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CLGL73TP3

Durapore® 0.22 µm, High Area, Cartridge

pore size 0.22 μm, cartridge nominal length 30 in. (75 cm), Code 7 (2-226; O-rings w/locking-tabs)

Synonym(s):

Durapore® II Cartridge Filter 30 in. 0.22 m Code 7, Durapore® 0.22 µm, High Area, Cartridge

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About This Item

eCl@ss:
32031690
UNSPSC Code:
23151806
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Product Name

Durapore® High Area Cartridge, Chemistry: 0.22 µm Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 30 in. Code 7

Quality Segment

400

material

PVDF , polypropylene , polypropylene support, silicone seal

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®

parameter

≤61.8 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)

technique(s)

sterile filtration: suitable

L

30 in.

W

2.7 in.

cartridge nominal length

30 in. (75 cm)

diam.

6.9 cm (2.7 in.)

filtration area

3.3 m2

impurities

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

gravimetric extractables

≤90 mg/cartridge

matrix

Durapore® High Area  

pore size

0.22 μm pore size

input

sample type liquid

bubble point

≥3450 mbar (50 psig), air with water at 23 °C

cartridge code

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

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
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1500 mL

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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Certificates of Analysis (COA)

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