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Merck
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KPGEG2TBB1

Millipore Express® PHF 0.2µm, Opticap® XLT 20 Capsule

Fittings 1 in. HB/HB, Gamma Compatible

别名:

Millipore Express® PHF, Opticap® XLT 囊式

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UNSPSC Code:
23151806

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产品名称

Opticap XLT 20 Millipore Express PHF 可γ辐照 0.2 µm 1 in.HB/HB, inlet connection diam. 1 in., Opticap® XLT 20, cartridge nominal length 20 in. (50 cm)

material

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

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® XLT 20

feature

gamma compatible
hydrophilic

manufacturer/tradename

Millipore Express®

parameter

≤65.5 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

62.5 cm (24.6 in.)

W

7.8 in.

cartridge nominal length

20 in. (50 cm)

diam.

10.7 cm (4.2 in.)

filtration area

1.14 m2

inlet connection diam.

1 in.

inlet to outlet W

19.8 cm (7.8 in.)

outlet connection diam.

1 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
 (25 mm (1 in.) Hose Barb Inlet and Outlet)

Quality Level

400

相关类别

General description

Device Configuration: 取样皿滤膜
T-line/Gauge Port: T-line

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 22 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 ≥3 L

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 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.

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

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
Gamma compatible to 40 kGy; 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).

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

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