Ama-biopharmaceuticals abhekisela emithini ekhiqizwa esebenzisa i-biotechnology, efana namalungiselelo ezinto eziphilayo, imikhiqizo yemvelo, izidakamizwa zemvelo, njll. Selokhu ubumsulwa, ubuchwepheshe begumbi elihlanzekile budinga ukusetshenziselwa ukukhiqizwa inqubo yokuqinisekisa ikhwalithi yomkhiqizo nokuphepha. Idizayini, ukwakhiwa nokusebenza kwegumbi elihlanzekile le-GMP ye-GMP ye-GMP adinga ukuhambisana nokucaciswa kwe-GMP, okubandakanya ukulawulwa kokuhlanzeka komoya okuhlanzekile, izinga lokushisa, umswakama, umehluko wengcindezi kanye namanye amapharamitha, kanye nokuphathwa kwezisebenzi egumbini elihlanzekile. Ngasikhathi sinye, ubuchwepheshe begumbi elihlanzekile elihlanzekile kanye nemishini, njengokuhlunga kwe-hepa, ukugeza komoya, ibhentshi elihlanzekile, njll.
Idizayini yegumbi elihlanzekile le-GMP Pharmaceutical
1. Idizayini yegumbi elihlanzekile ayikwazi ukufeza izidingo zangempela zokukhiqiza. Kumaphrojekthi amasha egumbi elihlanzekile noma amaphrojekthi amakhulu okuvuselela amakamelo ahlanzekile, abanikazi ngokuvamile bathambekele ekuqashweni kwezikhungo ezihlelekile zokwakhiwa ukuze baklanywe. Kumaphrojekthi amancane ahlanzekile futhi aphakathi nendawo ahlanzekile, okucabanga ngezindleko, umnikazi uvame ukusayina isivumelwano nenkampani yobunjiniyela, futhi inkampani yobunjiniyela izoba nesibopho somsebenzi wokuqamba.
2. Ukudida inhloso yokuhlolwa kwegumbi elihlanzekile, ukuhlolwa kokusebenza kwegumbi elihlanzekile kanye nomsebenzi wokuhlola ukucubungula kuyisinyathelo esidingekayo kakhulu sokukala ukuthi izidingo zokwamukelwa zihlangatshezwa (ukuhlolwa kokwamukela) kanye nokuqinisekisa isimo esijwayelekile sokusebenza kwegumbi elihlanzekile (ukuhlolwa okujwayelekile) lapho ukwakhiwa kwegumbi elihlanzekile sekuphothuliwe. Ukuhlolwa kokwamukela kufaka izigaba ezimbili: Ukuqedelwa kokuqalisa nokuhlola okuphelele kokusebenza okuphelele kwegumbi elihlanzekile.
3. Izinkinga ekusebenzeni kwegumbi elihlanzekile
Ikhwalithi ye-①air ayikho ku-standard
Ukusebenza kwabasebenzi bakwa-②irregular
Ukulungiswa kwe-③Equipment akusona isikhathi
Ukuhlanza Okuhlanzekile
Ukulahlwa kukadoti ngokweqile kwe-⑤Improper
⑥Influence yezici zezemvelo
Kunamapharamitha ambalwa abalulekile ukunaka lapho uklama igumbi elihlanzekile le-GMP Pharmaceutical.
1. Ukuhlanzeka komoya
Inkinga yokuthi ungayikhetha kanjani kahle amapharamitha ku-Craft Products Workshop. Ngokusho kwemikhiqizo ehlukene yezandla, ukuthi ungakhetha kanjani kahle amapharamitha design kuyinkinga eyisisekelo ekwakhiweni. I-GMP ibeka izinkomba ezibalulekile ezibalulekile, okungukuthi, amazinga okuhlanzeka komoya. Ithebula elilandelayo libonisa amazinga okuhlanzeka komoya achazwe ezweni laku-1998 GMP e-My 20198: Ngasikhathi sinye, ubani (World Health Organisation) ne-EU (European Union) bobabili banezidingo ezihlukile zamazinga okuhlanzeka. . Amazinga angenhla abonise ngokusobala inombolo, usayizi, kanye nesimo sezinhlayiya.
Kuyabonakala ukuthi ukuhlanzeka kokuhlushwa kothuli okuphezulu kuphansi, futhi ukuhlanzeka kokuhlushwa kothuli okuphansi kuphezulu. Izinga lokuhlanzeka komoya liyinkomba ebalulekile yokuhlola imvelo yomoya ehlanzekile. Isibonelo, amazinga aphezulu angama-300,000 aqhamuka ekucacisweni okusha okukhishwe yi-Medical Bureau. Okwamanje akufanele kusetshenziswe kwinqubo yomkhiqizo oyinhloko, kepha kusebenza kahle lapho kusetshenziswa amakamelo asizayo.
