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KVVLA1TTH1

Millipore

Durapore® 0.1 µm, Opticap® XLT Capsule

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

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UNSPSC Code:
23151806

material

polypropylene filter
polypropylene housing
polypropylene support
silicone seal

Quality Level

400

reg. compliance

FDA 21CFR177-182 (all component materials)

sterility

non-sterile

Sterilization Compatibility

autoclavable compatible

product line

Opticap® XLT 10

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

≤20 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
1.7 bar max. differential pressure (25 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 23 °C
80 psig max. inlet pressure

technique(s)

sterile filtration: suitable

L

15.0 in.

W

6.9 in.

cartridge nominal length

10 in. (25 cm)

device size

10 in.

filter diam.

4.2 in. (10.7 cm)

filtration area

0.69 m2

inlet connection diam.

1-1/2 in.

inlet to outlet width

17.5 cm (6.9 in.)

outlet connection diam.

5/8 in.

impurities

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

16 mm (5/8 in.) fitting (hose barb inlet/oulet)
38 mm (1 1/2 in.) fitting (sanitary flange inlet/oulet)
1/4 in. fitting (vent/drain hose barb with double O-ring seal)
 (38 mm (1 1/2 in.) Sanitary Flange Inlet and 16 mm (5?8 in.) Hose Barb Outlet)

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General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method:
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

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: ≤ 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 ≥ 1 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

Regulatory Information

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