.html. The revisions will become offcial
on June 1, 2008, and will be included in USP 32NF 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
offcial date.
BASF completes European electronic materials center
The Electronic Materials Center Europe at BASFs 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 purifcation facilities as well as cleanroom flling
stations to ensure high purity and consistent quality of the products.
After completion of the qualifcation activities at the end of 2007,
routine production was scheduled to commence on Jan. 1.
Microtest expands facilities and services
Microtest, 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 signifcantly expanding its medical
device packaging laboratory and its GMP pharma fll/fnish contract
manufacturing services at its Agawam, MA-based headquarters.
Package validation is needed to support our medical device clients.
Were also dedicating additional new space to our growing product
stability testing laboratories as well as our GMP drug manufacturing
services, says president and scientifc 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 cant improve
its science, prepare for the future, or protect American consumers without
signicant additional resources. Congress is negotiating FDAs FY 2008
[current year] budget right now and can start to x this critical problem.
The cry for more FDA resources was echoed by the Coalition for a
Stronger FDA, which comprises patient groups, non-prot organizations,
consumer and public health advocates, and innovative companies
with the goal of working alongside policymakers to bolster and preserve
public condence in FDA. Over the last decade, complex scientic
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 denitely 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 beat
IEST sets goals for new nanotechnology Recommended Practice
Working Group activities
By John R. Weaver II, Senior Member, IEST
T
he 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 dened 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 eld
of nanotechnology by building on the established experience and expertise
of IESTs membership. In addition, the Nanotechnologies S&P Commit-
tee will strive to enhance IESTs participation in this 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 Groups 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 47 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 signicant portion of
the event will center on the burgeoning science of nanotechnology (see
ESTECH 2008: Focus on nanotechnology
Keynote
IEST 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
Offce (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 felds 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 track
In 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 Tour
Concluding 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 fre standards for
cleanrooms. He has published numerous papers in both the process development and
contamination control felds, has two patents in process development, and authored a
book and two book chapters in contamination control technology.
About IEST
Founded 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 rst
successful products to combine two unique medical tools in a single
package.
Prior to the drug-eluting stents 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) denes 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 growth
The recent rapid growth of the combination medical device industry
is undeniable. Independent 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 ofce 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
dont, they need to know whats going on because its a big trend.
Cutting-edge device companies who want to 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
rmsif they can gure out how to produce them successfully. It has
become an emerging growth area, particularly in the last few years, and
many 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 rm (Waltham, MA). But its a high
risk, high reward market.
It can test a companys resolve, adds PRTMs Sam Baldwin,
manager of the life sciences group, who notes that developing the
rst product in particular can be very difcult. The time to develop is
signicantly 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 tape
The rapid growth of this market has left the medical device industry in
unfamiliar territory as it gures out how to characterize and regulate
this hybrid category of products. Even FDA is struggling to dene a
roadmap for these devices. While its ofce of combination products offers
guidance and development considerations to manufacturers, it has yet to
clearly dene a set of good manufacturing practices (GMPs) specic to
this product category. That has left companies to dene 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 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 wont 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 didnt 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 precedence
Aside 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, airow 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 its more difcult 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 efcacy, says Foster-Millers 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 consideredmany 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 ow
hoods, and control over the exhaust air around a 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 difculty is that device material and biologics
or chemicals can have conicting 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-Millers 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 wont 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 its
much harder to make changes.
Maintenance and monitoring
Controlling 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 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 airow, temperature, humidity, and any
motor malfunctions that could compromise
the manufacturing or storage spaces, says
Microtests 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-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 airow 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. Its
critical for the service people to be able to get
above the cleanroom to pull 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 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 nished product are analyzed for
contaminants using high-performance liquid
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sales@modularcleanrooms.com
Even FDA is
struggling to defne
a roadmap for
combination medical
devices.
special report
chromatography, and the product is bagged
and terminally sterilized.
Sterility options
How the product is sterilized at the end of the
manufacturing process is one of the most dif-
cult decisions developers of combination medi-
cal devices will make, says PRTMs Baldwin. Its
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 together
The 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 signicant
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 doesnt mean the non-biological
material should be compromised. Rather,
it means the device material, along with
the assembly methods, airow 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 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 companys In-Check lab-on-chip platform incorporates silicon-based
MEMS microfuidic technology to facilitate the diagnosis of specifc diseases or detect bacterial
contaminants in liquid biological samples. Photo courtesy of STMicroelectronics.
special report
supplier of microuidic 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 rst attempt at a combination product is to de-
sign the elements independently of each other. Its
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 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 cant be
predicted, especially when you work with biologics, he points out,
adding that engineers in particular dont expect these kinds of problems
because they dont occur when working with pure electronics.