2. Ukushintshaniswa komoya
Inani lokushintsha komoya ohlelweni olujwayelekile lokufaka umoya lungamahlandla ayi-8 kuya kwayi-10 ngehora, kanti inani lomoya lishintsha egumbini elihlanzekile lezimboni linezinga eliphansi kakhulu nangamakhulu ambalwa ezingeni eliphakeme. Ngokusobala, umehluko ngenombolo yezinguquko zomoya ubangela umehluko omkhulu womoya umehluko ekusebenziseni amandla. Emklameni, ngesisekelo sokuma okunembile kokuhlanzeka, izikhathi ezanele zokushintshana komoya kufanele ziqinisekiswe. Ngaphandle kwalokho, imiphumela yokusebenza ngeke ibe sezingeni eliphakeme, ikhono lokulwa negumbi elihlanzekile lizoba mpofu, umthamo wokuzihlanza uzoba ngcono ngokulandelana, futhi uchungechunge lwezinkinga luzodlula izinzuzo.
3. Umehluko wengcindezelo ye-static
Kunochungechunge lwezidingo ezifana nebanga phakathi kwamakamelo ahlanzekile amazinga ahlukene namakamelo angahlanzekile awakwazi ukuba ngaphansi kwama-5pa, futhi ibanga phakathi kwamakamelo ahlanzekile nangaphandle alikwazi ukuba ngaphansi kwe-10PA. Indlela yokulawula umehluko wengcindezi ye-static ikakhulukazi ukuhlinzeka ngevolumu yomoya othile omuhle. Amadivayisi wengcindezi amahle asetshenziswa ngokujwayelekile ekwakhiweni ama-valves asele asele, ama-aurol of volures ahlukene kagesi kanye nezingqimba zomoya ezifakiwe ezitolo ezibuyayo. Eminyakeni yamuva nje, indlela yokungafaki idivaysi enhle yokucindezela kepha yenza ivolumu yomoya etholakalayo kunevolumu yomoya kanye nokuphelisa ivolumu yomoya ngesikhathi sokukhokhiswa kokuqala kuvame ukusetshenziswa ekwakhiweni, futhi uhlelo oluhambisanayo lokuzenzakalelayo lungafinyelela umphumela ofanayo.
4. I-AirFlow Inhlangano
Iphethini yenhlangano ye-AirFlow yegumbi elihlanzekile yinto ebalulekile ekuqinisekiseni izinga lokuhlanzeka. Ifomu le-AirFlow lenhlangano livame ukwamukelwa emklamo wamanje kunqunywa ngokusekelwe kwizinga lokuhlanzeka. Isibonelo, igumbi elihlanzekile le-Class 300,000 livame ukusebenzisa okuphakelayo okuphezulu kanye nokubuyiselwa kwezindiza okuphezulu, ikilasi le-Clean 10000 Cleaseroom Cleading livame ukusebenzisa ukuhamba komoya okuphezulu kanye nokuhlanza okuphezulu kwe-airkuw, kanye nokuhlanza okuphezulu kokugeleza okuvundlile .
5. Ukushisa kanye nomswakama
Ngokungeziwe kubuchwepheshe obukhethekile, ngokombono wokushisa, umoya omncane kanye nesimo somoya, ikakhulukazi ugcina induduzo yokusebenzisa, okungukuthi, izinga lokushisa elifanele nomswakama ofanele. Ngaphezu kwalokho, kunezinkomba eziningana okufanele zidonse ukunaka kwethu, njengesivinini somoya esiphambanisa nesigaba se-tuyere duct, umsindo, isivinini somoya esisezingeni eliphansi se-dutere duct, umsindo, nesilinganiso, kanye nesilinganiso sevolumu yomoya entsha, njll. Lezi zici azinakunakwa ekwakhiweni. Cabanga.
Idizayini yegumbi elihlanzekile le-biopharmaceutical
Amakamelo okuhlanza okuzalwa ahlukaniswe izigaba ezimbili; Amakamelo okuhlanza okujwayelekile okujwayelekile kanye namakamelo okuphepha okuphilayo. Abaqambi be-HVAC Engineering bavame ukuvezwa kwangaphambili, okulawula ngokuyinhloko ukungcoliswa kopharetha ngezinhlayiya eziphilayo. Ngokwezinga elithile, yigumbi elihlanzekile lezimboni elingeza izinqubo zokufaka izinsimbi. Okwezikameli ezihlanzekile zezimboni, ekwakhiweni ochwepheshe kohlelo lwe-HVAC, izindlela ezibalulekile zokulawula izinga lokuhlanzeka kungokuhlunga nokucindezela okuhle. Kwamakamelo okuhlanza okuphilayo, ngaphezu kokusebenzisa izindlela ezifanayo namakamelo okuhlanza izimboni, kuyadingeka futhi ukubheka isici sokuphepha esiphilayo. Kwesinye isikhathi kuyadingeka ukusebenzisa ingcindezi engemihle ukuvikela imikhiqizo ekungcoliseni imvelo.
Isikhathi sePosi: Dec-25-2023