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安全信息

CVHL03PP3

Millipore

Durapore 筒式过滤器，无预滤器 30 in.0.45 µm 0 号

pore size 0.45 μm, cartridge nominal length 30 in. (75 cm), Code 0 (2-222; O-rings)

别名:

Durapore® 0.45 µm，小柱

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About This Item

UNSPSC代码:
23151806
eCl@ss:
32031690

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®

特点

hydrophilic

制造商/商品名称

Durapore®

参数

≤45 mL/min air diffusion at 1.5 bar (22 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)

技术

bioburden reduction: suitable

长度

30 in.

宽度

2.7 in.

纯化柱标称长度

30 in. (75 cm)

直径

6.9 cm (2.7 in.)

过滤面积

2.07 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)

重量萃取物

≤60 mg/cartridge

基质

Durapore®

孔径

0.45 μm pore size

输入

sample type liquid

泡点

≥1930 mbar (28 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

Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L

法律信息

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

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