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K003A10FF1

Opticap® XL Capsule Filter

pore size 0.3 μm, cartridge nominal length 10 in. (25 cm), filter diam. 4.2 in. (10.7 cm)

Synonym(s):

Opticap® XL Capsule Filter

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About This Item

UNSPSC Code:
23151806
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Product Name

OPTICAP® XL 10 Capsule Media: CLARIGARD® 0.3 µm Nominal, Chemistry: Polypropylene (PP)Inlet: 3/4 in. Sanitary Flange Outlet: 3/4 in. Sanitary FlangeMax Operating Pressure: 80 psi @ 25 °C

Quality Level

400

material

polypropylene filter, polypropylene housing, polypropylene support, silicone seal

reg. compliance

meets FDA 21 CFR 177-182 (all component materials)

manufacturer/tradename

Opticap®

parameter

max. inlet temp. at 25 °C, 1.0 bar max. inlet pressure (15 psi) at 80 °C, 2.75 bar max. inlet pressure (40 psi) at 60 °C, 4.8 bar max. differential pressure (70 psid) at 20 °C, 5.5 bar max. inlet pressure (80 psi) at 23 °C, 80 psig max. inlet pressure

cartridge nominal length

10 in. (25 cm)

device size

10 in.

filter L

13.2 in. (33.5 cm)

filter diam.

4.2 in. (10.7 cm)

inlet connection diam.

3/4 in. , sanitary flange

inlet to outlet width

33.5 cm (13.2 in.)

impurities

≤0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)

matrix

Clarigard®

pore size

0.3 μm pore size

fitting

inlet/outlet connection for 19 mm (3/4 in.) sanitary flange

General description

Cartridge Type: Liquid
Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method:
3 autoclave cycles of 30min at 126°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: ≤ 55mg per capsule after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3L

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

CLARIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

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Regulatory Information

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Global Trade Item Number

SKUGTIN
K003A10FF104053252462634