Igumbi elihlanzekile liyindawo elawulwa ngokukhethekile lapho izici ezinjengenombolo yezinhlayiya emoyeni, umswakama, izinga lokushisa kanye nogesi we-tuli kungalawulwa ukuze kufinyelelwe amazinga athile okuhlanza. Amakamelo ahlanzekile asetshenziswa kabanzi kwizimboni zobuchwepheshe obuphakeme njengama-semiconductors, ama-elekthronikhi, amakhamishini, izindiza, i-aerospace kanye ne-biomedicine.
Emikhakheni yokulawulwa kokukhiqizwa kwemithi, igumbi elihlanzekile lihlukaniswe ngamazinga ama-4: a, B, C no-D.
I-Class A: Izindawo ezinobungozi obusengozini enkulu, njengokugcwalisa izindawo, izindawo lapho kufakwa khona iziqukathi zokufaka ama-rubber kanye nezindawo lapho kufakwa khona umhlangano we-aseprife, kufanele kufakwe itafula elisebenzayo lokugeleza kwe-anidire ukugcina isimo semvelo sendawo. Uhlelo lwe-UnidiRectional Flow System kumele lunikeze umoya ngokulinganayo endaweni yalo yokusebenza nge-Air Velocity ka-0.36-0.54m / s. Kufanele kube nedatha ukufakazela isimo sokugeleza okungafanele futhi iqinisekiswe. Ebhokisini elivaliwe, elihlala lilodwa noma ibhokisi le-glove, i-velocity yomoya ephansi ingasetshenziswa.
I-Class B: isho indawo yangemuva lapho ikilasi indawo ehlanzekile itholakala khona ngokusebenza kobungozi obukhulu njengokulungiselela i-asuptic nokugcwaliswa.
I-Class C no-D: bhekisa ezindaweni ezihlanzekile ezinezinyathelo ezingabalulekile kakhulu ekukhiqizweni kwemikhiqizo yezemithi eyinyumba.
Ngokusho kwemithetho ye-GMP, imboni yezemithi yezwe lami ihlukanisa izindawo ezihlanzekile zibe ngamazinga ama-4 we-ABCD njengoba ngenhla kususelwa kwizinkomba ezinjengokuhlanzeka komoya, umfutho womoya, okuqukethwe kwe-microbial, okuqukethwe kwe-microbial.
Amazinga wezindawo ezihlanzekile ahlukaniswe ngokweqiniso kwezinhlayiya ezimisiwe emoyeni. Ngokuvamile, okuncane inani, kukhuphuka izinga lokuhlanzeka.
1. Ukuhlanzeka komoya kubhekisele kusayizi nenombolo yezinhlayiya (kufaka phakathi ama-microorganisms) aqukethe emoyeni ngevolumu ngayinye yeyunithi yesikhala, okuyindinganiso yokuhlukanisa isimo sokuhlanzeka kwesikhala.
I-Static ibhekisa kumbuso ngemuva kokuthi uhlelo lokuhlanza indawo ehlanzekile lufakiwe futhi lusebenza ngokugcwele, futhi abasebenzi begumbi elihlanzekile bakhiphe indawo futhi bahlanzeke imizuzu engama-20.
I-Dynamic isho ukuthi igumbi elihlanzekile lisesimweni esijwayelekile sokusebenza, imishini isebenza ngokujwayelekile, futhi abasebenzi abaqokiwe basebenza ngokuya ngemininingwane.
2. I-ABCD Grading Standard ivela kwi-GMP ekhuliswe yi-World Health Organisation (WHO), okuyinto evamile yokuphepha kwekhwalithi yemithi embonini yezemithi. Okwamanje isetshenziswa ezifundeni eziningi emhlabeni wonke, kufaka phakathi i-European Union neChina.
I-Chinese Old Version ye-GMP ilandele amazinga wokulinganisa waseMelika (isigaba 100, isigaba 10,000, isigaba 100,000) kuze kube ukuqaliswa kwenguqulo entsha yamazinga we-GMP ngonyaka we-GMP. amazinga ezindawo ezihlanzekile.
Amanye amazinga okuhlukaniswa kwamagumbi ahlanzekile
Igumbi elihlanzekile linezindinganiso ezihlukile zokulinganisa ezifundeni ezahlukahlukene nasezimbonini. Izindinganiso ze-GMP ziye zangethulwa phambilini, futhi lapha ikakhulukazi sethula amazinga aseMelika namazinga e-ISO.
(1). I-American Standard
Umqondo we-Grading Clean Igumbi wahlongozwa okokuqala yi-United States. Ngo-1963, izindinganiso zokuqala zombuso zengxenye yezempi yegumbi elihlanzekile zaqaliswa: FS-209. Isigaba esijwayelekile 100, isigaba 100,0000 kanye namazinga we-Class 100000 wonke asuselwa kuleli Zinga. Ngo-2001, amazwe ase-United States ayeka ukusebenzisa i-FS-209E standard futhi waqala ukusebenzisa i-ISO Standard.
(2). Izindinganiso ze-ISO
Izindinganiso ze-ISO zihlongozwa yinhlangano yamazwe omhlaba ukuze ziveze ama-ISO futhi zimboze izimboni eziningi, hhayi nje imboni yemithi. Kunamazinga ayisishiyagalolunye avela ku-Class1 kuya ekilasini 9
(3). Ukuqinisekisa izinga le-Class indawo ehlanzekile, ivolumu yesampula yephuzu ngalinye lesampula ngeke ibe ngaphansi kwemitha engu-1 cubic. Izinga lezinhlayiya zezindiza ekilasini izindawo ezihlanzekile yi-ISO 5, enezinhlayiya ezimisiwe ≥5.0μm njengezinga lomkhawulo. Izinga lezinhlayiya zomoya ekilasini b Hlanza indawo (i-Static) yi-ISO 5, futhi ifaka izinhlayiya ezimisiwe zosayizi amabili etafuleni. Ngezindawo ezihlanzekile zeClass C (i-Static and Dynamic), amazinga wezinhlayiya zomoya ayi-ISO 7 ne-ISO 8 ngokulandelana. Okwezindawo ezihlanzekile zeClass D (i-Static) izinga lezinhlayiya zomoya yi-ISO 8.
