"Zviri nyore" rinogona kunge risiri izwi rinouya mupfungwa pakugadzira nzvimbo dzakaoma kudaro. Nekudaro, izvo hazvireve kuti haugone kuburitsa yakasimba yekuchenesa dhizaini nekugadzirisa nyaya mune zvine musoro kutevedzana. Ichi chinyorwa chinobata nhanho yega yega yakakosha, kusvika kune anoshanda-mazano chaiwo ekugadzirisa maverengero emutoro, kuronga nzira dzekuburitsa, uye kutenderedza kwenzvimbo yakaringana yekamuri yekamuri inoenderana nekirasi yeimba yekuchenesa.
Mazhinji maitiro ekugadzira anoda iyo yakaomesesa mamiriro ekunze anopihwa neimba yekuchenesa. Nekuda kwekuti dzimba dzekuchenesa dziine masisitimu akaomesesa uye kuvaka kwakakwira, kushanda, uye kudhura kwesimba, zvakakosha kuita dhizaini yekuchenesa nenzira yakarongeka. Ichi chinyorwa chichapa nhanho-ne-nhanho nzira yekuongorora nekugadzira makamuri ekuchenesa, kuisa muvanhu / kuyerera kwezvinhu, nzvimbo yekuchenesa nzvimbo, nzvimbo yekutsikirira, nzvimbo yekufambisa mhepo, nzvimbo yemhepo yemhepo, nzvimbo yemhepo yemhepo, zvinosiyana-siyana zvinoongororwa, mechanical system sarudzo, kupisa / kutonhora mutoro kuverenga, uye kutsigira nzvimbo zvinodiwa.
Danho Rokutanga: Ongorora Kurongeka Kwevanhu/Kuyerera Kwezvinhu
Zvakakosha kuongorora vanhu uye kuyerera kwezvinhu mukati meimba yekushambidzika suite. Vashandi vemudzimba dzekuchenesa inzvimbo huru yetsvina yemumba uye maitiro ese akakosha anofanirwa kuparadzaniswa nemagonhi evashandi uye nzira.
Nzvimbo dzakanyanya kukosha dzinofanirwa kuwana mukana mumwe chete kudzivirira nzvimbo kubva pakuva nzira inoenda kune dzimwe, nzvimbo dzisinganyanyi kukosha. Mimwe mishonga yemishonga uye biopharmaceutical maitiro anogona kutapukirwa kubva kune mamwe mishonga uye biopharmaceutical maitiro. Maitiro ekuyambuka-kusvibiswa kunoda kunyatsoongororwa kune yakabikwa zvinhu inflow nzira uye midziyo, zvinhu kugadzirwa kwega, uye yakapedzwa chigadzirwa kubuda nzira uye midziyo. Mufananidzo 1 muenzaniso webhonzo sement nzvimbo ine zvose zvakakosha maitiro ("Solvent Packaging", "Bone Cement Packaging") nzvimbo dzine mukana mumwe chete uye kuvhara kwemhepo sezvivharo kune nzvimbo dzepamusoro dzevashandi ("Gown", "Ungown").
Nhanho Yechipiri: Sarudza Nzvimbo Yehutsanana Classification
Kuti ukwanise kusarudza kupatsanurwa kwemukamuri yekuchenesa, zvakakosha kuziva chiyero chekutanga chekuchenesa mukamuri uye kuti chii chinodiwa chekuita chega chega chehutsanana. The Institute of Environmental Sayenzi neTekinoroji (IEST) Standard 14644-1 inopa hutsanana hwakasiyana-siyana (1, 10, 100, 1,000, 10,000, uye 100,000) uye nhamba inobvumirwa yezvikamu zvakasiyana-siyana.
