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Merck
CN

KWL6A10FF1

Milligard® LPB 0.5 µm 标称l, Opticap® XL 囊式

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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UNSPSC Code:
23151806
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产品名称

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

material

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

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.

3/4 in.

inlet to outlet width

33.5 cm (13.2 in.)

outlet connection diam.

3/4 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

(19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

Quality Level

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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

Features and Benefits

Filter Grade: Low Protein Binding Milligard® Media
Single Layer

General description

Device Configuration: Capsule

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

Packaging

Double Easy-Open bag

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).

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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