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Merck
CN

KVSSA10FF1

Opticap® XL胶囊过滤器

cartridge nominal length 10 in. (25 cm), filter diam. 4.2 in. (10.7 cm)

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material

mixed cellulose esters (MCE) prefilter, polypropylene filter, polypropylene housing, polypropylene support, silicone seal

reg. compliance

FDA 21CFR177-182 (all component materials)

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

≤10.8 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water), 1 bar max. inlet pressure (15 psi) at 80 °C, 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward:), 2.8 bar max. inlet pressure (40 psi) at 60 °C, 25 °C max. inlet temp., 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 25 °C, 80 psig max. inlet pressure

cartridge nominal length

10 in. (25 cm)

device L

33.0 cm (13.0 in.)

device size

10 in.

filter diam.

4.2 in. (10.7 cm)

filter filtration area

0.34 m2

inlet connection diam.

3/4 in.

outlet connection diam.

3/4 in.

impurities

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

matrix

Multimedia Durapore®

pore size

0.2 μm pore size, 0.22 μm pore size, 0.5 μm pore size

bubble point

≥3450 mbar (50 psig), air with water at 23 °C

fitting

19 mm (3/4 in.) fitting (sanitary flange inlet/oulet), 1/4 in. fitting (vent/drain hose barb with double O-ring seal)

Quality Level

400

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General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method:
3 autoclave cycles of 60min at 3°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

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.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 5 L

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

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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