Semuyenzaniso, Class 100 cleanroom inobvumidzwa inodarika 3,500 particles/cu ft uye 0.1 microns uye hombe, 100 particles/cubic ft. pa 0.5 microns uye hombe, uye 24 particles/cubic ft. pa 1.0 microns uye yakakura. Iyi tafura inopa inobvumidzwa nemhepo particle density patafura yerucheno rwekuronga:
Kurongeka kwehutsanana hwenzvimbo kune simba guru pakuvaka, kugadzirisa, uye mutengo wesimba weimba yakachena. Izvo zvakakosha kuti unyatso ongorora kurambwa / kusvibiswa mitengo pazvikamu zvakasiyana zvehutsanana uye zvinodikanwa zvesangano, seFood and Drug Administration (FDA). Kazhinji, iyo inonyanya kutarisisa maitiro, iyo yakanyanya kuomesesa yerutsanana kupatsanura kunofanira kushandiswa. Iyi tafura inopa hutsanana kupatsanurwa kune akasiyana maitiro ekugadzira:
Maitiro ako ekugadzira angangoda kuomesesa kirasi yehutsanana zvichienderana nezvakasiyana zvinodiwa. Ngwarira paunopa hutsanana zvikamu kune imwe neimwe nzvimbo; hapafanirwe kuve neanodarika maodha maviri ekusiyana kwehukuru mukuronga kwehutsanana pakati penzvimbo dzinobatanidza. Semuyenzaniso, hazvitenderwi kuti Kirasi 100,000 yekuchenesa imba ivhure mukamuri yekuchenesa yeKirasi 100, asi zvinotenderwa kuti imba yekuchenesa yeKirasi 100,000 ivhure mukamuri yekuchenesa yeKirasi 1,000.
Tichitarisa nzvimbo yedu yekurongedza simende yebhonzo (Figure 1), "Gown", Ungown" uye "Final Packaging" inzvimbo dzisinganyanyi kukosha uye dzine Class 100,000 (ISO 8) yehutsanana classification, "Bone Cement Airlock" uye "Sterile Airlock" yakavhurika kunzvimbo dzakakosha uye vane Class 0 (Ceneification 70,0Bo Class 10,0) Packaging” ihuruva yakakosha maitiro uye ine Class 10,000 (ISO 7) yehutsanana classification, uye 'Solvent Packaging” ibasa rakaoma uye rinoitwa muClass 100 (ISO 5) laminar flowhoods muKirasi 1,000 (ISO 6) yekuchenesa imba.
Nhanho Yetatu: Sarudza Space Pressurization
Kuchengetedza kudzvanywa kwenzvimbo yemhepo yakanaka, maererano nenzvimbo dzinobatanidza tsvina dzehutsanana, zvakakosha mukudzivirira zvinosvibisa kuti zvisapinde muimba yakachena. Zvakanyanya kuoma kugara uchichengetedza kuchena kwenzvimbo kana isina kwayakarerekera kana isina kunaka nzvimbo yekumanikidza. Musiyano wemuchadenga unofanirwa kuva wei pakati penzvimbo? Zvidzidzo zvakasiyana-siyana zvakaongorora kupinda kwetsvina mukamuri yakachena vs. kudzvanywa kwemuchadenga musiyano pakati peimba yekuchenesa nenzvimbo yakabatana isingadzoreki. Izvi zvidzidzo zvakawana kudzvinyirirwa kwakasiyana kwe0.03 kusvika ku0.05 mu wg kuti ibudirire mukuderedza kusvibiswa kunopinda. Space pressure differentials pamusoro pe 0.05 in. wg haipe zvirinani zvirinani zvinosvibisa kupinza control then 0.05 in. wg
Ramba uchifunga, yakakwira nzvimbo yekumanikidza musiyano ine yakakwira simba mutengo uye yakanyanya kuoma kudzora. Zvakare, mutsauko wepamusoro wekumanikidza unoda simba rakawanda mukuvhura nekuvhara magonhi. Iyo yakakurudzirwa yakanyanya kudzvanywa kusiyanisa pamusuwo ndeye 0.1 in. wg pa 0.1 in. wg, 3 tsoka ne7 tsoka gonhi inoda 11 mapaundi esimba kuvhura nekuvhara. Imba yekuchenesa suite ingangoda kugadziridzwa zvakare kuchengetedza iyo static kudzvanywa mutsauko pamagonhi mukati memiganhu inogamuchirwa.
