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M AY 2 0 1 3W W W . C E M A G . U S

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leanroomCleanroom aintenanceMaintenance

Validation of AsepticCleanrooms for Food

A Closer Look atMini-Environments

Perfect Water Sustainable Packaging
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Controlled EnvironMAY 2013

Vol. 16 No. 5

TABLE OF CONTENTS May 2013 www.cemag.us4

8 Sustainable PackagingIts not easy to be green in a cleanroom, but packaging choices are one way to lessenenvironmental impact.

10 Trimming Down Cleanroom InsulationCleanrooms in pharmaceutical and semiconductor industries are adopting PVDF-basedinsulation that can reduce cleanroom size requirements.

12 Cleanroom Maintenance: Sanitation via FiltrationPortable industrial vacuum cleaners protect cleanroom integrity by collecting and trappingunwanted particles.

15 Perfect WaterWhat quality of water should I use? The answer dependson the application.

16 Validation of Aseptic Cleanrooms forCo-Packing Food ItemsHow do I build a credible and stable validation process?

22 A Closer Look at Mini-EnvironmentsA mini-environment enhances the cleanroom setting bybringing it to a higher standard.

24 Benches and Workstations S how case

12 Cleanroom

Maintenance

8

DEPARTMENTS

6

From the Editor21 Industry News27 Index

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10

26

16

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Controlled EnvironVol. 16 No.5

6 FROM THE EDITOR May 2013 www.cemag.us

Clean, Flexible, and Sustainable LabsTim Studt, Editorial Director

[email protected] 973-920-7748Patrice Galvin, Editor

[email protected] 973-920-7652

MaryBeth DiDonna, Managing Editor [email protected] 973-920-7045

Press Releases: [email protected]

EDITORIAL ADVISORY BOARDCharles W. Berndt , C.W. Berndt Associates Ltd.

Ahmed A. Busnaina , PhD, NSF Center forMicrocontamination 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 ServicesRaymond K. Schneider, PE

Consultant and Faculty Member, Clemson UniversityHoward Siegerman, Ph.D.

Siegerman and Associates LLCMatt 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 PRODUCTIONDeb Jorgensen, Art Director


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Recent trends in new lab designs require thatlabs be more flexible than they have been inthe pastallowing changes to be made quicklyand inexpensively to accommodate the often-changing specific research and development

targets for the organization. These new labs (and oftenexisting labs) also need to be more sustainableallowingcost effective utilization of power, resources, and wastemanagement systems. Of course, during these flexibility-induced changes and increasingly restrictive sustainabilityrequirements, the labs also have to be cleanto varyingspecific standards depending upon the specific researchbeing performed. Many times the labs could require increased levels of cleanli-ness that will directly impact the overall structure, operation, and maintenancerequirements of the facility.

Obviously, when planning, designing, and constructing a new lab, all of the pos-

sibilities and requirements cannot be fully accommodated and built into a new lab,otherwise the costs would be prohibitive. But the rule here should be that somedifferent research activity may be required other than what is the initial plannedactivity. It should be one of the lab planner, lab manager, and lab designers primaryconcerns that future requirements will be established for these new labs and possi-bly within a time-frame of one to three years. Often these requirements may includesome increased level of environmental isolation, automation, analytical instrumen-tation, sustainability, and/or cleanliness.

The primary drivers for these changes are the overall costs and time required

for building either entirely new structures or implementing massive renovations toaccommodate the new research requirements. Of course, there are limits to whatcan be accommodated within an existing structure, and common sense rules haveto be considered when evaluating new applications for an existing laboratory facility.However, the use of structurally sound design principles and the initial implementa-tion of quality instrumentation and monitoring systems can go a long way towardmaking the transition easier and more cost effective in the long-run.

Implementing a new lab configuration should minimize the structural and oper-ating system changes that are physically required for the change. Walls should notbe torn down or new duct work or utilities installed or removed, all of which maycreate unacceptably large amounts of particulate matter and sources that could dis-rupt research applications for a long period of time. Changes from one applicationto another should also be considered as an ongoing process. The successful ability toquickly and efficiently make one change will provide the incentive and consensus toperform similar activities in the future when research activities dictate that it wouldbe wise to do so. That first successful change-over will likely make a second and thirdchange-over go faster and with less problems. Of course, there are always unforeseenproblems that could occur in these types of transitions; however, a good plan beingput in place with input from all related parties should minimize those problems.

Tim StudtEditorial Director

TM
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Sustainable PackagingIts not easy to be green in a cleanroom, but packaging choices are one way to lessen environmental impact.Michael MillsPresident

Justin MillsMarketing

Mills IndustriesLaconia, N.H.

Sustainability is defined as meeting the needs of todaywithout compromising the ability for the next generationto meet theirs. Today, many manufacturers have begunpracticing green initiatives such as environmental man-

agement systems (EMS) and complying with ISO 14000 standards.According to a survey by the American Production andInventory Control Society (APICS),1 67% of respondents report-ed that they practice policies that are conducive to sustainability,and 60% of respondents said they practice policies that reassessnatural capital, raw materials, and ecological processes. The studyalso states, Sustainability is increasingly a domain of innovationthat is reducing cost by reducing demands on resources whileincreasing reuse of existing assets.

As a whole, manufacturers need to focus on reducing theconsumption of non-renewable resources, while still remain-ing aware of reducing environmental impact by reviewingpackaging and container usage. For example, one study 2 indi-cated switching to reusable packaging required 39% less ener-gy; produced 95% less total solid waste; and generated 29%less total greenhouse gas emissions than single use containers.

There are unique specifications required for packaging tobe cleanroom-suitable. Corrugated paper packaging is prob-lematic since it emits fibers and paper dust contaminants.

Also, the porous surface of corrugated paper is unable to becleaned adequately for cleanrooms. It also supports moldgrowth and contains sulfur, which is corrosive.

Rigid plastic packaging and containers are more expen-sive than corrugated paper; however, they can becleaned to meet cleanroom requirements. They aregenerally non-porous and non-shedding, whichhelps control particle contamination. Rigid plastic

containers include those made by amolding process such

as vacuum form-ing and injectionmolding. Other

rigid containers,which includeplastic cor-rugated, are

made by anextrusion and die

cutting process.Rigid plasticcontainers haveoptional additiveswhich will reduce

static discharges. The additives are generally grouped into threecategories: conductive, static dissipative, and antistatic. Whichtype to use in various situations has been a subject of muchdebate over the last 30 years. Conductive and antistatic are the

most common additives. Below are general definitions.

Conductive (surface resistivity 104 to 105 ohms):Conductiveadditives are created by compounding special carbon blackmaterial into plastic resin that permanently changes surfaceresistivity to prevent static build up. These additives are moreexpensive that antistatic additives, but they provide a Faradaycage and electromagnetic shielding protection. Containerswith Faraday cage protection shield contents by conductingstatic charges away from the contents.

Static dissipative (surface resistibility 106 to 108 ohms):Theseadditives are achieved using proprietary resin additives, though theymay not be as readily available as conductive or antistatic material.

Antistatic (surface resistivity 109 to 1012 ohms):Antistatic addi-tives cost less than conductive or static dissipative; however, theymay not be permanent depending on the humidity of the room.

When analyzing resource use, it can often be tricky to definewhich alternative is the most environmentally sound. To mea-sure or compare environmental impacts, a quantitative toolcalled life cycle assessment (LCA) is used. The primary objectiveof an LCA is to judge the environmental impacts of a product.LCAs are conducted under ISO 14000 standards. The assess-ment follows the acquisition of the raw materials to produce theproduct, to the disposal at the end of its use. A commissionedLCA3 measured the environmental impact outcomes in six cat-egories. The results revealed that the corrugated plastic contain-ers yielded the least amount of environmental impact out of thethree alternatives.

There are simple principles that help review packagingselection and lessen environmental impactreduce, reuse, andrecycle.

