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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

别名:

Opticap XLT 30 CapsuleMedia: Millipore Express SHR w/Prefilter High Area 0.5 / 0.1 µm

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UNSPSC Code:
23151806

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产品名称

Millipore Express® SHRP High Area, Opticap® XLT Capsule, Chemistry: Hydrophilic Polyethersulfone (PES)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 1 in. Hose BarbT-lineMax Operating Pressure: 80 psi @ 25 °C, Opticap® XLT 30, cartridge nominal length 30 in. (75 cm), filter diam. 4.2 in. (10.7 cm)

fitting

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

application(s)

filtration

material

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

reg. compliance

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

Quality Level

400

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

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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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