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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

32
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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

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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


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


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


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


15/36

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


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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18/36

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

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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

[email protected]

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

[email protected]

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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23

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.


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

[email protected]

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.


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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