Reduce weight and thicknessThe most important idea of this concept is to reduce the useof a resource if it is not needed. Reduction of weight and wall

thickness of packages to what is structurally adequate is anexample of this principle. General reduction of weight canreduce environmental impact by 20%, according to Packaging for Sustainability 4 by Karli Verghese. It is important to opti-mize package design for its specific use rather than to simply

8 CLEANROOM PACKAGING

Over time, reusable

containers will signi-ficantly lower thecost of packaging. Photo: Mills Industries

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minimize it. For example, in many cases the use of alternatelight yet rigid material such as corrugated plastic instead ofmolded plastic designs will provide lightweight structuralintegrity. A corrugated plastic tote 18.5 by 12.20 by 13.38 in.weighs 75% less than a molded plastic tote of the same sizewhile providing the same performance in most circumstances.

Manufacturing products out of recycled material isanother method of reduction, as it eliminates the need touse untouched virgin resources and will reduce environmen-tal impact. Recycled content is divided into two categories:post-consumer (generated by the general public) and post-

industrial (generated by companies internally from industrialprocesses). Many industrial container manufacturers limittheir recycled content to internally created post-industrial tocontrol the quality of the material. Manufacturers also limitthe amount of recycled content. The overuse of recycled con-tent may degrade the physical properties and then may notperform as needed.

Design to reuseReusable containers work the best in a closed loop systemwhere a durable tote can provide a high number of reuses. Aclosed loop system will work best if totes can be controlledand economically returned. Ideally, containers should be engi-neered for reuse with the following criteria in mind: designedfor durability and part protection; designed to take ergonomicconsiderations in mind for manual handling; designed to becollapsible or nest-able for storage; and sized to maximize partdensity lot size while making the best use of truck cube, ware-house space, racks, carts, conveyors, etc.

Recycle and buy back programsRecycling captures losses from the manufacturing valuestream, which provides more value. A recent article in Plastics News stated that 934 million pounds of post-consumer rigidplastics (not including bottles) was recycled in the U.S. andCanada in 2011. This amount was up 13% from the previous year and the number of recycling facilities that accept rigidplastics is up 40%. Most rigid plastic containers are madefrom thermoplastics with oil or natural gas being its primaryfeedstock. The advantage with thermoplastics is that they canbe ground down, re-melted, and processed as recycled contentinto plastic articles. Most common thermoplastics used inrigid plastic containers for various industries are: high densitypolyethylene (HDPE); polyvinyl chloride (PVC, vinyl); plypro-pylene (PP); polystyrene (PS); and high impact polystyrene(HIPS); and others including but not limited to acrylonitrilebutadiene styrene (ABS).

Many manufacturers of rigid plastic containers offer take

back or buy back programs. These programs offer a price perpound set by manufacturers; oftentimes there are also freightcosts to consider.

The price of recycling depends on the quantity of scrapmaterial produced. Companies that buy plastics are generally

looking for a truckload quantity of baled plastic or granulated(ground down) and sorted according to resin type. They willpay a market price per pound, otherwise the regional mate-rial recovery facility or municipal recycling facility shouldbe contacted. The demand is generally is higher for highdensity polyethylene (HDPE PP). Ideally, packaging shouldbe designed for disassembly and recycling. Here are a few keythings that can make the recycling process easier:

Indicate recycle symbol with resin code on packaging Design containers to be made from homogenous material Design for collapsibility or to be disassembled

Sustainability is profitableIn general, reusable packaging costs five times as muchas expendable packaging; however, according to EricFredrickson, 2 president of Thor Consulting in Boston, itlasts 100 times longer. Gradually, reusable containers willsignificantly lower the cost of packaging. A study found thatwithout new technological advances, simply moving to thegreen supply chain could reduce costs up to 20%. 5 Severalcompanies have transitioned to returnable containers andhave saved money by doing so. For example, General Motors saved $12 million in waste disposal costs by switching toreusable containers. 6 Pitney Bowes spent $100,000 annuallyon corrugated paper boxes, only getting five uses per con-tainer. Since they have switched to reusable collapsible cor-rugated plastic totes, the company has been able to utilize theboxes for 200 to 300 round trips. 7 Texas Instruments saved$20 million in real costs by getting suppliers to return theirpackaging over a three-year span.

Many companies are searching for methods to lessen theirenvironmental impact in all steps of production. Add in thenecessity of cleanroom compatibility, and the challenge to begreener becomes a bit more difficult. However, at least in the fieldof packaging, all functional needs and environmentally-friendlywants can be achieved by looking into alternative packaging.

References1. APICS 2012 Sustainability Challenges and Practices, p. 2-32. http://www.sustainableplant.com/2013/03/guide-for-reusable-packaging/3. 2011 LCA Commissioned by Mills Industries (available bycontacting Mills Industries)4. Packaging for Sustainability Karli Verghese. p. 515. Green Supply Chains: An Action ManifestoStuart Emmet &Vivek Sood, Preface xiii, p 56. Lean and GreenPamela J. Gordon. p 6, 1247. Packaging World , August 2000 www.packworld.com

Michael Mills is president of Mills Industries, a third genera-tion family owned and operated company. Justin Mills is a member of the marketing team and assists

with technical writing as well as marketing functions.www.millsind.com

9 May 2013 www.cemag.us
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Trimming Down CleanroomCleanrooms in pharmaceutical and semiconductor industries are adopting PVDF-basedinsulation that can reduce cleanroom size requirements.

Ed SullivanHermosa Beach,

Calif.

In some respects, the insulation traditionally used incleanroom manufacturing is like those 1980s-era cellular

phonesmuch too clunky and somewhat prone to perfor-mance problems. But then, the conventional open-celledpolyethylene foam insulation used in cleanrooms dates back tothe 1980s or earlier.

The problems with cumbersome insulation designsbecome very pronounced in the manufacturing cleanroomenvironment, where thousands of feet of fairly narrow reac-tor piping form a congested maze of plumbing once theinsulation has been installed.

A half-inch line with three-inch insulation becomes 6.5inches in diameter. When you consider the multitude of linesin the typical manufacturing cleanroom, its no wonder thespace gets crowded.

One of the problems with the traditional melamine fiberor foam insulation design used in most cleanrooms is that itseverely constricts the space needed by technicians to accessthe many points in the lines where instruments and controlsare located, explains Mark Ginchereau, vice president ofTermar Inc. , a Ventura, Calif.-based maintenance contractor

and insulation installer.Ginchereau adds that, until recently, the only alternative

to having a cleanroom densely packed with open-celled orpolyethylene insulated lines was to build a larger cleanroom

and install longer lines so that there would be more elbowroom for techniciansan expensive solution.He mentions other drawbacks to conventional insulation

as well. Standard open-celled insulation sheds particulatewhen cut. This makes it necessary to provide additional pro-tection from cross contamination and exposure.

Yet, standard open-celled insulation can also shed partic-ulate due to everyday contact from workers who need to gainaccess through tight spaces. Any uncontrolled particulateshedding can require extensive replacement and unscheduledcleanroom downtime.

Ginchereau also mentions that cleanrooms withmelamine fiber-filled insulation in some chilled-water appli-cations may be susceptible to condensates forming in fiber,due to chinks or even cracks resulting from impact damageor normal wear and tear from worker contact. Condensateformations can provide a breeding ground for biologicalgrowth, a highly undesirable intruder to any cleanroomenvironment. The condensate problem aside, cracks or other

leaks in insulation are detrimental to maintaining exactingtemperatures in cleanroom applications.

Pipe lines can be a maze. Thinner pipe insulation offers more space and easier access for maintenance and repair.

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InsulationAnother serious concern about the use of bulky tradi-tional insulation is the possibility of serious worker injuriesdue to contact with superheated or frigid lines. Ginchereauexplains that the greater the congestion of plumbing due tothe use of insulation, the greater the potential for injury.

A new breed of insulation

One of the newer materials that provides a new option incleanroom insulation is a PVDF-based, high-purity foam.This specialty plastic material is a closed-cell foam that ina thickness of only one-quarter inch offers chemical andheat resistance as well as other properties that are equiva-lent to eight times of what conventional foam provides forcleanroom applications. In other words, one-quarter inch ofPVDF-based insulation is equivalent to two inches of open-celled insulation.

