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Merck
CN
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LCGL04TP6

Millipore

Optiseal Charged Durapore 筒式过滤器 0.22 µm

OptiSeal® 4 in., matrix Charged Durapore®

别名:

Durapore® 0.22 µm, Optiseal® 筒式

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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

无菌性

non-sterile

灭菌适用性

autoclavable compatible
steam-in-place compatible

产品线

OptiSeal® 4 in.

特点

hydrophilic

制造商/商品名称

OptiSeal®

参数

≤4 mL/min air diffusion at 2.1 bar (30 psig) and 23 °C (in water)
0.35 bar max. differential pressure (5 psid) at 121 °C (Forward)
0.35 bar max. inlet pressure (5 psi) at 121 °C (Forward)
15 L/min flow rate at 850 mbar (ΔP)
3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse)
3.5 bar max. differential pressure (50 psid) at 80 °C (Forward)
3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse)
3.5 bar max. inlet pressure (50 psi) at 80 °C (Forward)
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

sterile filtration: suitable

长度

4 in.

纯化柱标称长度

4 in. (10 cm)

过滤面积

0.2 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

≤10 mg/cartridge

基质

Charged Durapore®

孔径

0.22 μm

输入

sample type liquid

泡点

≥2760 mbar (40 psig), air with water at 23 °C

柱代码

not applicable

相关类别

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
10 SIP cycles of 30 min @ 135 °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.
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL

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

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