Imiboniso Yokuqala Kokuseta Kwekhalenda Ekuhlutheniwe

Ukucaciswa Kwemithetho YeKleniroom Kunye Nezisebenziso Ezinhle

Yini eyi-kleniroom kwaye kuyimfuneko kakhulu kuzindawo ezihlukileyo?

Izicathami zokuhlukumeza yizindawo ezinhlelwe ngokuthi zilungisele ukungena kwezinhlanu zokuxwayisa nezinhlanu zokuxwayisa, njengokwehlukumelela, amabhaktera, nokuxwayisa kwezinhlanu zokuchitha, ngemuva kwezinyathelo ezisetshenziswa ngemigomo egama yayo i-ISO 14644. Lezi zindawo zibaluleke kakhulu kumaqondana okhethwe ngoba izici ezincane zokuhlukumeza zingavikela amathuluzi aphelele. Sebenzisa izithuthi zemikrokhondwa njengesibonelo, okunye okungaphezulu kwe-0.5 microns ekhona ngemva kwesimo sokwenza kungavikela izindlela ezinhle ngokuxhumana nezincazelo ezifinyelela kuma-ISO 2023. Ukuvikela lelihlalo lezokuhlukumeza, izindawo zokuthutha izinhlanu zokuxwayisa ezinhlelwe, zenza amadiffirensi wokugcinwa phakathi kwezindawo, bese benza izwi ezinkimbini ngokuthi abantu bathatha kanjani le ndawo. Konke lezi zindlela zisebenza ngokunxulumene ukuze abathengi bafumane imiphumo embalwa ngendlela engavimbelwa.

Izimali ezibalulekileyo ezithintse teknolojithi yezicathami zokuhlukumeza: izempilo, izithuthi zemikrokhondwa, nezinhlanhlayo zokubonakala

Izindzaba ezintathu ziyasebenzisa teknolojiyo yekhamera engenakugcina ngokuba kudinga ukunciphisa okuphezulu:

• Izimedicine : Imizuzwana engenakugcina iyadingeka ekwenzeni izivakalwe nezivakalwe ezifiswe, lapho ukungcola kwegciyeli kubangela imiphatho eshakela ubungozi bempilo yabantu.
• Isemikondaktile : Ukwenza amachip amakhulu kudinga imizuzwana ye-ISO Class 1–3 ukuvikela ukungcola kwamandla ethekwini le-silicon.
• Izibonano zemvelo : Izindlela ezijwayele ukuthwala izimboni nezilwane zokulungisa izicelo zidinga imizuzwana engenakugcina ukugcina ubungozi bokuthi izithombi zingenakugcinwa.

Lezi zindzaba zisebenzisa izindlela zokuhlelo kanye nezilinganiselweyo zokuguqula amagugu ukulayisha ukungcola ngokuhambisana nefficiency yokusebenza.

Izinhlelo zokuhlelo kanye nezidingo zokuguqula amagugu

Ukuvikela ukungcola kude kubegina ngokuzwa izinhlelo zokuhlelo kanye nezidingo zabo zokusebenzisa amagugu. Lezi zinhlobo ziyaziwa ukuthi kune njalo ukusebenza kwezindzaba ezidinga ukunciphisa okuphezulu.

Imigomo Yekhelasimithi ye-Cleanroom (ISO 1–9) kanye nezimali zokuphakama kwezinhlanu

Isistanda ye-ISO 14644-1 ishadi amagomo amayisikhombisa ngokuchaphazela kwezinhlanu zokuphakama. Kwisigaba esikhulu kakhulu, i-ISO Class 1 ikhathiwa ukuba kube nezinhlanu ezi-12/m³ kwa-0.3µm, ngelokho i-ISO Class 9 ikhathiwa ukuba kube nezinhlanu ezingu-1,020,000. Imigomo ephakathi kudinga ukulawulwa okuhle kakhulu:

Ukulinganisa Imi-standerdi ye-ISO 14644 ne-FS 209E kanye ne-Tikhiyela Kwezokusebenza ezigcineni (Ikhadi A, B, C, D)

