Cleanroom Design in 10 Easy Steps Easy" may nol be a word that comes to mind for designing Such sensve envzonments. However, that does mean you cat produee a sok leancoom design by tacking issues na logical sequence, Tha aril covers each xey stp, down to handy application specie tps for adjusting load caeustons, plannng exttration pha and anging for adequate mechanical room space relatve tothe cleanroom cass Many manulacturing processes need the very tingentenvitonmental condons provided bya elearvaom. Because clearvooms have co and high constuction, operating, and energy costs, tis mporant to perform the cleanroom design ina methodical way. This atl wil pe for evaluating and designing cleanrooms, facorng in peoplelmatetal ow, space cleanness classeaton, space pressurization, spa entiation, space ar balance, varebles tobe evaluated, mechanical system selecion, heatnglcoolng aad calculations, ané supper spa Step One: Evaluate Layout for People/Material Flow chanical systems epeby-sep mathod tis important o evakate the people and material ow within the cleanroom aut, leenroom workars area clearraom’s largest contamination source and al etical processes shouldbe isolated frm personnel accoss doors and pathways,‘The most etal spaces should have a single aocess to prevent the space trom being a pathway to cthe, less eical spaces. Some pharmaceutical and bopharm 'nd biopharmaceutcal processes. Process coss-contaminaton needs ished product auilow Figure ‘ig an example of a bone coment acy that has both erical process (Solvent Packaging”. "Bone Cement Packaging") spaces wih a single access and locks 88 baller to high personnel tafe areas ("Gown “Ungown") Step Two: Determine Space Cleanliness Classification ‘Tobe able o selec a cleanroom classfcaion, iis important to know the primary cleanroom clssfiaton standard and wh he patculte performance Feauirements are for each cleanness cassitcation. The Insitute of Enyrans-tlal Scunce and Technology (=ST) Standard 14044-1 provdes the dorent ‘earliness classifications (1,10, 10, 1,000, 70,000, and 100,000 andthe alowablo numberof partes at diferent particle ses. For example, a Clas 100 cleanroom is allowed a maximum of 3,600 partclaicu ft and 0.1 microns and larger, 100 partcles/ubic a0 microns and larger. and 2¢ pattclos/eubie fal 1.0 microns and larger. This lable proves the allowable airborne particle densily per cleartinesscassiaton table:cee ar in 1 ay Sa Maximum Particlesim® Classification FED STD 209E Equivalent 2otum | 202ym | 203ym | 20-5ym ztym | 25pm 1804 0 2ar 1.02, 03s 0.083 | 0.0029 1802 100 237 102 35 083 0.028 1803 1,000 237 102 35 83 0.028 Class 1 Is04 10,000 | 2,370 41,020 352 8 23 Class 10 Iso5 100,000 | 23,700 | 10,200 3.520 832 29 Class 100 1806 10x10" | 237,000 | 102000 | 35,200 8320 293 lass 1,000 1so7 10x10" | 237x10° | 1,020,000 | 352,000 83,200 | 2.980 Class 10,000 1808 10x10" | 237x10' | 102x140" | 3,520,000 | 832,000 | 29,300 Class 100,000 Ws09 | 10x10" | _2.97x10 | 102x109" | 35,200,000 | 8,820,000 | 293,000 Room Air ‘Space cleantnes cassicaton has a substantial impact ona cleanoom’s constuction, maintenance, and energy cost. Its mportant to carelully evaluate rejecttontamination rats at diferent cleanness classificatons and regulatory agency requirements, such as tne Fa0d and Drug Adminis (FDA), Typical the more sersive the process, the mare stingent cleanness classfemon should be Used. Ths able provides cleanness dassieatons for varely of manufacturing processes: Industrial Application ‘Application Classification ‘Aerospace 180 Class 5.7 ‘Assembly of Touch Screen Membranes 180 Class 7 ‘Composite Materials 180 Class 8 General Industrial ISO Class 8 Isolation of Injection Molde: 180 Class 78 Optical 180 Class 57 ons epecmietrheneom teen tO.sree chance ar in 1 sy Application Classification ‘Semiconductor 180 Class 5 ‘SMT Assembly 180 Class 78 Solar 180 Class 5-7 Water Board 180 Class 5 ‘Consumables and Pharmaceuticals Application Classification E-Liquid 180 Class 78 Food Packaging No Classification Nutraceutical Packaging 180 Class 78 Pharmaceutical Compounding 180 Class 7 Pharmaceutical Packaging 180 Class 8 Sterile Compounding 180 Class 5 Medical Devies ‘Application Classification Device Reprocessing 180 Class 7 Inplantable Devices 180 Class 5 Medical Device Packaging 180 Class 78 Your ranstactring process may neod a more sngentcloariness class depending upon ts unique requirements, Se careful whon assigning clanliness classiteatons fo each space; there should be no more than two otders of magnituse dferencein clearness cassicaton betwoen connecting spaces. For