Kinda filtration tau tsim cov chav kuaj loj, uas tuaj yeem muab cov kev sim ua tiav thiab kev pabcuam rau kev siv tshuaj, zaub mov & dej haus thiab lim vaj tsev kev lag luam, nrog rau kev pom tseeb thiab cov ntaub ntawv uas ua raws li cov cai thiab cov cai.
Cov ntsiab lus tshwj xeeb valication yog raws li nram no:
| Cov khoom pov thawj | Qhov project 1 | Qhov project 2 |
| Lim cawv piv txwv + 1 teeb lim caij | Lim cawv piv txwv + 3 teeb lim caij | |
| Viability ntawm cov kab mob | √ | √ |
| Integnty ntawm lim ntub dej | √ | √√√ Ib |
| Bacterial challenge test | √ | √√√ Ib |
| Tshuaj Compatibility | √ | √ |
| Particle tso tawm | √ | √√ Ib |
| Precipitates thiab adsorbate sim | ntsuas | ntsuas |
Lus Cim: √stand rau lub sij hawm siv tau raws li 《Kev Ua Zoo Zoo rau Cov Khoom Siv Tshuaj》(Hloov kho hauv 2010)
Cov khoom siv ntawm kev txheeb xyuas kev ua haujlwm ntawm lim vaj tsev
1. cov kab mob viability
Kev lees paub kev muaj sia nyob ntawm cov kab mob hauv cov tshuaj hauv peb cov txheej txheem thev naus laus zis, txhawm rau txiav txim siab txoj hauv kev tsim nyog rau cov kab mob sib tw.Xws li cov khoom uas tsis muaj kev ua kom tsis muaj menyuam, cov khoom siv tsis muaj menyuam thiab cov khoom ua kom tsis muaj menyuam.
2. kev ncaj ncees ntawm lim ntub dej
Nyob rau hauv qhov ntsuas kub, txiav txim siab qhov ntws tawm, kev ntsuas kev sib tsoo, kev ntsuas npuas tom qab lub lim yog 100% ntub.
3. Cov kab mob sib tw
Cov txheej txheem yog ua raws li ASTIM F 838 uas yog ib qho kev sim khaws cia rau cov kab mob BREVUNDIMONAS DIMMINUTA (ATCC 19146).Sterilized dej nrog yam tsawg kawg nkaus concentration 107 cfu/cm2 Kev pom zoo hauv cheeb tsam los ntawm kev pom daim nyias nyias los yog cov lim dej los ntsuas qhov cuam tshuam ntawm microoganism nyob rau hauv qee yam mob.Cov kab mob sib txawv yuav raug xaiv los kuaj qhov sib txawv micron loj lim.
4. Tshuaj Compatibility
Nyob rau hauv cov xwm txheej tshwj xeeb ntawm cov txheej txheem, kuaj cov tshuaj muaj txiaj ntsig ntawm qhov tshwm sim thiab lub cev lub zog ntawm lub lim dej, qhov hloov pauv ntawm cov npuas dej, kev hloov pauv hloov pauv, txhawm rau txheeb xyuas qhov cuam tshuam ntawm cov lim dej thiab cov txheej txheem dej.
5. Particle tso tawm
Particle tso tawm thiab gravimetric extractables, yog qhia ncaj qha los ntawm kev soj ntsuam ntau ntawm tsis muaj volatilization residue (NVR)
Post lub sij hawm: Feb-16-2021