Ukugcwaliswa kwamaphilisi angenalutho kuyinqubo ewumnyombo ekukhiqizeni amafomu omthamo oqinile, futhi ikhwalithi yendawo yokukhiqiza yawo inquma ngokuqondile ukuphepha, ukuqina, nokusebenza ngempumelelo komuthi. Ngenxa yokuthi amaphilisi angenalutho ane-hygroscopic, athambekele ekungcoleni, futhi athintana ngqo nemithi ngesikhathi sokugcwaliswa, indawo yokukhiqiza ingaphansi kwezidingo eziqinile kakhulu. Kufanele ilawulwe kuzo zonke izici ngokuhambisana ngokuqinile Nemikhuba Yokukhiqiza Okuhle (GMP), okuhlanganisa ukuhlanzeka, izinga lokushisa kanye nomswakama, umehluko wengcindezi, okokusebenza kwesikhungo, nokuphathwa kwabasebenzi.
1. Ukulawulwa Kwenhlanzeko: Ukuvimba Ukungcola Kwe-Microbial kanye Nezinhlayiyana
Ukuhlanzeka kuyinkomba eyinhloko yendawo yokugcwalisa i-capsule engenalutho. Ngokwamazinga e-GMP, ukugcwaliswa kwe-capsule okungeyona{1}}inyumba eyinyumba ngokuvamile kwenziwa endaweni ehlanzekile yeBanga D, edinga izinhlayiya eziphathwa ngomoya ezingaphezu kuka-3,520,000 Ezinkulu noma ezilingana no-0.5μm m³ futhi ukulungisa ama-microbes angekho ngaphezu kuka-200 CFU/ipuleti. Kuma-capsules angenalutho, ukugcwaliswa kufanele kwenziwe endaweni yeBanga A ukugeleza okukodwa ngaphakathi kwesizinda seBanga D, enezinhlayiya eziphathwa ngomoya ezingekho ngaphezu kuka-3,500 m³ futhi kuhlaliswe amagciwane angeqi ku-1 CFU/ipuleti. Izindawo ezihlanzekile kufanele zihlanzwe{12}ngohlelo lokuhlunga umoya oluyizigaba ezintathu (ngaphambili{13}}, olumaphakathi-, kanye{15}}nokusebenza kahle{15}okuphezulu) futhi njalo zihlolelwe izinkomba ezifana nezinhlayiya ezihamba emoyeni, amagciwane antantayo, kanye nokuhlalisa amagciwane ukuze kuqinisekiswe ukuthobelana okuqhubekayo, ukuvimbela ukungcoliswa kwama-microbial kanye nengxenye yezidakamizwa.
2. Ukulawulwa Kwezinga lokushisa Okunembile Nomswakama: Ukuqinisekisa Ukuzinza Kwamakhepsuli kanye Nezinto Zokusebenza
Ingxenye eyinhloko yama-capsules angenalutho i-gelatin, ezwela kakhulu izinga lokushisa nomswakama. Umswakama ophezulu ungabangela amaphilisi ukuthi athambe, anamathele, noma akhubazeke, kuyilapho umswakama ophansi ungawenza abe brittle futhi andise izinga lokuphuka. Ngesikhathi esifanayo, izinga lokushisa nomswakama nakho kuthinta ukugeleza kwezinto kanye nokunemba kokugcwalisa. Ngakho-ke, izinga lokushisa endaweni yokugcwalisa kufanele lilawulwe ngokuqinile phakathi kuka-18-no-26℃kanye nomswakama ohlobene phakathi kuka-45% -65%. Ukuze kuzuzwe lokhu, izindawo ezihlanzekile kufanele zifakwe ngokunemba kwezinhlelo zesimo somoya eziqapha futhi zilungise izinga lokushisa kanye nomswakamo ngesikhathi sangempela, ziqinisekise indawo yokukhiqiza ezinzile kanye nokuvimbela izinkinga zekhwalithi noma ukungalungi kwemithamo okubangelwa ukushintshashintsha kwemvelo.
3. Umehluko Wengcindezi kanye Nenhlangano Yokugeleza Komoya: Ukuvimbela Ukuphambana{1}}Ukungcoliswa
Ukuze uvimbele ukubuyela emuva komoya ezindaweni-ezisezingeni eliphansi ezingabangela-ukungcola, umehluko ozwakalayo wengcindezi kufanele ugcinwe phakathi kwezindawo ezinamaleveli ahlukene okuhlanzeka. Ngokuvamile, umehluko wengcindezi phakathi kwendawo ehlanzekile -nendawo engahlanzekile, naphakathi kwamagumbi aseduze amaleveli okuhlanzeka ahlukene, kufanele abe Mkhulu noma alingane no-10 Pa, kuyilapho umehluko wengcindezi yendawo ehlanzekile uma uqhathanisa nengaphandle kufanele ube Mkhulu noma ulingane no-15 Pa. Inhlangano yokugeleza komoya kufanele isebenzise i-Unidirectional Flow isuka ezindaweni ezihlukene{7}}Zokugeleza okuqondile noma kokungaqondile{7}}kusuka endaweni eqondile{7}} ukuhlanzeka ezindaweni zokuhlanzeka okuphansi, ukugwema ama-eddies namakhona afile. Lokhu kususa ngempumelelo uthuli namagciwane akhiqizwa ngesikhathi sokukhiqiza futhi kuvikela ikhwalithi yomoya yendawo yokusebenza.
