Daim ntawv no lees paub cov khoom uas tsim los ntawm TS Filter raws li cov qauv kev xyaum ua haujlwm zoo tam sim no.
Cov khoom no yog tsim, tsim tawm thiab faib tawm raws li kev tswj hwm uas tau ntawv pov thawj los ntawm ISO9001: 2015.
Cov Qauv Kev Ntsuam Xyuas Zoo
Kev Huv Si
Cov khoom lim dej no ua raws li lub npe 21 CFR, ntu 210.3 (b)(5)(6) thiab 211.72
❖ TOC & Kev Coj Hluav Taws Xob
Tom qab tswj tau dej ntws, cov qauv kuaj muaj tsawg dua 0.5mg (500 ppb) ntawm cov pa roj carbon ib litre, thiab qhov conductivity tsawg dua 5.1 S/cm @ 25°c.
❖ Cov kab mob Endotoxins
Ib lub tshuaj ntsiav uas muaj cov kua dej rho tawm muaj tsawg dua 0.25EU/ml
❖ Kev nyab xeeb ntawm tsiaj txhu
Txhua yam khoom siv ntawm cov khoom lim no ua tau raws li qhov yuav tsum tau ua ntawm USP rau cov yas chav kawm VI-121 ° c.
❖ Cov Khoom Noj Ntxiv Tsis Ncaj Qha
Txhua yam khoom siv sib xyaw ua tau raws li FDA cov cai ntxiv rau cov khoom noj tsis ncaj qha uas tau hais nyob rau hauv 21CFR. Txhua yam khoom siv sib xyaw ua tau raws li qhov yuav tsum tau ua ntawm EU txoj cai 1935/2004/EC. Tiv tauj cov neeg muag khoom kom paub ntau ntxiv txog cov ntaub ntawv siv rau kev tsim kho.
❖ Cov Lus Qhia Txog Keeb Kwm Tsiaj
Raws li cov ntaub ntawv tam sim no los ntawm peb cov neeg muag khoom, txhua yam khoom siv hauv cov khoom no yog tsis muaj tsiaj.
❖ Kev Khaws Cov Kab Mob
Cov khoom no tau raug sim ua tiav rau kev khaws cia cov kab mob me me uas tsim nyog, siv cov txheej txheem piav qhia hauv TS Filter Validation Guides thiab sib raug zoo rau ASTM Standard Test Methos ASTM F838, ua raws li cov kev cai ntawm FDA Guideline Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice (Cuaj Hlis 2004).
❖ Cov Qauv Tso Tawm Ntau Yam
Cov khoom tsim khoom no tau raug kuaj, sim thiab tso tawm los ntawm TS Filter Quality Assurance.
❖ Kev Ntsuas Kev Ncaj Ncees
Txhua lub lim dej tau raug sim los ntawm TS Filter kev lees paub zoo raws li cov qauv hauv qab no, tom qab ntawd tso tawm.
Kev Ntsuas Kev Ncaj Ncees (20 ° c):
Chaw Npuas (BP)
Kev Ntws Tawm (DF)
Los yog Kev Nkag Mus Rau Hauv Dej (WI)
Lus Cim: BP thiab DF yuav tsum tau kuaj tom qab lub lim dej ntub lawm.
Rau cov lim dej no, cov qauv kev xeem kev ncaj ncees no tau raug sib raug zoo tag nrho rau ASTM F838 bacteria Challenge test, ua raws li cov kev cai ntawm FDA Guideline Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice (Lub Xya Hli 2019).
❖ Kev Ntsuas Qhov Tawg
Txhua lub lim dej tau raug sim los ntawm TS Filter kev lees paub zoo raws li cov Qauv hauv qab no, tom qab ntawd tso tawm: