controlled environments - 01 jan 2012

JANUARY • 2012 VOL. 15 • NO. 1

Failure Modes and Effects Analysis

Static-Control Flooring

Pharma Facility Quality Audits

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4 � January 2012 Controlled Environments � www.cemag.us

7 Point of View An Apple To Apple Comparison on Cleanroom ProposalsKELLY BARTON

9 Failure Modes and Effects Analysis (FMEA)A tool to balance cost and schedule while maintaining Facilities Readiness SCOTT MACKLER

11 Why Static-Control Flooring Is So Important—And How to Find Solutions to Keep You GroundedSelecting the right kind of ESD (electrostatic discharge) flooring is always a challenge, and in controlledenvironments, the stakes are particularly high. DAVE LONG

17 Pharma Facility Quality Audits: A Primer for Design TeamsHere is a familiar demand: “Show me where in the regulations it says to do that!” If you’ve spent any time inQuality, working on a facility or equipment project in the pharmaceutical industry, you have certainly hadthat put to you at some point. SCOTT OVERTON

20 NanoTalkNano is Big in North CarolinaAHMAD SOUEID, AIA, LEED AP

22 Ask the Facilities GuyHow do I produce a Disaster Recovery Plan?RICHARD BILODEAU, PE

27 Contamination Control in and Out of the CleanroomCosmetics and CleanroomsBARBARA KANEGSBERG, DR. KEVINA O’DONOGHUE, AND ED KANEGSBERG

29 C4: Critical Cleaning for Contamination ControlAll the News That’s Fit to Print...JOHN DURKEE, PH.D., P.E.

24 Featured Products Consumables and Supplies

25 Pencil It In25 Business Marketplace

26 Industry News30 Advertiser Index

Controlled Environments Magazine® (ISSN1556-9268) is published eleven times per year, by Vicon Publishing, Inc., 4 Limbo Lane, Amherst, NH 03031.USPS 021-493 Periodicals Postage Paid at Amherst, NH 03031 and at additional mailing office. A requester publication, Controlled EnvironmentsMagazine® is distributed free to qualified subscribers in the US and Canada. Non-qualified subscription rates in the U.S and Canada: $120 per year.All other countries: $180 per year, payable in U.S. funds. Back issues may be purchased at a cost of $15 each in the U.S. and $20 elsewhere. Whileevery attempt is made to ensure the accuracy of the information contained herein, the publisher and its employees cannot accept responsibility for thecorrectness of information supplied, advertisements, or opinions expressed. POSTMASTER: Send address changes to Controlled EnvironmentsMagazine, PO Box 1273, Skokie, IL 60076.

©2012 Controlled Environments Magazine® by Vicon Publishing, Inc. All rights reserved. No part of this publication may be reproduced withoutpermission from the publisher. Permission is granted for those registered with the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers,MA 01923 (phone: 978-750-8400; fax: 978-750-4470) to photocopy articles for a base fee of $1 per copy of the article plus $.35 per page.

Canada Agreement number: PM40063731, Return Undeliverable Canadian Addresses to: Station A , PO Box 54, Windsor, ON N9A 6J5, Email:[email protected]

JANUARY 2012VOL. 15 • NO. 1

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EDITORIAL Mary Williams - [email protected] x113

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

Ahmed A. Busnaina, Ph.D.NSF Center for Microcontamination Control -Northeastern University

Scott MacklerCleanroom Consulting, LLC

Gregg A. Mosley Biotest Laboratories, Inc.

Conor Murray3dimension

Robert NightingaleCleanroom Garments

Bipin Parekh, Ph.D.Entegris, Inc.

Morgan PolenLighthouse Worldwide Solutions

Michael RatajAramark Cleanroom Services

Raymond K. Schneider, P.E.Consultant and Faculty MemberClemson University

Howard Siegerman, Ph.D. Siegerman and Associates, LLC

Matt Smith, P.E., PMPCH2M HILL

Scott Sutton, Ph.D.Microbiology Network, Inc.

Art Vellutato, Jr. Veltek Associates, Inc.

Bob Vermillion, CPP/Fellow RMV Technology Group LLC

ART & PRODUCTIONBarbara Longfellow - Production [email protected] Scofield - Ad Traffic [email protected] x101

ADMINISTRATIONPatrick Murphy - C.E.O./[email protected] Galvin - Editorial [email protected]

ADVERTISING SALES Luann Kulbashian Associate Publisher/Sales [email protected]

REPRINTS/ePRINTSBetsy [email protected]

CUSTOMER [email protected] subscriptions, renewals, changes of address,back issues, and all customer service questions

EXECUTIVE OFFICESVICON PUBLISHING, INC.4 Limbo Lane • Amherst, NH 03031603-672-9997 • fax 603-672-3028 www.cemag.us

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How Do I Get An Apple To Apple Comparison On Cleanroom Proposals?

That’s a tough one, but for simple, relatively small cleanroom projects there are a few things thatyou can do to help ensure everyone bidding the job is “singing from the same song sheet.” Nomatter how simple, it’s very important to generate a specification sheet and conceptual drawing orsketch and make sure all the prospective bidders get it and reference it in their proposal. Thesketch must include the ceiling height in the cleanroom and room sizes. Ask them to separatelyitemize any items that they feel are needed but are not included in the spec sheet. If you do nothave anyone in your organization qualified to generate this document, hire an outside consultantwith the understanding that all you need is a very basic scope statement. The time you spend try-ing to figure out the differences between bids will cost you more time, money, and frustration thanthe consultant will charge. Plan on at least two bid phases, initial and final bids. As you evaluatethe bids you will get a better understanding of what is needed and can make better decisionsregarding what to specify in the final bid phase. The evaluation phase of the bids can almost be aneducation on cleanroom design for your staff. Don’t be shy about asking contractors why one pro-posal is different than another. Make sure you are comfortable with their explanation.

Here are some very important specifications to include in your document that are critical for acontractor to determine cost. If everyone gets a spec sheet with these variables defined, your finalbids will be more accurate and should be more consistent.

1. Room Classification, either Fed Std or Iso spec should work here.2. Temperature specification and tolerance. Example: 68 +/- 5 Deg. 3. Humidity specification and tolerance. Example: 50 +/- 10% RH. Let the bidder know if the

temperature and humidity specifications are process critical or operator comfort. If humiditycontrol does not affect your product, leave it out. It is the most costly specification to controlfor the HVAC system.

4. Amount of process exhaust in CFM. This is relevant since both outside air to generate roompositive pressure and air removed from the cleanroom by the process has to be accountedfor.

5. Process heat load in kilowatts (KW). Are there ovens, large process machines, or just opera-tors in the cleanroom? If you are not sure about this item, list the connected electrical voltageand current draw (amps) to start with. This will ensure some A/C tonnage is dedicated to thisspecification.

6. Number of operators. This affects temperature and to some degree, humidity.7. A brief definition of the manufacturing process or product in the cleanroom may also help.8. A description of the host building is helpful since this may affect where the HVAC equipment

can be placed.You may have other critical parameters, but these values will help everyone size the mechanical

system. Wide variation in A/C tonnage numbers is an indication that the contractor may not under-stand cleanroom design and you should ask them to explain the differences. For lowerclassification or more complicated cleanrooms, a professional generated specification is needed.Always check references.

Kelly Barton, is Sr. Sales Engineer with Clean Rooms West, he may be reached at [email protected].

POINT OF VIEWKelly Barton

Controlled Environments � www.cemag.us January 2012 � 7

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Failure Modes and Effects Analysis (FMEA)A tool to balance cost and schedule while maintaining facilities readiness.

Scott Mackler

In the October issue of Controlled Environments,Richard Bilodeau, “Ask the Facilities Guy” wrote aboutestablishing an “Equipment Reliability” program. Whileclearly an important issue, it is one that often facilitiesdepartments have a hard time getting their armsaround—as Richard points out. One tool that we havefound quite useful in supporting high facility on-stream time and process yield factors, as well assustainability, is the equipment or hardware FMEA(Failure Modes and Effect Analysis). The FMEA exer-cise will provide the facilities team with a prioritized“risk burn-down” plan for ensuring readiness and canserve as a convenient basis for capital and operatingexpense budget creation and execution.

