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Hand Washing, Hygiene, CGMP, and Science Scott Sutton K£Y POINTS The follOWing key points are discussed in this article Good personal hygiene is a requirement of all pharmaceutical activi- ties, from operating on the line through laboratory good manufac- turing practice (GMP) studies. However, studies show poor hand washing compliance is the rule in a variety of occupations. • Poor hand washing technique may result in increased absenteeism, particularly in time of a potential HINI pandemic. • Limited availability to adequate lacilities may lead to poor com- pliance or poor erficacy of washing if performed These facilities include appropriately constructed and sourced water supply, soap supply and, perhaps most importantly, adequate provisions for thor- ough drying of hands This is the basis for the current good manu- facturing practice (CGMP) requirement for adequate facilities. While "antibacterial" label claims do no harm, they should not be relied upon to protect against poor practice. • Jewelry can interfere with adequate cleansing and should be removed berore washing Jewelry should be discouraged in areas where hand cleanliness is important. Training for compliance in hand washing is diflicull. There have been numerous repons of the difficulty in training and the subse- quent monitoring of healthcare workers lor compliance with hand washing requirements Suggestlons for training and a potentially useful monitoring tool are provided • Many studies use extended periods of time during the wash 05-2 minutes in some). This is not a practical regimen. A hand wash- "Microbiology Topics" discusses various topiCS In microbIology of practical use In validation an compliance. We intend this column to I:le a useful resource for dally work applications Reader comments. questions and suggestions are needed to help us fulfill :fJ our objective for his column. Please send your comments and suggestions 0 >- column coordinator Scott Sutton at scott suttonCimlcroblol.org or journal COOrdl- nating editor Susan Halgney at shaigneyOadvanstar.com 6 Ci w ::; u1 u a; is if) w " vol /L/ no. /

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Page 1: Hand Washing, Hygiene, CGMP, and · PDF fileHand Washing, Hygiene, CGMP, and Science ... ing and leaving the lab or manufacturingarea. The ... no sense in risking the contamination

Hand Washing, Hygiene,CGMP, and ScienceScott Sutton

K£Y POINTSThe follOWing key points are discussed in this article

• Good personal hygiene is a requirement of all pharmaceutical activi­ties, from operating on the line through laboratory good manufac­turing practice (GMP) studies. However, studies show poor handwashing compliance is the rule in a variety of occupations.

• Poor hand washing technique may result in increased absenteeism,particularly in time of a potential HINI pandemic.

• Limited availability to adequate lacilities may lead to poor com­pliance or poor erficacy of washing if performed These facilitiesinclude appropriately constructed and sourced water supply, soapsupply and, perhaps most importantly, adequate provisions for thor­ough drying of hands This is the basis for the current good manu­facturing practice (CGMP) requirement for adequate facilities.

• While "antibacterial" label claims do no harm, they should not berelied upon to protect against poor practice.

• Jewelry can interfere with adequate cleansing and should be removedberore washing Jewelry should be discouraged in areas where handcleanliness is important.

• Training for compliance in hand washing is diflicull. There havebeen numerous repons of the difficulty in training and the subse­quent monitoring of healthcare workers lor compliance with handwashing requirements Suggestlons for training and a potentially

useful monitoring tool are provided• Many studies use extended periods of time during the wash 05-2

minutes in some). This is not a practical regimen. A hand wash-

"Microbiology Topics" discusses various topiCS In microbIology of practical useIn validation an compliance. We intend this column to I:le a useful resource fordally work applications

Reader comments. questions and suggestions are needed to help us fulfill:fJ our objective for his column. Please send your comments and suggestions 0

~>- column coordinator Scott Sutton at scott suttonCimlcroblol.org or journal COOrdl-

~ nating editor Susan Halgney at shaigneyOadvanstar.com

6

~Ciw::;u1ua;

isif)w

"~

vol /L/ no. /

Page 2: Hand Washing, Hygiene, CGMP, and · PDF fileHand Washing, Hygiene, CGMP, and Science ... ing and leaving the lab or manufacturingarea. The ... no sense in risking the contamination

...ing regiment is suggcstcd for pharmflceuticalindustry workers based on CeI1lt'fs lor DiseaseControl (CDC) hand washing protocol.

