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Merck
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KWSSA2ZTT1

Opticap® XLT 20 Capsule Media: Milligard® 0.5 / 0.2 µm Nominal

Chemistry: Mixed Cellulose Esters (MCE) Inlet: 1-1/2 in. Sanitary Flange Outlet: 1-1/2 in. Sanitary Flange T-line with 3/4 in. Gauge Port T-line side Max Operating Pressure: 80 psi @ 25 °C

别名:

Milligard® 0.5/0.2 µm nominal, Opticap® XLT Capsule

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UNSPSC Code:
23151806

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产品名称

Milligard® 0.5/0.2 µm 标称，Opticap® XLT囊式滤器, Chemistry: Mixed Cellulose Esters (MCE) Inlet: 1-1/2 in. Sanitary Flange Outlet: 1-1/2 in. Sanitary Flange T-line with 3/4 in. Gauge Port T-line side Max Operating Pressure: 80 psi @ 25 °C

sterility

non-sterile

sterilization compatibility

autoclavable compatible

product line

Opticap® XLT 20

impurities

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

matrix

Milligard®

pore size

0.5/0.2 μm nominal pore size, 0.5/0.2 μm pore size

fitting

(38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

material

polyester support, polypropylene filter, polypropylene housing, silicone seal

reg. compliance

FDA 21CFR177-182 (all component materials)

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

20 in. (50 cm)

device size

20 in.

inlet connection diam.

1-1/2 in.

outlet connection diam.

1-1/2 in.

Quality Level

400

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General description

Device Configuration: Capsule

Features and Benefits

Double 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: ≤ 110 mg per capsule 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 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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