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IZIMPENDULO NEMIBUZO EHLOBENE NEGUMBI LOKUHLANZA

igumbi elihlanzekile
igumbi lokuhlanza le-gmp

Isingeniso

Ngomqondo wezokwelapha, igumbi elihlanzekile libhekisela ekamelweni elihlangabezana nezimfuneko ze-GMP ze-aseptic. Ngenxa yezidingo eziqinile zokuthuthukiswa kobuchwepheshe bokukhiqiza endaweni yokukhiqiza, igumbi elihlanzekile lelabhorethri laziwa nangokuthi "umqaphi wokukhiqiza okuphezulu."

1. Liyini igumbi elihlanzekile

Igumbi elihlanzekile, elaziwa nangokuthi igumbi elingenazintuli, livame ukusetshenziswa njengengxenye yokukhiqiza kwezimboni noma ucwaningo lwesayensi, okuhlanganisa ukukhiqizwa kwemithi, amasekethe ahlanganisiwe, izibonisi ze-CRT, i-LCD, i-OLED kanye ne-micro LED, njll.

Igumbi elihlanzekile lenzelwe ukugcina amazinga aphansi kakhulu ezinhlayiya, njengothuli, izinto eziphilayo eziphefumulayo, noma izinhlayiya eziphefumulayo. Ngokukhethekile, igumbi elihlanzekile linezinga lokungcola elilawulwayo, elichazwa yinani lezinhlayiya ngemitha eyi-cubic ngobukhulu bezinhlayiya ezithile.

Igumbi elihlanzekile lingabhekisela kunoma iyiphi indawo yokubeka lapho kubekwa khona izinyathelo zokunciphisa ukungcoliswa kwezinhlayiya nokulawula ezinye izilinganiso zemvelo ezifana nokushisa, umswakama kanye nengcindezi. Ngomqondo wezokwelapha, igumbi elihlanzekile liyigumbi elihlangabezana nezidingo ze-GMP specifications ezichazwe ku-GMP aseptic specifications. Kuyinhlanganisela yokuklama kobunjiniyela, ukukhiqiza, ukuqeda kanye nokulawula ukusebenza (isu lokulawula) okudingekayo ukuguqula igumbi elivamile libe yigumbi elihlanzekile. Amakamelo ahlanzekile asetshenziswa ezimbonini eziningi, lapho izinhlayiya ezincane zingaba nomthelela omubi enqubweni yokukhiqiza.

Amakamelo ahlanzekile ayahlukahluka ngobukhulu nangobunzima futhi asetshenziswa kabanzi ezimbonini ezifana nokukhiqiza ama-semiconductor, imithi, i-biotechnology, amadivayisi ezokwelapha kanye nesayensi yokuphila, kanye nokukhiqizwa kwezinqubo ezibalulekile ezivamile ezindiza, optics, ezempi kanye noMnyango Wezamandla.

2. Ukuthuthukiswa kwegumbi elihlanzekile

Igumbi lokuhlanza lesimanje lasungulwa yisazi sefiziksi saseMelika uWillis Whitfield. UWhitfield, njengesisebenzi seSandia National Laboratories, waklama umklamo wokuqala wegumbi elihlanzekile ngo-1966. Ngaphambi kokusungulwa kukaWhitfield, igumbi lokuhlanza lokuqala lalivame ukubhekana nezinkinga ngezinhlayiya kanye nokugeleza komoya okungalindelekile.