In recent years UFP Technologies , Georgetown, Mass., aproducer of foam, plastic, and composite products, incorpo-rated the new PVDF technology into an advanced tube andpipe insulation system specifically developed for process linesand equipment in cleanroom environments.

When you consider that instead of six-inch-plus insula-tion on dozens of reactor lines, you are adding only one halfinch in diameter to a one-inch or two-inch pipe, you cansave a lot of real estate, Ginchereau explains. In the overall,

the insulation is taking up only about one-tenth the space oftraditional fiberglass.This savings of space translates to many benefits, includ-

ing reduced cleanroom size requirements. When you con-sider the space requirements of cleanrooms housing multiplereactors connected to thousands of feet of pipeline with fatinsulation, the amount of space is dramatically reduced withthe use of a slimmer product.

Also, with thinner pipe insulation, more space is availablefor technicians to access reactors and plumbing, resultingin improved worker productivity as well as less exposure tocontact with super-heated or super-cooled lines.

This PVDF-based product offers several other featuresthat render important benefits to operators of manufactur-ing cleanrooms. The system includes custom-molded cover-ings for fittings, and an overlapping, self-adhering tape thatprovides a superior seal. This reduces the possibility of con-densate, which can saturate ordinary foam insulation, creat-ing leaks and enabling biological contamination.

Unlike traditional open-cell insulation, this technologydoes not shed when cut. This means fewer impurity prob-lems while cleanrooms are live, and no need for protectivebags and hoods or downtime during installation.

The PVDF-based product doesnt burn or smoke, which is

very important to pharmaceutical cleanrooms where millionsof dollars worth of drugs could become tainted and lost ifexposed to smoke; and it is compliant with Factory MutualApprovals 4910 standard for cleanroom materials. It has alsosuccessfully completed FMs 4924 Pipe Chase FlammabilityTest and is rated for use by the semiconductor industry.

Ginchereau describes this PVDF-based insulation systemas very easy to install. And ease of installation spells majorsavings of manpower. Traditional foam or polyurethaneproducts coated with melamine require added installationtime and efforts because there are two layers involved. ThePVDF-based product is literally a single layer installation. Inone case the labor savings on a 30,000-ft. insulation projectsaved a customer over $800,000.

Ed Sullivan is a technical writer based in Hermosa Beach,

Calif.UFP Technologies Inc. is located at 172 East Main St.,

Georgetown, Mass. 01833; 877-881-4811 ; [email protected];www.t-tubes.com

mailto:[email protected]:[email protected]://www.t-tubes.com/http://www.cemag.us/http://www.goodway.com/vacuumhttp://www.goodway.com/vacuummailto:[email protected]:[email protected]://www.t-tubes.com/http://www.cemag.us/

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Cleanroom Maintenance: SanitationPortable industrial vacuum cleaners protect cleanroom integrity by collecting andRob DeckerApplication EngineerNilsk IndustrialVacuum

Morgantown, Pa.

Contamination control is vital for maintaining clean-room environments. Pharmaceutical and semiconductorcompanies require especially stringent maintenance andsanitation programs to meet demanding standards for

air quality, room design, and operation, such as those set by theInternational Organization for Standardization (ISO). ISO

14644-1, which definesguidelines for the clas-sification of air cleanli-ness determined by thepermissible particle sizeand levels of concentra-tion, forces manufactur-ing facilities to maintain

high standards for a con-taminant-free facility toprotect their equipment,products, and employ-ees. Operational costs,long-standing cleaningprocedures, and lackof proper equipmentcan stymie a companys

efforts to build a com-prehensive maintenanceprogram.

Ultimately, thiscan create opportuni-ties for contaminantsto enter cleanroomsand negatively impactoperational efficiency,employee health

and safety, and thecompanys bottomline. Facilities can sig-nificantly reduce therisk of contamination,however, by utilizingHEPA-filtered, portableindustrial vacuums forgeneral maintenance

and hazardous materialspills. These vacuumsare integral tools forensuring a cleanroomis free of contaminants

and for reclaiming active pharmaceutical ingredients (APIs).Portable industrial vacuums are effective tools for clean-

room applications that require personnel to safely removecontaminants from controlled environments. Any foreignmatter, typically particulate, that detracts from a productsperformance is considered a contaminant, and traditional pro-cesses for cleanroom facilities focus on preventing one of threecategories: airborne, fluid, or transfer particulates. While wipe-down methods and dusting systems are common practice,vacuuming is an efficient and effective method to thoroughlyclean these environments.

Improving cleaning efficiencyVacuums with high-efficiency particulate air (HEPA) or ultra-

low penetration air (ULPA) filtration systems help cleanroompersonnel better control factors that contribute to sterile envi-ronments. When included in maintenance procedures, thesevacuums keep particles safely contained after removal andensure optimal air quality. From collection through to disposal,they also protect users from potent compounds and offer theflexibility to clean remote areas efficiently (i.e., hard-to-reachareas, overhead spaces, in and around equipment). Portableindustrial vacuums are designed to safeguard cleanrooms and

improve a companys approach to controlling contaminationfrom personnel, materials, and machinery. Toxic compoundsand other contaminants can be very small particles, whichmakes collecting airborne particulates an extremely difficult andtimely process. Particulates align with the flow of the air streamand can easily penetrate porous filter media. However, HEPAfilters capture 99.97% of particles as small as 0.3 microns andULPA filters collect 99.999% of material down to 0.12 microns.Trapping matter of this size significantly improves air qualityand upholds the integrity of cleanrooms.

Vacuum filtration to mitigate riskIndustrial-strength vacuum cleaners featuring a superior filtra-tion system with HEPA or ULPA filters offer the level of sanita-tion cleanrooms require. Depending on the size of particles, amulti-stage system is an important line of defense for protectingfilters from blockage and excessive wear and tear, maintainingpeak performance and, most importantly, preventing contami-nants from recirculating into the air. The key to graduated filtra-

tion is a series of progressively finer filters which trap and retainparticles as they travel through the vacuum.While companies cannot absolutely omit all poten-

tial sources for unwanted matter, they can mitigate risk byinvesting in reliable, efficient cleaning equipment. Portable

As part of a regular maintenance program, vacuums keep particlessafely contained and ensure optimal air quality.

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via Filtration trapping unwanted particles.industrial vacuums easily remove and disposeof contaminants with minimal risk to users.Personnel have a safe means for cleaning hazard-ous materials spills and the ability to quickly andeasily address sanitation concerns. Facilities thatinvest in multiple vacuums can also specify onevacuum per application, further eliminating thepotential for cross-contamination or accidents.A filtered exhaust stream is also vital for collect-ing fine particles like dust and powder. Vacuumsshould have upstream and downstream filtersinstalled before and after the motor to captureparticulates from its airflow and exhaust stream.Upstream filters also protect the motor and

extend the vacuums lifespan, while a down-stream filter captures dust from the motorscommutator and carbon brushes.

Maintenance and cleaning programs shouldfacilitate simple sanitation and validation pro-cesses for cleanrooms. A portable industrialvacuum, made out of non-particle-generatingmaterials such as stainless steel, eliminates thechance for contamination by the vacuum itselfand helps cleanroom personnel meet criticalstandards for contamination control. Oversizedmain filters slow airflow across large surfacesso that the vacuum can capture larger volumesof debris during use. As a result, vacuums runmore efficiently for longer time periods andoptimize air-to-cloth ratios for easy, efficientcleaning.

Applications for cleanroom maintenanceWhen hazardous materials are a concern incleanrooms, portable vacuum cleaners can great-ly assist in the clean-up and disposal of thesematerials. Removable collection containers offerthe ability to collect, contain, and dispose ofpotent compounds without coming in contactwith toxic materials. Bag-in/bag-out systems arebeneficial as well, because they facilitate the safereplacement of HEPA filters.

