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UKUHLOLA IGUMBI ELIHLANZEKILE NOKUQUKETHWE

igumbi elihlanzekile
ukwakhiwa kwegumbi elihlanzekile

Ngokuvamile ububanzi bokuhlolwa kwegumbi elihlanzekile buhlanganisa: ukuhlolwa kwebanga lendawo ehlanzekile, ukuhlolwa kokwamukelwa kobunjiniyela, okuhlanganisa ukudla, imikhiqizo yezempilo, izimonyo, amanzi asemabhodleleni, indawo yokusebenzela yokukhiqiza ubisi, indawo yokusebenzela yokukhiqiza umkhiqizo kagesi, indawo yokusebenzela ye-GMP, igumbi lokuhlinza esibhedlela, indawo yokusebenzela yezilwane, izindawo zokusebenzela zokuphepha kwezinto eziphilayo, amakhabethe okuphepha kwezinto eziphilayo, amabhentshi ahlanzekile, izindawo zokusebenzela ezingenalo uthuli, izindawo zokusebenzela ezihlanzekile, njll.

Okuqukethwe kokuhlolwa kwegumbi elihlanzekile: ijubane lomoya kanye nomthamo womoya, inani lokushintsha komoya, izinga lokushisa kanye nomswakama, umehluko wokucindezela, izinhlayiya zothuli ezilengayo, amabhaktheriya antantayo, amabhaktheriya azinzile, umsindo, ukukhanya, njll. Ukuze uthole imininingwane, sicela ubheke amazinga afanele okuhlolwa kwegumbi elihlanzekile.

Ukutholwa kwamakamelo ahlanzekile kufanele kuveze ngokucacile isimo sawo sokuhlala. Izimo ezahlukene zizoholela emiphumeleni yokuhlola ehlukene. Ngokusho kwe-"Clean Room Design Code" (GB 50073-2001), ukuhlolwa kwamakamelo ahlanzekile kuhlukaniswe ngezimo ezintathu: isimo esingenalutho, isimo esingaguquki kanye nesimo esiguquguqukayo.

(1) Isimo esingenalutho: Isakhiwo sakhiwe, wonke amandla axhunyiwe futhi ayasebenza, kodwa azikho izinto zokukhiqiza, izinto zokwakha kanye nabasebenzi.

(2) Isimo esiqinile sakhiwe, imishini yokukhiqiza ifakiwe, futhi isebenza njengoba kuvunyelwene ngumnikazi nomhlinzeki, kodwa abekho abasebenzi bokukhiqiza.

(3) Isimo esiguqukayo sisebenza esimweni esithile, sinabasebenzi abathile abakhona, futhi senza umsebenzi esifundazweni okuvunyelwene ngaso.

1. Ijubane lomoya, ivolumu yomoya kanye nenani lezinguquko zomoya

Ukuhlanzeka kwamakamelo ahlanzekile nezindawo ezihlanzekile kufezwa kakhulu ngokuthumela umoya ohlanzekile owanele ukuze kususwe futhi kuncishiswe ukungcola okubangelwa yizinhlayiya ezikhiqizwa ekamelweni. Ngakho-ke, kubaluleke kakhulu ukukala umthamo womoya, isivinini somoya esimaphakathi, ukufana komoya, indlela yokugeleza komoya kanye nephethini yokugeleza kwamakamelo ahlanzekile noma izindawo ezihlanzekile.

Ukuze kwamukelwe ngokuphelele amaphrojekthi amakamelo ahlanzekile, "Izincazelo Zokwakhiwa Nokwamukelwa Kwamakamelo Ahlanzekile" (JGJ 71-1990) zezwe lami zichaza ngokusobala ukuthi ukuhlolwa nokulungiswa kufanele kwenziwe esimweni esingenalutho noma esimweni esingaguquki. Lo mthetho ungahlola ikhwalithi yephrojekthi ngesikhathi nangokungakhethi, futhi ungagwema nezingxabano ngokuvalwa kwephrojekthi ngenxa yokwehluleka ukufeza imiphumela eguquguqukayo njengoba kuhleliwe.

