I-TS Filter isungule ilabhorethri enkulu, enganikeza isethi ephelele yesevisi yokuhlola nokuqinisekisa yezemithi, ukudla neziphuzo kanye nemboni yezindlu zokuhlunga, kanye nezixazululo zokuhlunga ezinembile kanye nemibhalo ehambisana nemithetho nemigomo.
Okuqukethwe kokuqinisekisa okuthile kungokulandelayo:
| Izinto zokuqinisekisa | iphrojekthi yokuqinisekisa 1 | iphrojekthi yokuqinisekisa 3 |
| isampula yotshwala bokuhlunga + isethi eyodwa yesici sokuhlunga | isampula yotshwala bokuhlunga + isethi engu-3 yesici sokuhlunga | |
| ukuphila kwamagciwane | √ | √ |
| ubuqotho bokumanzisa kwesihlungi | √ | √√√ |
| ukuhlolwa kwenselele yamagciwane | √ | √√√ |
| ukuhambisana kwamakhemikhali | √ | √ |
| ukukhishwa kwezinhlayiya | √ | √√ |
| ukuhlolwa kokushisa kanye nokufaka i-adsorbate | hlola | hlola |
Qaphela: √ imele izikhathi zokuqinisekisa, ngokusho kwe-"Good Manufacturing Practice for Pharmaceutical Products" (Eyashintshwa ngo-2010)
Izinto zesevisi zokuqinisekisa ukusebenza kwendlu yokuhlunga:
1. ukuphila kwamagciwane
Ukuqinisekisa ukusinda kwezinto eziphilayo ezidakamizweni ngaphansi kwezimo zethu zobuchwepheshe, ukunquma indlela efanelekile yokuhlola inselelo yamagciwane. Kubandakanya imikhiqizo engahlanzi, imikhiqizo yokuhlanza engathathi hlangothi kanye nemikhiqizo yokuhlanza.
2. ubuqotho bokumanzisa kwesihlungi
Ngaphansi kwezinga lokushisa elibekiwe, nquma ukugeleza kokusabalalisa, ukuhlolwa kokubola kwengcindezi, ukuhlolwa kwephuzu lebhamuza ngemva kokuba isihlungi simanzise ngo-100%.
3. Ukuhlolwa kwenselele yamagciwane
Le nqubo isekelwe ku-ASTM F 838 okuwukuhlolwa kokugcinwa kwamagciwane i-BREVUNDIMONAS DIMUNUTA (ATCC 19146). Amanzi ahlanziwe anendawo yokuhlunga esezingeni eliphansi engu-107cfu/cm2 ngokusebenzisa ulwelwesi lokuhlunga noma izihlungi ukuhlola ikhono lokuvimba amagciwane ngaphansi kwezimo ezithile. Kuzokhethwa izinhlobo ezahlukene zamagciwane ukuze kuhlolwe izihlungi ezahlukene zosayizi we-micron.
4. Ukuhambisana Kwamakhemikhali
Ngaphansi kwesimo esithile senqubo, hlola ithonya lamakhemikhali ekubukekeni nasezimpahleni zomzimba zesihlungi, izinguquko zamaphuzu ebhamuza, izinguquko zokugeleza kokusabalalisa, ukuqinisekisa imiphumela ehambisanayo yesihlungi kanye noketshezi lwenqubo.
5. Ukukhululwa kwezinhlayiya
Ukukhishwa kwezinhlayiya kanye nezinto ezikhishwa nge-gravimetric, kuboniswa ngqo ngokuhlaziywa kwenani kanye nekhwalithi kwe-no volatilization residue (NVR).