产品名称
Durapore® 0.65 µm，小柱, Chemistry: 0.65 µm Hydrophilic Polyvinylidene Fluoride (PVDF)Configuration: 10 in. Code 0
material
PVDF membrane, silicone O-ring
reg. compliance
meets EU 1935/2004/EC (all component materials; regarding materials and articles intended to contact food), meets FDA 21 CFR 177-182 (all component materials)
Quality Level
sterility
non-sterile
sterilization compatibility
autoclavable compatible
steam-in-place compatible
product line
Durapore®
feature
hydrophilic
manufacturer/tradename
Durapore®
technique(s)
prefiltration: suitable
L
10 in.
W
2.7 in.
cartridge nominal length
10 in. (25 cm)
device size
10 in.
filtration area
0.69 m2
impurities
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤20 mg/cartridge
matrix
Durapore®
pore size
0.65 μm pore size
code
Code 0
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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
Gravimetric Extractables: The extractables level was ≤ 20 mg per 10-inch cartridge after 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
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
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