UWhitfield waklama igumbi elihlanzekile elinomoya ogeleza njalo futhi ohlungiwe ngokuqinile ukuze kugcinwe indawo ihlanzekile. Iningi lezindawo zokukhiqiza izifunda ezihlanganisiwe eSilicon Valley zakhiwe yizinkampani ezintathu: iMicroAire, iPureAire, kanye neKey Plastics. Bakhiqiza amayunithi okugeleza kwe-laminar, amabhokisi amagilavu, amakamelo ahlanzekile kanye neshawa yomoya, kanye namathangi amakhemikhali kanye namabhentshi okusebenzela ekwakhiweni "kwenqubo emanzi" yamasekethe ahlanganisiwe. Lezi zinkampani ezintathu nazo zazingamaphayona ekusetshenzisweni kweTeflon kwezibhamu zomoya, amaphampu amakhemikhali, ama-scrubbers, izibhamu zamanzi, kanye neminye imishini edingekayo ekukhiqizweni kwezifunda ezihlanganisiwe. UWilliam (Bill) C. McElroy Jr. wasebenza njengomphathi wobunjiniyela, umphathi wegumbi lokubhala, i-QA/QC, kanye nomklami wezinkampani ezintathu, futhi imiklamo yakhe yanezela amalungelo obunikazi okuqala angu-45 kubuchwepheshe baleso sikhathi.

3. Izimiso Zokugeleza Komoya Egumbini Elihlanzekile

Amakamelo ahlanzekile alawula izinhlayiya eziphuma emoyeni ngokusebenzisa izihlungi ze-HEPA noma ze-ULPA, kusetshenziswa izimiso zokugeleza komoya ezi-laminar (ukugeleza okuhamba ngendlela eyodwa) noma eziguquguqukayo (ukugeleza okungeyona indlela eyodwa).

Izinhlelo zomoya ezi-laminar noma ezi-one-way ziqondisa umoya ohlungiwe ngokugeleza okuqhubekayo phansi noma ngokuvundlile ezihlungini ezisodongeni eduze kwephansi legumbi elihlanzekile, noma ezijikeleziswa ngamaphaneli aphansi aphakanyisiwe anezimbobo.

Izinhlelo zokugeleza komoya ezithambile zivame ukusetshenziswa ngaphezu kuka-80% wophahla lwegumbi elihlanzekile ukuze kugcinwe umoya ungashintshi. Insimbi engagqwali noma ezinye izinto ezingaphumi zisetshenziselwa ukwakha izihlungi zokugeleza komoya ezithambile kanye nama-hood ukuvimbela izinhlayiya ezengeziwe ukuthi zingangeni emoyeni. Ukugeleza komoya okuguquguqukayo, noma okungaqondile kusebenzisa ama-hood okugeleza komoya athambile kanye nezihlungi zejubane ezingaqondile ukugcina umoya egumbini elihlanzekile ushukuma njalo, yize kungezona zonke eziqonde ohlangothini olufanayo.

Umoya onzima uzama ukubamba izinhlayiya ezingase zibe semoyeni bese uziqhubela phansi, lapho zingena khona esihlungini bese zishiya indawo ehlanzekile yegumbi. Ezinye izindawo zizokwengeza namakamelo ahlanzekile e-vector: umoya unikezwa emakhoneni aphezulu egumbi, kusetshenziswa izihlungi ze-hepa ezimise okwefeni, kanti izihlungi ze-hepa ezijwayelekile zingasetshenziswa nezindawo zokungenisa umoya ezimise okwefeni. Izindawo zokungenisa umoya ezibuyayo zibekwe engxenyeni engezansi yolunye uhlangothi. Isilinganiso sokuphakama nobude begumbi ngokuvamile siphakathi kuka-0.5 no-1. Lolu hlobo lwegumbi elihlanzekile lungaphinde lufinyelele ukuhlanzeka kweSigaba sesi-5 (IsiGaba 100).

Amakamelo ahlanzekile adinga umoya omningi futhi ngokuvamile asezingeni lokushisa elilawulwayo kanye nomswakama. Ukuze kuncishiswe izindleko zokushintsha izinga lokushisa noma umswakama ozungezile, cishe u-80% womoya uyajikeleziswa (uma izici zomkhiqizo zivuma), bese umoya ojikeleziswayo uqala uhlungwe ukuze kususwe ukungcola kwezinhlayiya ngenkathi kugcinwa izinga lokushisa kanye nomswakama ofanele ngaphambi kokudlula egumbini elihlanzekile.