We have recently performed FMEA exercises foraerospace assembly, integration, and test facilities,aseptic filling laminar flow units and accompanyingHVAC systems, thermal vacuum test chambers, pow-der metallurgy processing lines, precision cleaningequipment, and continuous web processing machin-ery. In many cases not only were predictive andpreventive maintenance issues uncovered andaddressed with corrective action plans developed as aconsensus among customers, users, service providers,and subject matter experts, but in a few cases, seriouslife safety and product safety issues were brought tolight and effectively dealt with before a catastrophe—likely one without warning—could occur.

An FMEA identifies the severity, occurrence, anddetection of failure effects and then establishes prior-ity-ranked corrective action plans. A cross-functionalteam including the customer or process owner, subjectmatter experts, facilities and maintenance specialists,quality assurance, and design engineering participatein a brain-storming exercise that identifies each poten-tial failure and ranks the possible effects of eachfailure and develops a resulting RPN or “Risk PriorityNumber.” The RPN is the arithmetic product of theseverity multiplied by the (probability of) occurrencemultiplied by the (ability of) detection.

The objectives of the FMEA are to:• Ensure that potential failure modes and their effects

are identified and ranked as to severity, occurrence,and detection.

• Provide assessment as to risk ranking based on RPN(Risk Priority Number) and generate action registerto burn down risk—thereby reducing life cyclecosts, improving reliability and durability of systems.

• Prioritize the engineering efforts and resourcesbased on the assessment of potential failure impactsto the product and eliminate or minimize the impactof potential failures to the product.

• Provide information for development of an efficientand effective preventive maintenance plan.

• Establish closer links between production, quality,facilities engineering, and maintenance. ➤


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Examples of suggested scales for severity, detection, and occurrence mightbe:


Severity Rank Criteria (Effect)

None 1 Process parameter variability within specification limits.Adjustment to process controls can be done duringnormal maintenance.

Minor 2 Downtime of up to 30 minutes but not out of specifica-tion environment.

Low 3 Downtime of greater than 30 minutes and less than 4hours and/or out of specification environment.

High 4 Downtime of greater than 4 hours and/or out of speci-fication environment.

Hazardous/ 5 High Severity ranking—affects personnel and safety Very High and/or causes non-compliance with government regu-

lations with or without warning.

Occurrence Rank Criteria: Possible Numberof Failures within Hoursof Operation

Failure occurs every 5 years 1 1 in 25,000

Failure occurs every year or more 1 1 in 5,000

Failure occurs every 3 months 2 1 in 1,000

Failure occurs every week 3 1 in 80

Failure occurs every shift 4 1 in 8

Detection Rank Criteria

Certain 1 Controls certain to detect a potential cause and subse-quent failure. Controls will prevent an imminent failureand isolate the cause.

High 2 High chance that controls will detect a potential causeand subsequent failure. Controls will prevent an immi-nent failure and isolate the cause.

Medium 3 Medium chance that controls will detect a potentialLikelihood cause and subsequent failure. Controls will provide an

indication of imminent failure and may, or may not,prevent failure.

Low 4 Controls do not prevent failure from occurring. Likelihood Controls will isolate the cause and failure mode after

the failure has occurred.

Remote 5 Very remote chance that controls will detect a potential Likelihood cause and subsequent failure mode, or there are no

controls.

Typically the deliverables ofthe FMEA include a Pareto Chartillustrating the number of failureitems and risk effects that wereidentified and subsequentlyranked by RPN during the brain-storming and analysis sectionsof the exercise, and then eithera projected or an achieved burn-down of the RPNs afterdevelopment and execution ofthe Corrective Action Plan.

FMEAs are an easy to applytool and provide a structure fora cohesive, well thought outapproach to prioritizing andresolving facilities and equip-ment issues. The hardest part ofany FMEA exercise is that whena team of true “problem solvers”is first brought together, thegreatest temptation is to jumpright to the action register with-out first taking the time to reallyunderstand the contributors tothe risk and the risk ranking. Agood facilitator makes all thedifference in our experience.

Scott Mackler is founder and principalof Cleanroom Consulting, LLC, a firmspecializing in contamination controlindustry services, including require-ments development, cGMP cleanroombasis of design, process isolation appli-cations, clean environmenttroubleshooting and Foreign ObjectElimination, assessment and correctiveactions for FDA validatable critical facil-ities, contamination controlconsultation, cleanroom facilities valua-tion, and new product development forthe contamination control marketplace.

pp09-10_-- 12/12/11 3:06 PM


Why Static-Control Flooring Is So Important—And How to FindSolutions to Keep You GroundedSelecting the right kind of ESD (electrostatic discharge) flooring isalways a challenge, and in controlled environments, the stakesare particularly high.

Dave Long

While cleanroom environments are known for theexacting standards used to control contaminants,it’s ironic that their anti-static flooring doesn’talways meet industry specifications. This is a criti-cal concern on several levels:• First, the ESD problem is intensifying as elec-

tronic devices continue to become smaller andmore powerful. Miniaturization, also known asdevice scaling, reduces the room for on-chipprotection, increasing vulnerability to ESD andaccenting the need for static-control, fault-tolerant flooring.

• In addition, recent and proposed changes toESD standards, including ANSI (AmericanNational Standards Institute), increases chal-lenges to manufacturing facilities seeking ISOcertification. These changes address the need tocomply with revised static-prevention perform-ance parameters, with failure to do so exposingcompanies to potential lost business due tonon-compliance.

• Floors installed in cleanrooms have enormousbottom-line implications if you consider thepotential costs of installing a new, correctlyspecified, floor after your facility is operational. In other words, it is paramount to get your ESD

flooring right the first time, and there should be no

room for compromising within the precious realestate of cleanrooms. Yet, problems persist. Why?

INITIAL CONSIDERATIONSUnderstandably, many engineers and facility man-agers are frustrated and confused when it comesto selecting static-control floors for their factories.They typically don’t have the time nor the expert-ise needed to deal with electrical specificationsand standards. Selecting a floor includes consider-ations like maintenance, durability, ergonomics,safety, installation procedures, and, most impor-tantly, how the floor controls static charges onpeople based on their footwear.

In cleanroom environments, the process oftenrequires the assistance of outside experts whospecialize in ESD, contamination control, ionchromatography, material out-gassing tests, andparticle analysis.

Overall, depending on the application and siteconsiderations, ESD floors can be installed overold floors, over bare concrete, or on top of raisedaccess-flooring panels. However, due to contami-nation and particle control considerations, onlythree forms of ESD flooring are generally consid-ered suitable for cleanroom environments: rubber,vinyl, and epoxy. ➤

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With this as the backdrop, the following will focuson key factors to consider in the evaluation and selec-tion process, including electrical resistance, footwear,cleanliness, mechanical properties, and ergonomics.

ELECTRICAL RESISTANCE Rubber, vinyl, and epoxy floors can be produced ineither the conductive or the static-dissipative ohmsrange. According to the ESD Association, a conductivefloor measures below one million ohms (1.0 X 10 E6)when using test method ANSI/ESD S7.1-2005. Using thesame test, a floor measuring between one million ohmsand one billion ohms (1.0 X 10 E9) is defined as staticdissipative. As a general rule, most experts believe thatfloors measuring below 10 million ohms (1.0 X 10 E7)offer the best static-control performance for electronicmanufacturing and handling. Floors measuring above 10million ohms drain static more slowly than floors meas-uring in the conductive or lower end of thestatic-dissipative range (< 1.0 X 10 E7).

Also, ESD floors that are too conductive may not beconsidered safe. Most safety engineers refer to NFPA 99to define the minimum resistance of conductive floors.According to the 2005 version of NFPA 99, a floorshould not measure below 25,000 ohms (2.5 X 10 E4).There is a caveat when referencing NFPA 99, however:This test requires measuring a floor’s resistance usingan ohmmeter with a 500 volt output, and most of themeters used for testing conductive floors operate at 10volts. Unfortunately, this creates a potential safetydilemma for specifiers because a floor measuring25,000 ohms at 10 volts will measure far below theNFPA minimum of 25,000 ohms when tested at 500volts. For this reason, we recommend setting the resist-ance minimum above 50,000 ohms to address thediscrepancy caused by the two different test methods.

Upshot: Recommended floor range: greater than50,000 ohms and less than 10,000,000 ohms (5.0 X 10E4 – 1.0 x 10 E7).

