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CLGL02TP3

Durapore® 0.22 µm, High Area, Cartridge

pore size 0.22 μm, cartridge nominal length 20 in. (50 cm), Code 0 (2-222; O-rings)

Synonym(s):

Durapore® II Cartridge Filter 20 in. 0.22 m Code 0, Durapore® 0.22 µm, High Area, Cartridge

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About This Item

eCl@ss:
27293007
UNSPSC Code:
23151806
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Product Name

Durapore® High Area Cartridge, Chemistry: 0.22 µm Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 20 in. Code 0

material

PVDF

Quality Level

400

reg. compliance

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

sterility

non-sterile

sterilization compatibility

autoclavable compatible
steam-in-place compatible

product line

Durapore®

feature

hydrophilic

manufacturer/tradename

Durapore® II

technique(s)

sterile filtration: suitable

L

20 in.

W

2.7 in.

cartridge nominal length

20 in. (50 cm)

filtration area

2.2 m2

impurities

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

gravimetric extractables

≤60 mg/cartridge

matrix

Durapore® High Area  

pore size

0.22 μm pore size

input

sample type liquid

cartridge code

Code 0 (2-222; O-rings)

General description

Device Configuration: Cartridge

Preparation Note

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).

Analysis Note

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

Other Notes

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.

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

Legal Information

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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Regulatory Information

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Global Trade Item Number

SKUGTIN
CLGL02TP304053252488771