nybanner

Quality Assurance

Quality Assurance Certificate

Cov ntaub ntawv no tau lees paub cov khoom lag luam uas tsim los ntawm TS Filter nyob rau hauv lub teeb ntawm Current Good Manufacturing Practice standards. Cov khoom no yog tsim, tsim thiab xa tawm raws li kev tswj hwm uas tau lees paub los ntawm ISO9001: 2018.

Quality Assurance Criteria

Kev huv huv
Cov khoom lim dej no ua raws li lub npe 21 CFR, ntu 210.3 (b)(5)(6) thiab 211.72

❖ TOC & Kev coj ua
Tom qab tswj cov dej ntws tawm, cov qauv muaj tsawg dua 0.5mg (500 ppb) ntawm carbon ib liter, thiab cov conductivity tsawg dua 5.1 S / cm @ 25 ° c.

❖ Cov kab mob endotoxins
Ib lub capsule aqueous extraction muaj tsawg dua 0.25EU / ml

❖ Biosafety
Tag nrho cov ntaub ntawv ntawm lub lim dej no ua tau raws li qhov yuav tsum tau ua ntawm USP <88> tam sim no rau cov chav kawm yas VI-121°c.

❖ Indirect Food Additive
Tag nrho cov khoom siv ua tau raws li FDA cov khoom noj khoom haus tsis ncaj qha rau hauv 21CFR. Txhua yam khoom siv ua tau raws li qhov yuav tsum tau ua ntawm EU txoj cai 1935/2004/EC. Hu rau cov chaw muag khoom kom paub ntau ntxiv txog cov ntaub ntawv ntawm kev tsim kho.

❖ Cov Lus Qhia Txog Tsiaj
Raws li cov ntaub ntawv tam sim no los ntawm peb cov neeg muag khoom, tag nrho cov khoom siv hauv cov khoom siv no tsis muaj tsiaj.

❖ Kev Tiv Thaiv Kab Mob
Cov khoom no tau raug sim ua tiav rau kev tuav pov hwm cov kab mob uas tau txais txiaj ntsig, siv cov txheej txheem piav qhia hauv TS Filter Validation Guides thiab correlated rau ASTM Standard Test Methos ASTM F838, ua raws li cov kev cai ntawm FDA Guideline Sterile Drug Products Produced by Aseptic Processing- Kev Ua Haujlwm Zoo Tam Sim No (Lub Cuaj Hli 2004).

❖ Cov Txheej Txheem Tshaj Tawm Ntau
Qhov kev tsim khoom no tau raug coj mus kuaj, kuaj thiab tso tawm los ntawm TS Filter Quality Assurance.

❖ Kev Ntsuam Xyuas Kev Ncaj Ncees
Txhua lub lim dej tau raug kuaj los ntawm TS Filter kev lees paub zoo raws li cov qauv hauv qab no, tom qab ntawd tso tawm.

Kev Ntsuam Xyuas Kev Ncaj Ncees (20°c):

Bubble Point (BP), Diffusion Flow (DF)

Nco tseg: BP thiab DF yuav tsum tau kuaj tom qab lub lim dej ntub dej.
Rau cov lim dej no, cov qauv ntsuas kev ncaj ncees no tau muaj feem cuam tshuam nrog ASTM F838 cov kab mob sib tw, ua raws li cov kev xav tau ntawm FDA Cov Lus Qhia Cov Tshuaj Tsis Muaj Tshuaj Uas Ua los ntawm Aseptic Processing-Tam sim no Kev Tsim Khoom Zoo (Lub Xya Hli 2019).

❖ Leak Test
Txhua lub lim dej tau raug kuaj los ntawm TS Filter kev lees paub zoo raws li cov qauv hauv qab no, tom qab ntawd tso tawm: Tsis muaj qhov xau ntawm 0.40MPa hauv 5 min.