Igumbi elihlanzekile liyindawo elawulwa ngokukhethekile lapho izici ezifana nenani lezinhlayiya ezisemoyeni, umswakama, izinga lokushisa kanye nogesi omile zingalawulwa ukuze kuzuzwe izindinganiso ezithile zokuhlanza. Amakamelo ahlanzekile asetshenziswa kakhulu ezimbonini zobuchwepheshe obuphezulu ezifana nama-semiconductors, electronics, pharmaceuticals, ezondiza, i-aerospace kanye ne-biomedicine.
Ezicacisweni zokulawulwa kokukhiqizwa kwemithi, igumbi elihlanzekile lihlukaniswe ngamaleveli angu-4: A, B, C kanye no-D.
Ikilasi A: Izindawo zokusebenza ezinobungozi obukhulu, njengezindawo zokugcwalisa, izindawo lapho imiphongolo yokuvimba irabha neziqukathi zokupakisha ezivulekile zithintana ngqo namalungiselelo angenalutho, nezindawo lapho ukuhlanganiswa kwe-aseptic noma ukuxhumeka kwenziwa khona, kufanele kufakwe ithebula lokusebenza lokugeleza okukodwa. ukugcina isimo semvelo saleyo ndawo. Isistimu yokugeleza kwe-unidirectional kufanele inikeze umoya ngokulinganayo endaweni yayo yokusebenza ngesivinini somoya esingu-0.36-0.54m/s. Kufanele kube nedatha yokuqinisekisa isimo sokugeleza kwe-unidirectional futhi iqinisekiswe. Ku-opharetha evaliwe, eyedwa noma ibhokisi legilavu, isivinini somoya esiphansi singasetshenziswa.
Ikilasi B: libhekisela endaweni engemuva lapho indawo ehlanzekile yekilasi A itholakala khona ukuze kwenziwe imisebenzi enobungozi obufana nokulungiswa nokugcwaliswa kwe-aseptic.
I-Class C kanye no-D: ibhekisela ezindaweni ezihlanzekile ezinezinyathelo ezingabalulekile ekukhiqizeni imikhiqizo yemithi eyinyumba.
Ngokwemithetho ye-GMP, imboni yezemithi yezwe lami ihlukanisa izindawo ezihlanzekile zibe amazinga angu-4 e-ABCD njengenhla ngokusekelwe ezinkomba ezifana nokuhlanzeka komoya, umfutho womoya, umthamo womoya, izinga lokushisa kanye nomswakama, umsindo kanye ne-microbial content.
Amazinga ezindawo ezihlanzekile ahlukaniswa ngokuya ngokuhlangana kwezinhlayiya ezimisiwe emoyeni. Ngokuvamile, inani elincane, izinga lokuhlanzeka liyakhuphuka.
1. Ukuhlanzeka komoya kubhekisela kusayizi nenani lezinhlayiya (kuhlanganise nama-microorganisms) aqukethwe emoyeni ngeyunithi ngayinye yevolumu, okuyindinganiso yokuhlukanisa izinga lokuhlanzeka kwendawo.
I-Static isho isimo ngemva kokufakwa kwesistimu ye-air conditioning yegumbi elihlanzekile futhi isebenza ngokugcwele, futhi abasebenzi basegumbini elihlanzekile bakhiphe isayithi futhi bazihlanza imizuzu engu-20.
I-Dynamic isho ukuthi igumbi elihlanzekile lisesimweni esivamile sokusebenza, okokusebenza kusebenza ngendlela evamile, futhi izisebenzi eziqokiwe zisebenza ngokuvumelana nemibandela ebekiwe.
2. Izinga lokugreda le-ABCD livela ku-GMP emenyezelwe yi-World Health Organization (WHO), okuwumgomo ojwayelekile wokuphathwa kwekhwalithi yokukhiqizwa kwemithi embonini yezemithi. Njengamanje isetshenziswa ezifundeni eziningi emhlabeni jikelele, okuhlanganisa i-European Union ne-China.
