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Hunhu Hwakanaka

Chitupa Chekusimbisa Hunhu

Gwaro iri rinosimbisa chigadzirwa chakagadzirwa neTS Sefa muchiedza cheYazvino Yakanaka Kugadzira Kudzidzira zviyero. Ichi chigadzirwa chinogadzirwa, chinogadzirwa uye chinogovaniswa zvinoenderana neiyo manejimendi system inosimbiswa ne ISO9001:2018.

Chimiro Chekusimbisa Hunhu

Utsanana
Ichi chigadzirwa chesefa chinoenderana nemusoro wekuti 21 CFR, chikamu 210.3 (b) (5) (6) uye 211.72

❖ TOC & Conductivity
Mushure mekudzorwa kwemvura, sampuli dzine isingasviki 0.5mg (500 ppb) yekabhoni parita, uye conductivity iri pasi pe5.1 S/cm @ 25°c.

❖ Utachiona hweEndotoxins
A capsule aqueous extraction ine isingasviki 0.25EU/ml

❖ Biosafety
Zvese zvinhu zveiyi sefa element zvinosangana nezvinodiwa zveUSP yazvino <88> yepurasitiki kirasi VI-121 ° c.

❖ Chikafu chinowedzera
Zvese zvechikamu zvinosangana neFDA zvisina kunanga chikafu chekuwedzera zvinodiwa zvakataurwa mu21CFR. Zvese zvikamu zvinosangana nezvinodiwa zveEU regulation 1935/2004/EC. Bata vatengesi kuti uwane rumwe ruzivo nezve zvinhu zvekuvaka.

❖ Chirevo cheMhuka
Zvichienderana neruzivo rwazvino kubva kune vedu vatengesi, zvese zvinoshandiswa zvinoshandiswa muchigadzirwa ichi hazvina mhuka.

❖ Kuchengeta Mabhakitiriya
Ichi chigadzirwa chakaedzwa zvakabudirira kuchengetedza chinogamuchirika chinonetsa microorganism, uchishandisa maitiro anotsanangurwa muTS Filter Validation Guides uye ane hukama neASTM Standard Test Methos ASTM F838, inoenderana nezvinodiwa zvinoshanda zveFDA Guideline Sterile Drug Products Yakagadzirwa neAseptic Processing- Yazvino Yakanaka Kugadzira Maitiro (Gunyana 2004).

❖ Maitiro ekuburitsa Roti
Iyi mijenya yekugadzira yakatorwa sample, yakaedzwa uye yakaburitswa neTS Filter Quality Assurance.

❖ Kuedzwa Kuvimbika
Yese sefa chinhu chakayedzwa neTS Filter yemhando yekusimbisa zvichibva pane pazasi zviyero, wobva wasunungura.

Kuperera Muedzo Standard (20°c):

Bubble Point (BP) , Diffusion Flow (DF)

Ongorora: BP neDF zvinofanirwa kuongororwa mushure mesefa chinhu chakanyorova.
Kune iyi sefa, aya mayedzo ekuyedzwa akanyatsoenderana neiyo ASTM F838 mabhakitiriya Challenge bvunzo, inoenderana nezvinodiwa zveFDA Guideline Sterile Drug Products Yakagadzirwa neAseptic Processing-Yazvino Yakanaka Kugadzira Maitiro (Chikunguru 2019).

❖ Leak Test
Chese chesefa chinhu chakayedzwa neTS Sefa simbisiro yemhando yakavakirwa pazasi Mayero, wobva waburitsa: Hapana kuvuza pa 0.40MPa mukati me5 min.