Ukuhamba koketshezi akuhlukaniseki nomphumela "womehluko wokucindezela". Endaweni ehlanzekile, umehluko wokucindezela phakathi kwegumbi ngalinye uma kuqhathaniswa nomoya wangaphandle ubizwa ngokuthi "umehluko wokucindezela ophelele". Umehluko wokucindezela phakathi kwegumbi ngalinye eliseduze nendawo eseduze ubizwa ngokuthi "umehluko wokucindezela ohlobene", noma "umehluko wokucindezela" ngamafuphi. Umehluko wokucindezela phakathi kwegumbi elihlanzekile namakamelo axhumene eduze noma izikhala ezizungezile kuyindlela ebalulekile yokugcina ukuhlanzeka kwangaphakathi noma ukunciphisa ukusabalala kokungcola kwangaphakathi. Izimboni ezahlukene zinezidingo ezahlukene zomehluko wokucindezela kwamakamelo ahlanzekile. Namuhla, sizokwabelana nawe ngezidingo zomehluko wokucindezela zemininingwane eminingi evamile yegumbi elihlanzekile.
Imboni yezemithi
①I-"Good Manufacturing Practice for Pharmaceutical Products" ibeka ukuthi: Umehluko wokucindezela phakathi kwezindawo ezihlanzekile nezindawo ezingahlanzekile kanye naphakathi kwezindawo ezihlanzekile ezahlukene akufanele ube ngaphansi kwama-10Pa. Uma kudingeka, kufanele kugcinwe imingcele yokucindezela efanele phakathi kwezindawo zokusebenza ezahlukene (amakamelo okusebenza) zezinga elifanayo lokuhlanzeka.
②I-"Veterinary Drug Manufacturing Good Manufacturing Practice" ibeka ukuthi: Umehluko wokucindezela okungaguquki phakathi kwamakamelo ahlanzekile aseduze (izindawo) anamazinga ahlukene okuhlanzeka komoya kufanele ube ngaphezu kwama-5 Pa.
Umehluko wengcindezi engaguquki phakathi kwegumbi elihlanzekile (indawo) kanye negumbi elingahlanzekile (indawo) kufanele ube ngaphezu kwama-10 Pa.
Umehluko wengcindezi engaguquki phakathi kwegumbi elihlanzekile (indawo) kanye nomoya ongaphandle (kufaka phakathi izindawo ezixhunywe ngqo ngaphandle) kufanele ube ngaphezu kuka-12 Pa, futhi kufanele kube nedivayisi ekhombisa umehluko wengcindezi noma uhlelo lokuqapha kanye ne-alamu.
Kuma-workshop ahlanzekile egumbi lokusebenzela lemikhiqizo yezinto eziphilayo, inani eliphelele lomehluko wokucindezela okungaguquki ochazwe ngenhla kufanele linqunywe ngokuya ngezidingo zenqubo.
③Izindinganiso Zokuklama Amakamelo Okuhlanzeka Kwemithi zithi: Umehluko wokucindezela komoya okungaguquki phakathi kwamakamelo okuhlanzeka kwezokwelapha anamazinga ahlukene okuhlanzeka komoya kanye naphakathi kwamakamelo ahlanzekile namakamelo angahlanzekile akufanele ube ngaphansi kuka-10Pa, kanye nomehluko wokucindezela okungaguquki phakathi kwamakamelo okuhlanzeka kwezokwelapha kanye nomoya wangaphandle akufanele ube ngaphansi kuka-10Pa.
