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KHGLS2THH1

Millipore

Multilayer Durapore® 0.45/0.22 µm, Opticap® XLT Capsule

Opticap® XLT 20, sterile, inlet connection diam. 5/8 in., pore size 0.45/0.22 μm, cartridge nominal length 20 in. (50 cm)

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Synonym(s):
Opticap Sterile Multilayer XLT20 Durapore 0.45/0.22 m 5/8 in. HB
UNSPSC Code:
23151806

material

PVDF
polyester support
polyethylene support
polypropylene
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 20

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

≤30.0 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
1.05 bar max. differential pressure (15 psid) at 80 °C (Forward)
2.75 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

62.5 cm (24.6 in.)

cartridge nominal length

20 in. (50 cm)

diam.

10.7 cm (4.2 in.)

filtration area

1.2 m2

inlet connection diam.

5/8 in.

inlet to outlet W

19.8 cm (7.8 in.)

outlet connection diam.

5/8 in.

impurities

≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

matrix

Multilayer Durapore®

pore size

0.45/0.22 μm pore size

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)
 inlet hose barb
 outlet hose barb
 (16 mm (5?8 in.) Hose Barb Inlet and Outlet)

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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 @ 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 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.
TOC/Conductivity
After sterilization and a controlled water flush, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 ºC.
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

Disclaimer

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.

Regulatory Information

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