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Merck

KVVLG10HH1

Millipore

Durapore® 0.1 µm, Opticap® XL Capsule

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

Synonym(s):

Opticap Gamma Compatible Sterilizing Grade XL10 Durapore 0.1 μm Gamma Compatible 9/16 in. HB/HB

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About This Item

UNSPSC Code:
23151806

Pricing and availability is not currently available.

material

PVDF
polyester support
polyethylene support
polypropylene (gamma-stable)
polypropylene housing
polypropylene vent cap
silicone outer O-ring
silicone-coated EPDM rubber lead O-ring

Quality Level

reg. compliance

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

sterility

non-sterile

Sterilization Compatibility

gamma compatible

product line

Opticap® XL 10

feature

gamma compatible
hydrophilic

manufacturer/tradename

Opticap®

parameter

≤21.1 mL/min air diffusion at 3.9 bar (56 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

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This Item
H3393H5515H4784
solubility

water: soluble 50 g/L, alcohol: insoluble, chloroform: insoluble, acetone: insoluble, diethyl ether: insoluble, benzene: insoluble

solubility

H2O: 50 mg/mL, clear, colorless to faintly yellow

solubility

H2O: 50 mg/mL, clear, colorless to faintly yellow

solubility

H2O: 50 mg/mL, clear, colorless to faintly yellow

Quality Level

200

Quality Level

200

Quality Level

200

Quality Level

200

form

powder

form

powder

form

powder

form

powder

storage temp.

room temp

storage temp.

room temp

storage temp.

room temp

storage temp.

2-8°C

impurities

endotoxin, free

impurities

-

impurities

-

impurities

-

General description

Device Configuration: Capsule

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.

Linkage

Replaces: KVVL01HB1

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; 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 ≥1 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.

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