FOOTWEARESD floors should never be evaluated solely on electri-cal resistance parameters, since that is only part of thestory. ESD standards like ANSI/ESD S20.20-2007require testing of both the resistive properties (ohms)and the charge-generation properties (volts) of thefloor. The ESD Association requires that the floor’s per-formance be evaluated in combination withstatic-control footwear. The first requirement in S20.20evaluates a property called “system resistance,” whichis determined using the ANSI/ESD S97.1 test method.In this test, the ohms resistance is measured from aperson’s hand to the ground—through the body, thefootwear, the floor itself, and the ground. As of

November 2011, an acceptable reading requires a sys-tem resistance below 35 million ohms (3.5 X 10 E7).(Note that before writing this article, we interviewedseveral members of the ANSI/ESD S20.20 committeeabout possible changes in the system resistancerequirement. We were informed that the requirementmight be raised to a maximum of 1 billion ohms (1.0 X10 E9). However, if this system resistance is increased,requiring body voltage testing at the same time willlikely offset it.)

Body voltage generation is determined by measur-ing static charges using test method ANSI/ESD S97.2.With this method, subjects wearing special static-con-trol footwear walk on ESD flooring while connected toan instrument that measures the amount of staticcharge the subject generates from the interaction of thefootwear and grounded floor. To meet ANSI/ESDS20.20, a person wearing approved, groundedfootwear cannot generate over 100 volts. Achievingthis parameter may be difficult in cleanrooms, how-ever, depending on the contamination-control footwearrequirements. Standard cleanroom shoe covers gener-ate static voltages in excess of 1,000 volts. Severalsuppliers offer disposable and permanent static-controlshoe covers with conductive or static-dissipative mate-rial on the bottom side.

Regardless of the shoe cover specifications, theyshould always be tested with the grounded floor. Test-ing has shown that many conductive andstatic-dissipative vinyl and epoxy floors will generatewell over the 100 volt maximum on test subjects wear-ing these types of booties and shoe covers. The sametesting has proven that conductive rubber flooring will


Body Voltage Generation. In controlled environments, bodyvoltage must measure below 100 volts to meet the parametersof ANSI/ESD S20-20.

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generate well under 100 volts combined with moststatic-control cleanroom footwear. This is because con-ductive rubber flooring generates significantly lessstatic than vinyl or epoxy flooring, regardless offootwear.

Upshot: Current system resistance requirement: < 35million ohms (3.5 X 10 E7). Proposed requirements:system resistance < 25 million ohms and body voltage< 100 volts.

CLEANLINESSWhen determining the compatibil-ity between construction materialslike flooring and cleanroomprocesses, there are numerous con-siderations. Here, we will touch onthe main factors: out-gassing andparticle transfer. According to ESDand contamination-control consult-ant Carl Newburg, president ofMicrostat Laboratories and River’sEdge Technical Services inRochester, Minnesota, “Out-gassingis a measurement of the quantity ofvolatile chemicals released from amaterial while it is heated. Con-densable volatile residue (CVR),Static Headspace, and DynamicHeadspace are typical tests used tomeasure out-gassed materials. Testresults offer an indication of thematerial’s tendency to contaminatesurfaces in a controlled environ-ment with airborne molecularcompounds.”

Most vinyl flooring materials failstringent, elevated temperature out-gassing testing due to the inclusionof plasticizers in the flooring mate-rial. Plasticizers are problematicbecause they can migrate out ofthe flooring material and create sig-nificant contamination problems incleanroom applications like opticsand MR head manufacturing. Wehave all experienced plasticizermigration through what we refer toas “new car smell.” This smell isthe result of airborne plasticizerout-gassing from all of the variousplastics used in an automobile’sinterior. Without thorough testing,this plasticizer migration would bedifficult to identity and quantify.

Many flooring manufacturers will state that their floor-ing will meet all out-gassing requirements at ambienttemperature, but most contamination-control expertsdo not believe that ambient testing is adequate.

Before specifying any flooring for installation, werecommend discussing the application with an expertin contamination control and ESD. As a rule of thumb,conductive rubber flooring and conductive epoxy ➤


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flooring will perform the best in elevated temperatureout-gassing tests. Unlike vinyl, rubber and epoxy aremade without plasticizers.

Upshot: Floors that pass elevated temperature out-gassing tests: conductive rubber and conductiveepoxy.

MECHANICAL PROPERTIESMost cleanroom floors are installed using methods thatcreate a seamless floor, which can be achieved withepoxy coatings because the material is coated ontothe floor in liquid form and allowed to flow across thesurface. The downside to seamless epoxy coatingsinvolves the difficulty and time required to makerepairs in the event of damage from scratches orcracking. A typical cure time for an ESD epoxy floor isbetween 24 and 72 hours, depending on the numberof layers. If a repair is performed in an operationalcleanroom, the epoxy could create contamination orodor problems during the time it takes to harden fromits liquid state. Additionally, epoxy repairs usuallyrequire some form of abrasive floor preparation tomake the surface fit for recoating. Abrasive floor

preparation could generate particles that contaminatefixtures and HEPA filters.

Rubber and vinyl can also be installed withoutseams using a technique called seam welding, whichfills in and fuses gaps resulting from the interactionsof sheet floor flooring or adjacent tiles. Both tiles andsheet floors can be seam welded (similar to caulking),but most specifiers prefer sheet flooring since thereare fewer seams to weld. The welds in rubber sheetflooring are less visible compared with vinyl weldsbecause, unlike vinyl, rubber does not shrink. Rubberand vinyl floors can be repaired more easily thanepoxy using simple techniques that don’t require abra-sive floor preparation techniques. Conductive rubbersheet flooring can be installed with fast-drying, pres-sure-sensitive adhesives that can usually be applied inan operational cleanroom. Pressure-sensitive adhesivesallow for foot traffic within an hour of the repair.

ERGONOMICSOf the three most common cleanroom flooringoptions, rubber offers the most slip-resistant walkingsurface, wet or dry. Rubber is also softer underfoot,and it absorbs ambient noise better than hard epoxyand vinyl surfaces. Even though it is much harder thangeneric rubber used in forms like anti-fatigue matting,rubber can become damaged from rolling heavy loadsover it. Compared with epoxy, it is also more difficult


Shoe Cover or Bootie. This is a com-mon shoe cover, or bootie, worn incleanrooms. To meet the ANSI/ESDS20.20 standard, people wearingapproved footwear cannot generateover 100 volts. Anti-static Rubberflooring works best with thisfootwear, generating well under 100volts.

Disposable Shoe Cover. Specialized footwear like this isrequired in controlled environments; unlike the booties, theseshoe covers are typically used in less stringent environments.

Out-gassing. Conductive rubber flooring and conductiveepoxy flooring perform the best in elevated temperature out-gassing tests because, unlike vinyl, rubber and epoxy aremade without plasticizers.

pp11-15_-- 12/15/11 9:34 AM

to roll heavy racks weighing thousands of poundsover rubber. In some cases, epoxy may be the onlypractical flooring option due to its toughness and abil-ity to handle rolling loads and chemical spills.

Upshot: Rubber offers the most ergonomicallyfriendly solution.

SIMPLIFYING THE SELECTION PROCESSIndeed, there is a vast amount of technical informationto consider when selecting static-free flooring in con-trolled environments—and it would be short-sightedto look for shortcuts in the process. In the final analy-sis, the key concepts are prevention and protection.

To prevent ESD problems, select the flooringoption that best meets current and anticipated industryspecifications. While there are different variables, hereis what industry sources recommend for cleanroomsand electronic manufacturing facilities:

• Conductive Rubber the only ESD flooring certifiedas Class-0 Qualified is rated “ideal;” it also has lowbody voltage generation.

• Conductive Vinyl Tile and Conductive Epoxy mayalso be suitable.

• Other flooring options are not recommended.As far as protection, if you plan wisely from the

get-go, you can avoid costly liability issues later on.We encourage installation floor audits to determine ifyou are ground safe.

In short, when it comes to ESD flooring in con-trolled environments, it makes sense to exercisemaximum control.

Dave Long is CEO and founder of Staticworx, Inc., in Watertown,Mass., Staticworx offers comprehensive flooring options includingrubber, vinyl tile, carpet, epoxy, and adhesives. All products meet in-ternational standards, are environmentally friendly, and comewith lifetime warranties. For more information, visit www.staticworx.com or e-mail [email protected].