• Personnel should carefully evaluate commonpranices when microbial control is required.It is likely that simple processes, such as handwashing, are generally assumed to be undercontroL They may, however, be an undC'lcctedsource of product or sample contamination.

• [tmd scrubs are not l'urrently covered by GX P,but there may be a role for their use in a compli­ant facility in addition to hand washing.

EVERYONE KNOWS HOW TO WASH HIS OR HERHANDS, RIGHT?The US current good manufacturing practice (CGMP)guidelines have clear expectations for hygiene andcleanliness. 21 Code Ol federal Regulations (CfR) 211St::ltc-; the following:

"2JCFR 21128 Personnel responsibililies"(a) rersonnel engaged in the manufacture, pro­

cessing, packing, or holding of a drug product shallwear clean clothing appropriate for the duties theyperform, Protective apparel, such as head, fflce, hand,and arm coverings, shall be worn as ncccssary toprotect drug products from conram ination.

"(b) Personnel shall practice good sanitation andhealth habits

"(c) Only personnel authorized by supervisorypersonnel shall enter those areas of the buildings andfacilities deSignated as Iimited-access areas.

"(d) Any person shown at any time (either bymedicfll examination or supervisory observation) tohave an apparent illness or open lesions that mayadversely affect the safety or quality of drug productsshall be ex.cluded from direct contact with compo­nents, drug product containers, closures, in-processmaterials, and drug products until the condition isconected or determined by competent medical per­sonnel not to Jeopardize the safety or quality of drugproducts, All personnel shall be instructed to reportto supervisory personnel any health conditions that

may have an adverse effecl on drug producls" (1)This is a basic contamination control issue for the

quality of our finished product, in both the ster-

ile and the non-sterile process. In addition to theconcern over proccss control, there is a personnelconsideration as welL Proper hand washing tech­nique is the most effective means to slow the spreadof discase in our facilities Proper hand washingIS particularly important in this time of increasedconcern over global pandemic. There have been ascore of recent articles on the best ways to mll1imizethe spread of the HJ N1 virus lfJnsmisSlOn (2,3)Recent work has shown that hand washing maybe anex.tremely effective and economical way to slow thespread of the vIrus (4)

An obvious consideration in trying to establish theefficacy of hand-washing regimens is the method to

determine that clTicacy. An in-depth review of meth­odology is outside the scope of this article, but theinterested reader is referred to American Society forTesting and Materials (ASTM)-E1174-00, StundardTest Method for Evaluation of the Ej)c'clivcllcss of HealthCare Personnel or Con.lrmler Hand Wash Formulations,or the two European standards Preliminary Europe­an Norm (prEN) 12054 (describing suspension tcsts)and prEN 12791 (describing the in vivo test) We willnot discuss the testing methodologies any further,but the reader is cautioned that all results reportedby the different studies will, of course, be dependenton how the regimen was tested.

FACILITIESThe CGMP for basic requirements IS as follows

"21 CFR 211.52 Washing and toilet facilities. Ad­equate washing facilities shall be provided, includinghot and cold water, soap or detergent, air driers orSingle-service towels, and clean toilet facilities easilyaccessible to working areas" (1)

WaterSome aspects of the availability of soap and water(in terms of sinks) are self-evident. first of all, thereshould be soap and wilter available to those enter-ing and leaving the lab or manufacturing area. Thewater should he of suifIcient quality (at least potable).

The mechanism LO operate the water flow should notencourage the recontamination of the hands immedi­ately after washing. This is commonly accomplished

wr~r/!l' ~r! 10 Vglu~ I~ NUnJt,lY! 63

-~.-.-,.d

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through the use 01 elbow laucets or loot switchesto turn the water on and off. The importance ofthIs consideration was emphasIzed in the study 01Griffith et at. (5), who showed a positive correla­tion between surlace lilth and recontamination 01hands-the faucets were the most consistently con­taminated leature olthe immediate environment.

