I-Biopharmaceuticals ibhekisela emithini ekhiqizwa kusetshenziswa i-biotechnology, njengamalungiselelo ebhayoloji, imikhiqizo yebhayoloji, izidakamizwa zebhayoloji, njll. Njengoba ubumsulwa, umsebenzi kanye nokuzinza komkhiqizo udinga ukuqinisekiswa ngesikhathi sokukhiqizwa kwe-biopharmaceuticals, ubuchwepheshe begumbi elihlanzekile budinga ukusetshenziswa ekukhiqizeni. inqubo yokuqinisekisa ikhwalithi nokuphepha komkhiqizo.Ukwakhiwa, ukwakhiwa kanye nokusebenza kwegumbi elihlanzekile le-biopharmaceutical GMP kudinga ukuthotshelwa okuqinile kwemininingwane ye-GMP, okubandakanya ukulawulwa kokuhlanzeka komoya kwegumbi, izinga lokushisa, umswakama, umehluko wengcindezi kanye neminye imingcele, kanye nokuphathwa kwabasebenzi, imishini, izinto zokwakha kanye nemfucuza. ekamelweni elihlanzekile.Ngesikhathi esifanayo, ubuchwepheshe obuthuthukisiwe begumbi elihlanzekile kanye nemishini, njengesihlungi se-hepa, ishawa yomoya, ibhentshi elihlanzekile, njll nakho kuyadingeka ukuze kuqinisekiswe ukuthi izinga lomoya kanye namazinga e-microbial ekamelweni elihlanzekile ahlangabezana nezidingo.
Idizayini yegumbi elihlanzekile le-gmp elenziwe ngemithi
1. Idizayini yegumbi elihlanzekile ayikwazi ukuhlangabezana nezidingo zangempela zokukhiqiza.Kumaphrojekthi amasha ekamelo elihlanzekile noma amaphrojekthi amakhulu okulungiswa kwamakamelo ahlanzekile, abanikazi ngokuvamile bavame ukuqasha izikhungo zedizayini ezisemthethweni zokuklama.Kumaphrojekthi amakamelo ahlanzekile amancane naphakathi nendawo, uma kucatshangelwa izindleko, Umnikazi ngokuvamile uzosayina inkontileka nenkampani yobunjiniyela, futhi inkampani yobunjiniyela izoba nesibopho somsebenzi wokuklama.
2. Ukuze kudideke injongo yokuhlolwa kwegumbi elihlanzekile, ukuhlola ukusebenza kwegumbi elihlanzekile nomsebenzi wokuhlaziya kuyisinyathelo esidingeka kakhulu sokulinganisa ukuthi izidingo zedizayini ziyahlangatshezwa yini (ukuhlolwa kokwamukelwa) nokuqinisekisa isimo esivamile sokusebenza segumbi elihlanzekile (ukuhlola okuvamile) lapho ukwakhiwa kwegumbi elihlanzekile sekuqediwe.Ukuhlolwa kokwamukela kuhlanganisa izigaba ezimbili: ukuthunyelwa kokuqedwa nokuhlola okuphelele kokusebenza okuphelele kwegumbi elihlanzekile.
3. Izinkinga ekusebenzeni kwegumbi elihlanzekile
①Ikhwalithi yomoya ayikho ezingeni
②Ukusebenza kwabasebenzi okungajwayelekile
③Ukulungiswa kwezisetshenziswa akufike ngesikhathi
④Ukuhlanza okungaphelele
⑤Ukulahlwa kukadoti ngendlela engafanele
⑥Ithonya lezici zemvelo
Kunemingcele eminingana ebalulekile okufanele uyinake lapho uklama igumbi elihlanzekile lezemithi le-GMP.
1. Ukuhlanzeka komoya
Inkinga yendlela yokukhetha kahle amapharamitha ku-workshop yemikhiqizo yezandla.Ngokusho kwemikhiqizo yezandla ehlukene, indlela yokukhetha kahle amapharamitha wokuklama kuyinkinga ebalulekile ekwakhiweni.I-GMP ibeka phambili izinkomba ezibalulekile, okungukuthi, amazinga okuhlanzeka komoya.Ithebula elilandelayo libonisa amazinga okuhlanzeka komoya ashiwo ku-GMP yezwe lami ka-1998: Ngesikhathi esifanayo, i-WHO (World Health Organization) kanye ne-EU (European Union) zombili zinezidingo ezihlukene zamazinga okuhlanzeka..Amazinga angenhla abonise ngokucacile inombolo, usayizi, kanye nesimo sezinhlayiya.
Kungabonakala ukuthi ukuhlanzeka kokugxila kothuli oluphezulu kuphansi, futhi ukuhlanzeka kokugxila kothuli oluphansi kuphezulu.Izinga lokuhlanzeka komoya liyinkomba eyinhloko yokuhlola indawo yomoya ehlanzekile.Isibonelo, izinga leleveli engu-300,000 livela encazelweni entsha yokupakisha ekhishwe yi-Medical Bureau.Okwamanje akufanelekile ukusetshenziswa enqubweni yomkhiqizo oyinhloko, kodwa isebenza kahle uma isetshenziswa kwamanye amagumbi asizayo.
