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J U L Y / A U G U S T 2 0 1 3W W W . C E M A G . U S
TM
Water Tension CleaningMaterials Compatibility
ESD Control
Cleanroom SafetyFlexible Facilities
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Controlled EnvironmentsJULY/AUGUST 2013
Vol. 16No. 7
TABLE OF CONTENTS July/August 2013 www.cemag.us4
10 Flexible Production Platforms of the FutureThe future processes and facilities will be driven by the product, and by
economic and regional parameters, but the key will be flexibility.
14 ESD Control Using Adiabatic HumidificationSelecting an appropriate adiabatic humidifier can result in energy
efficiency, worker comfort, and increased productivity.
16 Key Considerations When Specifying CleanroomLightingCleanroom lighting design should provide the right amount of illumination
while also being appropriately gauged to the cleanroom classification.
18 Measuring the Speed of AirImproper air velocity rates can put a cleanroom at risk.
26 Engineering a Culture of SafetyWhile usually under the purview of an Environmental Health & Safety department,the facilities department cant ignore its role in maintaining a safe workplace.
28 Materials Compatibility in CleanroomsChemicals have the potential to interact with the product, and
not always in a desirable manner.
30 QbD Takes a Step Forward with ICH Q11New guidance represents the most recent example of the FDAs
commitment to the principles of QbD.
32Cleanroom Components Product Showcase
DEPARTMENTS
6 From the Editor19 Company Profiles34 Index
10
TM
Substrate Drying
Using Surface TensionGradient TechnologyAs the geometries of circuitry
shrink, the drying of the substrate
becomes a more critical step.
8
14
16
26
30
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Controlled EnvironmentsVol. 16 No. 7
6 FROM THE EDITOR July/August 2013 www.cemag.us
Automated ContaminationTim Studt, Editorial Director
[email protected] 973-920-7748Patrice Galvin, Editor
[email protected] 973-920-7652
MaryBeth DiDonna, Managing [email protected] 973-920-7045
Press Releases: [email protected]
EDITORIAL ADVISORY BOARD
Charles W. Berndt, C.W. Berndt Associates Ltd.
Ahmed A. Busnaina, PhD, NSF Center orMicrocontamination Control - Northeastern University
Scott Mackler, Cleanroom Consulting LLC
Gregg A. Mosley, Biotest Laboratories Inc.Robert Nightingale,Cleanroom Garments
Bipin Parekh, PhD, Entegris Inc.
Morgan Polen, Lighthouse Worldwide Solutions
Michael Rataj, Aramark Cleanroom Services
Raymond K. Schneider, PEConsultant and Faculty Member, Clemson University
Howard Siegerman, Ph.D.Siegerman and Associates LLC
Matt Smith, PE, PMP, CH2M HILL
Scott Sutton, PhD, Microbiology Network Inc.
Art Vellutato, Jr. , Veltek Associates Inc.
Bob Vermillion, CPP/Fellow,RMV Technology Group LLC
ART AND PRODUCTION
Deb Jorgensen,Art [email protected] 973-920-7119
Chris DeCellio, Production [email protected] 973-920-7159
Alice Scofeld,Ad Traf c [email protected] 973-920-7661 Fax 973-607-5631
ADVERTISING SALES
Elizabeth Vickers, [email protected] 631-241-6161
Luann Kulbashian,Associate Publisher/Sales [email protected] 603-249-9424
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Products and processes surrounding cleanrooms
continue to decrease the dimensions of their fea-
ture sizes, thereby increasing the potential issues
surrounding contamination, particularly in semi-
conductor-based processes. While most traditional
contamination issues in a cleanroom are operator-based,
these new smaller feature size processes are increasingly
being integrated and automated. As such, these automated
processes and equipment have to be examined for their
ability to generate contaminants on their own.
Obviously, automation system equipment manufactur-
ers are aware of these potentialities. Non-gassing lubricants,
vacuum systems, non-corrosive materials, and shipping wrappers are just a few of the
measures used to minimize contamination. Long-term warm ups and operation in
vacuum-based environments prior to installation are also recommended. New instru-
mentation for finding these new smaller contaminants are also required to ensure that
certification and validation (also newly written) specifications are met.But the complexity of these new systems is also increasingas seen with 450-
mm semiconductor wafer sizes with sub-nanoscale features. The same effects are
likely to be valid for biotech systems and products based on DNA structures.
Thats the technology of now. But, what about the technology of tomorrow? The
processes will assuredly be more complex. The feature sizes will be even smaller.
And the cleanliness requirements will be more demanding. Device, equipment,
and process designs will most likely need to change. New assembly procedures and
enhanced instrumentation will also need to be developed. Much of this new instru-
mentation will likely be based on non-invasive optical techniques to avoid the cre-ation of contamination on its own.
For life science applications, self-assembly techniques are already being studied,
but their integration and packaging into biological drugs will still need to be devel-
oped, although the scales needed for those may be obtainable with current exist-
ing tools. Production-level analytical tools for ensuring the quality of the products
being created are not developed and will need to bethe potential ramifications of
biologics being either poorly produced or misproduced are critical.
For solid-state applications, the integration of smaller-scale features will likely be
combined with three-dimensional structures making production and assembly even
more difficult (and contamination even more critical), requiring increased levels of
precision with new automation systems. Probes for measuring the accuracy of these
3-D devices should be readily obtainable with current technologies.
Of course, the vast production of cleanroom-based products will still be at the
level of current technologies, measurements, and contamination control. These new
devices and systems are the next generation of products and processes and likely
more than 10 years away from realization. But they will become the bulk of prod-
ucts and processes for the next 20 years after their development in the 2020s with
increasing production volumes each year. New automation systems as of now not
even conceptualized will be the basis of their implementation.
Tim StudtEditorial Director
TM
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As the geometries of circuitry shrink, the drying of the substrate becomes a more critical step.
Tom VukosavPresident
MicroTech
Fremont, Calif.
In the production of microelectronics, substrate drying to
obtain a clean, contamination-free surface often centers on
the term Marangoni drying.
The Marangoni effect is the mass transfer along an interface
between two fluids due to surface tension gradient. Since a liq-uid with a high surface tension has higher cohesive forces than
one with a low surface tension, the presence of a gradient in
surface tension will naturally cause the liquid to flow away from
regions of low surface tension. The general effect is named after
Italian physicist Carlo Marangoni, who studied it for his doc-
toral dissertation and published his results in 1865 and was first
documented as a drying method by University of California,
Berkeley scientists in the early 1960s.
The Marangoni drying technique uses a volatile organic
compound with a lower surface tension than water that isintroduced in the vicinity of the substrate as it is slowly with-
drawn from the water. As the small quantity of alcohol vapor
comes into contact with the refreshed water meniscus, it dis-
solves into the water creating a surface tension gradient. The
gradient causes the meniscus to partially contract and assume
an apparent finite angle via a Marangoni flow. This causes the
thin water film to flow off the substrate, leaving it dry. The
Marangoni flow also removes contaminants and particles.