Hodges learned this lesson the 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 its 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 t for the semiconductor manu-
facturing process, he says, now that ST has the development process g-
ured out. We are driven by quality. Thats the mindset of semi and its the
mindset of the medical industry.
Hodges is currently working on STs lab-on-chip combination de-
vice, which facilitates the diagnosis of specic 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 microu-
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. Its the kind of innovation we need for
the growth of our future.
Resources and contacts
Foster-Miller, Inc.
Waltham, MA
781-684-4000
www.foster-miller.com
Microtest Labs
Agawam, MA
425-446-4519
www.microtest.com
Navigant Consulting
Chicago, IL
312-573-5600
www.navigantconsulting.com
PharmaMedDevice
Norwalk, CT
www.pharmameddevice.com
PRTM
Waltham, MA
781-434-1200
www.prtm.com
STMicroelectronics
Dallas, TX
512-225-6161
www.st.com
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Our industry is evolving. Pharma, biotechnology
and medical devices are converging. The time to market
is accelerating. The traditional rules have changed. Now,
more than ever, industry professionals are looking to
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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 applications
Barrier technology offers clean spaces for pharmaceutical
flling and packaging, as well as protection for operators
By Jack Lysfjord, Lysfjord Consulting LLC
B
arrier technology is designed to replace the use of con-
ventional ISO 5 cleanrooms in pharmaceutical lling and
packaging (i.e., ampoules, vials, cartridges, and pre-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 efciency particulate air (HEPA) lters supplying ISO 5 airow 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-
sied 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 isolators
Compared to isolators, RABS can allow for
faster start-up and ease of changeover, and,
accepting certain restrictions, offer increased
operational 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 ow hoods (LFHs)
in that they are fed clean air from fan units through HEPA 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 airow. 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 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) 443-1267
WWW.SHORTRIDGE.COM
Figure 2. Aseptic powder flling in a passive RABS. Photo courtesy of Bosch Packaging Technology, Valicare
Division.
barrier systems
C L E A N R O O MS J A N U A R Y 2 0 0 8 25 w 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 oor-level air exit openings.
Responding to current trends
in the pharmaceutical market
There 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 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 applicationsimmunosuppressive cancer
drugs are a key examplealso demand strin-
gent barrier technology to protect operators.
Broadly speaking, there is a trend toward
Environmental
monitoring is
necessary to ensure
the integrity of the
ISO 5 environment in
both systems.
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Figure 3. FLC vial flling 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 m 26 C L E A N R O O MS 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 exible congurations and en-
able manufacturers to respond rapidly to changes in market demand.
Isolators are ideal for smaller facilities that employ exible,
reduced-footprint systems. Compared to conventional cleanroom
processing, isolators offer pharmaceutical rms signicant 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 consider
The 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 airow 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 isolator
Many 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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res|start oacter|a
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sarp||r po|rts
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 barbarak@pennwell.com.
With 25,500
1
BPA-qualied, 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.
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planetary protection
New detection methods reinforce
protocols for planetary protection
NASA planetary protection programs charged with keeping
biocontamination out of space
By Patrick Hogue, Johns Hopkins University, Applied Physics Laboratory
N
ational 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 efcient. 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 policy
The 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 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 scientic
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 125C, are considered the gold
standard for planetary protection.
Detailed microbial burden requirements
NPR 8020.12 allows alternatives to 125C dry heat sterilization
provided that procedures and quality controls are approved by the NASA
Planetary Protection Ofcer (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 specication
numbers. Microbial barriers may be used to prevent recontamination
of previously sterilized areas; a pressure of at least 1,244 Pa (5 inches
H
2
O) is considered satisfactory to prevent the entry of microorganisms.
High efciency particulate air (HEPA) lters (99.97 percent efcient
for 0.3 m) 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/m
2
); 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 sterilizationmeaning 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
Acrylic
& Other
Plastics
BioSafe
Aseptic
Chambers
Hundreds of standard enclosures
Stainless steel Dissipative PVC Polycarbonate
Polypropylene Acrylic More!
Mix and match standard process controls for
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High/low humidity Particle filtration Static control
Process gas generation & mixing
To order: 714-578-6000
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Origin of spores Requirement Possible reduction
Electronic parts 3150/cm
3
Burn-in, radiation screening
Other non-metallics 130/cm
3
Dry heat sterilization in bulk
Class 10k highly controlled 50/m
2
Preferred for PP mission
Class 10k normal control 500/m
2
Described in Reduction section
Class 100k highly controlled 1,000/m
2
Class 100k normal 10,000/m
2
Uncontrolled manufacturing 100,000/m
2
Clean tent; upgrade discipline
Assessing microorganism levels
Most 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) 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 ofcer.
