Kinda filtration yakamisa marabhoritari hombe, iyo inogona kupa yakazara seti yekuyedza uye yekusimbisa sevhisi yemishonga, chikafu & chinwiwa uye mafirita edzimba indasitiri, pamwe nemhinduro dzakakwana dzekusefa uye zvinyorwa zvinoenderana nemitemo nemirau.
Iyo chaiyo yekuzorora yemukati ndeyekutevera:
| Zvinhu zvezororo | Valiation project 1 | Valiation project 2 |
| Sefa doro sampuli+1 set sefa chinhu | Sefa doro sampuli+3 set sefa chinhu | |
| Kubudirira kwebhakitiriya | √ | √ |
| Kutendeseka kwesefa wetting | √ | √√√ |
| Bacterial challenge test | √ | √√√ |
| Chemical Compatiblity | √ | √ |
| Particle kusunungurwa | √ | √√ |
| Precipitates uye adsorbate kuyedza | evaluate | evaluate |
Cherechedza: √kumirira nguva dzekusimbisa zvinoenderana ne《Good Manufacturing Practice for Pharmaceutical Products》(Yakagadziridzwa muna 2010)
Zvinhu zvesevhisi zvekuongorora kwekuita kwesefa imba
1. kushanda kwebhakitiriya
Kusimbisa kupona kwechipenyu mumishonga pasi pemamiriro edu etekinoroji, kuona nzira inonzwisisika yebhakitiriya dambudziko bvunzo.Kusanganisira non sterilization zvigadzirwa, neutral sterilization chigadzirwa uye sterilization zvigadzirwa.
2. kuvimbika kwesefa wetting
Pasi petembiricha yakasarudzwa, sarudza kuyerera kuyerera, bvunzo yekuora kwekumanikidza, bubble point bvunzo mushure mesefa yaive 100% wetting.
3. Bacterial dambudziko bvunzo
Maitiro acho anobva paASTIM F 838 inova bvunzo yekuchengeta bhakitiriya BREVUNDIMONAS DIMMINUTA(ATCC 19146).Mvura ine sterilized ine minimum concentration 107 cfu/cm2 inobudirira kusefa nzvimbo kuburikidza nefiltration membrane kana mafirita kuyedza iyo yekubata allity ye microoganism mune mamwe mamiriro.Mhando dzakasiyana dzebhakitiriya dzichasarudzwa kuti dziedze mafirita akasiyana siyana.
4. Chemical Compatiblity
Pasi pemamiriro chaiwo ekuita, edza maitiro ekemikari pakuonekwa uye hunhu hwesefa, bubble point inoshanduka, diffusion kuyerera shanduko, kusimbisa mhedzisiro yefirita uye maitiro emvura.
5. Particle kusunungurwa
Particle inoburitsa uye gravimetric inotorwa, inoratidzwa zvakananga nekuwanda kwekuongorora kweasina volatilization zvakasara (NVR)
Nguva yekutumira: Feb-16-2021