Imi-standerdi ye-FS 209E edlule ilandelwe ngokwezinye izinto zase-Imperial kanye nezilabeli zase-federali esaziwa kanye nekholeka, ngelokho ISO 14644 ishukile kabonke kwiindlela zase-Metric kanye nezilwanyana zaseMhlaba. Izifekeli zokugcina izinhlelo zokulingana zase-pharmaceutical zisebenza ngalezi zinhlelo eziphathelene. Ake sibheke izinto ezithile. Izindawo zekhadi A, ezifanayo ne-ISO 5 classification, kuzo kuzochithwa izinto eziphansi kakhulu njengokulayisha izivivinyo. Lezi zindawo zidinga ukuthi kuzoculwa amahora kweyohhwele kanye neyohhwele kwezimali phakathi kwe-240 kanye ne-480 ngeyohhwele. Ukuhlaba nokuthi kwezindawo zekhadi D ezilayelwe kwezinhlelo ye-ISO 8. Kwezokwenza okungenaphutha, kuzothola kuphela ukuthi kuzoculwa amahora kweyohhwele kanye neyohhwele phakathi kwe-10 kanye ne-25 ngeyohhwele. Kungenzeka ukuthi kuzozwa kahle ukuthi kuyiphi into ephansi kakhulu yokungena kwezinhlelo engeyona.

Ukuculwa Kweyohhwele Ngeyohhwele (ACH) Ngeklasi ye-ISO kanye nokuthi kungaphakathi kwezinhlelo

Ukukhula kwenqanawa nokuthawatha kwenqanawa kubangelisa ngqo ukusungwa kwezindlela. Imigomo ye-ACH efanayo iyabalance ukulula nokusebenza kwezindlela zokusebenza kwezindlela zokusebenza kwezindlela zokusebenza kwezindlela zokusebenza kwezindlela zokusebenza kwezindlela zokusebenza kwezindlela zokusebenza kwezindlela zokusebenza:

Ukudlula amathemu aqinisiweyo e-ACH ayenza ukunciphisa okuncane kanye nokongeza ukusetshenziswa kwezindlela zokusebenza, okubonisa ukubaluleka kwezindlela zokudlala kwezindlela zokusebenza kwezindlela zokusebenza kwezindlela zokusebenza kwezindlela zokusebenza kwezindlela zokusebenza.

Ukudizaina Kwezimali, Ukuhleleka Kwegunya, Namasimu Amathutha

Imithethe Yokusebenza Kwamandla Esikwakhiwe Ngokuphindaphinda Ngokungafani Noma Ngokuphindaphinda Kwamandla Esikwakhiwe

Kwemaphakamende enqamkqokweyo kwi-ISO Class 5 okanye ngapandle koko, sibona into okuwa ngokuthi unidirectional airflow apho imvula ephumayo kwi-HEPA iyahamba kumindlela emyane ngendlela engavukanga. Lesi sabelo sikhuselela ukuhlanjwa okuphezulu okuyindlela esenza ngayo amachip semiconductors okanye ukugcina imithi yemithi ngokuphezulu. Kwiindawo enqamkqokweyo ngaphantsi koko njenge-ISO Classes 7 ukuya kwi-9, amanye amaphakamende ayagqitha ngokuthi non-unidirectional okanye turbulent airflow. Le ndevo zisebenza ngokuthi zihlasela amagqabi ngokupheleleyo kwiindlela zokuxhuma kwaye zinzile kakhulu kwiindawo apho awukho ukunciphisa ngokuphezulu. Ngokwesicatshulwa esishicilelwe ngo-1990 malunga neendawo zokunciphisa, ukutshintsha kwi-turbulent ukuya kwi-unidirectional airflow kuncipha amagqabi apholileyo ngokupellega kwi-intela ezingama-8 kwiindawo efanayo zokunciphisa. Le nto ithetha ukuba yonke into engezweyo ekutheni kuyindlela eninziyo yabantu abaninzi abathanda ukunciphisa imali.

Imicaba yokulayisha futhi imicaba ye-Airflow engenakuphinda: Imisebenzi futhi Imali ehlukahlukene