Cleaning machinery and equipment isan important step in contamination control.Residual dust and powder can collect in machinesand on equipment surfaces, posing a health andsafety risk. By integrating portable vacuums into

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May 2013 www.cemag.us14 CLEANROOM MAINTENANCE

process equipment, clean-room personnel can thor-oughly remove particles

directly from the sourceand reclaim valuablecompounds and APIs.Vacuums with a small,compact design provideflexibility for processingenvironments with lim-ited space. Furthermore,if multiple vacuums areused, facilities can stream-line cleaning procedures,increase efficiency, andestablish proper protocolfor maintaining a clean-rooms integrity.

Sources of contamination

Despite rigid industrystandards and compre-

hensive cleaning pro-grams, some elements ofcontamination prevention are beyond a companyscontrol. Pharmaceutical production facilities thatrequire cleanroom environments often developprocedures around three major sources of particles:cleanroom materials, equipment, and personnel.Comparatively, the most common source of con-taminants is personnel.

While materials like gowns and gloves provide alayer of protection for skin, hair, and clothing, humanscan transmit unwanted matter into these environmentsin other ways. For example, sneezing or simple move-ments like sitting or walking can lead to organic mate-rial entering the air supply. Typically, a working persongenerates about one million organic airborne particlesthat are greater than 0.5 microns per minute.

Investing time and resources into educating per-sonnel about maintenance procedures and why certain

precautions are necessary can significantly improve theintegrity of cleanrooms. Key factors to address include: Personal hygiene Proper gowning materials and techniques Particulate behavior Government standards and protocols for cleanrooms

Providing quality cleaning equipment and neces-sary training in the use of tools like portable vacuumscan also prevent discrepancies in cleanroom mainte-

nance. Cleanroom personnel will not only be empow-ered to efficiently maintain the environment, but theywill also actively prevent costly missteps that can haveserious consequences.

Conclusion

Pharmaceutical and semiconductor manufactur-ing facilities face unique cleaning challenges that, ifnot addressed, can negatively impact their products,their employees, and their overall success. Controlledenvironments require thorough cleaning to remainfree of potent compounds and hazardous materi-als. Establishing proper protocols for contaminationcontrol and combining vacuuming with manual pro-cedures will create a much more effective process formaintenance and sanitation. As part of a comprehen-sive cleaning program, portable industrial vacuumsshould feature multi-stage filtration systems, wet/drycapabilities, and safe collection units. Taking thesesteps in cleanroom maintenance will mitigate risks forcontamination and allow personnel to easily addresshazards across various applications.

Rob Decker provides technical support to customersand the Nilfisk Industrial Vacuum sales force for productand application-specific inquiries and modifications.He develops, designs, and manages special vacuummodifications and accessories for unique applicationsand/or customer requests. Rob joined the Nilfisk teamin 2006. Nilfisk Industrial Vacuums is a division of Nilfisk-Advance Inc., Morgantown, Pa. Nilfisk Industrial

Vacuums supports three brandsNilfisk, Nilfisk CFM,and Nilfisk ALTOthat provide industrial vacuums tomanufacturing and industrial facilities. www.nilfiskin-dustrialvacuums.com.

A stainless steel vacuum eliminates the chance for contamination by the vacuum itself andhelps cleanroom personnel meet contamination control standards.
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e r fe c t W a te rPerfect WaterWhat quality of water should I use? The answer depends on the application.WW ater is the fluid most often used in cleaning,whether it is for personal, household, industrial,or the manufacture of high-value product. Wateris the most abundant cleaning chemical. With appropriate addi-tives, water-based cleaning has proven successful. However, partic-ularly in critical manufacturing, the wrong water quality can derailthe process and undermine product quality. How do you get waterto the right quality? Why might you have to treat water?

Not all water is the sameThere is no pure water. Naturally occurring water is not pure,whether it comes from underground wells, surface reservoirs,or even freshly fallen rain. This is because water is a veryaggressive solvent and picks up minerals from the ground or

gases from the air. Tap water

Tap water is water coming into the facility from the local waterdistrict. It may come directly from a well or reservoir andgenerally has been treated so that it is safe to drink or bathe inand, in many communities, materials such as fluorides havebeen added. One of the primary issues with using tap waterfor industrial processes is that the consistency varies greatlyfrom location to location and from season to season.

Hard water Water that contains higher levels of dissolved mineralssuch as calcium and magnesium is considered to be hard.Although hard water may taste better due to the includedminerals, it is not as effective for cleaning. Dissolved miner-als interfere with the effectiveness of soaps and may remainas residues when water evaporates or precipitates from thewater to form scale.

Water purification treatmentsFor personal and household use, many people employ somedegree of water conditioning. However, the quality of waterrequired for industrial and high precision applications is gener-ally higher. In order to determine the optimal treatment, it isimportant to understand both the terminology and the meth-odology of the various water treatment techniques.

Soft water Soft water is not necessarily mineral free. Hard water issoftened by using an ion exchange process. Many watersofteners employ a cation exchange resin where the nega-tively charged resin beads are bonded to positively chargedsodium cations. Calcium and magnesium cations, beingmore strongly bonded to the resins, displace the sodiumand thus are removed from the water. The exiting water

contains lower concentrations of the hard minerals butnow contains sodium. Although sodium interferes less withsoaps and does not precipitate as scale, the water still hasthe same ionic content.

Deionized water (DI)Deionized water is produced in a process in which ionexchange removes both positively charged cations such ascalcium or sodium, and negatively charged anions such aschlorine. In the exchange process, the cations are captured,releasing hydrogen (H+) ions; the anions exchange withhydroxyl (OH-) ions. Since the exchange ions recombine toform water, the result is a removal of most ionic impurities.With a reduced ionic content, the conductivity decreases(the electrical resistivity increases). Measuring the conduc-

tivity is the most common method of confirming the effec-tiveness of a DI process.

Reverse osmosis (RO)Osmosis is a filtration process. Suppose water is on one side ofa membrane and water with dissolved material is on the otherside. If the membrane is semi-permeable, meaning that watermore easily passes through it than dissolved materials, waterpasses through in both directions until the concentration ofwater on both sides is the same (isotonic). Normal osmosisthus results in a net flow of water from the purer side of themembrane to the more dissolved material side. However, ifsufficient pressure is applied to the dissolved material side,the process is reversed and water can be purified by flowingfrom the dissolved material side to the purer side.

Distilled water Distilled water is produced by evaporation, with the vaporcondensing (distilling) into another container. Since most ionicand inorganic impurities have a much lower vapor pressurethan water, the distillate is purer and has a lower conductivity.

Distilled water is not necessarily pure. If there is more than onevolatile chemical present, such as water containing alcohol oroil, each will distill proportional to its respective vapor pressureand will still be in the distillate.

Water for injection (WFI)WFI water is treated to meet USP specifications that limitorganic, inorganic and, particularly, biological impurities.Distillation and RO processes are most frequently used toproduce WFI water. Where ionics are an issue, WFI may notmeet manufacturing requirements. Acceptable ionic contentcan result in a resistivity less than 1 Mega-ohm, and limits oncalcium, magnesium, and chlorides refer to the color of theliquid, not specific amounts.

Barbara KanegsbergConsultant

Edward KanegsbergConsultantBFK Solutions LLCPacic Palisades, Calif.

CONTAMINATION CONTROL IN AND OUT OF THE CLEANROOM

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Validation of Aseptic CleanrooValidation of Aseptic Cleanroofor Co Packing Food Itemsfor Co-Packing Food Items

How do I build a credible and stable validation process?

Jan Eudy Corporate QualityAssurance ManagerCintas Corp.Mason, Ohio

he recent revisions of the GFSI (Global Food SafetyInitiative) standards and the FDA rulings to implementthe Food Safety Modernization Act have increased therequirements for controlled environments to prevent

contamination of high risk foods and high care areas. An asepticcleanroom is a very controlled environment and is sometimesused in the food industry especially in aseptic filling of liquids.You will want to consult with several cleanroom design/buildconstruction companies to get their proposals for buildingan aseptic cleanroom to your specifications as well as the ISO14644 and IEST industry standards. The recent revisions to thestandards also require validation and verification of the manu-facturing processes for high risk foods in high risk areas.