Inguqulo yakudala yaseShayina ye-GMP yalandela izindinganiso zokugreda zaseMelika (isigaba 100, isigaba 10,000, isigaba 100,000) kwaze kwaba yilapho kuqaliswa inguqulo entsha yamazinga e-GMP ngo-2011. Imboni yezokwelapha yaseShayina isiqalile ukusebenzisa izindinganiso zokuhlukaniswa kwe-WHO nokusebenzisa i-ABCD amazinga ezindawo ezihlanzekile.
Ezinye izindinganiso zokuhlukaniswa kwegumbi elihlanzekile
Igumbi elihlanzekile linamazinga okugreda ahlukene ezifundeni nasezimbonini ezahlukene. Izindinganiso ze-GMP zethulwe ngaphambilini, futhi lapha sethula ikakhulukazi amazinga aseMelika kanye namazinga e-ISO.
(1). I-American Standard
Umqondo wokulinganisa igumbi elihlanzekile uqale wahlongozwa yi-United States. Ngo-1963, indinganiso yokuqala yenhlangano yengxenye yezempi yegumbi elihlanzekile yethulwa: FS-209. Amazinga ajwayelekile ekilasi 100, isigaba 10000 kanye nesigaba 100000 wonke asuselwa kuleli zinga. Ngo-2001, i-United States yayeka ukusebenzisa izinga le-FS-209E futhi yaqala ukusebenzisa indinganiso ye-ISO.
(2). Izindinganiso ze-ISO
Amazinga e-ISO ahlongozwa yi-International Organisation for Standardization ISO futhi afaka izimboni eziningi, hhayi nje imboni yezemithi. Kunamazinga ayisishiyagalolunye ukusuka kukilasi1 kuya kwelesi-9. Phakathi kwawo, ikilasi lesi-5 lilingana nekilasi B, ikilasi lesi-7 lilingana nekilasi C, kanti ikilasi lesi-8 lilingana nekilasi D.
(3). Ukuqinisekisa izinga lendawo ehlanzekile Yekilasi A, ivolumu yesampula yephuzu ngalinye lesampula akufanele ibe ngaphansi kwe-cubic meter engu-1. Izinga lezinhlayiya ezihamba emoyeni ekilasini A izindawo ezihlanzekile yi-ISO 5, enezinhlayiya ezimisiwe ≥5.0μm njengezinga elilinganiselwe. Izinga lezinhlayiya ezihamba emoyeni endaweni ehlanzekile yekilasi B (emile) yi-ISO 5, futhi ihlanganisa izinhlayiya ezimisiwe ezinosayizi ababili etafuleni. Ezindaweni ezihlanzekile zekilasi C (ezimile neziguquguqukayo), amazinga ezinhlayiya ezihamba emoyeni yi-ISO 7 ne-ISO 8 ngokulandelanayo. Ezindaweni ezihlanzekile zekilasi D (ezimile) izinga lezinhlayiya ezihamba emoyeni yi-ISO 8.
(4). Lapho kuqinisekiswa izinga, isibali sezinhlayiyana zothuli esiphathwayo esineshubhu lesampula elifushane kufanele sisetshenziswe ukuvimbela izinhlayiya ezimisiwe ezingu-≥5.0μm ukuthi zingahlali kushubhu yesampula ende yesistimu yokusampula ekude. Ezinhlelweni zokugeleza ezingaqondile, amakhanda esampula e-isokinetic kufanele asetshenziswe.
(5) Ukuhlolwa okunamandla kungenziwa ngesikhathi sokusebenza okujwayelekile kanye nezinqubo zokugcwalisa ezilingisa zamasiko ukuze kuqinisekiswe ukuthi izinga lenhlanzeko eliguquguqukayo liyafinyelelwa, kodwa ukuhlolwa kokugcwalisa okulingisa okuphakathi nendawo kudinga ukuhlolwa okunamandla ngaphansi "kwesimo esibi kakhulu".
