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IZIMPENDULO NEMIBUZO EPHATHANA NEGUMBI LOKUHLANZA

igumbi elihlanzekile
gmp igumbi elihlanzekile

Isingeniso

Ngomqondo wokwenza imithi, igumbi elihlanzekile lisho igumbi elihlangabezana nokucaciswa kwe-GMP kwe-aseptic. Ngenxa yezidingo eziqinile zokuthuthukiswa kobuchwepheshe bokukhiqiza endaweni yokukhiqiza, igumbi lokuhlanza ilabhorethri laziwa nangokuthi "umnakekeli wokukhiqiza okuphezulu."

1. Liyini igumbi elihlanzekile

Igumbi elihlanzekile, elaziwa nangokuthi igumbi elingenalo uthuli, livame ukusetshenziswa njengengxenye yokukhiqiza kwezimboni eziqeqeshiwe noma ucwaningo lwesayensi, okuhlanganisa ukwakhiwa kwemithi, amasekethe ahlanganisiwe, i-CRT, i-LCD, i-OLED kanye nezibonisi ze-LED ezincane, njll.

Igumbi elihlanzekile lenzelwe ukugcina amazinga aphansi kakhulu ezinhlayiya, njengothuli, izinto eziphilayo ezihamba emoyeni, noma izinhlayiya ezihwamuke. Ngokuqondile, igumbi elihlanzekile linezinga lokungcola elilawulwayo, elicaciswe ngenani lezinhlayiya nge-cubic meter ngayinye kusayizi wezinhlayiyana ezithile.

Igumbi elihlanzekile lingaphinda libhekisele kunoma yisiphi isikhala esibekiwe lapho kubekwa khona izinyathelo zokunciphisa ukungcoliswa kwezinhlayiyana nokulawula ezinye izimiso zemvelo ezifana nezinga lokushisa, umswakama kanye nokucindezela. Ngomqondo wokwenza imithi, igumbi elihlanzekile yigumbi elihlangabezana nezidingo zokucaciswa kwe-GMP ezichazwe ekucacisweni kwe-GMP aseptic. Kuyinhlanganisela yomklamo wobunjiniyela, ukukhiqiza, ukuqeda kanye nokulawula ukusebenza (isu lokulawula) elidingekayo ukuze kuguqulwe igumbi elijwayelekile libe igumbi elihlanzekile. Amakamelo ahlanzekile asetshenziswa ezimbonini eziningi, nomaphi lapho izinhlayiya ezincane zingaba nomthelela omubi enqubweni yokukhiqiza.

Amakamelo ahlanzekile ayahlukahluka ngobukhulu nobunkimbinkimbi futhi asetshenziswa kakhulu ezimbonini ezifana nokukhiqiza i-semiconductor, ezemithi, i-biotechnology, izisetshenziswa zezokwelapha nesayensi yezempilo, kanye nezinqubo ezibucayi zokukhiqiza ezivamile ku-aerospace, optics, ezempi kanye noMnyango Wezamandla.

2. Ukuthuthukiswa kwekamelo elihlanzekile

Igumbi lesimanje elihlanzekile lasungulwa isazi sefiziksi saseMelika uWillis Whitfield. UWhitfield, njengesisebenzi seSandia National Laboratories, waklama umklamo wokuqala wegumbi elihlanzekile ngo-1966. Ngaphambi kokusungulwa kukaWhitfield, igumbi elihlanzekile ngaphambi kwesikhathi lalivame ukubhekana nezinkinga zezinhlayiya nokugeleza komoya okungalindelekile.

I-Whitfield yaklama igumbi elihlanzekile elinomoya oqhubekayo futhi ohlungiwe ngokuqinile ukugcina indawo ihlanzekile. Iningi lezindawo ezididiyelwe zokukhiqiza isekethe eSilicon Valley zakhiwa izinkampani ezintathu: iMicroAire, iPureAire, kanye nePlastiki eyisihluthulelo. Bakha amayunithi okugeleza kwe-laminar, amabhokisi amagilavu, amagumbi ahlanzekile nezishawa zomoya, kanye namathangi amakhemikhali namabhentshi okusebenzela okwakhiwa "kwenqubo emanzi" yamasekethe ahlanganisiwe. Lezi zinkampani ezintathu nazo zazingamavulandlela ekusetshenzisweni kweTeflon ngezibhamu zomoya, amaphampu amakhemikhali, izikhuhla, izibhamu zamanzi, nezinye izinto ezidingekayo ukuze kukhiqizwe isifunda esididiyelwe. UWilliam (uBill) C. McElroy Jr. usebenze njengomphathi wobunjiniyela, umqondisi wegumbi lokuhlela, i-QA/QC, kanye nomklami wezinkampani ezintathu, futhi imiklamo yakhe yengeza amalungelo obunikazi okuqala angama-45 kubuchwepheshe bangaleso sikhathi.

3. Izimiso Zokugeleza Komoya Kwegumbi Elihlanzekile

Amakamelo ahlanzekile alawula izinhlayiya ezihamba emoyeni ngokusebenzisa izihlungi ze-HEPA noma ze-ULPA, zisebenzisa i-laminar (ukugeleza kwendlela eyodwa) noma izimiso zokugeleza komoya ezineziyaluyalu (okunyakazayo, okungeyona indlela eyodwa).

I-Laminar noma amasistimu wokugeleza komoya wendlela eyodwa aqondisa umoya ohlungiwe ngokugeleza njalo phansi noma ngokuvundlile kuzihlungi ezisodongeni eduze nephansi legumbi elihlanzekile, noma aphinde ajikelezwe ngamaphaneli aphansi anezimbobo.

Amasistimu wokugeleza komoya we-laminar ngokuvamile asetshenziswa ngaphezu kwama-80% ophahleni lwegumbi elihlanzekile ukuze kugcinwe umoya ongashintshi. Insimbi engagqwali noma ezinye izinto ezingachithi zisetshenziselwa ukwakha izihlungi ze-laminar zokugeleza komoya kanye nama-hood ukuze kuvinjelwe izinhlayiya ezingaphezulu ukuthi zingangeni emoyeni. Ukugeleza komoya okuyaluzayo, noma okungeyona indlela eyodwa kusebenzisa izivalo zokugeleza komoya eziyisi-laminar kanye nezihlungi zesivinini ezingaqondile ukuze kugcinwe umoya usendaweni ehlanzekile lapho unyakaza njalo, nakuba zonke zingahambi ngendlela efanayo.

Umoya onolaka uzama ukuthwebula izinhlayiya ezingase zibe semoyeni futhi uziqhubele phansi, lapho zingena khona okokuhlunga bese zishiya indawo ehlanzekile yegumbi. Ezinye izindawo zizophinde zengeze amagumbi ahlanzekile e-vector: kunikezwa umoya emagumbini angaphezulu ekamelo, kusetshenziswa izihlungi ze-hepa ezimise okwefeni, futhi izihlungi ze-hepa ezijwayelekile zingasetshenziswa nezindawo zokuphakela umoya ezimise okwefeni. Izimpahla zomoya ezibuyayo zisethwe engxenyeni engezansi yolunye uhlangothi. Isilinganiso sobude nobude begumbi ngokuvamile siphakathi kuka-0.5 no-1. Lolu hlobo lwegumbi elihlanzekile lungaphinda lufinyelele ukuhlanzeka Kwekilasi 5 (Ikilasi 100).

Amakamelo ahlanzekile adinga umoya omningi futhi ngokuvamile asezingeni lokushisa elilawulwayo kanye nomswakama. Ukuze kuncishiswe izindleko zokushintsha izinga lokushisa elizungezile noma umswakama, cishe u-80% womoya ujikeleziswa kabusha (uma izici zomkhiqizo zivuma), futhi umoya ojikelezwe kabusha uyahlungwa kuqala ukuze ukhiphe ukungcola okuyizinhlayiyana kuyilapho kugcinwa izinga lokushisa elifanele kanye nomswakama ngaphambi kokudlula ekamelweni elihlanzekile.

Izinhlayiya zomoya (ukungcola) zintanta nxazonke. Izinhlayiya eziningi ezihamba emoyeni zihlala kancane kancane, futhi izinga lokumisa lincike ngobukhulu bazo. Isistimu yokuphatha umoya eklanywe kahle kufanele ilethe umoya ohlanzekile ohlanzekile ohlanzekile futhi ojikelezwe kabusha ukuze uhlanze igumbi ndawonye, ​​futhi uhambise izinhlayiya kude negumbi elihlanzekile ndawonye. Kuye ngokusebenza, umoya othathwe ekamelweni ngokuvamile ujikelezwa kabusha ngesistimu yokuphatha umoya, lapho izihlungi zisusa khona izinhlayiya.

Uma inqubo, izinto zokusetshenziswa noma imikhiqizo iqukethe umswakama omningi, umhwamuko oyingozi noma amagesi, lo moya awukwazi ukuphinda ubuyiselwe ekamelweni. Lo moya uvamise ukuphelela emoyeni, bese kuthi umoya ohlanzekile ongu-100% udonswe ohlelweni lwegumbi elihlanzekile futhi uphathwe ngaphambi kokungena ekamelweni elihlanzekile.

Inani lomoya ongena ekamelweni elihlanzekile lilawulwa ngokuqinile, futhi inani lomoya ophelile nalo lilawulwa ngokuqinile. Amakamelo amaningi ahlanzekile acindezelwa, okutholakala ngokungena ekamelweni elihlanzekile elinomoya ophezulu kunomoya ophelile ovela ekamelweni elihlanzekile. Izingcindezi eziphakeme zingabangela ukuba umoya uphume ngaphansi kweminyango noma ngemifantu emincane engagwemeki noma izikhala kunoma yiliphi igumbi elihlanzekile. Isihluthulelo sokuklama okuhle kwekamelo elihlanzekile yindawo efanele yokungenisa umoya (ukunikezwa) kanye ne-exhaust (i-exhaust).

Lapho ubeka igumbi elihlanzekile, indawo yokuhlinzeka kanye nokukhipha (ukubuya) ama-grilles kufanele kube yinto ehamba phambili. I-inlet (uphahla) kanye nama-grilles okubuyisela (ezingeni eliphansi) kufanele kube ezinhlangothini eziphambene zekamelo elihlanzekile. Uma u-opharetha edinga ukuvikelwa emkhiqizweni, ukugeleza komoya kufanele kube kude no-opharetha. I-US FDA kanye ne-EU baneziqondiso eziqinile nemikhawulo yokungcoliswa kwamagciwane, futhi ama-plenum phakathi kwesibambi somoya kanye neyunithi yesihlungi sabalandeli kanye nomata abanamathelayo nakho kungasetshenziswa. Emakamelweni angenalutho adinga umoya Wekilasi A, ukugeleza komoya kusuka phezulu kuye phansi futhi akuqondile noma ku-laminar, okuqinisekisa ukuthi umoya awungcolisiwe ngaphambi kokuthi uthinte umkhiqizo.

4. Ukungcola kwekamelo elihlanzekile

Usongo olukhulu lokuhlanza igumbi luvela kubasebenzisi ngokwabo. Embonini yezokwelapha kanye nemithi, ukulawula ama-microorganisms kubaluleke kakhulu, ikakhulukazi ama-microorganisms angase akhishwe esikhumbeni futhi afakwe emoyeni. Ukutadisha izitshalo ezincane zamakamelo ahlanzekile kubaluleke kakhulu kososayensi bezinto ezincane kanye nabasebenzi abalawula ikhwalithi ukuze bahlole amathrendi ashintshayo, ikakhulukazi ekuhlolweni kwezinhlobo ezimelana nezidakamizwa kanye nocwaningo lokuhlanza nezindlela zokubulala amagciwane. Izitshalo ezijwayelekile zegumbi elihlanzekile zihlobene kakhulu nesikhumba somuntu, futhi kuzoba nama-microorganisms avela kweminye imithombo, efana nemvelo namanzi, kodwa ngamanani amancane. Izinhlobo zamabhaktheriya ezivamile zihlanganisa i-Micrococcus, i-Staphylococcus, i-Corynebacterium ne-Bacillus, futhi i-fungal genera ihlanganisa i-Aspergillus ne-Penicillium.

Kunezici ezintathu ezinkulu zokugcina igumbi lihlanzekile.

(1). Ingaphakathi lekamelo elihlanzekile kanye nemishini yalo yangaphakathi

Isimiso siwukuthi ukukhethwa kwezinto ezibonakalayo kubalulekile, futhi ukuhlanza nsuku zonke nokubulala amagciwane kubaluleke kakhulu. Ukuze uhambisane ne-GMP futhi uzuze ukucaciswa kwenhlanzeko, zonke izindawo zegumbi elihlanzekile kufanele zibe bushelelezi futhi zingangeni umoya, futhi zingakhiqizi ukungcola kwazo, okungukuthi, kungabikho uthuli, noma imfucumfucu, ukumelana nokugqwala, ukuhlanza okulula, ngaphandle kwalokho kuzohlinzeka indawo yokukhiqiza amagciwane, futhi indawo engaphezulu kufanele iqine futhi ihlale isikhathi eside, futhi ayikwazi ukuqhekeka, ukuphuka noma ukubola. Kunezinhlobonhlobo zezinto ongakhetha kuzo, okuhlanganisa i-dagad panelning ebizayo, ingilazi, njll. Inketho engcono kakhulu futhi enhle kakhulu ingilazi. Ukuhlanza njalo nokubulala amagciwane kufanele kwenziwe ngokuhambisana nezidingo zamakamelo ahlanzekile kuwo wonke amazinga. Imvamisa ingaba ngemva kokuhlinzwa ngakunye, izikhathi eziningi ngosuku, nsuku zonke, njalo ngemva kwezinsuku ezimbalwa, kanye ngesonto, njll. Kunconywa ukuthi itafula lokuhlinza kufanele lihlanzwe futhi libulawe amagciwane ngemva kokuhlinzwa ngakunye, phansi kufanele kubulawe amagciwane nsuku zonke, udonga kufanele luhlanzwe amagciwane masonto onke, futhi indawo kufanele ihlanzwe futhi ibulawe amagciwane nyanga zonke ngokwezinga legumbi elihlanzekile futhi amarekhodi amisiwe kanye nokucaciswa kufanele kugcinwe.

(2). Ukulawula umoya ekamelweni elihlanzekile

Ngokuvamile, kuyadingeka ukukhetha umklamo ofanelekile wegumbi elihlanzekile, wenze ukunakekelwa okujwayelekile, futhi wenze ukuqapha kwansuku zonke. Kufanele kuqashelwe ngokukhethekile ukuqapha amagciwane antantayo emakamelweni ahlanzekile emithi. Amagciwane antantayo esikhaleni akhishwa isampula yebhaktheriya elintantayo ukuze kukhishwe umthamo othile womoya esikhaleni. Ukugeleza komoya kudlula esitsheni sokuxhumana esigcwele isiko elithile. Isitsha sokuxhumana sizobamba ama-microorganisms, bese isidlo sifakwa ku-incubator ukuze ubale inani lamakholoni futhi ubale inani lama-microorganisms esikhaleni. Ama-microorganisms kungqimba lwe-laminar nawo adinga ukutholwa, kusetshenziswa ungqimba lwe-laminar oluhambisanayo oluntantayo lwesampula yamagciwane. Isimiso sokusebenza siyefana nesokusampula kwendawo, ngaphandle kokuthi indawo yesampula kufanele ibekwe kungqimba lwe-laminar. Uma umoya ocindezelwe udingeka ekamelweni eliyinyumba, kuyadingeka futhi ukwenza ukuhlolwa kwe-microbial emoyeni ocindezelweyo. Ngokusebenzisa umtshina womoya ocindezelwe ohambelanayo, umfutho womoya womoya ocindezelweyo kufanele ulungiswe ube ibanga elifanele ukuze kuvinjwe ukucekelwa phansi kwama-microorganisms kanye nemidiya yesiko.

(3). Izidingo zabasebenzi abasegunjini elihlanzekile

Abasebenzi abasebenza emakamelweni ahlanzekile kumele bathole ukuqeqeshwa njalo ngethiyori yokulawula ukungcoliswa. Bangena futhi baphume egumbini elihlanzekile ngezingidi zomoya, izihlambi zomoya kanye/noma amakamelo okushintshela, futhi kufanele bagqoke izingubo eziklanywe ngokukhethekile ukuze bavale isikhumba kanye nokungcola okwenzeka ngokwemvelo emzimbeni. Kuye ngokuhlukaniswa noma ukusebenza kwegumbi elihlanzekile, izingubo zabasebenzi zingase zidinge kuphela isivikelo esilula njengamajazi aselabhorethri namahood, noma zingase zimbozwe ngokugcwele futhi zingavezi noma yisiphi isikhumba. Izingubo zegumbi ezihlanzekile zisetshenziselwa ukuvimbela izinhlayiya kanye/noma ama-microorganisms ukuthi akhululwe emzimbeni womuntu ozigqokile futhi angcolise indawo ezungezile.

Izingubo zasekamelweni ezihlanzekile ngokwazo akumele zikhiphe izinhlayiya noma imicu ukuze kuvinjelwe ukungcoliswa kwemvelo. Lolu hlobo lokungcoliswa kwabasebenzi lunganciphisa ukusebenza komkhiqizo ku-semiconductor kanye nezimboni zemithi, futhi lungaholela ekuthelelekeni okuphambene phakathi kwabasebenzi bezokwelapha neziguli embonini yezokunakekelwa kwempilo, isibonelo. Impahla ehlanzekile yegumbi lokuvikela ihlanganisa izingubo zokuzivikela, amabhuzu, izicathulo, amaphinifa, izembozo zentshebe, izigqoko eziyindilinga, imaski, izingubo zokusebenza/amajazi elebhu, amajazi, amagilavu ​​nombhede weminwe, imikhono nezihlangu nezingubo zebhuthi. Uhlobo lwezingubo zegumbi ezihlanzekile ezisetshenziswayo kufanele zibonise igumbi elihlanzekile nesigaba somkhiqizo. Amakamelo ahlanzekile asezingeni eliphansi angase adinge izicathulo ezikhethekile ezinezingqimba ezibushelelezi ngokuphelele ezingeke zime othulini noma ukungcola. Kodwa-ke, ngenxa yezizathu zokuphepha, izicathulo zezicathulo azikwazi ukubangela ingozi yokushelela. Izingubo zegumbi ezihlanzekile ngokuvamile ziyadingeka ukuze ungene ekamelweni elihlanzekile. Amajazi alula elebhu, amakhava ekhanda nesembozo sezicathulo angasetshenziswa ekamelweni elihlanzekile Lekilasi le-10,000. Egumbini elihlanzekile Lekilasi Le-100, ukusonga okugcwele umzimba wonke, izingubo zokuzivikela ezinoziphu, izibuko, imaski, amagilavu ​​namakhava ebhuthi ayadingeka. Ngaphezu kwalokho, inani labantu ekamelweni elihlanzekile kufanele lilawulwe, ngesilinganiso esingu-4 kuya ku-6 m2/umuntu, futhi ukusebenza kufanele kube mnene, kugweme ukunyakaza okukhulu nokusheshayo.

5. Izindlela ezivame ukusetshenziswa zokubulala amagciwane ekamelweni elihlanzekile

(1). Ukukhishwa kwe-UV

(2). Ukukhishwa kwe-ozone

(3). Ukuvala inzalo kwegesi Izibulala-magciwane zihlanganisa i-formaldehyde, i-epoxyethane, i-peroxyacetic acid, i-carbolic acid nezingxube ze-lactic acid, njll.

(4) Izibulala-magciwane

Izibulala-magciwane ezivamile zihlanganisa i-isopropyl alcohol (75%), i-ethanol (75%), i-glutaraldehyde, i-Chlorhexidine, njll. Indlela evamile yokubulala amagciwane emagumbini angenalutho ezimbonini zokwenza imithi yaseShayina ukusebenzisa ukufuthwa kwe-formaldehyde. Izimboni zemithi zakwamanye amazwe zikholelwa ukuthi i-formaldehyde inomonakalo othile emzimbeni womuntu. Manje basebenzisa isifutho se-glutaraldehyde. Isibulali magciwane esisetshenziswa emakamelweni angenazinyumba kufanele sivalwe amagciwane futhi sihlungwe ngolwelwesi lwesihlungi esingu-0.22μm kukhabhinethi yokuphepha yebhayoloji.

6. Ukuhlelwa kwegumbi elihlanzekile

Igumbi elihlanzekile lihlukaniswa ngokwenombolo nosayizi wezinhlayiya ezivunyelwe umthamo womoya ngamunye. Izinombolo ezinkulu ezifana ne-"Class 100" noma "Class 1000" zibhekisela ku-FED-STD-209E, ebonisa inombolo engu-0.5μm noma izinhlayiya ezinkulu ezivunyelwe ngecubic foot ngayinye yomoya. Izinga libuye livumele ukuhunyushwa; isibonelo, i-SNOLAB inakekelwa igumbi elihlanzekile Lekilasi 2000. Izibali zezinhlayiyana zomoya ezihlakazekayo ezikhanyayo zisetshenziselwa ukunquma ukuhlangana kwezinhlayiya ezihamba emoyeni ezilingana noma ezinkulu kunosayizi othile endaweni ethile yesampula.

Inani ledesimali libhekisela kuzinga le-ISO 14644-1, elicacisa i-logarithm yedesimali yenani lezinhlayiya ezingu-0.1μm noma ezinkulu ezivunyelwe yi-cubic meter yomoya ngayinye. Ngakho-ke, isibonelo, igumbi elihlanzekile le-ISO Class 5 linenani eliphakeme lezinhlayiya eziyi-105/m3. Kokubili i-FS 209E kanye ne-ISO 14644-1 icabanga ukuthi kukhona ubudlelwano be-logarithmic phakathi kosayizi wezinhlayiyana nokugxila kwezinhlayiyana. Ngakho-ke, ukugxila kwezinhlayiyana zero akukho. Amanye amakilasi awadingi ukuhlolwa kosayizi abathile bezinhlayiyana ngoba ukugxilisana kuphansi kakhulu noma kuphezulu kakhulu ukuthi kungasebenziseka, kodwa izikhala ezinjalo akufanele zithathwe njengeziro. Njengoba i-1m3 icishe ibe ngama-cubic feet angama-35, amazinga amabili acishe alingane lapho kulinganiswa izinhlayiya ezingu-0.5μm. Umoya ovamile wasendlini ucishe ube I-Class 1,000,000 noma i-ISO 9.

