CLGL03TP3
Durapore® 0.22 µm, High Area, Cartridge
pore size 0.22 μm, cartridge nominal length 30 in. (75 cm), Code 0
동의어(들):
Durapore® 0.22 µm, High Area, Cartridge
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제품정보 (DICE 배송 시 비용 별도)
UNSPSC Code:
23151806
제품 이름
Durapore® High Area Cartridge, Chemistry: 0.22 µm Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 30 in. Code 0
Quality Segment
material
PVDF membrane, polypropylene support, silicone O-ring
reg. compliance
meets FDA 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
30 in.
W
2.7 in.
cartridge nominal length
30 in. (75 cm)
device size
30 in.
filtration area
3.3 m2
impurities
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤30 mg/cartridge
matrix
Durapore® High Area
pore size
0.22 μm pore size
code
Code 0
General description
Device configuration: Cartridge
Cartridge type: Liquid
Cartridge type: Liquid
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: The extractables level was ≤ 30 mg per 10-inch cartridge 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 to 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
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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