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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

    Luann Kulbashian,Associate Publisher/Sales [email protected] 603-249-9424

    REPRINTS/ePrints

    For reprints and permissions, contact The YGS Group(800) 501-9571 or [email protected]

    CUSTOMER SERVICE

    [email protected] 847-763-9505New subscriptions, renewals, changes o address,

    back issues, and all customer service questions

    EXECUTIVE, EDITORIAL, and PRODUCTION OFFICES

    ADVANTAGE BUSINESS MEDIA100 Enterprise Drive, Suite 600, Rockaway, NJ 07866-0912

    Phone: 973-920-7000 Fax: 973-920-7541

    Terry Freeburg Chie Operating Of cer/Chie Financial Of cer

    George Fox President

    Prescott Shibles Chie Marketing Of cer/Chie Digital Of cer

    Susanne Foulds Vice President, Human Resources

    Controlled Environments Magazine

    VICON BUSINESS MEDIA, INC.A subsidiary o Advantage Business Media, LLC

    199 Route 101, Bldg. #7 PO Box 779 Amherst, NH 03031www.cemag.us

    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

    [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.

    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

    [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.

    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

    27July/August 2013 www.cemag.us

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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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