Uhlobo Olumanzi Lokuqunjelwe Okuphezulu Umugqa Wesithombe Esifakiwe

I-High Containment Wet Type Granulation Line

Incazelo emfushane:

Ilungele ukukhiqizwa kwezidakamizwa eziqinile ezinobuthi obuphezulu, ezisebenza kakhulu, kanye ne-allergenic kakhulu, futhi kufanele ifinyelele ku-OEB4 & OEB5 ukuze kuncishiswe izingozi zama-opharetha phakathi nenqubo yokukhiqiza kanye nomthelela emvelweni.

Amathuluzi athobela inguqulo ye-China ka-2010 ye-GMP, European GMP, kanye nemithetho ye-FDA, futhi ihlangabezana nezimfuneko zokungenisa umoya ze-OEB, ukuze kuncishiswe umonakalo womkhiqizo kothintana nabo amathuluzi;

Izinkombandlela Ezijwayelekile Ze-EHS Zemboni Yezemithi YaseShayina (2020);Imikhawulo Yokuchayeka Emsebenzini Yezinto Eziyingozi Emsebenzini

Thumela i-imeyili kithi

Imininingwane Yomkhiqizo

Omaka bomkhiqizo

Izici

1.Adopt air bag seal,ukuphepha interlock control;
2.Yemukela isikhwama se-PE noma i-ab valve ukuze ulayishe futhi ulayishwe;
3.Adopt uhlelo lwe-BIBO lokukhipha umoya, ngezihlungi ze-F9/H13;
4.WIP yokuhlanza/CIP yokuhlanza/Manuwali disassembly yokuhlanza.

Incazelo yokuqukatha ye-OEB

Ama-API ane-cytotoxicity nomsebenzi ophezulu ayikilasi lezithako zemithi ezinomsebenzi ophezulu wezokwelapha, anesilinganiso somtholampilo esiphansi kanye nemiphumela engemihle embalwa, futhi adonse ukunaka okuningi emakethe eminyakeni yamuva.Nakuba imakethe yezidakamizwa ezisebenza kakhulu ibanzi, nazo zibhekana nezinselele ezinkulu.Ngaphezu kokubulala amangqamuzana omdlavuza, izidakamizwa ezilwa nesimila zingase zibulale namaseli avamile.Ukuzwela kwabo kungabangela ukungezwani komzimba kubantu, futhi kuyingozi kakhulu empilweni yabantu abanempilo.Ngakho-ke, ubungozi obuyinhloko obucatshangelwa kunqubo yokukhiqiza ye-cytotoxic kanye nama-API asebenza kakhulu ukuchayeka ngothuli.Isixazululo esingcono kakhulu ukusebenzisa ubuchwepheshe bokuzihlukanisa ongangenisi umoya ukuze ulawule inani lokuvuza kothuli enqubweni yokukhiqiza.Ngenxa yalesi sici, le phrojekthi ikakhulukazi ifunda amanani e-OEL (Occupational Exposure Limit) asebenzayo ngaphansi kwamazinga engozi yezinto ezinobuthi obuhlukahlukene obusebenzayo, kanye nezisetshenziswa ezihambisanayo nezinga le-OEB lokungenisa umoya kanye nesu elingangeni moya.Ngokwezici ze-cytotoxic kanye nezinto zokusetshenziswa ezisebenzayo kakhulu, ngokusekelwe kubuchwepheshe obukhona bokuvalwa kwe-labyrinth, ubuchwepheshe bokuvalwa kwengcindezi engalungile kanye nobuchwepheshe bokuhlukanisa okungangeni moya, inhlanganisela yokufaka uphawu ehlukahlukene efanele izinto ezinjalo isihloliwe.Ubuchwepheshe bokuvala uphawu lwe-Micro-leakage bungavimba noma buvimbe nge-cytotoxicity ephezulu.Iziteshi ezivuzayo zama-API asebenzayo ukuze ulawule izinga lokuvuza

Izidingo zemishini ye-OEB

1.OEB 1~2 iyadingeka ukuze kumiswe izinsiza ezisalungiswa zasendaweni, njengokungena komoya okusebenzayo endaweni ezindaweni eziveziwe.

2.OEB 3 Uma ukuthintana emsebenzini kuhilelekile, okokusebenza okungangeni moya kanye nezinsiza kufanele kwamukelwe ngangokunokwenzeka, futhi izinyathelo zokulawula ezifana nokungena komoya, ihood yokugeleza kwe-laminar, indawo yokusebenza ezimele enomshini wendawo wokungenisa umoya, i-fume hood, njll. kufanele kusetshenziswe izingxenye eziveziwe zothuli lwezidakamizwa.

3. Izinga le-OEB 4-5 Okubalulekile kufanele kunikezwe ukusetshenziswa kwemishini evalekile egcwele inqubo kanye nezinsiza, kanye nokuklanywa kwemizila yokukhiqiza yobuchwepheshe evaliwe.Umugqa womkhiqizo kufanele wamukele zonke izinto ezifakiwe kanye nezinsiza.Kubandakanya ukuthintana emsebenzini, izinyathelo zokulawula ezifana ne-isolator, i-glove box ivaliwe ukusebenza, i-valve ye-α-β, isikhwama sokungena kanye nokuphuma kwesikhwama, njll. kufanele kusetshenziswe.Imishini yokukhiqiza kufanele isebenzise umoya wayo ophezulu ongangenisi umoya, njengomshini wokomisa amathathu kokukodwa.

Ukukhiqiza - imishini yokucubungula ethuthukisiwe

Ukukhiqiza - imishini yokucubungula ethuthukisiwe

Ukukhiqiza - Ukuphathwa kokuncika (Indawo yomhlangano)

Production- Quality ukuphathwa

Inqubomgomo yekhwalithi:
ikhasimende kuqala, izinga kuqala, ukuthuthukiswa okuqhubekayo kanye nobuhle.

Imishini yokucubungula ethuthukisiwe + amathuluzi okuhlola ukunemba + ukugeleza kwenqubo eqinile + ukuhlolwa komkhiqizo oqediwe + i-FAT yekhasimende
=Ukungasebenzi kahle kwemikhiqizo yasefekthri