What is validation?Validation in the manufacturing world is the establishment of

documented evidence. The data derived from rigorous testing,which results in a high degree of assurance that a specific processor system will consistently meet a predetermined specification orset of quality attributes, is the documented evidence required forvalidation. The validated process creates a validated product.

Why validate?Similar to what the FDA has mandated in the pharmaceutical,bio-pharmaceutical, and medical device industries, the foodmanufacturing industries are being required to validate themanufacturing processes of high risk foods to ensure that allof the systems have a consistent high level of assurance to pro-duce a product that consistently meets its pre-designed speci-fications. This gives a company a control system that is consis-

tent and reproducible. Further, a validated process is credibleand stable, because the acceptance criteria have already beenspecified in the qualification stages of validation.

If the specifications of the system, how it is designed, andhow it is to operate are known, then it becomes possible tomaximize the performance of that system. If validation isperformed properly and with the right objectives, it can be avalue-added process for the company.

Who is responsible for validation?The FDA has stated that the facility using the system is totally

May 2013 www.cemag.us16 ASK JAN

Example of Master Plan outline.

Validation Master Plan

Table of Contents Approvals Project Purpose and Scope Definitions Facility Specifications Descriptions of Systems and Equipment Standard Operating Procedures Responsibilities Schedule (with benchmarks) Acceptance Criteria

EXAMPLE

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responsible for validating the system. The sitemanagement team may either write their own

protocols and perform their own testing, orthey may contract with qualified outside valida-tion firms to perform these services for them. Ifan outside firm is contracted to perform theseservices, the facility using that system is stillresponsible for assigning personnel to review andapprove the protocols. Further, the facility is stillresponsible for executing the test procedures andthe validation processes while assuring the pro-tocols were designed to validate what is actuallyperformed at their facility, under their control.Employees who perform the validation haveownership of the equipment and the process.

What does validation involve?

Validation is a multi-disciplined process consist-ing of the installation qualification, operationqualification, performance qualification, andchange control. The entire process is mapped in

the Master Plan.

The Master Plan

The project, or the overview of the validationprocess, is the Master Plan for the validationprocess.

Once there is an overview, then the valida-

tion protocol is written. The validation protocolconsists of the design validation, a specific set

of test procedures and their acceptance criteriafor each of the systems being validated, andfor the specifications that are required over thewhole project. Once the validation Master Planhas been prepared, and during the preparationof the validation protocol, an assignment ofresponsible parties is determined.

The installation qualification is defined.These are specifications that must beachieved during the installation phase ofthe project.

The operation qualification is defined. Theseare all the operation specifications thatmust be met in order to assure that every-thing is going to operate as planned.

The performance qualification specificationsare prepared. This is taking all the informa-tion derived from the installation quali-fication and operation qualification and

assuring that all the systems consistentlyperform as specified.

Change control is defined.These arethe steps to be taken if any changes arerequired during the validation process.

In all of these phases, SOPs are prepared andserve as the blueprint to perform each of the

qualifications. These SOPs are contained in eachof the phase method sections. A change control

process is used, if any part of these results failto meet the required specifications, to make achange to either the specification or the system.The change control is also outlined in the SOPin the corrective action section.

Work the validation Master Plan!

There are several components of the validationMaster Plan, and it is imperative that the MasterPlan be written before executing the validationprocess. Otherwise, the validation can be par-tially completed, and bits of information thatare important can be lost. A validation MasterPlan consists of all the steps involved in theentire life cycle of the validation. It will also des-ignate responsibility and authority and who isauthorized to approve changes in the process ofvalidating the cleanroom. It will define the proj-ect purpose, scope, and definitions so that all

the individuals working on the validation teamare proceeding with the same directions, talkingabout the same pieces of equipment, and work-ing on the same process.

Also defined in the Master Plan are speci-fications that are to be distributed to vendorsand the documentation required to prove thesystems and equipment meet the end-use speci-fied requirements. The SOPs, in their entirety,become part of the Master Plan. These SOPsmay become a separate volume that will be usedon a continuing basis after the validation hasbeen completed to prevent deviations from thevalidated program.

Within the Master Plan protocol is the fulllife cycle including schedules, deliverables, duedates, and responsibility and authority designa-tions. A vendor audit protocol should be part ofthe validation process in the design specification

portion of the Master Plan. The SOPs should bevery specific to the system and equipment beingused because they will become the method ofdetermining how the system should be moni-tored once it is in place. The SOPs should bewritten clearly and concisely so they can beunderstood by everyone involved in validatingthe system.

Vendors are required to provide a completedocumentation package including certificatesof conformance on any of the specificationsthat are required. Prior to the start of specificvalidation testing, the necessary calibrationsExample of Master Plan flow chart.

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should be performed to NIST traceable stan-dards. The purpose, scope, and function of the

systems or equipment should be written so thatall those individuals executing the validationproject can understand the whole process flow,a detailed description of the system and how itfunctions, and where they fit into the scheme ofthe process. Flow diagrams and specifications,when documented, are very good ways of look-ing at the entire process and product flow. Thevalidation protocol should outline each of thedifferent steps used in the validation process.This will clarify that as one part of the processis completed and the next is begun, a differentbenchmark becomes the target.

Developing a validation protocolThere are different types of validation. The mostfrequently used is called a prospective validation.It is a validation that is planned and initiated atthe very beginning of the implementation of any

new instrumentation, equipment, process, or sys-tem. It is the easiest type of validation to performbecause there is total control of the validationprocess from the beginning. It is started wellbefore the system being installed is ordered.

The first step is to determine the scope ofthe validation, i.e. machinery versus systems.

This includes evaluating the vendors and theircapabilities to meet all the requirements within

the scope of the validation, including support-ing systems such as HVAC systems, electricalsystems, purified water systems, etc. The manu-facturer of each of these components is respon-sible for providing documentation regarding aparticular system and its compatibility and itssuitability for its intended use. The manufactur-er is also responsible for any quality testing andshould provide installation instructions, oper-ating parameters, and technical support. Thisshould be specified as part of the parameters inthe purchase agreement with the manufacturer.The documentation package is the verifica-tion of conformance that is requested from themanufacturer.

After documentation is received from ven-dors of equipment and for systems installed bycontractors, a facility develops specific SOPsfor the operation of those systems. The manu-

facturer should provide adequate training forpersonnel to operate the system, including pre-ventive and corrective maintenance. The facil-ity is responsible for selecting the appropriatepersonnel and assigning specific responsibilitiesto each member of the validation team. Thesemembers probably have been designated in

the writing of the validation protocol and aregiven necessary and appropriate responsibili-

ties and authority. When the written validationprotocol and test procedures are developed andapproved, then the actual testing is performedas outlined in the protocol. It is performed asstipulated in the protocols, with each step beingfully documented. All results are verified by asecond-party to assure that (a) the test resultsare correct and within the specifications, and(b) that the test results are what was expectedduring this validation process.

Test proceduresThese tests must show not only the responsesunder ideal conditions, but simulated worst casescenarios. Ideal operating conditions should bedefined and then adverse conditions addressedin a disaster prevention/response/recovery planin case of a partial or total failure of the processor system. Should there be a process or system

failure, this plan defines the procedures to bringthe process or system back in line and to assureit operates within the previously required speci-fications.

Once these test procedures are written andthe specifications defined, alert and actionparameters are established to set the limitsof the systems capabilities. This will assurethat when the process deviates from normaloperating ranges and trends towards upper orlower limits, the operator can take correctiveaction.

Training responsibility and authorityPrior to the execution of the validation proto-col, all operators should be trained in proce-dures for operating the system, including specif-ic goals and objectives. The parties responsiblefor validation are identified and recorded in

the validation Master Plan. The qualificationsof the personnel that are to perform the valida-tion process are defined. Documentation thatthe selected personnel meet these qualifications,completed appropriate training, duration oftraining, and that the training was effective areretained in training files.