I-ISO 14644-1 kanye ne-ISO 14698 ingamazinga angekho ngaphansi kukahulumeni athuthukiswe yi-International Organisation for Standardization (ISO). Owokuqala usebenza ekamelweni elihlanzekile ngokujwayelekile; okokugcina ukuhlanza igumbi lapho ukungcola kwe-biocontamination kungase kube yinkinga.

Izikhungo ezilawulayo zamanje zifaka: ISO, USP 800, US Federal Standard 209E (izinga langaphambilini, lisasetshenziswa) Umthetho Wekhwalithi Nokuphepha Kwezidakamizwa (DQSA) wasungulwa ngoNovemba 2013 ukuze kubhekwane nokufa okuhlanganiswe nezidakamizwa kanye nezigameko ezimbi kakhulu. I-Federal Food, Drug, and Cosmetic Act (FD&C Act) isungula imihlahlandlela ethile nezinqubomgomo zokwenziwa kwabantu. I-503A igadwe izisebenzi ezigunyaziwe (osokhemisi/odokotela) yizikhungo ezigunyazwe zikahulumeni noma zikahulumeni 503B ihlobene nezindawo zokukhishwa kwemisebenzi futhi idinga ukugadwa okuqondile ngusokhemisi onelayisensi futhi ayidingi ukuba yikhemisi enelayisensi. Izikhungo zithola amalayisense ngeFood and Drug Administration (FDA).

Imihlahlandlela ye-EU GMP iqinile kunezinye iziqondiso futhi idinga indawo ehlanzekile ukuze kuzuzwe izibalo zezinhlayiya lapho isebenza (ngesikhathi sokukhiqiza) futhi lapho kuphumula (lapho kungekho kukhiqizwa okwenzekayo kodwa igumbi i-AHU livuliwe).

8. Imibuzo evela kubafunda lab

(1). Ungena futhi uphume kanjani egunjini elihlanzekile? Abantu nezimpahla bangena baphinde baphume ngezindlela ezahlukene zokungena nokuphuma. Abantu bangena baphinde baphume ngezingidi zomoya (abanye banezishawa zomoya) noma bengenazo izingidi zomoya futhi bagqoke izinto zokuzivikela ezifana namahood, imaski, amagilavu, amabhuzu nezingubo zokuzivikela. Lokhu okokunciphisa nokuvimba izinhlayiya ezilethwa abantu abangena egumbini elihlanzekile. Izimpahla zingena futhi ziphume egumbini elihlanzekile ngomzila wezimpahla.

(2). Ingabe kukhona okukhethekile mayelana nesakhiwo segumbi elihlanzekile? Ukukhethwa kwezinto zokwakha zekamelo elihlanzekile akufanele kukhiqize noma yiziphi izinhlayiya, ngakho-ke i-epoxy jikelele noma i-polyurethane flooring iyakhethwa. Insimbi engagqwali epholishiwe noma amaphaneli okuhlukanisa amasemishi ensimbi enziwe ngempushana kanye namaphaneli osilingi asetshenziswa. Amakhona anama-engeli angakwesokudla agwenywa izindawo ezigobile. Wonke amalunga ukusuka ekhoneni kuye phansi kanye nasekhoneni kuye kusilingi adinga ukuvalwa nge-epoxy sealant ukugwema noma yikuphi ukufakwa kwezinhlayiyana noma isizukulwane emalungeni. Izinto zokusebenza ezisegunjini elihlanzekile ziklanyelwe ukukhiqiza ukungcoliswa komoya okuncane. Sebenzisa kuphela ama-mops namabhakede enziwe ngokukhethekile. Ifenisha yegumbi ehlanzekile kufanele futhi yakhelwe ukukhiqiza izinhlayiya ezincane futhi kube lula ukuyihlanza.