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 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
uorescence of energetic metabolic chemicals
(e.g., adenosine triphosphate, or ATP, riboa-
vin) induced by ultraviolet light
4,5
, although continued on page 30
immunoafnity-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
rey. 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 lter-based
media with ATP bioluminescence enumeration
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Figure 1. Astronaut Suni Williams, Expedition 14/15 fight engineer, works with
the Lab-on-a-Chip Application DevelopmentPortable 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 specic organisms after the non-
specic uorescence enumeration measurement is accomplished.
10
Implementation of NPR 5340.1
The cost of a fully equipped microbiology laboratory to support a
spacecraft program with full PP requirementsa Mars Lander, for
exampleis 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
program
2. Management buy-in and support of the PP engineer
3. Universal personnel training (including purchasing and support
groups)
4. Pre-planned bio-assay database that parallels the assembly ow
5. Lessons learned from the MPL program:
Daily change of cleanroom garments
Purchase of 200 new sets
Strict enforcement of aseptic techniquesa departure from the

usual
Sterile, powder-free cleanroom gloves
Daily janitorial service (IPA used instead of ammonia for oors

and walls)
Facility modications 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 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 brieng 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/veried biobarrier (it tears through this barrier
when deployed)
Be prepared: NASAs independent bio-assay testing might re-

quire re-cleaning or re-sterilization of spacecraftcould impact
launch date
Reducing microorganism levels
Several 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
2
O
2
) or a combination of H
2
O
2
and peracetic acid
(CH
3
COOOH); chlorine dioxide is also very effective. Compatibility of
these chemicals with materials of construction should be veried with
the supplier prior to use. Spore strips are used to determine the effec-
tiveness of the kill. H
2
O
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 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 biolm.
Sterilization, and verication of effectiveness, may be performed prior
to the start of a PP program.
Genomic inventory of spacecraft
A 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
ULPA-filtered drying modules provide warm, particle-free air
Cleansing stations integrate sink, dryer, soap dispenser
Isolated, insulated motor minimizes noise, vibration
Also ideal for drying tools, bottles, and other small parts
Dryers and
washing stations in
many congurations
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 fuidics 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 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 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.
Conclusion
Missions 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
ofcer 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.
References
1. Astrobiology, Vol. 6, No. 5, 2006, The Astrobiology
Primer: An Outline of General KnowledgeVersion
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 system
The latest regulations call for a shift in particle monitoring strategies
By Mark Hallworth and Edward Applen, Particle Measuring Systems
F
or 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 (GAMP
2
)
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 timeline
The key to a successful project is to ensure that all phases of the
implementation are executed in a timely manner. The identication 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 resourcesboth material and laborare 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 design
There are several documents
3,4
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 dened in the User Requirement Specication (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 sufcient 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 installation
As 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, 120240 VAC, and 3 phase); signal wiring 420 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, re hazards, length of runs, and signal speed. Cables
are normally run in either cable tray or conduit specic 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: 714-578-6000
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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 designs
Ionization, UV/germicidal lighting, airflow monitoring
Customized to your requirements
PLC control
over shield, FFU
and light
Figure 2: Facility monitoring system schematic
Central vacuum
system
Viable
atrium
Non-viable
sensor
Control and
automation
T/RH, DP, etc.
Alarms
Viable monitoring
(ow meter)
Viable control (valve)
Vacuum
header
ENODE Ethernet
switch
Server
Network
stations
Site LAN
Real-time
station
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 specic. 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 airow 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 ll-
ing equipment, on the 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 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 ofce 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 validation
The validation of the installed system follows
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For additional company and product information, visit cleanrooms.com today!
Figure 3: Vacuum manifold schematic

Header: 2-inch diameter - schedule 80 PVC
Braided PVC tubing
connects to hose barb
Looped design maintains consistant vacuum
throughout 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 identied 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 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-congured 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 implementation
This 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 510 pages of data
per day. If this is extrapolated to a 10-sensor
system, 50100 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: 714-578-6000
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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
conguration 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 implementationreading
the data to deliver information relative to
proving environmental control, necessary for
compliance to the current standards.
Summary
Solid 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).
References
1. 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.
Particles, J. Aerosol Sci., Vol. 36, 2005.
5. C. Bolotin, Instantaneous Microbial Detection
(white paper), BioVigilant, Tucson, AZ, 2006.
6. P. Scholl et al., Immunoafnity Based Phosphorescent
Sensor Platform for the Detection of Bacterial Spores,
Proc. SPIE, Vol. 3913, 2006.