Izinhlayiya eziphuma emoyeni (izinto ezingcolile) ziyantanta. Izinhlayiya eziningi eziphuma emoyeni zihlala kancane kancane, futhi izinga lokuhlala lincike kubukhulu bazo. Uhlelo lokuphatha umoya oluklanywe kahle kufanele lulethe umoya ohlanzekile ohlanzekile ohlanzekile nophinde ujikeleziswe uye ekamelweni elihlanzekile ndawonye, ​​futhi luthwale izinhlayiya kude negumbi elihlanzekile ndawonye. Kuye ngokusebenza, umoya othathwe ekamelweni uvame ukujikeleza ngohlelo lokuphatha umoya, lapho izihlungi zisusa khona izinhlayiya.

Uma inqubo, izinto zokusetshenziswa noma imikhiqizo iqukethe umswakama omningi, umusi noma amagesi ayingozi, lo moya awukwazi ukubuyiselwa ekamelweni. Lo moya uvame ukukhishelwa emoyeni, bese umoya omusha ongu-100% udonswa ohlelweni lwegumbi elihlanzekile bese uphathwa ngaphambi kokungena ekamelweni elihlanzekile.

Inani lomoya ongena egumbini elihlanzekile lilawulwa ngokuqinile, kanti inani lomoya ophelile nalo lilawulwa ngokuqinile. Amakamelo amaningi ahlanzekile acindezelwa, okutholakala ngokungena egumbini elihlanzekile elinomoya ophezulu kunomoya ophelile ekamelweni elihlanzekile. Ukucindezeleka okuphezulu kungabangela ukuthi umoya uphume ngaphansi kweminyango noma ngemifantu emincane noma izikhala ezingenakugwenywa kunoma yiliphi igumbi elihlanzekile. Isihluthulelo sokwakheka kwegumbi elihle elihlanzekile yindawo efanele yokungenisa umoya (ukunikezwa) kanye nokukhipha umoya (ukukhipha umoya).

Uma ubeka igumbi elihlanzekile, indawo yama-grilles okuhambisa kanye nawokukhipha umoya (okubuyisa umoya) kufanele ibe yinto eza kuqala. Ama-grilles okungena (ophahleni) kanye nama-grilles okubuyisa umoya (asezingeni eliphansi) kufanele abekwe ezinhlangothini eziphambene zegumbi elihlanzekile. Uma umqhubi edinga ukuvikelwa kumkhiqizo, ukugeleza komoya kufanele kube kude nomqhubi. I-US FDA kanye ne-EU baneziqondiso eziqinile kakhulu kanye nemikhawulo yokungcoliswa kwamagciwane, futhi ama-plenum phakathi kwesiphathi somoya kanye neyunithi yesihlungi sefeni kanye nama-sticky mat nawo angasetshenziswa. Emakamelweni angenamagciwane adinga umoya we-Class A, ukugeleza komoya kusuka phezulu kuya phansi futhi kuqondiswa ngakunye noma ku-laminar, okuqinisekisa ukuthi umoya awungcoliswanga ngaphambi kokuthi uthinte umkhiqizo.

