产品名称
疏水性Durapore® 0.22 µm滤膜，筒式, pore size 0.22 μm, Code 0 (2-222; O-rings)
material
PVDF
sterility
non-sterile
sterilization compatibility
steam-in-place compatible
product line
Durapore®
feature
hydrophobic
manufacturer/tradename
Durapore®
technique(s)
sterile filtration: suitable
L
5 in.
W
2.7 in.
cartridge nominal length
5 in.
filtration area
0.35 m2
impurities
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤10 mg
matrix
Durapore®
pore size
0.22 μm pore size
cartridge code
Code 0 (2-222; O-rings)
Quality Level
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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 a 70/30% IPA/water mixture at controlled room temperature
General description
Device Configuration: Cartridge
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 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.
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
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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