7. J. Popp, Identication of Micro-organisms by Raman
Spectroscopy, Proc. SPIE Biomedical Imaging,
2007.
8. Space.com, Astronaut Suni Williams, Expedition
14/15 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.
509521, 2007.
17. As presented by Dr. Catherine Conley, acting NASA PP
Ofcer, during the 2007 NASA PP Policy and Practices
Workshop, Santa Cruz, CA.
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product spotlight
cl eanroom gar ments
Since 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 technology
Ansell offers AlphaTEC gloves, the frst chemi-
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Ansell
Red Bank, NJ
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Cleanroom garment
tracking service
CleanTrak is ARAMARKs 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 ARAMARKs
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
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history; a customer report that provides a fve-
week summary that can be downloaded into an
Excel fle or viewed onscreen; and receiver review.
To learn more, call 800-759-0102 or visit the
web site.
ARAMARK Cleanroom Services
Burr Ridge, IL
www.ARAMARK-Cleanroom.com
Custom garment and consum-
ables programs available
Ameripride and Canadian Uniform Services
announce their CleanStyle Cleanroom Division.
CleanStyle represents fne reusable and
consumable cleanroom services and products.
With multiple certifed ISO 4/Class 10 cleanroom
laundry facilities in the United States and
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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 fexibility as needs change. On-site inventory
management programs ensure excellent product
availability and accountability while saving
both time and money; and CleanStyles large
product inventory of cleanroom reusable and
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source provider for cleanroom requirements. For
more information, contact a cleanroom specialist
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CleanStyle Cleanroom Division
Vancouver, BC, Canada
Extensive in-house quality
testing on garment offerings
Established in 1979, Dastex Reinraumzubehr 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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tested by independent and internationally
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approved. Dastex also operates its own body
box, equipped with a Helmke drum test facility
to determine flter effciency of cleanroom fabrics
and other tests to determine air permeability
and retention of particles in technical fabrics.
Continuous development in the feld of
garments and the companys 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 Reinraumzubehr GmbH and Co. KG
Muggensturm, Germany
www.dastex.com
Line of personal
protection products
DuPont is dedicated to the science of protection.
The goal of DuPont Controlled Environments is to
provide high-performance so-
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innovation and material, gar-
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cleanroom environments. Du-
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ing DuPont Tyvek IsoClean
garments for premium protec-
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ments specialists are industry experts who can
help customers with site assessment and a variety
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each customers critical environment is as effcient
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DuPont Controlled Environments
Richmond, VA
www.dupont.com
Disposable and
reusable garments
Innotech Products, Inc. launderable contamina-
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The company offers a wide selection of fabric
that meets specifc ESD and cleanliness require-
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to controlled environments. DuPonts Tyvek, Iso-
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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-
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<797> compliance, call 888-270-0458 or e-mail
info@innotechprod.com.
Innotech Products, Inc.
Minneapolis, MN
www.innotechprod.com
Low-linting face masks
KIMTECH PURE* M3 Face Masks from Kimberly-
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The masks low-linting apertured polyethylene
flm outer layer provides protection from con-
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bacterial and particle fltration, along with good
breathability.
Kimberly-Clark Professional
Roswell, GA
www.kcprofessional.com
100 percent nylon gloves
Magid 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
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is manufactured entirely in a cleanroom with
an ISO 6 rating using heat-treated, texturized,
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produced, the gloves are then taken to an onsite
laundering facility and pre-laundered to retain
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their size after multiple launderings and then
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Best, 3M, Uvex, MSA, and more.
Magid Glove & Safety Manufacturing Co. LLC
Chicago, IL
www.magidglove.com
Garment replenishment
program
Prudential Cleanroom Services, a leader in
cleanroom laundry service systems, has an IN-
STOCK reusable cleanroom apparel program
that represents many of the industrys 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
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established in 1932. Since 1960, Prudential
Cleanroom Services is recognized as a leader
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companys network of ISO 9001:2000 certifed
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extends throughout the United States, along with
an operation in Malaysia.
Prudential Cleanroom Services
Irvine, CA
www.pcs-clean.com
Clean apparel for
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Transforming 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
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Recent product innovations include conductive
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Transforming Technologies, LLC
Sylvania, OH
www.transforming-technologies.com
Ultra-clean boot covers
with non-skid soles
Valutek, a partner in contamination control
since 1988, offers a variety of disposable and
reusable cleanroom apparel designed to provide
complete protection. The companys ultra-clean,
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signed to protect operators exposed to splashes
from certain chemicals, blood, and particulates,
Valutek boot covers are impervious to liquids
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Sterilizable boots available in various fabrics
GripLine boots by White Knight are designed
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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 ft. Other fabrics and
confgurations are available on request.
