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Merck
CN

KPHLS3THH1

Durapore® 0.45 µm，Opticap® XLT囊式

Opticap® XLT 30, cartridge nominal length 34.3 in. (87.1 cm), filter diam. 4.2 in. (10.7 cm)

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UNSPSC Code:
23151806

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material

polyester support, polyethylene support, polypropylene filter, polypropylene housing, silicone seal

reg. compliance

FDA 21CFR177-182 (all component materials)

sterility

sterile; irradiated

product line

Opticap® XLT 30

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

≤45.0 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

34.3 in. (87.1 cm)

device L

87.1 cm (34.3 in.)

device size

30 in.

filter diam.

4.2 in. (10.7 cm)

filter filtration area

1.86 m2

inlet connection diam.

5/8 in.

inlet to outlet width

87.1 cm (34.3 in.)

outlet connection diam.

5/8 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), (16 mm (5?8 in.) Hose Barb Inlet and Outlet)

Quality Level

400

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General description

Device Configuration: Capsule

Preparation Note

Sterilization Method:
Minimum sterilization up to 25 kGy. 3 autoclave cycles of 60min at 3°C; not in-line steam sterilizable

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 ≥ 4500 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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