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CWSC54S03

Milligard® 1.2/0.5 µm nominal, Cartridge

cartridge nominal length 40 in. (100 cm), filter diam. 2.8 in. (7.1 cm)

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About This Item

UNSPSC Code:
23151806
Technical Service
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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

General description

Filter Grade: Standard MILLIGARD® Media
Cartridge Type: Liquid
Device Configuration: Cartridge

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).

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  

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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Certificates of Analysis (COA)

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