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YIZIPHI IZINDINGANISO ZEGUMBI LOKUHLANZA LEKLASI A, B, C NO-D?

igumbi elihlanzekile lekilasi A
igumbi elihlanzekile lekilasi B

Igumbi elihlanzekile libhekisela endaweni evalwe kahle lapho imingcele efana nokuhlanzeka komoya, izinga lokushisa, umswakama, ingcindezi, nomsindo kulawulwa khona njengoba kudingeka. Amakamelo ahlanzekile asetshenziswa kabanzi ezimbonini zobuchwepheshe obuphezulu njenge-semiconductors, i-electronics, imithi, izindiza, izindiza kanye ne-biomedicine. Ngokusho kwenguqulo ka-2010 ye-GMP, imboni yemithi ihlukanisa izindawo ezihlanzekile zibe amazinga amane: A, B, C, kanye no-D ngokusekelwe ezinkombeni ezifana nokuhlanzeka komoya, ingcindezi yomoya, ivolumu yomoya, izinga lokushisa kanye nomswakama, umsindo, kanye nokuqukethwe kwamagciwane.

Igumbi elihlanzekile lekilasi A

Igumbi elihlanzekile le-Class A, elaziwa nangokuthi igumbi elihlanzekile le-class 100 noma igumbi elihlanzekile kakhulu, lingenye yegumbi elihlanzekile kakhulu. Lingalawula inani lezinhlayiya nge-cubic foot emoyeni libe ngaphansi kwama-35.5, okungukuthi, inani lezinhlayiya ezingaphezu noma ezilingana no-0.5um nge-cubic meter yomoya alikwazi ukudlula ama-3,520 (aqinile futhi aguquguqukayo). 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. Igumbi elihlanzekile le-Class A liyizindawo zokusebenza ezinobungozi obukhulu. Njengendawo yokugcwalisa, indawo lapho imiphongolo yerabha yokumisa kanye nezitsha zokupakisha ezivulekile ezithintana ngqo namalungiselelo ahlanzekile, kanye nendawo yokuhlanganisa noma ukuxhumanisa okungaphephile. Isetshenziswa kakhulu ekucubungulweni kwe-microelectronics, i-biopharmaceuticals, ukukhiqizwa kwezinsimbi ezinembile, izindiza kanye neminye imikhakha.

Igumbi elihlanzekile lekilasi B

Igumbi elihlanzekile le-Class B libizwa nangokuthi igumbi elihlanzekile le-Class 100. Izinga lalo lokuhlanzeka liphansi kakhulu, futhi inani lezinhlayiya ezingaphezu kuka-0.5um nge-cubic meter yomoya livunyelwe ukufinyelela ku-3520 (static) 35,2000 (dynamic). Izihlungi ze-Hepa kanye nezinhlelo zokukhipha umoya zisetshenziselwa ukulawula umswakama, izinga lokushisa kanye nomehluko wokucindezela kwendawo yangaphakathi. Igumbi elihlanzekile le-Class B libhekisela endaweni yangemuva lapho kutholakala khona indawo ehlanzekile ye-class A yemisebenzi enobungozi obukhulu njengokulungiselela nokugcwalisa i-aseptic. Isetshenziswa kakhulu kwezokwelapha nge-biomedicine, ekukhiqizeni imithi, emishinini enembile kanye nasekukhiqizeni amathuluzi nakwezinye izinkambu.

Igumbi elihlanzekile lekilasi C

Igumbi elihlanzekile le-Class C libizwa nangokuthi igumbi elihlanzekile le-class 10,000. Izinga lalo lokuhlanzeka liphansi kakhulu, futhi inani lezinhlayiya ezingaphezu noma ezilingana no-0.5um nge-cubic meter yomoya livunyelwe ukufinyelela ku-352,000 (static) 352,0000 (dynamic). Izihlungi ze-Hepa, ukulawula ukucindezela okuhle, ukujikeleza komoya, ukulawula izinga lokushisa nomswakama kanye nobunye ubuchwepheshe kusetshenziswa ukufeza amazinga abo okuhlanzeka athile. Igumbi elihlanzekile le-Class C lisetshenziswa kakhulu kwezemithi, ekukhiqizeni amadivayisi ezokwelapha, emishinini enembile kanye nasekukhiqizeni izingxenye ze-elekthronikhi nakwezinye izinkambu.

Igumbi elihlanzekile lekilasi D

Igumbi elihlanzekile le-Class D libizwa nangokuthi igumbi elihlanzekile le-class 100,000. Izinga lalo lokuhlanzeka liphansi kakhulu, okuvumela izinhlayiya ezingu-3,520,000 ezinkulu noma ezilingana no-0.5um nge-cubic meter yomoya (static). Izihlungi ezijwayelekile ze-hepa kanye nezinhlelo zokulawula ukucindezela okuhle kanye nokujikeleza komoya ngokuvamile zisetshenziselwa ukulawula indawo yangaphakathi. Igumbi elihlanzekile le-Class D lisetshenziswa kakhulu ekukhiqizweni kwezimboni okujwayelekile, ekucubungulweni kokudla nasekupakishweni, ekunyatheliseni, ekugcinweni kwempahla nakwezinye izinkambu.

Amazinga ahlukene amakamelo ahlanzekile anobubanzi bawo bokusetshenziswa futhi akhethwa futhi asetshenziswa 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.

igumbi lokuhlanza lekilasi C
igumbi lokuhlanza lekilasi D

Isikhathi sokuthunyelwe: Juni-27-2025