Yedu pfupa simende yekurongedza nzvimbo iri kuvakwa mukati meimba yekuchengetera iripo, ine isina kwayakarerekera nzvimbo yekumanikidza (0.0 in. wg). Iyo yekukiyiwa kwemhepo pakati peimba yekuchengetera uye "Gown / Ungown" haina nzvimbo yehutsanana kupatsanurwa uye haizove nenzvimbo yakatarwa yekumanikidza. "Gown / Ungown" ichange iine nzvimbo yekumanikidza ye 0.03 in. wg "Bone Cement Air Lock" uye "Sterile Air Lock" ichava nemhepo inodzvinyirira ye 0.06 in. wg "Final Packaging" ichava nemhepo yekumanikidza ye0.06 in. wg "Bone Cement Packaging. kumanikidzwa kupfuura 'Bone Cement Air Lock' uye "Final Packaging" kuitira kuti ive neguruva rinogadzirwa panguva yekurongedza.
Mhepo inosefa mu 'Bone Cement Packaging' iri kuuya kubva munzvimbo ine hutsanana hwakafanana.Kupinda kwemhepo hakufanirwe kubva munzvimbo ine tsvina yerutsanana kuenda kune yakachena yerutsanana kupatsanura “Solvent Packaging” ichava nenzvimbo yekudzvanya ye0.11 in. yakakosha "Solvent Packaging" uye "Sterile Air Lock" ndeye 0.05 in. wg The 0.11 in. wg nzvimbo yekumanikidza haizodi kusimbiswa kwemaitiro emadziro kana sirin'i kumanikidzwa kwenzvimbo pamusoro pe0.5 in.
Nhanho Yechina: Sarudza Space Supply Airflow
Kurongeka kwehutsanana hwenzvimbo ndiyo inonyanya kusiyanisa pakuona kuyerera kwemhepo yeimba yakachena. Tichitarisa patafura 3, imwe neimwe yakachena kupatsanurwa ine mwero wekuchinja kwemhepo. Semuenzaniso, Class 100,000 cleanroom ine 15 kusvika 30 ach range. Mwero wekuchinja kwemhepo yemuimba yekuchenesa unofanirwa kutarisisa chiitiko chinotarisirwa mukati meimba yekuchenesa. Imba yeKirasi 100,000 (ISO 8) yekuchenesa ine mwero wakaderera wekugara, yakaderera yekugadzira chidimbu, uye yakanaka nzvimbo yekutsikirira maererano nenzvimbo dziri padyo netsvina yehutsanana inogona kushandisa 15 ach, nepo imba imwechete yekuchenesa inogara yakakwira, inogara mukati / kunze traffic, yakakwira particle generating process, kana kwayakarerekera space pressur.
Mugadziri anofanira kuongorora mashandisiro ake chaiwo uye kuona mwero wekuchinja kwemhepo uchashandiswa. Zvimwe zvinosiyanisa zvinokanganisa nzvimbo yekufambiswa kwemhepo ndeye process exhaust airflows, mhepo inopinda mukati nemagonhi / mazaru, uye mweya unobuda kunze nemagonhi / kuvhura. IEST yakaburitsa yakakurudzirwa shanduko yemhepo muStandard 14644-4.
Tichitarisa Mufananidzo 1, "Gown / Ungown" yaive nekufamba kwakanyanya mukati / kunze asi haisi nzira yakakosha nzvimbo, zvichiita kuti 20 a ch., 'Sterile Air Lock' uye "Bone Cement Packaging Air Lock" iri padyo nenzvimbo dzakakosha dzekugadzira uye mune iyo "Bone Cement Packaging Air Lock", iyo mhepo inoyerera ichiyerera kubva mumhepo inovhara mhepo. vane mashoma mukati / kunze kwekufamba uye pasina maitiro ekugadzira, kukosha kwavo kwakakosha sevhavha pakati pe "Gown / Ungown" uye maitiro ekugadzira anoita kuti vave ne40 ach.
"Final Packaging" inoisa pfupa simende / mabhegi ekunyungudutsa mune yechipiri pasuru iyo isingakoshi uye inoguma mune 20 ach rate. "Bone Cement Packaging" inzira yakaoma uye ine 40 ach rate. 'Solvent Packaging' inzira yakaoma zvikuru yakaitwa muClass 100 (ISO 5) laminar flow hoods mukati meClasi 1,000 (ISO 6) cleanroom. 'Solvent Packaging' ine diki-diki yekufamba mukati/kunze uye yakaderera maitiro echikamu, zvichikonzera chiyero che150 ach.