Igumbi elihlanzekile lekilasi A
Igumbi elihlanzekile Ikilasi A, elaziwa nangokuthi igumbi le-class 100 elihlanzekile noma igumbi elihlanzeke kakhulu, lingelinye lamagumbi ahlanzeke kakhulu anenhlanzeko ephezulu. Ingakwazi ukulawula inani lezinhlayiya nge-cubic foot ngayinye emoyeni ibe ngaphansi kuka-35.5, okusho ukuthi, inani lezinhlayiya ezinkulu noma ezilingana no-0.5um ku-cubic meter ngayinye yomoya ayikwazi ukudlula u-3,520 (i-static futhi iguquguqukayo). 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 kanye nomswakama njalo ukuze kuzuzwe izidingo zabo zokuhlanzeka okuphezulu. Amakamelo ahlanzekile Ekilasi A asetshenziswa kakhulu ekucubunguleni i-microelectronics, i-biopharmaceuticals, ukukhiqizwa kwezinsimbi ezinembayo, i-aerospace kanye neminye imikhakha.
Igumbi elihlanzekile lekilasi B
Amakamelo ahlanzekile ekilasi B abizwa nangokuthi amakamelo ahlanzekile ekilasi le-1000. Izinga labo lokuhlanzeka liphansi uma kuqhathaniswa, okuvumela inani lezinhlayiya ezinkulu noma elilingana no-0.5um nge-cubic meter yomoya ukuthi lifinyelele ku-3520 (static) kanye no-352000 (ashukumisayo). Amakamelo ahlanzekile Ekilasi B ngokuvamile asebenzisa izihlungi ezisebenza kahle kakhulu kanye nesistimu yokukhipha umoya ukuze alawule umswakama, izinga lokushisa nomehluko wengcindezi yendawo yasendlini. Amakamelo ahlanzekile Ekilasi B asetshenziswa kakhulu ku-biomedicine, ukukhiqizwa kwemithi, imishini enembile kanye nokukhiqizwa kwezinsimbi neminye imikhakha.
Igumbi elihlanzekile lekilasi C
Amakamelo ahlanzekile ekilasi C abuye abizwe ngokuthi amagumbi ahlanzekile ekilasi 10,000. Izinga labo lokuhlanzeka liphansi uma kuqhathaniswa, okuvumela inani lezinhlayiya ezinkulu noma elilingana no-0.5um per cubic meter yomoya ukufinyelela ku-352,000 (static) kanye nezi-352,0000 (ashukumisayo). Amakamelo ahlanzekile ekilasi C ngokuvamile asebenzisa izihlungi ze-hepa, ukulawula ukucindezela okuhle, ukujikeleza komoya, ukulawulwa kwezinga lokushisa nomswakama kanye nobunye ubuchwepheshe ukuze kuzuzwe izindinganiso zabo ezithile zokuhlanzeka. Amakamelo ahlanzekile ekilasi C asetshenziswa kakhulu kwezemithi, ekwenziweni kwemishini yezokwelapha, emishinini enembayo kanye nokukhiqizwa kwezingxenye zikagesi neminye imikhakha.
Igumbi elihlanzekile lekilasi D
Amakamelo ahlanzekile ekilasi D abizwa nangokuthi amagumbi ahlanzekile ekilasi elingu-100,000. Izinga labo lokuhlanzeka liphansi uma kuqhathaniswa, okuvumela inani lezinhlayiya ezinkulu noma elilingana no-0.5um nge-cubic meter yomoya ukuthi lifinyelele ku-3,520,000 (static). Amakamelo ahlanzekile ekilasi D ngokuvamile asebenzisa izihlungi ezijwayelekile ze-hepa kanye nokulawula ukucindezela okuhle okuyisisekelo kanye nezinhlelo zokujikeleza komoya ukulawula indawo yasendlini. Amakamelo ahlanzekile ekilasi D asetshenziswa kakhulu ekukhiqizweni kwezimboni okuvamile, ukucubungula ukudla kanye nokupakishwa, ukuphrinta, indawo yokugcina impahla kanye neminye imikhakha.
Amazinga ahlukene wamakamelo ahlanzekile anobubanzi bawo bokusebenza, okufanele akhethwe ngokwezidingo zangempela. Ekusetshenzisweni okungokoqobo, ukulawulwa kwemvelo kwamakamelo ahlanzekile kuwumsebenzi obaluleke kakhulu, ohilela ukucatshangelwa okuphelele kwezinto eziningi. Idizayini nokusebenza okungokwesayensi nokunengqondo kuphela okungaqinisekisa ikhwalithi nokuzinza kwendawo yegumbi elihlanzekile.
Isikhathi sokuthumela: Mar-07-2024