Current best practice suggests sinks convenientlylocated near entrance and exit points, with suitablecontrol mechanisms, and the availability of soap

SoapThe type of soap, and in particular the desLgn of thesoap dispenser, is another important aspect of the el­ficacy of hand washing We have three major choices:Bar soap, refillable liquid soap, and sealed liquid soapBar soap is not suitable as it is a proven reservoir forbacteria (6). This leaves us with liquid soap

Liquid soap dispensers come in two generaldesigns In the first, liquid soap can be added to areservoir when required. Best practice is LO com­pletely clean out this reservoir before filling it againLO prevent bacterial buildup as microorganisms cansurvive in soap (7, 8). It is nOl recommended LOmerely "top-off" the soap LO refill the reservoLr. So,in choosing between removing the residual soap andthoroughly washing out the reservoir belore rdilling,and the other choice of lifting the lid and LOpping itoff, which is the more likely practice? This does noteven consider the nozzle that gets LOuched by theuser's hand as soap is dispensed (to prevent that lastdrop from falling onto the counter), and is very likelyLO have dried soap caked LO ItS exterior.

The other variety of public area liquid soapdispenser has a sealed bag with an integral nozzle.Regardless 01 the formulation contained within thebag, this system enables a clean startup with eachrelill of the soap container Check out the nextliquid soap dispenser you see and come LO your owndecision alter you look closely at a few 01 the nozzlesand compare reservoir-style dispensers to sealed-bagdispensers. I would urge the use of the sealed bag

system In the lab and manufacturing area There isno sense in risking the contamination of your handsby the soap if this risk can be minimized

Antibacterial AdditivesThe concept of antibacterial additives to SO:lp soundsgood Take soap, arguably the most important medi­cal advance in the last few hundred years, and makeit better by adding a biocide LO it. The problem withthis scenario is that the vendor is not actually requiredLO show that the biocide works in the soap, only thatit is present In the formulation This is not LO say thatreputable manufacturers do not conduct appropriatetesting, only that this testing is not reqUIred to lahelyour product as an "antibacterial" soar In addition,there is the possibility 01 selecting for biocide resis­tance in soaps that might be only marginally moreeflicacious than standard soap, il morc cilLcacious atall (9, 10). However when this works, the resultantproduct can be quite good fuls et at. (11) lound thatwith a particular soap containing triclosan, the useof a greater volume of soap and longer wash time re­sulted in a marked superiority of the antibacterial soapover the traditional formulation.

The biocides most commonly used as soap addi­tives include triclosan, ehlorhexidine, ethylendiami­netetraacetic acid ([OTA), and alcohols. Triclosanhas come under intense scrutiny for potential selec­tion of antihiotic-resistant mutant microorganisms,particularly in Europe This prompted the EuropeanCommission (EC) to formally examine the salety 01triclosan and the Scientific Steering Committee ofthe European Commission adopted an ollicial opin­ion in 2002 that triclosan, used in biocidal concen­trations, is safe and effective (12) Chlorhcxidine stillhas a place in the surgical scrub arena but is not amajor component in consumer products.

To sum up, biocides added to soap make an anti­bacterial soap. However, this is not a guarantee thatthe resultant antihacterial soaps are, in fact, anti­bacterial as instances of antibacterial soap sufferingcontamination have been reported (13, 14).

HAND JEWELRYHand Jewelry (e.g., rings, bracelets, watches, etc)should be removed when washing your hands.