Aqueous cleaning in microelectronics has been increasinglyused due to stricter environmental regulation of organic clean-
ing agents, the widespread use of aqueous processing in the
semiconductor, flat panel display, and optics industries, plus
the increasing need for cleanliness brought about by decreases
in pattern geometries and the push for increased yields. These
ever-increasing demands dictate the need for an ultra-clean
drying process that removes residual water and contaminants
and mitigates watermark formation from critical surfaces.
This drying method is fundamentally cleaner and more
efficient than those using heat, forced air, or high-speed rota-tion of the substrate, like the spin rinser dryer used for so
many years in semiconductor fabs around the world.
Industry needs evolveSemiconductor device manufacturing tends to be at the lead-
ing edge of microelectronic development with the continued
advancement of Moores Law and constantly shrinking wafer
geometries. New drying methods for these smaller geometries
have evolved for several reasons.As geometries continue to decrease, the patterned struc-
tures become more fragile. Fragile structures can be easily
damaged by high-speed drying methods like the spin rinser
dryer. Dimensions with deeper trenches and higher aspect
ratio structures also dictate that surfaces are clean and con-
tamination-free. As geometries shrink below the sub 100-nm
level, both metal and particulate contamination becomes more
critical. Also, high speed rotation drying can chip the wafer
edge, resulting in particle contamination. All of these process-ing demands have increasingly escalated the use of surface ten-
sion gradient drying in semiconductor manufacturing, as well
as MEMS and solar devices.
Advantages of surface tension gradient dryingSince this method of drying completely eliminates water
from the surface of a substrate, no watermarks (a type of
contamination in themselves) are left on the surface (Figure
1). The newer, more evolved dryers have low particle counts
and only trace levels of organics compared to both spin rinserdryers and IPA vapor dryers. Drawing the water away from
the surface of the substrate with gravity results in no feature
damage, no edge chipping, and no substrate breakage. Because
there are no high-speed spinning steps in the drying process,
ESD (electrostatic discharge) damage to the wafer is virtually
eliminated; and the dryer produces very low metallic contami-
nation levels (Table 1).
Besides the elimination of watermarks on hydrophilic,
hydrophobic, and combination films, surface tension drying
provides other benefits. This drying method does not place
any mechanical stresses on the substrate. The technique workswell on practically any flat substrate. No surfactants are neces-
sary to change the substrate properties to enhance drying per-
formance. Compared to traditional vapor dryers, gradient dry-
ers consume very little IPA, reducing chemical consumption.
8 CLEAN APPLICATIONS
Substrate Drying Using Surface
Element Spec Limit Dryer ResultsAl 50 63
Mg 5 2.9
Ca 40 18.7
K 5 0.01
Na 20 14.9
Cu 2 1.7
Fe 5 1.4
Ni 3 0.6
Zn 3 0.7
Cr 2 0.05
Table 1: Selected Metal Contamination
VPD-ICP-MS Analysis 1 x E9 atoms/cm2
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Additionally, because the low-surface tension IPA does not
react with HF, these chemicals can be added in low concentration
to the rinse water to affect the final properties of the substrate.
For examples, the HF will keep the silicon surface hydrophobic
and facilitate drying, and also prevent watermark formation.
ApplicationsThere are several applications of surface tension gradient dryingthat uniquely take advantage of the benefits of this drying tech-
nique. Below is a quick summary of three.
1. Very thin substrates
Stiction from the rinsing process can pull the thin wafers
together, causing the wafers to stick to one another as they are
pulled from rinsing baths and placed into a drying chamber.
This is especially a concern when rinsing hydrophilic wafers were
the capillary action of the water pulls the wafers together. Once
between the wafers, the water can increase the chance of hydro-gen bonding of the water to the wafer surfaces, making it very
difficult to debond the wafers from one another. To prevent this
occurrence, the Marangoni dryer has an overflow rinse before the
drying step; this prevents the wafers from being pulled out of the
rinsing bath. The rinse water is used as the higher surface tension
liquid of the Marangoni dryer. The IPA layer on top of the water
bath displaces the water (Figure 2), lowering the surface tension,
and thus preventing the stiction from occurring. Wafers as thin as
80 m can be dried. MEMS, solar, and other thin wafers will ben-efit from this drying technique.
2. Substrates with significant topology
High aspect ratio feature drying can be facilitated by using a
low surface tension gradient liquid. Isopropyl alcohol vapor will
effectively dry the deep contact holes or vias of these structures,
but at the expense of leaving residue at the bottom of the trough,
because the IPA does not dissolve the residue. By drying with the
Marangoni method, not only are the deep
features dried from the displacement of the
water, but when the water is displaced, it
retains the contaminants from the bottom
of the feature, whether it be silicates orpost-etch reside in the form of particles.
Additionally, pattern collapse of
high aspect ratio features such as lines,
cantilever structures, or freestanding
capacitors used for DRAM fabrication
can succumb to stiction. The use of a
low surface tension fluid in the drying
process can help mitigate the stiction
in the same manner as thin substrates.
In this case, less stress is placed onthe features, and they do not collapse
when being removed from the rinsing
tank.
3. Combination hydrophobic and hydrophilic surfaces
Almost all device types have some layers to be dried that
are a combination of hydrophobic and hydrophilic surfaces,
for example after the delineation of shallow trench isolation
or prior to gate oxide formation. When this combination of
surface energies exist, there is a high probability of watermarkformation on the hydrophobic surface, especially at the inter-
face of the two surface energies, where droplets of water are
hard to remove. When these droplets evaporate, they leave
a watermark. When using a spin-drying technique, this is
very pronounced. By using a Marangoni dryer, there are no
remaining droplets, thus no remaining watermarks. The low
surface tension IPA wets both the hydrophobic area and the
hydrophilic area and can prevent the nucleation of the water
droplet, providing a watermark-free surface.
ConclusionWhen integrated with cleaning and rinsing of the substrate, surface
tension gradient drying can provide a one-step process of molecu-
lar level drying for such applications as the fabrication and cleaning
of ICs, solar cells, fuel cells, MEMS, and disk drives.
Tom Vukosav has been president of MicroTech, also known
as MT Systems, since its inception. A semiconductor industry
veteran, he has held management positions for several wafer pro-cessing equipment companies over the past 30 years. MicroTech
has licensed the patent rights of Marangoni drying from current
owners to develop and manufacture a surface tension gradient
dryer, called The Gradient Dryer. www.microtechprocess.com
9July/August 2013 www.cemag.us
Tension Gradient Technology
Figure 1: IPA
concentration
gradient induces
surface tension
gradient drying
without water-
marks.
Figure 2: Cross-sectional drawing of the surface tension gradient
drying process.
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Flexible Production PlatformsThe future processes and facilities will be driven by the product, and by economicMaik W. JornitzChief Operating
Officer
G-CON
Manufacturing LLCCollege Station,
Texas
With an increasing diversity of therapies and drug
product ranges, facility designs also require diver-
sification. Inevitably, the facility designs of the
future will not be a legacy of the known, but a uti-
lization of different tools from the toolbox of facility layouts.The therapeutic drug manufacturing industry has realized that
change is needed; flexibility in clinical material and full-scale
production is necessary to become more efficient and agile.
The topic of flexible facilities has become a hot button issue
and has received attention from industry experts and confer-
ence organizers alike. Flexibility, though, is often used in com-
bination with modular, which does not necessarily mean what
the industry expects. This article will review different facility
layouts and flexible design opportunities.
The need for flexibilityFacility flexibility has become a frequent discussion point
over the last few years1,2,3 and the question arises: Why
the focus on flexibility? The answer for this demand lies
within a multitude of factors, one certainly being the need to
increase capacity utilization to reduce the cost of goods sold
(COGS). Other reasons are to ramp capacity up and down in
accordance to demand or to utilize the process environment
for patient-by-patient basis treatments. More biopharma-ceutical drug product manufacturers are looking into enter-
ing specific global regions with smaller production facilities
instead of utilizing a central large-scale site and shipping the
product under cold chain scrutiny to different global regions.
Others want to secure raw material supplies, like excipients
or active ingredients, and therefore build sites instead of
relying on sub-suppliers. Or think about mobile sites, which
could be deployed from location to location, depending on
the demand base. All of these needs would be easier fulfilled
when the facility shows flexibility in purpose, design, deploy-ment, and implementation. Flexibility does not necessarily
mean one looks solely at the cost per cleanroom area, but the
total cost of a facility, time-to-run, repurposing, and product
life cycles. In addition, the typical one drug product clas-
sification industry is switching to other drug treatment pos-
sibilities and looks into the future for example, cell thera-
pies. The spread of facility designs is widening to fulfill the
different application requirements. The end-users requested
new choices in facility layouts and vendors developed suchchoices, from classical large scale brick and mortar facilities
to small-scale isolator solutions. However, when looking for
flexibility in a facility layout, one should consider the differ-
ent options to fully understand whether it meets the require-
ments or not. Flexibility needs to be defined by the end-user
and only then appropriate choices can be made, including
total cost and purpose.
The multitude of facility designsBrick and mortar environments are nowadays called tradi-
tional facilities and often represent large-scale, one product
facilities. These facilities are dedicated to a single product or
product line, even to the point that the facility has only one
product lifespan. Sometimes it is said that such-and-such
product financed the site,i.e., the site is commonly built
when the product is close to approval. It can then take up to
four years to have the facility up and running. There are alter-
native facility architectures availablefor example, modularcontainer and modular stick-built. These facility systems
have the advantage to have a time-to-run of half the time of
a traditional facility. The container solutions are planned and
equipped off-site and assembled at the future facility location.
Once assembled, these production site systems convert very
much into a traditional site. Similarly, modular stick-built
facilities, which are built by framing and wall-paneling a spe-
cific area, resemble a traditional production site format. The
stick-built cleanroom area can be erected in an inexpensiveshell space, which allows fast track implementation. For this
approach, the time consuming activity becomes the validation
of the area and the HVAC superstructure. Other, newly intro-
duced cleanroom options are isolator based or autonomousunit based systems. When one describes flexible cleanroom
designs, these two options are easily scalable with the potential
for multi-product use.
All of these designs have their purpose, benefits, and dis-
advantages. Most of these designs do not represent a single,
optimal solution, but are utilized in a hybrid mode. In some of
the applications, focus is on containment to protect the environ-
ment and personnel. In these instances, a hybrid of isolators
within an autonomous unit or modular environment would bemost suited. In other instances, process stream and space utiliza-
tion optimization is required, which can be done by segregation
forms and interconnections between the individual spaces. Once
10 MODULAR CLEANROOMS
Flexibility does not mean one looks solely at the cost
per cleanroom area, but the total cost of a facility,
time-to-run, repurposing, and product life cycles.
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to embedding utilities piping and HVAC ducts in the interspace
between the physical module limits and the suspended ceilingmaking refurbishment, if required, extremely complicated.5
A flexible factory means that the flexibility is available dur-
ing the planning and build phase, but moreover during utili-
zation. Flexibility of facilities is often related to two major fac-
torsmulti-product processing and scalability.6 Multi-product
use in a facility means the surrounding environment needs to
be easily cleanable and sanitizable. This includes the HVAC
system which can only be achieved when the cleanroom space
has separate air handling and HVAC units. Scalability means
meeting capacity demands. The facility may need to be able
to ramp-up fast if the drug demand is increasing and as easily
ramp-down, if the demands are reduced. That does not mean
that the production processes are out of controlthey are
just processing different demands of drug product at the same
quality. Therefore, the process and surrounding environment
requires being robust but duplicable. Other factors are mobil-
ity and achievable product-lifecycles. In some instances, one
may want to move a purification process dedicated cleanroom
system into a different position in the process or to a decon-tamination area. In others, the entire facility may be moved to
a different area or region, and the cleanroom areas are repur-
posed. Mobility of the cleanroom system is required in both
scenarios, which cannot be done with a fixed build cleanroom
area. Isolator based or autonomous systems run independently(Figure 1) and not necessarily from a centralized air handling
system. An autonomous system is a cleanroom box that
has typical cleanroom design, finish, supplies, etc., but has its
own redundant air handling system and quick connects for
the supplies.
This does not mean that these systems are an obvious choice
the best option always depends on the application, the purpose, and
the scope of the facility. A proper evaluation of all options available to
the end-user needs to be done, which probably often ends in a hybrid
solution, but hopefully an optimal solution.
The future of facilities
Facilities as we know them from the past will still exist in future
however, not with the prevalence as seen before. Current
drug manufacturers and engineering firms alike will have the
ability to make choices from the increasing portfolio of facility
components and designs. As with every aspect in manufactur-
ing processes, there is no one-size-fits-all system, neither in an
equipment piece nor unit operation, entire process, or produc-tion site. The future processes and facilities will be driven by the
product to be produced within the site by the economic as well
as regional parameters, but the key will be flexibility. Hopefully,
regulators will support such optimization and the potential for
facility redundancy by using the cookie cutter principle and
being able to ramp capacity up and down as needed. Ultimately,
quality will not be compromised, especially with cleanroom
segregation, increasingly compact air handling systems, contain-
ment using single-use technology, but most of all creating anenvironment minimizing any human failures or effects.
References
1. H. L. Levine, J. E. Lilja, R. Stock, H. Hummel, S. D. Jones
(2012) Efficient, Flexible Facilities for the 21st Century,
BioProcess International, 10(11).
