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Merck
CN

KHVEG3TTB1H

Millipore Express® SHR High Area with prefilter 0.5/0.1µm, Opticap® XLT 30 Capsule

Fittings 1-1/2 in. TC- 1 in. HB, Gamma Compatible

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UNSPSC Code:
23151806

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产品名称

Millipore Express® SHRP High Area, Opticap® XLT Capsule, Opticap® XLT 30, cartridge nominal length 30 in. (75 cm), filter diam. 4.2 in. (10.7 cm)

material

polyester support, polypropylene housing, silicone seal, vent cap (gamma stable polypropylene)

reg. compliance

meets FDA 21 CFR 177-182 (all component materials)

sterility

non-sterile

sterilization compatibility

gamma compatible

product line

Opticap® XLT 30

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

≤162.6 mL/min air diffusion at 3.45 bar (50 psig) (in water), 0.07 bar max. differential pressure (1 psi) at 135 °C (Reverse), 1 bar max. differential pressure (15 psid) at 80 °C (Forward), 1.0 bar max. inlet pressure (15 psi) at 80 °C, 2.07 bar max. differential pressure (30 psi) at 25 °C (Reverse), 2.75 bar max. inlet pressure (40 psi) at 60 °C, 25 °C max. inlet pressure, 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward), 5.5 bar max. inlet pressure (80 psi) at 25 °C, 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent), 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent), 80 psig max. inlet pressure

technique(s)

sterile filtration: suitable

L

34.3 in.

W

7.8 in.

cartridge nominal length

30 in. (75 cm)

filter diam.

4.2 in. (10.7 cm)

filter size

30 in.

filtration area

3.0 m2

impurities

≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction)

matrix

Millipore Express® SHR ((w/Prefilter High Area))

pore size

0.5/0.1 μm pore size

bubble point

≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water

fitting

1/4 in. drain/vent connection ( hose barb with double o-ring seal), (38 mm (1 1/2 in.) Sanitary Flange Inlet and 25 mm (1 in.) Hose Barb Outlet)

application(s)

filtration

Quality Level

400

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General description

Device Configuration: Capsule

Features and Benefits

T-line/Gauge Port: T-line

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method: Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min at 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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥6 L

TOC/Conductivity: After sterilization and a controlled water flush of 60 L, samples exhibited <500 ppb TOC per USP 643 and <1.3 μS/cm per USP 645 at 25 °C.

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 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.

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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