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Key Documents

CWSS04S03

Millipore

Milligard® 0.5/0.2 µm标称,小柱

cartridge nominal length 40 in. (100 cm), filter diam. 2.8 in. (7.1 cm)

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About This Item

分類程式碼代碼:
23151806

材料

polyester support
polypropylene device
silicone seal

品質等級

法律遵循

meets EU 1935/2004/EC (alll component materials)
meets FDA 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

Milligard®

特點

hydrophilic

製造商/商標名

Milligard®

參數

3.5 bar max. differential pressure (50 psid) at 25 °C
3.5 bar max. inlet pressure (50 psi) at 25 °C

技術

prefiltration: suitable

長度

40 in.

寬度

2.7 in.

柱標稱長度

40 in. (100 cm)

過濾器直徑

2.8 in. (7.1 cm)

過濾器尺寸

40 in.

過濾面積

2.8 m2

雜質

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

基質

Milligard®

pore size

0.5/0.2 μm nominal pore size
0.5/0.2 μm pore size

柱代碼

Code 0

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一般說明

Cartridge Type: Liquid
Device Configuration: Cartridge
Filter Grade: Standard MILLIGARD® Media

特點和優勢

Format: Double Layer

包裝

Double Easy-Open bag

準備報告

Sterilization Method: 10 autoclave cycles or SIP at 121 °C for 30 min

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

分析報告

Gravimetric Extractables: The extractables level was ≤50 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L  

其他說明

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 installation and wetting sections of OPTISCALE® -25 user guide and introduction section of Mixed cellulose esters Tech Brief
  • Storage Statement: Please refer Mixed cellulose esters Tech Brief
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

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

法律資訊

MILLIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany

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