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Merck
CN

KVGLA02NN3

Durapore® 0.22 µm，Opticap® XL囊式

Opticap® XL, inlet connection diam. 1/4 in.

别名:

Opticap XL2 Durapore 0.22 μm 1/4 in. NPT/NPT

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UNSPSC Code:
23151806

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产品名称

Durapore® 0.22 µm，Opticap® XL囊式, Opticap® XL, inlet connection diam. 1/4 in.

material

PVDF membrane
polypropylene housing
polypropylene support
polypropylene vent cap
silicone O-ring
silicone seal

reg. compliance

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

sterility

non-sterile

sterilization compatibility

autoclavable compatible

product line

Opticap® XL

feature

hydrophilic

manufacturer/tradename

Durapore®

parameter

1.0 bar max. differential pressure (15 psid) at 80 °C (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 °C
3.4 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

technique(s)

sterile filtration: suitable

L

2 in. (5.0 cm)

filtration area

0.09 m2

inlet connection diam.

1/4 in.

inlet to outlet W

12.7 cm (5.0 in.)

outlet connection diam.

1/4 in.

impurities

<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

gravimetric extractables

≤10 mg/capsule

matrix

Durapore®

pore size

0.22 μm

input

sample type liquid

bubble point

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

fitting

6 mm (1/4 in.) NPT (Inlet)
6 mm (1/4 in.) NPT (Outlet)

Quality Level

400

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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 ≥500 mL

General description

Device Configuration: 取样皿滤膜

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.

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.

Replaces: KVGL04HB3
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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).

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

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