Ekuhlolweni kwangempela kokuqedwa, izimo ezimile zivamile kanti izimo ezingenalutho azivamile. Ngoba eminye yemishini yenqubo egumbini elihlanzekile kumele ibe khona kusenesikhathi. Ngaphambi kokuhlolwa kokuhlanzeka, imishini yenqubo idinga ukusulwa ngokucophelela ukuze kugwenywe ukuthinta idatha yokuhlola. Imithethonqubo eku-"Clean Room Construction and Acceptance Specifications" (GB50591-2010) eyasetshenziswa ngoFebhuwari 1, 2011 icacile kakhulu: "16.1.2 Isimo sokuhlala kwegumbi elihlanzekile ngesikhathi sokuhlolwa sihlukaniswe kanje: ukuhlolwa kokulungiswa kobunjiniyela kufanele kungabi nalutho, Ukuhlolwa kanye nokuhlolwa kwansuku zonke kokwamukelwa kwephrojekthi kufanele kungabi nalutho noma kungabi nalutho, kuyilapho ukuhlolwa kanye nokuqapha ukwamukelwa kokusetshenziswa kufanele kube namandla. Uma kudingeka, isimo sokuhlola singanqunywa nangokuxoxisana phakathi komakhi (umsebenzisi) kanye neqembu lokuhlola."

Ukugeleza okuqondisiwe kuncike kakhulu ekugelezeni komoya okuhlanzekile ukuze kusunduzwe futhi kususwe umoya ongcolile egumbini nasendaweni ukuze kugcinwe ukuhlanzeka kwegumbi nendawo. Ngakho-ke, isivinini somoya kanye nokufana kwesigaba sokunikezwa komoya kuyimingcele ebalulekile ethinta ukuhlanzeka. Isivinini somoya esiphezulu nesifana kakhulu esingasusa ukungcola okukhiqizwa yizinqubo zangaphakathi ngokushesha nangendlela ephumelelayo, ngakho-ke yizinto zokuhlola igumbi elihlanzekile esigxila kuzo kakhulu.

Ukugeleza okungahambisani nohlangothi olulodwa kuncike kakhulu emoyeni ohlanzekile ongenayo ukuze kuncishiswe futhi kuncishiswe ukungcola egumbini nasendaweni ukuze kulondolozwe ukuhlanzeka kwalo. Imiphumela ikhombisa ukuthi uma inani lokushintsha komoya lilikhulu kanye nephethini yokugeleza komoya efanelekile, umphumela wokuxuba uzoba ngcono. Ngakho-ke, umthamo womoya kanye nezinguquko zomoya ezihambisanayo emakamelweni ahlanzekile okugeleza okungeyona ingxenye eyodwa kanye nezindawo ezihlanzekile kuyizinto zokuhlola ukugeleza komoya ezidonse ukunaka okukhulu.

2. Izinga lokushisa kanye nomswakama

Ukulinganiswa kwezinga lokushisa nomswakama emakamelweni ahlanzekile noma ezindaweni zokusebenzela ezihlanzekile ngokuvamile kungahlukaniswa ngamazinga amabili: ukuhlolwa okuvamile nokuhlolwa okuphelele. Ukuhlolwa kokwamukelwa kokuqedwa esimweni esingenalutho kufaneleka kakhulu ebangeni elilandelayo; ukuhlolwa kokusebenza okuphelele esimweni esingaguquki noma esiguquguqukayo kufaneleka kakhulu ebangeni elilandelayo. Lolu hlobo lokuhlolwa lufaneleka kakhulu ngezikhathi ezinezidingo eziqinile zokushisa nomswakama.

