Isimo esiphelele sobuchwepheshe obuhlanzekile yilokho esivame ukubiza igumbi elihlanzekile lefektri yezemithi, elihlukaniswe izigaba ezimbili ezihlanzekile ukulawula ukungcoliswa kwezinhlayiya zezinto eziphilayo, ngenkathi i-BIAD CHARCE CHERMECE I-CHESTING COINTSHESTESS NOKWENZA I-CLEANPITION yemithi. Esezinhlelweni zokwakhiwa, ukwakhiwa kanye nokusebenza kwamakamelo ahlanzekile embonini yezemithi, amazinga afanele amakamelo ahlanzekile kanye nezidingo zokubaluleka kokuphathwa kwemithi kufanele kulandelwe. Okulandelayo, sizokhuluma ngokuklanywa kwegumbi elihlanzekile lefektri ehlanzekile yezemithi ngokuya ngemigomo yokuhlobisa ingaphakathi embonini yezokwelapha ", ukuhlanganisa nolwazi lwe-shanghai iNin ekwakhiweni kobunjiniyela bezobunjiniyela zezokwelapha zezokwelapha.

Idizayini ye-Industrial Cleanroom
Emakamelweni ahlanzekile wezimboni, izitshalo zemithi yimiklamo yobunjiniyela esivame ukuhlangana nayo. Ngokwezidingo ze-GMP ngamakamelo ahlanzekile, kunamapharamitha ambalwa abalulekile okufanele anake.

1. Ukuhlanzeka
Inkinga yokuthi ungazikhetha kanjani kahle amapharamitha kumhlangano womkhiqizo wobuciko bezandla. Ngokusho kwemikhiqizo yezobuchwepheshe ehlukene, ukuthi ungayikhetha kanjani amapharamitha wokuklama kahle yinkinga eyisisekelo ekwakhiweni. Inkomba ebalulekile ihlongozwa ku-GMP, okungukuthi, izinga lokuhlanzeka komoya. Izinga lokuhlanzeka komoya liyinkomba eyinhloko yokuhlola ukuhlanzeka komoya. Uma izinga lokuhlanzeka komoya lingalungile, into yamahhashi amakhulu edonsa inqola encane izovela, okungeyona eyomnotho noma ukonga amandla. Isibonelo, ukucaciswa okusha kokupakisha okujwayelekile okujwayelekile okungama-300,000

Ngakho-ke, ukukhethwa kwalokho okuhlobene ngqo nezinzuzo zekhwalithi nezomnotho zomkhiqizo. Imithombo yothuli ethinta ukuhlanzeka ikakhulukazi ivela ekukhiqizeni uthuli lwezinto ezisezinhlelweni zokukhiqizwa, ukugeleza kwabasebenza kanye nezinhlayiya zothuli zasemkhathini ezilethwe umoya wangaphandle omusha. Ngaphezu kokusetshenziswa kwamadivayisi aphezulu okuphuma kanye namadivayisi wokususa uthuli lwemishini yokukhiqiza uthuli, izindlela ezisebenzayo zokulawula ukungena kwemithombo yothuli egumbini lokusebenzisa umoya omusha wohlelo lokuvuselela uhlelo lokuphola komoya kanye negumbi lokugeza lezisebenzi.

2. Izinga lokushintshana komoya
Ngokuvamile, inani lezinguquko zomoya ohlelweni lokufaka umoya lungamahlandla ayi-8 kuya kwayi-10 ngehora, kanti izinga eliphansi lomoya lishintsha egumbini elihlanzekile lezimboni izikhathi eziyi-12, kanti izinga eliphakeme kakhulu lingamakhulu amahlandla ayi-12. Ngokusobala, umehluko ngesilinganiso sokushintshaniswa komoya ubangela umehluko omkhulu ngevolumu yomoya kanye nokusetshenziswa kwamandla.Iklamidi, ngesisekelo sokuma okunenhla Ngaphandle kwalokho, kungenzeka ukuthi uchungechunge lwezinkinga lungavela, njengemiphumela yokusebenza ayiphezulu kokujwayelekile, amandla okulwa nokuphazamisa kwegumbi elihlanzekile ampofu.

3. Umehluko wengcindezelo ye-static
Umehluko wengcindezi phakathi kwamakamelo ahlanzekile namakamelo angahlanzekile emazingeni ahlukene ngeke abe ngaphansi kwama-5pa, kanye nengcindezi phakathi kwamakamelo ahlanzekile namakamelo angaphandle ngeke abe ngaphansi kwe-10pa. Indlela yokulawula umehluko we-static tress ngokuyinhloko ukuhlinzeka ngevolumu ethile yomoya omuhle. Amadivayisi wengcindezi amahle asetshenziswa ekwakhiweni yi-valve ye-design eyinsalela, umlawuli wevolumu yomoya ohlukile kanye nongqimba we-air Deamping olufakwe endaweni yokuphuma komoya. Eminyakeni yamuva nje, kuvame ukwamukelwa ekwakhiweni okuthi ivolumu yomoya we-Supply Air ikhudlwana kunevolumu yomoya kanye nevolumu yomoya ekuqedeni kokuqala ngaphandle kwensiza yengcindezi enhle, kanye nohlelo oluhambisanayo lokuzenzakalelayo lingafinyelela umphumela ofanayo.

