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KHGLS10FF1 Millipore

Opticap® XL10 Durapore®

sterile, inlet connection diam. 3/4 in., pore size 0.22 μm, pore size 0.45 μm, cartridge nominal length 10 in. (25 cm)

Synonym: Opticap Sterile Multilayer XL10 Durapore 0.45/0.22 m 3/4 in. TC/TC



Quality Level   400
material   PVDF
  polypropylene housing
  polypropylene support
  polypropylene vent cap
  silicone seal
reg. compliance   meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
sterility   sterile
feature   hydrophilic
mfr. no.   Opticap®
parameter   ≤15.0 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
L   33.5 cm (13.2 in.)
cartridge nominal length   10 in. (25 cm)
diam.   10.7 cm (4.2 in.)
filtration area   0.55 m2
inlet connection diam.   3/4 in.
inlet to outlet W   33.5 cm (13.2 in.)
outlet connection diam.   3/4 in.
overall size   10 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   0.22 μm pore size
  0.45 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 sanitary flange
  19 mm (3/4 in.) inlet/outlet sanitary flange
  outlet sanitary flange


General description

Device Configuration: Capsule


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.

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 ≥1.5 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


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.

Safety & Documentation

Safety Information

Safety Information for this product is unavailable at this time.
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