Lokhu kuhlolwa kwenziwa ngemuva kokuhlolwa kokufana komoya kanye nokulungiswa kohlelo lokupholisa umoya. Phakathi nalesi sikhathi sokuhlola, uhlelo lokupholisa umoya lusebenze kahle futhi izimo ezahlukahlukene ziye zaqina. Kungumsebenzi omncane ukufaka inzwa yomswakama endaweni ngayinye yokulawula umswakama, futhi unikeze inzwa isikhathi esanele sokuzinza. Ukulinganisa kufanele kufane nokusetshenziswa kwangempela kuze kube yilapho inzwa isizinzile ngaphambi kokuqala ukulinganisa. Isikhathi sokulinganisa kumele sibe ngaphezu kwemizuzu emi-5. 

3. Umehluko wokucindezela

Lolu hlobo lokuhlola luwukuqinisekisa ikhono lokugcina umehluko othile wokucindezela phakathi kwesakhiwo esiqediwe nendawo ezungezile, kanye naphakathi kwendawo ngayinye esikhungweni. Lokhu kuhlola kusebenza kuzo zonke izimo ezintathu zokuhlala. Lokhu kuhlola kubalulekile. Ukutholwa komehluko wokucindezela kufanele kwenziwe yonke iminyango ivaliwe, kusukela ekucindezelekeni okuphezulu kuya ekucindezelekeni okuphansi, kusukela ekamelweni elingaphakathi kude kakhulu nangaphandle ngokwesakhiwo, bese kuhlolwa ngaphandle ngokulandelana. Amakamelo ahlanzekile ezinhlobo ezahlukene anezimbobo ezixhumene aneziqondiso zokuhamba komoya ezifanele kuphela ezingeneni.

Izidingo zokuhlola umehluko wokucindezela:

(1) Uma yonke iminyango endaweni ehlanzekile kudingeka ivalwe, umehluko wokucindezela okungaguquki uyalinganiswa.

(2) Ekamelweni elihlanzekile, qhubeka ngokulandelana kusukela ekuhlanzekeni okuphezulu kuya kokuphansi kuze kube yilapho kutholakala igumbi elinokufinyelela ngqo ngaphandle.

(3) Uma kungekho ukugeleza komoya egumbini, umlomo wethubhu yokulinganisa kufanele ubekwe kunoma iyiphi indawo, futhi ubuso bomlomo wethubhu yokulinganisa kufanele buhambisane nokugeleza komoya.

(4) Idatha elinganisiwe nerekhodiwe kufanele ibe nembambo ku-1.0Pa.

Izinyathelo zokuthola umehluko wokucindezela:

(1) Vala yonke iminyango.

(2) Sebenzisa i-differential pressure gauge ukukala umehluko wokucindezela phakathi kwegumbi ngalinye elihlanzekile, phakathi kwemigwaqo yegumbi elihlanzekile, kanye naphakathi kwemigwaqo nezwe langaphandle.

(3) Yonke idatha kufanele iqoshwe.

Izidingo ezijwayelekile zomehluko wokucindezela:

(1) Umehluko wengcindezi engaguquki phakathi kwamakamelo ahlanzekile noma izindawo ezihlanzekile zamazinga ahlukene kanye namakamelo angahlanzekile (izindawo) kudingeka ube ngaphezu kwama-5Pa.

(2) Umehluko wengcindezi engaguquki phakathi kwegumbi elihlanzekile (indawo) kanye nengaphandle kudingeka ube ngaphezu kwama-10Pa.

(3) Emakamelweni ahlanzekile okugeleza aqonde ngqo anamazinga okuhlanzeka komoya aqinile kune-ISO 5 (Class100), lapho umnyango uvulwa, ukugcwala kothuli endaweni yokusebenza yangaphakathi engu-0.6m ngaphakathi komnyango kufanele kube ngaphansi komkhawulo wokugcwala kothuli wezinga elihambisanayo.

(4) Uma izidingo ezijwayelekile ezingenhla zingahlangatshezwanga, umthamo womoya omusha kanye nomthamo womoya ophumayo kufanele kulungiswe kuze kube yilapho kufaneleke.