(4). Lapho uqinisekisa lelo zinga, i-counter ephathekayo yothuli eligcwele ngeshubhu elifushane le-sampling kufanele lisetshenziselwe ukuvikela izinhlayiya ezimisiwe ze-≥5.0μm ezimisiwe kusuka kushubhu ende yesampula. Kuzinhlelo zokugeleza ezingafakwanga, amakhanda wesampula we-isokinetic kufanele asetshenziswe.
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Class igumbi elihlanzekile
Class Igumbi elihlanzekile, elaziwa nangokuthi ikilasi elihlanzekile le-100 noma igumbi elihlanzekile, lingelinye lamakamelo ahlanzekile kakhulu ngokuhlanzeka okuphezulu kakhulu. Ingalawula inani lezinhlayiya ngonyawo lwe-cubic emoyeni liye ngaphansi kwama-35,5, okusho ukuthi, inani lezinhlayiya likhulu kune-0.5um ku-3,520 (Static and Dynamic). Isigaba Igumbi elihlanzekile linezidingo eziqinile kakhulu futhi lidinga ukusetshenziswa kwezihlungi ze-hepa, ukulawulwa kwengcindezi ehlukile, amasistimu wokusakazwa komoya kanye nezinhlelo zokulawula ezingapheli kanye nomswakama ukufezekisa izidingo zabo eziphakeme zokuhlanzeka. I-Class Amakamelo ahlanzekile asetshenziswa ikakhulukazi ekucutshungweni kwe-microelectondics, i-biopharmaceuticals, ukubhala izinto zokukhiqiza, i-aerospace kanye nezinye izinkambu.
Igumbi elihlanzekile le-B
Amakamelo okuhlanza amakilasi abizwa nangokuthi amakamelo okuhlanza ahlanzekile ayi-1000. Izinga lazo lokuhlanzeka liphansi kakhulu, livumela inani lezinhlayiya likhulu kune- noma lilingana ne-0.5um ngemitha ye-cubic ngayinye yomoya ukuze ifinyelele ku-3520 (static) kanye nama-352000 (ashukumisayo). Amakamelo okuhlanza amaklasi avame ukusebenzisa izihlungi ezisebenza kahle kakhulu nezinhlelo zokuphelelwa amandla okulawula umswakama, izinga lokushisa kanye nengcindezi umehluko wendawo yangaphakathi. Amakamelo okuhlanza amakilasi asetshenziswa ikakhulukazi e-Bioomedicine, ekhiqiza amakhambi, imishini yokunemba kanye nokukhiqiza izinsiza kanye nezinye izinkambu.
Igumbi elihlanzekile c
Amakamelo okuhlanza amaklasi abizwa nangokuthi amakamelo okuhlanza ahlanzekile ayi-10,000. Izinga lazo lokuhlanzeka liphansi, livumela inani lezinhlayiya likhulu kune-0.5um ngemitha ye-cubic ngayinye yomoya ukuze ifinyelele ku-352,000 (ama-static) kanye nama-352,0000 (ashukumisayo). Amakamelo okuhlanza ama-Class C ajwayele ukusebenzisa izihlungi ze-hepa, ukulawulwa kwengcindezi emihle, ukusakazwa komoya, izinga lokushisa kanye nomswakama kanye nobunye ubuchwepheshe ukufeza amazinga abo okuhlanzeka athile. Amakamelo okuhlanza ama-Class C asetshenziswa ikakhulukazi emikhakheni, ukukhiqiza amadivaysi ezokwelapha, imishini yokunemba kanye nokukhiqiza okwenziwe nge-elekthronikhi nezinye izinkambu.
Class D Igumbi elihlanzekile
Amakamelo okuhlanza ama-Class D abizwa nangokuthi amakamelo okuhlanza ama-Class 100,000. Izinga lazo lokuhlanzeka liphansi kakhulu, livumela inani lezinhlayiya likhulu kune- noma lilingana no-0.5um ngamamitha ayi-cubic ngomoya ukuze afinyelele ku-3 520,000 (ama-static). Amakamelo ahlanzekile ekilasini ajwayele ukusebenzisa izihlungi ezijwayelekile ze-hepa kanye nokulawulwa okuyisisekelo kwengcindezi enhle nezinhlelo zokujikeleza komoya ukulawula imvelo yasendlini. Amakamelo we-Class D asetshenziswa ikakhulukazi ekukhiqizeni kwezimboni, ukucubungula kokudla kanye nokupakisha, ukuphrinta, ukugcinwa kwamasheya kanye nezinye izinkambu.
Amazinga ahlukene amakamelo ahlanzekile ane-scope yawo yesicelo, okufanele ikhethwe ngokuya ngezidingo zangempela. Kuzinhlelo zokusebenza ezisebenzayo, ukulawulwa kwemvelo kwamakamelo ahlanzekile kungumsebenzi obaluleke kakhulu, okubandakanya ukucatshangelwa okuphelele kwezinto eziningi. Ukwakheka nokusebenza kwesayensi kuphela nokunengqondo kungaqinisekisa ikhwalithi nokuqina kwendawo ehlanzekile yegumbi.
Isikhathi Sokuthumela: Mar-07-2024