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K002A05HH1

Opticap® XL Capsule Filter

pore size 0.2 μm, cartridge nominal length 5 in. (12.5 cm), filter diam. 4.2 in. (10.7 cm)

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Opticap® XL Capsule Filter

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UNSPSC Code:
23151806
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Nombre del producto

OPTICAP® XL 5 Capsule Media: CLARIGARD® 0.2 µm Nominal, Chemistry: Polypropylene (PP)Inlet: 9/16 in. Hose BarbOutlet: 9/16 in. Hose BarbMax Operating Pressure: 80 @ 25 °C

Quality Segment

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

5 in. (12.5 cm)

device size

5 in.

filter L

8.5 in. (21.6 cm)

filter diam.

4.2 in. (10.7 cm)

inlet connection diam.

9/16 in. , hose barb

inlet to outlet width

21.6 cm (8.5 in.)

impurities

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

matrix

Clarigard®

pore size

0.2 μm pore size

fitting

inlet/outlet connection for 14 mm (9/16 in.) hose barb

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 ≥2L

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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Clase de almacenamiento

10-13 - German Storage Class 10 to 13

Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «Batch»

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