White Knight Engineered Products
Charlotte, NC
www.wkep.com
product spotlight
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CleanRooms magazine is now soliciting contributed s
technical article submissions for entry into its double-
blind, peer-review process. As the contamination control
communitys largest international circulation (and the only
Business Press Association-audited), professional journal
serving the eld, acceptance and publication of original,
peer-reviewed technical content in CleanRooms magazine s
will ensure broad, targeted recognition and distribution of
your work throughout the entire professional
contamination control community worldwide.
The CleanRooms peer-review board is a voluntary panel of s
experts representing a wide range of contamination control
disciplines and industries, as well as a mix of both academ-
ic and industry expertise. The double-blind peer-review
process assures the objectivity and integrity of the review
process by ensuring that the identity and afliation of the
author(s) are not made known to the panel of experts that
will be evaluating their submission and vice versa.
Accepted articles submitted through the peer-review
process will be published with a special seal of merit,
identifying the paper as having successfully met the
requirements and standards of the independent
review board.
Topics of interest include (but are not limited to):
particulate, microbial and molecular contamination;
cleanroom design and construction; barrier isolation and
separative devices; disinfection, sanitation and hygiene;
certication and validation; cost control; ltration and
materials handling; practices and protocols; personnel
safety; ESD protection; industry standards and guidelines.
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Compiled by Carrie Meadows
High-purity foams for
insulation and construction
applications
Kynar PVDF-based closed cell foam is the
frst polymeric foam to meet the requirements
for Factory Mutual (FM) 4910 test protocols
for cleanroom materials fammability. The fame
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, PA
www.arkema-inc.com
Dusting system and
microfber wipers
Kimberly-Clark Professional has introduced a
new line of KIMTECH SCIENCE* brand products
for laboratory maintenance: the KIMTECH SCI-
ENCE* dusting system, lens-cleaning microfber
wipers, and large microfber 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, fexible, dust-trapping polyester fbers that
change shape for dust pick-up in crevices and
contours where dust cloths cant reach. The en-
vironmentally friendly system dusts without the
need for chemicals and leaves no residues.
Large, disposable microfber wipers have excel-
lent wet and dry strength and excellent water
and oil absorbency (absorbing 4.5 times their
weight). The lens-cleaning microfber 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 Professional
Roswell, GA
www.kcprofessional.com
Nitrile, powder-free exam glove
Sempermed, 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 ft, 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 fngertips. A standard-
sized box holds 200 gloves.
Sempermed
Clearwater, FL
www.SempermedUSA.com
Custom-colored hose
allows quick identifcation
of process lines
AdvantaPures 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 fuid transfer. The hose is
constructed of a core of low volatile, platinum-
cured silicone for purity. APSM is durable and
heavy-duty yet fexible 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.
AdvantaPure
Southampton, PA
www.advantapure.com
Wet-vacuum sample
collection system
Microbial-Vac Systems, Inc., an innovator in
pathogen surface sampling, has released a
new tool for pathogen collection. The Microbial-
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Vac (M-Vac) wet-vacuum collection system
utilizes LAMDAC principles (Liquid and Air-
assisted Microbial Detachment and Capture)
to collect laboratory or feld samplestypically
from 1 to 2 sq. ft. of surface area per sample
in 100150 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
effcient sampling.
Microbial-Vac Systems, Inc.
Bluffdale, UT
www.m-vac.com
ESD-safe binocular microscopes
Luxos 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-refective coating that
alters the electrical characteristics at the
surface of the material. The microscopes
provide 270X total optical magnifcation, 8-inch
working distance, and 15 percent greater feld
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 magnifcation range of 7X to 45X.
Luxo
Elmsford, NY
www.luxous.com
Shipper for 300-mm wafers
The Entegris 300-mm multiple flm frame shipper
(MFFS) provides manufacturers increased safety
and security while shipping fully processed
wafers or singulated die mounted to flm 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
flm frame movement and reduces particle
generation. The new shipper is stackable with
both Entegris 300-mm and 200-mm flm
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 fexibility to
accommodate either metal frames or Entegris
plastic frames.
Entegris, Inc.
Chaska, MN
www.entegris.com
Food-grade, FDA-approved
cleanroom hose
A fexible, 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 fexible, medium-weight, white thermoplastic
hose that is reinforced with a spring-steel helix
and operates over a 40 to +250F range.
Featuring a smooth interior to promote effcient
airfow, 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.
