material
mixed cellulose esters (MCE) membrane ((treated for low protein binding)), polyester support, silicone O-ring
sterility
non-sterile
sterilization compatibility
autoclavable compatible
steam-in-place compatible
product line
Milligard®
feature
hydrophilic
manufacturer/tradename
Milligard®
technique(s)
prefiltration: suitable
L
10 in.
W
2.9 in.
cartridge nominal length
10 in. (25 cm)
filter size
10 in.
filtration area
0.8 m2
impurities
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
matrix
Milligard® LPB
pore size
1.2 μm nominal pore size, 1.2 μm pore size
cartridge code
Code 0
General description
Cartridge Type: Liquid
Device Configuration: Cartridge
Filter Grade: Low Protein Binding MILLIGARD® Media
Features and Benefits
Format: Single Layer
Preparation Note
This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Analysis Note
Gravimetric Extractables: The extractables level was ≤250 mg per 10-inch cartridge after a 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 installation and wetting sections of OPTISCALE® -25 user guide and introduction section of Mixed cellulose esters Tech Brief
- Storage Statement: Please refer Mixed cellulose esters Tech Brief
- 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
MILLIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany