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KVVLG04TH3

Millipore

Durapore® 0.1 µm, Opticap® XL Capsule

Opticap® XL 4, inlet connection diam. 1.5 in., cartridge nominal length 4 in. (10 cm)

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Synonym(s):
Opticap Gamma Compatible Sterilizing Grade XL4 Durapore 0.1 μm 1-1/2 in. TC-9/16 in. HB
UNSPSC Code:
23151806

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

400

reg. compliance

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

sterility

irradiated
non-sterile

Sterilization Compatibility

gamma compatible

product line

Opticap® XL 4

feature

gamma compatible
hydrophilic

manufacturer/tradename

Opticap®

parameter

≤5.7 mL/min air diffusion at 3.9 bar (56 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
2.8 bar max. differential pressure (40 psid) at 25 °C (Reverse; intermittent)
2.8 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
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

L

7.7 in.

W

3.3 in.

cartridge nominal length

4 in. (10 cm)

diam.

6.1 cm (2.4 in.)

filtration area

0.18 m2

inlet connection diam.

1.5 in.

outlet connection diam.

9/16 in.

impurities

≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

matrix

Durapore®

pore size

0.1 μm

input

sample type liquid

bubble point

≥4830 mbar (70 psig), air with water at 23 °C

fitting

1/4 in. drain/vent 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)

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.

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.
TOC/Conductivity
After sterilization and a controlled water flush, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 ºC.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL

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.

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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