屬性

物料

PVDF membrane
PVDF vent cap
polycarbonate
polycarbonate support

質(zhì)量水平

400

無菌性

sterile

產(chǎn)品線

EMPROVEFilter

特點

hydrophilic

manufacturer/tradename

Millipak

參數(shù)

0.35 bar max. differential pressure (5 psid) at 123 °C (Forward)
0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
25 °C max. temp.
3.8 L/min flow rate at 1.75 bar (ΔP)
4.1 bar max. differential pressure (60 psid) at 25 °C (Forward)
5.2 bar max. inlet pressure (75 psi) at 25 °C

過濾面積

300cm2

inlet connection diam.

1/4in.

outlet connection diam.

1/4in.

雜質(zhì)

≤0.5EU/mL (LAL test, Aqueous extraction)
<0.5EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

gravimetric extractables

≤2mg/device

基質(zhì)

Durapore

孔徑

0.22μm nominal pore size
0.22μm pore size

bubble point

≥3450mbar (50psig), air with water at 23°C

配件

inlet hose barb
6 mm (1/4 in.) inlet/outlet hose barb (with bell)
outlet hose barb (with bell)

運輸

ambient

說明

一般描述

Device Configuration: Gamma Gold Capsule

包裝

水泡眼包裝

其他說明

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Directions for Use

Organism Retention: Microorganism

Mode of Action: Filtration (size exclusion)

Application: BioProcessing

Intended Use: Reduction or removal of microorganism/bioburden

Instructions for Use: Please refer Wetting Instructions for Filter Units with DuraporeMembrane user guide

Storage Statement: Store in dry location

Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

制備說明

Sterilization Method
123 °C 時 90 分鐘的 3 個高壓高溫周期；不進行在線蒸汽消毒

This product was manufactured with a Duraporemembrane which meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6).

分析說明

Bacterial Retention
Samples were quantitatively retentive of a minimumBrevundimonas diminutachallenge concentration of 1 x 10 CFU/cm2 using ASTMF838 methodology.

使用 ≥200 mL 水沖洗后，將符合“USP 氧化物檢測”要求

Gravimetric Extractables: using sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature