Ukubonakaliswa okuphelele kobuchwepheshe obuhlanzekile yilokho esivame ukukubiza ngokuthi igumbi elihlanzekile lefektri yemithi, elihlukaniswe kakhulu ngezigaba ezimbili: igumbi elihlanzekile lezimboni kanye negumbi elihlanzekile lezinto eziphilayo. Umsebenzi oyinhloko wegumbi elihlanzekile lezimboni ukulawula ukungcola kwezinhlayiya ezingezona ezezinto eziphilayo, kanti umsebenzi oyinhloko wegumbi elihlanzekile lezinto eziphilayo ukulawula ukungcola kwezinhlayiya zezinto eziphilayo. I-GMP iyindinganiso yokukhiqiza imithi kanye nokuphathwa kwekhwalithi, okuqinisekisa ngempumelelo ukuphepha kanye nekhwalithi yemithi. Enkambisweni yokuklama, ukwakhiwa kanye nokusebenza kwamakamelo ahlanzekile embonini yemithi, amazinga afanele amakamelo ahlanzekile kanye nezidingo zemininingwane yokuphathwa kwekhwalithi yokukhiqiza imithi kufanele kulandelwe. Okulandelayo, sizokhuluma ngokuklama kwegumbi elihlanzekile lefektri elihlanzekile lemithi ngokuhambisana nemithethonqubo yokuhlobisa ingaphakathi ku-"Imininingwane Yokuklama Yefektri Ehlanzekile Yemboni Yemithi", kuhlanganiswe nesipiliyoni se-Shanghai IVEN ekwakhiweni kobunjiniyela kwezimboni zemithi ezihlanganisiwe.

Umklamo Wezindawo Zokuhlanza Zezimboni
Emakamelweni ahlanzekile ezimbonini, izitshalo zemithi ziyimiklamo yobunjiniyela esivame ukuhlangana nayo. Ngokwezidingo ze-GMP zamakamelo ahlanzekile, kunemingcele embalwa ebalulekile okufanele inakwe.

1. Ukuhlanzeka
Inkinga yokuthi ungazikhetha kanjani kahle imingcele endaweni yokusebenzela yomkhiqizo wobuciko. Ngokusho kwemikhiqizo ehlukene yobuchwepheshe, indlela yokukhetha imingcele yokuklama ngendlela efanele yinkinga eyisisekelo ekwakhiweni. Kuphakanyiswa inkomba ebalulekile ku-GMP, okungukuthi, izinga lokuhlanzeka komoya. Izinga lokuhlanzeka komoya liyinkomba eyinhloko yokuhlola ukuhlanzeka komoya. Uma izinga lokuhlanzeka komoya lingalungile, kuzovela isimo samahhashi amakhulu adonsa inqola encane, okungeyona eyonga imali futhi engonga amandla. Isibonelo, incazelo entsha yokupakishwa kwezinga elijwayelekile elingama-300,000 elingafanele ukulisebenzisa enqubweni yomkhiqizo oyinhloko njengamanje, kodwa elisebenza kahle kakhulu kwamanye amakamelo asekelayo.

Ngakho-ke, ukukhetha ukuthi yiliphi izinga elihlobene ngqo nekhwalithi kanye nezinzuzo zezomnotho zomkhiqizo. Imithombo yothuli ethinta ukuhlanzeka ivela kakhulu ekukhiqizweni kothuli lwezinto enqubweni yokukhiqiza, ukugeleza kwabasebenzi kanye nezinhlayiya zothuli ezisemoyeni ezilethwa umoya omusha wangaphandle. Ngaphezu kokusetshenziswa kwamadivayisi okukhipha uthuli avaliwe kanye nokususa uthuli emishinini yenqubo yokukhiqiza uthuli, izindlela ezisebenzayo zokulawula ukungena kwemithombo yothuli egumbini ukusebenzisa ukuhlunga okuyisisekelo, okuphakathi kanye nokusebenza kahle kwezigaba ezintathu zomoya omusha obuyayo wesistimu yokupholisa umoya kanye negumbi lokugeza ukuze kudlule abasebenzi.

2. Izinga lokushintshana komoya
Ngokuvamile, inani lokushintsha komoya ohlelweni lokupholisa umoya liyizikhathi ezingu-8 kuya kwezingu-10 ngehora, kanti izinga eliphansi kakhulu lokushintsha komoya ekamelweni elihlanzekile lezimboni liyizikhathi ezingu-12, kanti izinga eliphakeme kakhulu liyizikhathi ezingamakhulu. Ngokusobala, umehluko esilinganisweni sokushintshana komoya ubangela umehluko omkhulu kumthamo womoya kanye nokusetshenziswa kwamandla. Ekwakhiweni, ngokusekelwe ekubekweni okunembile kokuhlanzeka, kuyadingeka ukuqinisekisa izikhathi zokungenisa umoya ezanele. Ngaphandle kwalokho, kungase kuvele uchungechunge lwezinkinga, njengokuthi imiphumela yokusebenza ayifiki ezingeni elijwayelekile, amandla okulwa nokuphazamiseka kwegumbi elihlanzekile aphansi.

3. Umehluko wengcindezi eqinile
Umehluko wokucindezela phakathi kwamakamelo ahlanzekile namakamelo angahlanzekile emazingeni ahlukene akufanele ube ngaphansi kwama-5pa, kanti ukucindezela phakathi kwamakamelo ahlanzekile namakamelo angaphandle akufanele kube ngaphansi kwama-10Pa. Indlela yokulawula umehluko wokucindezela okumile ngokuyinhloko ukunikeza ivolumu ethile yomoya ocindezelayo omuhle. Amadivayisi okucindezela amahle avame ukusetshenziswa ekwakhiweni yi-valve yokucindezela eseleyo, isilawuli somoya kagesi ocindezelayo ohlukile kanye nesendlalelo sokunciphisa umoya esifakwe endaweni yokukhipha umoya obuyayo. Eminyakeni yamuva nje, kuvame ukwamukelwa ekwakhiweni ukuthi ivolumu yomoya ophakelwayo inkulu kunevolumu yomoya obuyayo kanye nevolumu yomoya ophumayo ekuqalisweni kokuqala ngaphandle kwedivayisi yokucindezela okuhle, futhi uhlelo lokulawula oluzenzakalelayo oluhambisanayo lungafinyelela umphumela ofanayo.

4. Ukusatshalaliswa komoya
Indlela yokusabalalisa umoya ekamelweni elihlanzekile iyisici esibalulekile ukuqinisekisa ukuhlanzeka. Indlela yokusabalalisa umoya evame ukusetshenziswa ekwakhiweni kwamanje inqunywa ngokwezinga lokuhlanzeka. Isibonelo, igumbi elihlanzekile elinamaklasi angu-300,000 livame ukusebenzisa indlela yokuthumela phezulu kanye neyokufaka phezulu, amakamelo ahlanzekile anamakilasi angu-100,000 kanye namakilasi angu-10,000 avame ukusebenzisa indlela yokugeleza komoya yokubuyisela ohlangothini oluphezulu noluphansi, kanti igumbi elihlanzekile elinamaklasi aphezulu lisebenzisa ukugeleza okuvundlile noma okuqondile okuqonde ngqo.

5. Izinga lokushisa kanye nomswakama
Ngaphezu kwezinqubo ezikhethekile, ngokombono wokushisa, ukupholisa umoya kanye nokupholisa umoya, ikakhulukazi ukugcina induduzo yabasebenzi, okungukuthi, izinga lokushisa elifanele kanye nomswakama. Ngaphezu kwalokho, kunezinkomba eziningana okufanele zivuse ukunaka kwethu, njengesivinini somoya esinqamula isigaba somsele womoya, umsindo, ukukhanya kanye nesilinganiso somthamo womoya omusha njll., konke okungenakunakwa ekwakhiweni.