4. Isikhungo, Izinsiza, kanye Nokuphathwa Kwezinto: Ukunciphisa Izingozi Zokungcoliswa
Iphansi, izindonga, nosilingi ezindaweni ezihlanzekile kufanele kwakhiwe ngendlela engenamthungo, engagqwali-engagqwali, futhi{1}}nezisetshenziswa{2}}zokuhlanza kalula (njenge-epoxy resin noma amapuleti ensimbi anombala) anezindawo ezibushelelezi, eziyisicaba ezingaqongeleli kalula uthuli. Izinto ezingaphezulu kufanele zibe bushelelezi futhi zingabi namakhona afile. Izingxenye ezithintana ngqo nezinto ezibonakalayo kufanele zenziwe{5}ngensimbi engagqwali{5}engenabuthi,{6}}engazweli ku-316L futhi zihlale zihlanzwa futhi zibulawe amagciwane. Imishini efana nemishini yokugcwalisa kanye nemishini yokupholisha kufanele yakhelwe njengezinhlelo ezivalekile ukuze kuncishiswe ukusakazeka kothuli, futhi ifakwe imishini yokukhipha uthuli yendawo. Ngaphambi kokungena endaweni ehlanzekile, izinto ezisetshenziswayo kufanele zidlule endaweni yokuvala umoya noma efasiteleni lokudlulisa, futhi ukupakishwa kwazo kwangaphandle kufanele kuhlanzwe futhi kubulawe amagciwane ukuze kuvinjelwe ukungenisa ukungcola kwangaphandle.
5. Ukuphathwa Kwabasebenzi Nenhlanzeko: Ukunqamula Abantu{1}}Imithombo Yokungcolisa Okwenziwe
Abasebenzi bawumthombo omkhulu wokungcola. Ukungena endaweni ehlanzekile kudinga inqubo yokugqoka eqinile: ukushintsha izicathulo, ukugeza izandla, nokugqoka izingubo zegumbi elihlanzekile (okuhlanganisa nesigqoko, imaski, amagilavu, nezicathulo zegumbi elihlanzekile) ukuqinisekisa ukuthi azikho izinwele noma isikhumba esivezwayo. Abasebenzisi kufanele bathole ukuqeqeshwa kochwepheshe ukuze bajwayelane nemithetho ye-GMP kanye nezinqubo zokusebenza. Izimonyo nobucwebe akuvunyelwe, futhi ukunyakaza okungadingekile nengxoxo kufanele kuncishiswe. Ngaphezu kwalokho, izindawo ezihlanzekile kumele zibe nezinqubo eziqinile zokuhlanza nokubulala amagciwane ukuze zihlanzwe nsuku zonke kanye nokubulala amagciwane ngezikhathi ezithile phansi, izinto zokusebenza namathuluzi ukuvimbela ukukhula kwamagciwane.
6. Ukuqapha Nokugcinwa Kwemvelo: Ngokuqhubekayo Ukuqinisekisa Ukuthobelana
Izinkampani kufanele zisungule uhlelo oluphelele lokuqapha imvelo ukuze zihlole njalo izinkomba ezifana nezinhlayiya ezihamba emoyeni, amagciwane, izinga lokushisa, umswakama, nokwehluka kwengcindezi endaweni ehlanzekile. Idatha kufanele irekhodwe futhi ihlaziywe ukuze kutholwe futhi kulungiswe ngokushesha noma yikuphi ukungahambi kahle. Uhlelo lokuhlanza umoya ludinga ukunakekelwa okuvamile, okuhlanganisa ukushintshwa kwesihlungi, ukuqinisekisa ukusebenza kahle kwalo. Ukwengeza, ukuqhubeka nokusebenza kahle nokuthembeka kwezinhlelo zokulawula imvelo kufanele kuqinisekiswe ngokuqinisekiswa kanye{3}}nokuqinisekisa kabusha, kuhlinzekwe ngendawo yokukhiqiza ezinzile futhi ethobelayo yokugcwaliswa kwekhepisi elingenalutho.
Sengiphetha, ukulawula indawo yokugcwalisa i-capsule engenalutho kuwumsebenzi ohlelekile odinga ukunakwa okuqinile ezingxenyeni eziningi, okuhlanganisa ukuhlanzeka, izinga lokushisa kanye nomswakama, umehluko wengcindezi, imishini yesikhungo, nokuphathwa kwabasebenzi. Kuphela ngokusungula uhlelo lwesayensi lokulawulwa kwemvelo lapho izinga lamaphilisi angenalutho lingaqinisekiswa ngokuphumelelayo, kuqinisekiswe ukuphepha kwezidakamizwa kanye nokuhlinzeka iziguli ngemithi ethembekile. Uma kukhona imibuzo mayelana namaphilisi angenalutho, wamukelekile ukuthintanaKornnacCaps.
