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MilliporeSigma

KHGLG10TH1

Millipore

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

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

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About This Item

UNSPSC Code:
23151806

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material

polyester support
polyethylene support
polypropylene filter
polypropylene housing
silicone outer O-ring
silicone-coated EPDM rubber lead O-ring

Quality Level

reg. compliance

FDA 21CFR177-182 (all component materials)

sterility

non-sterile

sterilization compatibility

gamma compatible

product line

Opticap® XL 10

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

≤15.0 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
1.05 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

W

4.2 in.

cartridge nominal length

10 in. (25 cm)

device L

33.5 cm (13.2 in.)

device size

10 in.

filter diam.

4.2 in. (10.7 cm)

filter filtration area

1.86 m2

inlet connection diam.

1-1/2 in.

inlet to outlet width

33.5 cm (13.2 in.)

outlet connection diam.

9/16 in.

impurities

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

matrix

Multilayer Durapore®

pore size

0.45/0.22 μm pore size

bubble point

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

fitting

1/4 in. fitting (vent/drain hose barb with double O-ring seal)
(38 mm (1 1/2 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)

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This Item
KHGLS3THH1KVVLS1THH1KHGLA1THH1
pore size

0.45/0.22 μm pore size

pore size

0.45/0.22 μm pore size

pore size

-

pore size

0.45/0.22 μm pore size

product line

Opticap® XL 10

product line

Opticap® XLT 30

product line

Opticap® XLT 10

product line

Opticap® XLT 10

technique(s)

sterile filtration: suitable

technique(s)

sterile filtration: suitable

technique(s)

sterile filtration: suitable

technique(s)

sterile filtration: suitable

sterility

non-sterile

sterility

sterile; irradiated

sterility

sterile; irradiated

sterility

non-sterile

manufacturer/tradename

Opticap®

manufacturer/tradename

Opticap®

manufacturer/tradename

Opticap®

manufacturer/tradename

Opticap®

matrix

Multilayer Durapore®

matrix

Multilayer Durapore®

matrix

Durapore®

matrix

Multilayer Durapore®

General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method:
Gamma compatible to 45 kGy; 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.
TOC/Conductivity: After sterilization and a controlled water flush, samples exhibited less than 500ppb TOC per USP < 643 > and less than 1.3μS/cm per USP < 645 > at 25°C.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1.5 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

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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