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KVGBA04TT3

Hydrophobic Durapore® 0.22 µm, Opticap® XL Capsule

pore size 0.22 μm, Opticap® XL 4

Synonym(s):

Durapore® Capsule Filter 4 in. 0.22 µm, Hydrophobic Durapore® 0.22 µm, Opticap® XL Capsule

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About This Item

eCl@ss:
32031690
UNSPSC Code:
23151806
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Product Name

Opticap® XL 4 CapsuleMedia: Durapore® 0.22 µm, Chemistry: Hydrophobic Polyvinylidene Fluoride (PVDF)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 1-1/2 in. Sanitary FlangeMax Operating Pressure: 80 psi @ 25 °C

material

PVDF

Quality Segment

400

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 4

feature

hydrophobic

manufacturer/tradename

Durapore®

parameter

25 °C max. inlet temp., 80 psig max. inlet pressure

technique(s)

sterile filtration: suitable

inlet connection diam.

1.5 in.

outlet connection diam.

1.5 in.

size

4 in.

impurities

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

matrix

Durapore®

pore size

0.22 μm pore size

fitting

(38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

General description

Device Configuration: Capsule

Preparation Note

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.

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 installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules 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.

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Certificates of Analysis (COA)

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