4. Ukusatshalaliswa komoya
Uhlobo lokusabalalisa komoya lwegumbi elihlanzekile yinto ebalulekile ukuqinisekisa ukuhlanzeka. Ifomu lokusabalalisa umoya livame ukwamukelwa ekwakhiweni kwamanje kunqunywa ngokuya ngezinga lokuhlanzeka. Isibonelo, igumbi elihlanzekile le-300,000-Class livame ukwamukela indlela ephezulu yokuthumela nokubuyela emuva, amakamelo okuhlanza aphezulu angu-10,000 avame ukwamukela indlela yokugeleza komoya ephezulu, bese igumbi elihlanzekile eliphakeme lamukela ukugeleza okuphezulu noma okuqondile.

5. Ukushisa kanye nomswakama
Ngaphezu kwezinqubo ezikhethekile, ngokombono wokushisa, umoya omncane kanye nesimo somoya, ikakhulukazi ukugcina induduzo yabasebenza, okungukuthi, izinga lokushisa elifanele kanye nomswakama ofanele. Ngaphezu kwalokho, kunezinkomba eziningana okufanele zivuse ukunaka kwethu, njengejubane lomoya elisezingeni eliphakeme le-duct yomoya, umsindo, ukukhanyiselwa kanye nesilinganiso sevolumu yomoya omusha njll, konke okungenakunakwa ekwakhiweni.

Idizayini yegumbi elihlanzekile
Amakamelo okuhlanza okuzalwa ahlukaniswe izigaba ezimbili; Amakamelo okuhlanza okujwayelekile okujwayelekile kanye namakamelo okuphepha okuphilayo. Amakamelo okuhlanza izimboni, ekwakhiweni komoya wobungcweti kokushisa, umoya kanye nomoya womoya, izindlela ezibalulekile zokulawula izinga lokuhlanzeka kungokuhlunga nokucindezela okuhle. Ngamakamelo okuhlanza okuzalwa, ngaphezu kokusebenzisa izindlela ezifanayo namakamelo okuhlanza izimboni, kufanele futhi kubhekwe ngokubuka kokuphepha kwemvelo, futhi kwesinye isikhathi kuyadingeka ukusebenzisa ukucindezela okungalungile kunesimo somkhiqizo.
Ukusebenza kwezinto ezinobungozi obuhle kakhulu kubandakanyeka kwinqubo yokukhiqiza yomkhiqizo wokusebenza, futhi uhlelo lwayo lokuhlanza umoya nezinye izikhungo kufanele futhi zihlangabezane nezidingo ezikhethekile. Umehluko phakathi kwegumbi elihlanzekile le-biosafety kanye negumbi elihlanzekile lezimboni ukuqinisekisa ukuthi indawo yokusebenza igcina isimo esingesihle sokucindezela. Yize izinga lendawo yokukhiqiza elinjalo aliphakeme kakhulu, lizoba nezinga eliphakeme le-biohazard. Ngokuphathelene nengozi yemvelo, kunamazinga ahambisanayo eChina, ama-WTO nakwamanye amazwe emhlabeni. Ngokuvamile, izindlela ezamukelwa zedwa zedwa. Okokuqala, i-pathogen isolated kusuka opharetha yikhabethe lezokuphepha noma ibhokisi lokuhlukanisa, ikakhulukazi isithiyo ukuvimbela ukuchichima kwama-microorganisms ayingozi. Ukuhlukaniswa kwesibili kubhekisele ekuhlukanisweni kwelebhu noma kwendawo yomsebenzi kusuka ngaphandle ngokuyiguqula kube yindawo yokucindezela engemihle.

I-Shanghai ihlala igcina umuzwa ophakeme wokuzibophezela futhi inamathela kuzo zonke izinga ngenkathi isiza amaklayenti akhe amafektri emithi. Njengenkampani enamashumi eminyaka wokuhlangenwe nakho kokuhlinzeka ngobunjiniyela obuhlanganisiwe wezemithi, i-INEn inolwazi lwamakhulu ekubambisaneni komhlaba wonke. Yonke iphrojekthi yeShanghai i-IVing ihambisana ne-EU GMP / US FDA GMP, ubani i-GMP, i-PIC / S GMP, i-PMP kanye nezinye izimiso ezijwayelekile. Ngaphezu kokuhlinzeka amakhasimende ngezinsizakalo ezisezingeni eliphakeme, i-INEnNEn iphinde inamathele emcabangweni wokuthi "ukuhlinzeka ngempilo yabantu".

UShanghai Iven ubheke phambili ekusebenzeni nawe.