Quality Level
material
mixed cellulose esters (MCE)
reg. compliance
meets EU framework regulation [1935/2004/EC] (all component materials; regarding materials and articles intended to contact food), 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
Milligard®
feature
hydrophilic
manufacturer/tradename
Milligard®
technique(s)
prefiltration: suitable
L
10 in.
W
2.9 in.
cartridge nominal length
10 in. (25 cm)
filtration area
0.8 m2
impurities
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤50 mg/cartridge
matrix
Milligard®
pore size
0.2 μm nominal pore size, 0.2 μm pore size
input
sample type liquid
cartridge code
Code F (double open end w/flat gaskets)
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General description
Device Configuration: Cartridge
Features and Benefits
Filter Grade: Standard Milligard® Media
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: after 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 to the installation and wetting sections of OptiScale®-25 user guide and introduction section of the Mixed cellulose esters Tech Brief
- Storage Statement: Please refer to the 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
signalword
Danger
hcodes
Hazard Classifications
Flam. Sol. 1
存储类别
4.1B - Flammable solid hazardous materials
wgk
WGK 2
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