2. Ukushintshana komoya
Inombolo yezinguquko zomoya ohlelweni olujwayelekile lwe-air-conditioning izikhathi ezingu-8 kuya kweziyi-10 kuphela ngehora, kuyilapho inani lokushintsha komoya ekamelweni elihlanzekile lezimboni liphindwe izikhathi ezingu-12 ezingeni eliphansi kakhulu futhi izikhathi ezingamakhulu ambalwa ezingeni eliphakeme kakhulu.Ngokusobala, umehluko enanini lezinguquko zomoya kubangela umthamo womoya Umehluko omkhulu ekusetshenzisweni kwamandla.Emklamo, ngesisekelo sokuma okunembile kokuhlanzeka, izikhathi ezanele zokushintshaniswa komoya kufanele ziqinisekiswe.Uma kungenjalo, imiphumela yokusebenza ngeke ibe sezingeni, ikhono legumbi elihlanzekile lokunqanda ukuphazamiseka lizoba lincane, umthamo wokuzihlanza uzokwelulwa ngokuhambisanayo, futhi uchungechunge lwezinkinga luzodlula izinzuzo.
3. Umehluko we-Static pressure
Kukhona uchungechunge lwezidingo ezifana nebanga phakathi kwamagumbi ahlanzekile amazinga ahlukene namagumbi angahlanzekile awakwazi ukuba ngaphansi kuka-5Pa, futhi ibanga phakathi kwamagumbi ahlanzekile nangaphandle alikwazi ukuba ngaphansi kuka-10Pa.Indlela yokulawula umehluko wengcindezi emile iwukuhlinzeka ngevolumu yomoya wengcindezi ethile.Imishini yokucindezela i-positive evame ukusetshenziswa ekuklanyeni ama-valve okucindezela ayinsalela, izilawuli zevolumu yomoya kagesi ohlukile kanye nezendlalelo zokudambisa umoya ezifakwe ezindaweni zokubuya komoya.Eminyakeni yamuva nje, indlela yokungafaki idivayisi yokucindezela okuhle kodwa okwenza umthamo womoya wokuhlinzeka ube mkhulu kunomthamo womoya obuyayo kanye nevolumu yomoya wokukhipha umoya ngesikhathi sokugunyazwa kokuqala ivame ukusetshenziswa ekwakhiweni, futhi uhlelo lokulawula oluzenzakalelayo oluhambisanayo lungakwazi futhi ukufeza umphumela ofanayo.
4. Inhlangano ye-Airflow
Iphethini yenhlangano yokugeleza komoya yegumbi elihlanzekile iyisici esibalulekile ekuqinisekiseni izinga lokuhlanzeka.Ifomu lenhlangano yokugeleza komoya elivame ukwamukelwa ekwakhiweni kwamanje linqunywa ngokusekelwe ezingeni lokuhlanzeka.Isibonelo, igumbi elihlanzekile lekilasi elingu-300,000 livamise ukusebenzisa ukugeleza komoya okuphezulu nokubuya okuphezulu, amadizayini egumbi elihlanzekile lekilasi 10000 kanye nesigaba 10000 ngokuvamile asebenzisa ukugeleza komoya okuseceleni eliphezulu nokubuya komoya ohlangothini oluphansi, futhi amagumbi ahlanzekile asezingeni eliphezulu asebenzisa ukugeleza okuqondile okuvundlile noma okuqondile. .
5. Izinga lokushisa kanye nomswakama
Ngaphandle kobuchwepheshe obukhethekile, ngokombono wokushisa, umoya omncane kanye nesimo somoya, ikakhulukazi igcina induduzo yomqhubi, okungukuthi, izinga lokushisa elifanele kanye nomswakama.Ngaphezu kwalokho, kunezinkomba ezimbalwa okufanele zidonse ukunaka kwethu, njengesivinini somoya esiphambanayo se-tuyere duct, umsindo, isivinini somoya esinqamula isigaba se-tuyere duct, umsindo, ukukhanya, kanye nesilinganiso sevolumu yomoya omusha, njll. Lezi zici azikwazi ukuzitshwa ekwakhiweni.cabangela.
Umklamo wegumbi elihlanzekile le-Biopharmaceutical
Amakamelo ahlanzekile ezinto eziphilayo ahlukaniswe ikakhulukazi izigaba ezimbili;amagumbi ahlanzekile ezinto eziphilayo kanye namakamelo ahlanzekile okuphepha kwezinto eziphilayo.Abaklami bonjiniyela be-HVAC ngokuvamile bavezwa kokwangaphambili, okulawula ngokuyinhloko ukungcoliswa komsebenzisi yizinhlayiya eziphilayo.Ngokwezinga elithile, liyigumbi elihlanzekile lezimboni elengeza izinqubo zokuvala inzalo.Emakamelweni ahlanzekile ezimbonini, ekwakhiweni kochwepheshe kohlelo lwe-HVAC, indlela ebalulekile yokulawula izinga lenhlanzeko iwukuhluza nokucindezela okuhle.Emakamelweni ahlanzekile ngokwebhayoloji, ngaphezu kokusebenzisa izindlela ezifanayo njengamagumbi ahlanzekile ezimbonini, kuyadingeka futhi ukucabangela isici sokuphepha sebhayoloji.Kwesinye isikhathi kuyadingeka ukusebenzisa ingcindezi engalungile ukuvimbela imikhiqizo ukuthi ingangcolisi imvelo.
Isikhathi sokuthumela: Dec-25-2023