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pp16-19_-- 12/14/11 3:27 PM

Pharma Facility Quality Audits: A Primer for Design Teams

Scott Overton

Here is a familiar demand: “Show me where inthe regulations it says to do that!” If you’ve spentany time in Quality, working on a facility orequipment project in the pharmaceutical industry,you have certainly had that put to you at somepoint. And why not?

Far and away, what most people (including ourindustry engineers, technicians, and operators)think about when they think “Quality” is “Compli-ance with Regulations.” Compliance is certainly anissue of vital importance, but Quality does notstop there, and there is no time when that is moreclear than during a Quality Audit. This article willshow that understanding the potential audit out-comes in the future can serve as powerful designcriteria today.

For many companies today, the majority oftheir external quality audits will not be performedby regulatory agencies, but by other companies.This company auditor has a day or two to assessthe overall “quality culture” of a potential supplieror contractor. Unlike the FDA that has a free passinto all FDA-regulated facilities in the U.S. at anytime, a company auditor performs the audit at thediscretion of the company being audited. Afterthis audit is complete, and provided that the audi-tor says everything is okay to link his company tothe manufacturing processes of the other, theauditor’s company will have little to no directexperience with day-to-day processing. In short,that’s a couple of days to make a full assessmentof all quality systems in a unique facility that willhave to be valid for a year or more. This is a chal-lenge for non-sterile raw material suppliers, which

only grows more challenging as cleanrooms andsterility claims are added to the mix.

With so little time to assess a facility and amanufacturing process (or many of them!), how isit that auditors can effectively and thoroughlymeasure the strength of all Quality Systems? It ishere that a large part of non-Quality personnelwould answer something along the lines of“directly measure the facility against the regula-tions using a checklist or other tool.” Thoughcompliance with regulations is absolutelyrequired, measuring against regulations is a verysmall part of an audit. Furthermore, it is difficultto do so “directly.” How would one measure“Appropriate measures should be established andimplemented to prevent cross-contamination frompersonnel and materials moving from one dedi-cated area to another”1 directly? And how would itbe done for every possible combination of per-sonnel, materials, and products in a contractformulation and sterile liquid filling company, forexample? In short, it can’t happen. Alternatively,there must be a way to achieve solid and defensi-ble results.

The alternative is this: in order to be effective,auditors focus on two things:

1) How is the system controlled?2) How is the system monitored?Superficially, these two questions appear to

provide a very narrow perspective. On the con-trary, they comprise a far more expansive view offacilities and processing than most, including thenormal view of design, for example, which is todesign for a specific production volume. The ➤


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first clear outcome of designing a facility or processwith these two questions in mind is that design deci-sions will be made knowing that the final design mustbe auditable. A simple example would be to imaginean airlock that does not have any sort of air pressuregauges. The original design intent may be to have 10Pa over each door, but without data provided by moni-toring devices, how could it be proven that the airlockis behaving as designed? Without data, how couldadjustments to controls be justified to an auditor? Thefact that an audit trail must be available may be veryinfluential, which will be seen through some examplesbelow.

Now it is great that we understand that systems ofcontrol and monitoring will be the way an auditorapproaches the facility once it is built and the processis running, and it’s also great that we understand thatthe final facility or process must be auditable. Butthese facts are not very useful to design engineers andarchitects if they cannot be leveraged to inform designof projects in specific ways up front. Having a holistic,“eyes of the auditor” type quality influence in thedesign phase of a project would be incredibly valuablesince all projects in the pharmaceutical industry willeventually be production facilities or manufacturingsystems, which will go for Pre-Approval Inspection andthen biennial inspections by the FDA and internationalregulatory bodies, and also countless supplier auditsfor as long as that that facility or process exists.

Some people may balk at the notion of using thepotential results of future audits as design criteria as itis commonly held that “regulations keep changing.” Ideny that. What happens most often is that over time,the rest of society continually develops more sophisti-cated technologies like computers, advanced materials,and precision equipment. As the rest of society keepsprogressing (or in production lingo, “continuouslyimproving”), our industry is expected to do the same.Thirty years ago, a daily monitoring of room pressureon a written log was the norm. Today, it is very com-mon to see Building Management Systems monitoringroom pressures constantly. Physics didn’t change. Airitself didn’t change. Over time, technology advancedand the Pharmaceutical Industry just kept up with it.

Furthering that idea, better data monitoring reducesbusiness and quality risk overall, so these advancingtechnologies are implemented as companies’ assess-ment of risk changes. The written regulations alsochange—usually pretty slowly—to keep up withchanging technology and risk perceptions. As anexample, consider a smartphone. These devices haveincredibly simple user interfaces and are powerfulenough to let the user do almost everything a laptopdoes. With that level of simplistic technology available

to anyone, why should a confusing Operator Interfaceon a process skid be acceptable?

What does it really mean to focus on systems ofcontrol and monitoring? Said another way, it means anauditor will focus on systems that will assure productwill continuously meet specifications, that any issueswith that production are identifiable, and that all activ-ity is traceable. So the auditor focus on control andmonitoring systems is truly a focus on “assurance” and“reliability.” Here, it seems that the goal of the designteam and the auditor are the same. In project develop-ment, no design team aims to create a facility or aprocess that is unreliable; an auditor merely seeks tovalidate those efforts. Approaching design from thisperspective of “assurance” and “reliability” is obviouslyconstructive and helps projects in our life-saving indus-try come to the best decisions for our products and ourpatients. The area where this is most clear is clean-room design, which will be the focus of the examplesbelow.

Consider a situation in two different ways. In eachof these scenarios, the product has some specificrequirements, such as sterility throughout the processas the product cannot undergo any downstream sterili-zation steps. Also, for clarity, these processes are in asingle-product facility:

SCENARIO 1: AN OPEN PROCESSIn an open process for a sterile product, the spacerequired is a Grade A with a Grade B background. Per-sonnel in that space are fully gowned. In Grade A,there is continuous particulate monitoring, minimalper-process microbial monitoring, and a lot of airbeing pumped into the space (laminar in Grade A toboot!).

SCENARIO 2: A CLOSED PROCESSIn a closed process for a sterile product, operations arein Grade C, D, or maybe even unclassified (dependingon risk and the way the process is set-up). Personnelare wearing dedicated clean-area clothes and shoes,EM is radically reduced from an aseptic area, and theair change rate is maybe half of that in aseptic areas.

Now, both of these process scenarios have thepotential to be completely compliant. For one, though,compliance is far more costly, challenging, time-consuming, labor-intensive, and complex, whichmeans that there are many more tools required to con-trol the environment, many more items to monitor, andfar more opportunities for failure. Each of these addi-tional failure modes adds another parameter to theprocess that must be auditable and increases the num-ber of people required to audit. There is nothing in theregulations that would state one of these approaches is


pp16-19_-- 12/14/11 3:27 PM

completely wrong. And maybe with more informationavailable, the system with fewer parameters to controland monitor is actually the best choice for the produc-tion material. What if the product in question here isexperimental, unproven, and therefore in need of thedevelopmental flexibility that comes with multi-useGrade A areas? What if product volumes are so vanish-ingly small that product hold-up (potentially greater inthe closed system) is critical? This may come intogreater relief with another example:

POTENTIAL SYSTEM A:The production system is fully stainless steel. Every-thing was engineered, with measured and exact slopesfor all piping. In between uses, all parts must bewashed and, before that, the cleaning cycles had to bevalidated. Their control is automatic and also validated,so repeatability is almost certainly assured.

POTENTIAL SYSTEM B:This is a completely disposable system. The disposablecomponents can be purchased from multiple vendors(some of which are not as reliable as others), havesome potential variability in tubing length, and sincethey come coiled in sterilized bags, the tubing oftensags when outstretched, leading to variability in hold-up in the system. The disposable components need nocleaning validation or cleaning cycles. These systemsare sterilized by an outside vendor, but are never putthrough a validated cleaning cycle to remove any parti-cles introduced during assembly at the vendor.

Knowing that outcomes like purity and yield arecritical parameters, which system should be selected?What if the product is moderately sensitive to materialsused in a disposable system? What if cleaning chemicalresidues have an exponential negative effect onpotency? Again, understanding the way the entireprocess will be audited quickly digs into many detailsnot always at the forefront of a facility design.