Ngaphezu kwalokho, amakamelo alandelayo ahlanzekile emithi kufanele afakwe amadivayisi abonisa umehluko wokucindezela:
Phakathi kwegumbi elihlanzekile negumbi elingahlanzekile;
Phakathi kwamakamelo ahlanzekile anamazinga ahlukene okuhlanzeka komoya
Ngaphakathi kwendawo yokukhiqiza enezinga elifanayo lokuhlanzeka, kunezindawo zokusebenza ezibaluleke kakhulu ezidinga ukugcina ingcindezi engemihle noma ingcindezi enhle;
Isikhiya somoya egumbini lokuhlanza impahla kanye nesikhiya somoya sokucindezela okuhle noma okubi ukuvimba ukuhamba komoya phakathi kwamagumbi okushintsha anamazinga ahlukene okuhlanzeka egumbini lokuhlanza abasebenzi;
Izindlela zemishini zisetshenziselwa ukuthutha izinto ngokuqhubekayo zingena futhi ziphuma egumbini elihlanzekile.
Amakamelo alandelayo ahlanzekile kwezokwelapha kufanele agcine ingcindezi engemihle ngamakamelo ahlanzekile kwezokwelapha aseduze:
Amakamelo ahlanzekile emithi akhipha uthuli ngesikhathi sokukhiqiza;
Amakamelo ahlanzekile emithi lapho kusetshenziswa khona izinyibilikisi eziphilayo enqubweni yokukhiqiza;
Amakamelo ahlanzekile ezokwelapha akhiqiza inani elikhulu lezinto eziyingozi, amagesi ashisayo nanomswakama kanye namaphunga ngesikhathi senqubo yokukhiqiza;
Amakamelo okucwenga, okomisa kanye nokupakisha ama-penicillin kanye neminye imithi ekhethekile kanye namakamelo awo okupakisha ukuze kulungiselelwe.
Imboni yezokwelapha kanye nezempilo
"Imininingwane Yobuchwepheshe Yokwakhiwa Kweminyango Yokuhlinza Ehlanzekile Yezibhedlela" ibeka:
● Phakathi kwamakamelo ahlanzekile axhumene anamazinga ahlukene okuhlanzeka, amakamelo ahlanzekile kakhulu kufanele agcine ingcindezi enhle emakamelweni ahlanzekile kancane. Umehluko omncane wengcindezi engaguquki kufanele ube mkhulu noma ulingane no-5Pa, kanti umehluko omkhulu wengcindezi engaguquki kufanele ube ngaphansi kuka-20Pa. Umehluko wengcindezi akufanele ubangele umsindo noma uthinte ukuvulwa komnyango.
● Kufanele kube nomehluko ofanele wokucindezela phakathi kwamakamelo ahlanzekile axhumene anezinga elifanayo lokuhlanzeka ukuze kulondolozwe ukugeleza komoya okudingekayo.
● Igumbi elingcoliswe kakhulu kufanele ligcine ingcindezi engemihle emakamelweni axhumene eduze, futhi umehluko omncane wengcindezi engaguquki kufanele ube mkhulu noma ulingane no-5Pa. Igumbi lokuhlinza elisetshenziselwa ukulawula ukutheleleka emoyeni kufanele libe yigumbi lokuhlinza elinengcindezi engemihle, kanti igumbi lokuhlinza elinengcindezi engemihle kufanele ligcine umehluko wengcindezi engemihle uphansi kancane kuno-"0" ku-mezzanine yobuchwepheshe ophahleni lwayo olulengayo.
● Indawo ehlanzekile kufanele igcine ingcindezi enhle endaweni engahlanzekile exhunywe kuyo, futhi umehluko omncane wengcindezi engaguquki kufanele ube mkhulu noma ulingane no-5Pa.
Imboni yokudla
"Imininingwane Yobuchwepheshe Yokwakhiwa Kwamagumbi Ahlanzekile Embonini Yokudla" ibeka:
● Umehluko wokucindezela okungaguquki ongu-≥5Pa kufanele ugcinwe phakathi kwamakamelo ahlanzekile axhumene eduze naphakathi kwezindawo ezihlanzekile nezindawo ezingahlanzekile. Indawo ehlanzekile kufanele igcine umehluko wokucindezela omuhle ongu-≥10Pa ngaphandle.
● Igumbi lapho kwenzeka khona ukungcola kufanele ligcinwe linomfutho ophansi. Amakamelo anezidingo eziphezulu zokulawula ukungcola kufanele agcine umfutho ophansi.
● Uma umsebenzi wokugeleza kokukhiqiza udinga ukuvula imbobo odongeni lwegumbi elihlanzekile, kuyanconywa ukuthi kugcinwe ukugeleza komoya okuqondile emgodini kusukela ohlangothini kanye nezinga eliphakeme legumbi elihlanzekile liye ohlangothini olungezansi lwegumbi elihlanzekile ngomgodi. Ijubane lomoya elijwayelekile lokugeleza komoya emgodini kufanele libe ngu-≥ 0.2m/s.
Ukukhiqizwa okunembile
① "Ikhodi Yokuklama Igumbi Lokuhlanza Imboni Ye-elekthronikhi" ikhomba ukuthi umehluko othile wokucindezela okungaguquki kufanele ugcinwe phakathi kwegumbi elihlanzekile (indawo) nendawo ezungezile. Umehluko wokucindezela okungaguquki kufanele uhlangabezane nemithetho elandelayo:
● Umehluko wokucindezela okungaguquki phakathi kwegumbi ngalinye elihlanzekile (indawo) nendawo ezungezile kufanele unqunywe ngokwezidingo zenqubo yokukhiqiza;
● Umehluko wengcindezi engaguquki phakathi kwamakamelo ahlanzekile (izindawo) zamazinga ahlukene kufanele ube mkhulu noma ulingane no-5Pa;
● Umehluko wokucindezela okungaguquki phakathi kwegumbi elihlanzekile (indawo) kanye negumbi elingahlanzekile (indawo) kufanele ube ngaphezu kwama-5Pa;
● Umehluko wengcindezi engaguquki phakathi kwegumbi elihlanzekile (indawo) kanye nendawo yangaphandle kufanele ube ngaphezu kwama-10Pa.
② "Ikhodi Yokuklama Amakamelo Ahlanzekile" ibeka:
Umehluko othile wokucindezela kumele ugcinwe phakathi kwegumbi elihlanzekile (indawo) nendawo ezungezile, futhi umehluko wokucindezela omuhle noma omubi kufanele ugcinwe ngokwezidingo zenqubo.
Umehluko wokucindezela phakathi kwamakamelo ahlanzekile anamazinga ahlukene akufanele ube ngaphansi kwama-5Pa, umehluko wokucindezela phakathi kwezindawo ezihlanzekile nezindawo ezingahlanzekile akufanele ube ngaphansi kwama-5Pa, kanye nomehluko wokucindezela phakathi kwezindawo ezihlanzekile nezindawo zangaphandle akufanele ube ngaphansi kwama-10Pa.
Umoya wokucindezela ohlukile odingekayo ukuze kugcinwe amanani ahlukene okucindezela ekamelweni elihlanzekile kufanele unqunywe ngendlela yokuthunga noma indlela yokushintsha umoya ngokuya ngezici zegumbi elihlanzekile.
Ukuvulwa nokuvalwa komoya ophakelayo kanye nezinhlelo zokukhipha umoya kufanele kuxhumene. Kuhlelo olufanele lokuxhumanisa igumbi elihlanzekile, ifeni lokuhambisa umoya kufanele liqalwe kuqala, bese kuqala ifeni lomoya elibuyayo kanye nefeni lokukhipha umoya; lapho kuvalwa, uhlelo lokuxhumanisa kufanele luguqulwe. Inqubo yokuxhumanisa yamakamelo okuhlanza umfutho ongemuhle kufanele iphambene naleyo engenhla yamakamelo ahlanzekile umfutho ongemuhle.
Kumakamelo ahlanzekile angasebenzi njalo, ukunikezwa komoya emsebenzini kungahlelwa ngokwezidingo zenqubo yokukhiqiza, futhi kufanele kwenziwe ukuhlanza umoya opholile.
Isikhathi sokuthunyelwe: Septhemba-19-2023