Igumbi elihlanzekile liyindawo elawulwa ngokukhethekile lapho izinto ezifana nenani lezinhlayiya emoyeni, umswakama, izinga lokushisa kanye nogesi ongashintshi zingalawulwa khona ukuze kufezwe amazinga athile okuhlanza. Amakamelo ahlanzekile asetshenziswa kabanzi ezimbonini zobuchwepheshe obuphezulu njenge-semiconductors, i-electronics, imithi, izindiza, izindiza kanye ne-biomedicine.
Ezimisweni zokuphathwa kokukhiqiza imithi, igumbi elihlanzekile lihlukaniswe amazinga amane: A, B, C kanye no-D.
Isigaba A: Izindawo zokusebenza ezinobungozi obukhulu, njengezindawo zokugcwalisa, izindawo lapho imiphongolo yerabha kanye nezitsha zokupakisha ezivulekile zithintana ngqo namalungiselelo ahlanzekile, kanye nezindawo lapho kwenziwa khona imisebenzi yokuhlanganisa noma yokuxhumanisa, kufanele ifakwe itafula lokusebenza lokugeleza eliqondiswe ohlangothini olulodwa ukuze kulondolozwe isimo sendawo. Uhlelo lokugeleza oluqondiswe ohlangothini olulodwa kumele lunikeze umoya ngokulinganayo endaweni yalo yokusebenza ngesivinini somoya esingu-0.36-0.54m/s. Kufanele kube nedatha yokufakazela isimo sokugeleza okuqondiswe ohlangothini olulodwa futhi kuqinisekiswe. Ku-opharetha ovaliwe, ohlukanisiwe noma ebhokisini lamagilavu, isivinini somoya esiphansi singasetshenziswa.
Isigaba B: sibhekisela endaweni engemuva lapho kutholakala khona indawo ehlanzekile yesigaba A yemisebenzi enobungozi obukhulu njengokulungiselela nokugcwalisa i-aseptic.
Isigaba C no-D: sibhekisela ezindaweni ezihlanzekile ezinezinyathelo ezingabalulekile kangako ekukhiqizweni kwemikhiqizo yemithi engcolile.
Ngokwemithethonqubo ye-GMP, imboni yezokwelapha yezwe lami ihlukanisa izindawo ezihlanzekile zibe amazinga ama-4 e-ABCD njengoba kushiwo ngenhla ngokusekelwe ezinkombeni ezifana nokuhlanzeka komoya, umfutho womoya, umthamo womoya, izinga lokushisa kanye nomswakama, umsindo kanye nokuqukethwe kwamagciwane.
Amazinga ezindawo ezihlanzekile ahlukaniswe ngokwezinga lezinhlayiya ezilenga emoyeni. Ngokuvamile, uma inani lincane, izinga lokuhlanzeka liyanda.
1. Ukuhlanzeka komoya kubhekisela kusayizi kanye nenani lezinhlayiya (kufaka phakathi ama-microorganisms) eziqukethwe emoyeni ngeyunithi ngayinye yesikhala, okuyindinganiso yokuhlukanisa izinga lokuhlanzeka kwendawo.
I-Static ibhekisela esimweni ngemva kokuba uhlelo lokupholisa umoya oluhlanzekile lwegumbi selufakiwe futhi lusebenza ngokugcwele, futhi abasebenzi begumbi elihlanzekile sebephumile endaweni futhi bazihlanza imizuzu engama-20.
I-Dynamic isho ukuthi igumbi elihlanzekile lisesimweni esijwayelekile sokusebenza, imishini isebenza kahle, futhi abasebenzi abaqokiwe basebenza ngokwezimfuneko.
2. Izinga lokulinganisa le-ABCD livela ku-GMP emenyezelwe yi-World Health Organization (WHO), okuyincazelo evamile yokuphathwa kwekhwalithi yokukhiqizwa kwemithi embonini yemithi. Njengamanje isetshenziswa ezifundeni eziningi emhlabeni jikelele, okuhlanganisa i-European Union kanye ne-China.
Inguqulo endala yaseShayina ye-GMP ilandele izindinganiso zokuhlola zaseMelika (isigaba 100, isigaba 10,000, isigaba 100,000) kwaze kwaba yilapho kuqaliswa inguqulo entsha yezindinganiso ze-GMP ngo-2011. Imboni yezokwelapha yaseShayina isiqalile ukusebenzisa izindinganiso zokuhlukanisa ze-WHO futhi isebenzisa i-ABCD ukuhlukanisa amazinga ezindawo ezihlanzekile.
