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KPHLS10HH1

Millipore

Durapore® 0.45 µm, Opticap® XL Capsule

Opticap® XL 10, cartridge nominal length 13.2 in. (33.5 cm), filter diam. 4.2 in. (10.7 cm)

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About This Item

UNSPSC Code:
23151806

material

polyester support
polyethylene support
polypropylene filter
polypropylene housing
silicone outer O-ring
silicone-coated EPDM rubber lead O-ring

Quality Level

400

reg. compliance

FDA 21CFR177-182 (all component materials)

sterility

sterile; irradiated

product line

Opticap® XL 10

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

≤15.0 mL/min air diffusion at 3.9 bar (56 psig) and 23 °C (in water)
1 bar max. inlet pressure (15 psi) at 80 °C
2.1 bar max. differential pressure (30 psid) at 4-40 °C (Reverse:)
2.8 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
4.1 bar max. differential pressure (60 psid) at 25 °C (Forward:)
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

technique(s)

bioburden reduction: suitable

cartridge nominal length

13.2 in. (33.5 cm)

device L

33.5 cm (13.2 in.)

device size

10 in.

filter diam.

4.2 in. (10.7 cm)

filter filtration area

0.62 m2

inlet connection diam.

9/16 in.

inlet to outlet width

33.5 cm (13.2 in.)

outlet connection diam.

9/16 in.

impurities

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

matrix

Durapore®

pore size

0.45 μm pore size

bubble point

≥1930 mbar (28 psig), air with water at 23 °C

fitting

1/4 in. fitting (vent/drain hose barb with double O-ring seal)
 (14 mm (9/16 in.) Hose Barb Inlet and Outlet)

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General description

Device Configuration: Capsule

Preparation Note

Sterilization Method:
Gamma compatible to 40 kGy. 3 autoclave cycles of 60min at 126°C; not in-line steam sterilizable

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

Gravimetric Extractables: ≤ 25 mg per capsule after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1500 mL

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

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

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