Ukufanekiswa okuphelele kobuchwepheshe obuhlanzekile yilokho esivame ukukubiza ngokuthi igumbi elihlanzekile lemboni yemithi, elihlukaniswe ngokuyinhloko izigaba ezimbili: igumbi elihlanzekile lezimboni kanye negumbi elihlanzekile lezinto eziphilayo. izinhlayiya zezinto eziphilayo, kuyilapho umsebenzi oyinhloko wegumbi elihlanzekile lezinto eziphilayo ukulawula ukungcoliswa kwezinhlayiya zezinto eziphilayo.I-GMP iyindinganiso yokukhiqiza imithi kanye nokuphathwa kwekhwalithi, okuqinisekisa ngokuphumelelayo ukuphepha kanye nekhwalithi yemithi. Enqubweni yokuklama, ukwakhiwa kanye nokusebenza kwamakamelo ahlanzekile embonini yezemithi, izindinganiso ezifanele zamakamelo ahlanzekile kanye nezidingo zokucaciswa kwekhwalithi yokulawulwa kokukhiqizwa kwemithi kufanele kulandelwe. Okulandelayo, sizokhuluma ngomklamo wegumbi elihlanzekile lefekthri ehlanzekile yezemithi ngokuhambisana nemithethonqubo yokuhlobisa ingaphakathi “ku-Design Specifications for the Clean Factory of the Pharmaceutical Industry”, kuhlanganiswe nolwazi luka-Shanghai IVEN ekwakhiweni kobunjiniyela. izimboni ezididiyelwe zemithi.

I-Industrial Cleanroom Design
Emakamelweni ahlanzekile ezimbonini, izitshalo zemithi ziyimiklamo yobunjiniyela esivame ukuhlangana nayo. Ngokwezidingo ze-GMP zamakamelo ahlanzekile, kunemingcele eminingana ebalulekile okufanele inakwe.

1. Inhlanzeko
Inkinga yendlela yokukhetha kahle amapharamitha ku-workshop yomkhiqizo wobuciko. Ngokusho kwemikhiqizo ehlukene yobuchwepheshe, indlela yokukhetha imingcele yokuklama ngendlela efanele kuyinkinga eyisisekelo ekwakhiweni. Inkomba ebalulekile ihlongozwa ku-GMP, okungukuthi, izinga lokuhlanzeka komoya. Izinga lokuhlanzeka komoya liyinkomba eyinhloko yokuhlola ukuhlanzeka komoya. Uma izinga lokuhlanzeka komoya lingalungile, kuzovela umcimbi wamahhashi amakhulu adonsa inqola encane, engeyona ukonga noma ukonga amandla. Isibonelo, ukucaciswa kwephakheji okusha kwezinga lezinga elingu-300,000 elingafanele ukulisebenzisa kunqubo yomkhiqizo oyinhloko okwamanje, kodwa elisebenza kahle kakhulu kwamanye amagumbi asizayo.

Ngakho-ke, ukukhetha ukuthi yiliphi izinga elihlobene ngokuqondile nekhwalithi nezinzuzo zezomnotho zomkhiqizo. Imithombo yothuli ethinta ukuhlanzeka ikakhulukazi ivela ekukhiqizweni kothuli lwezinto ohlelweni lokukhiqiza, ukugeleza kwama-opharetha kanye nezinhlayiya zothuli lwasemkhathini ezilethwa umoya ohlanzekile wangaphandle. Ngaphezu kokusetshenziswa kwemishini yokukhipha imfucumfucu evaliwe kanye nokukhipha uthuli imishini yenqubo ekhiqiza uthuli, izindlela ezisebenzayo zokulawula ukungena kwemithombo yothuli ekamelweni ukusebenzisa ukuhlunga okuyisisekelo, okumaphakathi kanye nokusebenza kahle okuphezulu kwezigaba ezintathu kwentsha. buyisela umoya wesistimu ye-air-conditioning kanye negumbi lokugeza lephaseji labasebenzi.

2. Isilinganiso sokushintshana komoya
Ngokuvamile, inani lezinguquko zomoya ohlelweni lwe-air-conditioning izikhathi ezingu-8 kuya kweziyi-10 kuphela ngehora, kuyilapho izinga eliphansi lokushintsha komoya ekamelweni elihlanzekile lezimboni liphindwe izikhathi ezingu-12, futhi izinga eliphakeme kakhulu izikhathi ezingamakhulu. Ngokusobala, umehluko wezinga lokushintshaniswa komoya kubangela umehluko omkhulu kumthamo womoya kanye nokusetshenziswa kwamandla.Ekuklanyweni, ngesisekelo sokuma okunembile kokuhlanzeka, kuyadingeka ukuqinisekisa izikhathi ezanele zokuphuza umoya. Uma kungenjalo, uchungechunge lwezinkinga lungase luvele, njengemiphumela yokusebenza engekho ezingeni, amandla okulwa nokuphazamiseka kwekamelo elihlanzekile ampofu.

3. Umehluko we-Static pressure
Umehluko wengcindezi phakathi kwamagumbi ahlanzekile namagumbi angahlanzekile emazingeni ahlukene akufanele abe ngaphansi kuka-5pa, futhi ukucindezela phakathi kwamagumbi ahlanzekile namagumbi angaphandle akufanele kube ngaphansi kuka-10Pa. Indlela yokulawula umehluko wengcindezi emile iwukuhlinzeka ngomthamo othile womoya wokucindezela okuhle. Imishini yokucindezela okuhle evame ukusetshenziswa ekwakhiweni i-valve yokucindezela eyinsalela, isilawuli sevolumu yomoya kagesi ehlukile kanye nongqimba oludambisa umoya olufakwe endaweni yokuphuma komoya. Eminyakeni yamuva nje, kuvame ukwamukelwa ekwakhiweni kokuthi umthamo womoya wokuhlinzeka mkhulu kunomthamo womoya wokubuyisela kanye nevolumu yomoya wokukhipha ekuthumeni kokuqala ngaphandle kwedivayisi yokucindezela okuhle, futhi uhlelo lokulawula oluzenzakalelayo oluhambisanayo lungafinyelela umphumela ofanayo.

4. Ukusabalalisa umoya
Ifomu lokusabalalisa umoya wekamelo elihlanzekile yisici esibalulekile sokuqinisekisa ukuhlanzeka. Ifomu lokusabalalisa umoya elivame ukutholwa ekwakhiweni kwamanje linqunywa ngokwezinga lokuhlanzeka. Isibonelo, igumbi elihlanzekile lekilasi elingu-300,000 livamise ukusebenzisa indlela yokuthumela phezulu nangemuva, amagumbi ahlanzekile ekilasi elingu-100,000 kanye nesigaba esingu-10,000 ngokuvamile asebenzisa indlela yokugeleza komoya yokubuya kwezinhlangothi ezingenhla neziphansi, kanye nesigaba esiphezulu esihlanzekile. igumbi lithatha ukugeleza kwendlela eyodwa evundlile noma eqondile.

5. Izinga lokushisa kanye nomswakama
Ngaphandle kwezinqubo ezikhethekile, ngokombono wokushisa, ukungena komoya kanye nomoya womoya, ikakhulukazi ukugcina induduzo yabaqhubi, okungukuthi, izinga lokushisa elifanele kanye nomswakama. Ngaphezu kwalokho, kunezinkomba eziningana okufanele zivuse ukunaka kwethu, njengesivinini somoya esiphambanayo se-air duct, umsindo, ukukhanya kanye nesilinganiso sevolumu yomoya omusha njll, konke okungenakunakwa ekuklanyeni.

Idizayini yegumbi elihlanzekile
Amakamelo ahlanzekile ezinto eziphilayo ahlukaniswe ikakhulukazi izigaba ezimbili; amagumbi ahlanzekile ezinto eziphilayo kanye namakamelo ahlanzekile okuphepha kwezinto eziphilayo. Emakamelweni ahlanzekile ezimbonini, ekwakhiweni kobuchwepheshe bokushisa, ukungena komoya kanye nesimo somoya, izindlela ezibalulekile zokulawula izinga lokuhlanzeka zingokuhlunga nokucindezela okuhle. Emakamelweni ahlanzekile ngokwebhayoloji, ngaphezu kokusebenzisa izindlela ezifanayo njengamagumbi ahlanzekile ezimbonini, kufanele futhi kubhekwe ngokombono wokuphepha kwezinto eziphilayo, futhi ngezinye izikhathi kuyadingeka ukusebenzisa izindlela zokucindezela okungekuhle ukuvimbela ukungcoliswa komkhiqizo endaweni ezungezile.
Ukusebenza kwezici eziyingozi kakhulu ze-pathogenic kuhilelekile ekukhiqizeni umkhiqizo ongaphakathi kwenqubo, futhi uhlelo lwayo lokuhlanza umoya nezinye izikhungo kufanele futhi zihlangabezane nezidingo ezikhethekile. Umehluko phakathi kwegumbi elihlanzekile le-biosafety kanye negumbi elihlanzekile lezimboni uwukuqinisekisa ukuthi indawo yokusebenza igcina isimo sengcindezi esibi. Nakuba izinga lendawo yokukhiqiza enjalo lingephezulu kakhulu, izoba nezinga eliphezulu le-biohazard. Mayelana nengozi yezinto eziphilayo, kunezindinganiso ezihambisanayo e-China, WTO nakwamanye amazwe emhlabeni. Ngokuvamile, izinyathelo ezithathwayo ziwukuhlukaniswa kwesibili. Okokuqala, i-pathogen ihlukaniswe no-opharetha yikhabhinethi yokuphepha noma ibhokisi lokuzihlukanisa, okuyinto ngokuyinhloko isithiyo sokuvimbela ukuchichima kwama-microorganisms ayingozi. Ukuhlukaniswa kwesibili kubhekisela ekuhlukaniseni ilabhorethri noma indawo yokusebenza ngaphandle ngokuyiguqula ibe indawo enengcindezi engalungile.Ohlelweni lokuhlanza umoya, izinyathelo ezithile nazo zithathwa ngokufanele, njengokugcina ingcindezi engemihle engu-30Pa~10Pa endlini, kanye ukusetha indawo yebhafa yengcindezi engalungile phakathi kwendawo engahlanzekile eseduze.

I-Shanghai VEN ihlale ilondoloza umuzwa ophezulu wokuba nesibopho futhi inamathela kuwo wonke amazinga kuyilapho isiza amakhasimende akhe izimboni zokwenza imithi. Njengenkampani enamashumi eminyaka yokuhlangenwe nakho ekuhlinzekeni ubunjiniyela bemithi obudidiyelwe, i-IVEN inamakhulu okuhlangenwe nakho ekubambisaneni kwamazwe ngamazwe. Yonke iphrojekthi ye-Shanghai IVEN ihambisana ne-EU GMP/US FDA GMP, WHO GMP, PIC/S GMP nezinye izimiso ezijwayelekile. Ngaphandle kokuhlinzeka amakhasimende ngezinsizakalo ezisezingeni eliphezulu, i-VEN iphinde ihambisane nomqondo "wokunikeza impilo kubantu" .

I-Shanghai VEN ibheke ngabomvu ukusebenza nawe.