Inqanaba lokuhlanjululwa kothuli lamawaka alishumi
Ngokuqhelekileyo, kukho amabanga kumagumbi acocekileyo.Xa iinkqubo ezininzi zisetyenziselwa, amabakala ahlukeneyo okucoceka komoya kufuneka asetyenziswe ngokweemfuno ezahlukeneyo zenkqubo nganye, kwaye ibakala kufuneka limiselwe ngokweemfuno zenkqubo.
Iklasi yokucoceka komoya ngumgangatho wokuhlela ubuninzi beengqungquthela ezinkulu okanye ezilingana nobukhulu becala elicatshangelwayo kwiyunithi yomthamo womoya kwindawo ecocekileyo.
Inqanaba lokucoceka kunye nokwahlulwa kweendawo ezicocekileyo kwinkqubo yokuvelisa amayeza kwishishini lamachiza kufuneka kumiselwe ngokubhekiselele kumalungiselelo kunye nomxholo wenkqubo ye-API kunye nokwahlulwa kweendawo zokusingqongileyo kwi "Pharmaceutical Production Quality Management Code".Ukucoceka komoya kwegumbi elicocekileyo lokuvelisa amayeza lihlukaniswe ngamanqanaba amane.
Ngaphantsi kwesiseko sokuhlangabezana neemfuno zenkqubo yokuvelisa, okokuqala, umgangatho ophantsi ococekileyo omanzi okanye ukucocwa komoya wendawo kufuneka yamkelwe;okwesibini, ukudityaniswa kwendawo yokusebenza yendawo yokucocwa komoya kunye nokucocwa komoya kwidolophu yonke okanye ukucocwa komoya okubanzi kungasetyenziswa.
Inqanaba lokucoceka kwamaqhekeza amisiwe emoyeni wamagumbi acocekileyo kunye neendawo ezicocekileyo
| Inqanaba lococeko lomoya(N) | Inkulu kuno okanye ilingana nowona mda woxinaniso uphezulu wesayizi yesuntswana kwitafile(pc/m³) | |||||
| 0.1um | 0.2um | 0.3um | 0.5um | 1um | 5um | |
| 1 | 10 | 2 | ||||
| 2 | 100 | 24 | 10 | 4 | ||
| 3 | 1000 | 237 | 102 | 35 | 8 | |
| 4(Ten） | 10000 | 2370 | 1020 | 352 | 83 | |
| 5(Ikhulu） | 100000 | 23700 | 10200 | 3520 | 832 | 29 |
| 6(Iwaka） | 1000000 | 237000 | 102000 | 35200 | 8320 | 293 |
| 7(Amawaka alishumi） | 352000 | 83200 | 2930 | |||
| 8(Ikhulu lamawaka） | 3520000 | 832000 | 29300 | |||
| 9(Iklasi yesigidi esinye） | 35200000 | 8320000 | 293000 | |||
