产品名称
Durapore® 0.1 µm,小柱, Chemistry: 0.1 µm Hydrophilic Modified Polyvinylidene Fluoride (PVDF)Configuration: 10 in. Code 7
material
PVDF
reg. compliance
meets FDA Indirect Food Additive requirements cited in 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)
sterile filtration: suitable
L
10 in.
W
2.7 in.
cartridge nominal length
10 in. (25 cm)
filtration area
0.69 m2
impurities
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤24 mg/cartridge
matrix
Durapore®
pore size
0.1 μm pore size
input
sample type liquid
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.
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Other Notes
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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