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Key Documents

CLVL71TP3

Millipore

Durapore II 筒式过滤器 10 in.0.1 µm 7 号

pore size 0.1 μm, cartridge nominal length 10 in. (25 cm), Code 7 (2-226; O-rings w/locking-tabs)

别名:

Durapore® 0.1 µm, 高面积,小柱

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About This Item

分類程式碼代碼:
23151806
eCl@ss:
27293007

材料

PVDF

品質等級

法律遵循

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

無菌

non-sterile

滅菌相容性

autoclavable compatible
steam-in-place compatible

產品線

Durapore®

特點

hydrophilic

製造商/商標名

Durapore® II

技術

sterile filtration: suitable

長度

10 in.

寬度

2.7 in.

柱標稱長度

10 in. (25 cm)

過濾面積

1.1 m2

雜質

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

重量法萃取物

≤30 mg/cartridge

基質

Durapore® High Area  

孔徑

0.1 μm pore size

輸入

sample type liquid

柱代碼

Code 7 (2-226; O-rings w/locking-tabs)

一般說明

Device Configuration: Cartridge

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

準備報告

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).

分析報告

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 a 1.5 L flush and 24 hours in water at controlled room temperature

法律資訊

ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany

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