Similarly, across the industry, room air quality mustbe monitored. But monitoring a Grade A space meanscontinuous particle monitoring, whereas Grade C mon-itoring may be only weekly or even monthly. For acritical product-contact utility, an auditor will reviewevery document from Design Qualification throughroutine monitoring over the previous year or two indetail. For a Grade C EM program, the procedure willbe reviewed and enough data to show compliance willbe reviewed.

In all of these examples, different teams will cometo different final selections and it is highly unlikely thatany selection will be “wrong.” The unfortunate poten-tial is that for either path taken, the selection will bemade, designed to, and built from a single perspective:

the perspective that comes with budgets and sched-ules, that moves in one direction from original conceptto construction and validation, and that is ultimatelyinflexible because it was scoped and designed to meeta specific need (throughput or production volumes, forexample) without including the need to control ormonitor the process and be fully transparent in anaudit, regardless of the volumes.

This is perhaps the best case for viewing projectsfrom an auditor’s perspective. Ten years from the initialbuild, an auditor will be in that facility. In those tenyears, dozens of changes will have happened, produc-tion volumes would have increased (hopefully), andsystems would have been updated. Cleanroomsdesigned to hold one production lot at a time mightnow hold multiple lots. It is here where controllingand monitoring systems for multiple quality systemscome together to form an overall quality assuranceprogram. It is here where an auditor could look at theinitial design and aid in recognizing how, over thelong term, systems to control and monitor differentaspects of production can be stressed to the point offailure.

At a minimum, the products of the PharmaceuticalIndustry improve the quality of life and, in many cases,save lives or prevent disease entirely. Competition inthis field is inevitable and tenacious. Increasing pro-duction and lowering cost cannot result in products oflower quality with unreasonable risk to patients.2 Forsuccessful products, processes and facilities are askedto increase production over time as demand increasesand lower costs as patents expire and competitorscome to market. These pressures are as inevitable for aproduction facility as is the fact that it will be auditeddozens of times. We would all do well to employ thetools of an auditor in the design of facilities andprocesses.

References:

1. FDA Guidance for Industry / ICH Q7A Good Manufacturing PracticeGuidance for Active Pharmaceutical Ingredients, Section D(4.4), August2001

2. See Eudralex, Annex 11, Principle section

Scott Overton is a Site Compliance Specialist for Merck & Co., Inc.He is the Site Quality lead for Viral Vaccine facility improvementprojects. Merck & Co., Inc., 770 Sumneytown Pike, PO Box 4, WestPoint, PA, 19486 (mail stop WP38M-7); [email protected];www.merck.com


pp16-19_-- 12/14/11 3:27 PM

Nano is Big inNorth Carolina


Gateway University Research Park’s Joint School ofNanoscience and Nanoengineering

The Joint School of Nanoscience and Nanoengineering(JSNN) began with a simple but powerful idea: to cre-ate a facility where nanoscience and nanoengineeringcould be accessible to everyone. In addition to the sci-entists, engineers, and post-docs already working in thefield, this facility would allow undergraduate and K-12students access to advanced knowledge emanatingfrom exciting research activities in this emerging fieldof science and technology. Additionally, this facilitywould serve as a community and industry outreachcenter.

The envisioned facility was realized with the con-struction of Gateway University Research Park’s JSNN, aproduct of the combined vision and resources of twoacademic institutions: North Carolina Agricultural &Technical State University (NCA&T) and the Universityof North Carolina at Greensboro (UNCG). The JSNN isone of only ten universities in the country to offeradvanced degrees (M.S. and Ph.D.) in the field ofNanoscience and one of only four universities in thecountry to offer M.S. and Ph.D. degrees in Nanoengi-neering.

“The JSNN Facility is a critical part of our strategy,enabling our mission of nano-based education,research, and outreach,” said Dr. James G. Ryan,Founding Dean of JSNN. “The laboratory and gatheringspace design encourages discovery through collabora-tion and helps to educate our students and visitorsalike.” JSNN is designed to promote collaborationamong industries such as pharmacology, biotechnol-ogy, aerospace, and manufacturing. Bringing academicresearch together with industry will help move pro-grams beyond theory and into practice, betterpreparing students for success in the working world.

The equipment and instrumentation required bynanoscience and nanoengineering programs is exorbi-tantly expensive; and it often requires highly-controlledenvironments which represents an additional steepexpense. “Collaboration is a way to help reduce costsand speed up the research process. It brings in newproblem sets and new perspectives that promote inno-vation,” said Ryan. “JSNN’s collaborative model isalready paying dividends by producing scientific insightin areas from signal propagation in nerves to high reso-lution observation of biological structures to newmethods to build aircraft.”

“For two universities to collaborate on a project likethis is unique. This joint project will advance entrepre-neurial activities and create an environment that allowsfor the enhanced transfer of research innovation intopractical applications, which should produce positive

pp20-21.qxp_-- 12/13/11 3:58 PM

economic effects,” said John Merrill, Executive Directorof Gateway University Research Park in Greensborowhere the JSNN is located. Both the collaborativenature of the facility and the positive economic poten-tial has allowed JSNN to garner wide communitysupport. When determining what disciplines to includewithin JSNN, Dr. Ryan focused on local industries suchas pharmaceutical, biotech, aerospace, and manufactur-ing, making sure the programs at JSNN support localindustry.

JSNN resources include: • Nanoelectronics and nanobioelectronics clean-

room• Nanofabrication facility with nanoparticle synthe-

sis, characterization, mixing, and scale-up facilities• Characterization suite, including NMR, analytical,

and microscopy labs• Nanoscience labs, including nanobiology, BSL-3,

genomics, nanophysics, and nanochemistry• Biomass laboratory• Visualization and computing facility• Auditorium• Faculty, staff, graduate student, and unassigned

offices• Collaborative spaces including small conference

rooms and huddle spaces To celebrate this unprecedented experiment in col-

laboration, and to kick off development of theGateway University Research Park, it was important tocreate an iconic image for JSNN. The “public side” ofthe building, facing Lee Street, is designed to be warmand inviting, a welcome member of the community ofGreensboro. The focal point of JSNN—a cone-shapedauditorium visible to the public through a glass enclo-sure—creates an unexpected, playful image for thebuilding, inviting researchers, students, and the com-munity to take another look at nanotechnology.

The building is designed to facilitate collaborationand to create connections among students, research-ers, and the scientific endeavors taking place in thebuilding. In addition to 7,000 square feet of cleanroomspace, JSNN features 80,000 square feet of primarilyopen laboratory and office space, along with 14,000square feet of classroom and research support space,including a Visualization Facility classroom thatimmerses students in the design of nanomaterials witha 3-dimensional video screen. Modular laboratories aredesigned with a minimum of internal walls for flexibil-ity and increased visibility throughout. The designencourages interdisciplinary collaboration, and acts as acatalyst for the development of a “nano-community”

that supports and encourages job creation and entre-preneurial spirit.

One of the goals of the building is to create an openforum for communication with the public, especiallychildren and students, sparking curiosity and creatingawareness of this important emerging field. Open pub-lic spaces, such as the lobby and the double-height,light-filled auditorium, are designed to foster outreach.Cleanrooms and labs featuring state-of-the-art equip-ment are purposely located to be visible from thelobby, with windows located low to the floor so thatchildren can see into the science on display. The designestablishes a connection among researchers and stu-dents, and also creates an image that invites the publicto share in the celebration of the exceptional scienceconducted here.

As an important component of the Gateway Univer-sity Research Park, JSNN will be an economic engine inboth the short- and long-term. JSNN is expected toattract nano-related businesses to locate in the area.These new businesses and the research produced atJSNN will create jobs. Greensboro is home to seven col-leges and universities. A highly educated, highlymotivated workforce will further propel Greensboro andthe rest of North Carolina into the knowledge economy.

JSNN is a true mix of teaching, research, and serviceto the community, offering opportunities for collabora-tion at all levels. Its fruition was also the result of acollaborative effort, involving Gateway executive direc-tor John Merrill and his team; Dr. Ryan and his faculty,staff, and students; the leadership of UNC Greensboroand NCA&T; the team of architects and engineers ofHDR Architecture, Inc.; and the Joint Venture construc-tion team of Barton Malow/Samet/SRS.

