Ukunyakaza koketshezi akunakuhlukaniswa nomphumela "womehluko wengcindezi".Endaweni ehlanzekile, umehluko wengcindezi phakathi kwegumbi ngalinye elihlobene nomoya wangaphandle ubizwa ngokuthi "umehluko ophelele wengcindezi".Umehluko wengcindezi phakathi kwegumbi ngalinye eliseduze nendawo eseduze ubizwa ngokuthi "umehluko wengcindezi ehlobene", noma "umehluko wengcindezi" ngamafuphi.Umehluko wengcindezi phakathi kwegumbi elihlanzekile namakamelo axhumene aseduze noma izindawo ezizungezile kuyindlela ebalulekile yokugcina ukuhlanzeka kwangaphakathi noma ukunciphisa ukusabalala kokungcola kwasendlini.Izimboni ezihlukene zinezidingo ezihlukene zokuhlukanisa ingcindezi emakamelweni ahlanzekile.Namuhla, sizokwabelana nawe ngezidingo zomehluko wengcindezi zokucaciswa okujwayelekile kwegumbi elihlanzekile.
Imboni yezemithi
① "Umkhuba Omuhle Wokukhiqiza Wemikhiqizo Yemithi" uyacacisa: Umehluko wengcindezi phakathi kwezindawo ezihlanzekile nezindawo ezingahlanzekile naphakathi kwezindawo ezihlanzekile ezihlukene akufanele ube ngaphansi kuka-10Pa.Uma kudingekile, ama-gradients okucindezela afanelekile kufanele futhi agcinwe phakathi kwezindawo zokusebenza ezihlukene (amagumbi okusebenza) wezinga lokuhlanzeka elifanayo.
②I-"Veterinary Drug Manufacturing Practice Good Manufacturing Practice" iyacacisa: Umehluko wengcindezi emile phakathi kwamagumbi ahlanzekile aseduze (izindawo) anamazinga ahlukene okuhlanzeka komoya kufanele ube mkhulu kuno-5 Pa.
Umehluko wengcindezi emile phakathi kwegumbi elihlanzekile (indawo) negumbi elingahlanzekile (indawo) kufanele libe mkhulu kuno-10 Pa.
Umehluko wengcindezi emile phakathi kwegumbi elihlanzekile (indawo) nomoya wangaphandle (okuhlanganisa nezindawo ezixhumeke ngokuqondile ngaphandle) kufanele ube mkhulu kuno-12 Pa, futhi kufanele kube nedivayisi ebonisa umehluko wengcindezi noma isistimu yokuqapha ne-alamu.
Ezingxoxweni zamagumbi ahlanzekile emikhiqizo yebhayoloji, inani eliphelele lomehluko wengcindezi emile eshiwo ngenhla kufanele linqunywe ngokuya ngezidingo zenqubo.
③I-"Pharmaceutical Clean Room Standards" iyacacisa: Umehluko wengcindezi yomoya emile phakathi kwamagumbi ahlanzekile ezempilo anamazinga ahlukene okuhlanzeka komoya naphakathi kwamakamelo ahlanzekile namagumbi angahlanzekile akufanele abe ngaphansi kuka-10Pa, kanye nomehluko wengcindezi emile phakathi kwamagumbi ahlanzekile ezempilo kanye umoya wangaphandle akufanele ube ngaphansi kuka-10Pa.
Ngaphezu kwalokho, amagumbi alandelayo ahlanzekile ekhemisi kufanele ahlonyiswe ngemishini ekhombisa umehluko wengcindezi:
Phakathi kwegumbi elihlanzekile negumbi elingahlanzekile;
Phakathi kwamakamelo ahlanzekile anamazinga ahlukene okuhlanzeka komoya
Ngaphakathi kwendawo yokukhiqiza yezinga lenhlanzeko elifanayo, kunamagumbi okuhlinza abaluleke kakhulu adinga ukugcina ingcindezi engalungile noma ingcindezi enhle;
Isihluthulelo somoya egumbini elihlanzekile lezinto ezibonakalayo kanye nengcindezi eyakhayo noma isikhiye somoya esibi ukuze kuvinjwe ukugeleza komoya phakathi kwamakamelo okushintsha amazinga ahlukene okuhlanzeka egumbini elihlanzekile lezisebenzi;
Izindlela zikagesi zisetshenziselwa ukuthutha izinto ezisetshenziswayo ngokuqhubekayo ngaphakathi nangaphandle kwegumbi elihlanzekile.