2. G. Hodge (2009) The Economic and Strategic Value of
Flexible Manufacturing Capacity. ISPE Strasbourg Conference,
2829 September 2009, Strasbourg, France.
3. A. Shanley, P. Thomas (2009) Flexible Pharma: Puzzling Outthe Plant of the Future, PharmaManufacturing.com.
4. P. Thomas (2013) On Simplicity, Single-use and Shire,
Pharmaceutical Manufacturing, pp. 12-14.
5. A. Pralong (2013) Single-use technologies and facility layout
a paradigm shift, Biopharma Asia Magazine, Vol 2, Issue 1.
6. R.B. Holtz, D. Powers (2012) Integration of a Single-
Use Platform Process within an Innovative Facility Design,
BiopharmInternational.com
Maik W. Jornitz is Chief Operating Officer for G-CON
Manufacturing LLC, manufacturer of G-CON PODS.
www.gconbio.com
12 MODULAR CLEANROOMS
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ESD Control Using AdiabaticSelecting an appropriate adiabatic humidifer can result in energy e ciency, workercomort, and increased productivity.
Ido Goldstein
Chief Engineer
Smart Fog Inc.Reno, Nev.
A
ir conditioning, heating, and fresh air intake during win-
ter conditions and dry summer months cause electro-
static discharge (ESD) in cleanroom environments. ESD
can result in costly damage to the equipment and prod-
ucts manufactured, as well as delays or downtime. The following
looks at some of the forms of ESD control and their atributes.
De-correlation air atomizing: A de-correlation type systemprovides a humidification which generates equal sized micron
droplets with equal spacing that do not attract to each other
but oxidize into the air. It is completely non-wetting and forces
the humidity into the air evenly and completely.
Droplet size: 4.2 micronsPowered by: Standard air compressor
Regulation required: Not required
Installation: In-room and in-duct
Air and water atomizing: Air atomizing humidifiers usecompressed air to break down the water droplets in the nozzle. It
provides uneven droplets between 7 to 20 microns.
Droplet size: 7 microns
Powered by: Regulated air compressor and requires water pressure
Regulation required: Compressed air and water pressure
regulation required
Installation: In-room only
High pressure: High pressure water pumps push waterthrough miniature holes which are sprayed into the air. The
miniature holes can clog and require maintenance of the
nozzle and water pump, and duct installation requires droplet
filters and drainage.
Droplet size: 10 to 20 micronsPowered by: High pressure pump
Regulation required: Water
pressure regulation is required
Installation:In-room and
in-duct
Ultrasonic: Ultrasonic typehumidifiers use a submerged
vibrating disk to create a high-frequency oscillation, dispers-
ing small water droplets that
travel a short distance into
the air.
Droplet size: 5 to 20 microns
Powered by: Vibrating disk
Regulation required: Not required
Installation: In-room and in-duct
Centrifugal: Centrifugal humidifiers deliver supply waterto a fast-spinning disk that fractures water into large uneven
droplets, which requires a fan, warm air, and high ceilings to
distribute the humidity and evaporate the water. This type of
humidifier is not recommended for cleanroom use.
Droplet size: 20 micron+
Powered by: Spinning disk
Regulation required: Not required
Installation: In-room only
Wet Media: Wet media humidifiers use a water absorbingmesh placed inside a duct or AHU airstream. It can be difficult
to achieve a non-fluctuating relative humidity control. A wetmedia type humidifier is not recommended for cleanroom use.
Droplet size: No droplets, as the water evaporates
Powered by: Water pump
Regulation required: Not required
Installation: In-duct only
System selectionWhen selecting a humidification system for a cleanroom to
remove ESD, it is recommended to take the following factorsinto consideration.
Installation in the room or in the duct?
Humidification systems can be installed in the duct as well as
14 CLEAN OPERATIONS
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Humidificationdirectly in the room. Some technologies create larger droplet sizethat may wet or create condensation on sensitive equipment.
Adiabatic humidifiers that can be installed inside the duct:
De-correlationa atomizing can be installed in the duct and
on the wall.
Air atomizer, high pressure water, ultrasonic, and wet media
all need special ducts with a drain and fan.
The humidification system must not introduce any mineral
or particulates into the space.
When water evaporates any minerals present in the water can
shoot out as white residue dust. To avoid this, install a water
filter system. De-correlation air atomizing technology, air atom-
izing types, and high pressures system can use a filtered water
system. For humidifiers using compressed air, there must be air
filters installed inline to filter any particulates or oil from the
compressed air going into the nozzle.
What is the annual maintenance cost involved?
If the cleanroom requires 24/7 ESD control, choose a humidi-
fier that does not require a system shut-down to conduct
maintenance. Sizing the system correctly and injecting the
correct capacity of water into the air ensures correct relative
humidity control.
The minimum required humidity for eliminating ESD is
30%. However, if you are already installing a humidification
system, why not use it to make better conditions for the people
who work in the space all day? Maintaining 50% relative
humidity level can make the human body feel better and be
more productive.
The key condition for the adiabatic humidifier to achieve
100% ESD elimination is the ability to maintain non-fluctuat-
ing humidity. The humidity level should not fluctuate more
than plus/minus 1% throughout the controlled environment.
Wetting and condensation causes fluctuation and uneven
humidity levels and should be avoided. Maintaining the exact
amount of water content in the air at all times will ground all
the charges and maintain a static-free environment.
Ido Goldstein is Chief Engineer at Smart Fog Inc. He has over
20 years of experience in the humidification market.
www.smartfog.com
15July/August 2013 www.cemag.us
Minncare
Dry Fog
Solutions
Mar Cor PurificaWLRQFor more info visitwww.mcpur.comor [email protected]
Dry Fog System Minncare Cold Sterilant
The Safest & Most Effective Clean RoomDisinfection Procedure Available
Mini Dry Fog System
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Key Considerations When SpecifyingCleanroom lighting design should provide the right amount of illuminationJamie PearsonSenior Value Stream
Manager
Acuity BrandsLighting
Atlanta, Ga. S
pecifying lighting systems for cleanroom facilities
requires considerations beyond energy and maintenance
savings. While lighting for cleanrooms should be energy
efficient and provide proper illumination for the task at
hand, it is crucial that lighting coordinates with air-supply sys-
tems and minimizes any chances for contamination.
The first step to identifying what lighting solution can be
utilized in the cleanroom facility is determining the ISO clas-
sification. The higher the ISO classification, the greater the
number of particles allowed into the controlled environment.
This means there will be fewer air filters taking up space
in the ceiling. In the most stringent cases, the entire ceiling
must be covered with filters to allow the absolute minimum
amount of particles into the environment.
Airflow systems create lighting challengesEverything in the cleanroom, including the lighting fixtures,
is designed to ensure successful air filtration and maintain
the laminar airflow in a contamination-free environment.