Ahmad Soueid, AIA, LEED AP, serves as HDR CUH2A’s National Di-rector for the Advanced S+T Research program. He is an architect thatprovides creative design solutions and leadership on projects requir-ing critical environments. He has over two decades of focusedexperience on the design of technically challenging facilities and is afrequently invited speaker at international technical conferences. Mr.Soueid is considered a global leader in planning, design, and con-struction of facilities established for nano-scale research. He can bereached at [email protected].


The “public side” of JSNN is designed to be warm and inviting.

pp20-21.qxp_-- 12/13/11 3:58 PM

22 � May 2011 Controlled Environments � www.cemag.us

A question has arisen about terminology. Whether called a“disaster recovery plan” or a “crisis plan” or a “business con-tinuity plan,” the end game is the same. Your goal is toresume manufacturing operations and fiscal stability, asquickly as possible, after a disruptive event. Some facilitiesand operations professionals believe that abandoning theterm “disaster recovery plan” in favor of “business continuityplan” is more effective in procuring funding and supportfrom senior management, and more palatable to the invest-ment community. While the substance remains the same,the impression created by an undertaking titled “businesscontinuity plan” is a focus on the future, generating productand profits. There is also a move afoot in some sectors touse the label BC/DR (business continuity / disaster recov-ery), suggesting the dual purpose of the process. You’llneed to decide what’s best for your organization, and facili-tating your end goals.

This month in Round 2, I’ll guide you through some ofthe specifics of producing a disaster recovery plan tailoredto the requirements of your manufacturing needs, includingcontent. Pour that cup of Joe and settle in—those of us infacilities like nothing better than to write a plan, or readabout writing one. But the pain you’ll feel today is minisculecompared to the pain of being unprepared for an unex-pected disaster that impairs your manufacturing.

THE BEGINNINGYou’ve completed the spadework: management is on boardand has funded the effort; risk assessments are completedand prioritized regarding both probability of occurrence anddamage potential; key team members are identified andrecruited. Now what?

Before drafting the plan, make sure that all key depart-ments of the organization are surveyed to a levelappropriate to both their risk exposure and the potentialfinancial impact a business disruption would produce. Rankand prioritize the information you glean and build it intoyour plan.

Following are some key components of the plan that willensure its functionality. Consider using graphs, flow charts,and bold/bulleted text to convey the information as con-cisely as possible.• Executive summary: not a bad place to outline the plan’s

objectives, assumptions used in the process, and thescope of the plan.

• Statement of purpose: Make sure everyone reading thedocument understands what it is, and what it is not. o Outline the conditions under which the plan will be

implemented and clear chains of responsibility to make

Ask the Facilities Guy Richard Bilodeau, PE

Question: How do I develop aDisaster Recovery Plan?

Answer: Last month’s column laidthe groundwork for developing afunctional Disaster Recovery Plan.We reviewed key components ofa disaster recovery plan andcritical planning, discovery, andorganizational steps one must taketo develop a plan that functionsbeyond becoming a dust magneton your bookshelf. www.cemag.us/article/ask-facilities-guy-how-do-i-develop-disaster-recovery-plan

Fac Guy_STDB_-- 12/12/11 3:55 PM

the call declaring an emergency and invoking theplan.

o Clearly outline notification triggers, processes/pro-cedures, and recording requirements.

• Clearly delineate the names, contact information, androles of the disaster recovery team members. Makesure each person has one, if not two, designated back-ups—depending upon your company’s travelschedules. Back-ups must be qualified individuals whoare fully trained and can command the role for whichthey’re designated. It’s critical that this section of theplan be scrupulously updated.o For companies with multiple locations, consider

developing both a corporate team and site specificteams at each of your locations. Work hard todevelop a sense of camaraderie and teamwork.

o Depending on the risks contemplated by the planand your company’s organization structure, you willlikely have several or all of the following teams:Emergency Management Team (including manage-ment, finance, logistics, procurement etc.), CrisisCommunications Team, Incident Response Teamand/or Emergency Response Team, Technical Serv-ices Team, Services Restoration Team. Some plansroll each of these groups under the Disaster Recov-ery Team mantle, with sub-groups with specificresponsibilities selected from the list above.

o Make sure applicable outside emergency responseand governmental agencies are listed, including alead contact and their back-up. It’s critical that theemergency management team develop strong rela-tionships, and undertake joint training, with localgovernment officials and emergency response per-sonnel.

• Keep a clear record of revisions chart near the front ofthe document. Make sure the plan is reviewed fre-quently, updated, and the new information isdistributed to all team members. Do NOT wait for ascheduled review to update business changes, newpersonnel, or new risks. Ensure that any revisions areintegrated in all copies of the plan.

• Extended team member roles, responsibilities, andauthority: the heat of a crisis is no place for turf warsor lack of clarity in execution.

• Communications authority guidelines: Clearly desig-nate who has the authority to speak with the press orother outside parties or governmental agencies, yourinvestors (if applicable), customers, suppliers, andemployees.

o Develop a strong communications protocol guide.Remember, in worse case scenarios, loose lips sinkships; in even the best cases they create confusion,conflicting information, and reputation damage.

• Emergency management standards and procedures:this is the heart of your plan. Many companies catego-rize potential disasters and develop specific protocolfor each type, or for individual scenarios within thesecategories. Some broad categories include: natural dis-asters, workplace violence, key employee deaths orresignations, IT systems crises, chemical spills andrelease issues, supply chain disruption, fire, strikes,accidents, acts of terrorism, and criminal investigations.o For each scenario, outline trigger thresholds for

invoking the plan, escalation factors, notificationrequirements, and procedures.

• Checklists: Develop checklists that your teams can useto ensure a complete response and to organize actionsduring a crisis.Focus on developing a draft document—don’t get

caught up in the pursuit of perfection. Once you’vedeveloped a draft, make sure it’s thoroughly vetted—preferably in workshop forums set up with operationsgroups and members of the team. Encourage an open,constructive review format—your goal is not to collectkudos but to be sure everything is covered, clear, andstructured in a way that will be most efficient in a crisis.

Scrupulously record the comments and suggestionsand resolve any edits. Go back for a rewrite and thendistribute the second draft for individual review andcomment with a firm deadline for replies. Integrate anycorrections into the final draft—the emphasis here is onthe word “draft.” Business recovery plans are organicdocuments that must be constantly updated andamended to align with changing information and busi-ness conditions.

In the next issue of Controlled Environments Maga-zine, we’ll look at how to roll out the plan, ensuremanagement and employee support, train to the plan,and execute the plan in times of crisis.

Until next time…

Richard Bilodeau, PE, is director of engineering at SMRT, architectsand engineers (www.smrtinc.com). His 30 year career includes plantengineering positions in clean manufacturing. Richard has designed,operated, and supervised the construction of advanced technology fa-cilities, numerous industrial projects, healthcare facilities, andcorporate offices. He’s engineered clean manufacturing facilities forlithium-ion batteries, medical devices, electronics, and pharmaceuticalclients. Richard can be reached at: [email protected]. .


Fac Guy_STDB_-- 12/12/11 3:55 PM

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PENCIL IT IN...For more industry events, go to www.cemag.us

February 7-9, 2012SEMICON KoreaSeoul, Korea www.semiconkorea.org

March 20-22, 2012SEMICON ChinaShanghai, China http://semiconchina.semi.org

April 16-20, 20122012 PDA Annual MeetingPhoenix, Arizona www.pda.org/annual2012

April 30-May 2, 2012ESTECH 2012Orlando, FLwww.iest.org

May 1-3, 2012INTERPHEX New York, NY www.interphex.com

May 2-4, 2012SEMICON SingaporeSuntec, Singapore, Singapore www.semiconsingapore.org

May 14-16, 2012SEMICON RussiaMoscow, Russia www.semiconrussia.org

June 4- 5, 2012PDA/FDA Glass Quality ConferenceBethesda, MD www.pda.org/glass2012

June 18-21, 2012TechConnect WorldSanta Clara, CA www.nsti.org

pp25 12/16/11 1:23 PM


in the newsSamsung Promotes Kwon Oh Hyun ____________________________________________________Samsung Electronics Co. named KwonOh Hyun, its computer-memory chipbusiness head, as vice chairman after heled the company out of the industry’sworst slump.

