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KHGLS10FH1

Multilayer Durapore® 0.45/0.22 µm, Opticap® XL Capsule

Opticap® XL 10, cartridge nominal length 10 in. (25 cm)

Synonym(s):

Multilayer Durapore® 0.45/0.22 µm, Opticap® XL Capsule

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About This Item

UNSPSC Code:
23151806
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Product Name

Opticap® XL 10 CapsuleMedia: Sterile Multilayer Durapore® 0.45 / 0.22 µm, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF)Inlet: 3/4 in. Sanitary FlangeOutlet: 9/16 in. Hose BarbMax Operating Pressure: 80 psi @ 25 °C

Quality Level

400

material

polyester support, polyethylene support, silicone outer O-ring, silicone-coated EPDM rubber lead O-ring

reg. compliance

FDA 21CFR177-182 (all component materials)

sterility

sterile; irradiated

product line

Opticap® XL 10

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

1 bar max. inlet pressure (15 psi) at 80 °C, 25 °C max. inlet temp., 80 psig max. inlet pressure

technique(s)

sterile filtration: suitable

cartridge nominal length

10 in. (25 cm)

device size

10 in.

inlet connection diam.

3/4 in.

outlet connection diam.

9/16 in.

matrix

Multilayer Durapore®

pore size

0.45/0.22 μm pore size

fitting

(19 mm (3/4 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)

General description

Device Configuration: Capsule

Preparation Note

Sterilization Method:
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).

Analysis Note

TOC/Conductivity: After sterilization and a controlled water flush, samples exhibited less than 500ppb TOC per USP < 643 > and less than 1.3μS/cm per USP < 645 > at 25°C.

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 Wetting Instructions for Filter Units with Durapore® Membrane user guide
  • Storage Statement: Store in dry location
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

Legal Information

Durapore 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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Certificates of Analysis (COA)

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Global Trade Item Number

SKUGTIN
KHGLS10FH104053252379482