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KWL6A10HH1

Millipore

Milligard® LPB 0.5 µm nominal, Opticap® XL Capsule

nominal pore size 0.5 μm, Opticap® XL 10, cartridge nominal length 10 in. (25 cm), filter diam. 5.7 in. (14.5 cm)

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About This Item

UNSPSC Code:
23151806

material

mixed cellulose esters (MCE) membrane
polyester support
polypropylene filter
polypropylene housing
silicone seal

Quality Level

400

reg. compliance

FDA 21CFR177-182 (all component materials)

sterility

non-sterile

Sterilization Compatibility

autoclavable compatible

product line

Opticap® XL 10

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

1 bar max. inlet pressure (15 psi) at 80 °C
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
3.5 bar max. differential pressure (50 psid) at 25 °C
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

technique(s)

prefiltration: suitable

cartridge nominal length

10 in. (25 cm)

device L

33.5 cm (13.2 in.)

device size

10 in.

filter diam.

5.7 in. (14.5 cm)

filter filtration area

0.8 m2

inlet connection diam.

9/16 in.

inlet to outlet width

33.5 cm (13.2 in.)

outlet connection diam.

9/16 in.

impurities

≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
<0.5 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)

matrix

Milligard® LPB

pore size

0.5 μm nominal pore size
0.5 μm pore size

fitting

(14 mm (9/16 in.) Hose Barb Inlet and Outlet)

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General description

Device Configuration: Capsule

Features and Benefits

Single Layer

Packaging

Double Easy-Open bag

Specifications

Filter Grade: Low Protein Binding Milligard® Media

Preparation Note

Sterilization Method:
3 autoclave cycles of Sterilization Method: 30min at 121°C; not in-line steam sterilizable

This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).

Analysis Note

Gravimetric Extractables: ≤ 105 mg per capsule 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 ≥ 5 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 section of Opticap® XL Capsules and Opticap® XLT Capsules user guide
  • Storage Statement: Store in dry location
  • 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
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

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