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Merck
CN

KVVLA3STT1

Durapore® 0.1 µm，Opticap® XLT囊式

cartridge nominal length 30 in. (15 cm), Opticap® XLT 30, filter diam. 5.7 in. (14.5 cm), pore size 0.1 μm

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UNSPSC Code:
23151806

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产品名称

Durapore® 0.1 µm，Opticap® XLT囊式, cartridge nominal length 30 in. (15 cm), Opticap® XLT 30, filter diam. 5.7 in. (14.5 cm), pore size 0.1 μm

material

polypropylene device
polypropylene housing
polypropylene support
polypropylene vent cap

reg. compliance

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

sterility

non-sterile

sterilization compatibility

autoclavable compatible

product line

Opticap® XLT 30

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

max. inlet temp. at 25 °C
≤60 mL/min air diffusion at 3.9 bar (56 psig) (in water)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
2.8 bar max. inlet pressure (40 psi) at 60 °C
3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

technique(s)

sterile filtration: suitable

L

34.3 in.

W

6.0 in.

cartridge nominal length

30 in. (15 cm)

device size

30 in.

filter diam.

5.7 in. (14.5 cm)

filter filtration area

2.1 m2

inlet to outlet width

34.3 in. (87.1 cm)

impurities

≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

matrix

Durapore®

pore size

0.1 μm pore size

bubble point

≥4830 mbar (70 psig), air with water at 23 °C

fitting

1/4 in. drain/vent connection (with double O-ring Seal)
 (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Quality Level

400

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Analysis Note

Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm2 using ASTM® F838 methodology.
Gravimetric Extractables: ≤ 75 mg per capsule after 24 hours in water at controlled room temperature.

Features and Benefits

T-line/Gauge Port: T-line

General description

Device Configuration: Cartridge
Cartridge Type: Liquid

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

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Preparation Note

Sterilization Method: Capsule integrity was maintained after 3 autoclave cyclces of 60 minutes at 126 °C.
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

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