These ilems ofjewelry make it very difficult toclean your hands eflectively. Alp et al. (2006) (15)examined the hand washing practices of laboratory

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workers, figuring that regular exposure to pathogen­ic organisms would make them aware or the dan­gers Compliance was 100% ror the act itselr altC'ftraining, but 36.7% wore a ring, 46.9% a watch, and6.1% a bracelet, all or which harbored pathogenicorganisms arter hand washing This was correctedby repeated interventions Fagernes et al (16), in astudy or healthcare workers, examined the impact orwearing a single plain ring (rather like the weddingring many or us are no longer able to remove). Thegood news is that the total bioburden arter washingwas not dirrerent between ring wearing and no ringsuhJects, although the study showed a clear increasein Enterbactcriacae contamination when compared tothe subjects without rings

DRYINGSeveral teams have looked at paper towels vs hot aIrdryer in regards to cleaning and transmission or con­tamination. Matthews and Newsom (17) comparedhot air driers and papcr towels ror the potential tospread anborne microorganisms during the dryingprocess Their deSign rocused on air sampling usingCasella slit-to-agar sampler ror anhorne bacteria dur­ing drying (in the somewhat controlled environmentor a biological sarety cabinet). They round minordirrerences in airborne viable counts in a comparisonbetween one model or dryer and paper towcls, andsignificantly less airborne viable counts ror two othermodels in comparison to paper towels. Blackmoreexpanded this comparison, conducting a study (8)on the drect or drying by air blower, by paper towel,and by cloth towel on a continuous roller. Thefinger tips or the left hand were sampled by touchingto nutrient agar and then the hands were washedArter washing, the hands were dried by one or thethree methods and sampled again. The expelled airrrom the air driers was sampled by blowing it Onto"nutrient agar" from 6 inches ror a controlled periodor time (dirrering by cycle time or the model or airdner) The paper and cloth towels were sampled bytouch plates. Blackmore repons that the air blow­

ers tested (in public locatiolls) harbored bacteria andcould serve as a source ror recontamination or handsarter washing. The situation with continuous cloth

., .drying was not encouraging either The cloth rollertowels were very good when new but over the courseor three months (the length or time studied) they be­came contaminated In addition, she found (in 1989)that these continuous cloth towcls are laundered andre-used, the laundered m:nerial was contaminated aswell (range or 10-60 CFU/touch plme) as installed inthe roller dispenser. One explanation for the appar­ent contradiction in the results is orrered by Meers andLong (19) who did a limited study to evaluate the pur­chase or hot-air dryers ror their hospital and sampledthe air before, during, and arter drying, finding an in­crease in counts only arter drying Thcy concluded thatit was di{ficult ror small particles to cscape rrom skinwhile moist (covered with water) What was importantwas that the skin he thoroughly dried.

Harrison Ct at (20) took a closer look at transmis­sion or bacteria bell.veen hands and paper towels.They looked at both directions or transmission, rea­soning that the concern over a contaminated toweltransmitting to the hand is clear, but there i,; also apossibility ror a contaminated hand to transfer bac­teria to the dispenser while rreeingiammed towelsUsing a wall-mounted paper towel dispenscr and arange or paper towels, volunteCfs (With either cleanor contaminated hands) were asked to clear pmmedtowels rrom the dispenser (the dispmser eitherclean or contaminated) They round that while thecontaminated hands only marginally contaminatedthe dispenser (001%-064%) the dispenser was rairlyefrective at contaminating hands (12.4-13.1%)

In looking at the potential lor diny hands to con­taminate surraces we should also consider dryness.Patrick et al (21), in studying this issue, concludedthat "... bacterial numbers translocating on touchcontact decreased progressively as drying with anair or cloth towel system removed residual moisturerrom the hands ... Careful hand drying is a criticalractor determining the level or touch-contact-associ­ated bacterial transrer arter hand washing and itsrecognition could make a significant contributiontowards improving hand c:lre practices in clinical

and public health sectors."Reinrorcing this consideration is the recent study

of Yamamoto et a!. (22) who looked at drying by

"r 1II",r..,20'0 Vll~ 14 lJ<JmtIeI,' 6S ."'" ,{'" I .. - • "":T......~~

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paper towel, by hot air, and by hot air supplementedwith ultraviolet (UV) light. In addition, the hot airdrying was performed cit her by holding the handsstationery or by rubbing the hands together. Afterlooking at all variables they concluded that the hotair dryer is erlective il the hands were held motion­tess (ie, not rubbed) until dry. The UV light alsoseemed to help in decreasing residual viable cellsfor the hot air dryer. Paper towels were shown to bemore effective when measured by fingertip sampling,but equivalent by other measures.

