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Ubwishingizi bufite ireme

Icyemezo cy'ubwishingizi bufite ireme

Iyi nyandiko yemeza ibicuruzwa byakozwe na TS Muyunguruzi ukurikije ibipimo ngenderwaho byiza byo gukora. Ibicuruzwa byatejwe imbere, byakozwe kandi bikwirakwizwa hakurikijwe sisitemu yubuyobozi yemejwe na ISO9001: 2018.

Ibipimo by'ubwishingizi bufite ireme

Isuku
Ibicuruzwa byungurura byujuje umutwe wa 21 CFR, igice 210.3 (b) (5) (6) na 211.72

❖ TOC & Imyitwarire
Nyuma yo kugenzurwa n’amazi, ingero zifite munsi ya 0.5mg (500 ppb) ya karubone kuri litiro, kandi ubwikorezi buri munsi ya 5.1 S / cm @ 25 ° c.

Act Indwara ya bagiteri
Gukuramo capsule y'amazi arimo munsi ya 0.25EU / ml

Osa Ibinyabuzima
Ibikoresho byose byiyungurura byujuje ibisabwa USP <88> iriho icyiciro cya plastiki VI-121 ° c.

Yongeweho ibiryo bitaziguye
Ibikoresho byose byujuje ibyangombwa bya FDA byongeweho ibiryo byongeweho byavuzwe muri 21CFR. Ibikoresho byose bigize ibice byujuje ibisabwa n’amabwiriza y’ubumwe bw’ibihugu by’Uburayi 1935/2004 / EC. Menyesha abatanga amakuru menshi yerekeye ibikoresho byubwubatsi.

Statement Itangazo ryinkomoko yinyamaswa
Ukurikije amakuru agezweho kubaduha isoko, ibikoresho byose bikoreshwa muri iki gicuruzwa nta nyamaswa.

Ret Kubika Bagiteri
Iki gicuruzwa cyageragejwe neza kugirango kigumane mikorobe yemewe, hakoreshejwe uburyo bwasobanuwe muri TS Filter Validation Guides kandi bifitanye isano na ASTM Standard Test Meteth ASTM F838, ijyanye nibisabwa bikenewe bya FDA Guideline Sterile Ibiyobyabwenge Byakozwe na Aseptic Processing- Ibikorwa byiza byo gukora muri iki gihe (Nzeri 2004).

❖ Ibipimo byo Kurekura Lot
Iyi fagitire yakozwe yakozwe, yapimwe kandi irekurwa na TS Filter Quality Assurance.

Test Kwipimisha ubunyangamugayo
Buriyungurura ibice byageragejwe na TS Muyunguruzi ubuziranenge bushingiye kubipimo bikurikira, hanyuma kurekura.

Ikigereranyo cy'Ubuziranenge (20 ° c):

Ingingo ya Bubble (BP), Diffusion Flow (DF)

Icyitonderwa: BP na DF bigomba kugeragezwa nyuma yo kuyungurura ibintu.
Kuriyungurura, ibipimo ngenderwaho byikizamini byahujwe rwose na test ya ASTM F838 ya bagiteri Ikibazo cya Challenge, ijyanye nibisabwa bikenewe mubicuruzwa bya FDA biyobora ibiyobyabwenge bya FDA byakozwe na Aseptic Processing-Current Good Manufacturing Practice (Nyakanga 2019).

Ikizamini
Buri muyunguruzi wageragejwe na TS Muyunguruzi ubuziranenge bushingiye kubipimo bikurikira, hanyuma urekure: Nta kumeneka kuri 0.40MPa muminota 5.