Lawa magumbi alandelayo ahlanzekile kwezokwelashwa kufanele agcine ingcindezi engemihle ehambisana namagumbi ahlanzekile ezempilo aseduze:
Amakamelo ahlanzekile ekhemisi akhipha uthuli ngesikhathi sokukhiqiza;
Amakamelo ahlanzekile emithi lapho kusetshenziswa khona izinyibilikisi zemvelo lapho kukhiqizwa khona;
Amakamelo ahlanzekile ezokwelapha akhiqiza inani elikhulu lezinto eziyingozi, amagesi ashisayo namanzi kanye nephunga ngesikhathi sokukhiqiza;
Amakamelo okucwenga, okomisa nokupakisha ama-penicillin nezinye izidakamizwa ezikhethekile kanye namakamelo azo okupakisha ukuze kulungiselelwe.
Imboni yezokwelapha nezempilo
"Imininingwane Yezobuchwepheshe Yokwakhiwa Kweminyango Yokuhlinza Izibhedlela" iyabeka:
● Phakathi kwamakamelo ahlanzekile axhumene anamazinga ahlukene okuhlanzeka, amakamelo anenhlanzeko ephakeme kufanele alondoloze ukucindezela okuhle uma kuqhathaniswa namakamelo anenhlanzeko encane.Umehluko omncane wengcindezi emile kufanele ube mkhulu noma ulingane no-5Pa, futhi umehluko omkhulu wengcindezi emile kufanele ube ngaphansi kuka-20Pa.Umehluko wengcindezi akufanele ubangele ikhwela noma uthinte ukuvulwa komnyango.
● Kufanele kube nomehluko ofanele wengcindezi phakathi kwamagumbi ahlanzekile axhumene asezingeni elifanayo lokuhlanzeka ukuze kugcinwe indawo yokugeleza komoya edingekayo.
● Igumbi elingcoliswe kakhulu kufanele ligcine ingcindezi engemihle eya emagumbini axhumene eduze, futhi umehluko omncane wengcindezi emile kufanele ube mkhulu noma ulingane no-5Pa.Igumbi lokuhlinzela elisetshenziselwa ukulawula izifo ezitholakala emoyeni kufanele libe yigumbi lokusebenza elinengcindezi engalungile, futhi igumbi lokusebenza elinengcindezi engalungile kufanele ligcine umehluko ongemuhle wengcindezi ube ngaphansi kancane kuno-"0" ku-mezzanine yobuchwepheshe kusilingi wayo omisiwe.
● Indawo ehlanzekile kufanele igcine ingcindezi eyakhayo endaweni engahlanzekile exhunywe kuyo, futhi umehluko omncane wengcindezi emile kufanele ube mkhulu noma ulingane no-5Pa.
Imboni yokudla
"Izici Zobuchwepheshe Zokwakhiwa Kwamagumbi Ahlanzekile Embonini Yokudla" iyabeka:
● Umehluko wengcindezi emile engu-≥5Pa kufanele ugcinwe phakathi kwamagumbi ahlanzekile axhunyiwe aseduze naphakathi kwezindawo ezihlanzekile nezindawo ezingahlanzekile.Indawo ehlanzekile kufanele igcine umehluko wengcindezi omuhle ongu-≥10Pa ukuya ngaphandle.
