material
polyester support, polypropylene device, silicone seal
reg. compliance
meets EU 1935/2004/EC (alll component materials), meets FDA 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®
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
40 in.
W
2.7 in.
cartridge nominal length
40 in. (100 cm)
filter diam.
2.8 in. (7.1 cm)
filter size
40 in.
filtration area
2.8 m2
impurities
≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction), <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
matrix
Milligard®
pore size
1.2/0.5 μm nominal pore size, 1.2/0.5 μm pore size
cartridge code
Code 5
Quality Level
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General description
Cartridge Type: Liquid
Device Configuration: Cartridge
Filter Grade: Standard MILLIGARD® Media
Features and Benefits
Format: Double Layer
Packaging
Double Easy-Open bag
Preparation Note
Sterilization Method: 10 autoclave cycles or SIP at 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).
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 ≤50 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥9 L
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥9 L
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
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