example, It not aeseptabl ora Clase 100,000 cleanroom to apes into a Class 100 elwantoom, bul tis aceapiabe for Clas 700,000 dloanroom o-opon into @ Class 1000 Looking at our bone esrent packaging faci (Figure 1), "Gown", Ungown’ and Final Packaging” roles ical spaces and have @ Class 100,000 (ISO 8) ‘leantiness classification, “Bone Cement ocx” and “Sterile Aifock” open to ical spaces and have Class 10,000 ({SO 7 leaninss casseation; ‘Bone Cement Packaging a dust elieal process and has Clas 10,000 (SO 7 cleanness clatseation, and Solvent Packaging” a ery eal process ans performed nts sepecomietc cane tesent Ons usClass 100 (80 5) laminar fowhoeds in a Class 1,000 'S0 6) cleanroom, Step Three: Determine Space Pressurization Ouaside a Mors 5 fiter (2034) Marv 11 fier (20%) Coating eo Heating col lh | Ail Lumister Co] toro Eaten ere cen, Sines 168,000 eur si |)Maintaining a postive ai space pressure, in relation to adjoining dtr cleanliness classiicaton spaces, is essential in preventing contaminants frm nating into a Cleanroom. lis very fc to consistently maintain a space'scesnineesclas‘eaton when fas neural or negative space pressurization, What should th space pretaure diferent be between spaces? Vanous studies svalvated contaminant nfiralon naa cleanroom ve, space pressure dferenial btween tne cleanroom 4nd adjoining uncontoled onvronment. Those studios found a prossuro diferent of 0.03 o 0.05 inw.. to be efectve in roducing cortarinat inflaton. Space prossutedifecentias above 0.05 nw, do nat provide substatalybettor contaminant inition corr then 0.08 in m9. ‘oop in ming, a higher space prossue diferent has a hghar energy cost ands more diftcut to contro. Also, a higher prossure differen requires more force in ‘pening and clesing door. The recommended maximum pressure cfferenial acrosea door i 0.1. wig. ati. wg, 3 foot by 7 foot door requires 17 pounds of foree to open and close, A cleanroom site may need lobe reconfigured to Keep the stale preseur difornial across doors within accoptabe bt, COurbone coment packaging fait is being bul within an existing warehouse, which has a neutal space pressure (0.0 in. wg). The airlock between the warehouse ‘and "Gown/Ungown does not have @ space cleanliness clagsfiatlon and wil not have a Gesignated space preseurzaon,"Gow/Ungown” wil havea space prossurizaton of 0.03 n. wg. "Bone Cement Air Lock” and Store A Lock" wil have a space pressurization of 0.06 in. w 9. "Final Packaging” wil have a space prossurzaton of0.08 nw. “Bone Cement Packaging” wil have a space pressraton of 0.03 nw, and» lower space pressure than ‘Bone Gomant Mir Lock” ‘anginal Packaging” n order to conta he dst generated during packaging ‘The ar loin into the "Bone Coment Packaging is coming om a space withthe same cleanliness classification. Ai infitation should not go trom a iter cleanliness classification space toa cleane” cleanliness caesfieaton space. “Solvent Packaging" wil Mave a space pressurization of 0.11 wg. Note the space pressure dfeental between the less etea spaces 0.03 wg. an the space difereial between the very cfleal "Solvent Packaging” and Stele Ne Loe Boos in. wg. The 0-111n wg. space pressure wi not requre spec stuctural renforcements for wals or cellng. Space pressures above On. wg. should be ‘evaluated for potenaly needing additonal sructuralreforcement Step Four: Determine Space Supply Airflowsnes nae Dar in 10 ay Sa cing ct Mec 1 tar 9036) iooiaaile Mex 5 har 2% >fosie ae (2) 7 Huicier ‘Nicharling unit Maw 11 fee Recirculation tan a Fr Seat cesar Return air chase ae = Petum e oo aoc cieteberaoedagr Oats am‘Te space cleanliness dassieation isthe primary variable in determining a clesnroom's supply alow: Looking at table 3, each clean classifcaion has an ar change rate. For example, a Class 100,000 clearraom has @ 15 to 30 ach range. The claanroon's a change rte shuld take the anitcipated acy within the cleanvoom Into account, A Class 100,000 (60 8) cleanroom having alow occupancy rate, low paicle generating process, ang postive space pressurization in elation fo adjacent itor clartiness spaces migh uso 15 ach whl the samo cleanroom having high occupancy, equont info traf, righ parce gonoraing process, heutal space pressuzaion wil probably neod 30 ach ‘Te designer needs to evaluate his specife application and determine the air chango rat to be used, Other variables affecting space supply arfew ar process exhaust ariows ai infitatng n hveugh doorsfoperings, and ar exiting oul through doorsioprings.IEST has published recommended ai change raos in Standaré 844-4, Looking at Figure 1,"Gown/Ungown” had he