4. Ukungcoliswa kwegumbi elihlanzekile

Usongo olukhulu ekungcolisweni kwegumbi elihlanzekile luvela kubasebenzisi ngokwabo. Ezimbonini zezokwelapha nezemithi, ukulawulwa kwamagciwane kubaluleke kakhulu, ikakhulukazi amagciwane angase akhishwe esikhumbeni afakwe emoyeni. Ukufunda izitshalo zamagciwane zamakamelo ahlanzekile kubaluleke kakhulu kososayensi bezinto eziphilayo kanye nabasebenzi bokulawula ikhwalithi ukuhlola izitayela ezishintshayo, ikakhulukazi ekuhlolweni kwezinhlobo ezingamelana nemithi kanye nocwaningo lwezindlela zokuhlanza nokubulala amagciwane. Izitshalo zamakamelo ahlanzekile ezijwayelekile zihlobene kakhulu nesikhumba somuntu, futhi kuzoba khona nezinambuzane ezivela kweminye imithombo, njengasemvelweni nasemanzini, kodwa ngobuningi obuncane. Izinhlobo zamagciwane ezivamile zifaka iMicrococcus, Staphylococcus, Corynebacterium kanye neBacillus, kanti izinhlobo zefungal zifaka i-Aspergillus kanye nePenicillium.

Kunezici ezintathu ezibalulekile zokugcina igumbi lihlanzekile.

(1). Ubuso bangaphakathi begumbi elihlanzekile kanye nemishini yalo yangaphakathi

Isimiso siwukuthi ukukhetha izinto kubalulekile, futhi ukuhlanza nokubulala amagciwane nsuku zonke kubaluleke kakhulu. Ukuze kuhambisane ne-GMP futhi kufezwe izidingo zokuhlanzeka, zonke izindawo zegumbi elihlanzekile kufanele zibe bushelelezi futhi zingangeni moya, futhi zingakhiqizi ukungcola kwazo, okungukuthi, akukho uthuli, noma imfucumfucu, ezingamelani nokugqwala, okulula ukuzihlanza, ngaphandle kwalokho kuzohlinzeka ngendawo yokuzala kwamagciwane, futhi indawo kufanele ibe namandla futhi ihlale isikhathi eside, futhi ayikwazi ukuqhekeka, ukuphuka noma ukuqhekeka. Kunezinhlobonhlobo zezinto ongakhetha kuzo, kufaka phakathi amaphaneli abizayo e-dagad, ingilazi, njll. Ukukhetha okuhle kakhulu nokuhle kakhulu ingilazi. Ukuhlanza nokubulala amagciwane njalo kufanele kwenziwe ngokuhambisana nezidingo zamakamelo ahlanzekile kuwo wonke amazinga. Imvamisa ingaba ngemva kokusebenza ngakunye, izikhathi eziningi ngosuku, nsuku zonke, njalo ezinsukwini ezimbalwa, kanye ngesonto, njll. Kunconywa ukuthi itafula lokusebenza kufanele lihlanzwe futhi lihlanzwe amagciwane ngemva kokusebenza ngakunye, phansi kufanele lihlanzwe amagciwane nsuku zonke, udonga kufanele luhlanzwe amagciwane njalo ngesonto, futhi indawo kufanele ihlanzwe futhi ihlanzwe amagciwane njalo ngenyanga ngokwezinga legumbi elihlanzekile kanye nezindinganiso ezibekiwe kanye nemininingwane, futhi amarekhodi kufanele agcinwe.

(2). Ukulawulwa komoya egumbini elihlanzekile

Ngokuvamile, kuyadingeka ukukhetha umklamo wegumbi elihlanzekile ofanele, ukwenza ukulungiswa njalo, nokwenza ukuqapha kwansuku zonke. Kufanele kuqashelwe ngokukhethekile ukuqapha amabhaktheriya antantayo emakamelweni ahlanzekile emithi. Amabhaktheriya antantayo esikhaleni akhishwa yisampula yamabhaktheriya antantayo ukuze kukhishwe umoya othile esikhaleni. Ukuhamba komoya kudlula esitsheni sokuxhumana esigcwele indawo ethile yokukhulisa. Isitsha sokuxhumana sizobamba ama-microorganism, bese isitsha sifakwa ku-incubator ukuze kubalwe inani lamakholoni futhi kubalwe inani lama-microorganism esikhaleni. Ama-microorganisms asengqimbeni ye-laminar nawo kudingeka atholakale, kusetshenziswa isampula yama-bacteria antantayo esengqimbeni ye-laminar ehambisanayo. Umgomo wokusebenza ufana nowokuthatha isampula sesikhala, ngaphandle kokuthi indawo yokuthatha isampula kumele ibekwe kusendlalelo se-laminar. Uma kudingeka umoya ocindezelwe ekamelweni elihlanzekile, kuyadingeka futhi ukwenza ukuhlolwa kwama-microbial emoyeni ocindezelwe. Usebenzisa i-detector yomoya ocindezelwe ehambisanayo, umfutho womoya womoya ocindezelwe kumele ulungiswe ube nobubanzi obufanele ukuvimbela ukubhujiswa kwama-microorganism kanye nemidiya yokukhulisa.

(3). Izidingo zabasebenzi egumbini elihlanzekile

Abasebenzi abasebenza emakamelweni ahlanzekile kumele bathole ukuqeqeshwa njalo ngethiyori yokulawula ukungcola. Bangena futhi baphume ekamelweni elihlanzekile ngezingidi zomoya, amashawa omoya kanye/noma amakamelo okushintsha, futhi kumele bagqoke izingubo eziklanyelwe ngokukhethekile ukumboza isikhumba kanye nokungcola okuvela ngokwemvelo emzimbeni. Kuye ngokuhlukaniswa noma umsebenzi wegumbi elihlanzekile, izingubo zabasebenzi zingadinga kuphela ukuvikelwa okulula njengezingubo zelebhu kanye nama-hood, noma zingase zimbozwe ngokuphelele futhi zingavezi noma yisiphi isikhumba. Izingubo zasekamelweni ezihlanzekile zisetshenziselwa ukuvimbela izinhlayiya kanye/noma ama-microorganisms ukuthi akhishwe emzimbeni womuntu ogqokile futhi angcolise imvelo.

Izingubo zasekamelweni ezihlanzekile ngokwazo akumele zikhiphe izinhlayiya noma imicu ukuvimbela ukungcoliswa kwemvelo. Lolu hlobo lokungcola kwabasebenzi lunganciphisa ukusebenza komkhiqizo embonini ye-semiconductor kanye neyemithi, futhi lungaholela ekuthelelekeni okuhlukahlukene phakathi kwabasebenzi bezokwelapha kanye neziguli embonini yezempilo, isibonelo. Imishini yokuvikela yasekamelweni ehlanzekile ihlanganisa izingubo zokuzivikela, amabhuzu, izicathulo, ama-apron, izembozo zentshebe, izigqoko eziyindilinga, imaski, izingubo zomsebenzi/amajazi elebhu, amagawuni, amagilavu ​​​​nemibhede yeminwe, imikhono kanye nezembozo zezicathulo nezicathulo. Uhlobo lwezingubo zasekamelweni ezihlanzekile ezisetshenziswayo kufanele lubonise isigaba segumbi elihlanzekile kanye nomkhiqizo. Amakamelo ahlanzekile asezingeni eliphansi angadinga izicathulo ezikhethekile ezinezithende ezibushelelezi ngokuphelele ezingeke zime othulini noma odakeni. Kodwa-ke, ngenxa yezizathu zokuphepha, izithende zezicathulo azikwazi ukubangela ingozi yokushelela. Izingubo zasekamelweni ezihlanzekile ngokuvamile ziyadingeka ukuze kungene ekamelweni elihlanzekile. Amajazi alula elebhu, izembozo zekhanda nezembozo zezicathulo zingasetshenziswa ekamelweni elihlanzekile leKlasi 10,000. Ekamelweni elihlanzekile leKlasi 100, kudingeka izimbozo zomzimba wonke, izingubo zokuzivikela ezineziphu, amazibuko, imaski, amagilavu ​​​​nezembozo zebhuthi. Ngaphezu kwalokho, inani labantu egumbini elihlanzekile kufanele lilawulwe, ngokwesilinganiso esingu-4 kuya ku-6 m2/umuntu, futhi umsebenzi kufanele ube mnene, ugweme ukunyakaza okukhulu nokusheshayo.

