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Tabbacin inganci

Takaddar Tabbataccen Tabbataccen Takaddar

Wannan takaddar tana ba da tabbacin samfurin wanda TS Filter ya ƙera a cikin hasken ƙa'idodin Kyawawan Ƙirar Ƙarfafawa na Yanzu.An haɓaka, samarwa da rarraba wannan samfurin bisa ga tsarin gudanarwa wanda ISO9001: 2018 ya tabbatar.

Ma'aunin Tabbacin Inganci

Tsafta
Wannan samfurin tacewa ya dace da take 21 CFR, sashe na 210.3 (b)(5)(6) da 211.72

OC OCD & Gudanarwa
Bayan sarrafa ruwan da aka sarrafa, samfuran suna da ƙasa da 0.5mg (500 ppb) na carbon kowace lita, kuma ƙarfin aiki bai wuce 5.1 S/cm @ 25°c ba.

❖ kwayoyin cutar Endotoxins
Haɗin ruwan capsule ya ƙunshi ƙasa da 0.25EU/ml

❖ Biosafety
Duk kayan wannan nau'in tacewa sun cika buƙatun USP na yanzu <88> don aji na filastik VI-121°c.

❖ Additiven Abincin Kai tsaye
Duk kayan kayan aikin sun cika buƙatun kayan abinci na FDA kai tsaye da aka ambata a cikin 21CFR.Duk kayan aikin sun cika buƙatun ƙa'idar EU 1935/2004/EC.Tuntuɓi masu kaya don ƙarin bayani game da kayan gini.

❖ Bayanin Asalin Dabbobi
Dangane da bayanin na yanzu daga masu samar da mu, duk kayan da ake amfani da su a cikin wannan samfurin ba su da dabba.

❖ Riƙewar ƙwayoyin cuta
An gwada wannan samfurin cikin nasara don riƙe ƙalubalen ƙalubale mai karɓuwa, ta amfani da hanyoyin da aka bayyana a cikin Jagororin Tabbatar da Fitar da Filter da kuma alaƙa da Tsarin Gwajin Matsayin ASTM ASTM F838, daidai da ƙa'idodin ka'idodin FDA Jagororin Samfuran Magungunan Magunguna waɗanda Aseptic Processing ke samarwa- Kyakkyawar Ɗabi'ar Ƙirƙirar Ƙwararrun Halitta (Satumba 2004).

❖ Sharuɗɗan Sakin Kuɗi
An ƙididdige wannan ƙirar masana'anta, an gwada shi kuma an sake shi ta TS Tabbacin Ingancin Tace.

❖ Gwajin Mutunci
An gwada kowane nau'in tacewa ta TS Tabbacin ingancin Filter dangane da ƙa'idodin ƙasa, sannan a saki.

Matsayin Gwajin Mutunci (20°c):

Bubble Point (BP), Rarraba Yawo (DF)

Lura: BP da DF yakamata a gwada su bayan an jika abin tacewa.
Don wannan tacewa, waɗannan ƙa'idodin gwajin amincin sun sami cikakkiyar alaƙa da gwajin ƙalubalen ƙwayoyin cuta na ASTM F838, daidai da ƙa'idodin ƙa'idodin FDA Jagororin Kayayyakin Magungunan Magungunan Magunguna waɗanda Aseptic Processing-Kyakkyawan Kyawawan Ƙwararru na Yanzu (Yuli 2019).

❖ Gwajin Leak
An gwada kowane nau'in tacewa ta TS Tabbacin ingancin Filter dangane da ƙa'idodin ƙasa, sannan a saki: Babu yabo a 0.40MPa a cikin mintuna 5.