most vou ravel but is nat process crical space, resulting in 20a ch, ‘Slee Ar Lock” and “Bona Camant Packaging Ar Lock are adjacent ta crea production spaces an inthe case othe "Bone Cement Packaging Ar Lock, te alr flaws from the ar lock nto the [packaging space. Though these a locks have limited iniout avel and no particule generating processes, ther crcl importance as a butler tween *GowniUngowr and manufacturing processes asl in tho having 40 ach "Final Packaging” places the bone cement/olvant bags into a secondary package which i ot ctial and resus ina 20 ach ato, "Bone Cement Packaging is a citcal process and has a 40 ach rato. "Solvont Packaging" ica vory c'zal process which performed in Clas 100 (ISO 5) laminar tow hoods witin a Class 1,000 (180.6) leanroom. ‘Solvent Packaging” has very tiled infut rave and low process parclate generation, resuling in 8 150 ach ae, Cleanroom Classification and Air Changes Per Hour [Ar cleanliness is aeheved by passing the ai through HEPA fiters. The mote olen the ar passes through the HEPA fiers, he fewer artiles are let in the room aie ‘The volume of a Titered in one nour vised by te volume af the room gives the number a a changes per Nout. 180 Class ‘Average number of air changes per hour 1s05 ‘240-260 air changes per hour (unidirectional airflow) Is06 90-180 air changes per hour 1807 30-60 air changes per hour Iso8 10-25 air changes per hour Conventional building 2-4 alr changes per hour ‘Te above-suggested alr cnanges per nour are only @ design rule of thumb. They should be computed by an HVAC cleanoom expert. 35 many aspects must be ken into consideration, suchas the sizeof tre rom, the numb of people inthe room, he equpmantin he foam, the processes invlved, he heat gan tc Step Five: Determine Space Air Exfiltration Flow‘The majonty of cleanrooms ace under postive pressure, resulting in planned ar exlrating inte adjoining spaces having lower state pressure and unplanned a exfitraton trough slocrcal cua, Ign ficures, wndow frames, coor rames, walfoer interface, walceling interface, and aoassa coors is important 0 Understand rooms are not hameticaly seal ard’do have leakage, A wsl- sealed cleanroom wal have 21% lo 2% volume leakage rato. Is hs laakage bad? Not necessary Fst tis impossible to have zero leakage. Secon, fusing actve supply return, and exhaust air contol devices, there needs to be a minimum of 10% ference between supply and return alow io slatcaly decouple the supply ret, and exhaust ir valves ‘rom gach other. The amount of ar exiaing trough doors ‘dependent upon the doors, the pressure ciferental across the door and how well the doar ls sealed (gaskets, door dope, closure). \We know he planned infitationvexitvaton ai goes rom one space to the other space. Where does the unplanned exflraton go? The air releves within the stud pace and out tha op. Looking atau example pret (Figure 4) the ar exitraton trough te 3 by T= foot doors 120 cfm tha dferantal ite pressure of 0.03 iw. and 270 cfm with a ferential stat pressure of 0.05 in. wa. Step Six: Determine Space Air Balance ‘Space lr balance consist of ang a the alow into the space (cupely,nflration) and all the arto lasvng the space (exhaust, exftratin,rtum) being equal Looking athe bone cement facty space air balance (Figure 2), "Solvent Packaging” has 2.250 cfm supoly alow and 270 cim of ir exflration to theStele A Lock esting in a return alow of 1980 cfm, "Serle A Loc” has 290 cim of supply a, 270 cfm of infiraton from ‘Solvent Packaging”. and 190 cfm exltraton to "GowivUngow" resulting n a rotum alow of 370 cfm "Bone Cement Packaging” has 600 cim supply sirtow, 190 cfm far lraton Fam Bone Cement Ar Lock, 300 cm dust collection exhaust, and 490 cfm of rtum a "Bone Cement A Lock" has 280 cm supply a, 190 cm exilalion to Bone Cemant Packaging’ has 670 cfm eupaly a. 190 cfm exfraton fo "Gown/Ungour ral Packaging" has 670 cim supply at, 180 cim exvation to ‘GawnlUngowr and 480 cm of rtum a. “Gown/Ungown has 480 cfm of supply ai, 570 chm of Intraton, 180 cfm of exftvaon, and 660 elm oft a, Wie have now determined the cleanroom supply, nfiration, exflraton exhaust and retum allows. The fal space return alow wil be adjusted during star-up for Unplanned a exitraton, Step Seven: Assess Remaining Variables Other variables needing tobe evaluated include + Temperature: Cleanroom workers wear smocks a fl buna sits ove the regular dlothes to reduce patculale generation and potenatcontaminaton. Because Giteirestra cbting, tls mparant fo maitane lower space lomperure for worker confor. A space temperature ange besween 65°F ana 70" mi provide ‘omforable condone + Humaty: Dus fo a cleanroom high aiow, a large electostatc charge is developed. When the cslng and walls have ahigh electrostatic charge and space has a low roatve humidity, airborne parila wil attach isl fo tho surface. When te space relative hum increases, he electrostatic charge is escharged and al ‘he captured parca ie elessod ina shor time period. causing te cleanroom to go oxo specication Having high electrostatic charge can also camage ‘locrosiatealsenage senstive materials I's impostant wo Koop the space felalve humialy hgh enough to redUee the sletostae charge blé-up. An RH oF 445% +58 Is considered the optimal humid level + Laminarty Ver ertcal processes might requ laminar flow o reduce te chance of contaminates geting int the airstream between the HEPA fier andthe process. IEST Standard #1EST-WG-CCOOS provides arfow lamiarly requirementsElectostate Discharge: Beyond the space humidification, some processes are very sense o electrostatic clscharge damage and itis necessary to install grounded conducive fooeng. + No's Levels and Vibcton: Some pracision processes are very sensve to noise and vibration. Step Eight: Determine Mechanical System Layout [Anumber of variables affect a cleanroom's mechanical system layout: space aval, avalable funding, process requirements, cleanliness classcetlon, requires relay. energy cost, buldng codes, and local climate. Unke normal AC systems, cleanvoom AC eysteme nave substantially more supply ar than needed to most oaling an heating loads. Class 100,000 (IS0 8) and lower ach Class 10,000 (ISO 7) eleanrooms can have alhe ago through the AHU. Looking a Figure 3, the ret ar and outside alr are mined, fired, cooled, reheated, and humic before being supplied to ternal HEPA fiers inthe celng. To prevent carta yin the cleanroom the rtum alr picked up by low wal returns, For higher clas 10.000 (SO 7) and cleaner clanrooms, tn allows are too high fra the arto go tough the APU, Woking at Figtr 4 sma portion ofthe rlum aris sent back fo the AHL for condoning, The remaining a elumed the crulabon fan Alternatives to Tra nal Air Handling Units Fan fiter unt, also known as integrated blower modules, ae a modular cleanroom fiation solution wth some advantages over tradtonal a handing systems They are applied in bath smal and lage spaces wih a dealiessraling as low as ISO Class 3. Al change ‘ales and deaiiness requements datermine the number ofan ttre requtes. An 180 Class & cleanroom collng may only oqure 515% of cling coverage while an ISO Class 3 or cleaner cleanroom may require 60-100% coverage, Find Out You Eactiy would Bene tm a Modular Fan Flee System over a Teadonal A Handing Unt Step Nine: Perform Heating/Cooling Calculations \When pororming the cleanroom heatingicooing calculations, tae tho folowing into consideration: 2 the mast conservative clmats conditions (09.5% heating design, 0.4% drybulo/medlan wetbule cooling deign, and 04% wetbublmelan dryeulb coating Gesign data). include firation ilo calulatons. Inclise imi tr marifol heat into caleulatons, ineluse process load ilo eataons + Include reeeultion far heat ino calculations Step Ten: Fight for Mechanical Room Space Cleanrooms are mechanical ang elect intensive. As the cleanrooms cleaniness classification becomes cleaner, more mechanical infasnucture space i needed to prowdo adequate Support tothe cleanroom. Using a 1,000-eqit learvogm as an example, a Class 100,000 (150 8) cleanroom wil neod 2500 400 6 of support space, a Class 10,000 (80 7) cleanroom wil need 250 to 750 sq fof support space, a Class 1,000 (180 6) cleanroom wil need $00 to 1,000 sqft of support pace, ana a Clase 700 (SO 5) cleanroom wil nea 780 to 1,500 29 of support space‘The actual support square foctage wl vary epanting upon the AHU airlow ana complexty (Simple fie, heating col, cacling col, and fan; Complex: sound ‘tenuator,retum fan, rele ar secton, ouside a take iter secon, heating section, cooling secon, hum, supely fan, and dscharge plenum) ana numberof ‘ecieated cleanroom support systems (exhaust, recrulaton ar unt, chled water, hot water, seam, and OURO water). le important to communicate te requires ‘mechanical equipment space square fectage to ths project archtect early in the dosign process Final Thoughts Cleanrooms are ke race cars. When properly designed and bul they are highly ficient performance machines. When poorly designed and built they operate poorly and are unretable. Cleanrooms have many potential pital, and supervision By an engineer wih axonsive clearvoom experiance is recommended for Your frst couple of eloarroom projct.