Depending on the function of the controlled environment,
a cleanroom will use either HEPA or ULPA filtration. These
air-filtering systems are typically an expensive component
and one of the first to be considered in construction. They
take up a majority of the ceiling space, which leaves a real
challenge for lighting the environment.
Hours of thorough research and design are required to
create cleanroom lighting fixtures that maintain the integrity
of the space and work effectively with the HVAC system.
Regardless of the industry, every cleanroom lighting design
should be virtually maintenance-free and provide the right
amount of illumination.
Common fixture stylesThe need for multiple air filters in cleanroom facilities leaves
minimal space for light fixtures. There are three common
fixture styles for cleanrooms that maximize the use of the
space: recessed troffers, surface-mount fixtures, and surface-
mount teardrop fixtures. These are best-suited for use in
cleanroom facilities, depending on ISO classification.
Recessed troffers: These fixtures are ideal for cleanrooms
designated with an ISO 8 to ISO 5 classification because
they have enough space in the ceiling and plenum. While
rooms with an ISO 8 and ISO 7 classification have more
space in the plenum than rooms with a classification of ISO
6 or ISO 5, both environments can use recessed fixtures.
Environments with these classifications are typically elec-
tronic assembly, pharmaceutical processing, semiconductor
manufacturing, and chemical lab facilities.
Surface mounts: For more demanding environmentsthose
with ISO 3 and ISO 4 classificationssurface-mount fixtures
can be installed below the ceiling plane. Because of the high
air-filtration level required, there typically is not enough ple-
num space for recessed troffers so surface-mount fixtures are
especially efficient.
Surface-mount teardrops: Surface-mount teardrop fixtures
are suitable for controlled environments with an open-area
design and moderately demanding classifications of ISO 5
and ISO 4. These fixtures are mounted to a 2-in.-wide ceil-
ing grid and are suitable for individual or continuous row
mounting. The aerodynamic shape of the teardrop fixture
minimizes any disturbance of the laminar airflow.
Achieving effective light qualityIn addition to becoming familiar with the fixture styles for
each ISO classification, it is important to know what to con-
sider when selecting the exact fixture. Understanding what
lighting features are most important for cleanroom environ-
ments will help determine the most efficient solution thatrequires the least amount of maintenance possible.
Light levelsIn most cases, cleanroom facilities produce and/or test small
objects. Pharmaceutical and semiconductor industries, for
example, typically use cleanrooms to manufacture small pills
and computer chips, respectively.
Lighting fixtures must provide a high level of illumination
so employees have enough light to carefully handle small
components. Illumination levels may vary depending on the
different process areas within the cleanroom, so it is impor-
tant for the specifier to review each process area to determine
the illumination level required for each task.
16 CLEAN ENVIRONMENTS
The need for more energy efficient and
reduced maintenance options meansadvancements in LED luminaires for
cleanrooms are on the horizon.
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Measuring the Speed of AirImproper air velocity rates can put a cleanroom at risk.MaryBeth DiDonnaManaging Editor
A
ccurate measurement of airflow in a cleanroom is vital
to making sure that the facility is up to code and func-
tioning properly. Precise air velocity measurement can
be used to reveal proper or improper performance of an
airflow system, and steps can be taken from there to correct any
potential problems.
Why measure?Air velocity measurement in cleanrooms is often one of the
indices monitored for cleanroom performance in smaller
rooms or facilities, says Rick Gastner, Technical/Safety Manager
at ENV Services Inc., Hatfield, Pa.
There are several reasons for measuring airflow in a
cleanroom, one being verification of the cleanroom per-formance. Closely tied to that is the air changes per hour
(ACH), with different minimums required for different ISO
classes of cleanliness, or in the case of USP 797, different
minimums required for different room usage.
Measuring velocityAir velocity measurement is usually accomplished by taking
velocity (linear) readings on a grid not to exceed 12 inches
apart, starting 6 inches in from the edges of the filter (per IST-
RP-CC002). Although a single point thermoanemometer (hot
wire) reading can be done at each point, the instrument of
choice is usually the square pitot array read by a micromanom-
eter. This instrument covers an area of 1 square foot, taking
multiple readings and averaging them into one. Gastner notes
that, Unfortunately, measuring velocity this way is not the
most accurate measure of airflow from the filters. The velocity
measurement grid referenced in the standard is 12 inches off
the filter face, or as agreed upon. Most square pitot arrays come
with an assortment of stand-offs, allowing measurement at 2inches, 6 inches, or 12 inches off the filter face, giving you dif-
ferent velocities at different distances. The air exiting a filter in a
cleanroom ceiling will pull air from around it off the ceiling and
entrain it into the airflow, skewing your reading.
The most accurate way to measure airflow in a clean-
room is with a balometer and shroud, taking a volumetric
measure. The frame of the shroud has gasketing on it to
ensure a complete seal around the perimeter of the filter for
accurate measure, says Gastner.
There are new velocity measuring instruments commer-
cially available using infrared technology, and other multiple
sensor arrays with either thermistor beads or mini hotwires,
but they can be extremely expensive. Gastner notes, Until
such time as the standards that apply to the industry require
a new technology, or even recognize the new instruments as
legitimate and valid, the best approach is to verify with the
owner of the facility what they want used for the testing, and
have them sign off on that choice.
Gastner cautions against quick inspections, however.
Although handheld monitors exist, performing spot
checks is not a valid overall method of assessing room per-
formance. Ductwork monitors are normally placed in the
ducts by the HVAC crew as a means of monitoring the AHU
performance and just one more performance index to moni-
tor. The duct monitors are more closely tied to duct pres-
sures and duct velocitiesand now youre getting in to static
pressure, velocity pressure, total pressure, and how a velocitypressure equates to a velocity independent of the duct size,
per the Industrial Ventilation handbook.
Measuring airflow in a biosafety cabinet is an altogether
different application. Hood velocities differ from cleanroom
velocities, Gastner says. In a laminar flow hood, the veloci-
ties are normally taken on a vertical plane, 6 inches off the
filter face (or diffuser screen), starting 6 inches in from the
edges, on a grid not to exceed 12 inches apart. In the case of
a hood, the air exiting the filter has a surround, or a struc-
ture that directs the air in a laminar fashion until it reaches
the front face of the hood, at which point it diffuses into the
room. On a lone ceiling terminal filter, the air tends to dif-
fuse the moment it exits the filter and gets hard to measure
accurately.
Monitoring performanceGastner suggests that velocity or volume be checked periodi-
callynormally, every six monthsto help gauge the perfor-
mance of the room. However, a drop in either area will beaccompanied and evidenced by a corresponding drop in room
pressure relative to the outer area or next room.
The way room performance is monitored depends on
several factorssize of the room or facility, capacity of
the AHU (air handling unit), length of duct runs, etc.,
he says.
Doing whats right for your cleanroomGastner adds a disclaimer that this is a simplified overview of
air velocity measurement, and not specific enough to warrant
changing an approach to cleanroom performance monitoring.
Consulting with an expert is advisable when evaluating the
process and options.
18 FACILITY MONITORING
A
19July/August 2013 www.cemag.us
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2013
CompanyPROFILES
Welcome to this yearsCompany Profiles. Here you
will find information on select
businesses that provide clean-
room equipment and services.
Berkshire Corp. .........................20
Great Barrington, Mass.
www.berkshire.com
Contec Inc. ................................21
Spartanburg, S.C.www.contecinc.com
Crane Composites Inc. ...............22
Channahon, Ill.
www.cranecomposites.com
EMD Millipore Corp. ..................23Billerica, Mass.
www.emdmillipore.com
Lighthouse Worldwide..............24
Fremont, Calif.
www.golighthouse.com
Veltek Associates Inc. ................25
Malvern, Pa.
www.sterile.com
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21
Contec, Inc., is a leading manufacturer of contamination con-
trol products for mission-critical cleaning in manufacturing
environments worldwide. For 25 years, Contec has provided
solutions to customers across many industries including bio-
medical, pharmaceutical, medical device, microelectronics,
optics, semiconductor, data storage, automotive OEM and
aerospace. Meeting customer
needs in all these markets and
exceeding customer expectations
are part of our core values at
Contec.
So what makes Contec stand
out? Why should you choose
Contec for your contamination
control needs?
INNOVATION: As a long
established leader in custom
designed cleaning products forspecific applications, many of
our products were developed at
customer requests. We take pride
in developing innovative products
that not only deliver outstanding
performance but are cost-effective
for our customers.
TECHNICAL SUPPORT:
Contec has the largest, most experienced sales team in the criti-cal environment industry and a technical support team with
over 100 years in critical environment solutions. Contec indus-
try experts provide unmatched technical training and customer
seminars.
GLOBAL SCOPE AND DUAL MANUFACTURING
CAPABILITY: Contec owns and operates state-of-the-art
manufacturing facilities in Spartanburg, South Carolina and
Suzhou,
China, and
has additional
distribution
centers in
Toledo, Ohio
and Europe.
Contec sales
representatives
and techni-
cal specialists
are strategi-
cally located
in North
America,
Europe and
Asia. These
facilities andteam members give us the ability to provide products and sup-
port to multinational customers with global needs.
QUALITY: Contec manufacturing facilities in the US andChina are ISO 9001:2008 registered. As a vertically integrated
manufacturer, Contec controls more of the manufacturing pro-
cess than any of our competitors.
BROAD CAPABILITY AND PRODUCT LINE: Our exten-
sive product offering includes knitted, woven and nonwoven
wipes, presaturated wipes, sterile and non-sterile wipes, mop-
ping systems, wall washing systems, disinfectants, sponges and
swabs for cleanrooms and controlled environments.Contec, Inc.
525 Locust GroveSpartanburg, SC 29303
+1 (864) 503-8333
1 (800) 289-5762
www.contecinc.com
Founded: 1988
Celebrating 25 years of Innovation
Manufacturing Locations:
North America Spartanburg, SC
China Suzhou, China
Europe- Vannes, France
Contec, Inc.Mission Critical Cleaning and Contamination Control
2013 Company ProflesJuly/August 2013 www.cemag.us
Saturated with Isopropyl Alcohol, PROSAT Sterile wipes are ideal for
cleaning applications in pharmaceutical cleanrooms.
Contec manufactures a wide variety of mops for cleaning
and disinfecting floors, walls and ceilings.
Contec offers low endotoxin wipes, which minimize the introduction
of pyrogens into sterile environments.
Contec knitted polyes-
ter wipes are available
dry, sterile and
presaturated to meet
the needs of many
different industries.
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22 2013 Company Profles
Crane Composites, Inc.Fiberglass Reinforced Plastic FRP Panels
Crane Composites, Inc.
23525 W EamesChannahon, IL 60410
Phone: 1 (800) 435-0080
1 (815) 467-8666
www.cranecomposites.com
Crane Composites Inc., a subsidiary of Crane Co. (CR - NYSE),
is the worlds leading provider of fiber-reinforced composite
materials. We combine our understanding of customer needs
with our expertise in materials, process and technology to
deliver solutions that replace traditional metals and woods. Our
composite products offer superior performance characteristics,
such as strength, durability and minimal weight. Since 1954,
we have been using new technologies to pioneer products into
industrial and commercial applications, while earning numer-
ous patents and a reputation for industry leadership.
Our mission statement is to be a performance driven orga-
nization, committed to being a global leader in providing high
quality composite materials. We partner with customers and
suppliers to deliver innovative, industry-leading solutions. And
we are committed to Operational Excellence and to Crane
Values as our path to profitable growth for the benefit of our
employees and stakeholders. You can depend onCrane Composites for in-service support. Our
extensive product support program is imple-
mented at facilities worldwide, with a high-
caliber staff that is focused on the needs of the
customer.
The industry leading Fiberglass Reinforced
Plastic panel, Glasbord with Surfaseal, is widely
used throughout the construction and build-
ing materials industries. FRP offers a numberof significant features including resistance to
mold, mildew, and bacteria growth, high impact
strength, high moisture resistance, chemical
resistance, stain resistance, sanitary finish, low
maintenance, and easy installation.
July/August 2013 www.cemag.us
232013 C P fl
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EMD Millipore
290 Concord Road
Billerica, MA 01821, U.S.A.
(800) [email protected]
www.emdmillipore.com
EMD MilliporeMicrobiological monitoring and testing solutions
2013 Company Profles
OverviewEMD Millipore, a division of Merck KGaA, Darmstadt,
Germany, offers solutions that enable scientists to conduct life
science research easily, efficiently and economically. With a
range of more than 40,000 products, EMD Millipore is one of
the top three suppliers of tools to the life science industry. The
company has over 200 years of microbiological expertise, USP
regulatory understanding and the technical solutions to help
customers comply with microbiology testing requirements.
Environmental MonitoringTo enable efficient and cost-effective environmental monitoring
of ambient air, surfaces and personnel in your controlled areas,
EMD Millipore designs its products to be reliable, flexible,
convenient, fast and easy to handle. All instruments are fully
compliant with FDA and other established standards. EMD
Millipore also provides study data, expertise and technical sup-
port to aid your in-house implementation, minimizing yourburden of complying with all of todays challenging regulatory
guidelines and standards.
As a one-stop supplier, EMD Millipore maintains a wide range
of instruments and culture media:
Non-viable air particle counting solutions
Viable microbial air monitoring solutions
Settle plates for passive air monitoring
Contact plates, swabs and slides for surface and personnel
monitoring
Microbial Testing Solutions for Sterile Compounding
USP provides guidelines for facilities in which com-
pounded sterile preparations are prepared, stored and dis-
pensed. Unfortunately, guidelines are purposely left
vague to allow for flexibility, which can be challenging when
an organization is trying to define the right approach. EMD
Millipore is your one-source supplier of sterile compounding
solutions, expertise and education. We can help you complywith USP , reduce your risk of microbial contamination,
and enable you to meet all standards.
Sterility TestingSterility testing is a crucial step in the prod-
uct release and Beyond-Use Dating (BUD)
of many sterile compounded products. For
more than 35 years, EMD Millipore has set
the industry benchmark for closed mem-
brane filtration with Steritest, a closedsystem which allows samples to be with-
drawn aseptically from any container type
without being exposed to the surrounding
environment. It is avail-
able with a wide range of
rigorously tested mem-
brane filters, adapters,
accessories, sterile media
and rinse fluids, all of
which meet USP
requirements.
Benefits from EMD
Millipores know-how and experience in sterility testing:
Solutions that meet all requirements for critical and con-
trolled environments
Exceptionally consistent product quality for accurate and
reliable results
The entire testing process with minimal exposure to the
environment reduces risk of false positive results
Steritest EZ filtration units are the right answer to the
danger that false negative results pose to patients
Media FillMedia fill trials are a valuable test, necessary to validate the
aseptic manipulations of operators and filling lines. A major
concern for users is that the media itself does not compromise
the process. EMD Millipore provides highly soluble and filter-
able media that are available either in an exclusive, dust-reduc-
ing granulated form, or a dehydrated powder. For additional
flexibility and convenience, EMD Millipore provides ready-pre-pared liquid media in screw-cap bottles or H
2O
2-impermeable
foil bags for aseptic connections.
ServicesIn its long history of serving the microbiological testing
requirements by pioneering and refining groundbreaking
solutions, EMD Millipore has gained the regulatory and tech-
nological expertise to offer you a comprehensive range of
professional, best-in-class services that help optimize your lab
workflow and ensure regulatory compliance.
Application: Our scientists will design reliable, regulatory-
compliant, cost-effective and time-saving SOPs for your
product requirements.
Validation Protocols: Save precious time with our pre-
written, comprehensive validation protocols from valida-
tion master plan to final report
Maintenance: Stay cGMP compliant with our robust
maintenance agreements.Education: Stay current on regulations and technology by
attending one of our lunch and learn seminars or request
a visit from one of our specialists.
July/August 2013 www.cemag.us
Key EMD Millipore productsfor enviromental monitoring
Technician
perfoming the
media fill test with
EMD Millipore
TSB media
24 2013 Company Profles J l /A t 2013
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24 2013 Company Profles July/August 2013 www.cemag.us
252013 Company ProflesJuly/August 2013 www cemag us
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25
Veltek Associates, Inc.
15 Lee Blvd.
Malvern PA 19355Phone: (610) 644-8335
Fax: (610) 644-8336
www.sterile.com
Veltek Associates, Inc.
2013 Company Profles
Company BackgroundFor more than 30 years, Veltek Associates, Inc.
(VAI), headquartered in Malvern, PA, has pio-
neered the design and manufacture of hundreds
of solutions to address the challenges of aseptic
operations. These innovations, many of them
landmarks in the industrys history, allow our
customers to overcome challenges and reach
their business goals. VAI clients have more thana solutions provider; they have a partner and
trusted advisor. With todays complex research
challenges, new competition and increasing
government regulations, a true partnership are
more important than ever.
With its continued strong growth, VAI is poised to create
advanced products and services to further simplify and advance
the pharmaceutical, biotechnology, and research and develop-
ment indus-
tries. Our
inspiration
is to use the
knowledge
we have
acquired
along with
the assis-
tance of our
customersto continue
to develop
alternative methods to aid and simplify established industry
practices as well as create new and innovative processes.
Veltek Associates, Inc. (VAI) designs innovative solutions to
address the control of particulate and microbial contamination
in pharmaceutical, biotechnology and Healthcare operations
worldwide. We focus on the identification and control of con-
tamination in classified areas.
VAIs Sterile Chemical Manufacturing Division (SCMD)
produces a complete range of sterile disinfectants, sanitizers,
sporicides, lubricants, cleaners, detergents (CIP), and buffer
solutions. We offer hand sanitizers and hands-free dispensing
systems in addition to developing the Core2Clean Plus System
that can spray, mop or fog in one device. All VAI chemical
manufacturing operations are completely validated and trace-
able. Assurances are taken in every aspect of this operation
concerning sterility and particulate removal to provide our
clients with the highest quality products.VAIs Environmental Control Monitoring Division
(ECMD) designs an assortment of viable air sampling equip-
ment. SMA Microbial Sampling Systems, sample air within
the clean room environment for the purpose of discerning the
level of viable contamination that is present in a volume of air.
As one of the premier sampling methods in the Pharmaceutical
and Biotechnology industries for over 30 years, SMA Microbial
Sampling Systems offer a complete range of products to meet
all requirements for quantitative microbial air testing. The
SMA portfolio includes the SMA Atriums, SMA Remote
Atriums, SMA Digital Control Centers, SMA OneTouchTM
Control Panels, SMA MicroPortableTM Air Sampler, and SMA
Compressed Air/Gas Samplers.
VAIs Disposable Products Manufacturing Division
(DPMD) offers sterile cleanroom garments, face masks and
nylon packaging material. DPMD Face Masks provide excel-
lent barrier capabilities and the material is soft, cool and
comfortable. In additional the Face Masks are designed toeliminate the fogging of goggles. VAIs disposable garment
material is CE marked under the EU Harmonized Standards
and tested according to ASTM methods. These can be used in
ISO 5 (Grade A/Class 100) operations or as a personal protec-
tion garment. The material is cool, comfortable and low in
particulate shedding. These garments also come in a patented
fold (Eay2Gown) that makes gowning simple, easy and efficient
for operators.
VAI Laboratory Services (VAI Labs) provide microbiologi-
cal testing ranging from the identification of microorganisms
to antimicrobial effectiveness studies, a disinfectant validation
service. These services are delivered to assist our clients with
ever changing regulatory compliance challenges.
Aseptic Processing Inc. (API) consulting services assist our
clients with training and consulting with aseptic technique,
environmental monitoring, component entry systems, person-
nel gowning, cleaning and disinfecting systems, and media fill
trials.
In every facet, Veltek Associates, Inc. is here to assist andsource our clients with high quality products and services, as
a leader in contamination control solutions for any aseptic
manufacturing challenge.
July/August 2013 www.cemag.us
Clean Room Innovations
26 ASK THE FACILITIES GUY
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AWhats the Facilities Guys view of therole of the engineering professionalon safety?
