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KPGEG03HH3

Millipore

Millipore Express® PHF, Opticap® XL Capsule

Opticap® XL 3, inlet connection diam. 9/16 in., cartridge nominal length 3 in. (7.5 cm)

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Synonym(s):
Opticap XL 3 Millipore Express PHF Gamma Compatible 0.2 μm 9/16 in. HB/HB

material

polyester support
polyethersulfone
polypropylene (gamma-stable)
polypropylene housing
polypropylene vent cap
polysulfone
silicone seal

Quality Level

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 3

feature

gamma compatible
hydrophilic

manufacturer/tradename

Millipore Express®

parameter

≤9.5 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C (in water)
1.0 bar max. inlet pressure (15 psi) at 80 °C
1000 bar max. differential pressure (15 psi) at 80 °C
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
5.5 bar max. inlet pressure (80 psi) at 25 °C
5500 mbar max. differential pressure (80 psi) at 25 °C
80 psig max. inlet pressure

technique(s)

bioburden reduction: suitable

L

17.3 cm (6.8 in.)

W

4.2 in.

cartridge nominal length

3 in. (7.5 cm)

diam.

10.7 cm (4.2 in.)

filtration area

0.17 m2

inlet connection diam.

9/16 in.

inlet to outlet W

17.3 cm (6.8 in.)

outlet connection diam.

9/16 in.

impurities

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

matrix

Millipore Express® PHF

pore size

0.2 μm

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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KPGEG03TB3KPGEG03TH3KPGEA03TT3
sterility

irradiated, non-sterile

sterility

irradiated, non-sterile

sterility

irradiated, non-sterile

sterility

non-sterile

product line

Opticap® XL 3

product line

Opticap® XL 3

product line

Opticap® XL 3

product line

Opticap® XL 3

feature

gamma compatible, hydrophilic

feature

gamma compatible, hydrophilic

feature

gamma compatible, hydrophilic

feature

hydrophilic

technique(s)

bioburden reduction: suitable

technique(s)

bioburden reduction: suitable

technique(s)

bioburden reduction: suitable

technique(s)

bioburden reduction: suitable

filtration area

0.17 m2

filtration area

0.17 m2

filtration area

0.17 m2

filtration area

0.16 m2

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 of Filters with MILLIPORE EXPRESS® Membrane user guide
  • Storage Statement: Please refer Filters with MILLIPORE EXPRESS® Membrane user guide
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
This product was manufactured with a Millipore Express® 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 of membrane used in this filter 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 of 3.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
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
MILLIPORE EXPRESS 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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