The core of the validation Master Plan isthe execution of the installation, operation, andperformance qualification.

Installation qualification (IQ)The installation qualification (IQ) documents


Example of IQ checklist.

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that all equipment, control loops, and devicesare installed and functioning as specified. Thisincludes any computerized hardware and soft-ware that control the installed equipment. Thesteps of IQ include ensuring that the equipmentcomplies with the design specifications and a cer-tificate of conformance accompanies the equip-ment or components of the systems.

The IQ documentation consists of a series ofverification checklists and forms, P & ID drawings,electrical schematics, and equipment manuals.

An audit of the installed system is performedto confirm that the system installed meets theintended specifications.

Operation qualification (OQ)The operation qualification (OQ) documents thateach piece of equipment and its control systemused in the process is performing within speci-fied parameters. The OQ starts after the installedsystem has been thoroughly audited and deemedoperational. Completion of the OQ ensures thatall the installed equipment and processes operateas designed. It proves that all the alert and actionlimits and system tracking mechanisms that havebeen designed into the system by the manufac-turer are in place and functioning as specified.

Performance qualification (PQ)The performance qualification (PQ) starts asthe system begins commercial operation. ThePQ documents that the entire system can oper-ate consistently and will produce a productmeeting the predetermined specifications ofthe facility. Even though it has been establishedthat all components of the system have beeninstalled according to the installation specifica-tions, and that they operate according to thespecifications of the manufacturers, it is stilluncertain that the system is robust and willfunction consistently over time.

Performance qualification puts the entire

cycle of the process together to validate that itproduces consistently according to specifica-tions. The PQ also ensures that the equipmentand personnel are adequately monitoring, sam-pling, and testing the product and process.

Additionally, performance qualification con-tains the disaster prevention/response/recoveryplan. It ensures that mechanisms are establishedto trigger an action when an alert limit has beenreached. Also, PQ documents action steps takenin the case of a facility failure or shutdown dueto mechanisms beyond the control of the system,such as a tornado, hurricane, or earthquake.

Change controlDuring the validation process, changes may berequired. Change control is the procedure toprovide documented evidence of any changethat has been performed. Once it is determinedthat a change is required, the change is docu-mented and implemented. After implementa-tion of the change, the changed process must berevalidated. Revalidation starts at the beginningand continues through the entire validation lifecycle of the process, reviewing the effects of thechange on the previously documented IQ, OQ,and PQ results.

The summary reportOnce all the documentation is accumulatedfrom the installation qualification, operationqualification, and performance qualification, asummary report is prepared. This completes thevalidation Master Plan. It consists of a summa-

tion of the life cycle that has been outlined inthe validation protocol, documentation of thetesting, and verification of the test data. Oncedata is compiled and verified, statistical analysisis performed on the data and included in thesummary report.

ConclusionThe concluded validation process is a docu-mented and verified record of the installation,operation, and performance of a manufactur-ing system, which was defined in the validationMaster Plan. The execution of the validationprocess defines the normal operating func-tions, provides documented procedures toevaluate the system, and allows preventive andcorrective actions to be executed in worst casescenarios. The facility staff is able to operate,monitor, and evaluate the validated system.

The summary report becomes the referencethat defines the operational and performancecharacteristics of the system that can bereferred to when questions arise or changes tothe system are proposed.

Jan Eudy is a technical resource for ESD,cleanroom, food, and healthcare garments and products. At Cintas, she directs the quality systemand ISO registration for cleanrooms and supportsvalidation and sterile services. She is PresidentEmeritus and Fellow, Institute of EnvironmentalSciences and Technology.

20 ASK JAN

Example of OQ checklist.

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21 May 2013 www.cemag.usNEWS

Fujifilm Diosynth BiotechnologiesCommissions Cell Banking Facility

Fujifilm Diosynth Biotechnologies has commis-sioned its new mammalian cGMP Cell BankingFacility at its Billingham, U.K. site.

The CBF is available to the companys cus-tomers either as part of a larger developmentand manufacturing program or as a stand-aloneservice. It forms the second stage of a majorexpansion of the companys mammalian cellculture capabilities at the site. The asset will sup-port delivery of manufacturing programs for bothof Fujifilm Diosynth Biotechnologies facilities inBillingham and Research Triangle Park, N.C.

The next stage of the companys expansionwill be the commissioning of a new cGMP manu-facturing facility, also in Billingham, which is underconstruction and due on-line in early Q4 2013.This manufacturing facility, which will primarily uti-lize single-use technologies, has been designed tooffer high flexibility for meeting customers needsand setting new standards. It will initially offer 200L and 1,000 L single-use bioreactors, with 2,000Lbioreactors already planned for 2014.

NASA Selects MIT-led TESSProject for 2017 MissionFollowing a three-year competition, NASAhas selected the Transiting Exoplanet SurveySatellite (TESS) project at MIT for a plannedlaunch in 2017. The mission will be funded by a$200 million grant to the MIT-led team.

The project will use an array of wide-fieldcameras to perform an all-sky survey to discovertransiting exoplanets, ranging from Earth-sizedplanets to gas giants, in orbit around the brighteststars in the suns neighborhood. An exoplanet isa planet orbiting a star other than the sun, whilea transiting exoplanet is a planet that periodicallyeclipses its host star.

Every two weeks TESS approaches closeenough to the Earth for high data-downlinkrates, while remaining above the planets harm-ful radiation belts. This special orbit will remainstable for decades, keeping TESSs sensitivecameras in a very stable temperature range.

With TESS, it will be possible to study themasses, sizes, densities, orbits, and atmo-spheres of a large cohort of small planets,including a sample of rocky worlds in the habit-able zones of their host stars. TESS will provideprime targets for further characterization by the

Industry NEWS

Continued on page 26

Cell banking facility expands site capabilities.

Artists rendering of TES S in orbit.Illustration: Chet Beals/MIT Lincoln Lab
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Q Can you providean overview onthe use of mini-environments incleanrooms?Good things come in(sometimes) small(er) packages.

-Proverb (edited)

There was a timewhen micro- andmini-environmentswere hailed as the

next big thing. When they appeared onthe scene, some of the more rash futurists(generally not engineers) predicted that theywould someday be the death knell of thecleanroom. Obviously not soas evidencedin the electronics industry by the ongo-ing evolution to 450 mm wafers. Despiteremaining and unprecedented technicalchallenges, the 450 mm movement will drivethe largest electronics industry retooling inhistory. 450 mm fabs are projected to costapproximately $10 billionwith the rstslated to come on line in 2017. Hardly thewhimpering expected from the deathbed ofany facility type.

Definitional confusionThere was (and still continues to be) someconfusion, or perhaps exibility, aroundterminology: mini-environments versusmicro-environments. And common us-

age can vary from industry to industry,sometimes used a bit loosely, and extendto additional industry specic terms, likeisolation units.

For the purposes of this column, wellconsider the terms mini-environmentand micro-environment interchangeablebut use the term mini-environment. Wellexclude classically dened micro-environ-ments, such as containers to enclose wafersfor transport or isolate parts of a wafer. For

clarity, well dene mini-environments as anengineered enclosure, custom built or pre-manufactured, that controls and maintainsa specied environment around a produc-tion process or product to protect either theproduct or the operator. Whether to accom-modate specialty coatings processes, phar-maceutical production, or critical dryroomhumidity controls for a lithium-ion battery

manufacturer, the root purpose of a mini-environment remains the same: to enhancethe controlled environment to a higherstandard, creating a higher class cleanroomwithin an existing clean facility.

Mini-environments can be controlled forparticulate matter concentration, humidity,temperature, pressure, make-up and re-cir-culated air, gaseous inltration, or hazardouschemical containment to protect the opera-tor. In short, consider these environmentsa cleanroom within a cleanroom used toenhance the environment within a clean-room to a higher standard for either process,protection, or production purposes.

