material
PTFE , polypropylene , polypropylene support, stainless steel housing
manufacturer/tradename
Solvex™
parameter
1.8 bar max. differential pressure (25 psid) at 80 °C, 5.5 bar max. differential pressure (80 psig) (at ambient temperature)
L
1.5 cm (32.1 in.)
cartridge filtration area
1.95 m2 (21.0 ft2)
cartridge nominal length
30 in.
diam.
2.8 in.
impurities
<0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction), <0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
gravimetric extractables
≤105 mg/cartridge
matrix
Solvex™
pore size
0.2 μm nominal pore size, 0.2 μm pore size
input
sample type solvent(s)
cartridge code
Code 7
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General description
Device Configuration: Cartridge
Packaging
Double Easy-Open bag
Preparation Note
PTFE membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6).
Sterilization Method
Steam sterilized 50 times forward and 50 times reverse for 30 minutes at 135 °C
Steam sterilized 50 times forward and 50 times reverse for 30 minutes at 135 °C
Analysis Note
Gravimetric Extractables: after 24 hours in a 70/30% IPA/water mixture at controlled room temperature
Legal Information
Solvex is a trademark of Merck KGaA, Darmstadt, Germany
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