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Ukuqinisekisa umgangatho

Isatifikethi soQinisekiso loMgangatho

Olu xwebhu luqinisekisa imveliso eyenziwe yi-TS Filter ekukhanyeni kwemigangatho yeNdlela yokuSebenza ngokuLungileyo yaNgoku. Le mveliso iphuhliswa, iveliswe kwaye isasazwe ngokwenkqubo yolawulo engqinisiswe yi-ISO9001:2018.

Iinqobo zokuqinisekisa uMgangatho

Ucoceko
Le mveliso yokucoca ihambelana nesihloko 21 CFR, icandelo 210.3 (b) (5) (6) kunye ne-211.72

❖ I-TOC kunye noKuqhuba
Emva kokugungxulwa kwamanzi alawulwayo, iisampulu zingaphantsi kwe-0.5mg (500 ppb) yekhabhoni ilitha nganye, kwaye i-conductivity ingaphantsi kwe-5.1 S / cm @ 25 ° c.

❖ Iintsholongwane ze-Endotoxins
I-capsule ye-aqueous extraction iqulethe ngaphantsi kwe-0.25EU / ml

❖ Ukhuseleko lwendalo
Zonke izixhobo zesi sihluzo zihlangabezana neemfuno ze-USP yangoku <88> yeklasi yeplastiki VI-121 ° c.

❖ Isongezo sokutya ngokungangqalanga
Zonke izixhobo zecandelo zihlangabezana neemfuno ze-FDA ezongezo zokutya ezingathanga ngqo ezikhankanywe kwi-21CFR. Zonke izinto zecandelo zihlangabezana nemfuneko yommiselo we-EU 1935/2004/EC. Qhagamshelana nabanikezeli ngolwazi oluthe vetshe malunga nemathiriyeli yokwakha.

❖ Ingxelo ngemvelaphi yezilwanyana
Ngokusekwe kulwazi lwangoku oluvela kubaboneleli bethu, zonke izinto ezisetyenziswa kule mveliso azinazilwanyana.

❖ Ukugcinwa kweentsholongwane
Le mveliso ivavanyelwe ngempumelelo ukugcinwa komngeni owamkelekileyo kwimicroorganism, kusetyenziswa iinkqubo ezichazwe kwi-TS Filter Validation Guides kwaye zihambelana ne-ASTM Standard Test Methos ASTM F838, ngokuhambelana neemfuno ezisebenzayo ze-FDA Guideline Sterile Drug Products Produced by Aseptic Processing- Inkqubo yangoku yokuVelisa (ngoSeptemba 2004).

❖ Iikhrayitheriya zokuKhululwa kweNqashiso
Le ndawo yokuvelisa yathathwa iisampulu, yavavanywa yaza yakhutshwa yi-TS Filter Quality Assurance.

❖ UVavanyo lweMfezeko
Indawo nganye yokucoca ivavanyiwe yi-TS Filter uqinisekiso lobulunga olusekwe kwimigangatho engezantsi, emva koko iyakhululwa.

Umgangatho woVavanyo lweMfezeko (20°c):

Indawo yeBubble (BP) , ukuHamba kweDiffusion (DF)

Qaphela: I-BP kunye ne-DF kufuneka ivavanywe emva kokuba into yokucoca imanziswe.
Kwesi sihluzo, le migangatho yovavanyo lwemfezeko iye yanxulunyaniswa ngokupheleleyo novavanyo lwe-ASTM F838 bacteria Challenge, ngokuhambelana neemfuno ezisebenzayo ze-FDA Guideline Sterile Drug Products Veliswa yi-Aseptic Processing-Current Good Manufacturing Practice (Julayi 2019).

❖ Uvavanyo lokuvuza
Into nganye yokucoca ihlolwe yi-TS Filter ukuqinisekiswa komgangatho ngokusekelwe kwiMigangatho engezantsi, emva koko ukhulule: Akukho kuvuza kwi-0.40MPa ngaphakathi kwe-5 min.