TRAINING AND MONITORINGAll budgetary resources spent on a personnelhygiene program will be inerlective il training andmanagement attention is incomplete or indifferent.Compliance is universally the major problem inhand washing programs (23) The first problem toaddress is to determine a suitable procedure for handwashing. Several are available, although none arespecifIcally directed to the pharmaceutical worker.

Training becomes the next issue. Training byrote is always an option, but this is not a particularlyerfective one as "everyone knows" how to wash theirhands and any changes madc solely to meet standardoperating procedure (SOP) requirements will betransitory at best There are several tools availablelor assistance in training, particularly in the evalu­ation of cleaning efficacy. A common method is toapply a fluorescent gel as a marker prior to washing.After washing, the hands are held under UV light todetermine efficacy of cleaning One such activity isavailable on the Internet at http://www.bamgov/teachers/activities/epi_4_hand_wash.pdf (down­

loaded 9/27/09) This activity guide is useful insupplying a teaching resource for hand washing thatincludes a lesson outline and three separate sourcesof the fluorescent gel to use as a marker.

The linal issue is monitoring compliance. This isparticularly difficult as self-assessment is notoriouslyinaccurate, at least among healthcare workers whoconsistently sel f-repon more conscientious hygiene

behavior than what is observed independently(24-27) On the other hand, Stevenson et al. (28)report a tool for self-reponing that is directed at the

general population that might have use as a moni­toring method, perhaps coupled with observationObservation of behavior should be included in anyevaluation, however else compliance is measured inyour faCility.

A SUGGESTED HAND WASHING PROTOCOLThe follOWing stepwise procedure is recommendedfor hand washing in the pharmaceutical environ­ment. The following protocol is based on a CDC(Centers for Disease Control) hand washing protocol

• Remove jewelry from hands and wrists.• Consider the sink, including the laucet controls,

contaminated. Avoid touching the sink andlaucet controls with your hands.

• Turn water on using elbow controls (or foot con­trol). If these are not avatlable, use a paper toweland then wet your hands and wrists.

• Apply soap from a dispenser (do not use barsoap which will certainly be contaminated withmicrobes) Assume the control levCT for the soapis contaminated. Work soap into a lather.

• Vigorously rub together all surfaces of the lath­ered hands for at least 20 seconds Friction helpsremove dirt and microorganisms. Wash aroundcuticles, in the linger webbing, the back olthehands, and under fingernails in addition to rub­bing the palms together

• Rinse hands thoroughly under a strcam of water.Running water carries away din and debris.Point fingers down so water and contaminationwon't drip toward elbows

• Dry hands completely (leave water running)• Use a clean dry paper towel Bc aware that if

the towel jams and you need to work to release ityou should re-wash your hands if you touch thedispenser.

• Use a hot-air blower (preferably one that hasan integral UV light) Start the unit with yourelbow (not your weI hands) Do not rub yourhands together while drying them completelyunder the hot air flow.

• Use elbow or foot to turn faucet off. Ifappropri­ate faucet controls are not avatlable, use a cleanpaper towel to turn off the faucet.

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• Do not top off the soap dispenser This leads tocontaminated reservoirs in addition to the con­tamination in the nozzle. If possible, use a soapdispenser that is refliled in a scaled containerthat mcludes the soap in a plastic bag and a freshnozzle

• Do not assume ant ihacterial soaps are clTica­cious. Treat all soaps as potentially contami­nated and cxercise sanitary practices in regularlycleaning dispcnsers

IMPLICATIONS FOR COMPLIANCEPersonnel properly trained in routine cleanliness arc anobvious need for all manufacturing and testing. Thisneed is heigh ted in high risk nunufacturing such asin aseptic processing. This need is also heighted insituations wherein microbial testing is part of valida­tion testing but is not usually conducted in routinemanufacturing. For example, preparation of granulat­ing liquids for solid products does nor usually includemicrobial testing Preparation of aqueous coating liq­uids does not usually include microbial tesung. Cleanequipment storage does not usually include microbialtesting. All of these examples would likely includemicrobial testing for process validation or cleaning vali­dation. The two aforementioncd formulation exampleslikely do not contain preservatives in their respectiveformulations Depending on the formulation, microbi­al growth could be easily supported in these situationsClean equipment hold time validauon should includemicrobial testing Drug dispenSing practices maynot routinely include microbial testing even thoughliquid materials that support microbial growth may beroutinely dispensed for use in manufacturing com­mercial product Validation personnel should carefullyevaluate personnel practices when microbwl testingis required in validation protocols it is likely thatSimple processes, such as hand washing, are generallyassumed to be under control when they may be anundetected source of product contamination.

HAND SCRUBSThe producL caLegory of "antibanerial hand scrubs"should be considered. Even though antibacterialhand scrubs are not covered in the CFR, their enor-

mous popularity has made them a common fixturein m:my companies. Recent literature studies \vouldsuggest that they can be vcry useful. Suchomel, M,et al. (29) looked at three commercial products withalcohols (propanols or ethanol) at no;" - 78% andfound propanol prepamtions more c1fcctive, passingthe requirements of EN 1279] after a 90-second rubAn earlier study by Rotter, Jv1L ct al. (30) evaluateda series of alcohol-based sanitizing rubs and foundseveral that performed suitably (under LN 12791)when applied for 90 seconds. They made the strongrecommendation, however, that their results not begeneralized to all alcohol-based rubs as they did seedifferences among those tested. Each rub needs to

be qualified for its application Finally, Witt (31) ar­gues that the use of hand sanitizns as an adjunct tohand washing can be extremely effective, particularlyif coupled with effective technique Jnd aw:ntion tothose portions of the hands most commonly over­looked on hand washing

What we are left with then is that it would heprudent to include a hand sanitizer in the hygienepractice. This can be used with a 90-second rub asa sanitization step between hand washings or afterhand washing once the skin is completely dry. Thesanitizing rub should cover the entire hand, butprovide particular auention to the fll1gcrtips, hack ofthe thumbs (to the base), and webbing of the fingers(areas sometimes neglected during h::md washing).

SUMMARYHand washing is an activity that is frequently taken forgranted. Every pharmaceutical process that includessome aspect of human intervention is subject to

contamination and the integrity of well-designed andcontrolled phJrmaceutical processes may be compro­mised by careless hJnd waShing. Employee awarenessof this potential coupled with effective training willminimize inadvertent contamination due to carelesshand washing techniques.

There are several key points to ensure effective handwashing. It is important to use proper technique instoring Lhe soap in a cll'JlI manner (to prevent exces­sive contamination), remove alljewelry, to use enoughsoap to do the job, wash thoroughly (time and applica-

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, MICROBIOLOGY TOPICS

tion), and to completely dry your hands while prevent­ing recontamination.

As for drying method, there does not seem to bestrong, unambiguous data showing superiority for ei­ther paper towel drying or hot air drying (although UVirradiation when used with hot air seems preferahle).

Techniquc and procedure are paramount inminimizing transmission Once trainee!, ongoingcompliance with thc hand washing procedure shouldbe monitored as pan of an ongoing conwminatloncontrol program for the faCility, and an aid to mini­mize employee ahsence due to illness.

REFERENCESFDA, 21CFR21128, Code of Federal Regulation" Title 21,

Volume 4, Title 21-fuod And Drug'. Chapter I-Food And

Drug Adminislration, Department Uf Hcalth And Iluman

Servia" Subchapter C-Dru '5: General. Pan 211-Current

Good Manufacturing Practice '01' l'imshed !'hurmdceutic"b,

Subpart B-OrganizatLon and Personnel, Revised as of April

1,2009.

