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Key Documents

CGW904S03

Millipore

PolysepII 2.0/1.2 µm 标称,小柱

pore size 2.0/1.2 μm, filter diam. 7.1 cm (2.8 in.), cartridge nominal length 100 cm (40 in.)

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About This Item

分類程式碼代碼:
23151806

材料

borosilicate glass fiber (BGF) membrane
mixed cellulose esters (MCE) membrane
polypropylene prefilter
polypropylene support
silicone seal

品質等級

法律遵循

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

Polysep

特點

hydrophilic

製造商/商標名

Polysep

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

100 cm (40 in.)

過濾器直徑

7.1 cm (2.8 in.)

過濾器過濾面積

1.84 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

Polysep II

pore size

2.0/1.2 μm nominal pore size
2.0/1.2 μm pore size

柱代碼

Code 0

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一般說明

Device Configuration: Cartridge

特點和優勢

Double Layer

包裝

Double Easy-Open bag

準備報告

Non-Fiber Releasing: This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).
Sterilization Method: 10 autoclave cycles or SIP for 30 min at 121 °C

分析報告

Gravimetric Extractables: the extractables level was equal to or less than 140 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 ≥ 20 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 first page of Visual Inspection 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

Polysep is a trademark of Sigma-Aldrich Co. LLC

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