Umklamo wegumbi elihlanzekile
Amakamelo ahlanzekile ngokwezinto eziphilayo ahlukaniswe kakhulu ngezigaba ezimbili; amakamelo ahlanzekile ngokwezinto eziphilayo kanye namakamelo ahlanzekile ngokwezinto eziphilayo. Kumakamelo ahlanzekile ngokwezinto eziphilayo, ekwakhiweni kobuchwepheshe bokushisa, ukungenisa umoya kanye nokupholisa umoya, izindlela ezibalulekile zokulawula izinga lokuhlanzeka ziwukuhlunga kanye nokucindezela okuhle. Kumakamelo ahlanzekile ngokwezinto eziphilayo, ngaphezu kokusebenzisa izindlela ezifanayo namakamelo ahlanzekile ngokwezinto eziphilayo, kufanele futhi kucatshangelwe ngokombono wokuphepha ngokwezinto eziphilayo, futhi ngezinye izikhathi kuyadingeka ukusebenzisa izindlela zokucindezela ezimbi ukuvimbela ukungcola komkhiqizo emvelweni.
Ukusebenza kwezinto ezibangela izifo eziyingozi kakhulu kuhilelekile enqubweni yokukhiqizwa komkhiqizo ocutshungulwayo, kanti uhlelo lwayo lokuhlanza umoya nezinye izikhungo kufanele futhi zihlangabezane nezidingo ezikhethekile. Umehluko phakathi kwegumbi lokuhlanza le-biosafety kanye negumbi lokuhlanza lezimboni ukuqinisekisa ukuthi indawo yokusebenza igcina isimo sokucindezela okungekuhle. Nakuba izinga lendawo enjalo yokukhiqiza lingephezulu kakhulu, lizoba nezinga eliphezulu le-biohazard. Ngokuphathelene nengozi yezinto eziphilayo, kunezindinganiso ezifanayo eShayina, e-WTO nakwamanye amazwe emhlabeni. Ngokuvamile, izinyathelo ezisetshenziswayo ziwukuhlukaniswa kwesibili. Okokuqala, i-pathogen ihlukaniswa kumqhubi yikhabhinethi yokuphepha noma ibhokisi lokuhlukanisa, okuyisithiyo esikhulu sokuvimbela ukugcwala kwamagciwane ayingozi. Ukuhlukaniswa kwesibili kubhekisela ekuhlukanisweni kwelabhorethri noma indawo yokusebenza ngaphandle ngokuyiguqula ibe yindawo yokucindezela okungekuhle. Ohlelweni lokuhlanza umoya, izinyathelo ezithile nazo zithathwa ngokufanele, njengokugcina ingcindezi engekuhle engu-30Pa~10Pa ngaphakathi, kanye nokusetha indawo yokucindezela engekuhle phakathi kwendawo eseduze engahlanzekile.

I-Shanghai IVEN ihlala igcina umuzwa womthwalo wemfanelo omkhulu futhi inamathela kuzo zonke izindinganiso ngenkathi isiza amaklayenti ukwakha amafektri emithi. Njengenkampani enolwazi lwamashumi eminyaka ekuhlinzekeni ngobunjiniyela bemithi obuhlanganisiwe, i-IVEN inezinkulungwane zesipiliyoni ekubambisaneni kwamazwe ngamazwe emhlabeni jikelele. Yonke iphrojekthi ye-Shanghai IVEN ihambisana nezindinganiso ze-EU GMP/US FDA GMP, WHO GMP, PIC/S GMP kanye neminye imigomo. Ngaphezu kokunikeza amakhasimende izinsizakalo ezisezingeni eliphezulu, i-IVEN iphinde inamathele emqondweni "wokuhlinzeka ngempilo kubantu".

I-Shanghai IVEN ilangazelela ukusebenza nawe.