2. Gallaher, WR., "Towards d Sane and Rational Approach to

Management of InnuenlJ HINI 2009," Virology 6')1-57,

200'!.

3. I Iellemans, A., "Bealing the Flu in a Singk Shot," Sci Amer,

lutlc: 104 - 107, 200S.

4. Gr~ys"n, M, et aI, "Elfrcacy of Soap and Water and Akohol­

Based Hand-Rub Prcparations against Live HINI InllUl.:nza

Virus on the Hands of Human Volunte('r".'· Clin Inferl Dis,

48285 - 291, 2009.

5. Grilhth, CJ et ul., "environmental Surface Cleanlincss and the

Potential for Contamination During Handwashing," Amer)

Infect Conlrol 31(2):93-96, 2003.

6 Hegde, P, et aI., "Microbial Contamination of "in use" Bar Soap

in Dental Clinic"'- Ind) Dent Re;. 17(2)70 - 73,2006

7. Buffet-Balaillon, 5, el aI., "Outbreak of Serratia marce;cens in a

Neonatal Intensive Care l:nit: Contaminated Cnmedicated

l.iquLd Soap and Risk F:Klor"'" ) Hasp Infect. 7217 - 22,

2009

8. Sartor, C, et al .. "Nosocl1Inial Serralia mWU,(l'ns Infections As­

sociate with L\trinsic Contamination of a Liquid NonmcJi­

cated Soap," Infecl (onlrol Ho,p tpidonk11., 21(3)196 - 199,

20009 Aiello, A.E., Larson, E.L., Levy, S.B., "Consumer Antibacterial

Soaps: EITective or Just Risky?" ClimcallnffCli(lu.1 Olscu_<rs, 45

Surrl 25137-47, 2007

10. Kampf, G. and KramlT iI., . I'ridcmiologic [Jacl'grnund 01

Hand I Iyglcnc .md b'aluJtion of the ~ost Imronant Agents

for ~crubs and Rubs,"' Clill ,\1",,;hiol Re\', 17(4):863 - S'! 3,

2004.

II Fuls,J, Rodg"ls, N. et aI., "Altcrnath'c Hand Contamination

Tcchni4ue tll Cnmpare thc Activities of Antimic:robraland

Nonantil11ierobial Soaps under Different Test Conditions,"

Appl Envir IvlLCI'ubiul., 74(12):3739 - 3744, 2008

12. European Comml,sion, Opinion 01 Ill" SunLlil)( Cummillcc on

(',,,m"1ic ProduCls and Non·food Products Inlcndcd /or Cumllm­

as, 2002. hltr://ec .europa.eu/hcalth/ph_rLsk/com miltet's/

sccp/documents/outI82 _en.pd f

13. Archibald. LI<., et aI., "sCI raUa mwcrsccn.< Outbreak Associ­

ated with Cxtrinsic Contamination 011';:, chlorxylenol soap,"'

InJrrt Conlmlll(l.<p Ipi<lcm., 19(7)704-709.1997

14. Dolan, SA el aI., "Buhhlc, to Wuhbles: An lnveqigalion

Involving thl Contaminat ion of S()~p lJubble Products at a

Pedial ric Ho:<pital,' )SPN, .I (0) 18'1-95,2006

IS. Alp, c, ~t aI., "1·land Hygiene Among Lahoratory Workcrs,"'

Infcu COI11I0I Hasp Cpidcmiol, 27(9):978-980, 2006

16 Fagernes. \1, et aI., "Impact of a Single Plain Finger Ring on

the Bauerial Load on the Hands of 11e~lthc"rc Workers,"'

Infw Contrul Hasp tpidcmlul., 2H(l0)119l-1195, 2007

17 Matthews. JA and SWH Newsom, "Hot f\ir Electric Hand

Driers Compared with Paper Towels for Potential Spread of

Airborne [Jaucria:') Ho,p Infect., 9:S5-88, 1987

18 Blackmore, HA . "A Comparison of Hand Drying Methods,"

Calermg linn Ilrallh. 1: IH9-109,l989

19 Mcns, PDand KY Leong, '1Iot-air Ijand Drkr'.) [[(1,1' Infecl

14:169-181, 1989

20 Harrisun, "V,\ ct aI., "[lactcrial Transfer and Cross-cuntamina·

tion l'otlOntial Associated wLth PJpcr-towel Dispensing," Amer

) In/crt Control .. 31(7):387-391,2003.