Size mattersDont let the use of words like mini andmicro fool you. Mini-environments canrange from small gloveboxes to an enclosurethe size of a room. Sizing specs are gener-ally dictated by the industry sector, as well

as the specic process an engineer is design-ing to. For example, in the solar industry itwould be common to insert a 10 ft. by 10 ft.mini-environment into the beginning andend of a 100 ft. long production process,to protect against exposure. Recently, for apharmaceutical client, we designed a 20,000lb. glovebox. While it was dimensionally 4 ft.by 10 ft., it required full lead lining due to itsrequirement to handle radioactive materi-als. In a vivarium, the facilities engineer may

opt to control throughout the entire facilityhousing the animals, or create individualmini-environments the size of cages to allowfor variable air circulation, as well as tem-perature and humidity control.

Design considerationsFirst, a basic premise: you cant create aclean mini-environment within a dirty

environment. Mini-environments are ofteninserted in a cleanroom when exibility,expansion, process requirements, energy, orcost are the driving considerations. The useof a mini-environment can be more costeffective, for example, when one aspect of aproduction process requires a class upgradenot required for the rest of the productioncycle. It can be less expensive to insert amini-environment controlled for a higherstandard of particulate control, humidity,or air ow, for example, than to upgrade anentire clean manufacturing facility.

The selected use of mini-environmentscan also dramatically reduce the cost of newconstruction, as it can be more cost effectiveand operationally efcient to selectively insertmini-environments to accommodate higherlevel processing needs than to overdesign anentire controlled environment facility. Thiscost savings can manifest itself both in initialconstruction and ongoing operations.

22 ASK THE FACILITIES GUY

A mini-environment enhances the cleanroom setting by bringing it to a higher standard.

Richard Bilodeau, PEDirector of Engineering

SMRT, Andover, Mass.

:

A Closer Look at

A:
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Mini-environments can be customdesigned and constructed or purchasedas a pre-fabricated unit. The decisionto deploy a pre-manufactured unit orcustom build will be driven by a varietyof factors, including but not limited toproduct dimensions, availability, criti-cal components the mini environmentmust regulate and control, schedule, andanticipated future expansion needs.

The design considerations in creatinga mini-environment go well beyond thescope of this article. The seminal guide

to recommended practices in the engi-neering of mini-environments is IEST(RP)CC 028.1 (available at www.iest.org).

IEST (RP) CC 028.1 was six years duein part by the continuing evolution ofthis concept and its adaptation to vari-ous industries. The guide covers, amongother topics: Applications and Concepts: An over-

view of mini-environments, and theiruse, applications, and characteristics

(with sketches). Planning: This section reviews not onlythe advantages and disadvantages oneshould consider when analyzing the useof a mini-environment, but it also delvesinto the always important (but too oftenoverlooked) facility support needs. As afacilities engineer considers the use ofmini-environments, its important todene, for example, how often one needsto adjust the equipment and what clear-ances are required to easily access theprocess equipment.

Design Considerations: Every facilityengineers favorite topic! The RP delvesinto topics including construction mate-rials, temperature and humidity controls,vibration and noise considerations,electromagnetic compatibility, lighting,safety, and ergonomic issues. Evaluation and Testing: Providing amethodology for testing and evaluat-

ing mini-environments, the RP helpsguide the facilities engineer or operator

through a sound evaluation process ofvarious mini-environments. Specied testmethods are outlined for particle counts,air ow issues, as well as air velocity,volume, and pressurization among otherfactors.

The RP does not address microbio-logical issues or applications. The docu-ment was prepared by Working Group028 of the IEST Contamination ControlDivision.

Mini-environments raise macro ques-tions for the facilities engineer and the best

advice going is to use the ISPE Best Practicedocument as a guideline to be sure you walkthrough and answer the myriad questions anysound planning process requires.

Richard Bilodeaus 30-year career includes plantengineering positions in clean manufacturing. He hasdesigned, operated, and supervised the constructionof advanced technology facilities and engineered cleanmanufacturing facilities for lithium-ion batteries,medical devices, electronics, and pharmaceuticals.Contact: [email protected]


Mini-Environments

Continued from page 15

Perrfect water?No single water treatment process meets allmanufacturing requirements. Water softeningreplaces one ionic material with another. DI pro-cesses do not remove non-ionic materials, eitherdissolved or particulate. One industrial facility inthe Northwest U.S. found fragments of salmoneggs in the effluent of a DI system. Distillationwill not eliminate impurities such as organicsolvents with substantial vapor pressure. ROprocesses separate most, but not all, dissolvedmaterial. Ultra-violet (UV) light may kill bacte-

ria and other life forms but does not separate thedead bacteria from the water.

Getting water to be purer and keeping itpure are two separate issues. Because water is

such an aggressive solvent, ultra-pure 18 Mega-ohm water generally does not remain purefor long. Ions can leach into pure water fromcontainers and pipes. Even small amounts ofatmospheric gases, including carbon dioxide orlaboratory acid fumes, can rapidly degrade thepurity (and resistivity) of water.

What process is best for my application?The answer, again, depends on knowing what you need. For cleaning of gross amounts of con-taminants at an early stage of assembly, tap watermay be adequate, provided that the seasonal

consistency is acceptable. Keep in mind that ifthe process is moved to another location, the tapwater may be different. Also, because dried-oncontaminants tend to be more adherent, any

impurities in the tap water that remain when thepart is dry may be more difficult to remove ata later stage of operation. For general cleaning,perhaps a single stage DI or RO system will pro-vide the purity and consistency needed. Manyhigh performance applications employ systemsthat incorporate more than one treatment pro-cess, or have a multi-pass system to increase thepurity. Any system must be properly monitoredand maintained.

Barbara Kanegsberg and Ed Kanegsberg (theCleaning Lady and the Rocket Scientist) are inde-

pendent consultants in cr itical and precision clean-ing, surface preparation, and contamination control.They are the editors of T he Handbook for CriticalCleaning , Second Ed., CRC Press. Contact:[email protected]

BENCHES AND WORKSTATIONS24
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BENCHES AND WORKSTATIONS24

Horizontal Flow Clean BenchClean Rooms International offers a horizontal flow clean bench that provides Class 100HEPA filtered air in a horizontal laminar flow pattern across an isolated inspection table. Theinspection table is independent from the clean bench for vibration-free applications.

The isolation inspection table utilizes a back-lit translucent acrylic work surface on apowder-coated frame. Air is taken into the unit through a pleated type, disposable pre-filterrated at 30% ASHRAE efficiency, then passes through the final HEPA or ULPA filter. The stan-dard HEPA filter is 99.99% efficient at 0.3 micron or larger. The ULPA grade filter is 99.9995%efficient at 0.12 micron and is available as an option. Final filters are easy to replace fromthe front of the unit.

A panel-mounted Magnehelic gauge monitors HEPA filter static pressure. Pressureincreases in correlation with a dirty filter to indicate that a new HEPA filter is required. Filter

life is dependent on frequency and type of use of the clean bench. All models are equippedwith a flourescent light fixture, with a T8 electronic ballast and universal voltage.www.cleanroomsint.com

Wet Process BenchesLeatherwood Plastics offers cleanroom benches for etch-ing, plating, stripping, cleaning, and other wet chemicalprocesses. Manual or semi-automatic control technol-

ogy, an ergonomic design, and multiple bath configura-tions are tailored to suit the users process specificationswhile emphasizing safety.

Process options include heaters, filters, recirculation,cooling coils with an optional temperature recirculator,and ultrasonic and megasonic processing. Rinse optionsinclude spray, cascade, overflow, and still and quickdump rinses. Other options include bulk fill, mechani-cal and/or air agitation, updraft or downdraft exhaust,onboard and removable waste reservoirs, HEPA filtration,nitrogen, and CDA or DI water spray guns.

The benches are made from FM4910 approved plas-tics or stainless steel, meeting or exceeding SEMI S2 andS8 specifications. They include options for third-partySEMI S2 and S8 evaluation and FM-approved fire sup-pression systems.www.leatherwood.com

Height-Adjustable WorkbenchesIAC Industries introducesits 930 Pro Series and 940Pro Series of height-adjust-

able workbenches. Theversatility of easy worksurface height adjustmenthas popularized this typeof workbench in a varietyof environments such asmanufacturing, assembly,and laboratories.