Kwon was promoted at Asia’s largestmaker of semiconductors in a broadmanagement reshuffle across SamsungGroup companies, South Korea’s biggestconglomerate said in an e-mailed state-ment today. He will continue overseeingchip and display operations at SamsungElectronics, according to the statement.

Samsung Electronics was the onlyprofitable maker of the chips known asDRAM in the third quarter after pricesplunged to a record low. The Suwon,South Korea-based company is benefit-ing from diversification intosemiconductors for mobile devices andservers at a time when slowing growth ofpersonal-computer sales has causedother chipmakers to suffer mountinglosses.

“Samsung has quickly shifted awayfrom PC chips to specialty chips, so

they’ve been relatively unaffected bymarket conditions,” Kim Young Chan, aSeoul-based analyst at ShinhanInvestment Corp., said by telephone.“Going forward, they’ll keep focusing onchips going into mobile products.”

Samsung Electronics rose 1.2 percentto 1.06 million won at the close in Seoultrading, and was the biggest contributorto the benchmark Kospi index’s 0.9 per-cent advance. The shares have advanced11 percent this year, compared with the6.4 percent decline in the benchmark.

Mars Curiosity Off-Course ____________________________________________________________NASA’s multibillion-dollar Mars ScienceLaboratory is purposely hurtling throughdeep space on a course that would missthe red planet by tens of thousands ofmiles.

The Centaur upper stage of the AtlasV rocket that launched the lab was not

put through super-stringent sterilizationprocesses to ensure no Earthly microbeswould be hitching a ride through inter-planetary space. So NASA wants toensure it doesn’t crash land on Mars,spreading microorganisms such as bacte-ria, fungi, algae, plankton, or planarian.

The NASA officials ultimately deter-mined that pre-launch tests to assesslevels of organic contamination showedthe bits nonetheless met cleanliness stan-dards. Scientists involved in the missionare not interested in finding signs of lifeon Mars that evolved back on earth.

Leica Biosystems Wins Manufacturing Excellence Award __________________________________Leica Biosystems GmbH in Nussloch haswon the Manufacturing Excellence (MX)Award 2011 in the Customer Focus cate-gory. With a workforce of 336employees, the German plant inNussloch near Heidelberg makes prod-ucts for different stages of specimenpreparation in the histopathological lab-oratory. These include cryostats andmicrotomes for ultra-thin sections of tis-sue as well as automatic coverslippersand tissue processors to produce high-

quality samples that can be kept forextremely long periods of time withoutloss of quality.

The jury decided that customerinvolvement in the development of theproducts, several customer satisfactionsurveys and, not least, tailored productsolutions designed to ease the customers’workload set Leica Biosystems well apartfrom the other competitors.

The aims of this benchmarking award,which is being conferred for the seventh

time this year, are to promote cross-sector and international cooperation tostrengthen industry, and to set up a com-munication platform for expertacademics and practitioners. Innovativeand creative solutions are not only toboost the international competitiveness ofthe individual company, but, throughholistic interaction, sustainably enhancethe status of Germany as a businesslocation.

Gartner Downgrades Semiconductor Outlook for 2012 ___________________________________Gartner reports that worldwide semicon-ductor spending won’t be quite as highas previously thought. The psychic beancounters at Gartner now believe semi-conductor spending in 2012 will reach$309 billion worldwide, a 2.2 percent

increase from 2011, but down fromGartner's previous forecast of 4.6 per-cent growth.

The floods in Thailand earlier thisyear resulted in a hard drive shortage,and that in turn has slowed the PC mar-

ket. But lest anyone talk about the post-PC era, PC production unit growth is stillexpected to grow 5 percent in 2012.Gartner's previous forecast had the PCmarket growing by 10.1 percent.

pp26_- 12/15/11 10:57 AM


“I have to let off steam, Barbara. Let’s talk” saidKevina.

Kevina was driving home from a cleanroom train-ing session. Barbara really needed a break from thereport she was writing. So, devoting part of a crisp,morning in Southern California and a cool evening inIreland, they discussed some of the challenges facingour cleanrooms today with regard to cosmetics suchas tattooed makeup, fake tans, and long, fake, gelnails. After lengthy discussions they came up with afew suggestions and ideas that perhaps may be wortha thought.

TATTOOED MAKEUPMost cleanroom protocols state ‘No makeup allowed’.So imagine the fashion gurus concocting the idea of‘glamour in the cleanroom without contamination’ the“ideal” solution—permanent makeup! Surely thereshould be no problem with a cleanroom employeearriving at work on Monday morning sporting tattooedeyeliner and lipstick.

Well, there is a problem. Other employees start toarrive at work in the cleanroom sporting eyeliner andlipstick that may not be tattooed, permanent makeup.So now the problem arises as to how we prove who isor is not wearing permanent makeup. Suddenly thestandard cleanroom protocol of ‘No makeup allowed’is non-existent. In some instances, the employee hasrequested a document from the tattoo artist certifyingthat the makeup was tattooed; this was kept in theirfile. This was the only escape route to avoid a findingof “non-conformance to procedure” during audits.

One approach to avoiding controversy regarding tat-toos, natural beauty, and makeup would be to requireeveryone to wash their hands and faces before enter-ing the cleanroom. Of course, as Kevina pointed out,there is the issue of contamination due to skin flakesfrom dry skin. Moisturized skin is preferable to dryskin. One solution might be to require everyone to

wash their faces and then apply a cleanroomapproved, non silicone moisturizer. Doctors have spec-ified “scrub” procedures prior to performing surgery.One would think that employees should have specifieddecontamination procedures before they enter clean-rooms, particularly where products impacting publicsafety and patient safety are being produced.

FAKE TANSWhat about fake tans? Employees might assert thatobtaining a fake tan does not constitute makeup.Analysing the components of every type of fake tanand their impact on the specific product manufacturedwould be costly, and an overall policy banning faketans may be difficult to enforce. However, the appear-ance of an orange “ring-around-the-collar” wouldseem to be a tell tale sign that body makeup is in use.Asking all employees to shower prior to entering thecleanroom might be an extreme measure. However, itwould be reasonable to update rules regarding clean-room protocol to reflect the most recent beautificationtechnologies. It would also be useful to provideemployees with the understanding and awareness asto why makeup is banned in the cleanroom and toclearly state that body makeup including artificial tan-ning lotions are included.

FAKE NAILSAnother common policy includes the banning of long,fake, artificial or gel nails as well as nail polish in thecleanroom, and hopefully everybody knows why.Fake nails have been detected in finished packagedproduct by experienced vigilant inspectors. Kevinaindicates that these instances have been reportedaround the time of Christmas parties. This is an areawhere firming up the protocols is essential. Saying thatlong nails or fake nails “SHOULD” be avoided is thesort of statement that can result in product recalls, thatendangers public safety and that endangers lives. ➤

Contamination Control IN and OUT of the Cleanroom

BARBARA KANEGSBERG AND ED KANEGSBERG

Cosmetics and CleanroomsBarbara Kanegsberg with special guest columnist Dr. Kevina O’DonoghueReviewed by Ed Kanegsberg

pp27-30_~ 12/16/11 11:18 AM


Contamination Control IN and OUT of the Cleanroom - continued

BREAKDOWN IN COMPLIANCEThe overall breakdown in compliance with the abovecleanroom protocol is exacerbated by a “double-tiered”policy. That is, some companies allow visitors to wearmakeup on the grounds that they will not be assem-bling product. In our opinion this is not a good enoughjustification. Whether a visitor, auditor, external person,or internal person who does not enter the cleanroomregularly and is not familiar with the cleanroom proto-cols, all should abide by the same set of rules. Allowingdifferent cleanroom rules and policies for visitors orexternal people creates a caste system that is counter-productive.

Barbara has a different opinion about protocol forvery occasional cleanroom observers. She feels therewill always be occasional exceptions and that approach-es to exemptions should be developed. Consider ascenario where the president of a small biotech compa-ny arrives with a potential investor. The investor wantsto inspect the cleanroom. The investor is wearing shellpink fingernails with tiny hand-painted flowers. In suchan instance, Barbara would suggest explaining thecleanroom rules carefully. If the investor insists oninspecting the cleanroom, it should be required that thisvisitor wear gloves, be prohibited from touching prod-uct and be required to stand a respectful distance fromany fabrication, cleaning, or assembly operation. At thesame time, it is more than reasonable to communicatecleanroom requirements and to require compliance bythose involved in cleanroom activities. This includesconsultants, motivational speakers, safety/environmentalprofessionals, facilities people, repair personnel, andvisiting dignitaries.

