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Chitsimikizo chadongosolo

Satifiketi Yotsimikizira Ubwino

Chikalatachi chikutsimikizira malonda omwe amapangidwa ndi TS Fyuluta potengera miyezo Yapano Yabwino Yopanga Zinthu.Izi zimapangidwa, kupangidwa ndikugawidwa molingana ndi kasamalidwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwekazi-bundubundujojojojojojojo mongansongwangwangwa3weniweniweniweniweniweniweni kwanga kwa mujibu wa womvera Mulungu'

Zofunikira Zotsimikizira Ubwino

Ukhondo
Zosefera izi zikugwirizana ndi mutu 21 CFR, gawo 210.3 (b) (5) (6) ndi 211.72

OC OCD & Conductivity
Pambuyo poyendetsa madzi othamanga, zitsanzo zimakhala ndi mpweya wochepera 0.5mg (500 ppb) wa carbon pa lita, ndipo ma conductivity ndi osachepera 5.1 S/cm @ 25°c.

❖ Mabakiteriya Endotoxins
Kapisozi wamadzimadzi m'zigawo zili zosakwana 0.25EU/ml

❖ Chitetezo cha Zamoyo
Zida zonse za sefayi zimakwaniritsa zofunikira za USP <88> ya pulasitiki VI-121 ° c.

❖ Chowonjezera Chakudya Chachindunji
Zida zonse zamaguluwa zimakwaniritsa zofunikira za FDA zowonjezera zakudya zomwe zatchulidwa mu 21CFR.Zida zonse zamagulu zimakwaniritsa zofunikira za EU regulation 1935/2004/EC.Lumikizanani ndi ogulitsa kuti mumve zambiri zokhudzana ndi zida zomangira.

❖ Ndemanga za Chinyama
Kutengera zomwe zaperekedwa ndi ogulitsa athu, zinthu zonse zomwe zimagwiritsidwa ntchito pamtunduwu ndizopanda nyama.

❖ Kusunga Mabakiteriya
Izi zidayesedwa bwino kuti zisunge kachilombo kovomerezeka, pogwiritsa ntchito njira zomwe zafotokozedwa mu TS Filter Validation Guides ndi zogwirizana ndi ASTM Standard Test Methos ASTM F838, mogwirizana ndi zofunikira za FDA Guideline Sterile Drug Products Produced by Aseptic Processing- Mchitidwe Wamakono Wopanga Zabwino (September 2004).

❖ Zoyenera Kutulutsa Loti
Malo opangirawa adayesedwa, kuyesedwa ndikutulutsidwa ndi TS Filter Quality Assurance.

❖ Kuyesedwa kwa Umphumphu
Chilichonse chosefera chayesedwa ndi chitsimikizo chamtundu wa TS Filter kutengera zomwe zili pansipa, kenako ndikutulutsa.

Muyezo Woyesa Umphumphu (20°c):

Bubble Point (BP), Diffusion Flow (DF)

Zindikirani: BP ndi DF ziyenera kuyesedwa pambuyo ponyowa.
Pazosefera izi, miyezo yoyezetsa umphumphuyi ikugwirizana kwathunthu ndi mayeso a ASTM F838 bacteria Challenge, mogwirizana ndi zofunikira za FDA Guideline Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice (July 2019).

❖ Mayeso a Leak
Chilichonse chosefera chayesedwa ndi chitsimikizo cha TS Filter kutengera Miyezo yomwe ili pansipa, kenako ndikutulutsa: Palibe kutayikira pa 0.40MPa mkati mwa 5 min.