产品名称
Durapore 筒式过滤器 30 in.0.45 µm 7 号, cartridge nominal length 30 in. (75 cm), Code 7 (2-226; O-rings w/locking-tabs)
material
PVDF
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®
technique(s)
bioburden reduction: suitable
L
30 in.
W
2.7 in.
cartridge nominal length
30 in. (75 cm)
filtration area
2.07 m2
impurities
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤60 mg/cartridge
matrix
Durapore®
pore size
0.45 μm
input
sample type liquid
cartridge code
Code 7 (2-226; O-rings w/locking-tabs)
Quality Level
General description
Device Configuration: Cartridge
Analysis Note
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.
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).
Legal Information
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
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