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KVGLS3TTT1

Millipore

Durapore® 0.22 µm, Opticap® XLT Capsule

sterile, Opticap® XLT 30, inlet connection diam. 1.5 in., cartridge nominal length 30 in. (75 cm)

Synonym(s):

Opticap Sterile XLT30 Durapore 0.22 μm1-1/2 in. TC

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About This Item

UNSPSC Code:
23151806

material

PVDF
polyester support
polyethylene support
polypropylene (gamma-stable)
polypropylene housing
polypropylene vent cap
silicone seal

Quality Level

400

reg. compliance

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

sterility

irradiated
sterile

product line

Opticap® XLT 30

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

≤42 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)
1.0 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

87.1 cm (34.3 in.)

cartridge nominal length

30 in. (75 cm)

diam.

10.7 cm (4.2 in.)

filtration area

2.17 m2

inlet connection diam.

1.5 in.

inlet to outlet W

15.2 cm (6.0 in.)

outlet connection diam.

1.5 in.

impurities

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

gravimetric extractables

≤75 mg/capsule

matrix

Durapore®

pore size

0.22 μm

input

sample type liquid

bubble point

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

fitting

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

General description

Device Configuration: Capsule
T-line/Gauge Port: T-line

Packaging

Double Easy-Open bag

Other Notes

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

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 123 °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 21 CFR 210.3 (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: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L

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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