The work surfacereduces strain and fatiguein shoulders, arms, andthe back. Both seriesincorporate a cantileversupport system, housingthe hydraulic lifters, thatprovides maximum leg andknee room by eliminatingthe front legs found onconventional benches. The

180 rolled front edge forthe work surface provides a comfortable rest for forearms.A rotating hand crank manually controls height adjustment on the 930

Pro Series, and the crank handle folds out of the way when not in use.Adjustment on the 940 Pro Series is electrically actuated via up/down push-buttons. Either controller may be positioned on the right or left side, underthe work surface support frame.

A steel channel frame and 1/25-in.-thick work surface provide for a full500-lb. evenly-distributed load capacity. The work surface in both modelstravels 12 in. to provide heights ranging from 30 to 42 in. The work surfaceis available in standard or ESD laminate, with a wide variety of color choice. There are different options available for suspended drawers/cabinets,electrical channels, and upper utility structures with shelving and lighting,offering many configurations.www.iacindustries.com

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Stainless SteelFurnishings

RPA offers a full line of stainless steeltables, benches, and workstations. These

all designed for cleanliness, practicality,ergonomics, and strength in a clean-

room environment.Palbam Class designs

and produces stainlesssteel cleanroom furni-

ture that can be found in

cleanroom production lines,biomedical and pharma-ceutical labs, and semicon-ductor fabrication facilities. The furnishings are used byhigh-technology companieswhenever sterility, endur-ance, and productivity arevital to a companys well-being.www.rpaproducts.com

Ergonomic Workstations Teknomeksheight-adjustableworkstation hasbeen designed andmanufactured with

health and safetyin mind to reducethe risk of injuries. The hydraulically-powered worktopensures employeesarent using make-shift platforms like pallets, which pose an additional health andsafety threat. An adjustable production line allows employees to

move positions without compromising their comfort, efficiency,health and safety, factory aesthetics, or general hygiene. The ergonomic workstations seek to end repetitive motion

injuries and musculoskeletal disorders that result from static-loading duties or doing repetitive tasks over prolonged periods. The workstation remains hygienic and robust in even the moststringent hygienic environments.

Manufactured from quality 304-grade stainless steel to exactingstandards, using precision welding, the steels chromium oxide self-healing film ensures the surface is hygienic even when damaged. The tabletop height adjustment is available from 27 to 39 in., with amaximum load of 1,300 lbs. The workstation can also be fitted withan optional polyethylene worktop for extra protection, and can alsoaccommodate the optional drawer units and retractable waste bins.www.teknomek.co.uk

Customized ExhaustWorkstationsBrewer Sciences Cee X-PRO workstationsoffer customized exhaust enclosures thatintegrate with their stand-alone cabinets andcreate a virtual cleanroom environment. Theupper enclosures can be designed for ductlessor ducted exhaust. The enclosure features afan filter unit for vertical laminar flow througha particle filter (ULPA, HEPA, or carbon aminefiltration) of various efficiencies.

The hood is also compatible with optionalprogrammable meters for detecting and logging(with X-series software) environmental conditionsincluding air pressure, velocity, flow, humidity, andtemperature stability and uniformity. The X-series softwarewill automatically monitor these conditions in real time and pro-vide users with the ability to program error limit warning thresholds.

Brewer Sciences Cee products offer a matching stainless steel exhaust-ed cabinet that provides secondary containment for all process chemicalsincluding the waste tank. The result is a fully capable stand-alone equip-ment system that allows the system to ship fully assembled. This optioncan be combined with a Brewer Science Cee X-PRO workstation to con-trol vapor fumes and/or create a mini-environment. The options for anexhausted cabinet and upper enclosure are SEMI S2 and CE compliant.www.brewerscience.com

PCR EnclosuresErlabs CaptairBio PCR Workstationsprotect sample preparations frommolecular and particulate contamina-tion. The workstations use a UV lamp,which allows the working environmentto be decontaminated in order to pre-vent contamination of samples. Thesterile housing filtration is controlledby a fan that draws in air from the lab

and passes it through a HEPA H14 filter,which traps particles 0.1 microns andhigher. The CaptairBio technology workswith positive pressure and has a flowrate of 183 to 235 CFM to ensure ISO5 air quality standards within theenclosure. The air flow meter system allowsair face velocity to be constantly monitored and indicates blockage ofthe HEPA H 14 filter, and the energy ports located on the side panelsof the enclosure offer convenience for the user. The ergonomic worksurface is made of stainless steel, with an arm rest to provide a comfort-able working position. Each fume hood is outfitted with energy efficientinternal lighting. The workstations come in sizes ranging from 32 to 71in. and work with both HEPA and carbon filters.www.captair.com

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BUSINESS MARKETPLACE

26 May 2013 www.cemag.usNEWS

James Webb Space Telescope, as well as otherlarge ground-based and space-based telescopesof the future.

Previous sky surveys with ground-based tele-scopes have mainly picked out giant exoplanets.NASAs Kepler spacecraft has recently uncovered theexistence of many smaller exoplanets, but the starsKepler examines are faint and difficult to study. Incontrast, TESS will examine a large number of smallplanets around the very brightest stars in the sky.

Masdar Institute EtchesFirst Silicon Wafer in UAEMasdar Institute of Science and Technology, anindependent, research-driven graduate-level univer-sity focused on advanced energy and sustainabletechnologies, announces that its research staff have

etched a silicon wafer for the first time in the UnitedArab Emirates.

With the etching of the silicon wafer, the MasdarInstitute Fabrication Facility has entered the opera-tional phase. Etching is used in micro-fabrication tochemically remove layers from the surface of a waferduring manufacturing.The facility achievedDeep Reactive IonEtching (DRIE) throughthe Bosch process,which also enables theuse of silicon mechani-cal components in high-

end wristwatches.DRIE was devel-oped for micro-elec-tromechanical systems (MEMS), which is also

used for high-density capacitors for direct randomaccess memory (DRAM). More recently they areused for creating through silicon vias (TSVs) inadvanced 3D wafer level packaging technology.TSV interconnects are emerging to serve a widerange of 3D packaging applications.

MEMS devices can be made using siliconwafers and the manufacturing process can incor-porate semiconductor manufacturing processessuch as sputtering, deposition, etching, and lithog-raphy. Some MEMS devices include smartphones,tablets, game controllers, notebooks, and digitalcameras. The technology also enables function-alities such as augmented reality applications,

indoor navigation, immersive video gaming, heartrate/blood pressure monitoring, e-reader displays,and improved voice communications.

Brookhaven Lab OpensEnergy Research BuildingThe doors have opened at the InterdisciplinaryScience Building, a new research facility at theU.S. Department of Energys Brookhaven NationalLaboratory where scientists will work to drive break-

through solutions to the nations energy challenges.Scientists at the ISB will engineer and optimizematerials with the goal of developing technologiesfor batteries, biofuels, and solar panels. This hubfor energy research at Brookhaven Lab will pro-vide customized laboratories for multidisciplinaryresearch teams.

The ISB is an 87,700 ft 2 facility which con-tains offices, 60 standard laboratories, and four

specialty labs with unique features, including ahumidity-controlled dry room where researcherscan safely assemble and test new lithium-ion bat-teries; two ultra-low vibration laboratories housingthe Spectroscopic Imaging Scanning TunnelingMicroscope (SI-STM) used to explore materialselectronic structure at the atomic scale; and theOASIS laboratory, which connects a lab custom-ized for molecular beam epitaxy (MBE)a process

researchers use to fabricate new materials oneatomic layer at a timewith one of the ultra-lowvibration labs via a vacuum-locked system. Thissystem allows scientists to transport MBE-createdsamples directly to the SI-STM microscope with-out exposing them to air.

Continued from page 21

The Interdisciplinary Science Building houses a

humidity-controlled dry room, among other labs.

Etching process aids on-going faculty research.

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EDITORIAL INDEX

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