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Merck

KV06A10HH1

Multimedia Durapore® 0.5/0.22 µm, Opticap® XL Capsule

Opticap® XL 10, inlet connection diam. 9/16 in., pore size 0.5/0.22 μm, cartridge nominal length 10 in. (25 cm)

Synonym(s):

Opticap XL10 Multimedia 0.5/0.22 μm 9/16 in. HB/HB, Multimedia Durapore® 0.5/0.22 µm, Opticap® XL Capsule

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About This Item

UNSPSC Code:
23151806

Key Documents

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Product Name

Opticap® XL 10 CapsuleMedia: Multimedia Durapore® 0.5 / 0.22 µm, Chemistry: Hydrophilic Mixed Cellulose Esters /Polyvinylidene Fluoride (MCE / PVDF)Inlet: 9/16 in. Hose BarbOutlet: 9/16 in. Hose BarbMax. Operating Pressure: 80 psi @ 25 °C

material

PVDF , mixed cellulose esters (MCE) , mixed cellulose esters (MCE) prefilter, polypropylene , 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)

Quality Level

400

sterility

non-sterile

sterilization compatibility

autoclavable compatible

product line

Opticap® XL 10

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

≤13.3 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water), 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward), 1.0 bar max. inlet pressure (15 psi) at 80 °C, 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 25 °C, 80 psig max. inlet pressure, 80 °C max. temp.

technique(s)

sterile filtration: suitable

L

33.5 cm (13.2 in.)

W

4.2 in.

cartridge nominal length

10 in. (25 cm)

diam.

10.7 cm (4.2 in.)

filtration area

0.69 m2

inlet connection diam.

9/16 in.

outlet connection diam.

9/16 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

≤50 mg/capsule

matrix

Multimedia Durapore®

pore size

0.5/0.22 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, (14 mm (9/16 in.) Hose Barb Inlet and Outlet)

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General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

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.
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥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.

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

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.

Storage Class

4.1B - Flammable solid hazardous materials

wgk

WGK 3

Certificates of Analysis (COA)

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Global Trade Item Number

SKUGTIN
KV06A10HH104053252352980

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