Flexaust
Warsaw, IN
www.fexaust.com
Chemical concentration
monitor for semiconductor
processes
The 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
fuids. The CR-288 is the frst 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 fuid 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, OH
www.swagelok.com/semiconductor
Class 10/ISO 3
modular cleanrooms
Terra Universals 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 Universal
Fullerton, CA
www.terrauniversal.com
Polymers for
SPE-based analysis
Varian, 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 specifcally 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, CA
www.varianinc.com
Glass flter products
Robu VitraPOR borosilicate glass flter
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
flter 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 flters can be provided in any shape up to
400 mm, in almost any thickness. Any cylindrical
or conical flter candle can be produced to
customer specifcations. The glass flters are
available in porosities ranging from 1 to 550 m,
following ISO and NIST standards. Each batch is
carefully tested to ensure uniformity. The sintered
glass flters can be used safely in applications
where operating temperatures reach 515C.
Andrews Glass Co.
Vineland, NJ
www.andrews-glass.com
Mobile, ductless fume hoods
Air 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 flter has been independently tested
to have 99.9 percent fltration effciency for
chemicals normally found in a typical chemistry
curriculum. The units exceed OSHA, ANSI, BSI,
and AFNOR safety standards.
Air Science USA
Fort Myers, FL
www.air-science.com
Imprinted liquid-dispensing
bottles
Menda HDPE Pure-Touch liquid dispensing
bottles are now available printed with the most
commonly used chemical names: Item 35395
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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 bottles
contents remain uncontaminated. Pure-Touch
pumps are a genuine Menda product and made
in America. Bottle capacity is 4 oz.
Menda
Chino, CA
www.mendapump.com
Thermoform machine
incorporates CIP system
Multivacs latest R 535 form-fll-seal system
simplifes and accelerates the cleaning process
for food processors, and provides enhanced
performance, ergonomics, and effciency.
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.
Multivac
Kansas City, MO
www.multivac.com
Residual gas analyzer family
The 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-flter technology offers precise
analytical capability with high contamination
resistance, high abundance sensitivity, and
detection capability to 5 ppb. Application-
specifc ionization sources are available to enable
system confgurations 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 Analytical
Livonia, MI
www.hidenanalytical.com
Autoclavable mechanical
pipettors
In 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 effciency. 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 calibrateno
opening tools are needed and only a few parts
need to be cleaned. The pipettors are equipped
with replaceable tip cone flters that give addi-
tional protection against contamination.
Biohit Oyj
Helsinki, Finland
www.biohit.com
ISO 14611-1 certifed cables
Igus Inc., the developer of Energy Chain
Systems, Chainfex continuous-fex cables,
and iglide plastic bearings, recently achieved
certifcations in cleanroom environments for both
its Chainfex 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 Chainfex
cables and Energy Chains provide customers with
off-the-shelf cable management solutions that
require no modifcations, leading to faster, easier
installations in applications for the electronics and
pharmaceutical industries, medicine technology,
and food processing.
Igus Inc.
East Providence, RI
www.igus.com
Spill detector
KD Scientifc 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, fash 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 Scientifc
Holliston, MA
www.kdscientifc.com
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Atomic force
microscopy accessory
Asylum Research, a manufacturer of advanced
atomic force microscopes (AFMs), introduces
the iDrive cantilever holder. The microscope ac-
cessory simplifes AFM fuid imaging and allows
auto-tuning of cantilevers in fuid. 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 feld. Multiple peaks that are
typically associated with piezo driven fuid 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 Research
Santa Barbara, CA
www.asylumresearch.com
Portable air sampler
The 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 airfow of 180 lpm
per head.
International PBI S.p.a
Milan, Italy
www.internationalpbi.it
Disinfectant for manual and
automated processing
Metrex 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, CA
www.metrex.com
Integral water
purifcation system
Millipore Corp. has announced the availability of
the new Milli-Q Integral water purifcation 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
Millipores 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 fow rate adjustable from drop-by-drop to
2 L/min. The fexible PODs can be adapted with
a choice of fnal polishers to remove specifc
contaminants, including pyrogens, nucleases,
bacteria, particulates and organics.
Millipore Corp.
Billerica, MA
www.millipore.com
Aseptic vial-flling equipment
To accommodate special handling for liquids
and lyophilized injectables, Flexicon America Inc.
introduces the FMB210 fller. It offers an aseptic
flling process that combines sterile containment
and gentle peristaltic dispensing action to safely
and accurately fll injectable products into vials.
