Izinto Zokwakha

Isikhwama

I-Double Layer Hydrophilic PES

Amaprosesa asekelwe

PP

I-Core, i-Cage ne-Drainage

PP

Qeda Izikhala

I-PP (222/226 ene-encaps) engenasici  
indandatho yokuqinisa insimbi)

O-izindandatho / i-Gasket

I-Silicone / EPDM / Viton

Ubuchwepheshe bokubopha uphawu

Isibopho Esishisayo, Azikho Izibambiso

Ubukhulu

ububanzi

Φ70

ubude

5 intshi, 10 intshi, 20 intshi, 30 intshi

Indawo yokuhlunga, ft²

≥ 4.9 igobolondo ngalinye elingu-10 intshi

Usayizi wePore, μm

0.45 + 0.22

Ubunzima obukhulu bokucindezela

Dlulisa: 4.2 ibha @ 23 ℃; 1.5 ibha @ 85 ℃

Ukuhlolwa Kobuqotho ku-23 ℃

Iphuzu le-bubble yamanzi

≥ 3500 mbar (50 psig)

Ukugeleza okunzima

≤ 30ml / min / 10 ”@ 2.8bar

Ukugcinwa Kwegciwane

Kuphumelele ukuhlolwa kwenselele yamagciwane kusetshenziswa UBrevundimonas
ukunciphisa (ATCC19146) ekuphingeni kwenselele okuyi-1 x 10⁷ CFU / cm².

Izithasiselo, ngebhokisi ngalinye le-10-intshi

≤ 10 mg ngemuva kokucwilisa u-24-h emanzini

Izinga lezinhlayiyana ezisebenzayo

Ihlangabezana nezidingo ze-Chinese Pharmacopoeia 2010, Umqulu Ⅱ, isithasiselo Ⅸ C.

Ukukhishwa Kwe-non-Fibre

Ihlangabezana nenqubo yokuhlunga "okungeyona i-fiber" njengoba kuchaziwe ku-21 CFR 210.3 (b) (6).

Ubuthi

Component materials   meet GB/T 14233.2<2005>of Chinese
Izinga Likazwelonke Lokuhlola Ukuphepha.

TOC

<500 ppb ngemuva kokugeleza kwamanzi amalitha angama-60 nge-cartridge eyi-10-intshi

Imijikelezo Yokuhlanzeka Amaningi

40 umjikelezo we-stamilization noma umjikelezo we-autoclave wemizuzu engama-30 ku-123 ℃

Izinto Ezingaxekeka

Ihlangabezana nemibandela ye-Chinese Pharmacopoeia 2010, ivolumu Ⅱ yamanzi ahlanziwe.

Ama-Endotoxin wamagciwane

<0.25 EU / ml njengoba kunqunywe ukuhlolwa kwe-LAL