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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)

别名:

Durapore® 0.22 µm, 高面积，小柱

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eCl@ss:
32031690
UNSPSC Code:
23151806
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产品名称

Durapore II 筒式过滤器 30 in.0.22 µm 7 号, Chemistry: 0.22 µm Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 30 in. Code 7

Quality Segment

material

polypropylene support, PVDF membrane, polypropylene housing, polypropylene vent cap, silicone O-ring

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

0.35 bar max. differential pressure (5 psid) at 135 °C (Forward), 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)

technique(s)

sterile filtration: suitable

W

2.7 in.

cartridge nominal length

30 in. (75 cm)

device L

30.0 in. (75.0 cm)

diam.

6.9 cm (2.7 in.)

filtration area

3.21 m2

impurities

<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 (50.0 psi), 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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