Ezinye izindinganiso zokuhlukaniswa kwegumbi elihlanzekile
Igumbi elihlanzekile linezindinganiso ezahlukene zokuhlola ezifundeni nasezimbonini ezahlukene. Izindinganiso ze-GMP zethulwe ngaphambilini, futhi lapha sethula kakhulu amazinga aseMelika kanye nezindinganiso ze-ISO.
(1). I-American Standard
Umqondo wokubeka izinga legumbi elihlanzekile wahlongozwa okokuqala yi-United States. Ngo-1963, kwaqalwa indinganiso yokuqala kahulumeni yengxenye yezempi yegumbi elihlanzekile: i-FS-209. Izindinganiso ezijwayelekile zekilasi 100, zekilasi 10000 kanye nezekilasi 100000 zonke zithathwe kule ndinganiso. Ngo-2001, i-United States yayeka ukusebenzisa indinganiso ye-FS-209E yaqala ukusebenzisa indinganiso ye-ISO.
(2). Izindinganiso ze-ISO
Izindinganiso ze-ISO ziphakanyiswa yi-International Organisation for Standardization ISO futhi zihlanganisa izimboni eziningi, hhayi imboni yezokwelapha kuphela. Kunezigaba eziyisishiyagalolunye kusukela esigabeni 1 kuya esigabeni 9. Phakathi kwazo, isigaba 5 silingana nesigaba B, isigaba 7 silingana nesigaba C, kanti isigaba 8 silingana nesigaba D.
(3). Ukuqinisekisa izinga lendawo ehlanzekile yeKlasi A, umthamo wesampula wendawo ngayinye yokuthatha isampula akufanele ube ngaphansi kwe-1 cubic meter. Izinga lezinhlayiya ezisemoyeni ezindaweni ezihlanzekile zeKlasi A yi-ISO 5, nezinhlayiya ezilengisiwe ≥5.0μm njengendinganiso elinganiselwe. Izinga lezinhlayiya ezisemoyeni endaweni ehlanzekile yeKlasi B (static) yi-ISO 5, futhi lifaka izinhlayiya ezilengisiwe ezinobukhulu obubili etafuleni. Ezindaweni ezihlanzekile zeKlasi C (static kanye ne-dynamic), amazinga ezinhlayiya ezisemoyeni yi-ISO 7 kanye ne-ISO 8 ngokulandelana. Ezindaweni ezihlanzekile zeKlasi D (static) izinga lezinhlayiya ezisemoyeni yi-ISO 8.
(4). Uma kuqinisekiswa izinga, kufanele kusetshenziswe ikhawunta yezinhlayiya zothuli ephathekayo enethubhu elifushane lokuhlola isampula ukuvimbela izinhlayiya ezilengayo ezingama-≥5.0μm ukuthi zingahlali ethubhini elide lokuhlola isampula lohlelo lokuhlola isampula olukude. Ezinhlelweni zokugeleza eziqondiswe ohlangothini olulodwa, kufanele kusetshenziswe amakhanda okuhlola isampula e-isokinetic.
(5) Ukuhlolwa okunamandla kungenziwa ngesikhathi sokusebenza okuvamile kanye nezinqubo zokugcwalisa ezilingisiwe ze-culture medium ukuze kuqinisekiswe ukuthi izinga lokuhlanzeka okunamandla liyafinyelelwa, kodwa ukuhlolwa kokugcwalisa okulingisiwe kwe-culture medium kudinga ukuhlolwa okunamandla ngaphansi "kwesimo esibi kakhulu".
Igumbi elihlanzekile lekilasi A
Igumbi elihlanzekile le-Class A, elaziwa nangokuthi igumbi elihlanzekile le-class 100 noma igumbi elihlanzekile kakhulu, lingenye yamakamelo ahlanzekile kakhulu anokuhlanzeka okuphezulu kakhulu. Lingalawula inani lezinhlayiya nge-cubic foot emoyeni libe ngaphansi kuka-35.5, okungukuthi, inani lezinhlayiya ezingaphezu noma ezilingana no-0.5um kumitha ngayinye ye-cubic yomoya alikwazi ukudlula u-3,520 (ongaguquki futhi oguquguqukayo). Igumbi elihlanzekile le-Class A linezidingo eziqinile kakhulu futhi lidinga ukusetshenziswa kwezihlungi ze-hepa, ukulawulwa kokucindezela okuhlukile, izinhlelo zokujikeleza komoya kanye nezinhlelo zokulawula izinga lokushisa nomswakama ezihlala njalo ukuze kufezwe izidingo zazo zokuhlanzeka okuphezulu. Amakamelo ahlanzekile e-Class A asetshenziswa kakhulu ekucubungulweni kwe-microelectronics, i-biopharmaceuticals, ukukhiqizwa kwezinsimbi ezinembile, izindiza kanye neminye imikhakha.
Igumbi elihlanzekile lekilasi B
Amakamelo ahlanzekile ekilasi B abizwa nangokuthi amakamelo ahlanzekile ekilasi 1000. Izinga lawo lokuhlanzeka liphansi kakhulu, okuvumela inani lezinhlayiya ezingaphezu noma ezilingana no-0.5um ngemitha eyi-cubic yomoya ukuthi zifinyelele ku-3520 (static) kanye no-352000 (dynamic). Amakamelo ahlanzekile ekilasi B avame ukusebenzisa izihlungi ezisebenza kahle kakhulu kanye nezinhlelo zokukhipha umoya ukulawula umswakama, izinga lokushisa kanye nomehluko wokucindezela kwendawo yangaphakathi. Amakamelo ahlanzekile ekilasi B asetshenziswa kakhulu kwezokwelapha ngemithi, ekukhiqizeni imithi, emishinini enembile kanye nasekukhiqizeni amathuluzi kanye neminye imikhakha.
Igumbi elihlanzekile lekilasi C
Amakamelo ahlanzekile ekilasi C abizwa nangokuthi amakamelo ahlanzekile ekilasi 10,000. Izinga lawo lokuhlanzeka liphansi kakhulu, okuvumela inani lezinhlayiya ezingaphezu noma ezilingana no-0.5um ngemitha eyi-cubic yomoya ukuthi zifinyelele ku-352,000 (ezimile) kanye no-352,0000 (eziguquguqukayo). Amakamelo ahlanzekile ekilasi C avame ukusebenzisa izihlungi ze-hepa, ukulawula ukucindezela okuhle, ukujikeleza komoya, ukulawula izinga lokushisa kanye nomswakama kanye nobunye ubuchwepheshe ukuze kufezwe amazinga awo okuhlanzeka athile. Amakamelo ahlanzekile ekilasi C asetshenziswa kakhulu emithini yezokwelapha, ekukhiqizeni amadivayisi ezokwelapha, emishinini enembile kanye nasekukhiqizeni izingxenye ze-elekthronikhi nakwezinye izinkambu.
Igumbi elihlanzekile lekilasi D
Amakamelo ahlanzekile ekilasi D abizwa nangokuthi amakamelo ahlanzekile ekilasi 100,000. Izinga lawo lokuhlanzeka liphansi kakhulu, okuvumela inani lezinhlayiya ezingaphezu noma ezilingana no-0.5um ngemitha eyi-cubic yomoya ukuthi zifinyelele ku-3,520,000 (ezimile). Amakamelo ahlanzekile ekilasi D avame ukusebenzisa izihlungi ze-hepa ezijwayelekile kanye nezinhlelo zokulawula ukucindezela okuhle kanye nokujikeleza komoya ukulawula indawo yangaphakathi. Amakamelo ahlanzekile ekilasi D asetshenziswa kakhulu ekukhiqizweni kwezimboni okujwayelekile, ekucubungulweni nasekupakishweni kokudla, ekunyatheliseni, ekugcinweni kwempahla nakwezinye izinkambu.
Amazinga ahlukene amakamelo ahlanzekile anobubanzi bawo bokusetshenziswa, okufanele akhethwe ngokwezidingo zangempela. Ezisetshenzisweni ezisebenzayo, ukulawulwa kwemvelo kwamakamelo ahlanzekile kuwumsebenzi obaluleke kakhulu, ohilela ukucatshangelwa okubanzi kwezinto eziningi. Umklamo nokusebenza kwesayensi nokunengqondo kuphela okungaqinisekisa ikhwalithi nokuzinza kwendawo ehlanzekile yamakamelo.
Isikhathi sokuthunyelwe: Mashi-07-2024