Cleanroom Classification uye Mhepo Shanduko Paawa
Kuchena kwemhepo kunowanikwa nekupfuura mhepo kuburikidza neHEPA mafirita. Kazhinji kazhinji mhepo inopfuura nepakati peHEPA mafirita, mashoma mashoma anosara mumhepo yekamuri. Huwandu hwemhepo yakasefa muawa imwe yakakamurwa nehuwandu hwekamuri inopa huwandu hwekuchinja kwemhepo paawa.
Mhepo yakataurwa pamusoro inoshanduka paawa inongova mutemo wekugadzira wegunwe. Iwo anofanirwa kuverengerwa nenyanzvi yeHVAC yekuchenesa imba, sezvo zvinhu zvakawanda zvinofanirwa kutariswa, senge saizi yekamuri, huwandu hwevanhu vari mukamuri, midziyo yemukamuri, maitiro anobatanidzwa, kuwedzera kupisa, nezvimwe.
Nhanho yechishanu: Sarudza Space Air Exfiltration Flow
Mazhinji emakamuri ekuchenesa ari pasi pekumanikidzwa kwakanaka, zvichikonzera kuti mweya wakarongwa upinde munzvimbo dzakabatanidzwa dzine yakaderera static pressure uye isina kurongeka yemhepo yekubuda kuburikidza nemagetsi emagetsi, zvigadziriso zvemwenje, mafuremu emahwindo, mafuremu emagonhi, madziro / pasi interface, madziro / sirin'i interface, uye magonhi ekupinda. Izvo zvakakosha kuti unzwisise makamuri haana kuvharwa uye ane kuvuza. Imba yekuchenesa yakavharwa zvakanaka ichave ne1% kusvika 2% vhoriyamu yekudonha chiyero. Kubuda uku kwakaipa here? Kwete hazvo.
Kutanga, hazvibviri kuve ne zero leakage. Chechipiri, kana ukashandisa dhizaini inoshanda, kudzoka, uye kupera simba rekudzora mhepo, panofanirwa kuve nehushoma hwegumi muzana mutsauko pakati pekupa uye kudzoka kwemhepo inoyerera kuti iite statically decouple kugovera, kudzoka, uye kupedza mavharuvhu emhepo kubva kune mumwe. Huwandu hwemhepo inobuda nemumikova hunoenderana nekukura kwegonhi, kudzvanywa kwakasiyana pamusuwo, uye kuti gonhi rakavharwa sei (magaskets, madonhwe egonhi, kuvharwa).
Tinoziva kuti mhepo yakarongwa yekupinza / yekuburitsa inoenda kubva kune imwe nzvimbo kuenda kune imwe nzvimbo. Kubuditswa kusina kurongwa kunoendepi? Mhepo inosunungura mukati menzvimbo yestud uye kunze kumusoro. Tichitarisa muenzaniso wedu wepurojekiti (Mufananidzo 1), kubuda kwemhepo kuburikidza ne 3- ne 7- mukova wetsoka ndeye 190 cfm ine musiyano we static pressure ye 0.03 mu wg uye 270 cfm ine musiyano we static pressure ye 0.05 in. wg
Nhanho yechitanhatu: Sarudza Space Air Balance
Space air balance inosanganisira kuwedzera kwese kuyerera kwemhepo munzvimbo (kupa, kupinza) uye kuyerera kwese kwemhepo kunosiya nzvimbo (kupedza, kuburitsa, kudzoka) kuenzana. Tichitarisa pabhonzo simende nzvimbo yemhepo chiyero chemhepo (Mufananidzo 2), "Solvent Packaging" ine 2,250 cfm inopa mhepo uye 270 cfm yemhepo inokwidziridzwa kuenda ku'Sterile Air Lock", zvichikonzera kudzoka kwemhepo ye1,980 cfm. 'Solvent Packaging', uye 190 cfm exfiltration ku "Gown/Ungown", zvichikonzera kudzoka kwemhepo ye370 cfm.
"Bone Cement Packaging" ine 600 cfm inopa kuyerera kwemhepo, 190 cfm yekusefa kwemhepo kubva 'Bone Cement Air Lock", 300 cfm guruva rekuunganidza exhaust, uye 490 cfm yemhepo inodzoka. 670 cfm inopa mhepo, 190 cfm exfiltration ku "Gown / Ungown". “Final Packaging” ine 670 cfm supply air, 190 cfm exfiltration to 'Gown/Ungown”, uye 480 cfm yemhepo inodzoka.“Gown/Ungown” ine 480 cfm yemhepo inopihwa, 570 cfm yekupinda, 190 cfm, uye exfilt of 860 air.
