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Safety Information

CW03N4S03

Millipore

Milligard® 0.2 µm nominal, Cartridge

cartridge nominal length 4 in. (10 cm), filter diam. 2.8 in. (7.1 cm)

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About This Item

UNSPSC Code:
23151806

material

polyester support
polypropylene device
silicone seal

Quality Level

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

4 in.

W

2.9 in.

cartridge nominal length

4 in. (10 cm)

filter diam.

2.8 in. (7.1 cm)

filter size

4 in.

filtration area

0.34 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

0.2 μm nominal pore size
0.2 μm pore size

cartridge code

Code N

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General description

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

Features and Benefits

Format: Single 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 ≤20 mg per 4-inch cartridge 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 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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Regulatory Information

新产品

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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