Kungenjani ama-80 kuya kuma-90 pho yama-air ephindwe kabusha kusebenziswa kakhulu kuma-recirculating systems, okuphansi kakhulu kuma-HVAC energy expenses ngokungenjani ama-34% ayilandelwa nge-ASHRAE ngo-2022. Ngokwesibili, kuma-single pass systems kungenjani kuthathwa kabusha konke leyo moya esetshenziswe. Kusebenziswa kakhulu lezi sistimu lapho kusebenzela nezinto eziphishongo kanti nezinto ezinokuthi zikhanyiswe kakhulu. Bona ngokwesibonelo labo biotech cleanrooms lapho kusebenzela ngokuphelele nezinto eziyisombululo. Labo labo kusebenzisa kakhulu lezi sistimu zokulayisha singathintwa ngokuphelele ukuthi akukho miphumela yokuvinjelwa phakathi kwezombululo ezahlukene noma kwezinyathelo. Kodwa kunezimali eziphansi kule ndlela yokuphepha. Ukusebenzisa lezi sistimu zokulayisha singathintwa kutholela ngokungenjani ama-dholola ama-12.50 kusikhwama esinye sezansi ngasinye ngendzaka engu-7.20 kuma-recirculating systems. Lokhu kude kube khona kakhulu ngokwehamba kwesikhathi kanti kumaqondo amakhulu.

Ukugcina Imiselwano Yeqondo Ukuvikela Ukungena Kwezindlela

Izindlu zokulula ziguqula umugqa wesimanye kwe +10–15 Pa ngokuhambisana nezindawo ezingaphandle, ngokuthi imvula yeqondo ithuthukisa ukulula kwezindawo ezintsha kuya kuzo ezifulekayo. Izifekelo okungu-10% yokuguqula imiselwano yeqondo kuvikela ukungena kwezindlela ngo 63% (IEST-RP-CC006.3 izindlela). I-EU GMP manje iba yindlela yokugcina imiselwano ngokuzenzekelayo ngezindlela zokubika ngokushesha kuzindawo zemali Grade B–D.

Ukudizayina I-Airlocks kwezinto nezinto Ukugcina Imiselwano Yesimanye

Izilokhi zokulula nezilokhi eziphambene kanye nezinsuku zokuphazamiseka kwe15–30 sekondi zisiza ukugcina ubunzima besimanye. Izindlela eziphambene kubantu kuyinhloko:

• Izilokhi zeqondo lezinto : Izindawo zokugcina ngaphakathi nezilokhi zokulula kwe-UV kuzintambo
• Izilokhi zeqondo labantu abasebenzisa amagowni : Amakhela aphakathi noma aphansi enqamulela neziciko kanye nezishayeli zokuvulindlela
  Isibonelo se-2024 sithole ukuthi izikhiwo ezimbili zokungena zikhansela ukungena kweziciqininiho 41% kunokulingana nezicaba ezingxenyeni eziyodwa.

Indima ye-HEPA kanye nezishayeli ze-ULPA ekutholeni umoya oqinile okulinganiselweyo

Izifilti eZulu lula ukugcina ama-99.97% wamaqondana odwana 0.3 microns, ngelokho izifilti eZulu kancane kakhulu ziyafika kuma-99.999% weqenqeno kumaqondana amancane kakhulu angu-0.12 microns. Lokhu kwenza bantu abafanelekile ukululeka ama-ISO 14644 amadoda amaningi ayanayo. Ngokomcwaningo opublikiwe ngu-Fuji Electric ngo-2022, ukuqala ukusebenzisa izifilti eZulu kunciphisa ukungcono kwezinhlobo zama-wafer eSemiconductor ngama-18% edlule kocansi lwe-ISO 3 uma kuhumeshwa nezindawo ezisebenzisa kuphela izifilti eZulu. Xa ukhetha phakathi kwezinhlobo zezifilti, kubaluleke ukucinga ukuthi zifanipha kanjani nezilingo zokuguqula amahlaya. Isibonelo, amacleanroom amaningi ase-Ngokwesikhathi 5 ayanamaqoshqo kusukela ku-240 kuya ku-600 ngemizuzwana, okungenzeka ukuthi kufuneka kudluliswe izifilti ezifanayo ezine-MERV 17 kuya ku-20 ukwesekela isistimu esifundweni.