PROACTIVE INVOLVEMENT WITHIN THE CLEANROOMWhen asked about the most important factor in manu-facturing, many employees put people ahead ofproduction. It is important that our priorities are righton this one. The most important factor in our clean-rooms is the end product and ensuring that the endproduct is safe and of the highest quality possible con-sistently and reproducibly for the end user. Breaches incleanroom protocol must not be allowed to result in anunsafe product. At the same time, skilled, educatedcleanroom employees are essential for production ofquality product.

It would be productive to have greater proactiveinvolvement within a company and to provide an

unambiguous message to employees. In general prac-tice, Human Resources people seem to be independentof cleanroom operations. HR may bow to pressuresfrom technicians and assemblers and perhaps may alsorespond to company policies to foster employee inde-pendence. HR may even prohibit policies set forth byQuality Assurance. Kevina trains personnel working incleanrooms facilities regarding cleanroom protocol toreduce contamination risks. She trains people from alllevels, from directors to operators. However she cannotrecall ever having an HR person sit in on her trainingcourses. Barbara cannot recall any HR involvement,either.

Perhaps HR could be made part of the solution toreconciling employee self-esteem with requirements forcontamination control. In larger companies, perhaps aHR cleanroom liaison could be appointed. This personwould participate in the training/education required ofnew and existing employees. It would be very reason-able to require HR people to invest some time inobserving actual cleanroom practices and to explain theimportance of those practices.

Other groups besides HR could benefit from engag-ing in the cleanroom experience. In our two previouscolumns, we discussed superfluous design and activityin the cleanroom. Engineers have been known to speci-fy unnecessary, illogical, and redundant procedures andrequirements, sometimes under the general guise of“cleanroom discipline”. Where such procedures areunnecessarily, invasive, or even downright unachiev-able, cleanroom operators will either defy/ignore therules outright or develop creative interpretations ofthose rules. Requiring engineers writing the protocoland process flow to spend an entire shift in the clean-room actually practicing what they preach could be anexcellent investment in moving toward higher reliableproduct, rugged processes, saving money, and achiev-ing enforceable cleanroom personnel practices.

Dr. Kevina O’Donoghue is a microbiologist at Micro Matters, Gal-way, Ireland. She has worked with cleanrooms for nearly 10 years.She developed and delivers a internationally accredited training pro-gram on “contamination control practices within the clean roomenvironment” and is one of the founders and facilitators of a cleanroom technology network group. Contact her at [email protected].

Barbara Kanegsberg and Ed Kanegsberg, Ph.D. “The CleaningLady” and “The Rocket Scientist,” are independent consultants in sur-face quality including critical/precision cleaning, contaminationcontrol, and validation. They are editors of “The Handbook for Criti-cal Cleaning,” CRC Press; an updated two-volume second edition.Contact BFK Solutions LLC, 310-459-3614; [email protected].

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a-e

act

pp27-30_~ 12/16/11 11:18 AM


JOHN DURKEE, PH.D., P.E.

This column reports on three unrelated outcomes aboutwhich you need know to manage critical cleaning work,and points out their significance.

IT’S NOT OVER UNTIL WE SAY IT’S OVER... IT’S OVER!1

Trichloroethylene (TCE) has been found to be a humancarcinogen.

In early October, EPA released its final health hazardassessment categorizing TCE as “...carcinogenic tohumans and as a human non-cancer health hazard...”This assessment is part of EPA’s Integrated Risk Informa-tion System (IRIS) which conducts scientific reviews oflaboratory and epidemiological data upon which someagency decisions are based.

Many had thought it was so, for years, and managedtheir affairs accordingly.

Many others had chosen to believe that it was not so,and used it per NESHAP equipment requirementsbecause of the absence of other options. That dearth ofoptions hasn’t been returned to abundance by thisnews.

The practical meaning of this assessment is substan-tial. EPA will now have a stronger basis to:

• Revise the Maximum Contaminant Level for TCE aspart of the carcinogenic volatile organic com-pounds group in drinking water,

• Establish benchmarks and methodology forcleanup of the 761 Superfund sites where TCE hasbeen identified as a contaminant,

• Provide legal reference in personal injury lawsuits,and

• Revise downward the workplace exposure limit ofthis Hazardous Air Pollutant (HAP).

Make no mistake, those using TCE in cleaning opera-tions would do well to view the common alternative toTCE (n-propyl bromide) as if this finding applied to itfive-to-ten years from now,2 and consider other alterna-tives such as binary azeotropes and solvent blends.

SANITARY STAINLESSMaterials scientists at the University of Birmingham (UK)have devised a way of making stainless steel surfaces

resistant to bacteria. Their technique not only kills bac-teria but makes the material very hard and resistant towear during cleaning. It involves infusing Silver (orCopper), Nitrogen, and Carbon within the steel surface(rather than coating it on to the surface).

They have replicated the FDA process for cleaningmedical instruments,3 applied it 120 times, and foundthat the antibacterial properties of the stainless steelwere still intact and the surface still resistant to wear.

Intended applications are: hospitals, food service,and dentistry. To my mind, current proper sanitary prac-tices will be more cost effective until (and if) volumeapplications are developed. It’s too soon to know if thistechnology is a curiosity, or can be later accepted bythe FDA.

NO-CHEMISTRY SONICATIONAn interesting and recent paper4 describes experimentsin cleaning of Silicon wafers (to be used in photovoltaiccells) of nanometer-sized particles without use of eitherof the customary cleaning chemistry systems: SC1(H2O/H2O2/NH4OH: 40/2/1) or piranha (3:1 volumesolution of H2SO2 and 30% H2O2).

The method was to use acoustic streaming pressurewaves produced at super-megasonic frequencies in ahot (80°C) bath of distilled water. Test objectives wereto: (1) minimize surface damage, (2) avoid use of corro-sive chemicals, and (3) learn if/how #1 and #2 couldactually be done with organic contamination andsilica/silicon nitride particles between 10 and 100 nm insize.

Results were not defining of a commercial process.But removal of organic contamination was equivalent tothat obtained with the piranha solution. However, theremoval mechanism was unclear (though it was notdirect oxidation). At short contact times of cleaning (20min.) wafer performance in photovoltaic service wasacceptable; at longer contact times (60 and 120 min.)surface degradation had taken place.

Clearly, if this process could be understood andmade repeatable it could have substantial value in criti-cal cleaning in the photovoltaic and microelectronicindustries.

c4 CRITICAL CLEANING FOR CONTAMINATION CONTROL

All the News That’s Fit to Print...

➤

pp27-30_~ 12/19/11 4:15 PM


Critical Cleaning for Contamination Controlc4

References:

1. Actually, it may not be over–thought it should be so. Problems withEPA’s methodology in their IRIS have been identified by the GovernmentAccounting Office, and the National Academy of Sciences (NAS).Some industry participants feel that a recent study completed by theNAS of use, disposal, and groundwater contamination by TCE at CampLejeune produced evidence called “convincing” by EPA was at most“limited or suggestive of an association.”

2. See http://ntp.niehs.nih.gov/go/34797.

3. Not the one proposed for comment in May 2011, which can be studiedat http://www.fda.gov/MedicalDevices/DeviceRegulationandGuid-ance/GuidanceDocuments/ucm252999.htm., but the proceduredescribed in 21 CFR Part 801.

4. Podoliana, A., Nadtochiya, A., Kuryliuka, V., Korotchenkova, O.,Schmidt, J., Drapalik, M., and Schlosser, V., “The Potential of SonicatedWater in the Cleaning Processes of Silicon Wafers,” Solar Energy Mate-rials and Solar Cells, Vol. 95, No. 2, February 2011, pages 765 to777.

John Durkee is the author of the book Management of Indus-trial Cleaning Technology and Processes, published by Elsevier(ISBN 0-0804-48887). He is the author of the forthcoming bookSolvent Cleaning for the 21st Century, also to be published by El-sevier, and is an independent consultant specializing in criticalcleaning. You can contact him at PO Box 847, Hunt, TX 78024 or122 Ridge Road West, Hunt, TX 78024; 830-238-7610; Fax 612-677-3170; or [email protected].

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