Flexicon flling technology features a sterile fll
channel that ensures repeatable accuracy in fll
volumes. Since product comes in contact only
with the medical-grade silicone tubing and the
flling needle, there is no risk of product cross-
contamination between batches or between
product change-over. With only a simple change
of the tubing, fll 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, VT
www.fexiconamerica.com
Environmental monitoring
systems
RLE 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
frmware 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 (420 mA) that
provide variable information such as tempera-
ture, humidity, voltage, current, or pressure.
RLE Technologies
Fort Collins, CO
www.rletech.com
Proof of sterilization labels
LGInternational, 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 specifc sterilization procedures. LGIs 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 specifc 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.
LGInternational
Portland, OR
www.lgintl.com
Barrier-coated
non-woven fabrics
Jen-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, fuids, and most chemicals,
they can be made to exhibit specifc 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 frm
also coats, laminates, and metallizes a full range
of flms, foils, and papers with a host of resins
and offers print, slit, and rewind services. Jen-
Coat fabrics for medical products are made to
specifcation. Price quotations and samples are
available upon request.
Jen-Coat, Inc.
Westfeld, MA
www.jencoat.com
new literature
Lab safety products
VWR International has published its 20072009
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, LLC
West Chester, PA
www.vwr.com
Tubing and hose
selection information
Two 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 fexible 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 fttings
and clamps for attachment. NewAge Industries
Products & Services brochure gives an overview of
the companys tubing, hose, fttings, clamps, and
accessories. Products are listed by material with
each styleunreinforced, braid or wire reinforced,
overbraided, coiledhighlighted. The brochure
details sizes stocked as well as the many custom
options available, such as heat-formed shapes,
hose assemblies, and thermal bonding.
NewAge Industries
Southampton, PA
www.newageindustries.com
Updated gas and
fow control site
CONCOAs enhanced web site, www.concoa.
com, has been designed with a comprehensive
presentation of features and benefts 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 programsthe Regulator, Blender, Laser,
and Flowmeter Wizardsthat 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 CONCOAs technical sales engineers.
CONCOA
Virginia Beach, VA
www.concoa.com
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sales representatives
National Sales Manager
BARBARA KOVALCHEK
(603) 891-9296
barbarak@pennwell.com
Digital Media Sales Manager
BARBARA KOVALCHEK
(603) 891-9296
Exhibit Sales Manager
BARBARA KOVALCHEK
(603) 891-9296
Reprints
DIANE TROYER
(603) 891-9385
dianet@pennwell.com
List Rentals
BOB DROMGOOLE
(603) 891-9128
bobd@pennwell.com
United Kingdom, Scandinavia
AMANDA LOFTUS
+44 (0) 1793 641571
+44 (0) 1793 610001
amandal@pennwell.com
France, Netherlands, Belgium, Greece,
AndorraSouth Switzerland, Spain,
Portugal, Monaco
LUIS MATUTANO
33-1-39-66-16-87
33-1-39-23-84-18
luism@pennwell.com
Austria, Eastern Europe, Germany,
Northern Switzerland
JOHANN BYLEK
(49) 89 904 80 144
(49) 89 904 80 145
johannb@pennwell.com
Singapore, Malaysia, Indonesia,
Thailand
ADELINE LAM
65-6-836-2272
65-6-735-9653
alam@publicitas.com
Korea
KEVIN HWANG
(82) 2 3142 4151
(82) 2 323 5324
aimex@chomdan.co.kr
Japan
MANAMI KONISHI
(81) 3 3556 1575
(81) 3 3556 1576
manami.konishi@ex-press.jp
Taiwan
CINDY YANG
(886) 2 2396 5128
(886) 2 2395 9571
cindy@arco.com.tw
Italy
VITTORIO ROSSI PRUDENTE
(39) 04-9723548
(39) 04-98560792
vrossiprudente@hotmail.com
India
RAJAN SHARMA
91-11-6861113
91-11-6861112
rajan@interadsindia.com
Israel
DAN ARONOVIC
972-9-899-5813
aronovic@actcom.co.il
China, Hong Kong
ADONIS MAK
(86) 755-25988572
(86) 755-25988567
adonism@actintl.com.hk
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CleanRooms Call for Papers ....... 39 ......................... www.cleanrooms.com
CleanRooms Europe 2008 ............ 2.............. www.cleanrooms-europe.com
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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 MS 47
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Calendar
To announce your organizations upcoming conferences and meetings (date, location, and information), email: carriem@pennwell.com.
FEBRUARY 58
The Aseptic Filling Conference 2008. Danubius
Hotel, Regents Park, London, U.K. For more
information: www.iir-events.com
FEBRUARY 1415
INTERPHEX Puerto Rico 2008. Puerto Rico
Convention Center, San Juan. For more
information: www.interphexpuertorico.com
MARCH 17
PITTCON 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 1113
CleanRooms Europe 2008 Conference & Exhibi-
tion. Neue Messe Stttgart, Stttgart, Germany.
