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CVGL01TP3

Durapore 筒式过滤器 10 in.0.22 µm 0 号

Name: Durapore <TMSYMBOL></TMSYMBOL> 筒式过滤器 10 in.0.22 µm 0 号
Brand: MM

pore size 0.22 μm, cartridge nominal length 10 in. (25 cm), Code 0 (2-222; O-rings)

别名:

Durapore^® 0.22 µm，小柱

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About This Item

UNSPSC代码:

23151806

eCl@ss:

27293007

物料

PVDF
polypropylene
polypropylene support
silicone seal

质量水平

400

管理合规性

meets EU framework regulation [1935/2004/EC] (all component materials; regarding materials and articles intended to contact food)
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

无菌性

non-sterile

灭菌适用性

autoclavable compatible
steam-in-place compatible

产品线

Durapore^®
EMPROVE^® Filter

特点

hydrophilic

制造商/商品名称

Durapore^®

参数

≤13.3 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)
0.35 bar max. differential pressure (5 psid) at 135 °C (Forward)
0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward)
3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse)
3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)
50 L/min flow rate at 1.4 bar (ΔP)

技术

sterile filtration: suitable

长度

10 in.

宽度

2.7 in.

纯化柱标称长度

10 in. (25 cm)

直径

6.9 cm (2.7 in.)

过滤面积

0.69 m²

杂质

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

基质

Durapore^®

孔径

0.22 μm pore size

输入

sample type liquid

泡点

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

柱代码

Code 0 (2-222; O-rings)

一般描述

Device Configuration: Cartridge

包装

Double Easy-Open bag

其他说明

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 Durapore^® Membrane user guide
Storage Statement: Store in dry location
Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

制备说明

Sterilization Method
30 SIP cycles of 30 min @ 135 °C; 30 autoclave cycles of 60 min @ 126 °C

This product was manufactured with a Durapore^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

分析说明

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

TOC/Conductivity
After sterilization and a controlled water flush of 5.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

法律信息

ASTM is a registered trademark of American Society for Testing and Materials

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

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