● Igumbi lapho ukungcola kwenzeka khona kufanele ligcinwe linengcindezi engemihle uma kuqhathaniswa.Amagumbi anezidingo eziphezulu zokulawula ukungcola kufanele agcine ukucindezela okuhle uma kuqhathaniswa.
● Uma umsebenzi wokugeleza kokukhiqiza udinga ukuvula imbobo odongeni lwegumbi elihlanzekile, kuyatuseka ukugcina ukugeleza komoya oqonde ngqo embobeni ukusuka ohlangothini ngezinga eliphezulu legumbi elihlanzekile ukuya ohlangothini olungezansi lwegumbi elihlanzekile ngokusebenzisa umgodi.Isilinganiso sesivinini somoya sokugeleza komoya emgodini kufanele sibe ≥ 0.2m/s.
Ukukhiqiza okunembayo
① "Ikhodi Yokuklama Igumbi Lomkhakha Wezogesi" ikhomba ukuthi umehluko othile wengcindezi emile kufanele ugcinwe phakathi kwegumbi elihlanzekile (indawo) nendawo ezungezile.Umehluko we-static pressure kufanele uhlangabezane nemithetho elandelayo:
● Umehluko wengcindezi emile phakathi kwegumbi ngalinye elihlanzekile (indawo) nendawo ezungezile kufanele unqunywe ngokuya ngezidingo zenqubo yokukhiqiza;
● Umehluko wengcindezi emile phakathi kwamagumbi ahlanzekile (izindawo) zamaleveli ahlukene kufanele ube mkhulu noma ulingane no-5Pa;
● Umehluko wengcindezi emile phakathi kwegumbi elihlanzekile (indawo) negumbi elingahlanzekile (indawo) kufanele libe mkhulu kuno-5Pa;
● Umehluko wengcindezi emile phakathi kwegumbi elihlanzekile (indawo) nangaphandle kufanele ube mkhulu kuno-10Pa.
② "Ikhodi Yokuklama Igumbi Elihlanzekile" iyacacisa:
Umehluko othile wengcindezi kufanele ugcinwe phakathi kwegumbi elihlanzekile (indawo) nendawo ezungezile, futhi umehluko wengcindezi omuhle noma omubi kufanele ugcinwe ngokuvumelana nezidingo zenqubo.
Umehluko wengcindezi phakathi kwamakamelo ahlanzekile amazinga ahlukene akufanele ube ngaphansi kuka-5Pa, umehluko wengcindezi phakathi kwezindawo ezihlanzekile nezindawo ezingahlanzekile akufanele ube ngaphansi kuka-5Pa, futhi umehluko wengcindezi phakathi kwezindawo ezihlanzekile nangaphandle akufanele ube ngaphansi kuka-10Pa.
Umoya wokucindezela okuhlukile odingekayo ukuze kugcinwe amanani ahlukene okucindezela ingcindezi ekamelweni elihlanzekile kufanele kunqunywe indlela yokuthunga noma indlela yokuguqula umoya ngokuvumelana nezici zekamelo elihlanzekile.
Ukuvulwa nokuvalwa kwezinhlelo zomoya wokuhlinzeka kanye ne-exhaust kufanele kuhlanganiswe.Ngokulandelana okufanele kwegumbi elihlanzekile elihlanganayo, isiphephetha-moya sokuhambisa umoya kufanele siqalwe kuqala, bese kuqalwa isiphephetha-moya esibuyayo kanye nefeni yokukhipha umoya;lapho uvala, ukulandelana okuhlangene kufanele kubuyiselwe emuva.Inqubo yokuxhumanisa yamagumbi ahlanzekile anengcindezi engemihle kufanele ihambisane nalokhu okungenhla ukuze kuhlanzwe umfutho omuhle.
Emakamelweni ahlanzekile anomsebenzi ongaqhubeki, ukuhlinzekwa komoya osemsebenzini kungenziwa ngokuhambisana nezidingo zenqubo yokukhiqiza, futhi ukuhlanza umoya kufanele kwenziwe.
Isikhathi sokuthumela: Sep-19-2023