For more information: www.cleanroomseurope.
com
MARCH 1719
Food Safety & Security Summit 2008. Washington
DC Convention Center, Washington, DC. For more
information: www.foodsafetysummit.com
MARCH 1820
SEMICON China 2008. Shanghai New
International Expo Center, Shanghai, China. For
more information or to register: www.semi.org
MARCH 2529
Semiconductor 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 2628
INTERPHEX 2008. Pennsylvania Convention
Center, Philadelphia, PA. For more information:
www.interphex.com
MARCH 2628
PharmaMedDevice Conference and Exhibition.
Pennsylvania Convention Center, Philadelphia, PA.
For more information: www.pharmameddevice.
com
MARCH 31APRIL 2
2008 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 69
Food Automation & Manufacturing Conference
and Expo 2008. Sheraton Sand Key, Clearwater
Beach, FL. For more information: www.bnpevents.
com/FE/FAM/
APRIL 1215
Controlled Environment Testing Association
(CETA) 16th Annual Meeting. Crown Plaza Hotel,
San Antonio, TX. For more information: www.
cetainternational.org
APRIL 1418
Parenteral Drug Association (PDA) Annual
Meeting. The Broadmoor, Colorado Springs, CO.
For more information: www.pda.org
APRIL 2122
ESD Device/Design Seminar. ESD Association
Headquarters, Rome, NY. For more information:
www.esda.org
APRIL 2125
Hannover Fair/Microtechnology 2008. Hannover
Messegelnde, Hannover, Germany. For more
information: www.ivam.de
MAY 47
ESTECH 2008, 54th IEST Annual Technical
Meeting. Hilton Bloomingdale Indian Lakes
Resort, Bloomingdale, IL. For more information:
www.iest.org
MAY 57
SEMICON Singapore 2008. Suntec Singapore
International Convention & Exhibition Center,
Singapore. For more information: www.semi.org
MAY 57
19th Annual IEEE/SEMI Advanced Semiconductor
Manufacturing Conference (ASMC). Boston, MA.
For more information: www.semi.org
MAY 1215
2nd Annual International Electrostatic Discharge
Workshop (IEW). Port DAlbret, France. For more
information: www.esda.org
MAY 1821
The ConFab, semiconductor conference and
exhibition. Loews Las Vegas Resort, Las Vegas, NV.
For more information: www.theconfab.com
MAY 2829
International 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.InternationalP
harmaCongress.com
JUNE 15
Nano Science and Technology Institute (NSTI)
Nanotech 2008. Hynes Convention Center,
Boston, MA. For more information: www.nsti.org
JUNE 15
American 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 25
Medical Design & Manufacturing (MD&M) East.
Jacob K. Javits Convention Center, New York, NY.
For more information: www.mdmeast.com
JUNE 1518
21st international Symposium, Exhibit, & Work-
shops on Preparative/Process Chromatography.
Doubletree San Jose Hotel, San Jose, CA. For
more information: www.prepsymposium.org
JUNE 1720
BIO International Convention 2008. San Diego
Convention Center, San Diego, CA. For more
information: www.bio2008.org
JUNE 2325
2008 AAPS National Biotechnology Conference.
Metro Toronto Convention Centre, Toronto,
Ontario, Canada. For more information: www.
aapspharmaceutica.com
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__________________
MAY 1821, 2008
LOEWS 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 intimate
and 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 jayn@pennwell.com.
Semiconductor Device Manufacturing Executives: If you are a senior
level decision maker and would like to attend our event, please email
Luba Hrynyk at lubah@pennwell.com, or visit us at www.theconfab.com
to 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 its
arguably the best place for suppliers to network with chip makers in
the world it was one of the best third-year conferences Ive 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 by
providing opportunities to meet with top executives and to engage in
open discussions within an informal setting. The event is well organized
and 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 was
great. 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 and
your team for a flawless execution and logistic support to make our
whole experience so much more enjoyable.
COO AND CFO, CSMC TECHNOLOGIES CORPORATION
THE CONFERENCE:
Managing the New Economics
of Semiconductor Manufacturing
Hear 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 Manufacturers
Participate 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 Collaboration
Join your semiconductor manufacturing peers, suppliers and industry
thought leaders.
2005
THE CONFAB IS A HIT!
2006
THE CONFAB
A SECOND GREAT YEAR!
2007
ONE OF THE BEST
THIRD-YEAR CONFERENCES
PENNWELLS 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
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