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    17704524 Understand Pharmaceutical Cleanroom Design

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    3K views5 pages

    Understand Pharmaceutical Cleanroom Design

    Uploaded by

    iamkea

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    of 5
    ‘hs ning en ui ASHE oa Span 20 © Cap 20 Amn Sy ig, ging ‘caught ee pees en paeo Tsaemayab cape ons Sern Understanding Pharmaceutical Cleanroom Design yt Zhang, PE. proper HVAC sytem sare partofphammacoutil cleanroom design. Eventhough vious design gudelnes and standards are salable, there io cear-ct guidance fr many crucal HVAC design parameters, particularly ar changes per hour fora specific cass of ‘lesnrooms, FDA guideline! only spect aminimuen of 20air changes per hour for controled aress without providing any specif. Sot nicht ben repeal = od wih 10 64) dria Asano ee macnn (hus 100 cence whe ee eles iene new SO stn om ek he an tole and bichon dd The Flat of cleo ‘eco or svt sures te up ‘stoaAr Cone Paces om he py sir ely contaledty wag igen rt ie, Mo EDA ter 703 meron gern IO "00 pres er? (39 00 pes ‘ea douno tir: hp parler) art ‘beta er There, Ge py ete ‘nae conn aries fm aacent paces acre cont the acres clon han cane fear a lettin ca be minmze ong to ‘ton tha a ws he leno ajceat ‘pace Tiscan decay sccm paying moet an ing i sigh presen he oe, ‘nt Genin Conte The ra act semana te fc of ‘embargo Fon eer orm bidngelenens nb minnie yng raced on pros mates prin pe oxy psd at and gs bd sings The nr eran pein abe mew gre ogo ail the ar Body stet lthig om he Pact Opt, ‘Ae mend wi top ee in of ‘ent iin pres as aca, At ‘he cam clas bowmes mere rsget 0d te om Frith and gvning eqerenes Neves, 8 plea ‘lems repaint esr prety Th peril of0 Smee perscoper 580 pari pea) ofa volume eee 3 Ch AS). A Setinga ison of 20832098 m>om 275m) Neh wit operas therein eb “rts wold be 60 pe ioe (236 per inte perm, named wiper aie oweer ees huh ph ishnge as vide 2 ‘amply ven seat tte pata mater Why ‘alley. Te soe inet ard ope wl hse shes consents th ef nay fom tem ‘Wh tind enter intl pn ted cpr laos 00 pars pense pee (17 O00 pres or mite per) pe ancom conta ‘ough ISO agh 1505 enms we wnle so fiw designs. mst place even tend nthe nile tone sone parte For rel- ‘ane a ay hen nc ie neon ‘Snbe erp the flowing equating no erase pnt © the lyse rie ono in pic ‘isthe supply ar volume flow ate in terms of sr-change sete nen gratin eel piles erp tow: a wr _Aneing enn om concn Xo a net tape vrai ohne the ove dental ea (ie chealn}serale a Aster great yt ecb te te he ‘oc il encntion sng Pcs aly o vette) oy Wik Egon 4th ishnge te cmb ey ee tne incon fan as — ‘Us ese ean, when be serene 80 7 leno = 100 ing 7S HEPA ee =3) wh ‘typ eral pnts = 50 sy ai ‘hang ate val be pointe 30 ere Byte same nen ne een hati parce sum the om wold be apy SO. ‘lip prs courses wold ster hin 8 mes) vance opera ito rai filtro cons Never (ced tc up ice nso rely peri foe ‘sso ntl agreement ih SPE ie Tee Fe ers pvng sg HEPA es fens doe ‘help noe he seminal This can be tate han, wen dovie HEPA Shr re ie neo pamacetal einer rete += 0.000), ‘rite sue ahs 3) lil eer te {G0 te tal pari com wo be prone {he previow 603 600 aig roe sans rn peeve ivi hat et ef September 2004 te way af cooly te secon romans adegneIEM ae ‘limite acpi comesdar 1 Ing FDA gens a inion of 8 'S0 (Cs 10018)coor ty fe 80 er ne me ‘Srepetefe notion ge shgharchnge te cimt bested wages Neves) HEPA. That woud bee findane mise Torta S07 ce with intra generation of apeimatty 100 pe fn 1 40 per) veal) coxssnfan-3) ‘Of cou, theese tht neal geen i si cay igh, meen woul ed ‘AeChange ata an 1808 Soa ‘Wik den oso nS (Cs 100 pce nud Hone ne, de roe hi, ey few pa Clafaton a ECA) For ose at, they 2 aly sern lock or alle ne sparing to etc ‘ling rom pial 180 5 soe) nd to 130 7 ‘pees salve) nepal ohve 190 3 iis ‘eprom IS aoc) hs eee ‘nora prick pnron voy ml er the sec peru Tobecomenate vanes 100060 ‘htt the oe ng te wold be = elles) = 100.00 -3) ean ea ined epertonl a B06 ro reas mn ide a t-cange toan'803 soase “Toe males fr wre se pte on he ion ri ‘le at agli toy 5D 6 and beyond Fo 80 3 ‘le Selected sirnee preteens ‘le 2: UMC altace patel caeaton. sys. apace sip apis od hat eet Fevau ean et Noro 80 Syne ‘hie covery HEP ego hod Inte worse see toy piles uly a ‘ton They mn chico Bow Tw elfen hg soy ou of EPA Mer, {ay 30pm (08 mh orig etl meme byrne 80 ce ome Ings fond aoe bundy Tetlre eichge re ‘Neve of ub cane dae one isto ‘terra ny oe oni eing ae EDR Fie dee ce vey 90 fm (05 ms). Tle te sup some pl 72 ef (366 Us pr). An ISO's suc araghcaing Asminga 98 (275m) ‘ling hs sgn tp wold are et #80 a anor er he celing bp nly 82 me ‘Rag nt oat 40 lath go ian Sisal 180 spc og 50 arcane pt Impact of Presreton ‘es he mt npr patra leno VAC leone rom diet presure ey woesnd that maiiing pti restr ves le space [Allin 005i (128s ileal es

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