material
mixed cellulose esters (MCE) (low protein-binding), polyester support, polypropylene , silicone seal
sterility
non-sterile
sterilization compatibility
autoclavable compatible
steam-in-place compatible
product line
Milligard®
feature
hydrophilic
manufacturer/tradename
Milligard®
parameter
3.5 bar max. differential pressure (50 psid) at 25 °C, 3.5 bar max. inlet pressure (50 psi) at 25 °C
technique(s)
prefiltration: suitable
L
10 in.
W
2.9 in.
cartridge nominal length
10 in. (25 cm)
diam.
7.1 cm (2.8 in.)
filtration area
0.8 m2
impurities
≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤250 mg/cartridge
matrix
Milligard® LPB
pore size
1.2 μm nominal pore size, 1.2 μm pore size
input
sample type liquid
cartridge code
Code 7
Quality Level
General description
Device Configuration: Cartridge
Features and Benefits
Filter Grade: Low Protein Binding Milligard® Media
Format: Single Layer
Packaging
Double Easy-Open bag
Preparation Note
Sterilization Method
10 autoclave cycles or SIP @ 121 °C for 30 min
10 autoclave cycles or SIP @ 121 °C for 30 min
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 a 5 L flush and 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥9 L
Other Notes
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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.
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
法规信息
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