Izindleko zokubulala nezimo zokuphakama kwezifakelo

Amaqhobela awukhanyanga, amaqhobela awukhohlwa ngokwemhla: i-stainless steel, i-epoxy coatings, nezikhombisi ezingenazo zipha

Kwamazinga aphakeme kakhulu, amaqhobela kufanele akhazeke ukuphatswa kwezindlela kanye nokunyuka kwezilwane ezingcolileyo ukwesekwa kwezimo eziphambene ne-ISO 14644 kanye nezimo ze-GMP. Amakhampisi amaningi ayenza ngokusebenzisa i-stainless steel ngokuba iyaphila ngokude kwaye inokugcinwa ngokuphunyeziwe kuzipha. Kwezinye izindawo, i-epoxy coatings enemikrobiya yenza ukuba amandla aphakeme ayilungisiwe. Iziphaneli ngokwabo zingaba yinto ezingenazo zipha noma zinemachawula amabolene edola engenazo zipha, engenakwa kwezilimi zokwenza. Le ndawo yenza ukuba amakhawulezwe kanye nezilwane ezicokwa ayilungisiwe. Okuthi kubaluleke ngempela ngale ndawo yinto engaqhobanga ukusebenzisa amadlula amakhulu a-antimicrobial ezingcono njengesiprobiti sokweyisela. Lokhu kubaluleke kakhulu kuzindlela zokwenza izinhlanzi ezinezinga eliphezulu (Grade A/B) lapho kuzothatha izimo eziphambene nezinga elincane kakhulu elingaphantsi kokuqala okungu-1 colony forming unit ngokunguwele kwekhweyitela esibonelwe kwiindlela zokusebenza ze-PDA ezilandelwa ngaleso sikhathi.

Ukucushwa kwezikhumba elijwayelekileyo nokuhlanganisa kwezindonga, izinsimu nezinye iindlela zokulanda

Ukudizayina okuhle kwezikhumba kuhlanganisa izindonga, izinsimu nezinye iindlela njengesiqephu esigcwele sokulawula ukungcola. Igridi yesinsimu enemigqa ye-HEPA iyasebenza ngokushintshana nezinye iindlela zokubuyela kwevili ezithiwe kuzo ukudala iphetheni le-airflow ephansi kwezikhumba. Kuzo nezindlela zokulanda, izicelo ezinhle kuvuma ukuthi kusetyenziswe amagugu akhulu kanye nezinwele ukulanda kude kakhulu kuzo okungu-6 kuya kuma-8 inci kuzo i-baseboards lezikhumba, lokhu kuthiwa ngokuthi kuvuma ukuthi kuthathwe ingceke yezindlela ezikhulu lapho ikati nezinye izinto eziphakeme kuzo. I-Cleanrooms yezinhlelo yokusebenza yemikro yasebenzisa le nto ngokufudumele ngokuthi kuzo kuthiwe kwezinye iindlela zokulanda ezitholakale ngaphezulu nezinye amatile ezithunyelwe. Le ndlela ingasebenze kakhulu kuya kuma-50 kuya kuma-70 amagugu okulanda owodwa ngamahora, lokhu kuthiwa ngokuthi kudingeka ukwenza uma kufuna ukwakha izimo ezithile zokulawula ukungcola kwe-ISO 5 kuya kuma-6.

I-Cleanroom ejwayelekileyo kumaphakathi noma yezindonga ezipermanenti: ukucinga izindleko, ukusebenzisa ngokushintsha nezimo ezingafani

Imithwalo yabantu, ukuboniswa, nokugcina kwekheli esebenza ngokweminyaka

Ukuphathiwa kwezikheli zokuhlukumeza kuvumelana nezintathu ezilandelayo: ukulindiswa kwabantu, ukulandela ukwamiswa nokulandelela izigaba ngokomdla. Abasebenzisa kuyona umthombo omkhulu wehlukumeze, nangokuthi izicelo zibonisa ukuthi amaphethini amathathu kwehlukumeze aziphumelela kwekucindezela okunguqinisiweyo noma iziphoso zamagama.

Imithombo yohlukumeze ekuhlukumeni: ukushaya kwekankera nokuphosa izimo

Izinhloso, izicithakaliso, nezindlela zokungena kwezinyoni zihlukanisa kwezinhlanu kanye nezinyoni ezingi-85% ekuhlukumeni kwemfundo ngokwemboni ye-2023. Izinto ezingezona eziphansi - njengokungasebenzi kwezibhobho noma izinto eziphansi zokuhamba ngokushesha - zingavimba ukulayela kwevali futhi zingenisa izinto.

Imigwebo yokuvukela nokubamba izimvume ye-ISO

Ukuvukela ngemigwebo eminingi esebenza ngokwezifansi ezingenakho ukuthatha izindlela zokuthatha izinto zihlukanisa kwezinhlanu kanye nezinyoni ngama-72% ngokulinganisa nezindlu zokuxhumana. Izinhlayiya zokungena nezimo ezilinganiselwe zilondoloza ukuphila kwevali, futhi izinhlapa zokubamba zokungena kubona amaphethini amathathu kwehlukumeze kwezinyoni ezingi-90% ngaphambi kokungena.

Imigomo yokuthiwa yekhamera eshesheni: ISO 14644, FS 209E, kunye ne-IEST-RP-CC006.3

ISO 14644-1 iyavuma ukuthi kufunwe ukuthiwa okuphawu kwayo kwayo kwezilishwe ezilishweyo kwayo kwezilishwe eziyi-ISO Class 5 nezinye izilishwe zokulinganisa. Izinga lezokwelapha zokwenza kwezokwelapha zokwenza i-IEST-RP-CC006.3 ukuya kwezokulinganisa ngokuphezulu. Nangona kwiqinisekiso elilodwa, i-FS 209E isele isikoza kwiikhamera zeshesheni zase-North American eziyi-38% ngokuba yenziwa ngokuchanekileyo kwi-0.1µm.

Ukuhlola ngokuvavanyo kunye nokulungisa ngaphambili: abakhankatha beziphumo, amafilti, kunye nezinhlelo zokulayisha nezokulayisha

Lapho izicathami zokubala izindlela ngokwesicathami zisebenza ngokuxhuma nezinhlelo zokuphathwa kwamakhaya, zingakwenza uhlelo lwokuguqula amahora wokushisa ngokuzenzekela lapho izindlela ziye kancipha kwezimali ezivumelekile. Ukwenza amagqirha aqondile kweHEPA kabili ngonyaka futhu ukusula amakhoyili ase HVAC ngenyaka yethule kunciphisa amakrobhaya ngama-64% emkhathini wokwenza izicelo. Ngokwabafakwe abaningi, izinkampani zinhlela ngama-740,000 dola lapho zihlanganisa ukufundisa kahle kwekhipha nezinhlelo zokupredicta ubudlelwano wefilta. Istituthi yePonemon yayivumela lokhu kunesicathami sa-2023.

Isikhombisi Sokuqala

Yiyiphi incazelo ekuhlaleni kwamakheli?

Amakheli akhiwe ukulawula imizimba yekhanda ngokulinda izindlela zokushisa ezifuywa kanye nezilithi, amabhaktera, futhu izilithi zokuchitha. Lokhu kuyakho kakhulu emkhathini wezicelo futhu izisembeni lapho izindlela ezingaphansi kwekugcinwa kungahlasela izinhlelo.

Yiziphi izigaba esingaba yabo ukusebenzisa amakheli?

Izinhloso ezintathu eziphambene ngokukhulu kakhulu ngezinhlelo zokulungisa izindawo zokusebenza: izindhleke, izinkimbini zokuxubha, nokwabi ukuphila. Zidinga ukunciphisa kahle nokulungisa ukungena kwezinto ezingenakho ukuthi zilungise ukuphepha nokuphephile kwezinhloso zazo.

Yiziphi izinhloso zokulungisa izindawo zokusebenza (ISO)?

Izinhloso zokulungisa ziyaphansi kweklasi 1 ukuya kweklasi 9, base ngokwehlukaningi lama-particulate aphelile. Kwezinhloso eziphezulu, njengokweklasi ISO 1, kungavunyelwe amapharticulate angaphansi futhi kudinga ukulungisa okukhulu ngokukhona.

Yini i-ACH ikwenzile kuzindawo zokulungiswa?

Amagama e-ACH (Air Change per Hour) iyakwenzelwa ukulungiswa kwezinto ezingenakho ngokuthi iyahlukanisa ukukhanya nokuhamba kwevali, okuncoma ukususa izinto ezingenakho ngokungcono. Imigomo ehlukene ye-ACH iyabalisa ukulungiswa nokusebenza ngokwehla kwezindleko zokushisa.

Yiziphi izindawo zokulungiswa ezifakwe ngezindlela ezithile nezindawo onke nezindle?

Izindawo zokulungiswa ezifakwe ngezindlela ezithile zinikeza ukuthi zilungiswa futhi zingaphansi kwezindleko kodwa kungakwazi ukulungisa ngendlela efanayo nezindawo onke nezindle, okunikeza ukulungiswa okungcono kwezindle, okudingekile kwezinhloso eziphezulu kwe-ISO.