CLGL01TP3
Durapore® 0.22 µm, High Area, Cartridge
pore size 0.22 μm, cartridge nominal length 10 in. (25 cm), Code 0 (2-222; O-rings)
别名:
Durapore® 0.22 µm, 高面积，小柱
产品名称
Durapore II 筒式过滤器 10 in.0.22 µm 0 号, Chemistry: 0.22 µm Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 10 in. Code 0
material
PVDF
reg. compliance
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
impurities
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤30 mg/cartridge
matrix
Durapore® High Area
pore size
0.22 μm pore size
input
sample type liquid
Quality Level
sterility
non-sterile
sterilization compatibility
autoclavable compatible
steam-in-place compatible
product line
Durapore®
feature
hydrophilic
manufacturer/tradename
Durapore® II
technique(s)
sterile filtration: suitable
L
10 in.
W
2.7 in.
cartridge nominal length
10 in. (25 cm)
filtration area
1.1 m2
cartridge code
Code 0 (2-222; O-rings)
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 a 1.5 L flush and 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 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.
Legal Information
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
ASTM is a registered trademark of American Society for Testing and Materials
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