Bahan konstruksi

Membran

Pinggir kaping pindho Hydrophilic PES

dhukungan

PP

Inti, Kandhang lan Saliran

PP

Pungkak Pungkasane

PP (222/226 with encapsulated stainless  
steel reinforcing ring)

O-ring / Gasket

Silikon / EPDM / Viton

Teknologi panyegelan

Pengambilan termal, Ora ana Pilihan

dimensi

diameter

Φ70

Length

5 inci, 10 inci, 20 inci, 30 inci

Filtration   Area, ft²

≥ 4.9 per 10-inch cartridge

Ukuran Pori, μm

0.45 + 0.22

Tekanan Bedane maksimal

Forward: 4.2 bar @ 23 ℃; 1.5   bar @ 85 ℃

Tes integritas ing 23 ℃

Titik gelembung banyu

≥ 3500 mbar (50 psig)

Aliran beda

≤ 30ml/min/10”@2.8bar

Penylametan bakteri

Lulus tes tantangan bakteri nggunakake Brevundimonas
diminuta (ATCC19146) kanthi konsentrasi tantangan minimal 1 x 10⁷ CFU / cm².

Extractables, saben kartrij 10 inci

≤ 10 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

40 siklus sterilisasi uap-ing utawa siklus autoclave 30 min ing 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