Bahan konstruksi

Membran

Hydrophilic   MCE

dhukungan  

PP

Inti, Kandang lan Saluran

PP

Tutup Akhir

PP (222/226 kanthi cincin penguat baja tahan karat sing enkapsulasi)

O-ring / Gasket

Silikon / EPDM / Viton

Teknologi Sealing

Ikatan Termal, Ora Ana Perekat

dimensi

diameter

Φ68

Length

5 inci, 10 inci, 20 inci, 30 inci, 40 inci

Area Filtrasi, ft²

≥ 6.4 saben elemen 10 inci

Ukuran Pori, μm       

0.1, 0.22, 0.45, 0.65,   1.0, 3.0, 5.0

Tekanan Bedane maksimal

Maju: 4.2 bar @ 23 ℃; 1.5 bar @ 85

Bacterial Retention (for 0.1 and 0.22 μm only)

Lulus tes tantangan bakteri nggunakake Brevundimonas
cilik(ATCC19146) ing konsentrasi tantangan minimal
saka 1 x 10⁵ CFU / cm².

Extractables, saben kartrij 10 inci

≤ 50 mg sawise banyu 24 jam direndhem

Tingkat Partikel sing Efektif

Meets the requirements   of Chinese Pharmacopoeia 2010,
Volume Ⅱ, appendix Ⅸ C.

Ngeculake Non-Serat

Meets the criteria for   a “non-fiber releasing” filter as defined
in 21 CFR 210.3 (b) (6).

Keracunan

Bahan komponen ketemu GB / T 14233.2 <2005> wong Tionghoa
Standar Nasional kanggo Tes Keamanan.

Kudus

<500 ppb sawise siram banyu 60 liter saben kartrid 10-inci

Akeh siklus Sterilisasi

15 steam-in-place sterilization or autoclave cycles of 30 min
at 123℃

Zat Pengoksidaan

Meets the criteria of Chinese Pharmacopoeia 2010, volume
Ⅱ for purified water.

Endotoxins bakteri

<0.25 EU / ml kaya sing ditemtokake dening tes LAL