21. Patrick, DR et aI., "Residual Moislurc Determines the Level of

Touch-contact Associated BaLleried Iramier Fullowing Hand

Washml',," tl'idcllliulll1{<'(I, 119:319-325, 1997

22. Yamamoto, Yet aI., "EITiercncy of Hand Dr)'ing for Rcmuving

Bacteria From Washed Hands: Comparison of Paper To\wl

Drying with Warm Air Drying." Infect Control rlu;" Epidemiol.

26(3).31b-320, 2005.

23. Jumaa, PA., Hand Hygiene Simple and Comriex,'" Inli)

Infecl DIS, 9l-14, 200524 Jenner, E., rktcher, B., et aI., "Di>erepancy Between Self-Re­

poned and ObserveU Hand Hygiene Behaviour in Healthcare

Page 8: Hand Washing, Hygiene, CGMP, and · PDF fileHand Washing, Hygiene, CGMP, and Science ... ing and leaving the lab or manufacturingarea. The ... no sense in risking the contamination

Prob"lonals,"] Hosl' 111{'·(1., 63:418 - 422, 2006

25 Haa,. JPam! FL Larson, "MeJSUlTmenl of Compliance with

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26. Larson, I:: Jnd r I.u,k, '!::vJlu3ting H3ndw3shing Technique,"

] Ad\' N'trsil1>;, ,,3(1)-+0-50,2008.

27. Cule M Exploring the H3nd Hygiene Compelence of Student

Nurses: A Case of f'iJwecl Self Assessmcnt, NtH", fdl!wlion

10duy, 29~80 - 188, 2009

2B. Slc"rnson, R, el aI., "A ::'c"k f(lr \>Jca"uring Hygi"l1c Bchdvior:

1'~\'l·lopl11l'l1l. RelielbililY, e1ml V"liuily." ,Imcr] In{ecl Conlml.,

37(7h,/-)64,2009

29. Suchomel, M, el aI., "Surgical Hand Disinrc~lton Using

Alcohol: The nrccl' 01 Alcoliol Typc. \lode and Dur31ion of

Application,"] "0'1' tn{ed., 71:228 - 233, 2009

30. ROller. ML et aI., "Long-Ierm ErfcTI of a 1.5 minute Surgi~al

Hanu Rub wilh a Propanol-based Product on the Re"uenl

Hand f·lora.'·] 11",1' InJce!, 66(1)84-85,2007.

11 Will, H., E:neuI\I' Use of Alcohol Hand Sanitiz",", Conlrol/ed

lnvimn., 11(8)26,2008. GXP

ARTICLE ACRONYM LISTINGASTM American Society for Testing and Materials

CDC Centers for Disease Control

CFR Code of Federal Regulations

CGMP Current Good Manufacturing Practice

EC European Commission

EOTA Ethylendiaminetetraacetic Acid

GMP Good Manufacturing Practice

prEN Preliminary European Norm

SOP Standard Operating Procedure

UV Ultraviolet

BOUT THE AUTHORSCOll SlillclO, Ph.D.. i" a consulunt and operat~,;The Microbiolo­

gy "let work (www.microhiol.org). which provides consulling and

training in contamination ClItHrol, C1l'\'ironmenlat monitoring,

GMP. investigations of bioburden-rd::necl manulacturing issues,

and QC microbilJlclgy laborJlory operations. Tile Microhiology

Network also "perales the c-m"il cli"'ussiun groups the Piv!['LiSl

(microbiology) and the I'SLJGList (stability issur5) Dr. 5ullon can

be reached at [email protected].