5. Izindlela zokubulala amagciwane ezisetshenziswa kakhulu ekamelweni elihlanzekile

(1). Ukubulala amagciwane nge-UV

(2). Ukubulala amagciwane nge-ozone

(3). Ukubulala amagciwane ngegesi Izinto zokubulala amagciwane zifaka i-formaldehyde, i-epoxyethane, i-peroxyacetic acid, i-carbolic acid kanye nezingxube ze-lactic acid, njll.

(4) Izibulali-magciwane

Izibulali-magciwane ezivamile zifaka phakathi i-isopropyl alcohol (75%), i-ethanol (75%), i-glutaraldehyde, i-Chlorhexidine, njll. Indlela yendabuko yokubulala amagciwane emakamelweni angenamagciwane ezimbonini zemithi zaseShayina ukusebenzisa i-formaldehyde fumigation. Izimboni zemithi zakwamanye amazwe zikholelwa ukuthi i-formaldehyde inomonakalo othile emzimbeni womuntu. Manje ngokuvamile zisebenzisa i-glutaraldehyde spray. Isibulali-magciwane esisetshenziswa emakamelweni angenamagciwane kumele sihlanzwe futhi sihlungwe nge-membrane yesihlungi esingu-0.22μm ekhabetheni lokuphepha lezinto eziphilayo.

6. Ukuhlukaniswa kwegumbi elihlanzekile

Igumbi elihlanzekile lihlukaniswa ngokwenani nosayizi wezinhlayiya ezivunyelwe ngomthamo womoya. Izinombolo ezinkulu ezifana ne-"Class 100" noma "Class 1000" zibhekisela ku-FED-STD-209E, okubonisa inani lezinhlayiya ezingu-0.5μm noma ezinkulu ezivunyelwe ngonyawo olulodwa lomoya. Indinganiso iphinde ivumele ukufakwa kwe-interpolation; isibonelo, i-SNOLAB igcinwa ekamelweni elihlanzekile le-Class 2000. Izibali zezinhlayiya zomoya ezihlakazekayo ezihlukanisayo zisetshenziselwa ukunquma ukuhlushwa kwezinhlayiya ezisemoyeni ezilingana noma ezinkulu kunosayizi ocacisiwe endaweni ethile yokuthatha isampula.

Inani ledesimali libhekisela ku-ISO 14644-1 standard, echaza i-decimal logarithm yenani lezinhlayiya ezingu-0.1μm noma ngaphezulu ezivunyelwe nge-cubic meter ngayinye yomoya. Ngakho-ke, isibonelo, igumbi elihlanzekile le-ISO Class 5 linomkhawulo wezinhlayiya ezingu-105/m3. Zombili i-FS 209E kanye ne-ISO 14644-1 zicabanga ukuthi kukhona ubudlelwano be-logarithmic phakathi kosayizi wezinhlayiya kanye nokuhlushwa kwezinhlayiya. Ngakho-ke, ukuhlushwa kwezinhlayiya ezingu-zero akukho. Amanye amakilasi awadingi ukuhlolwa kosayizi bezinhlayiya ezithile ngoba ukuhlushwa kuphansi kakhulu noma kuphakeme kakhulu ukuba kube wusizo, kodwa izikhala ezinjalo akufanele zibhekwe njengezinga-zero. Njengoba i-1m3 ingama-cubic feet angaba ngu-35, lezi zindinganiso ezimbili zilingana cishe uma kulinganiswa izinhlayiya ezingu-0.5μm. Umoya ojwayelekile wangaphakathi cishe u-Class 1,000,000 noma i-ISO 9.

I-ISO 14644-1 kanye ne-ISO 14698 yizindinganiso ezingekho ngaphansi kukahulumeni ezithuthukiswe yi-International Organisation for Standardization (ISO). Eyokuqala isebenza ekamelweni elihlanzekile ngokujwayelekile; eyesibili isebenza ekamelweni elihlanzekile lapho ukungcola okungokwemvelo kungaba yinkinga khona.

Izinhlangano ezilawulayo zamanje zifaka: i-ISO, i-USP 800, i-US Federal Standard 209E (izinga elidlule, lisasetshenziswa) UMthetho Wekhwalithi Nokuphepha Kwezidakamizwa (i-DQSA) wasungulwa ngoNovemba 2013 ukuze kulungiswe ukufa okwandisa izidakamizwa kanye nezenzakalo ezimbi kakhulu. UMthetho Wezokudla, Izidakamizwa, Nobuhle Kahulumeni (uMthetho we-FD&C) usungula iziqondiso nezinqubomgomo ezithile zemithi yabantu. I-503A iqondiswa ngabasebenzi abagunyaziwe (osokhemisi/odokotela) yizinhlangano ezigunyaziwe zikahulumeni noma zikahulumeni. I-503B ihlobene nokunikeza izikhungo zangaphandle futhi idinga ukubhekwa ngqo ngusokhemisi onelayisensi futhi akudingeki ukuthi ibe yikhemisi elinelayisensi. Izikhungo zithola amalayisense nge-Food and Drug Administration (FDA).

Iziqondiso ze-EU GMP ziqinile kunezinye iziqondiso futhi zidinga indawo ehlanzekile ukuze kufezwe ukubalwa kwezinhlayiya lapho kusebenza (ngesikhathi sokukhiqiza) kanye nalapho kuphumulile (lapho kungekho mkhiqizo owenzekayo kodwa igumbi le-AHU livuliwe).

8. Imibuzo evela kwabaqalayo kwelebhu

(1). Ungena futhi uphume kanjani egumbini elihlanzekile? Abantu nezimpahla bangena futhi baphume ngezindlela zokungena neziphuma ezahlukene. Abantu bangena futhi baphume ngezikhiye zomoya (abanye baneshawa zomoya) noma abangenazo izikhiye zomoya futhi bagqoka imishini yokuzivikela efana nama-hood, imaski, amagilavu, amabhuzu nezingubo zokuzivikela. Lokhu kwenzelwa ukunciphisa nokuvimba izinhlayiya ezilethwa abantu abangena egumbini elihlanzekile. Izimpahla zingena futhi ziphume ekamelweni elihlanzekile ngomzila wezimpahla.

(2). Ingabe kukhona okukhethekile mayelana nomklamo wegumbi elihlanzekile? Ukukhetha izinto zokwakha igumbi elihlanzekile akufanele kukhiqize noma yiziphi izinhlayiya, ngakho-ke ukugqoka phansi kwe-epoxy noma i-polyurethane kuyathandwa. Kusetshenziswa amaphaneli okuhlukanisa i-sandwich yensimbi engagqwali epholishiwe noma embozwe nge-powder-coated mild steel kanye namaphaneli ophahla. Amakhona ane-engeli yesokudla agwenywa yizindawo ezigobile. Wonke amajoyinti kusukela ekhoneni kuya phansi kanye nekhoneni kuya ophahleni kudingeka avalwe nge-epoxy sealant ukuze kugwenywe noma yikuphi ukufakwa kwezinhlayiya noma ukwakheka kwamalunga. Imishini esegumbini elihlanzekile yenzelwe ukukhiqiza ukungcola komoya okuncane. Sebenzisa kuphela ama-mop namabhakede enziwe ngokukhethekile. Ifenisha yegumbi elihlanzekile kufanele futhi iklanywe ukukhiqiza izinhlayiya ezincane futhi kube lula ukuyihlanza.

(3). Ungayikhetha kanjani i-disinfectant efanele? Okokuqala, kufanele kwenziwe ukuhlaziywa kwemvelo ukuqinisekisa uhlobo lwe-microorganisms ezingcolisiwe ngokuqapha kwemvelo. Isinyathelo esilandelayo ukuthola ukuthi iyiphi i-disinfectant engabulala inani elaziwayo le-microorganisms. Ngaphambi kokwenza ukuhlolwa kokubulala ngesikhathi sokuxhumana (indlela yokuxuba ithubhu yokuhlola noma indlela yezinto eziphezulu) noma ukuhlolwa kwe-AOAC, i-disinfectant ekhona idinga ukuhlolwa futhi iqinisekiswe ukuthi ifanelekile. Ukuze kubulawe i-microorganisms ekamelweni elihlanzekile, ngokuvamile kunezinhlobo ezimbili zezindlela zokujikeleza i-disinfectant: ① Ukujikeleza kwe-disinfectant eyodwa kanye ne-sporicide eyodwa, ② Ukujikeleza kwe-disinfectant ezimbili kanye ne-sporicide eyodwa. Ngemva kokuthi uhlelo lokubulala amagciwane selutholakele, ukuhlolwa kokusebenza kwe-bacterial kungenziwa ukuze kunikezwe isisekelo sokukhethwa kwe-disinfectant. Ngemva kokuqeda ukuhlolwa kokusebenza kwe-bacterial, kudingeka ukuhlolwa kwesifundo sensimu. Lena yindlela ebalulekile yokufakazela ukuthi i-SOP yokuhlanza kanye ne-disinfecting kanye nokuhlolwa kokusebenza kwe-bacterial kwe-disinfectant kusebenza kahle. Ngokuhamba kwesikhathi, ama-microorganisms angakatholakali ngaphambili angavela, futhi izinqubo zokukhiqiza, abasebenzi, njll. nazo zingashintsha, ngakho-ke ama-SOP okuhlanza nokubulala amagciwane kudingeka abuyekezwe njalo ukuqinisekisa ukuthi asasebenza yini endaweni yamanje.

(4). Ama-corridor ahlanzekile noma ama-corridor angcolile? Ama-powder afana namathebulethi noma ama-capsule ayi-corridor ahlanzekile, kuyilapho imithi engcolile, imithi ewuketshezi, njll. kuyi-corridor engcolile. Ngokuvamile, imikhiqizo yemithi enomswakama ophansi njengamathebulethi noma ama-capsule ayomile futhi inothuli, ngakho-ke kunethuba elikhulu lengozi enkulu yokungcoliswa okuphambene. Uma umehluko wokucindezela phakathi kwendawo ehlanzekile ne-corridor ulungile, i-powder izophuma ekamelweni iye e-corridor bese cishe idluliselwa ekamelweni elilandelayo elihlanzekile. Ngenhlanhla, amalungiselelo amaningi omile awasekeli kalula ukukhula kwamagciwane, ngakho-ke njengomthetho ojwayelekile, amathebulethi nama-powder akhiqizwa ezindaweni ezihlanzekile ze-corridor ngoba ama-microorganism antantayo e-corridor awakwazi ukuthola indawo lapho angachuma khona. Lokhu kusho ukuthi igumbi linengcindezi engemihle e-corridor. Emikhiqizweni yemithi engcolile (ecutshunguliwe), e-aseptic noma ephansi ye-bioburden kanye ne-liquid, ama-microorganism avame ukuthola amasiko asekelayo lapho angachuma khona, noma esimweni semikhiqizo ecutshunguliwe engcolile, i-microorganism eyodwa ingaba yinhlekelele. Ngakho-ke, lezi zikhungo zivame ukwakhiwa ngama-corridor angcolile ngoba inhloso iwukugcina ama-microorganism angaba khona engangeni ekamelweni elihlanzekile.

uhlelo lwegumbi elihlanzekile
igumbi elihlanzekile lekilasi elingu-10000
igumbi elihlanzekile lekilasi le-100

Isikhathi sokuthunyelwe: Feb-20-2025