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KWL3A02FF3

Opticap® XL 2 Capsule Media: Milligard® LPB 0.2 µm Nominal

Chemistry: Low Protein-Binding Mixed Cellulose Esters (MCE) Inlet: 3/4 in. Sanitary Flange Outlet: 3/4 in. Sanitary Flange Max Operating Pressure: 80 psi @ 25 °C

Sinónimos:

Milligard® LPB 0.2 µm nominal, Opticap® XL Capsule

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UNSPSC Code:
23151806
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Nombre del producto

Milligard® LPB 0,2 0.2 µm nominal, cápsula Opticap® XL, Chemistry: Low Protein-Binding Mixed Cellulose Esters (MCE) Inlet: 3/4 in. Sanitary Flange Outlet: 3/4 in. Sanitary Flange Max Operating Pressure: 80 psi @ 25 °C

Quality Segment

400

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 2

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

2 in. (5 cm)

device L

14.2 cm (5.6 in.)

device size

2 in.

filter diam.

4.9 in. (12.5 cm)

filter filtration area

0.1 m2

inlet connection diam.

3/4 in.

inlet to outlet width

14.2 cm (5.6 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

0.2 μm nominal pore size, 0.2 μm pore size

fitting

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

General description

Device Configuration: Capsule

Features and Benefits

Filter Grade: Low Protein Binding Milligard® Media
Single Layer

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).

Analysis Note

Gravimetric Extractables: ≤ 25 mg per capsule after a 1 L flush and 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1 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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