(3). Ungakhetha kanjani i-disinfectant efanele? Okokuqala, ukuhlaziya imvelo kufanele kwenziwe ukuze kuqinisekiswe uhlobo lwama-microorganisms angcolile ngokuqapha imvelo. Isinyathelo esilandelayo ukunquma ukuthi yisiphi isibulala-magciwane esingabulala inani elaziwayo lama-microorganisms. Ngaphambi kokwenza ukuhlolwa kobungozi besikhathi sokuxhumana (indlela yokuhlola i-tube dilution noma indlela yezinto ezingaphezulu) noma ukuhlolwa kwe-AOAC, izibulala-magciwane ezikhona zidinga ukuhlolwa futhi kuqinisekiswe ukuthi zifanelekile. Ukubulala amagciwane egumbini elihlanzekile, ngokuvamile kunezinhlobo ezimbili zezindlela zokuzungezisa isibulala-magciwane: ① Ukuzungezisa isibulala-magciwane esisodwa kanye ne-sporicide eyodwa, ② Ukuzungezisa izibulala-magciwane ezimbili kanye ne-sporicide eyodwa. Ngemva kokunqunywa kwesistimu yokubulala amagciwane, ukuhlolwa kokuphumelela kwe-bactericidal kungenziwa ukunikeza isisekelo sokukhethwa kwezibulala-magciwane. Ngemva kokuphothula ukuhlolwa kokusebenza kahle kwe-bactericidal, ukuhlolwa kocwaningo lwensimu kuyadingeka. Lena indlela ebalulekile yokufakazela ukuthi ingabe i-SOP yokuhlanza nokubulala amagciwane kanye nokuhlolwa kokusebenza ngempumelelo kwe-bactericidal kwesibulala-magciwane kuyasebenza yini. Ngokuhamba kwesikhathi, ama-microorganisms ayengabonwa ngaphambilini angase avele, nezinqubo zokukhiqiza, izisebenzi, njll. zingase zishintshe, ngakho ukuhlanza nokubulala amagciwane ama-SOP adinga ukubuyekezwa njalo ukuze kuqinisekiswe ukuthi ayasebenza yini endaweni yamanje.

(4). Hlanza amaphaseji noma amaphasishi angcolile? Izimpushana ezinjengamaphilisi noma amaphilisi amaphaseji ahlanzekile, kuyilapho izidakamizwa eziyinyumba, izidakamizwa eziwuketshezi, njll. zingamaphasishi angcolile. Ngokuvamile, imikhiqizo yemithi enomswakama ophansi njengamaphilisi noma amaphilisi omile futhi anothuli, ngakho-ke maningi amathuba okuba sengozini enkulu yokutheleleka. Uma umehluko wengcindezi phakathi kwendawo ehlanzekile kanye nephaseji ulungile, impushana izophuma ekamelweni iye ephaseji futhi cishe idluliselwe ekamelweni elihlanzekile elilandelayo. Ngenhlanhla, amalungiselelo amaningi okomile awakusekeli kalula ukukhula kwamagciwane, ngakho-ke njengomthetho ojwayelekile, amaphilisi kanye nezimpushana zenziwa ezindaweni ezihlanzekile zephaseji ngoba ama-microorganisms antantayo emhubheni awakwazi ukuthola indawo lapho angakhula khona. Lokhu kusho ukuthi igumbi linengcindezi embi emhubheni. Emikhiqizweni eyinyumba (ecutshunguliwe), i-aseptic noma i-bioburden ephansi kanye nemithi ewuketshezi, ama-microorganisms ngokuvamile athola amasiko asekelayo okumele achume kuwo, noma esimweni semikhiqizo ecutshunguliwe eyinyumba, i-microorganism eyodwa ingaba inhlekelele. Ngakho-ke, lezi zikhungo zivame ukuklanywa ngamaphasishi angcolile ngoba inhloso iwukuba amagciwane angaba khona angangeni ekamelweni elihlanzekile.

uhlelo lwegumbi elihlanzekile
iklasi 10000 igumbi elihlanzekile
iklasi 100 igumbi elihlanzekile

Isikhathi sokuthumela: Feb-20-2025
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