For safety is not a gadget but a stateof mind. ~Eleanor Everet
Todays controlled environments present an obstacle course
of varied safety challenges for the facilities professional ranging
from the benign to the life threatening. The program to manage
these assorted challenges must match that diversitydemand-
ing utilization of your engineering skills but also your people
skills, your training skills, and your management skills. While
the storage and utilization of hazardous production materials
is an exercise in engineering, its usually during use that thesematerials intersect with the wildcard that is the root of most
unwanted emissions, spills, releases, and toxic reactions: the
human factor. But its also important to keep the risk in per-
spective. According to the U.S. Bureau of Labor Statistics, trip-
ping and falling cause three times more workplace injuries than
harmful substances.
At the same time, lets not underestimate the potential
severity of safety issues in the controlled environment. A
review of controlled environment workplace deaths in the pastdecade reveal causal factors that no lab or clean manufacturing
facilities professional wants to deal with including explosions,
fire, electrocution, poisoning, radiation, equipment malfunc-
tions, and assorted viral and bacterial infections.
In this months column, well travel outside the comfort
zone of engineering and algorithms to look at managing the
less precise people and process side of safety. There is more to
heaven and earth, Horatio than your MSDS data bank. So
well leave discussions about HPM engineering, process pip-
ing, fume hoods, etc. to another column.
People always, engineering sometimesNo matter how precisely engineered a lab, cleanroom, dry
room, vivarium, or other controlled environment may be,
people are the catalyst that makes it function. And its people
that introduce the most significant risk into your planning anddesign efforts. Given that, todays facilities professional needs
to think beyond engineering and engage in the design and
development of standards, processes, and procedures to ensure
the safe and uninterrupted operation of the facility. Further,
the facilities professional needs to ensure that proper training
protocols and procedures are instituted and remain vibrant.
While this responsibility has traditionally been the domain
of Environmental Health & Safety (EH&S) staff, EH&S opera-
tions are more frequently migrating under the umbrella ofthe facilities department. This scenario makes it your ulti-
mate responsibility to create a culture of safety that is infused
throughout every operation and procedure.
Even if your organization maintains a separate EH&S
department, its incumbent upon the facilities group to ensure
their involvement in every aspect of safety planning and pro-
gram execution.
Utter the word safety or safety training and there is an
almost Pavlovian reaction among many employees to avoid
the topic or tune out. To counter that, the first challenge is tomake safety an ingrained part of your organizations culture.
This will only succeed if that message and sense of urgency is
delivered from the top. Its up to you to drive your CEO to the
conclusion that safety matters. Then, develop a sophisticated
communications program that ingrains the safety message in
almost everything your organization does. Were not talking
off the shelf inspirational posters herethey inspire no one
and are the subject of Dilbert-like employee comments.
Todays business climate adds further complications: manyin-house facilities groups are stretched thin and many have
downsized in recent years, while regulations continue to grow and
processes and operations become ever more sophisticated. In an
environment of competing demands, its important to ensure the
safety program doesnt slip to the back burner because that can
burn you, your department, and your organization.
If your staffing levels are driving a less than optimal level
of attention to safety, consider teaming with a trusted outside
consultant. For engineering issues, look to an engineering firm
with experience in controlled environments. For safety issues,
there are consulting firms who can function as your extended
staff, assisting with EH&S considerations for design, permits
and licensing, safety program development and execution,
26 ASK THE FACILITIES GUY
While usually under the purview of an Environmental Health & Safety department,
Richard Bilodeau, PE
Director of Engineering, SMRT
Andover, Mass.
::
Engineering a
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new employee or annual training, and a host of other services.
They can be retained for a single contract or on an ongoing
basis to provide a comprehensive program.
Planning for what you hope never happensRisk management is the science of identifying potential risks,
assessing their likely occurrence, and developing appropriate
measures (including training) to eliminate, reduce, or mitigate
those risks. Its important to integrate that process into a con-
tinuous loop of surveillance, mitigation, training, and testing
to ensure an effective safety program.
Understand the universe you need to plan foridentifypotential safety risks for each location. Review possible risks in
key categories like technology, system or equipment malfunc-
tions, natural disaster, and the myriad opportunities caused by
the human factor whether through error or intentional acts
including sabotage, terrorism, and accident.
The next step is to slice the categories into a more granu-
lar analysis of each locations vulnerabilities and the potential
impacts to your people and organizationincluding a look at
the impacts a safety incident has on production, the investment
community if youre publicly held, your company reputation(which will impact your business flow), and your financials.
Always remember that the impact on your employees and
their families must be your first prioritynot a media sound
bite. As part of your safety planning, engage management
in the hard core exercise of scenario planning, including the
organizations support and commitment to employees in the
event of a prolonged shutdown.
An ounce of preventionYour risk assessment exercise carries a bonus: the opportunityto reduce, minimize, or eliminate identified risks. Structure
this as a separate effort, with designated mitigation teams.
The value of their work will never be fully quantifiable since
a safety incident avoided cant be recorded. Keep the mitiga-
tion team fully informed of the safety teams efforts and vice-
versa the groups should work separately but parallel and
fully informed and closely coordinated.
Your SWAT teamEvery facility that deals with hazardous materials or processes
needs to have a vibrant first response team in placeequipped
and trained to deal with the potential incidents you outlined
in your planning, above. Select the
members of the Emergency Response
Team (ERT) carefully and make sure
your organization invests in their continued training. Make sure
strong relationships are built with the local and county or state
public safety teams police, fire, and medical emergency pro-
fessionals and conduct joint training exercises several timeseach year. The coordination of emergency response roles, pro-
cesses, and procedures between your inside team and the pro-
fessional responders is critical. Your team needs to understand
jurisdictions, including when incidents are elevated beyond the
local levels, up through and including federal authorities. An
actual emergency situation is no time to sort out command and
control roles. Chaos costs money and sometimes lives.
A parting wordIntegrating safety into the very backbone of your organiza-tions culture has to be Job #1. To do it well is an ongoing,
relentless challenge with little perceptible achievement. Pure
engineering projects are much more interesting. But at the end
of the day, ensuring the safety of your employees and the pub-
lic is a role too important to ignore or marginalize.
Richard Bilodeaus 30-year career includes plant engineering
positions in clean manufacturing. He has designed, operated,
and supervised the construction of advanced technology facili-
ties and engineered clean manufacturing facilities for lithium-
ion batteries, medical devices, electronics, and pharmaceuticals.
Contact: [email protected]
y g g
the facilities department cant ignore its role in maintaining a safe workplace.Culture of Safety
While controlled envi-
ronments are rife with
materials that have
safety consequencesand require special
handling, engineer-
ing is a science that
can be controlled. The
safety wild card in
a controlled environ-
ment is people. Photo:
SMRT-Architects and
Engineering
28 CONTAMINATION CONTROL IN AND OUT OF THE CLEANROOM
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