4. Izinhlayiya ezilengayo

(1) Abahloli bangaphakathi kumele bagqoke izingubo ezihlanzekile futhi kufanele babe bancane kunabantu ababili. Kufanele babe sendaweni ephansi yomoya endaweni yokuhlola futhi baqhelelene nendawo yokuhlola. Kufanele bahambe kancane lapho beshintsha izindawo ukuze bagweme ukuphazamiseka kwabasebenzi ekuhlanzekeni kwangaphakathi.

(2) Imishini kumele isetshenziswe ngaphakathi kwesikhathi sokulinganisa.

(3) Imishini kumele ihlanzwe ngaphambi nangemva kokuhlolwa.

(4) Endaweni yokugeleza okuqondile, i-probe yokuqoqa isampula ekhethiwe kufanele isondele ekutholeni isampula enamandla, futhi ukuphambuka kwejubane lomoya elingena kwi-probe yokuqoqa isampula kanye nejubane lomoya elithathwayo kufanele kube ngaphansi kuka-20%. Uma lokhu kungenziwa, i-port yokuqoqa isampula kufanele ibheke isiqondiso esiyinhloko sokugeleza komoya. Kumaphoyinti okuqoqa isampula okuqondile okungeyona isiqondiso esisodwa, i-port yokuqoqa isampula kufanele ibe phezulu phezulu.

(5) Ipayipi elixhumanisayo elivela echwebeni lokuhlola isampula liye enzwa yekhawunta yezinhlayiya zothuli kufanele libe lifushane ngangokunokwenzeka.

5. Amagciwane antantayo

Inani lamaphuzu okulinganisa aphansi lihambisana nenani lamaphuzu okulinganisa izinhlayiya ezilengisiwe. Amaphuzu okulinganisa endaweni yokusebenza angaba ngu-0.8-1.2m ngaphezu komhlaba. Amaphuzu okulinganisa ezindaweni zokungenisa umoya angaba ngu-30cm ukusuka ebusweni bokuphakelwa komoya. Amaphuzu okulinganisa angangezwa emishinini ebalulekile noma ezindaweni zomsebenzi ezibalulekile. , iphuzu ngalinye lokuhlola livame ukusampula kanye.

6. Amagciwane axazululiwe

Sebenza ibanga elingamamitha angu-0.8-1.2 ukusuka phansi. Beka isitsha sePetri esilungisiwe endaweni yokuthatha isampula. Vula isembozo sesitsha sePetri. Ngemva kwesikhathi esibekiwe, vala isitsha sePetri futhi. Beka isitsha sePetri endaweni yokushisa engaguquki ukuze usitshale. Isikhathi esidingekayo emahoreni angaphezu kwama-48, ibhetshi ngalinye kumele libe nokuhlolwa kokulawula ukuhlola ukungcola kwendawo yokukhulisa.

7. Umsindo

Uma ukuphakama kokulinganisa kungamamitha angu-1.2 ukusuka phansi futhi indawo yegumbi elihlanzekile ingaphakathi kwamamitha-skwele angu-15, iphuzu elilodwa kuphela phakathi negumbi elingalinganiswa; uma indawo ingaphezu kwamamitha-skwele angu-15, amaphuzu amane aqondile kufanele alinganiswe, iphuzu elilodwa ukusuka odongeni oluseceleni, amaphuzu okulinganisa abheke ekhoneni ngalinye.

8. Ukukhanya

Ubuso bendawo yokulinganisa buqhele ngamamitha angu-0.8 ukusuka phansi, futhi amaphuzu ahlelwe ngamamitha ama-2 ukusuka phansi. Emakamelweni angaphakathi kwamamitha-skwele angu-30, amaphuzu okulinganisa aqhele ngamamitha angu-0.5 ukusuka odongeni oluseceleni. Emakamelweni amakhulu kunamamitha-skwele angu-30, amaphuzu okulinganisa aqhele ngamamitha angu-1 ukusuka odongeni.


Isikhathi sokuthunyelwe: Septhemba 14-2023