Isu takasarudza iyo yekuchenesa imba yekugovera, kupinza, kuburitsa, kupera simba, uye kudzoka kuyerera kwemhepo. Iyo yekupedzisira nzvimbo yekudzoka kwemhepo inogadziriswa panguva yekutanga-yepamusoro yekusarongeka kwemhepo kubuda.
Danho rechinomwe: Ongorora Zvakasara Variables
Zvimwe zvakasiyana-siyana zvinoda kuongororwa zvinosanganisira:
Tembiricha: Vashandi vepaimba yekuchenesa vanopfeka smocks kana masutu akazara pamusoro pembatya dzavo dzenguva dzose kuderedza chizvarwa uye kusvibiswa kunogona kuitika. Nekuda kwezvipfeko zvavo zvekuwedzera, zvakakosha kuchengetedza tembiricha yenzvimbo yakaderera yekunyaradza kwevashandi. Tembiricha yemuchadenga iri pakati pe66°F ne70° ichapa magariro akanaka.
Humidity: Nekuda kwekuyerera kwemhepo kwemukamuri yakachena, hombe yemagetsi inogadzirwa. Kana sirin'i uye madziro zvine yakakwira electrostatic charge uye nzvimbo ine yakaderera hunyoro hunyoro, inofambiswa nemhepo inozvibatanidza pamusoro. Kana iyo nzvimbo hunyoro hunowedzera, iyo electrostatic charge inoburitswa uye zvese zvakabatwa zvinoburitswa munguva pfupi, zvichiita kuti imba yekuchenesa ibude kunze kwekutsanangurwa. Kuve yakakwira electrostatic charge inogonawo kukuvadza electrostatic discharge sensitive materials. Izvo zvakakosha kuchengetedza nzvimbo yehunyoro hunyoro hwakakwana kuti uderedze iyo electrostatic charge kuvaka-up. Iyo RH kana 45% +5% inoonekwa seyakanyanya humidity level.
Laminarity: Maitiro akaomesesa angangoda kuyerera kwelaminar kuderedza mukana wekusvibisa kupinda mumhepo yemhepo pakati peHEPA sefa uye maitiro. IEST Standard #IEST-WG-CC006 inopa kuyerera kwemhepo laminarity zvinodiwa.
Electrostatic Discharge: Kupfuura iyo nzvimbo humidification, mamwe maitiro anonyanya kutaridzika kune electrostatic discharge kukuvara uye zvinodikanwa kuisa pasi conductive flooring.
Noise Levels uye Vibration: Mamwe maitiro chaiwo anonyanya kunzwisiswa kune ruzha uye vibration.
Nhanho Yesere: Sarudza Mechanical System Layout
Zvimwe zvakasiyana-siyana zvinokanganisa dhizaini yemagadzirirwo emukamuri yekuchenesa: kuwanikwa kwenzvimbo, mari iripo, zvinodiwa pakuita basa, kurongeka kwehutsanana, kuvimbika kunodiwa, mutengo wesimba, macode ekuvaka, uye mamiriro ekunze enzvimbo. Kusiyana neakajairwa A/C masisitimu, akachena A/C masisitimu ane mweya wakawanda wekupa kupfuura unodiwa kusangana nekutonhodza uye kudziyisa mitoro.
Kirasi 100,000 (ISO 8) uye yakaderera ach Kirasi 10,000 (ISO 7) dzimba dzakachena dzinogona kuita kuti mhepo yese ipinde nemuAHU. Tichitarisa Mufananidzo 3, mhepo yekudzoka uye kunze kwemhepo inosanganiswa, inosefetwa, yakatonhodzwa, inopiswazve, uye yakanyoroveswa isati yapihwa kune terminal HEPA mafirita padenga. Kuti udzivise kusvibiswa kudzokororwa muimba yakachena, mhepo yekudzoka inotorwa nekudzoka kwakadzika kwemadziro. Kune kirasi yepamusoro 10,000 (ISO 7) nedzimba dzakachena dzakachena, mafambiro emhepo akakwira zvakanyanya kuti mhepo yese ipinde nemuAHU. Tichitarisa Mufananidzo 4, chikamu chiduku chemhepo yekudzoka chinotumirwa kudzokera kuAHU kuitira kugadzirisa. Mhepo yasara inodzoserwa kune feni yekutenderera.
Zvimwe kune zvechinyakare Air Handling Units
Fan filter units, inozivikanwawo seyakasanganiswa blower modules, ndeye modular yekuchenesa imba yekusefa mhinduro ine zvimwe zvakanakira pamusoro pechinyakare magadzirirwo emhepo. Izvo zvinoshandiswa munzvimbo dzose duku uye dzakakura dzine chiyero chehutsanana chakaderera seISO Class 3. Mhepo yekuchinja kwemhepo uye zvinodiwa zvehutsanana zvinotarisa nhamba yemafirita anodiwa. Iyo ISO Kirasi 8 sirin'i yekamuri yekuchenesa ingangoda 5-15% yekuvhara sirin'i nepo ISO Kirasi 3 kana yekuchenesa imba yekuchenesa ingangoda 60-100% kufukidzwa.
Nhanho yepfumbamwe: Ita Masvomhu ekupisa/kutonhora
Paunenge uchiita yekuchenesa imba yekudziya / kutonhora kuverenga, tora zvinotevera mukufunga:
Shandisa zvakanyanya kuchengetedza mamiriro ekunze (99.6% dhizaini yekudziya, 0.4% drybulb/median wetbulb cooling deign, uye 0.4% wetbulb/median drybulb cooling design data).
Sanganisira kusefa mukuverenga.
Sanganisira humidifier manifold heat mukuverenga.
Sanganisira process load mukuverenga.
Sanganisira recirculation fan kupisa mukuverenga.
Danho reGumi: Kurwira Mechanical Room Space
Dzimba dzekugezesa dzine michina uye nemagetsi. Sezvo kushambidzika kwekamuri yekuchenesa kunowedzera kuchena, nzvimbo yakawanda yezvivakwa zvemakina inodiwa kupa rutsigiro rwakakwana kuimba yekuchenesa. Uchishandisa 1,000-sq-ft cleanroom semuenzaniso, Class 100,000 (ISO 8) cleanroom inoda 250 kusvika 400 sq ft yenzvimbo yekutsigira, Class 10,000 (ISO 7) cleanroom inoda 250 kusvika 750 sq ft ye support space, Class 5000000000000000000000000000 ISO ISO 1,000room inoda ISO 1,000 sq ft yenzvimbo yekutsigira, uye Kirasi 100 (ISO 5) yekuchenesa ichada 750 kusvika 1,500 sq ft yenzvimbo yekutsigira.
Iyo chaiyo yerutsigiro square footage ichasiyana zvichienderana neAHU airflow uye kuoma (Zviri nyore: sefa, kupisa coil, inotonhorera coil, uye fan; Complex: sound attenuator, return fan, reservation air section, kunze kwemhepo yekupinda, sefa chikamu, heat section, cooling section, humidifier, supply fan, and discharge plenum) uye nhamba yezvitsaurirwa mvura yakachena, recircuust, air exhaust, recircuust yemvura, recircuust yemvura, recircuust. DI/RO mvura). Izvo zvakakosha kuti utaure inodiwa mechaniki yemidziyo nzvimbo square footage kune muvaki weprojekiti kutanga kwemaitiro ekugadzira.
Pfungwa dzekupedzisira
Dzimba dzekuchenesa dzakafanana nemotokari dzemujaho. Kana akagadzirwa nemazvo uye akavakwa, iwo akanyanya kushanda anoshanda michina. Kana zvikasagadzirwa zvakanaka uye zvikavakwa, zvinoshanda zvisina kunaka uye hazvivimbike. Imba dzekuchenesa dzine akawanda angangoita makomba, uye kutariswa nainjiniya ane ruzivo rwakakura rwemukamuri yekuchenesa kunokurudzirwa kune ako maviri ekutanga mapurojekiti emuimba yekuchenesa.
Kunobva: gotopac
Nguva yekutumira: Kubvumbi-14-2020
